# Petition — Rexall Drug Co. v. Sindell > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385007_0192%3A1 ## Record - **Collection:** Supreme Court brief - **Document type:** Petition - **Published:** January 1, 1980 - **Citation:** 449 U.S. 912 ## Text | Supreme Court, U. S. FILED AUG 5 1980 MICHAEL 'f 80-170 IN THE Supreme Court of the United States October Term, 1980 No. REXALL DRUG COMPANY and ELI LILLY AND COMPANY, Petitioners, VS. JUDITH SINDELL, et al., Respondents. REXALL DRUG COMPANY, Petitioner, VS. MAUREEN ROGERS, ef al., Respondents. PETITION FOR A WRIT OF CERTIORARI TO THE SUPREME COURT OF THE STATE OF CALIFORNIA ADAMS, DUQUE & HAZELTINE CROSBY, HEAFEY, ROACH & May RICHARD C. FIELD Profession Corporation DAvID L. BACON RICHARD J. HEAFEY 523 West Sixth Street PETER W. DAVIS Los Angeles, California 90014 1939 Harrison Street Oakland, California 94612 WINTHROP, STIMSON, PUTNAM & ROBERTS Attorneys for Petitioner A. EDWARD GRASHOF Eli Lilly and Company THEODORE S. STEINGUT 40 Wall Street New York, New York 10005 Attorneys for Petitioner Rexall Drug Company IN THE Supreme Court of the United States October Term, 1980 No. REXALL DRUG COMPANY and ELI LILLY AND COMPANY, Petitioners, VS. JUDITH SINDELL, ¢ al., Respondents. REXALL DRUG COMPANY, Petitioner, VS. MAUREEN ROGERS, et al., Respondents. PETITION FOR A WRIT OF CERTIORARI TO THE SUPREME COURT OF THE STATE OF CALIFORNIA The petitioners Rexall Drug Company (“Rexall”) and Eli Lilly and Company (“Lilly”) respectfully pray that a Writ of Certiorari issue to review the judgment and opinion of the Supreme Court of the State of California entered in these proceedings on March 20, 1980. QUESTIONS PRESENTED 1. Whether due process of law or equal protection of the laws is violated where plaintiffs who cannot prove which manufacturer’s product allegedly caused their injury are permitted to recover from a random selection of all manu- facturers making a similar product? il 2. Whether due process of law and equal protection of the laws are violated by a state court decision which pre- cludes a class of defendants from the right to a fair hearing on the question of whether any of the defendants manufac- tured the alleged injury-causing product? 3. Whether the commerce or supremacy clauses are violated by state action which frustrates, impedes and erodes federal policies encouraging the manufacturing and distribution of generic drugs? PARTIES TO THE PROCEEDINGS BELOW Defendants and respondents in Judith Sindell v. Abbott Laboratories, et al. were Abbott Laboratories, Lilly, E. R. Squibb & Sons, Inc., The Upjohn Company and Rexall. In Matreen Rogers v. Rexall Drug Company, et al., defendants and respondents were E. R. Squibb & Sons, Inc., The Upjohn Company and Rexall. ili TABLE OF CONTENTS Opinions Below ........sse ddnasdsnegonosebenbedebabhaohshanbibesess IIIS. iceinssacsitcssaccisdcecestonsapsetsa soehuconmsetiapnnlasiatoagh itis Constitutional Provisions Involved oc. .eeeeeeseeeeees Statement of the Case ........... saisdadivavenesnaboeovensiinnea koubepnek Bi BIRR OION 5osideecicisicaicitibicaccapuantenligthpispentossonie b. © The DES Comtroverey. accocrsicesscorsnccosssesveeteess ce. Prior Raising of Federal Issues ................. Reasons for Granting the Wit .........ccssssssssessseeeees 1. The Jurisdiction of This Court Is Properly ROW. sijasonvecssitsesessrevethcinesacssulibtcepalabatinianins 2. The Judgment Below Violates Procedural Due Process and Denies Equal Protection of the Laws by Creating Irrational, Un- workable and Unfair Procedural Devices to Do Away With Proof of Causation Linking A Defendant to the Product Allegedly CONES TI. is cvicsscssivcanpantgessvesentnncsioauniniios 3. The Judgment Below Is Preempted by the Supremacy Clause Because It Frustrates Federal Policy Governing the Develop- ment and Marketing of Prescription Drugs, and In Particular the Marketing of Drugs on a Generic Basis, and Creates an Invalid Burden on Interstate Commerce a ee GAGA RAT GTOET ROMP MRP OL Py MAN PAGE NI N on SO FF fF fH 21 iv Appendix A. Opinion of the Supreme Court of the State of California Appendix B. Eli Lilly and Company’s Petition for Re- hearing to the Supreme Court of the State of California Appendix C. Rexall Drug Company’s Joinder in Eli Lilly and Company’s Petition for Rehearing to the Supreme Court of the State of California Appendix D. Order of the Supreme Court of the State of California Denying Rehearing Vv TABLE OF CASES, STATUTES AND OTHER AUTHORITIES Cases Abel v. Eli Lilly and Co., Action No. 74-030-070NP Filed in the Wayne County Circuit Court, Detroit, Michigan, appeal pending to the Supreme Court of DESOTO | yicceseniniansesecsecesvnvenenciancenevisasiahtiegiemiataibaaadeinioah American Motorcycle Ass’n v. Superior Court, 20 Cal. 3d STG, GIS PBR GEO (RCTB). .cccinceineesticdiensnienntetsitins American Railway Exp. Co. v. Kentucky, 273 U.S. 269 CAGIRT ) sccocssocescopescasscneasnsesnstisbincanutibaaapianasditeealpnianltmiatc Armstrong v. Manzo, 380 U.S. 545, 552 (1965) ............ Baker v. Coca Cola Bottling Works of Gary, 132 Ind. App. Y Bae & & Fe. | peemcmununcsmmn an Bell v. Burson, 402 U.S. 535 (1971) w.ccccccsscecsseeeseeeeseees Judy K. Benny v. Abbott Laboratories, et al., Alameda Superior Court Case No. 525322-5 oc cssssseesseseeeees Bibb v. Navajo Freight Lines, Inc., 359 U.S. 520 (1959) Brinkerhoff-Farris Trust & Sav. Co. v. Hill, 281 U.S. 673, CF CIID) csisesincsscsiinnstansbletasitiatatiisinitcnmmimindatiameiiiaa Cindy Bocian v. Abbott Laboratories, et al., San Francisco Superior Court Case No. 760532 ........cscssscsssssssseeeees Carrington v. Rash, 380 U.S. 89 (1965) w..ccceceeseeecees Connolly v. Union Service Pipe Co., 184 U.S. 540 (1902) Cox Broadcasting Corp. v. Cohn, 420 U.S. 469 (1975) Cleveland Board of Education v. LaFleur, 414 U.S. 632, BOE (EDTA) crersecesrsessssscencercersncssssainaivsintettantmontsadenenstonsontal Dawson Chem. Co. v. Rohm & Haas Co., 40 CCH S&S. Ct. Bull. p. B3850, BS896 (1980) .....cccccsccsrcscseccessecsseseeees Diamond v. Chakrabarty, 40 CCH 8S. Ct. Bull. p. B3122, a A RARE EMS AMEN SNIOE NT PAGE 13 12 8 8 8 vi DiSanto v. Pennsylvania, 273 U.S. 34, 43-44 (1927) IE, Ws) GIN epnecsrectnediesinvicstrinnecnstantdstesavitanaveds Duke Power Co. v. Carolina Env. Study Group, 438 U.S. PP IPD: ssiccuidibieusondciaphogansseithanhellicseos dhasatiebenelapebiisinesens Dunn v. Blumstein, 405 U.S. 330, 349-352 (1971) ....... Farmers Union v. WDAY, Inc., 360 U.S. 525 (1959) .. Ford Motor Co. v. United States, 405 U.S. 562 (1972) Giaccio v. Pennsylvania, 382 U.S. 397, 403 (1966) ..... Goldberg v. Kelly, 397 U.S. 254 (1970) wvceccccscseeeseees Great Atlantic & Pacific Tea Co., Inc. v. Cottrell, 424 U.S. Ne Be IN sesisastcnnaacbecapssctinsisdaneselehinciioenencbcwedianabanneenadins Great A. & P. Tea Co. v. Supermarkei Equip. Corp., 340 U.S. 147, 154 (1950) (Concurring Opinion) ........0 Herndon v. Georgia, 295 U.S. 441, 443-44 (1935) ........ Hettinger v. Glass Specialty Co., 59 F.R.D. 286, 294 Siete Ms NUN whic snc.asdccnaascceedioiseaaatndeeeibcrievoobiansitetsas Jenkins v. McKeithen, 395 U.S. 411, 429 (1969) ........... Lyons v. Premo Pharmaceutical Labs, Inc., 170 Nw. Super. 183, cert. dented, 82 N.J. 267 (1969) ............. McCulloch v. Maryiand, 17 U.S. (4 Wheat.) 316 (1819) McCreery v. Eli Lilly & Co., 87 Cal. App. 3d 77, 89, 150 Cal, HEpte, TOD CEOTS) cccccscsnnscsorsscsscsscsscccessssoceseboccsacsons Mercantile National Bank v. Langdeau, 371 U.S. 555, 558 SREY “puitiGiiastteicseenibedavesidacaciac tas iekiieaaneniasiineestakedesbibies Moore v. East Cleveland, 431 U.S. 494, 502 (1977) ...... NAACP v. Alabama, 377 U.S. 288, 380 (1964) ............ Perez v. Campbell, 402 U.S. 637, 652 (1971) 0.0.0.0... Picker X-Ray Corp. v. Frerker, 405 F.2d 916 (8th Cir. EPL Vacca TSR Ts NS Pike v. Bruce Church, Inc., 397 U.S. 187 (1970) .......... Prudential Ins. Co. v. Cheeck, 359 U.S. 530 (1922) ..... PAGE Vii Raymond Motor Transportation, Inc. v. Rice, 434 U.S. 429 CUNARD Neldsibcuy senbiiashesiisdlesctseapdsecbeseaptasvensbionvaySeupilainivediotiam Reed v. Reed, 404 U.S. 71 (1971) weccececscsscssseseeeseessees Rees v. Watertown, 86 U.S. (19 Wall.) 107, 122 (1873) Reiter v. Sonotone Corp., 579 F.2d 1077, 1086 (8th Cir. 1978), rev’d, 442 U.S. 330 (1979) cecccccsssssssssseeseesseee Rekasie v. Bucyrus-Erie Co., 262 F.2d 804 (3d Cir. 1959) San Diego Bldg. Trades Council v. Garmon, 359 U.S. 236 CRUIIUED cocevsipnisnsochindinpnsobalicceaianidenlbachiondacaedditada taille is Saunders v. Shaw, 244 U.S. 317 (1917) cece eeeseeees Sears, Roebuck & Co. v. Stiffel Co., 376 U.S. 225 (1964) Shapiro v. Thompson, 394 U.S. 618 (1969) woe Smith v. Cahoon, 283 U.S. 553 (1981) ween Sola Elec. Co. v. Jefferson Elec. Co., 317 U.S. 173 (1943) Stanley v. Illinois, 405 U.S. 645, 648, 656 (1972) ....... Thompson-Hayward Chemical Co. v. Childress, 277 Ala. Ri UTI GD: CEOUOD snosccsesscciesckactdensineidinanndpatvessen Carol Trevallee v. Abbott Laboratories, et al., San Francis- co Superior Court Case No. 721204 ......cceseseseseseeees Vlandis v. Kline, 412 U.S. 441, 446 (1973) oo... cesses Weinberger V. Hynson, Wescott & Dunning, 412 U.S. 609, 612-614, 37 L.Ed2d 207 (1978) ........scscccsesscsrsesreeecees Wetzel v. Eaton Corp., 62 F.R.D. 22, 28 (D. Minn. 1973) Wolff v. McDonnell, 418 U.S. 539, 558 (1974) Constitutional Provisions Constitution of the United States, Article I, Section 89, CARIES icnincedssycutnenvcintadeaadicdeeecpaadianiaaimaieans Constitution of the United States, Article VI, Clause 2 Constitution of the United States, Fourteenth Amend- I, TMI Fh sesecesccennssestecncassanutatnes BRINE SS OR 18, viii PAGE Statutes California Businesses and Professions Code, Section CEE LD - vicicxitchinissnesvipteistnorivisnsssviersiteneivileataanisiaantbmniniii 21 California Welfare and Institutions Code, Sections 14000, et seg., and Sections 11152 and 11153.7 ......... 17 Ue ae ees OF OEE ac-.sanssentorstemanesdicngiealignaniiials 24 Be A Te OID ccicinsepicisisitipadelasmnchiinsadiMlncthaauiaiaiiiat 23 Ge eS lg 5 RS rer tence eae en 4 i: Ay a Bh SLD seinsnsiicnnsishaprtestieenacainidasheenaduagummeliaaials 5 Sa RAAB BUD pcksisrsasesocchinioniecbonsineinieicianadeininaeiat 5 Fk Sei Me IED cshcvcelsnnsiercanttsasabvavsseacniabusenataiemmaaiatal 4 SOD Pe BRUIT COD -cnctcserssnvasscittisseinersmiienbthantiinice Cala ee Other Authorities Brand Names and Generic Drugs, 1974, Hearings Before Subcommittee on Labor and Public Weifare, 93d Congress 2d Sess. (July 22, 1974) .o.ceeseseseesseeees 21 Coggins, Indusiry-Wide Liability, 13 Suffolk L. Rev. Sh DD CODER D: sccncicecicesvetpetveeesicbabenscialil 15, 23 Commerce Department, /nteragency Task Force on Prod- uct Liability: Final Report of the Insurance Study, Vol- ume 1 at 2-4, 2-5 (January 1977) wccecceccseseeseeeees 15, 16 Grabowski, Drug Regulation and Innovation: Empirical - Evidence and Policy Options (1976) ..cccccsccssssesseneencees 23 Hearings Before the Subcommittee on Health of the Com- mittee on Labor and Public Welfare, 94th Congress, p. ee gy 5 I ee ee 23 Herbst, Cole, Colton, Robboy and Scully, Age-Incidence and Risk of Diethylstilbestrol-Related Clear Cell Adeno- carcinoma of the Vagina and Cervix, 128 Am. J. Obst. RIN, TR CNS F ails titenascenscasantsbnioieeiccecseciiemncecaienainas 5 ix Herbst, Cole, Norusis, Welch and Scully, Epidemiolog- ic Aspects and Factors Related to Survival in 384 Regis- try Cases of Clear Cell Adenocarcinoma of the Vagina and Cervix, 135 Am. J. Obstet. Gynecol. 876 (1979) Herbst, Ulfedler and Poskanzer, Adenocarcinoma of the Vagina, 284 N. Eng. J. Med. 878 (1971) ween 1 Hursh & Bailey, American Law of Products Liability IE LOUIE, € ROTTED -chsnsseaisdinirslivabionssesennieniserinenpibooes Kinsley, Fate and Lawsuits, 182 The New Republic, 20, SN RNIN TU: RIED "ai. udcnssiptisnncnciingmminibinaibcsatmaghsiadisbonthdnenes Maximum Allowable Costs for Drugs, Office of the Secre- tary, Department of Heaith, Education and Welfare RE EEE, RED civarpssshecsssvnsiehissioonipinecsonmnienttnenipiblanngen Peltzman, Regulation of Pharmaceutical Innovation; The 1962 Amendments 1-3 (1974) w.ccccccccsccsssesssesseeeeeeseenes Annotation, Products Liability: Necessity & Sufficiency of Identification of Defendant as Manufacturer or Seller of Product Alleged to Have Caused Injury, 51 A.L.R.3d ESE SITE saris as acti beseiakenepeabimeadanevaimeiicnslioes Prosser, Handbook of the Law of Torts, 661 (4th Ed. rae ali crsnsensamtvaatenheovmuseessntanidiiajenietes Prosser, Res Ipsa Loquitur, a Reply to Professor Carpen- ter, 10 So. Calif. L. Rev. 459, 464 (1987) wo. Prosser, The Law of Torts, § 41 at 236 (4th Ed. 1971) Schwartzman, The Expected Return from Pharmaceutical Ey EINE Merete So WSO Oe George & Olive Smith, Prophylactic Hormone Therapy Relation to Complications of Pregnacy, 4 Obst. & Gyn. IIIT i iiinseia tdasnjaiabisiabacindpetonenenibienniin ibeauddhanniipeceiohistes Olive Smith, Diethylstilbestrol in the Prevention and Treatment of Complications of Pregnancy, 56 Am. J. IS SER BIDE D - scniccnsrsvectecnanapiinddolabshaninsousssee Source Book of Health Insurance Data, 1976-77, p. 21 .. White, P., Pregnancy Complicating Diabetes, J.A.M.A. EE IEE akc iietisk sh ds nlsiecthinsspiese posneiiebibdeiildpsabediethecsions PAGE 22 23 PAGE White, P., Pregnancy Complicating Diabetes, Amer. J. EE, hs PE CITI. scenudessinnelanieetelaiissdnacniinnbhreetiauidesoss 4 White, P., Pregnancy Complicating Diabetes, The Treat- ment of Diabetes Mellitus, 9th Edition, Philadelphia, BI OE CRE) wiccsscctcovesccscncescannsonspbhedavicuyeatiioade 4 OPINIONS BELOW The opinion of the Supreme Court of the State of Califor- nia, 26 Cal. 3d 588, 607 P.2d 924 (1980), is set forth in Appendix A hereto. JURISDICTION The judgment of the Supreme Court of the State of Cali- fornia was entered on March 20, 1980. Timely petitions for rehearing were denied on May 7, 1980, and this Petition for Certiorari was filed within 90 days of that date. This Court’s jurisdiction is invoked under 28 U.S.C. § 1257(3). CONSTITUTIONAL PROVISIONS INVOLVED Constitution of the United States, Article I, Section 8, Clause 3: “(The Congress shall have Power] To regulate Commerce with foreign Nations, and among the sev- eral States, and with the [ndian Tribes;” Constitution of the United States, Article VI, Clause 2: “This Constitution, and the Laws of the United States which shall be made in Pursuance Thereof; and all Treaties made, or which shall be made, under the Authority of the United States, shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any state to the Con- trary notwithstanding.” Constitution of the United States, Fourteenth Amend- ment, Section 1: “All persons born or naturalized in the United States, and subject to the jurisdiction thereof, are citizens of the United States and of the State wherein they reside. No State shall make or enforce any law which shall abridge the privileges or immunities of citizens of the United States; nor shall any State deprive any person of life, liberty, or property, without due process of law; nor deny to any person within its jurisdiction the equal protec- tion of the laws.” 2 STATEMENT OF THE CASE a. Introduction The California Supreme Court has imposed liability upon manufacturers of products who caused plaintiffs no injury. That Court has adopted what it itself concedes to be a novel and revolutionary theory of common law product liability in tort not raised by any party in any pleading, brief or argument at any stage of the litigation. The Court acknowledges that its new theory of liability finds no basis in, and indeed is contrary to, precedent from its own jurisdiction or any other common law jurisdiction. The Court holds that, in product liability actions involving thousands of claimants who bring suit against only a few of the more than 200 manufacturers making an identical and fungible product, those claimants need not establish the identity of the specific manufacturer whose product alleg- edly caused the injury. Indeed, the Court rules that a plaintiff need only join a sufficient, albeit quantitatively insignificant, number of such manufacturers so that in the aggregate they comprise a “substantial share” of the mar- ket for the product. Then plaintiff may recover, says the Court, against the group of defendants singled out for suit even though the injury may have been, and probably was, caused by a product they did not make and even though the group selected may represent less than 50% of the market. Thus, the judgment exposes each manufacturer offering identical and fungible products in a multi-source market to a random and potentially devastating liability for injuries it did not cause and over which it has absolutely no control. The judgment will erect major barriers to generic product marketing, to product research and development and to the freedom of market entry, and it will diminish the availabil- ity and increase the price of essential products flowing in interstate commerce — all in violation of federal policies designed to encourage such results. Sindell and Rogers are both products liability suits by women alleging injuries to their genital tracts as a result of in utero exposure over 20 years ago to diethylstilbestre: (“DES”), a synthetic estrogen prescribed to their mothers to prevent miscarriage or spontaneous abortion. Sinde!l alleges that she is unable to identify which manufacturer of DES produced the drug taken by her mother; Rogers 3 alleges that Lilly manufacturered the drug taken by her mother. Plaintiffs seek to impose strict liability in tort against a total of five defendants, including Rexall and Lilly, out of over 200 pharmaceutical companies which manufactured DES for sale in the United States. (App. A, p. 21). b. The DES Controversy’ Estrogen is a hormone produced naturally by the female human body. It is vital for sexual development and fertil- ity, plays a significant role during pregnancy, and has other functions, some of which are still not fully under- stood by medical science. After estrogens were isolated in the 1920s, numerous investigations were conducted to dis- cover their effects and functions. One of the most promi- nent series of studies was conducted by Dr. George Smith, who taught gynecology at the Harvard Medical School and later became head of that department. Dr. Smith’s early hormone research in the 1930s indi- cated that premature pregnancy terminations were asso- ciated with low progesterone levels, a condition which could be improved by the administration of estrogen. His research was hampered, however, because natural estrogen was difficult to administer and prohibitively expensive. Thus, when the synthetic estrogen called Diethylstilbestrol (DES) was created in 1938 by the English doctor E. C. Dodds, scientists who were conducting research with estro- gens believed a significant medical advance had been made. DES could be administered orally, was inexpensive and duplicated the action of natural estrogen. DES was not, however, immediately sold for use in treat- ing accidents of pregnancy. FDA approval for that use * The Sindell opinion quotes extensively from the unproven and disputed allegations of the complaint. See, for example, the factual dis- cussions in the dissenting opinion of the Court below and in Lyons v. Premo Pharmaceutical Labs, Inc., 170 N.J. Super. 183, cert. denied, 82 N.J. 267 (1969), McCreery v. Eli Lilly & Co., 87 Cal. App. 3d 77, 89, 150 Cal. Rptr. 730 (1978). 4 would not come until 1947, following nine years of further research and testing.* Dr. Smith’s clinical trials with DES in high risk pregnancies included 117 doctors in 48 cities. He con- cluded that untreated high-risk pregnancies ran twice the risk of mishap as those treated with DES.** This research was entirely independent of any pharmaceutical manufacturer. By 1952, DES was considered to be so safe that the FDA declared that it was no longer a “new drug” within the meaning of 21 U.S.C. Section 355(a). (CT 205)*** This classification allowed any manufacturer to market that drug without performing additional testing or submitting additional data to the FDA on the drug’s safety, thus avoid- ing all research and development costs. (CT 205) There- after, at least 191 companies produced DES. (CT 206) In 1971, following 30 years of use of DES for various purposes, medical studies suggested for the first time that there might be a statistical correlation between the use of * Indeed, DES was not sold for any purpose in this country until 1941, after the FDA had independently conducted an exhaustive inves- tigation of the drug’s safety. (CT 204-205) The designation “CT” refers to the Clarks transcript of the record in Sindell in the court below. ** For a recapitulation of Dr. Smith’s work, see George and Olive Smith, Prophylactic Hormone Therapy Relation to Complications of Preg- nancy, 4 Obst. & Gyn. 129 (1954), and Olive Smith, Diethylstilbestrol In The Prevention and Treatment of Complications of Pregnancy, 56 Am. J. Obst. & Gyn. 821 (1948). Dr. Smith’s results were duplicated by Dr. Priscilla White between 1938 and 1952. She found that high risk pregnancies treated with DES resulted in almost double the number of live babies as in the untreated group. Dr. White was also able to examine the offspring of many of these DES-treated women. She found no abnormalities like those the drug is accused of causing today. (White, P., Pregnancy Complicating Diabetes, J.A.M.A., 128, 181, 1945; White, P., Pregnancy Complicating Diabetes, Amer. J. Med. 7, 609, 1949; White, P., Pregnancy Complicating Diabetes, The Treatment of Diabetes Mellitus, 9th Edition, Philadelphia, Lea & Febiger, 1952.) *** The term “NOT A NEW DRUG” means that the composition of the drug is such that it is generally recognized among experts qualified by scientific training and experience to evaluate the safety of drugs to be safe for use under the conditions prescribed. 21 U.S.C. § 321 (p)(1). See, Weinberger v. Hynson, Wescott & Dunning, 412 U.S. 609, 612-614, 37 L. Ed. 2d 207 (1973). 5 the drug and a rare form of cancer (clear cell adenocarci- noma) in the daughters of women who had taken synthetic estrogen during pregnancy.* (CT 207) The correlation has been estimated to range between 0.14 to 1.4 per thou- sand daughters exposed to the product.**The cancer also occurs spontaneously in nature; its cause or causes are unknown.*** Consequently, it is not possible to attribute a specific person’s injury to DES exposure. Because of these medical reports, the FDA deterr-‘ined in 1971 that DES should no longer be indicated for use during pregnancy although it is still used today foy other purposes. The formula for DES is a scientific constant. All manu- facturers producing the drug are required to employ the same formula for DES set forth in the United States Pharmacopoeia, a standard compendium to establish the _ chemical identity of such products. (21 U.S.C. § 351(b)). Manufacturers are also required to employ the same description of the drug on labels or bottles containing it. (21 U.S.C. § 352(e)). DES was therefore distributed as a classie generic drug. The delay between the time of ingestion of the drug and the time litigation is instituted has led to the threshold issue in this litigation-whether manufacturer identifica- tion should be zequired. Separated from consumers by at least two levels of distribution, the defendants have no mean: of ascertaining the identity of the manufacturer whose product was ingested by a particular person; facts pertaining to manufacturer identification rest within plain- tiffs’ control if available at all. The plaintiffs’ mothers selected and consulted with the prescribing doctors, * Herbst, Ulfelder and Poskanzer, Adenocarcinoma of the Vagina, 284 N. Eng. J. Med. 878 (1971). ** Herbst, Cole, Norusis, Welch and Scully, Epidemiologic Aspects and Factors Related to Survival in 384 Registry Cases of Clear Cell Adenocar- cinoma of the Vagina and Cervix, 135 Am. J. Obstet. Gynecol. 876 (1979). *** Herbst, Cole, Colton, Robboy and Scully, Age-Incidence and Risk of Diethylstilbestrol-Related Clear Cell Adenocarcinoma of the Vagina and Cer- viz, 128 Am. J. Obst. Gyn. 43 (1977). 6 selected the pharmacies or hospitals from which they obtained the drug, had the opportunity to observe the drug’s color, size, coating, markings and other characteris- tics, and may have discarded the best practical evidence of identity such as pharmacy records, the container, package inserts and the drug itself. The California Supreme Court granted petitions for hear- ing by Rexall, Lilly and other defendants, thereby vacat- ing the the prior California Court of Appeal decision overruling trial court decisions that had sustained demurs to the complaints. The resulting four to three decision acknowledged that the Sindell complaint failed to state a cause of action based on any existing legal theory, but went on to create a new cause of action based on “market share” which obviated the need for manufacturer identification. melt commented that its holding would be applicable in Rogers only if plaintiff failed to establish her claim that the drug taken by her mother was manufacturered by Lilly. (App. A, p. 6) The court expressly based its decision on the belief it is more appropriate that the pharmaceutical industry, with (presumed) financial resources, should pay damages despite the lack of proof of causation than that the plain- tiffs should remain without a remedy against the industry. (App. A, p. 23) Borrowing from and modifying an idea first proposed in a student comment in the Fordham Law Review,* the court held that a plaintiff who cannot iden- tify the manufacturer of a fungible product which has caused her injury may recover the entire amount of her damages if suit is brought against manufacturers which in the aggregate produced a “substantial share” of the market. It did not define the concept of a substantial share. The court held that a defendant may overcome the artificial presumption that it caused the injury only by proving that it did not manufacture the specific product received by the * Comment, DES and a Proposed Theory of Enterprise Liability, 46 Fordham L. Rev. 963 (1978) (hereinafter “Student comment”), 7 plaintiff’s mother. A defendant lacking direct proof is barred, however, from the use of relevant statistical and market share evidence to overcome the presumption. The court permitted the defendants to attempt to file third- party complaints against other manufacturers which may be subject to the court’s jurisdiction, and to apportion liabil- ity among the defendants and cross-defendants based on respective market shares. (App. A, p. 25) c. Prior Raising of Federal Issues Because the theory of liability reached by the Court below was so revolutionary and completely unanticipated and was not raised or argued by any of the parties before the Court, the petitioners timely raised the constitutional objections pressed here in their petition for rehearing.* See Appendices B and C hereto. REASONS FOR GRANTING THE WRIT 1. THE JURISDICTION OF THIS COURT IS PROPERLY INVOKED. The California Supreme Court judgment has finally dis- posed of the federal issues involved for purposes of the state litigation and is a final judgment for purposes of 28 U.S.C. § 1257. In Cox Broadcasting Corp. v. Cohn, 420 U.S. 469 (1975), this Court reviewed four categories of cases in which it has treated state decisions on federal issues as final judgments for purposes of 28 U.S.C. § 1257 notwithstanding the pen- dency of further state proceedings. The fourth category includes those cases in which the state decision might seri- ously erode Federal policies, has finally disposed of the federal issues, and when reversal on the federal issues would preclude further litigation on the relevant cause of action. Jd. at 482-83. * Brinkerhoff-Faris Trust & Sav. Co. v. Hill, 281 U.S. 673, 678 (1929); Herndon v. Georgia, 295 U.S. 441, 443-44 (1935). 8 There can be no greater erosion of Federal policies than to compel petitioners to face long, protracted complex and expensive litigation premised on an unconstitutional the- ory of liability. Moreover, the decision below will inhibit generic distribution of pharmaceutical products in direct contravention of strong federal policies mandating and encouraging such generic distribution. In addition, the decision will erect anti-competitive barriers to entry in the pharmaceutical industry and otherwise impede socially desirable research and development efforts to invent new, life-saving products. Because of these effects, petitioners demonstrate, infra page 21 et seg., that California’s state action is preempted by the Supremacy and Commerce clauses. As this Court noted in Mercantile National Bank v. Lang- deau, 371 U.S. 555, 558 (1963), immediate review is fre- quently desirable “,. to determine now [ whether] appellants may be tried rather than to subject them ... to long and complex litigation which may all be for naught if consideration of the {federal issue] is postponed until the conclusion of the proceedings.” This Court’s immediate review of the judgment in Sindell and Rogers is essential in order to assure the fair, orderly and efficient administration of justice. Over 55 cases are pending in the federal and state courts of California where the revolutionary Sindell decision will in all likelihood be applied prior to resolution of the constitutional issues it involves. Those actions will all be for “naught” if, as Rexall and Lilly contend, the Constitution bars prosecution of the claims under the “market share” liability theory. 9 2. THE JUDGMENT BELOW VIOLATES PROCEDURAL DUE PROCESS BY CREATING IRRATIONAL, UNWORKABLE AND UNFAIR) PROCEDURAL DEVICES TO DO AWAY WITH PROOF OF CAUSA- TION LINKING A DEFENDANT TO THE PRODUCT CAUSING INJURY. The California Supreme Court judgment, by adopting a “market share” liability theory, strikes at the defendants’ fundamental right to be free from a wholly arbitrary and irrational rule of liability, and their right to fair and rational rules of procedure and evidence. The judgment violates the Fourteenth Amendment’s guarantee of due process* by substituting an unworkable and unreasonable quasi-legislative damage apportionment scheme for evi- dence of cause. The California Supreme Court decision is best under- stood in its historical context. * Although the arguments herein are devoted to showing how the decision below runs afoul of procedural due process, there is substantial reason to believe it violates substantive due process as well. Not only did the Court below create novel and untested rules governing liability for future conduct (cf. Duke Power Co. v. Carolina Env. Study Group, 438 U.S. 59 (1978)), but, in doing so, it abrogated fundamental common law safeguards developed to protect persons against randomized, specu- lative and conjectural liability on account of past conduct. This case thus fails within the category of cases where abrogation of common law rights is subject to constitutional substantive due process scrutiny. To pass muster, such action must “provide a reasonably just substitute for the common law or state tort law remedies protection it replaces” (Jd. at 88). Because the concepts of reasonableness and fairness permeate any analysis of due process invasions, petitioners demonstrate in their dis- cussions throughout this petition that the rules California has adopted to render an appearance of fairness are unreasonable and inequitable in the extreme and thereby violate procedural due process guarantees. But, because the predicates of those rules are also arbitrary and irra- tional in the extreme, they violate substantive due process guarantees as well. Wolff v. McDonnell, 418 U.S. 539, 558 (1974); Giaccio v. Penn- sylvania, 382 U.S. 399, 403 (1966). As this Court stated in Rees v. Watertown, 86 U.S. (19 Wall.) 107, 122 (1873), relying upon the Magna Carta and the due process clause: “A court of equity cannot, by avow- ing that there is a right but no remedy known to the law, create a remedy in violation of law, or even without the authority of law.” 10 Pursuant to the law of all jurisdictions in the United States, a factual chain linking the defendant with the allegedly defective product (1.¢., causation) is an essential element of every products liability action. See, eg., Picker X-Ray Corp. v. Frerker, 405 F.2d 916 (8th Cir. 1969); Rekasie v. Bucyrus-Erie Co., 262 F.2d 804 (3d Cir. 1959); Thompson- Hayward Chemical Co. v. Childress, 277 Ala. 285, 169 So. 2d 305 (1964); Baker v. Coca-Cola Bottling Works of Gary, 132 . Ind. App. 390, 177 N.E.2d 759 (1961); Wetzel v. Eaton Corp., 62 F.R.D. 22, 28 (D. Minn. 1973); 1 Hursh & Bailey, Ameri- can Law of Products Liability 2d, Section 1:41 (1974); Anno- tation, Products Liability: Necessity and Sufficiency of Identification of Defendant as Manufacturer or Seller of Product Alleged to Have Caused Injury, 51 A.L.R.3d 1344, 1349 (1973); Prosser, The Law of Torts, § 41 at 236 (4th ed. 1971). The common law safeguards afforded by the requirement of proof of causation insure fairness because they protect defendants from the imposition of liability premised upon mere speculation and conjecture: “An essential element of the plaintiff’s cause of action for negligence, or for that matter for any ‘other tort, is that there be some reasonable connection between the act or omission of the defendant and the damage which the plaintiff has suffered.” Prosser, supra, § 41 at 236. (Emphasis added) “!The plaintiff | must introduce evidence which affords a reasonable basis for the conclusion that it is more likely than not that the conduct of the defen- dant was a substantial factor in bringing about the result. A mere possibility of such causation is not enough; and when the matter remains one of pure speculation or conjecture, or the probabilities are at best evenly balanced, it becomes the duty of the court to direct a verdict for the defendant.” Jd. at 241. (Footnotes omitted. ) The California Supreme Court has chosen to forsake these policy considerations and safeguards on the notion that it is “reasonable” to establish causation by the joinder ¢ 11 of a substantial share of a given market where identifica- tion of the responsible party is not now possible.* In actu- ality, however, this does not represent an appropriate substitute for causation, and falls far short of satisfying the requirements of due process. The position of the California Supreme Court is that its new rule of liability may be imposed because of the pre- sumed fact that defendants are better able to bear the cost of injury than plaintiffs and that it has developed procedu- ral devices and standards to accomplish this goal in a just and fair fashion. (App. A, p. 26) Once the plaintiff has brought before the court manufac- turers which in the aggregate produced a “substantial” share of DES, the court indulges in the presumption that each and every defendant manufactured the drug ingested by plaintiff’s mother. (App. A, p. 25). A major error surrounding the presumption is patent - the presence of other manufacturers in the action does not :nake it more likely that a defendant produced the drug taken by a par- ticular mother. As pointed out by Justice Richardson in dissent, the use of market share evidence “does not impli- cate any particular defendant.” (App. A, p. 32). * The Court admitted, as defendants contended, that under tradi- tional product liability theories, there was no rational basis to connect the plaintiff’s injury to any one named defendant. “'Sjinee any one of 200 companies which manufactured DES might have made the product which harmed plaintiff, there is no rational basis upon which to infer that any defendant in this action caused plaintiff’s injuries, nor even a reasonable possibil- ity that they were responsible. “These arguments are persuasive if we measure the chance that any one of the defendants supplied the injury-causing drug by the number of possible tortfeasors. In such a context, the possibility that any of the five defendants supplied the DES to plaintiff’s mother is so remote that it would be unfair to require each defendant to exonerate itself. There may be a substantial likelihood that none of the five defendants joined in the action made the DES which caused the injury, and that the offending producer not named would escape liability altogether.” App. A, p. 13. 12 Defendants before the court might consist of Manufac- turer A with 40% of the market, Manufacturer B with 4% of the market, and Manufacturer C with 0.4% of the mar- ket. Since even plaintiffs would not dispute that the statis- tical correlation between DES exposure and clear cell adenocarcinoma does not exceed 1.4 per 1,000, there is no way to determine whether sales by the 4% or 0.4% market share defendants might have resulted in any injuries what- soever. A’s presence does not in any way increase the likelihood that either B or C was the responsible manufacturer. The court asserted that the “equity” of the presumption in which it indulges results from the assumption that once all of the cases are finally adjudicated “each manufac- turer’s liability would approximate its responsibility for the injuries caused by its own products.” (App. A, p. 26)* To the contrary, exactly the opposite is true and the court’s goal cannot be accomplished. Moreover, the court com- pletely ignored other factors which make the “market share” theory unreasonable and unfair. (a) In the first place, the theory uses the “market share” concept to impose a lower rather than an upper limit on liability. The theory assesses joint and several liability against defendants in the entire amount of damages sus- tained, including damages attributable to market shares of absent manufacturers.** Consequently, a defendant’s lia- bility will almost always exceed its market share. As explained by Justice Richardson in dissent: * This case is far different, however, from other modern product liability cases which assign the risk of loss to a solvent product manu- facturer because it can spread that risk in advance through higher prices or increased insurance coverage. In such a case, unlike here, since that manufacturer is called upon to pay damages only for injuries its own products caused, it is not unfair to impose that financial-ability based economic consequence on him. There, at least, the manufac- turer’s exposure is limited to production and distribution over which it has some control. Here, in contrast, no such primary justification exists for the classification created. ** See, e.g., American Motorcycle Assn. v. Superior Court, 20 Cal. 3d 578, 578 P.2d 899 (1978). 13 “ ,, those defendants who are brought to trial in this state will bear effective joint responsibility for 100 percent of plaintiffs’ injuries despite the fact that their ‘substantial’ aggregate market share may be considerably less... .” (App. A, p. 33). Applying the majority’s theory to the hypothetical above, it is clear that A, B and C will all be liable for more than twice their market shares. (b) The court’s assertion that “equity” will be accom- plished would be correct only if no plaintiff will be able to make product identification and no defendant will be able to exculpate itself. Yet that is clearly not the case, as the court itself acknowledged by providing for precisely those two contingencies. Some plaintiffs do make product identification and some manufacturers exculpate themselves. The Court below noted that Rogers can identify and, even prior to the appeal, one defendant had exculpated itself.* The court noted that Rogers can identify the manufacturer and, even prior to the appeal, one defendant had exculpated itself. Once identification or exculpation occurs, the defendants will bear disproportionate measures of liability. This point * In Abel v. Eli Lilly and Co., Action No. 74-030-070NP filed in the Wayne County Circuit Court, Detroit, Michigan, appeal pending to the Supreme Court of Michigan, 90 out of 144 plaintiffs, according to a brief filed by their counsel on appeal, identified the manufacturer of the DES at issue. The fact that such identification was not made in that case until after the trial court had determined that identification was required to state a cause of action highlights another unfair result which the California court overlooked and which necessarily flows from the theory which it has espoused. Under the “market share” theory, the plaintiff has a definite incentive to suppress identification evidence or at least to be conveniently ignorant of its existence. Why should she forego the right to sue 100 companies, any of whom might satisfy a judgment, for the right to sue one company, the company which actually made the product which allegedly injured her, when that company may no longer exist or be subject to suit where she wants to sue? Prosser addressed just this situation when he pointed out that “sheer ignorence might be, the most powerful weapon of the law.” Prosser, Res Ipsa Loquitur, a Reply to Professor Carpenter, 10 So. Calif. L. Rev. 459, 464 (1937). 14 is illustrated by Sindell and Rogers. If Rogers proves her mother took Lilly’s product and satisfies the other elements of her case, Lilly will be required to pay 100% of her damages. If Sindell prevails at trial, Lilly will be required to pay its market share and its proportion of the shares of the several hundred absent manufacturers. For the two cases together, Lilly’s exposure will greatly exceed its mar- ket share, and the exposure of other manufacturers may be more or less than their market shares depending on the shares represented by non-party manufacturers. As the number of plaintiffs who succeed in identifying the manu- facturer increases, the “equity” is increasingly out of balance. (c) The court also assumes that to achieve equity the appropriate market can now be reconstructed and will remain the same in all cases. Once again, there is no rational basis for this conclusion, The defendants’ market Shares will vary from case to case and the supposed “equity” arising from an averaging of results over all cases will be impossible. The initial definition of the product market will be arbitrary since DES was manufactured in at least 13 different dosages, ranging from .1 mg. to 250 mg., and was indicated and sold for many purposes other than prevention of accidents of pregnancy. (CT p. 204, 206-07). Equally arbitrary will be the definition of the geographic market. A national market would greatly distort regional sales; a California market would present distortions of its own. In Rogers, for example, the drug was obtained and taken in Illinois, while suit was filed in California. Finally, the court had no reason to assume, as it did, that sufficient records exist to rationally determine market shares of over 200 manufacturers, many of whom may be out of business or not otherwise subject to suit in California, based on production and sales 20 to 30 years ago. (App. A, p. 26) 15 (d) The Court disregarded transaction costs in its con- sideration of how to achieve “equity” under its theory. Prior to Sindell, when identification was required, a manu- facturer having 10% of the market would theoretically be a defendant in at most 10% of the cases and responsible for the costs of defending only those suits. Under Sindell, in contrast, that same 10% manufacturer would have to defend somewhat less than 100% of the suits and absorb defense costs in all of them. The court was blind to these costs of defense and to the special burden its theory places on defendants with small market shares. If it is assumed that defense costs in a given action range between $50,000 to $100,000, the costs of defending 100 actions would be $5,000,000 to $10,000,000. Since defend- ants with the smallest market shares may incur the same litigation costs as the largest, their costs of defense may dwarf their liability exposure. The repetition of such costs will progressively cripple the smaller companies producing multi-source drugs, thereby reducing competition, and will continually drain the resources available to the larger com- panies for research and development of new drugs. (e) The theory’s supposed “equity” further depends on the assumption that the defendant manufacturers are in a better position than plaintiffs to bear the cost of injury and to insure against it. (App. A, p.23) It is highly question- able, however, whether the pharmaceutical industry, and particularly its smaller firms, can withstand the extraordi- nary random liability imposed by the new theory. See, Coggins, Industry-Wide Liability, 13 Suffolk L. Rev. 980, 1003-06 (1979). Even before this decision, the pharmaceu- tical industry was virtually uninsurable. Commerce Department, Interagency Task Force on Product Liability: Final Repori of the Insurance Study, Volume 1 at 2-4, 2-5 (January 1977). The “market share” theory is likely to render manufacturers of generic drugs totally uninsurable, 16 since the insurer cannot determine the scope of the expo- sure if it may be liable for damages and litigation costs resulting from products manufactured by companies other than its insured. (f) The “market share” theory further assumes that litigation is an effective mechanism for compensating per- sons for drug-induced injuries. The opposite is true. Apart from the excessive transaction costs exacted by the Sindell formula, drug litigation remains a slow, costly, inef- ficient process for compensation. Not only do substantial delays occur between injury and payment; but plaintiffs also face uncertainties of proof, the necessity of proving defect and high litigation expenses. It has been estimated that it currently costs 77 cents to deliver 65 cents to a plaintiff in normal products liability suits. Kinsley, Fate and Lawsuits, 182 The New Republic, 20, 21 (June 14, 1980). See also, Commerce Department, /nteragency Task Force Report on Product Liability, Final Report of the Insur- ance Study, Volume 1 at 2-4, 2-5 (January 1977). The Court below has arbitrarily legislated a remedy which almost certainly will increase the delivery costs per case to as much as $3 per dollar of potential recovery.* Kinsley, supra, at p.21. In contrast, alternate means for assisting persons injured by drugs, including private health insurance and public health care programs,** appear vastly preferable to a radical, extraordinarily expensive restructuring of tort law. The California legislature itself has enacted a far- * For example, with 100 defendant and cross-defendant manufac- turers, 300 trial days will be added if each takes only three days to try the market share issues. At a time when the publie is becoming increasingly dissatisfied with our courts, it is unwise from any perspec- tive to create new mass litigation concepts which entail crippling costs to the litigants—and ultimately to the public-and huge delays to others who wish to utilize the limited resources of the courts. ** Source Book of Health Insurance Data, 1976-77, p. 21. The Source Book reports that at the end of 1975, private health insurance protected more than 80% of the civilian noninstitutionalized population, and that of persons under age 65, nearly 9 out of 10 were covered. I/d. 17 reaching and exemplary health care services program cov- ering both the indigent and many individuals with means of support.* Moreover, as the dissent below points out, the problem here “invites a legislative rather than an attempted judicial solution.” (App. A, p. 38) (g) The type of evidentiary hearing which the theory will permit in allowing defendants to rebut the presump- tion violates procedural due process. The theory seem- ingly preserves a degree of fairness to defendants in one respect — it allows them to offer certain types of exculpatory evidence. The appearance of procedural fairness disap- pears, however, upon review of other types of exculpatory evidence which the theory necessarily excludes. As to defendants which can offer direct proof they did not manufacture the specific drug taken by plaintiff’s mother, the presumption of causation may be overcome. (App. A, p. 25) If evidence establishes that a white tablet was taken, a defendant may exculpate itself by proof it manufactured only green tablets. Other direct evidence includes proof that plaintiff’s mother obtained the drug ata pharmacy which did not sell a particular defendant’s prod- ucts. Those defendants with direct proof should be able to secure Summary judgment. All defendants remaining at trial, however, will be man- ufacturers lacking direct proof. As to those defendants, the “market share” theory necessarily bars the use of rele- vant and admissible statistical and market share evidence to overcome the presumption.** (Student comment, p. 995. ) The supposed “equity” of the apportionment scheme falls * See, California Welfare and Institutions Code, Sections 14000, et seq., and Sections 11152 and 11153.7 (benefits payable for qualified persons with residential realty without value limitation up to $25,000 in income-producing realty). The California legislature also has been considering major reforms in products liability law and enacted, on July 31, 1980, special legislation to assist in identification and screen- ing of persons exposed to DES. (See App. A, p. 38) ** Equal protection of the laws has also been violated in that some defendants may use relevant exculpatory evidence while others are barred from using equally relevant, albeit circumstantial, exculpatory 18 of its own weight when such evidence is excluded. For example, a manufacturer which believes it has less than 1% of a given market would ordinarily present evidence of its market share as proof of exculpation. The Student comment acknowledges that failure to bar such evidence could result in one manufacturer with a sufficient market share being held liable for 100% of the liability in all cases. (Student comment, p. 995.) As to defendants without direct proof, the presumption cannot be overcome and con- sequently the theory bars a fair hearing on the issue of causation. — The unfairness of the Court’s procedure is exacerbated by the fact that it permits a plaintiff to use market share data in showing that she has sued manufacturers comprising a “Substantial share” of the relevant market, but precludes defendants from using that same data to exculpate themselves. The “market share” theory does not offer a principled basis for barring any defendants from use of statistical and market share evidence to overcome the presumption of cau- sation. The theory bars defendants from the right to a fair hearing and fair rules of procedure and evidence in viola- tion of procedural due process. Due process protects a defendant’s fundamental right to rational rules of proce- dure and evidence. Jenkins v. McKeithen, 395 U.S. 411, 429 (1969). In Jenkins, the Court stressed that due process evidence. Moreover, on the issue of causation, defendants in this case are treated differentiy from defendants in all other tort cases. Equal protection prohibits the states from treating similarly situated persons or business enterprises in different ways. Reed v. Reed, 404 U.S. 71 (1971); Smith v. Cahoon, 283 U.S. 553 (1931); Connolly v. Union Sewer Pipe Co., 184 U.S. 540 (1902). The singling out of a particular class of individuals and barring it from the right to a fair hearing violates equal protection notwithstanding a state’s interest in increasing the speed and efficiency of adjudication. Stanley v. Illinois, 405 U.S. 645, 648, 656 (1972). Seealso, Carrington v. Rash, 380 U.S. 89 (1965); Dunn v. Blumstein, 405 U.S. 330, 349-352 (1971); Shapiro v. Thompson, 394 U.S. 618 (1969). 19 protects the right to present evidence: “{T |he right to pre- sent evidence is, of course, essential to the fair hearing required by the Due Process Clause.” (h) The “equity” of the California court’s “market share” theory is not achieved by the supposed relief it proposes of according defendants the right to bring in through third-party actions unnamed manufacturers. By making the named defendants liable for 100% of the plain- tiff’s damages, those defendants, in attempting to equate liability with market share, must seek to bring in every other manufacturer. This will necessarily result in a trial which is not only an unmanageable spectacle, but which, because it will involve over 100 or possibly over 200 defend- ants, will deprive those defendants of any possibility of a fair hearing.* Surely, due process cannot countenance a trial where the courtroom (or, more likely, an amphithea- ter) is bursting with counsel for 200 corporate defendants, their clients, a plaintiff with serious injuries, her counsel, witnesses, a judge, court personnel and spectators. The chances of a jury being able to render a fair and impartial verdict when confronted with such a spectacle are so remote as to be nonexistent. * Literally hundreds of suits (some of them, like Sindell and Rogers, purporting to be class actions) involving DES claims are pend- ing. Several suits in California contain well over 150 pharmaceutical manufacturers as defendants in an effort by plaintiffs themselves to hurdle the manufacturer identification issue. (Carol Trevallee v. Abbott Laboratories, et al., San Francisco Superior Court Case No. 721204; Judy K. Benny v. Abbott Laboratories, et al., Alameda Superior Court Case No. 525322-5; Cindy Bocian v. Abbott Laboratories, et al., San Francisco Supe- rior Court Case No. 760532.) This sideshow aspect has been addressed in separate context: “As a practical matter the capacities of even the best judges and jurors to absorb the factual situation presented are finite and the capacity of a courthouse does not begin to reach that of a coli- seum. A class action in the instant case would stretch the facilities and abilities of this Court beyond their elastic limit.” aga v. Glass Specialty Co., 59 F.R.D. 286, 294 (N.D. II. 1973). 20 The Fourteenth Amendment’s guarantee of due process extends to state action, both legislative and judicial. Amer- ican Railway Exp. Co. v. Kentucky, 273 U.S. 269 (1927); Prudential Ins. Co. v. Cheek, 259 U.S. 580 (1922); Vlandis v. Kline, 412 U.S. 441 (1973). See also, Moore v. East Cleveland, 431 U.S. 494, 502 (1977); NAACP v. Alabama, 377 U.S. 288, 308 (1964). Although states have certain leeway in creating pre- sumptions through proper legislative classifications, con- clusive presumptions as to an essential element of a cause of action or defense, unless universally true, deprive persons of the opportunity to be heard on an individual basis and thus violate procedural due process. See, e.g., Bell v. Burson, 402 U.S. 5385 (1971); Cleveland Board of Education v. LaFleur, 414 U.S. 632, 644 (1974); Vlandis v. Kline, 412 U.S. 441, 446 (1973); Stanley v. Illinois, 405 U.S. 645 (1972). Due process requires a meaningful opportunity to pre- sent evidence and to be heard. Armstrong v. Manzo, 380 U.S. 545, 552 (1965); Sawnders v. Shaw, 244 U.S. 317 (1917). Substance, not form, is examined to determine whether constitutional minimums have been honored. Bell v. Bur- son, supra, 402 U.S. at 541; Goldberg v. Kelly, 397 U.S. 254 (1970). Petitioners have demonstrated by example that the Cali- fornia decision is, first, not reasonably calculated to achieve its stated goals, second, inequitable in the extreme, and third, will deprive defendants of any opportunity for a fair trial. Procedural due process requires that these criteria be met. The decision below falls far short of satisfying them and is, therefore, constitutionally invalid. 21 3. THE JUDGMENT BELOW IS PREEMPTED BY THE SUPREMACY CLAUSE BECAUSE IT FRUSTRATES FEDERAL POLICIES GOVERNING THE DEVELOP. MENT AND MARKETING OF PRESCRIPTION DRUGS, AND IN PARTICULAR THE MARKETING OF DRUGS ON A GENERIC BASIS, AND CREATES AN INVALID BURDEN ON INTERSTATE COMMERCE. The California Supreme Court’s “market share” liability theory will impose random, destructive liability and extraordinary litigation costs on manufacturers of drugs for the marketing of pharmaceuticals which are alleged to be defective 20 years after they were ingested, and after they passed the rigorous tests and standards established by the FDA. The immediate and unavoidable effect will be to drastically impede the development and marketing of new prescription drugs (in particular the marketing of drugs on a generic basis), and erect artificial barriers to entry in such markets with potential anticompetitive consequences. The federal government strongly encourages the devel- opment and marketing of new prescription drugs and the increased price competition which results from the market- ing of drugs on a generic basis.* See Brand Names and Generic Drugs, 1974, Hearings Before Subcommittee on Labor and Public Welfare, 93d Congress 2d Sess. (July 22, California likewise encourages the marketing of drugs on a generic basis. California Businesses and Professions Code, Section 4047.6. Moreover, there is a strong social interest in having more than one manufacturer of an unpatented product in any field. Society has repeatedly looked with favor upon the public policy of having multiple- manufacturers of identical products in other industries. For example, this Court in Sears, Roebuck & Co. v. Stiffel Co., 376 U.S. 225 (1964), reversed an unfair competition order of a state court which enjoined defendant from producing a lamp identical to a lamp provided by plaintiffs. The Court recently acknowledged the public interest in having more than one manufacturer of a product, even at the expense of one company’s goodwill, in the following terms: “ ‘Sharing in the good will of an article unprotected by patent or trade-mark is the exercise of a right possessed by all-and in the free exercise of which the consuming public is deeply inter- ested.’ ” 376 U.S. at 231. 22 1974). 21 U.S.C. § 301, et seg. Since more diseases can be treated by drugs than by surgery or radiology, and since drugs are a relatively inexpensive mode of therapy, drug therapy is of great benefit in reducing morbidity and mor- tality rates as well as the costs of medical treatment. Schwartzman, The Expected Return from Pharmaceutical Research, 1-3 (1975). This past term, the Court reiterated the strong public policy in favor of encouraging rather than, as here, discouraging research and development in pharmaceuticals and related fields: “Mr. Justice Douglas reminded that the inventions most benefiting mankind are those that ‘push back the frontiers of chemistry, physics, and the like.’ Great A. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 154 (1950) (coneurring opinion).” Diamond v. Chakrabarty, 40 CCH 8. Ct. Bull. p. B3122, B3135 (1980). The Department of Health, Education and Welfare has commented regarding generic drugs and “branded generics”: “About three-quarters of the drugs commonly pre- scribed in the United States are available only from asingle source. The remaining fourth are available from multiple sources, often at widely differing prices. Historically, the lower-cost versions of mul- tiple source drugs have been marketed by relatively small manufacturers. In recent years, however, the growing trend toward generic prescribing has encouraged major manufacturers to enter the mar- ket with so-called ‘branded generics’ with prices still greatly below those of the original brands. The MAC [maximum allowable cost} regulation is designed to adopt departmental policy to this increased price competition in the multiple-source market.” (Maximum Allowable Costs for Drugs, Office of the Secretary, Department of Health, Education and Welfare (July 25, 1976)). Any consideration of increased regulation or imposition of liability on the pharmaceutical industry must be 23 approached with extreme caution. Prosser, Handbook of the Law of Torts, 661 (4th ed. 1971); Hearings Before the Subcom- mittee on Health of the Committee on Labor and Public Welfare, 94th Congress, p. 119 (September 23, 1977). Indeed, com- mentators have argued that amendments to the Food, Drug, and Cosmetic Act inhibiting the introduction of new drugs have cost the American public over 300 million dol- lars and thousands of lives due to decreased availability of pharmaceuticais. Peltzman, Regulation of Pharmaceutical Innovation; The 1962 Amendments 1-3 (1974); Grabowski, Drug Regulation and Innovation: Empirical Evidence and Policy Options (1976). The identical concern was addressed by the Court last term in a different context. Dawson Chem. Co. v. Rohm & Haas Co., 40 CCH S. Ct. Bull. p. B3850, B38895 (1980). The “market share” theory raises a significant risk that smaller companies may be driven from the business of producing generic prescription drugs. See, Coggins, 13 Suf- folk L. Rev. 980, 1003-1006 (1979). If a company cannot obtain insurance, investment capital is almost impossible to attract. If the company does obtain the necessary capital, gambling that it would not be the arbitrary target in litiga- tion for injuries allegedly caused by a widely-used drug, the loss of the gamble could result in ruin. See Reiter v. Sonotone Corp., 579 F.2d 1077, 1086 (8th Cir. 1978), rev’d, 442 U.S. 330 (1979). A further anticompetitive effect is the development of barriers to entry by new firms. The existence of a high fixed cost (such as provision for “market share” liability and litigation expense) will bar a new firm from entering the industry unless it has sufficient capital or sales revenue to absorb the cost. A limitation on new entry is an important precondition for the emergence and mainte- nance of monopoly power. Under the antitrust laws, merg- ers have been forbidden where, among other matters, they would contribute to the development of such entry barriers. See, e.g., Ford Motor Co. v. United States, 405 U.S. 562 (1972). 24 The court’s decision impermissibly interferes with fed- eral objectives relating to the development and marketing of prescription drugs and avoidance of anticompetitive effects on interstate commerce in such markets. The Supremacy Clause voids a state’s statutory or decisional law if it would retard, impede, burden or otherwise frus- trate the full effectiveness of federal law. McCulloch v. Maryland, 17 U.S. (4 Wheat.) 316 (1819); Sola Elec. Co. v. Jefferson Elec. Co., 317 U.S. 173 (1942). Regardless of the court’s purpose in adopting the “market share” liability theory, its decision stands as a major obstacle to the accom- plishment of Congressional objectives in regulating the drug industry and encouraging the unfettered marketing of drugs on a generic basis. The decision is therefore inva- lid under the Supremacy Clause. Perez v. Campbell, 402 U.S. 637, 652 (1971); San Diego Bldg. Trades Council v. Gar- mon, 359 U.S. 236 (1959); Farmers Union v. WDAY, Inc., 360 U.S. 525 (1959). The court’s decision is also preempted because it creates an invalid burden on interestate commerce, and burdens commerce without resort to less burdensome alternatives. The purpose of the Commerce Clause was, of course, to “prevent discrimination and the erection of barriers or obstacles to the free flow of commerce, interstate or for- eign.” Di Santo v. Pennsylvania, 273 U.S. 34, 43-44 (1927) (Stone, J., dissenting). At the very least, the “market share” liability theory will significantly raise the cost of generic drugs,* if not destroy the market. Under a balancing test, cost increases are an important factor, especially where economic justifi- cation for the challenged rule is slight. See, Bibb v. Navajo Freight Lines, Inc., 359 U.S. 520 (1959); Raymond Motor * Nor will cost increases be limited to California. The Robinson- Patman Act would bar pharmaceutical companies from engaging in price discrimination between the states. 15 U.S.C. § 13, et seq. 25 Transportation, Inc. v. Rice, 484 U.S. 429 (1978). In addi- tion, the theory will cause manufacturers to avoid eco- nomic risks by emphasizing the distribution of older, established pharmaceuticals. The effect of such policy will be to decrease the variety of pharmaceuticals available, particularly those more recently developed, and the impact of the policy will be felt nationally. Even when a state can justify the establishment of rules which burden interstate commerce, the rules still are inva- lid if less burdensome alternatives exist. Great Atlantic & Pacific Tea Co., Inc. v. Cottrell, 424 U.S. 366 (1976); Pike v. Bruce Church, Inc., 397 U.S. 187 (1970). In adopting the “market share” liability theory, the court failed to consider less burdensome alternatives; instead it selected the most punitive solution of all. 26 CONCLUSION For the foregoing resaons, a Writ of Certiorari should issue, and the judgment of the California Supreme Court should be reversed. Respectfully submitted, ADAMS, DUQUE & HAZELTINE RICHARD C. FIELD DAVID L. BACON 523 West Sixth Street Los Angeles, California 90014 WINTHROP, STIMSON, PUTNAM & ROBERTS A. EDWARD GRASHOF THEODORE 8S. STEINGUT 40 Wall Street New York, New York 10005 Attorneys for Petitioner Rexall Drug Company CROSBY, HEAFEY, ROACH & MAY Professional Corporation RICHARD J. HEAFEY PETER W. DAVIS 1939 Harrison Street Oakland, California 94612 Attorneys for Petitioner Eli Lilly and Company APPENDIX A A-1l IN THE SUPREME COURT OF THE STATE OF CALIFORNIA L.A. 31063 JUDITH SINDELL, Plaintiff and Appellant, Vv. ABBOTT LABORATORIES et al., Defendants and Respondents. MAUREEN ROGERS, Plaintiff and Appellant, vi. REXALL DRUG COMPANY et al., Defendants and Respondents. This case involves a complex problem both timely and significant: may a plaintiff, injured as the result of a drug administered to her mother during pregnancy, who knows the type of drug involved but cannot identify the manufac- turer of the precise product, hold liable for her injuries a maker of a drug produced from an identical formula? A-2 Plaintiff Judith Sindell brought an action against eleven drug companies and Does 1 through 100, on behalf of her- self and other women similarly situated. The complaint alleges as follows: SEE DISSENTING OPINION Between 1941 and 1971, defendants were engaged in the business of manufacturing, promoting, and marketing diethylstilbesterol (DES), a drug which is a synthetic com- pound of the female hormone estrogen. The drug was administered to plaintiff’s mother and the mothers of the class she represents,’ for the purpose of preventing miscar- riage. In 1947, the Food and Drug Administration autho- rized the marketing of DES as a miscarriage preventative, but only on an experimental basis, with a requirement that the drug contain a warning label to that effect. DES may cause cancerous vaginal and cervical growths in the daughters exposed to it before birth, because their mothers took the drug during pregnancy. The form of cancer from which these daughters suffer is known as ade- nocarcinoma, and it manifests itself after a minimum latent period of 10 or 12 years. It is a fast-spreading and deadly disease, and radical surgery is required to prevent it from spreading. DES also causes adenosis, precancerous vaginal and cervical growths which may spread to other areas of the body. The treatment for adenosis is cauteriza- tion, surgery, or cryosurgery. Women who suffer from this condition must be monitored by biopsy or colposcopic exam- ination twice a year, a painful and expensive procedure. Thousands of women whose mothers received DES during pregnancy are unaware of the effects of the drug. 1. The plaintiff class alleged consists of “girls and woman who are residents of California and who have been exposed to DES before birth and who may or may not know that fact or the dangers” to which they were exposed. Defendants are also sued as representatives of a class of drug manufacturers which sold DES after 1941. A-3 In 1971, the Food and Drug Administration ordered defendants to cease marketing and promoting DES for the purpose of preventing miscarriages, and to warn physi- cians and the public that the drug should not be used by pregnant women because of the danger to their unborn children. During the period defendants marketed DES, thty knew or should have known that it was a carcinogenic substance, that there was a grave danger after varying periods of latency it would cause cancerous and precancerous growths in the daughters of the mothers who took it, and that it was ineffective to prevent miscarriage. Nevertheless, defend- ants continued to advertise and market the drug as a mis- carriage preventative. They failed to test DES for efficacy and safety; the tests performed by others, upon which they relied, indicated that it was not safe or effective. In viola- tion of the authorization of the Food and Drug Administra- tion, defendants marketed DES on an unlimited basis rather than as an experimental drug, and they failed to warn of its potential danger.’ Because of defendants’ advertised assurances that DES was safe and effective to prevent miscarriage, plaintiff was exposed to the drug prior to her birth. She became aware of the danger from such exposure within one year of the time she filed her complaint. As a result of the DES ingested by her mother, plaintiff developed a malignant bladder tumor which was removed by surgery. She suffers from adenosis and must constantly be monitored by biopsy or colposcopy to insure early warning of further malignancy. The first cause of action alleges that defendants were jointly and individually negligent in that they manufac- tured, marketed and promoted DES as a safe and efficacious 2. It is alleged also that defendants failed to determine if there was any means to avoid or treat the effects of DES upon the daughters of women exposed to it during pregnancy, and failed to monitor the carcino- genic effects of the drug. A-4 drug to prevent miscarriage, without adequate testing or warning, and without monitoring or reporting its effects. A separate cause of action alleges that defendants are jointly liable regardless of which particular brand of DES was ingested by plaintiff’s mother because defendants col- laborated in marketing, promoting and testing the drug, relied upon each other’s tests, and adhered to an industry- wide safety standard. DES was produced from a common and mutually agreed upon formula as a fungible drug interchangeable with other brands of the same product; defendants knew or should have known that it was custom- ary for doctors to prescribe the drug by its generic rather than its brand name and that pharmacists filled prescrip- tions from whatever brand of the drug happened to be in stock. Other causes of action are based upon theories of strict liability, violation of express and implied warranties, false and fraudulent representations, misbranding of drugs in violation of federal law, conspiracy and “lack of consent.” Each cause of action alleges that defendants are jointly liable because they acted in concert, on the basis of express and implied agreements, and in reliance upon and ratifica- tion and exploitation of each other’s testing and marketing methods. Plaintiff seeks compensatory damages of $1 million and punitive damages of $10 million for herself. For the mem- bers of her class, she prays for equitable relief in the form of an order that defendants warn physicians and others of the danger of DES and the necessity of performing certain tests to determine the presence of disease caused by the drug, and that they establish free clinics in California to perform such tests. Defendants demurred to the complaint. While the com- plaint did not expressly allege that plaintiff could not iden- tify the manufacturer of the precise drug ingested by her A-5 mother, she stated in her points and authorities in opposi- tion to the demurrers filed by some of the defendants that she was unable to make the identification, and the trial court sustained the demurrers of these defendants without leave to amend on the ground that plaintiff did not and stated she could not identify which defendant had manu- factured the drug responsible for her injuries. Thereupon, the court dismissed the action.’ This appeal involves only five of ten defendants named in the complaint.‘ Plaintiff Maureen Rogers filed a complaint containing allegations generally similar to those made by Sindell. She seeks compensatory and punitive damages on her own 3. There are minor variations in the procedures employed as to the various defendants. Thus, for example, Eli Lilly and Company filed a motion for summary judgment, or alternatively judgment on the plead- ings, rather than a demurrer; the court treated the motion as a demurrer. The Demurrer of Abbot Laboratories, the first defendant to file a demurrer and the first to secure a dismissal, was sustained with leave to amend on the ground that plaintiff had failed to allege that a product manufactured by Abbott had caused her injuries (as opposed to the reason given by the trial court for sustaining the demurrers of the other defendants that plaintiff expressly stated that she could not identify a particular manufacturer). Upon plaintiff’s failure to amend the com- plaint, the action was dismissed as to Abbott. A few days after the dismissal, plaintiff stated in a brief in opposition to the demurrers filed by defendants other than Abbott that she could not make the identification. Abbott asserts that as to it the issue we consider on appeal is not properly raised because plaintiff's statement that she could not identify the manufacturer was not made until after the action had been dismissed as to Abbott. This contention is without merit. Plaintiff's failure to amend her complaint after Abbott’s demurrer was sustained with leave to amend was based upon her inability to identify a specific manufacturer. Clearly, Abbott interpreted the complaint in this fashion, for it moved for dismissal on the ground that the complaint alleges that plaintiff “does not know the identity of the drug ... ingested” by her mother. Thus, Abbott may not now claim that the complaint is insufficient to raise the issue involved in this appeal. The trial court did not determine other issues raised by the complaint, such as whether the case was properly brought as a class action. 4. Abbott Laboratories, Eli Lilly and Company, E. R. Squibb and Sons, The Upjohn Company, and Rexall Drug Company are respondents. The action was dismissed or the appeal abandoned on various grounds as to other defendants named in the complaint; e.g., one defendant demon- strated it had not manufactured DES during the period plaintiff's mother took the drug. A-6 behalf, and on behalf of a class described in substantially the same terms as in Sindell’s complaint, as well as equita- _ble relief comparable to that sought by Sindell. The trial court sustained demurrers of E. R. Squibb & Sons, The Upjohn Company, and Rexall Drug Company.’ Subse- quent to the dismissal of her action against these defend- ants, Rogers amended the complaint to allege that Eli Lilly and Company, one of the defendants named in her com- plaint, had manufactured the drug used by their mother. Although Sindell’s action and the present case have been consolidated on appeal, much of the discussion which fol- lows will apply to Rogers only if she does not succeed in establishing that Eli Lilly and Company manufactured the DES taken by her mother. “Plaintiff” as used in this opin- ion refers to Sindell, and we discuss only the allegations of Sindell’s complaint. This case is but one of a number filed throughout the country seeking to hold drug manufacturers liable for inju- ries allegedly resulting from DES prescribed to the plain- tiffs’ mothers 1947. According to a note in the Fordham Law Review, estimates of the number of women who took the drug during pregnancy range from 114 million to 3 million. Hundreds, perhaps thousands, of the daughters of these women suffer from adenocarcinoma, and the inci- dence of vaginal adenosis among them is 30 to 90 percent. (Comment, DES and a Proposed Theory of Enterprise Liability (1978) 46 Fordham L.Rev. 963, 964-967 [hereafter Ford- ham Comment].) Most of the cases are still pending. With two exceptions,’ those that have been decided resulted 5. While the trial court did not specify the ground upon which the demurrers were sustained, the points and authorities filed by the parties emphasized the failure of Rogers to identify a particular manufacturer as the source of her injuries, and we may assume for the purpose of this appeal that this was the basis of the court's order. 6. DES was marketed under many different trade names. 7. Ina recent New York case a jury found in the plaintiff's favor in spite of her inability to identify a specific manufacturer of DES. An appeal is pending. ( Bichler v. Eli Lilly and Co. (Sup.Ct.N.Y. 1979).) A Michigan appellate court recently held that plaintiffs had stated a A-7 in judgments in favor of the drug company defendants because of the failure of the plaintiffs to identify the manu- facturer of the DES prescribed to their mothers.* The same result was reached in a recent California case. (McCreery Vv. Eli Lilly & Co. (1978) 87 Cal.App.3d 77, 84-93. ) The present action is another attempt to overcome this obstacle to recovery. We begin with the proposition that, as a general rule, the imposition of liability depends upon a showing by the plaintiff that his or her injuries were caused by the act of the defendant or by an instrumentality under the defen- dant’s control. The rule applies whether the injury resulted from an accidental event (e.g., Shunk v. Bosworth (6th Cir. 1964) 334 F.2d 309) or from the use of a defective product. (E.g., Wetzel v. Eaton Corporation (D.Minn. 19730 62 F.R.D. 22, 29-30; Garcia v. Joseph Vince Co. (1978) 84 Cal.App.3d 868, 873-875; and see annot. collection of cases in 51 A.L.R.3d 1344, 1351; 1 Hursh and Bailey, American Law of Products Liability 2d (1974) p. 125) There are, however, exceptions to this rule. Plaintiff’s complaint suggests several bases upon which defendants may be held liable for her injuries even though she cannot demonstrate the name of the manufacturer which pro- duced the DES actually taken by her mother. The first of these theories, classically illustrated by Summers v. Tice (1948) 33 Cal.2d 80, places the burden of proof of causation upon tortious defendants in certain circumstances. The second basis of liability emerging from the complaint is that defendants acted in concert to cause injury to plaintiff. There is a third and novel approach to the problem, some- times called the theory of “enterprise liability,” but which cause of action against several manufacturers of DES even though identi- fication could not be made. (Abel v. Eli Lilly and Co. (decided Dec. 5, 1979) Docket No. 60497.) That decision is on appeal to the Supreme Court of Michigan. 8. E.g., Gray v. United States (s. D, Texas 1978) 445 F.Supp. 337. In their briefs, defendants refer to a number of other cases in which trial courts have dismissed actions in DES cases on the ground stated above. A-8 we prefer to designate by the more accurate term of “indus- try-wide” liability,” which might obviate the necessity for identifying the manufacturer of the injury-causing drug. We shall conclude that these doctrines, as previously inter- preted, may not be applied to hold defendants liable under the allegations of this complaint. However, we shall pro- pose and adopt a fourth basis for permitting the action,to be tried, grounded upon an extension of the Summers doctrine. Plaintiff places primary reliance upon cases which hold that if a party cannot identify which of two or more defendants caused an injury, the burden of proof may shift to the defendants to show that they were not responsible for the harm. This principle is sometimes referred to as the “alternative liability” theory. The celebrated case of Summers v. Tice, supra, 33 Cal.2d 80, a unanimous opinion of this court, best exemplifies the rule. In Summers, the plaintiff was injured when two hunters negligently shot in his direction. It could not be determined which of them had fired the shot which actu- ally caused the injury to the plaintiff’s eye, but both defend- ants were nevertheless held jointly and severally liable for the whole of the damages. We reasoned that both were wrongdoers, both were negligent toward the plaintiff, and that it would be unfair to require plaintiff to isolate the defendant responsible, because if the one pointed out were to escape liability, the other might also, and the plaintiff- victim would be shorn of any remedy. In these circum- stances, we held, the burden of proof shifted to the defend- ants, “each to absolve himself if he can.” (/d., p. 86.) We stated that under these or similar circumstances a defen- dant is ordinarily in a “far better position” to offer evidence 9. The term “enterprise liability” is sometimes used broadly to mean that losses caused by an enterprise should be borne by it. (Klemme Enterprise Liability (1976) 47 Colo. L.Rev. 153, 158.) A-9 to determine whether he or another defendant caused the injury. In Summers, we relied upon Ybarra v. Spangard (1944) 25 Cal.2d 486. There, the plaintiff was injured while he was unconscious during the course of surgery. He sought damages against several doctors and a nurse who attended him while he was unconscious. We held that it would be unreasonable to require him to identify the particular defendant who had performed the alleged negligent act because he was unconscious at the time of the injury and the defendants exercised control over the instrumentalities which caused the harm. Therefore, under the doctrine of res ipsa loquitur, an inference of negligence arose that defendants were required to meet by explaining their eonduct."° The rule developed in Summers has been embodied in the Restatement of Torts. (Rest.2d Torts, § 433B, subsec. (3).)'' Indeed, the Summers facts are used as an illustra- tion (p. 447). 10. Other cases cited by plaintiff for the proposition stated in Sum- mers are only peripherally relevant. For example, in Ray v. Alad Corpo- ration (1977) 19 Cal.3d 22, the plaintiff brought an action in strict liability for personal injuries sustained when he fell from a defective ladder manufactured by the defendant’s predecessor corporation, We held that, although under the general rule governing corporate succession the defendant could not be held responsible, nevertheless a “special depar- ture” from that rule was justified in the particular circumstances. The defendant had succeeded to the good will of the manufacturer of the ladder, and it could obtain insurance against the risk of liability, whereas the plaintiff would be left without redress if he could not hold the defen- dant liable. The question whether one corporation should, for policy reasons, be answerable for the products manufactured by its predecessor is a different issue than that we describe above. 11. Section 433B, subsection (3) of the Restatement provides: “Where the conduct of two or more actors is tortious, and it is proved that harm has been caused to the plaintiff by only one of them, but there is uncertainty as to which one has caused it, the burden is upon each such actor to prove that he has not caused harm.” The reason underlying the rule is “the injustice of permitting proved wrongdoers, who among them have inflicted an injury upon the entirely innocent plaintiff, to escape liability merely because the nature of their conduct and the resulting harm has made it difficult or impossible to prove which of them has caused the harm.” (Rest.2d Torts, §433B, com. f, p. 446.) A-10 Defendants assert that these principles are inapplicable here. First, they insist that a predicate to shifting the burden of proof under Summers-Ybarra is that the defend- ants must have greater access to information regarding the cause of the injuries than the plaintiff, whereas in the present case the reverse appears. Plaintiff does not claim that defendants are in a better position than she to identify the manufacturer of the drug taken by her mother or, indeed, that they have the ability to do so at all, but argues, rather, that Summers does not impose such a requirement as a condition to the shifting of the burden of proof. In this respect we believe plaintiff is correct. In Summers, the circumstances of the accident them- selves precluded an explanation of its cause. To be sure, Summers states that defendants are “{o|rdinarily...ina far better position to offer evidence to determine which one caused the injury” than a plaintiff (33 Cal.2d 80, at p. 86), but the decision does not determine that this “ordinary” Situation was present. Neither the facts nor the language of the opinion indicate that the two defendants, simultane- ously shooting in the same direction, were in a better posi- tion than the plaintiff to ascertain Whose shot caused the injury. As the opinion acknowledges, it was impossible for the trial court to determine whether the shot which entered the plaintiff’s eye came from the gun of one defendant or the other. Nevertheless, burden of proof was shifted to the defendants. Here, as in Summers, the circumstances of the injury appear to render identification of the manufacturer of the drug ingested by plaintiff’s mother impossible by either plaintiff or defendants, and it cannot reasonably be said that one is in a better position than the other to make the identification. Because many years elapsed between the A-11 time the drug was taken and the manifestation of plain- tiff’s injuries she, and many other daughters of mothers who took DES, are unable to make such identification.” Certainly there can be no implication that plaintiff is at fault in failing to do so-—the event occurred while plaintiff was in utero, a generation ago.” On the other hand, it cannot be said with assurance that defendants have the means to make the identification. In this connection, they point out that drug manufacturers ordinarily have no direct contact with the patients who take a drug prescribed by their doctors. Defendants sell to wholesalers, who in turn supply the product to physicians and pharmacies. Manufacturers do not maintain records of the persons who take the drugs they produce, and the selection of the medication is made by the physician rather than the manufacturer. Nor do we conclude that the absence of evidence on this subject is due to the fault of defendants. While it is alleged that they produced a defec- tive product with delayed effects and without adequate warnings, the difficulty or impossibility of identification results primarily from the passage of time rather than from their allegedly negligent acts of failing to provide adequate warnings. Thus Haft v. Lone Palm Hotel (1970) 3 Cal.38d 756, upon which plaintiff relies, is distinguishable. 12. The trial court was not required to determine whether plaintiff had made sufficient efforts to establish identification since it concluded that her failure to do so was fatal toher claim. The court accepted at face value plaintiff's assertion that she could not make the identification, and for purposes of this appeal we make the same assumption. 13. Defendants maintain that plaintiff is in a better position than they are to identify the manufacturer because her mother might recall the name of the prescribing physician or the hospital or pharmacy where the drug originated, and might know the brand and strength of dosage, the appearance of the medication, or other details from which the manufac- turer might be identified, whereas they possess none of this information. As we point out in footnote 12, we assume for purposes of this appeal that plaintiff cannot point to any particular manufacturer as the producer of the DES taken by her mother. 14. In Haft, a father and his young son drowned in defendants’ swim- ming pool. There were no witnesses to the accident. Defendants were A-12 It is important to observe, however, that while defend- ants do not have means superior to plaintiff to identify the maker of the precise drug taken by her mother, they may in some instances be able to prove that they did not manufac- ture the injury-causing substance. In the present case, for example, one of the original defendants was dismissed from the action upon proof that it did not manufacture DES until after plaintiff was born. Thus we conclude that the fact defendants dc not have greater access to information which might establish the identity of the manufacturer of the DES which injured plaintiff does not per se prevent application of the Swmmers rule. Nevertheless, plaintiff may not prevail in her claim that the Summers rationale should be employed to fix the whole liability for her injuries upon defendants, at least as those principles have previously been applied.’® There is an negligent in failing to provide a lifeguard, as required by law. We held that the absence of evidence of causation was a direct and foreseeable result of the defendants’ negligence, and that, therefore, the burden of proof on the issue of causation was upon defendants. Plaintiff attempts to bring herself within this holding. She asserts that defendants’ failure to discover or warn of the dangers of DES and to label the drug as experimental caused her mother to fail to keep records or remember the brand name of the drug prescribed to her “since she was unaware of any reason to do so for a period of 10 to 20 years.” There is no proper analogy to Haft here. While in Haft the presence of a lifeguard on the scene would have provided a witness to the accident and probably prevented it, plain- tiff asks us to speculate that if the DES taken by her mother had been labelled as an experimental drug, she would have recalled or recorded the name of the manufacturer and passed this information on to her daughter. It cannot be said here that the absence of evidence of causation was a Ke og and foreseeable result” of defendants’ failure to provide a warning abel. 15. Plaintiff relies upon three older cases for the proposition that the burden of proof may be shifted to defendants to explain the cause of an accident even if less than all of them are before the court. (Benson v. Ross (Mich. 1906) 106 N.W. 1120; Moore v. Foster (Miss. 1938) 180 So. 73; Oliver v. Miles (Miss. 1927) 110 So. 666.) These cases do not relate to the shifting of the burden of proof; rather, they imposed liability upon one of two or more joint tort-feasors on the ground that they acted in concert in committing a negligent act. This theory of concerted action as a basis for defendants’ liability will be discussed infra. In Summers, we stated that these cases were “straining” the concept of concerted action A-13 important difference between the situation involved in Summers and the present case. There, all the parties who were or could have been responsible for the harm to the plaintiff were joined as defendants. Here, by contrast, there are approximately 200 drug companies which made DES, any of which might have manufactured the injury- producing drug.” Defendants maintain that, while in Summers there was a 50 percent chance that one of the two defendants was responsible for the plaintiff’s injuries, here since any one of 200 companies which manufactured DES might have made the product which harmed plaintiff, there is no rational basis upon which to infer that any defendant in this action caused plaintiff’s injuries, nor even a reasonable possibility that they were responsible.” These arguments are persuasive if we measure the chance that any one of the defendants supplied the injury- causing drug by the number of possible tortfeasors. In such a context, the possibility that any of the five defend- ants supplied the DES to plaintiff’s mother is so remote that it would be unfair to require each defendant to exonerate itself. There may be a substantial likelihood that none of and that the “more reasonable” basis for holding defendants jointly liable when more than one of them had committed a tort and plaintiff could not establish the identity of the party who had caused the damage was the danger that otherwise two negligent parties might be exonerated. (Sum- mers, 33 Cal.2d 80, at pp. 84-85.) 16. According to the Restatement, the burden of proof shifts to the defendants only if the plaintiff can demonstrate that all defendants acted tortiously and that the harm resulted form the conduct of one of them. (Rest.2d Torts, § 433B, com. g, p. 446.) It goes on to state that the rule thus far has been applied only where all the actors involved are joined as defendants and where the conduct of all is simultaneous in time, but cases might arise in which some modification of the rule would be necessary if one of the actors is or cannot be joined, or because of the effects of lapse of time, or other circumstances. (J/d., com. h, p. 446.) 17. Defendants claim further that the effect of shifting the burden of proof to them to demonstrate that they did not manufacture the DES which caused the injury would create a rebuttable presumption that one of them made the drug taken by plaintiffs’ mother, and that this presump- tion would deny them due process because there is no rational basis for the inference. A-14 the five defendants joined in the action made the DES which caused the injury, and that the offending producer not named would escape liability altogether. While we propose, infra, an adaptation of the rule in Summers which will substantially overcome these difficulties, defendants appear to be correct that the rule, as previously applied, cannot relieve plaintiff of the burden of proving the iden- tity of the manufacturer which made the drug causing her injuries."® The second principle upon which plaintiff relies is the so- called “concert of action” theory. Preliminarily, we briefly describe the procedure a drug manufacturer must follow before placing a drug on the market. Under federal law as it read prior to 1962, a new drug was defined as one “not generally recognized as...safe.” (§ 102, 76 Stat. 781 (Oct. 10, 1962).) Such a substance could be marketed only if a new drug application had been filed with the Food and Drug Administration and had become “effective.” If the 18. Garcia v. Joseph Vince Co., supra, 84 Cal.App.3d 868, relied upon by defendants, presents a distinguishable factual situation. The plaintiff in Garcia was injured by a defective saber. He was unable to identify which of two manufacturers had produced the weapon because it was commingled with other sabers after the accident. In a suit against both manufacturers, the court refused to apply the Summers rationale on the ground that the plaintiff had not shown that either defendant had vio- lated a duty tohim. Thus in Garcia, only one of the two defendants was alleged to have manufactured a defective product, and the plaintiff's inability to identify which of the two was negligent resulted in a judgment for both defendants. (See also Wetzel v. Eaton, supra, 62 F.R.D. 22.) Here, by contrast, the DES manufactured by all defendants is alleged to be defective, but plaintiff is unable to demonstrate which of the defen- dant’s supplied the precise DES which caused her injuries. 19. A new drug application became “effective” automatically if the Secretary of Health, Education and Welfare failed within a certain period of time to disapprove the application. If the agency had insufficient information to decide whether the drug was safe or had information that it was unsafe, the application was denied. (§ 505,52 Stat. 1052 (June 25, 1938).) Since 1962, affirmative approval of an application has been required before a new drug may be marketed. (21 U.S.C.A. § 355,subd. (c).) A-15 agency determined that a product was no longer a “new drug,” i.e., that it was “gengrally recognized as... safe,” (21 U.S.C.A. § 321, subd. (p) (1) ) it could be manufactured by any drug company without submitting an application to the agency. According to defendants, 123 new drug appli- cations for DES had been approved by 1952, and in that year DES was declared not to be a “new drug,” thus allowing any manufacturer to produce it without prior testing and without submitting a new drug application to the Food and Drug Administration. With this background we consider whether the com- plaint states a claim based upon “concert of action” among defendants. The elements of this doctrine are prescribed in section 876 of the Restatement of Torts. The section pro- vides, “For harm resulting to a third person from the tor- tious conduct of another, one is subject to liability if he (a) does a tortious act in concert with the other or pursuant to a common design with him, or (b) knows that the other’s conduct constitutes a breach of duty and gives substantial assistance or encouragement to the other so to conduct him- self, or (c) gives substantial assistance to the other in accomplishing a tortious result and his own conduct, sepa- rately considered, constitutes a breach of duty to the third person.” With respect to this doctrine, Prosser states that “those who, in pursuance of a common plan or design to commit a tortious act, actively take part in it, or further it by cooperation or request, or who lend aid or encourage- ment to the wrongdoer, or ratify and adopt his acts done for their benefit, are equally liable with him. [{] Express agreement is not necessary, and all that is required is that there be a tacit understanding....” (Prosser, Law of Torts (4th ed. 1971), sec. 46, p. 292.) Plaintiff contends that her complaint states a cause of action under these principles. She alleges that defendants’ wrongful conduct “is the result of planned and concerted action, express and implied agreements, collaboration in, A-16 reliance upon, acquiescence in and ratification, exploitation and adoption of each other’s testing, marketing methods, lack of warnings ... and other acts or omissions. . .” and that “acting individually and in concert, { defendants ] pro- moted, approved, authorized, acquiesced in, and reaped profits from sales” of DES. These allegations, plaintiff claims, state a “tacit understanding” among defendants to commit a tortious act against her. In our view, this litany of charges is insufficient to allege a cause of action under the rules stated above. The grava- men of the charge of concert is that defendants failed to adequately test the drug or to give sufficient warning of its dangers and that they relied upon the tests performed by one another and took advantage of each others’ promotional and marketing techniques. These allegations do not amount to a charge that there was a tacit understanding or a common plan among defendants to fail to conduct ade- quate tests or give sufficient warnings, and that they sub- stantially aided and encouraged one another in these omissions. The complaint charges also that defendants produce DES from a “common and mutually agreed upon formula,” allowing pharmacists to treat the drug as a “fungible com- modity” and to fill prescriptions from whatever brand of DES they had on hand at the time. It is difficult to under- stand how these allegations can form the basis of a cause of action for wrongful conduct by defendants, acting in con- cert. The formula for DES is a scientific constant. It is set forth in the United States Pharmacopoeia, and any manu- facturer producing that drug must, with exceptions not relevant here, utilize the formula set forth in that compen- dium. (21 U.S.C.A. § 351, subd. (b).) What the complaint appears to charge is defendants’ parallel or imitative conduct in that they relied upon each others’ testing and promotion methods. But such conduct describes a common practice in industry: a producer avails A-17 himself of the experience and methods of others making the same or similar products. Application of the concept of concert of action to this situation would expand the doc- trine far beyond its intended scope and would render virtu- ally any manufacturer liable for the defective products of an entire industry, even if it could be demonstrated that the product which caused the injury was not made by the defendant. None of the cases cited by plaintiff supports a conclusion that defendants may be held liable for concerted tortious acts. They involve conduct by a small number of individu- als whose actions resulted in a tort against a single plain- tiff, usually over a short span of time, and the defendant held liable was either a direct participant in the acts which caused damage,” or encouraged and assisted the person who directly caused the injuries by participating in a joint activity.” Orser v. George (1967) 252 Cal.App.2d 660, upon which plaintiff primarily relies, is also distinguishable. There, three hunters negligently shot at a mudhen in decedent’ direction. Two of them shot alternately with the gun which released the bullet resulting in the fatal wound, and the third, using a different gun, fired alternately at the same target, shooting in the same line of fire, perhaps act- ing tortiously. It was held that there was a possibility the third hunter knew the conduct of the others was tortious 20. Weinberg Co. v. Bixby (1921) 185 Cal. 87, 103, involved a hus- band who was held liable with his wife for wrongful diversion of flood waters although he had given his wife title to the land upon which the outlet causing the diversion was constructed. He not only owned land affected by the flood waters, but he was his wife’s agent for the purpose of reopening the outlet which caused the damage. In Meyer v. Thomas (1936) 18 Cal.App.2d 299, 305-306, both defendants participated in the conversion of a note and deed of trust. 21. In Agovino v. Kunze (1960) 181 Cal.App.2d 591, 599, a partici- pant in a drag race was held liable for injuries to a plaintiff who collided with the car of another racer. In Loeb v. Kimmerle (1932) 215 Cal. 143, 151, a defendant who encouraged another defendant to commit an assult was held jointly liable for the plaintiff's injuries. Also see Weirum v. RKO General, Inc. (1975) 15 Cal.3d 40. A-18 toward the decedent and gave them substantial assistance and encouragement, and that it was also possible his con- duct, separately considered, was a breach of duty toward decedent. Thus, the granting of summary judgment was reversed as to the third hunter. The situation in Orser is similar to Agovino v. Kunze, supra, 181 Cal.App.2d 591, in which liability was imposed upon a participant in a drag race, rather than to the facts alleged in the present case. There is no allegation here that each defendant knew the other defendants’ conduct was tortious toward plaintiff, and that they assisted and encouraged one another to inadequately test DES and to provide inadequate warnings. Indeed, it seems dubious whether liability on the concert of action theory can be predicated upon substantial assistance and encouragement given by one aileged tortfeasor to another pursuant to a tacit understanding to fail to perform an act. Thus there was no concert of action among defendants within the meaning of that doctrine. III A third theory upon which plaintiff relies is the concept of industry-wide liability, or according to the terminology of the parties, “enterprise liability.” This theory was sug- gested in Hall v. E. I. Du Pont de Nemours & Co., Ince. (E.D.N.Y. 1972) 345 F.Supp. 353. In that case, plaintiffs were 13 children injured by the explosion of blasting caps in 12 separate incidents which occurred in 10 different states between 1955 and 1959. The defendants were six blasting cap manufacturers, comprising virtually the entire blasting cap industry in the United States, and their trade association. There were, however, a number of Cana- dian blasting cap manufacturers which could have sup- plied the caps. The gravamen of the complaint was that the practice of the industry of omitting a warning on indi- vidual blasting caps and of failing to take other safety A-19 measures created an unreasonable risk of harm, resulting in the plaintiffs’ injuries. The complaint did not identify a particular manufacturer of a cap which caused a particular injury.” The court reasoned as follows: there was evidence that defendants, acting independently, had adhered to an indus- try-wide standard with regard to the safety features of blasting caps, that they had in effect delegated some func- tions of safety investigation and design, such as labelling, to their trade association, and that there was industry-wide cooperation in the manufacture and design of blasting caps. In these circumstances, the evidence supported a conclu- sion that all the defendants jointly controlled the risk. Thus, if plaintiffs could establish by a preponderance of the evidence that the caps were manufactured by one of the defendants, the burden of proof as to causation would shift to all the defendants. The court noted that this theory of liability applied to industries composed of a small number of units, and that what would be fair and reasonable with 22. We deliberately employ the term “suggested” to describe the effect of the Hall opinion because of the uncertain posture of the decision as authority. The defendants moved to dismiss the action on the ground that the plaintiffs had not stated a claim, and they also sought to sever the claims of the various plaintiffs and transfer them to the district court in the place where each accident occurred. The opinion discusses various possible bases of liability, including industry-wide liability, upon the assumption that there existed a national body of state tort law. (345 F.Supp. at p. 360.) At the conclusion of its opinion, the court called for briefs on the choice-of-law issues involved in the case. In a subsequent opinion, the same court decided, after briefs had been filed on the choice- of-law question, that the plaintiffs’ claims should be severed, and it trans- ferred each one to the federal court sitting in the district where the accident occurred. (Chance v. E. I. Du Pont de Nemours & Co., Inc. (E.D.N.Y. 1974) 371 F.Supp. 439.) Thereafter, the transferred cases resulted in judgments for defendants upon various grounds unrelated to the theory of industry-wide liability. (Lehtonen v. E. I. Du Pont de Nemours & Co., Inc. (D. Mont. 1975) 389 F.Supp. 633 [failure to amend complaint within 30 days]; Davis v. E. I. Du Pont de Nemours & Co., Inc. (W.D.N.C. 1974) 400 F.Supp. 1347 [statute of limitations]; Ball v. E. I. Du Pont de Nemours & Co., Inc. (6th Cir. 1975) 519 F.2d 715 [jury verdict in favor of defendant after plaintiff identified the manufacturer of the blasting cap which caused his injuries].) The parties have not indicated the status of the remaining cases transferred. A-20 regard to an industry of five or ten producers might be manifestly unreasonable if applied to a decentralized industry composed of countless small producers.” Plaintiff attempts to state a cause of action under the rationale of Hall. She alleges joint enterprise and collabo- ration among defendants in the production, marketing, pro- motion and testing of DES, and “concerted promulgation and adherence to industry-wide testing, safety, warning and efficacy standards” for the drug. We have concluded above that allegations that defendants relied upon one another’s testing and promotion methods do not state a cause of action for concerted conduct to commit a tortious act. Under the theory of industry-wide liability, however, each manufacturer could be liable for all injuries caused by DES by virtue of adherence to an industry-wide standard of safety. In the Fordham Comment, the industry-wide theory of liability is discussed and refined in the context of its appli- eability to actions alleging injuries resulting from DES. The author explains causation under that theory as follows, “... {T]he industrywide standard becomes itself the cause of plaintiff’s injury, just as defendants’ joint plan is the cause of injury in the traditional concert of action plea. Each defendant’s adherence perpetuates this standard, which results in the manufacture of the particular, uniden- tifiable injury-producing product. Therefore, each indus- try member has contributed to plaintiff’s injury.” (Fordham Comment, supra, at p. 997.) The Comment proposes seven requirements for a cause of action based upon industry-wide liability,“ and suggests 23. In discussing strict liability, the Hal/ court mentioned the drug industry, stating, “In cases where manufacturers have more experience, more information, and more control over the risky properties of their products than do drug manufacuturers, courts have applied a broader concept of forseeability which approaches the enterprise liability ratio- nale.” (345 F.Supp. 353 at p. 370.) 24. The suggested requirements are as follows: 1. There existed an insufficient, industry-wide standard of safety as to the manufacture of the product. A-21 that if a plaintiff proves these elements, the burden of proof of causation should be shifted to the defendants, who may exonerate themselves only by fnomtag that their product could not have caused the injury.” We decline to apply this theory in the present case. At least 200 manufacturers produced DES; Hall, which invoived 6 manufacturers representing the entire blasting cap industry in the United States, cautioned against appli- cation of the doctrine espoused therein to a large number of producers. (345 F.Supp. at p. 378.) Moreover, in Hall, the conclusion that the defendants jointly controlled the risk was based upon allegations that they had delegated some functions relating to safely to a trade association. There are no such allegations here, and we have concluded above that plaintiff has failed to allege liability on a concert of action theory. Equally important, the drug industry is closely regu- lated by the Food and Drug Administration, which 2. Plaintiff is not at fault for the absence of evidence identify- ing the causative agent but, rather, this absence of proof is due to defendant's conduct. 3. A generically similar defective product was manufactured by all the defendants. 4. Plaintiff's injury was caused by this defect. 5. Defendants owed a duty to the class of which plaintiff was a member. 6. There is clear and convincing evidence that plaintiff's injury was caused by a product made by one of the defendants. For example, the joined defendants accounted for a high percent- age of such defective products on the market at the time of plain- tiff’s injury. 7. All defendants were tortfeasors. 25. The Fordham Comment takes exception to one aspect of the theory of industry-wide liability as set forth in Hall, i.e., the conclusion that a plaintiff is only required to show by a preponderance of the evi- dence that one of the defendants manufactured the product which caused her injury. The Comment suggests that a plaintiff be required to prove by clear and convincing evidence that one of the defendants before the court was responsible and that this standard of proof would require that the plaintiff join in the action the producers of 75 or 80 percent of the DES prescribed for prevention of miscarriage. It is also suggested that the damages be apportioned among the defendants according to their share of the market for DES. (Fordham Comment, supra, 999-1000. ) A-22 actively controls the testing and manufacture of drugs and the method by which they are marketed, including the contents of warning labels.” To a considerable degree, therefore, the standards followed by drug manufacturers are suggested or compelled by the government. Adherence to those standards cannot, of course, absolve a manufac- turer of liability to which it would otherwise be subject. (Stevens v. Parke, Davis & Co. (1973) 9 Cal.3d 51, 65.) But since the government plays such a pervasive role in formulating the criteria for the testing and marketing of drugs, it would be unfair to impose upon a manufacturer liability for injuries resulting from the use of a drug which it did not supply simply because it followed the standards of the industry.” IV If we were confined to the theories of Summers and Hall, we would be constrained to hold that the judgment must be sustained. Should we require that plaintiff identify the manufacturer which supplied the DES used by her mother or that all DES manufacturers be joined in the action, she would effectively be precluded from any recovery. As defendants candidly admit, there is little likelihood that all the manufacturers who made DES at the time in question are still in business or that they are subject to the jurisdic- tion of the California courts. There are, however, forceful arguments in favor of holding that plaintiff has a cause of action. 26. Federal regulations may specify the type of tests a manufacturer must perform for certain drugs (21 C.F.R. § 436.206 et seq.), the type of packaging used (§ 429.10), the warnings which appear on_ labels a 369.20), and the standards to be followed in the manufacture of a drug (§ 211.22 et seq.). 27. Abel v. Eli Lilly & Company, the Michigan case referred to above which held that the plaintiffs had stated a cause of action against several manufacturers of DES even though they could not identify a particular manufacturer as the source of a particular injury (see fn. 7, ante), relied upon the theories of concerted action and alternative liability. A-23 In our contemporary complex industrialized society, advances in science and technology create fungible goods which may harm consumers and which cannot be traced to any specific producer. The response of the courts can be either to adhere rigidly to prior doctrine, denying recovery to those injured by such products, or to fashion remedies to meet these changing needs. Just as Justice Traynor in his landmark concurring opinion in Escola v. Coca Cola Bot- tling Company (1944) 24 Cal.2d 453, 467-468, recognized that in an era of mass production and complex marketing methods the traditional standard of negligence was insuffi- cient to govern the obligations of manufacturer to con- sumer, so Should we acknowledge that some adaptation of the rules of causation and liability may be appropriate in these recurring circumstances. The Restatement com- ments that modification of the Summers rule may be neces- sary in a situation like that before us. (See fn. 16, ante.) The most persuasive reason for finding plaintiff states a cause of action is that advanced in Summers: as between an innocent plaintiff and negligent defendants, the latter Should bear the cost of the injury. Here, as in Summers, plaintiff is not at fault in failing to provide evidence of causation, and although the absence of such evidence is not attributable to the defendants either, their conduct in mar- keting a drug the effects of which are delayed for may years played a significant role in creating the unavailabil- ity of proof. From a broader policy standpoint, defendants are better able to bear the cost of injury resulting from the manufac- ture of a defective product. As was said by Justice Tray- nor in Escola, “| t |he cost of an injury and the loss of time or health may be an overwhelming misfortune to the person injured, and a needless one, for the risk of injury can be insured by the manufacturer and distributed among the public as a cost of doing business.” (24 Cal.2d p. 462; see A-24 also Rest.2d Torts, § 402A, com. c, pp. 349-350.) The manu- facturer is in the best position to discover and guard against defects in its products and to warn of harmful effects; thus, holding it liable for defects and failure to warn of harmful effects will provide an incentive to product safety. (Cronin v. J.B.E. Olson Corp. (1972) 8 Cal.3d 121, 129; Beech Aircraft Corp. v. Superior Court (1976) 61 Cal.App.3d 501, 522-523.) These considerations are partic- ularly significant where medication is involved, for the consumer is virtually helpless to protect himself from seri- ous, Sometimes permanent, sometimes fatal, injuries caused by deleterious drugs. Where, as here, all defendants produced a drug from an identical formula and the manufacturer of the DES which caused plaintiff’s injuries cannot be identified through no fault of plaintiff, a modification of the rule of Summers is warranted. As we have seen, an undiluted Swmmers ratio- nale is inappropriate to shift the burden of proof of causa- tion to defendants because if we measure the chance that any particular manufacturer supplied the injury-causing product by the number of producers of DES, there is a possibility that none of the five defendants in this case produced the offending substance and that the responsible manufacturer, not named in the action, will escape liability. But we approach the issue of causation from a different perspective: we hold it to be reasonable in the present con- text to measure the likelihood that any of the defendants supplied the product which allegedly injured plaintiff by the percentage which the DES sold by each of them for the purpose of preventing miscarriage bears to the entire pro- duction of the drug sold by all for that purpose. Plaintiff asserts in her briefs that Eli Lilly and Company and 5 or 6 other companies produced 90 percent of the DES marketed. If at trial this is established to be the fact, then there is a corresponding likelihood that this comparative handful of A-25 producers manufactured the DES which caused plaintiff’s injuries, and only a 10 percent likelihood that the offending producer would escape liability.” If plaintiff joins in the action the manufacturers of a substantial share of the DES which her mother might have taken, the injustice of shifting the burden of proof to defendants to demonstrate that they could not have made the substance which injured plaintiff is significantly diminished. While 75 to 80 percent of the market is sug- gested as the requirement by the Fordham Comment (at p. 996), we hold only that a substantial percentage is required. The presence in the action of a substantial share of the appropriate market also provides a ready means to appor- tion damages among the defendants. Each defendant will be held liable for the proportion of the judgment repre- sented by its share of that market unless it demonstrates that it could not have made the product which caused plaintiff’s injuries. In the present case, as we have seen, one DES manufacturer was dismissed from the action upon filing a declaration that it had not manufactured DES until after plaintiff was born. Once plaintiff has met her burden of joining the required defendants, they in turn may cross- complain against other DES manufacturers, not joined in the action, which they can allege might have supplied the injury-causing product. Under this approach, each manufacturer’s liability would approximate its responsibility for the injuries caused 28. The Fordham Comment explains the connection between percent- age of market share and liability as follows: “[I]f X Manufacturer sold one-fifth of all the DES prescribed for pregnancy and identification could be made in all cases, X would be the sole defendant in approximately one- | fifth of all cases and liable for [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385007_0192%3A1. Public record. Not legal advice.