# Opposition Brief — Mazur v. Merck & Co. > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386011_1292%3A2 ## Record - **Collection:** Supreme Court brief - **Document type:** Opposition Brief - **Published:** January 1, 1992 - **Citation:** 506 U.S. 974 ## Text SS” No. 92-453 en | reece OF UME CLERK Supreme Court of the United States October Term, 1992 - ANTHONY MAZUR and EDNA MAZUR as Parents and Guardians of LISA MARIE MAZUR, a Minor, and ANTHONY MAZUR, and EDNA MAZUR, in their own right, Petitioners, MERCK & CO., INC., Respondent. ‘ On Petition For A Writ Of Certiorari To The United States Court Of Appeals For The Third Circuit © RESPONDENT'S BRIEF IN OPPOSITION . Epwarp M. Posner* MicHaeEL O’S. FLoyp WituiAM V. ROEDER DRINKER BippLe & REATH — Philadelphia National Bank Building 1345 Chestnut Street Philadelphia, PA 19107-3496 (215) 988-2700 Attorneys for Respondent Merck & Co., Inc. *Counsel of Record COUNTER-STATEMENT OF QUESTION PRESENTED FOR REVIEW Whether the Court of Appeals correctly followed long-established precedent of the Pennsylvania Supreme and Superior Courts in holding that the scope of a vac- cine manufacturer’s duty to warn of possible health risks associated with its product is governed by the “rea- sonableness” standard of Section 388 of the Restatement (Second) of Torts, and in holding that respondent Merck satisfied its duty by providing to the Centers for Disease Control adequate information concerning the vaccine and by contractually obligating that agency to communicate the risks and benefits of the vaccine to vaccinees. ii TABLE OF CONTENTS Page Counter-Statement of Question Presented for Review ._ i Table of Contents ©...540455 550 0n es Obese eee ii Table of Authoriltet «640454554555 ee eee iii Opinions Below .. . ..¢. The seminal case is the Pennsylvania Supreme Court’s decision in Incollingo v. Ewing, 282 A.2d 206 (Pa. 1971). There, the Pennsylvania Supreme Court explained that ordinarily Pennsylvania follows Section 402A of the Restatement (Second) of Torts which imposes strict lia- bility on the manufacturer of a product sold in a defective condition unreasonably dangerous to the user or con- sumer. The Court held, however, that these principles of Section 402A do not apply to “failure to warn” claims involving prescription drugs, which are “unavoidably unsafe products” within the meaning of comment k to Section 402A. Instead, for such products, the standard of care as defined by Section 388 of the Restatement is > Reference is primarily made to the Court of Appeals’ decision, particularly at 964 F.2d at 1353-55, 1364-66, for the court’s reasoning on this issue. A brief summary, however, is given against the backdrop of certain arguments made by Peti- tioners. 10 applied. Under this section, the manufacturer has a duty to exercise “reasonable care” to inform those for whose use the article is supplied of the facts that make it likely to be dangerous. Incollingo, 282 A.2d at 220 n.8. See also 964 F.2d at 1353-55. Thirteen years later, the Pennsylvania Supreme Court reaffirmed the Incollingo holding in Bald- ino v. Castagna, 478 A.2d 807, 810 (Pa. 1984). The Court of Appeais believed that there was nothing unclear or unsettled concerning the applicable Pennsyl- vania law and stated that “because the M-M-R II vaccine is an ‘unavoidably unsafe product’, we believe Incollingo is controlling here.” 964 F.2d at 1354. The Court of Appeals further recognized that “at least in cases involv- ing ‘unavoidably unsafe products’, the Pennsylvania Supreme Court has not distinguished between a prescrip- tion drug manufacturer’s duty to warn in negligence versus strict liability.” Id. at 1355 n.8. Petitioners urge here, as they did below, that Incol- lingo and Baldino are inapposite because they involved negligence rather than strict liability causes of action. However, as the Court of Appeals noted, the court’s reasoning in Incollingo was based on its analysis of the proper rules under section 402A with regard to “unavoidably unsafe products,” not on the absence in that case of a strict liability failure to warn claim.® This has certainly been the understanding of the Pennsylvania 6 Significantly, not one of the cases cited by Petitioners in support of their proposition that under Pennsylvania law negli- gence concepts have no place in strict liability failure to warn analysis involves prescription drugs or other “unavoidably unsafe products” as defined by comment k. - a a 11 Superior Court, which has uniformly applied the Incol- lingo/Baldino holding in numerous cases involving a phar- maceutical manufacturer’s duty to warn. See White v. Weiner, 562 A.2d 378, 384 (Pa. Super. Ct. 1989), aff’d without op., 583 A.2d 789 (Pa. 1991); McDaniel v. Merck, Sharp & Dohme, 533 A.2d 436, 445-46 (Pa. Super. Ct. 1987), Makripodis v. Merrell-Dow Pharm. Inc., 523 A.2d 374, 377 (Pa. Super. Ct. 1987). See also Hahn v. Richter, No. 00019, Phila., 1992 Pa. Super. LEXIS 275 (Pa. Super. Ct., Feb. 13, 1992), reh’g granted, May 1, 1992. It is noteworthy that the Petition for Certiorari does not cite to a single failure to warn case involving a prescription drug or “unavoidably unsafe product” that contradicts the law as applied by the Court of Appeals. The Court of Appeals also applied Section 388 of the Restatement in deciding whether Merck reasonably relied on the CDC’s contractual guarantee that M-M-R II would be administered by a physician or only after a meaning ful warning had been provided to the vaccinees or their parents. In evaluating Merck’s duty to warn under Sec- tion 388, the court turned to the comments to this section that provide that a manufacturer may meet its duty to warn by entrusting the communication of that warning to a third person.” 964 F.2d at 1367-69. Accordingly, the ” Berkebile v. Brantly Helicopter Corp., 337 A.2d 893, 903 (Pa. 1975), is inapposite as it did not involve the application of duty to warn concepts to an “unavoidably unsafe product”. Petitioners also cite to the “mass immunization” rule for the Proposition that Merck had a duty to warn directly vaccinees or their parents. Pet. For Writ Or Cert. at 16. Petitioners misstate that rule. The “mass immunization” exception provides that “it is the responsibility of the manufacturer to see that warnings 12 Court of Appeals correctly concluded, based on estab- lished law, that Merck had satisfactorily fulfilled its duty to warn.® B. The Court Of Appeals Acted Correctly In Deciding The Case Before It On The Basis Of Settled Pennsylvania Law. Petitioners raise an “abstention” issue for the first time in their Petition for Writ of Certiorari. “Where issues are neither raised before nor considered by the Court of Appeals, this Court will not ordinarily consider them.” Adickes v. Kress & Co., 398 U.S. 144, 147 n.2 (1970). Only in exceptional circumstances will such issues be reviewed. Youakim v. Miller, 425 U.S. 230, 234 (1976). Compare City of Houston, Texas v. Hill, 482 U.S. 451, 467 n.16 (1987). Merck seriously questions whether Petitioners should be able to raise this issue at this time. However, even if Petitioners reach the consumer, either by giving warning itself or by oblig- ating the purchaser to give warning.” Davis v. Wyeth Laborato- ries, 399 F.2d 121, 131 (9th Cir. 1968). This is exactly what Merck did here. In effect, Petitioners asked the courts below to adopt “half” of the “mass immunization” exception. 8 Because the Court of Appeals held that Merck satisfied its duty to warn as a matter of law, it did not reach the question of proximate causation. 964 F.2d at 1352 n.3. Petitioners have always contended that Lisa was vaccinated over her parents’ objections. If, in fact, Lisa’s parents never consented to her vaccination, it is difficult to conceive how any alleged failure to warn by Merck could have proximately caused Lisa’s vaccina- tion or her injuries. In any event, Merck does not concede that M-M-R II, in fact, caused Lisa Mazur’s SSPE. 13 could properly raise the issue before this Court, their arguments are meritless. It is the duty of a federal court sitting in diversity to decide questions of state law in rendering judgment. Abstention from this duty is the exception, not the rule. It is an extraordinary, limited and narrow exception. Colo- rado River Water Conservation Dist. v. U.S., 424 U.S. 800 (1976). As this Court determined in Meredith v. City of Winter Haven, 320 U.S. 228 (1943), it is inappropriate for a federal court sitting in diversity to defer or decline its decision in a wholly state law case merely because the answers to questions of state law are difficult or uncer- tain. Id. at 234-35. In this case, the questions of state law are not even “difficult” or “uncertain.” The state law is settled. See supra pp. 7-11. There is no reason, then, to require the Court of Appeals to “defer” making its deci- sion on a case that is properly before it. Petitioners seek to deviate from this Court’s estab- lished policies, thereby creating a new procedure on how and when federal courts sitting in diversity should render judgment. Petitioners ask this Court to require the Court of Appeals to wait for a ruling on a similar issue from a state intermediate appellate court, when the Pennsyi- vania Supreme Court already has squarely addressed the same issue. In support of such a request, Petitioners rely on the possibility that the Superior Court en banc might overturn the panel’s decision in Hahn v. Richter, No. 00019, Phila., 1992 Pa. Super. LEXIS 275 (Pa. Super. Ct., Feb. 13, 1992), reh’g granted, May 1, 1992, going so far as 14 to predict its reversal.? Assuming, arguendo, that the Superior Court did overturn Hahn, that decision would not be binding on the Court of Appeals. Commissioner v. Estate of Bosch, 387 U.S. 456, 465 (1967). Would the Court of Appeals then be required to stay further its decision until disposition of the inevitable appeal to the Pennsyl- vania Supreme Court? The same argument as is here made by Petitioners could be urged to require a federal court sitting in diversity to “defer” its decision whenever a case involving similar issues is pending, at any stage, in the state court system. The adoption of such arguments would unduly delay federal court decision-making and interfere with the proper exercise of diversity jurisdic- tion. a The Court of Appeals did not abuse its discretion in deciding the case before it based on what it believed was controlling authority by the Pennsylvania Supreme Court. Indeed, the Court of Appeals was obligated to decide rather than defer the case.!° ® Petitioners’ prediction as to the Superior Court’s decision is speculative at best. The majority in Hahn applied the same analysis and reached the same conclusion on the duty to warn issue as the District Court and the Court of Appeals. Further- more, a grant of rehearing by the Superior Court gives abso- lutely no indication as to what the Pennsylvania Supreme Court might decide. 10 Similarly, traditional doctrines of abstention do not afford any relief to Petitioners. The present case involves state common law claims and the state law to be applied is settled. There is no federal constitutional question that might be mooted or presented in a different posture by a state court determina- tion of pertinent state law. See, e.g., Railroad Comm'n of Texas v. Pullman Co., 312 U.S. 643 (1941). Federal jurisdiction in this case a 15 C. The Court of Appeals’ Decision, Correctly Applying Pennsylvania Law, Will Not Preclude Future Plaintiffs From Obtaining Proper Redress. It is the judicial function to decide whether the par- ticular plaintiff, on the particular facts before the court, is entitled to redress from the particular defendant. Draw- ing all inferences against respondent Merck, the Court of Appeals, as discussed above, applied established Penn- sylvania law, and determined that Petitioners were not entitled to recovery for their claims on the specific facts of this case. The practical effect of the Court of Appeals’ decision is no different from that of any other court decision. Petitioners’ assertion that the Court of Appeals’ deci- sion forecloses any redress for possible claims from future vaccine-related injuries is otherwise flawed. In 1987, Congress passed the National Childhood Vaccine Injury Program (the “Act”), 42 U.S.C. §§ 3U0aa-10, et seq. The Act provides a no fault system of compensation in has not been invoked to interfere or restrain the state court from proceeding in litigation with the same parties on the same issues. See, e.g., Younger v. Harris, 401 U.S. 37 (1971). Nor does the case involve a difficult question of state law which bears on policy problems in which the federal court’s action would dis- rupt the state’s interests. See, e.g., Colorado River Water Conserva- tion Dist. v. U.S., 424 U.S. 800 (1976); Louisiana Power & Light v. Thibodaux, 360 U.S. 25 (1959). This case also does not involve parallel state and federal suits between the same parties where exceptional circumstances might justify a stay or dismissal of the federal action. See, e.g., Moses H. Cone Hospital v. Mercury Constr. Corp., 460 U.S. 1 (1983). 16 which the claimant need not demonstrate that the manu- facturer was negligent or that the vaccine was defective. Furthermore, it reduces the difficulty of establishing cau- sation. Id. at § 300aa-11. Under the Act compensation may be available for unreimbursable expenses, pain and suf- fering, loss of earnings, reasonable attorneys’ fees, and other costs incurred in pursuing a claim. Id. at § 300aa-15. Petitioners elected not to present a claim under the Act and attempted to seek recovery through the civil tort system. Others remain free to seek redress under the Act. o CONCLUSION For all the foregoing reasons, the Petition for Writ of Certiorari should be denied. Respectfully submitted, Dated: October 14, 1992 Epwarp M. Posner* MicHaEL O’S. FLoyp WILLIAM V. ROEDER DriNKER BippLe & REATH Philadelphia National Bank Building 1345 Chestnut Street on Serer Philadelphia, PA KENNETH C. FRAZIER 19107-3496 JOANNE LAHNER (215) 988-2700 Merck & Co., INc. 126 East Lincoln Ave. Attorneys for Respondent P.O. Box 2000 Merck & Co., Inc. Rahway, NJ 07065 *Counsel of Record eT © App. 1 APPENDIX Rule 29.1 Listing Merck & Co., Inc. Subsidiaries: Banyu Pharmaceutical Co., Limited A.S.C. Service Co., Ltd. Nippon Merck-Banyu Co., Limited Merck & Co., Inc. Joint Ventures: Amrad Pharmaceuticals Pty. Ltd. The du Pont Merck Pharmaceutical Company Istituto di Ricerche di Biologia Molecolare S.p.A. Johnson & Johnson Merck Consumer Pharmaceuticals Company Laboratories Prosalud, S. de R.L. de C.V. Maquifar S. de R.L. de C.V. Prodome Quimica e Farmaceutica Ltda. --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386011_1292%3A2. Public record. Not legal advice.