Hannan v. Boston Scientific Corporation

1

2

3

4 UNITED STATES DISTRICT COURT

5 NORTHERN DISTRICT OF CALIFORNIA

6

7 TAMI HANNAN, et al.,

Case No. 19-cv-08453-PJH

8 Plaintiffs,

9 v. ORDER GRANTING IN PART AND

DENYING IN PART MOTION TO

10 BOSTON SCIENTIFIC CORPORATION, DISMISS

11 Defendant. Re: Dkt. No. 20

12

13

14 Before the court is defendant Boston Scientific Corporation’s (“Boston Scientific” or

15 “defendant”) motion to dismiss. The matter is fully briefed and suitable for decision

16 without oral argument. Having read the parties’ papers and carefully considered their

17 arguments and the relevant legal authority, and good cause appearing, the court hereby

18 rules as follows.

19 BACKGROUND

20 On December 30, 2019, plaintiffs Tami Hannan and Daniel Hannan (“plaintiffs”)1

21 filed a complaint alleging that one of defendant Boston Scientific’s pelvic mesh products

22 was implanted in Tami Hannan and has since caused her significant pain and other

23 harm. Dkt. 1. On February 25, 2020, plaintiffs filed a First Amended Complaint (“FAC”)

24 alleging seven causes of action: (1) product liability—defective manufacture and design;

25 (2) product liability—failure to warn; (3) negligence; (4) breach of express warranty; (5)

26 negligent misrepresentation; (6) violation of California Business & Professions Code

27

1 § 17200 et seq.; and (7) loss of consortium. Dkt. 19.

2 This case is related to a multi-district litigation (“MDL”) that consolidated cases

3 involving defendant’s transvaginal pelvic mesh products for pretrial purposes in the

4 District Court for the Southern District of West Virginia. See In Re: Bos. Sci. Corp., Pelvic

5 Repair Sys. Prods. Liab. Litig., No. MDL 2326 (S.D. W. Va. Jan. 29, 2012).2 Since its

6 inception in 2012, tens of thousands of cases have been transferred to the pelvic mesh

7 products MDL. The presiding MDL judge has worked up “waves” of individual cases

8 whereby the district court would handle all pretrial discovery and motions practice before

9 remanding each case to the appropriate district for trial. See, e.g., In re Bos. Sci. Corp.,

10 Pelvic Repair Sys. Prods. Liab. Litig., No. 2:12-CV-05950, 2015 WL 1405498, at *1

11 (S.D.W. Va. Mar. 26, 2015) (describing MDL process). In late June 2018, the Judicial

12 Panel on Multidistrict Litigation and the presiding judge issued orders such that new

13 plaintiffs could no longer file claims directly in the MDL. See Pretrial Order No. 188, In

14 Re: Bos. Sci. Corp., Pelvic Repair Sys. Prods. Liab. Litig., No. MDL 2326 (S.D. W. Va.

15 June 21, 2018).

16 Plaintiffs in this case were originally part of the fourth wave of cases in MDL 2326,

17 having filed their claims on December 29, 2015. See Hannan v. Bos. Sci. Corp., No. 15-

18 cv-16560 (S.D. W. Va.). While the parties engaged in discovery, they simultaneously

19 undertook efforts to resolve plaintiffs’ claims, which resulted in the presiding judge

20 transferring the case to the court’s “inactive docket.” The court later determined that

21 thousands of cases ended up on the inactive docket where they resided for much longer

22 than the court originally intended and ordered the inactive docket closed. See Pretrial

23 Order No. 195, In Re: Bos. Sci. Corp., Pelvic Repair Sys. Prods. Liability Litig., No. MDL

24 2326 (S.D. W. Va. Oct. 24, 2018). In an effort to continue settlement negotiations, the

25 parties agreed to dismiss plaintiffs’ claims without prejudice, which was granted on

26 January 14, 2019. Unable to resolve the claims, plaintiffs filed the present action as they

27

1 were no longer able to file directly in the MDL.

2 Defendant Boston Scientific manufactures a series of pelvic mesh products that

3 are used to treat pelvic organ prolapse and stress urinary incontinence. FAC ¶¶ 9–10.

4 Pelvic organ prolapse occurs when a pelvic organ drops from its normal position and

5 pushes against the wall of the vagina. Id. ¶ 11. Stress urinary incontinence is a type of

6 incontinence characterized by urine leakage during moments of physical stress. Id. ¶ 12.

7 Defendant’s pelvic mesh products contain surgical mesh that is generally used to repair

8 weakened or damaged tissue and is permanently implanted to reinforce weakened

9 vaginal walls which then helps repair pelvic organ prolapse or supports the urethra to

10 treat urinary incontinence. Id. ¶ 13.

11 Despite claims that surgical mesh is inert, scientific evidence shows that when

12 surgical mesh is implanted, the polypropylene mesh promotes severe foreign body

13 reaction and chronic inflammatory response. Id. ¶ 14. This immune response promotes

14 degradation of the mesh and pelvic tissue, causing chronic inflammation and pain. Id.

15 The Food and Drug Administration (“FDA”) cleared the first pelvic mesh products to treat

16 stress urinary incontinence in 1996 but did not require a formal review for safety or

17 efficacy because the products were deemed substantially equivalent to prior devices

18 marketed before May 1976. Id. ¶ 17. However, on July 13, 2011, the FDA issued a

19 safety communication in which it stated that “serious complications associated with

20 surgical mesh for transvaginal repair of [pelvic organ prolapse] are not rare.” Id. ¶ 18. In

21 addition to other warnings, the FDA stated “it is not clear that transvaginal [pelvic organ

22 prolapse] repair with mesh is more effective than traditional non-mesh repair in all

23 patients with [pelvic organ prolapse] and it may expose patients to greater risks.” Id.

24 ¶ 20. Simultaneous with the safety communication, the FDA released a white paper in

25 which it noted published peer-reviewed literature generally concluding that patients with

26 surgical mesh experienced complications that were not experienced by patients who

27 underwent traditional surgery without mesh. Id. ¶ 21.

1 incontinence and in September 2011, the FDA issued a communication acknowledging

2 the need for more data while also noting that information related to stress urinary

3 incompetence indicated that serious complications could occur. Id. ¶ 28. Plaintiffs allege

4 that defendant has not adequately studied the extent of the risks associated with the

5 stress urinary incontinence products. Id. ¶ 29. Plaintiffs allege that defendant knew or

6 should have known its pelvic mesh products unreasonably exposed patients to the risk of

7 serious harm while conferring no benefit over available feasible alternatives. Id. ¶ 30.

8 Plaintiffs allege that the pelvic mesh products continue to be marketed to the

9 medical community and patients as safe and effective, but defendant has omitted and

10 downplayed the risks and dangers of the products. Id. ¶¶ 34–35. While some problems

11 were made known to physicians, the magnitude and frequency of these problems were

12 not disclosed and instead hidden from physicians. Id. ¶ 35. Plaintiffs allege the pelvic

13 mesh products suffer from a variety of defects including, for example, the use of

14 polypropylene causes adverse tissue reactions, the use of raw materials were not

15 intended for use as human implant, and biomechanical issues with the design of the

16 products result in a nonanatomic condition leading to contraction or shrinkage of the

17 mesh inside the body. Id. ¶ 37. They further allege that defendant failed to warn plaintiff

18 or her physicians of facts concerning, for example, the products’ “propensities to contract,

19 retract and/or shrink inside the body” or the products’ “propensities for degradation,

20 fragmentation aid/or [sic] migration.” Id. ¶ 38.

21 Specific to this case, plaintiff Tami Hannan underwent transvaginal surgery on or

22 about December 3, 2012 during which Boston Scientific’s Obtryx Transobturator Mid-

23 Urethral Sling System (the “Obtryx Sling”) was implanted by plaintiff’s physicians. Id.

24 ¶ 67. As a result of the implant, plaintiff has suffered significant pain, unnecessary

25 expense, embarrassment, disfigurement, and harm as a result of the Obtryx Sling. Id.

26 ¶ 68.

27 / / /

1 DISCUSSION

2 A. Legal Standard

3 A motion to dismiss under Federal Rule of Civil Procedure 12(b)(6) tests for the

4 legal sufficiency of the claims alleged in the complaint. Ileto v. Glock Inc., 349 F.3d 1191,

5 1199–1200 (9th Cir. 2003). Under Federal Rule of Civil Procedure 8, which requires that

6 a complaint include a “short and plain statement of the claim showing that the pleader is

7 entitled to relief,” Fed. R. Civ. P. 8(a)(2), a complaint may be dismissed under Rule

8 12(b)(6) if the plaintiff fails to state a cognizable legal theory, or has not alleged sufficient

9 facts to support a cognizable legal theory. Somers v. Apple, Inc., 729 F.3d 953, 959 (9th

10 Cir. 2013).

11 While the court is to accept as true all the factual allegations in the complaint,

12 legally conclusory statements, not supported by actual factual allegations, need not be

13 accepted. Ashcroft v. Iqbal, 556 U.S. 662, 678–79 (2009). The complaint must proffer

14 sufficient facts to state a claim for relief that is plausible on its face. Bell Atl. Corp. v.

15 Twombly, 550 U.S. 544, 555, 558–59 (2007).

16 “A claim has facial plausibility when the plaintiff pleads factual content that allows

17 the court to draw the reasonable inference that the defendant is liable for the misconduct

18 alleged.” Iqbal, 556 U.S. at 678. “[W]here the well-pleaded facts do not permit the court

19 to infer more than the mere possibility of misconduct, the complaint has alleged—but it

20 has not ‘show[n]’—‘that the pleader is entitled to relief.’” Id. at 679 (quoting Fed. R. Civ.

21 P. 8(a)(2)). Where dismissal is warranted, it is generally without prejudice, unless it is

22 clear the complaint cannot be saved by any amendment. In re Daou Sys., Inc., 411 F.3d

23 1006, 1013 (9th Cir. 2005).

24 Review is generally limited to the contents of the complaint, although the court can

25 also consider documents “whose contents are alleged in a complaint and whose

26 authenticity no party questions, but which are not physically attached to the plaintiff’s

27 pleading.” Knievel v. ESPN, 393 F.3d 1068, 1076 (9th Cir. 2005) (quoting In re Silicon

1 other grounds as stated in In re Quality Sys., Inc. Sec. Litig., 865 F.3d 1130 (9th Cir.

2 2017)); see also Sanders v. Brown, 504 F.3d 903, 910 (9th Cir. 2007) (“[A] court can

3 consider a document on which the complaint relies if the document is central to the

4 plaintiff’s claim, and no party questions the authenticity of the document.” (citation

5 omitted)). The court may also consider matters that are properly the subject of judicial

6 notice (Lee v. City of Los Angeles, 250 F.3d 668, 688–89 (9th Cir. 2001)), and exhibits

7 attached to the complaint (Hal Roach Studios, Inc. v. Richard Feiner & Co., Inc., 896 F.2d

8 1542, 1555 n.19 (9th Cir. 1989)).

9 For plaintiffs’ claims that sound in fraud, the complaint must also meet the

10 heightened pleading standard of Federal Rule of Civil Procedure 9(b). See Kearns v.

11 Ford Motor Co., 567 F.3d 1120, 1125 (9th Cir. 2009). Rule 9(b) requires a party alleging

12 fraud or mistake to state with particularity the circumstances constituting fraud or mistake.

13 “To satisfy Rule 9(b)’s particularity requirement, the complaint must include an account of

14 the time, place, and specific content of the false representations as well as the identities

15 of the parties to the misrepresentations.” Depot, Inc. v. Caring for Montanans, Inc., 915

16 F.3d 643, 668 (9th Cir. 2019) (internal quotation marks omitted). In other words,

17 “[a]verments of fraud must be accompanied by ‘the who, what, when, where, and how’ of

18 the misconduct charged.” Kearns, 567 F.3d at 1124. Plaintiffs must also offer “an

19 explanation as to why the statement or omission complained of was false or misleading.”

20 In re GlenFed, Inc. Sec. Litig., 42 F.3d 1541, 1548 (9th Cir. 1994) (en banc), superseded

21 by statute on other grounds as stated in SEC v. Todd, 642 F.3d 1207, 1216 (9th Cir.

22 2011).

23 B. Analysis

24 1. First Claim: Product Liability—Defective Manufacture and Design

25 Plaintiffs’ first claim alleges product liability under two different theories: a

26 manufacturing defect and a design defect. With regard to the manufacturing defect, they

27 allege that one or more defects in the pelvic mesh products are the result of improper or

1 ¶ 72. The defects caused by improper or incorrect manufacturing rendered the products

2 unreasonably dangerous, deficient, and defective to plaintiff. Id. ¶ 73. With respect to

3 their design defect allegations, in a footnote, plaintiffs state that the design defect is

4 limited to defendant’s “failure to provide adequate warnings regarding the Obtryx device.”

5 Id. at 19 n.1.

6 Defendant moves to dismiss the first claim on two grounds. First, California law

7 rejects strict liability design defect claims relating to medical devices prescribed by a

8 physician. Mtn. at 3. Defendant says that this holding applies to plaintiffs’ strict liability

9 design defect claims even though plaintiffs’ assert the design defect claim sounds in a

10 failure to warn theory. Id. at 3. Second, plaintiffs have not identified a manufacturing

11 defect in the specific device that was surgically implanted in Tami Hannan. Id. at 4. In

12 response, plaintiffs assert that while they cannot demonstrate that the product differs

13 from others in its product line, they can demonstrate that no reasonable manufacturer

14 would intend for its product not to be the cure it advertised or be made from raw materials

15 not suitable for implantation in the human body. Opp. at 10.

16 Generally, California law extends the strict liability doctrine to three types of

17 product defect. Barker v. Lull Engineering Co., 20 Cal. 3d 413, 428 (1978). “First, there

18 may be a flaw in the manufacturing process, resulting in a product that differs from the

19 manufacturer’s intended result.” Brown v. Superior Court, 44 Cal. 3d 1049, 1057 (1988).

20 “Second, there are products which are ‘perfectly’ manufactured but are unsafe because

21 of the absence of a safety device, i.e., a defect in design.” Id. “The third type of defect

22 identified in Barker is a product that is dangerous because it lacks adequate warnings or

23 instructions,” i.e., a failure to warn. Id.

24 In Brown v. Superior Court, the California Supreme Court addressed whether a

25 plaintiff could recover against a pharmaceutical drug manufacturer based on a strict

26 liability design defect theory. In reviewing pertinent public policies, the court

27 distinguished between prescription drugs and other types of products; in non-prescription

1 prescription drugs “may be necessary to alleviate pain and suffering or to sustain life.” Id.

2 at 1063. The court noted a public policy favoring “the development and marketing of

3 beneficial new drugs, even though some risks, perhaps serious ones, might accompany

4 their introduction, because drugs can save lives and reduce pain and suffering.” Id.

5 Relying on that and similar public policy considerations, the court held “that a

6 manufacturer is not strictly liable for injuries caused by a prescription drug so long as the

7 drug was properly prepared and accompanied by warnings of its dangerous propensities

8 that were either known or reasonably scientifically knowable at the time of distribution.”

9 Id. at 1069. However, the court did not exempt drug manufacturers from strict liability for

10 manufacturing defects or from liability for negligence or failure to warn of reasonably

11 knowable side effects. Hufft v. Horowitz, 4 Cal. App. 4th 8, 17 (Ct. App. 1992) (citing

12 Brown, 44 Cal. 3d at 1069 n.12). In Hufft, the California Court of Appeal extended

13 Brown’s holding to manufacturers of implanted medical devices. Id. at 19–20; see also

14 Garrett v. Howmedica Osteonics Corp., 214 Cal. App. 4th 173, 184–85 (Ct. App. 2013)

15 (applying Brown to non-prescription implanted medical devices).

16 Here, plaintiffs first claim alleges both manufacturing and design defect theories of

17 liability. Plaintiffs’ strict liability design defect claim presents immediate issues. Brown

18 and its progeny clearly exempt medical device manufacturers from strict liability for

19 design defects. Garrett, 214 Cal. App. 4th at 183 (citing Brown, 44 Cal. 3d at 1065 n.10,

20 1066–69). Yet, in a footnote, plaintiffs state that their design defect claim is “limited to

21 [d]efendant’s failure to provide adequate warnings regarding the Obtryx device.” FAC at

22 19 n.1. Any failure to warn claim is duplicative of plaintiffs’ second and third claims for

23 strict liability and negligent failure to warn. Nor have plaintiffs cited a case for the

24 proposition that a design defect claim that is limited to failure to provide adequate

25 warnings survives Brown. No matter which interpretation plaintiffs intended, they cannot

26 state a claim for strict liability of a design defect.

27 Turning to plaintiffs’ strict liability manufacturing defect claim, they allege that “[t]he

1 p]roducts unreasonably dangerous, deficient, and defective to consumers and to

2 Plaintiff.” Id. ¶ 73. A manufacturing defect claim is predicated on a theory that “a suitable

3 design is in place, but that the manufacturing process has in some way deviated from

4 that design.” In re Coordinated Latex Glove Litig., 99 Cal. App. 4th 594, 613 (Ct. App.

5 2002). “A product has a manufacturing defect if it differs from the manufacturer’s

6 intended result or from other ostensibly identical units of the same product line.” Garrett,

7 214 Cal. App. 4th at 190 (citing Barker, 20 Cal. 3d at 429).

8 Plaintiffs have not identified a manufacturing defect in the specific Obtryx Sling

9 product that plaintiff’s physicians implanted in her. Indeed, their opposition brief admits

10 they cannot do this. Opp. at 10. Instead, they argue that the Obtryx Sling was made

11 from materials that defendant knew was not suitable for human implants. Judge Ishii in

12 the Eastern District of California recently issued two opinions dealing with similar

13 manufacturing defect claims pertaining to Boston Scientific’s Obtryx Sling. Zetz v. Bos.

14 Sci. Corp., 398 F. Supp. 3d 700, 709 (E.D. Cal. 2019); Garcia v. Bos. Sci. Corp., No. 19-

15 cv-0381 AWI SAB, 2019 WL 2598716, at *2 (E.D. Cal. June 25, 2019). In both cases,

16 the plaintiffs alleged that the Obtryx Sling failed to perform as Boston Scientific intended

17 and therefore gave rise to the inference that the product was improperly manufactured.

18 In both cases, the court determined that each complaint’s allegations were “insufficient to

19 support a manufacturing defect claim because the allegations failed to explain how much

20 the alleged deviation related to the manufacture.” Zetz, 398 F. Supp. 3d at 709; Garcia,

21 2019 WL 2598716, at *3. The reasoning in those cases is directly applicable here.

22 Plaintiffs’ argument suffers from a further complication. The FAC identifies defects

23 applicable to all Boston Scientific pelvic mesh products. For example, plaintiffs allege

24 “[o]ne or more of the defects . . . are a result of improper or incorrect manufacturing

25 processes that result in the Products . . . deviating from its intended design. The

26 incorrect manufacturing processes that plaintiffs identify include but are not limited to the

27 use of raw materials not intended for use in human medical implants and heat

1 as a manufacturing defect, the allegations are indicative of a flaw in the design of an

2 entire line of products rather than one product differing from other ostensibly identical

3 units. See Jager v. Davol, Inc., No. EDCV 16-1424 JB (KKx), 2017 WL 696081, at *5

4 (C.D. Cal. Feb. 9, 2017) (noting that a purported manufacturing defect in the product

5 “only suggests that the design of [a component of the product] was the problem . . . but

6 does not explain what aspect of manufacture made the particular product defective”). In

7 other words, plaintiffs’ manufacturing defect claim essentially advances a design defect

8 theory, i.e. “the benefits of the design do not outweigh the risk of danger inherent in the

9 design.” Garrett, 214 Cal. App. 4th at 182. Brown precludes such a theory when it is

10 brought as a strict liability claim.

11 In sum, plaintiffs’ design defect claim is either precluded by Brown or entirely

12 duplicative of their second cause of action. Their manufacturing defect claim does not

13 identify the defect in the particular Obtryx Sling implanted in plaintiff and otherwise seeks

14 to advance a design defect theory. None of those allegations state a claim.

15 For the foregoing reasons, defendant’s motion to dismiss plaintiffs’ first claim for

16 manufacturing and design defect is GRANTED.

17 2. Second Claim: Product Liability—Failure to Warn

18 Plaintiffs’ second claim alleges defendant is strictly liable for a failure to warn

19 plaintiff or her implanting physicians that the product was defective. FAC ¶ 82. Plaintiffs

20 allege that Boston Scientific failed to provide warnings or instructions based on

21 knowledge of certain risks at the time the Obtryx Sling left Boston Scientific’s control. Id.

22 ¶¶ 38, 85. They also allege that defendant received notices of numerous bodily injuries

23 resulting from its pelvic mesh products and failed to provide post-marketing or post-sale

24 warnings or instructions to plaintiff or her implanting physicians. Id. ¶ 86.

25 Under California law, a product may be defective because of the absence of an

26 adequate warning of the dangers inherent in its use. Brown, 44 Cal. 3d at 1057. A

27 failure-to-warn claim may be brought under either a theory of negligence or a theory of

1 (1991), the California Supreme Court held that manufacturers are strictly liable for injuries

2 caused by their failure to give warning of dangers that were known to the scientific

3 community at the time they manufactured and distributed the product. Five years later, in

4 Carlin v. Superior Court, 13 Cal. 4th 1104, 1117 (1996), the court held that Anderson’s

5 reasoning applies to prescription drug cases. The Carlin court quoted the following

6 excerpt from Anderson at length to explain the difference between strict liability and

7 negligence in failure to warn cases:

8 [F]ailure to warn in strict liability differs markedly from failure to

warn in the negligence context. Negligence law in a failure-to-

9 warn case requires a plaintiff to prove that a manufacturer or

distributor did not warn of a particular risk for reasons which fell

10 below the acceptable standard of care, i.e., what a reasonably

prudent manufacturer would have known and warned about.

11

Strict liability is not concerned with the standard of due

12 care or the reasonableness of a manufacturer’s conduct. The

rules of strict liability require a plaintiff to prove only that the

13 defendant did not adequately warn of a particular risk that was

known or knowable in light of the generally recognized and

14 prevailing best scientific and medical knowledge available at

the time of manufacture and distribution. Thus, in strict liability,

15 as opposed to negligence, the reasonableness of the

defendant’s failure to warn is immaterial . . . .”

16

17 Id. at 1112 (first alteration in original) (quoting Anderson, 53 Cal. 3d at 1003); see also

18 Wright v. Stang Mfg. Co., 54 Cal. App. 4th 1218, 1230–31 (Ct. App. 1997) (“[T]he more

19 severe the consequences from unprotected exposure, the greater the need to warn of

20 significant health risks.” (quoting Schwoerer v. Union Oil Co., 14 Cal. App. 4th 103, 112

21 (Ct. App. 1993))).

22 While Carlin permits a strict liability failure to warn theory of liability, it also held

23 that a failure to warn in the prescription drug context must be read with California’s

24 “learned intermediary” doctrine, which states that in the case of prescription drugs, the

25 duty to warn “runs to the physician, not to the patient.” Carlin, 13 Cal. 4th at 1116

26 (citations omitted); see also Bigler-Engler v. Breg, Inc., 7 Cal. App. 5th 276, 319 (Ct. App.

27 2017) (noting that the learned intermediary doctrine applies to implanted medical

1 Under the learned intermediary doctrine, “if adequate warning of potential dangers

2 of a drug has been given to doctors, there is no duty by the drug manufacturer to insure

3 that the warning reaches the doctor’s patient for whom the drug is prescribed.” Stevens

4 v. Parke, Davis & Co., 9 Cal. 3d 51, 65 (1973) (internal quotations and citation omitted);

5 see Brown, 44 Cal. 3d at 1062 n.9 (“[A] manufacturer fulfills its duty to warn if it provides

6 adequate warning to the physician.”).

7 Here, defendant argues that the learned intermediary doctrine bars plaintiffs’

8 claims to the extent they allege the duty runs from Boston Scientific as manufacturer to

9 anyone other than Tami Hannan’s physician. Mtn. at 6. Defendant further contends that

10 plaintiffs’ remaining claims do not plausibly allege that defendant failed to warn plaintiff’s

11 physician with any warning that would have changed her physician’s decision to use the

12 product. Id. Plaintiffs agree that the learned intermediary doctrine only runs from the

13 manufacturer to plaintiff’s physicians. Opp. at 11. They contend that the FAC alleges

14 several ways in which defendant did not warn or provided inadequate warnings to

15 Hannan’s implanting physicians. Id.

16 As both parties recognize, the learned intermediary doctrine means that Boston

17 Scientific fulfilled its duty to warn if it provided adequate warnings to Tami Hannan’s

18 physicians. Nonetheless, plaintiffs have pled sufficient allegations that defendant failed

19 to provide such adequate warnings to plaintiff’s physicians. For example, plaintiffs allege

20 that defendant “failed to properly and adequately warn and instruct the Plaintiff and/or her

21 health care providers as to the risks and benefits of Boston Scientific’s Pelvic Mesh

22 Products.” FAC ¶ 83 (emphasis added). As a second example, Boston Scientific failed

23 to provide adequate warning or instruction via its “Directions for Use of the Obtryx,

24 Physician training, and marketing to Plaintiff or her implanting physicians and health care

25 providers.” Id. ¶ 85 (emphasis added). The FAC contains other allegations pertaining to

26 a failure to warn plaintiff’s physicians. Id. ¶¶ 38, 82, 84

27 The court in Zetz found allegations similar to those in plaintiffs’ FAC plausibly

1 “knowingly provided incomplete and insufficient training and information to physicians

2 regarding the use of the Obtyrx and the aftercare of patients of patients implanted with

3 the Obtyrx.” 398 F. Supp. 3d at 707. As another example, the Zetz plaintiffs alleged

4 “[t]he risk of serious injuries was known or should have been known to Defendants, but in

5 spite of these risks, Defendants deliberately concealed these risks and, instead,

6 represented that the product was safe and effective and continued to market the Obtryx

7 to physicians and patients, including Plaintiffs, without adequate warnings.” Id. These

8 allegations are similar to the allegations here. Thus, defendant is on notice that it failed

9 to warn plaintiff’s physicians concerning the Obtryx Sling.

10 For the foregoing reasons, defendant’s motion to dismiss plaintiffs’ second claim

11 for product liability—failure to warn is DENIED.

12 3. Third Claim: Negligence

13 Plaintiffs’ third claim for negligence alleges that defendant had a duty to use

14 reasonable care in “designing, researching, manufacturing, marketing, labeling,

15 packaging, supplying, distributing and selling the Obtryx Product.” FAC ¶ 92. They also

16 allege that defendant had a duty to warn or instruct plaintiff or her health care providers.

17 Id. ¶ 95. Thus, plaintiffs are asserting design defect, manufacturing defect, and failure to

18 warn theories, all sounding in negligence.

19 As a general rule, to prevail on a negligence claim, “plaintiffs must show that

20 [Boston Scientific] owed them a legal duty, that it breached that duty, and that the breach

21 was a proximate or legal cause of their injuries.” Merrill v. Navegar, Inc., 26 Cal. 4th 465,

22 477 (2001) (citing Sharon P. v. Arman, Ltd., 21 Cal. 4th 1181, 1188 (1999), disapproved

23 on other grounds by Reid v. Google, Inc., 50 Cal. 4th 512 (2010)). To recover under a

24 negligence theory, a plaintiff must prove both that a defect caused the injury and “that the

25 defect in the product was due to negligence of the defendant.” Id. at 479 (quoting

26 Prosser, Strict Liability to the Consumer, 18 Hastings L.J. 9, 50–51 (1966); and citing

27 Jiminez v. Sears, Roebuck & Co., 4 Cal. 3d 379, 383 (1971)).

1 i. Failure to Warn

2 Defendant contends that the learned intermediary doctrine also applies to

3 plaintiffs’ negligent failure to warn claim. Mtn. at 6. Defendant further argues that

4 plaintiffs’ failure to warn claims should be dismissed for lack of plausible allegations that

5 Boston Scientific failed to warn plaintiff’s physicians. Id. Plaintiffs respond that they have

6 listed twenty specific defects in the warnings provided to physicians, including Tami

7 Hannan’s physicians. Opp. at 13.

8 In its reply brief, defendant cites (and attaches)3 an opinion by the Central District

9 of California in Fischer v. Boston Scientific Corp., No. SACV 19-02106 JVS (DFM) (C.D.

10 Cal. Mar. 25, 2020). Fischer dealt with a different Boston Scientific pelvic mesh product

11 and a similar negligent failure to warn claim. Slip. op. at 1–2. On a Rule 12(b)(6) motion,

12 the district court in Fischer dismissed a failure to warn claim because the plaintiff had not

13 identified “who her implanting physician was, what warning the physician received, or

14 how the warnings that were disclosed to the physician were inadequate.” Id. at 4.

15 The question here is whether plaintiffs have alleged sufficient factual content to

16 allows the court to draw the reasonable inference that defendant is liable for the

17 misconduct alleged. Iqbal, 556 U.S. at 678. Plaintiffs have done so in this case and

18 therefore their allegations are distinguishable from Fischer. They identify Tami Hannan’s

19 physicians by name (FAC ¶ 67) and allege that defendant “fail[ed] to adequately warn or

20 instruct the [p]laintiff and/or her health care providers, including her implanting

21 physicians” (id. ¶ 38). They then identify the facts or subjects that defendant failed to

22 warn or instruct her implanting physicians, which states how the warnings were

23 inadequate. Id. ¶ 38. That is, the warnings disclosed to plaintiff’s physicians were

24

25

3 Generally, “when a court takes judicial notice of another court’s opinion, it may do so

‘not for the truth of the facts recited therein, but of the existence of the opinion, which is

26

not subject to reasonable dispute over its authenticity.’” Lee, 250 F.3d at 690 (quoting S.

Cross Overseas Agencies, Inc. v. Wah Kwong Shipping Grp., Ltd., 181 F.3d 410, 426–27

27

(3d Cir. 1999)). Therefore, the court does not take notice of the truth of the facts recited

1 inherently inadequate because they failed to include warnings about various harmful

2 subjects. Other district courts evaluating negligent failure to warn claims involving pelvic

3 mesh products have found similar allegations sufficient. See Zetz, 398 F. Supp. 3d at

4 707; Hix v. Bos. Sci. Corp., No. CV-19-00422-PHX-DJH, 2019 WL 6003456, at *4–5 (D.

5 Ariz. Nov. 14, 2019); Garcia, 2019 WL 2598716, at *3. Therefore, plaintiffs have

6 sufficiently alleged that Boston Scientific had a duty to warn plaintiff’s physicians and

7 failed to do so.

8 As to the final element of a negligence claim, plaintiffs allege that defendant’s

9 negligence directly and proximately caused plaintiff’s mental and physical pain and

10 suffering. FAC ¶ 97. Of course, plaintiffs must plead factual allegations to support this

11 allegation. They have done so because the FAC alleges that plaintiff suffered from the

12 same injuries (e.g., pelvic pain, dyspareunia, and erosion of the product) as those injuries

13 identified in medical literature and associated with the potential defects in pelvic mesh

14 products. Id. ¶¶ 38, 47, 49, 68. This is sufficient to allege causation.4

15 In sum, plaintiffs have plausibly stated a claim that Boston Scientific negligently

16 failed to warn plaintiff’s physicians.

17 ii. Manufacturing Defect

18 Defendant avers that plaintiffs have not identified a manufacturing defect in the

19 implanted Obtryx Sling that caused plaintiff’s alleged injuries. Mtn. at 6. Similar to their

20 strict liability manufacturing defect argument, plaintiffs contend that they have alleged

21 how the Obtryx Sling deviated from Boston Scientific’s intended result. Opp. at 12–13.

22 The court’s reasoning and conclusion with regard to plaintiffs’ strict liability

23 manufacturing claim apply with equal weight here. See Marroquin v. Pfizer, Inc., 367 F.

24 Supp. 3d 1152, 1164 (E.D. Cal. 2019) (finding strict liability manufacturing defect analysis

25

4 In the FAC, plaintiffs allege that defendant failed to conduct post-marketing vigilance or

26

surveillance of its products by monitoring or investigating various reports of issues with

the products. FAC ¶ 96. Because plaintiffs have sufficiently stated a claim for a

27

negligent failure to warn based on a lack of disclosures made to Tami Hannan’s

1 applies equally to negligence manufacturing defect analysis). Plaintiffs have not alleged

2 that the specific Obtryx Sling inserted in Tami Hannan was negligently manufactured.

3 Instead, they are arguing that all Obtryx Slings deviate from defendant’s intended result.

4 This is a design defect argument and plaintiffs have not alleged sufficient facts that the

5 Obtryx Sling inserted in plaintiff was negligently manufactured. Therefore, plaintiffs fail to

6 state a claim for negligent manufacturing defect.

7 iii. Design Defect

8 With regard to plaintiffs’ design defect claim, defendant contends that plaintiffs

9 have failed to identify what aspect of the design of the Obtryx Sling, as opposed to the

10 Pelvic Mesh Products in general, is defective. Mtn. at 7. According to defendant,

11 plaintiffs never assert that a specific design defect in the Obtryx Sling caused plaintiff to

12 suffer a specific injury. Id. Plaintiffs respond that the FAC lists numerous flaws with the

13 Obtryx device and its component parts about which defendant either knew or should

14 have known. Opp. at 13. They further argue that they alleged medical literature

15 identified injuries caused by the products’ defects and that plaintiff suffered from these

16 same injuries. Id.

17 Generally, “the test of negligent design involves a balancing of the likelihood of

18 harm to be expected from a [product] with a given design and the gravity of harm if it

19 happens against the burden of the precaution which would be effective to avoid the

20 harm.” Merrill, 26 Cal. 4th at 479. “Even if a manufacturer has done all it reasonably

21 could have done to warn about a risk or hazard related to a product’s design, a

22 reasonable person could conclude that the magnitude of the reasonably foreseeable

23 harm as designed outweighed the utility of the product as designed.” Tucker v. Wright

24 Med. Tech., Inc., No. 11-CV-03086-YGR, 2013 WL 1149717, at *7 (N.D. Cal. Mar. 19,

25 2013) (citing Chavez v. Glock, Inc., 207 Cal. App. 4th 1283, 1305 (Ct. App. 2012)).

26 Here, plaintiffs allege a broad variety of potential defects with defendant’s pelvic

27 mesh products. For example, they allege that “[t]he use of polypropylene in the Products

1 material, caus[e] adverse reactions and serious, permanent injuries including, but not

2 limited to, painful recurrent erosions and associated intractable pain.” FAC ¶ 37. As

3 another example, plaintiffs allege that “[t]he propensity of the Products to become rigid

4 and inflexible, caus[es] them to be improperly mated to the delicate and sensitive areas

5 of the vagina and pelvis where they are implanted, and caus[es] discomfort and pain with

6 normal daily activities that involve movement in the pelvic region (e.g., intercourse,

7 defecation, walking). Id. Plaintiffs also allege that the Obtryx Sling is one of Boston

8 Scientific’s pelvic mesh products. Id. ¶¶ 7–8.

9 Plaintiffs’ allegations are sufficient to state a claim for negligent design defect.

10 They have identified several aspects of defendant’s pelvic mesh products that are

11 purportedly defective. Plaintiffs allege that the Obtryx Sling is one of those products, so it

12 is reasonable to infer that the defects in the design of the pelvic mesh products apply to

13 the Obtryx Sling.

14 For the foregoing reasons, defendant’s motion to dismiss plaintiffs’ third claim for

15 negligence is GRANTED IN PART AND DENIED IN PART as discussed herein.

16 4. Fourth Claim: Breach of Express Warranty

17 Plaintiffs’ fourth claim is for breach of express warranty. They allege that Boston

18 Scientific made assurances to the general public, hospitals, and health care professionals

19 that the pelvic mesh products were safe and reasonably fit for their intended purpose.

20 FAC ¶ 99. They claim that plaintiff, by and through her physician, reasonably relied on

21 defendant’s express warranty and defendant breached that warranty because the product

22 implanted in plaintiff was unreasonably dangerous and defective. Id. ¶¶ 101–02.

23 An express warranty “is a contractual promise from the seller that the goods

24 conform to the promise.” Daugherty v. Am. Honda Motor Co., 144 Cal. App. 4th 824, 830

25 (Ct. App. 2006) (citing Cal. Com. Code § 2313). As a general rule, “privity of contract is a

26 required element of a breach of express warranty cause of action.” Tapia v. Davol, Inc.,

27 116 F. Supp. 3d 1149, 1160 (S.D. Cal. 2015) (citing Burr v. Sherwin Williams Co., 42 Cal.

1 privity requirement. The exception relevant here applies where a “plaintiff’s decision to

2 purchase the product was made in reliance on the manufacturer’s written representations

3 in labels or advertising materials.” Fieldstone Co. v. Briggs Plumbing Prods., Inc., 54 Cal.

4 App. 4th 360, 369 n.10 (Ct. App. 1997) (citations omitted), superseded by statute on

5 other grounds as stated in Greystone Homes, Inc. v. Midtec, Inc., 168 Cal. App. 4th 1194

6 (Ct. App. 2008); Fundin v. Chi. Pneumatic Tool Co., 152 Cal. App. 3d 951, 957 (Ct. App.

7 1984).

8 “To prevail on a breach of express warranty claim, [p]laintiffs must prove: (1) ‘the

9 seller’s statements constitute an affirmation of fact or promise or a description of the

10 goods; (2) the statement was part of the basis of the bargain; and (3) the warranty was

11 breached.’” Brown v. Hain Celestial Grp., Inc., 913 F. Supp. 2d 881, 899–900 (N.D. Cal.

12 2012) (quoting Weinstat v. Dentsply Int’l, Inc., 180 Cal. App. 4th 1213, 1227 (Ct. App.

13 2010)).

14 The learned intermediary doctrine also applies to breach of warranty claims.

15 Carlin, 13 Cal. 4th at 1118 (“[O]rdinarily, it is the prescribing doctor who in reality stands

16 in the shoes of the ordinary consumer.”). “[B]reach of express or implied warranty claims,

17 like design defect claims, may not be maintained against a manufacturer of prescription

18 drugs who has properly prepared the product and marketed it with warnings of known or

19 knowable dangers.” Hufft, 4 Cal. App. 4th at 24 (citing Brown, 44 Cal. 3d at 1072).

20 Defendant argues that plaintiffs cannot state a claim for breach of express

21 warranty because the learned intermediary doctrine applies to warranty claims and

22 plaintiffs cannot maintain a claim for breach of express warranty. Mtn. at 10. Further,

23 plaintiffs have not identified the terms of the warranty, that plaintiff relied on those terms,

24 and the breach proximately caused her injury. Id. Plaintiffs respond that both plaintiff

25 and her physicians relied on defendant’s warranties. Opp. at 15. They further contend

26 that the FAC contains descriptions of those warranties. Id.

27 The court agrees with defendant that the learned intermediary doctrine applies to

1 allegations concerning the implanting physicians’ reliance on the express warranties on

2 the label of the Obtryx Sling or the advertising associated with the Obtryx Sling. They

3 have not done so. The FAC states:

4 Plaintiff, individually and/or by and through her physician,

reasonably relied upon Defendant’s express warranties and

5 guarantees that the Products were safe, merchantable, and

reasonably fit for their intended purposes, including but not

6 limited to that the Product was a safe and effective means of

treatment for Plaintiff’s condition, was suitable for implantation

7 into the human body, and would be a permanent, lifelong

implant.

8

9 FAC ¶ 101. The allegations do not describe the manufacturer’s written representations

10 or how Boston Scientific made those representations to plaintiff’s physician. Nor do

11 plaintiffs allege how the implanting physician relied on those representations.

12 The allegations here are similar to two district court opinions that likewise found

13 insufficient to state a claim. In Hammarlund v. C.R. Bard, Inc., No. 15-cv-05006-SVW-

14 JEM, 2015 WL 5826780, at *5 (C.D. Cal. Oct. 2, 2015), the plaintiff alleged that “Plaintiff,

15 individually and/or by and through his physician, reasonably relied upon Defendants’

16 express warranties and guarantees that the Ventralex patch was safe, merchantable, and

17 reasonably fit for its intended purpose.” The court reasoned that the plaintiff “must allege

18 facts demonstrating that Defendants’ affirmations formed the basis of the bargain, i.e.,

19 facts regarding how the warranties were made to Plaintiff’s physician, and that Plaintiff’s

20 specific physician relied on them.” In Tapia, 116 F. Supp. 3d at 1162, the court

21 determined that the “complaint fails to allege that Plaintiff’s prescribing physician read

22 and relied on the express warranties contained in the packaging and written

23 advertisements. Plaintiff only alleges that the ‘healthcare community’ relied on the

24 express warranties in the packaging and written advertisements.” The reasoning in those

25 cases applies here.

26 For the foregoing reasons, defendant’s motion to dismiss plaintiff’s fourth claim for

27 breach of express warranty is GRANTED.

1 5. Fifth Claim: Negligent Misrepresentation

2 Plaintiffs’ fifth claim is for negligent misrepresentation and they allege that

3 defendant had a duty to accurately and truthfully represent to the medical and healthcare

4 community, plaintiff, her physicians, and the public that the pelvic mesh products had not

5 been adequately tested and found to be safe and effective for treatment. FAC ¶ 106.

6 They allege that defendant negligently misrepresented the pelvic mesh products’ high

7 risk of unreasonable, dangerous, and adverse side effects. Id. ¶ 107.

8 Negligent misrepresentation requires “(1) the misrepresentation of a past or

9 existing material fact, (2) without reasonable ground for believing it to be true, (3) with

10 intent to induce another’s reliance on the fact misrepresented, (4) justifiable reliance on

11 the misrepresentation, and (5) resulting damage.” Apollo Capital Fund, LLC v. Roth

12 Capital Partners, LLC, 158 Cal. App. 4th 226, 243 (Ct. App. 2007). Negligent

13 misrepresentation “sounds in fraud” and is subject to Rule 9(b)’s heightened pleading

14 standard, though the claim does not require demonstrating an intent to deceive or

15 defraud. Errico v. Pac. Capital Bank, N.A., 753 F. Supp. 2d 1034, 1049 (N.D. Cal. 2010)

16 (citing Oakland Raiders v. Oakland-Alameda Cty. Coliseum, Inc., 144 Cal. App. 4th 1175,

17 1184 (Ct. App. 2006)).

18 Defendant argues that plaintiffs’ negligent misrepresentation claim fails to meet the

19 heightened pleading requirements of Federal Rule of Civil Procedure 9(b). For example,

20 the FAC fails to allege the “who, what, when where, and how” about the

21 misrepresentation and omissions underlying plaintiff’s misrepresentation claim. Mtn. at

22 7–8. Plaintiffs contend that defendant’s alleged misrepresentations and omissions were

23 part of an overall deceptive campaign regarding the Obtryx. Opp. at 14.

24 Plaintiffs’ allegations clearly do not meet the heightened pleading requirements of

25 Rule 9(b). “Rule 9(b) demands that the circumstances constituting the alleged fraud ‘be

26 specific enough to give defendants notice of the particular misconduct . . . so that they

27 can defend against the charge and not just deny that they have done anything wrong.’”

1 (quoting Bly–Magee v. California, 236 F.3d 1014, 1019 (9th Cir. 2001)). There is no

2 specificity concerning defendant’s alleged negligent misrepresentation. Plaintiffs’ own

3 argument demonstrates the lack of specificity; by citing an “overall deceptive campaign

4 concerning the Obtryx Sling,” they fail to point to any specific event or circumstance that

5 was deceptive. This claim fails Rule 9(b).

6 For the foregoing reasons, defendant’s motion to dismiss plaintiffs’ fifth claim for

7 negligent misrepresentation is GRANTED.

8 6. Sixth Claim: Unfair Competition Law—Cal. Bus. & Prof. Code § 17200

9 In their opposition brief, plaintiffs state that they have agreed to dismiss their sixth

10 claim for violation of California’s Unfair Competition Law and any claim for attorneys’

11 fees. Opp. at 2 n.1; Mtn at 1 n.1. Therefore, plaintiffs’ sixth claim for violation of

12 California Business & Professions Code § 17200 is DISMISSED WITH PREJUDICE.

13 7. Seventh Claim: Loss of Consortium

14 Plaintiffs’ seventh claim is for loss of consortium. They allege that plaintiff Daniel

15 Hannan has suffered and will continue to suffer loss of companionship of his spouse.

16 FAC ¶ 133. Defendant argues that a loss of consortium claim, by its nature, depends on

17 the existence of a cause of action for tortious injury to the spouse and that, to the extent

18 plaintiffs fail to state a claim for their other causes of action, then the court should dismiss

19 the loss of consortium claim. Mtn. at 11. Plaintiffs concede that loss of consortium is

20 dependent on the tortious injury of one’s spouse, it is not “parasitic” and belongs to the

21 spouse claiming the loss of consortium. Opp. at 16.

22 Plaintiffs’ loss of consortium claim is derivative of plaintiffs’ other tort claims. Hahn

23 v. Mirda, 147 Cal. App. 4th 740, 746 (Ct. App. 2007) (stating that loss of consortium claim

24 “stands or falls based on whether the spouse of the party alleging loss of consortium has

25 suffered an actionable tortious injury”). Because the court has found that some of

26 plaintiffs’ causes of action for tortious injury are plausible, then the loss of consortium

27 claim also survives the motion to dismiss.

1 for loss of consortium is DENIED.

2 CONCLUSION

3 For the foregoing reasons, defendant’s motion to dismiss plaintiffs’ first cause of

4 action for product liability—defective manufacture and design is GRANTED, and the strict

5 liability design defect claim is DISMISSED WITH PREJUDICE and the strict liability

6 manufacturing defect claim is DISMISSED WITH LEAVE TO AMEND; defendant’s

7 motion to dismiss plaintiff’s second cause of action for product liability—failure to warn is

8 DENIED; defendant’s motion to dismiss plaintiffs’ third cause of action for negligence is

9 GRANTED IN PART AND DENIED IN PART, and the negligence manufacturing claim is

10 DISMISSED WITH LEAVE TO AMEND; defendant’s motion to dismiss plaintiffs’ fourth

11 cause of action for breach of express warranty is GRANTED, and the claim is

12 DISMISSED WITH LEAVE TO AMEND; defendant’s motion to dismiss plaintiffs’ fifth

13 cause of action for negligent misrepresentation is GRANTED, and the claim is

14 DISMISSED WITH LEAVE TO AMEND; plaintiffs’ sixth claim is DISMISSED WITH

15 PREJUDICE; and defendant’s motion to dismiss plaintiffs’ seventh cause of action for

16 loss of consortium is DENIED. Plaintiffs shall file any amended complaint within 21 days

17 of the date of this order. Any amended complaint should allege each remaining product

18 liability claim separately (e.g. strict liability manufacturing defect, strict liability failure to

19 warn, negligent design defect, negligent manufacturing defect, and negligent failure to

20 warn) for ease of reference. No new parties or causes of action may be pleaded without

21 leave of court or the agreement of defendant.

22 IT IS SO ORDERED.

23 Dated: May 5, 2020

24 /s/ Phyllis J. Hamilton

PHYLLIS J. HAMILTON

25 United States District Judge

26

27