Posted on: 9/10/2012
Beth S. Rose, Vincent Lodato
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Generic pharmaceutical manufacturers scored a major victory in June 2011 when the United States Supreme Court decided Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011). In Mensing, the Court held that state law failure to warn claims against generic pharmaceutical manufacturers were impliedly preempted by federal law. The Court's decision was premised on its conclusion that generic manufacturers "have an ongoing federal duty of sameness" which requires that the labeling and warnings for generic products be identical to those of their brand-name counterparts. Mensing, 131 S. Ct. at 2574-75. Because the Court accepted the FDA's conclusion that the changes being effected (CBE) regulations were not available to generic manufacturers, the Court held that the state law failure to warn claims were preempted as it was impossible for a generic manufacturer to unilaterally change its label to strengthen or add new warnings without violating FDA regulations. Id. at 2575.
Since Mensing was decided, several trial courts have been asked to interpret the breadth and scope of the Court's decision. Plaintiffs have typically argued that Mensing preempts only a very narrow category of failure to warn claims against generic manufacturers, i.e., where plaintiff is alleging that the labeling for the generic product should have included new or additional warnings beyond those required by the FDA. Most generic manufacturers, on the other hand, have taken the position that Mensing should be broadly applied and that failure to warn claims are not the only types of claims which are now preempted. These competing theories are forcing courts to address the contours of Mensing.
Failure to Warn Claims
To the extent that a plaintiff is alleging that a generic manufacturer should be held liable because it failed to include additional or different warnings from those required by the FDA to be in the brand name product's label, the courts have held that such claims are impliedly preempted by Mensing. See, e.g., In re Fosamax (Alendronate Sodium) Products Liability Litigation, MDL No. 2243, 2011 U.S. Dist. LEXIS 135006, at *34 (D.N.J. Nov. 21, 2001) (dismissing plaintiffs' failure to warn claim that the defendant should have changed its label "to provide new, different, and stronger warnings"); In re Pamidronate Products Liability Litigation, No. 09-md-2120, 2012 U.S. Dist. LEXIS 10901, at *10-11 (E.D.N.Y. Jan. 30, 2012) (dismissing plaintiffs' failure to warn claim that the "defendants should have altered the labeling of pamidronate to provide stronger warnings about the drug's possible adverse side effects").
Despite Mensing's clear holding, some plaintiffs have tried to keep their failure to warn claims alive by raising two "creative" arguments. First, some plaintiffs have argued that Mensing does not preempt failure to warn claims where plaintiff is alleging that the generic manufacturer failed to update its product label to match that of the brand name product. For the most part, trial courts have been receptive to this "failure to update" argument because Mensing is premised on the theory that a generic manufacturer is under a "duty of sameness" and must ensure that its product label and warnings are identical to those of the brand name product. See, e.g., Fisher v. Pelstring, No. 09-cv-252, 2011 U.S. Dist. LEXIS 116162, at * 10-13 (D.S.C. Sep. 30, 2011) (holding that defendant's failure to timely update its label was sufficient grounds to deny its motion to dismiss on preemption grounds); Phelps v. Wyeth, Inc., No. 09-cv-6168, at pp. 7-8 (D. Or. Nov. 30, 2011) (dismissing all of plaintiff's failure to warn claims except for the claim that the generic manufacturers failed to timely update their label); Couick v. Wyeth, Inc., No. 09-cv-210, 2012 U.S. Dist. LEXIS 3699, at *9-14 (W.D.N.C. Jan. 11, 2012) (denying the generic defendants' motion to dismiss on preemption grounds because they failed to establish that their product labels matched the label of the brand name product). Furthermore, courts have held that generic manufacturers are entitled to use the CBE process to unilaterally update their labels and warnings so that they match those of the brand name product. Del Valle v. Pliva, Inc., No. 09-cv-6168, at p. 13 (S.D. Tex. Dec. 21, 2011) (noting that a generic manufacturer may use the CBE process to "match an updated brand-name label") Fisher, 2011 U.S. Dist. LEXIS 116162 at *13 (holding that a CBE supplement "is the appropriate process" for a generic manufacturer to update its label to conform to the brand name product's label). A few courts, while accepting that failure to update claims may not be preempted, have rejected those claims on other grounds. See, e.g., Del Valle, No. 09-cv-6168 at pp. 7-8 (declining to address the validity of plaintiff's failure to update argument because plaintiff failed to identify any harm that resulted from defendant's alleged failure to update its label to match the brand name product); Gross v. Pfizer, Inc., No. 10-110, 2011 U.S. Dist. LEXIS 134895, at *11-12 (D. Md. Nov. 22, 2011) (rejecting plaintiff's claim that the defendant's label differed from the brand-name label because Maryland law did not recognize such a cause of action).
Second, some plaintiffs have argued that Mensing only preempts claims that the generic manufacturer should have made content changes to the product's label. They have argued that Mensing does not preempt claims that the manufacturer should have communicated FDA-required warnings through more effective modes of communication than the product's label including sending Dear Doctor letters, holding physician seminars or publishing warnings in professional publications like the Physician's Desk Reference. See, e.g., Grinage v. Mylan Pharmaceuticals, Inc., No. 11-1436, 2011 U.S. Dist. LEXIS 149667, at *9-10 (D. Md. Dec. 30, 2011). Most courts have rejected these arguments with some concluding that the Mensing Court held that generic manufacturers were not free to unilaterally send Dear Doctor letters without prior FDA approval. Guarino v. Wyeth LLC, No. 10-cv-2885, 2011 U.S. Dist. LEXIS 128630, at * (M.D. Fla. Nov. 7, 2011) (holding that the Mensing Court "specifically rejected Plaintiff's failure-to-communicate argument"); Del Valle, No. 06-cv-6168 at p. 10 (holding that plaintiff's "Dear Doctor letter" argument was precluded by Mensing). Other courts have rejected such claims because plaintiffs were unable to allege how a Dear Doctor letter, which included the same information as the product label, would have prevented plaintiff's injuries. Grinage, 2011 U.S. Dist. LEXIS 149667 at *12-13; Metz v. Wyeth, LLC, No. 10-cv-2658, 2011 U.S. Dist. LEXIS 121549, at *5 n.2 (M.D. Fla. Oct. 20, 2011). A few courts, however, have permitted such claims to proceed, holding that the Mensing Court never addressed whether generic manufacturers could be held liable for failing to send Dear Doctor letters that are consistent with the product labeling, and that no FDA regulations prohibit generic manufacturers from issuing such letters. Brasley-Thrash v. Teva Pharmaceuticals USA, Inc., No. 10-031, 2011 U.S. Dist. LEXIS 102858, at *6-8 (S.D. Ala. Sep. 12, 2011); Sacks v. Endoscopy Center of Southern Nevada, LLC, No. 08A572315, 2011 WL 4915174, at *1-2 (Nev. Dist. Ct. Jul. 28, 2011) (holding that plaintiff's claim that the defendant could have sent a Dear Doctor letter containing warnings consistent with the product label did not violate Mensing); Keck v. Endoscopy Center of Nevada, LLC, No. A575837, 2011 WL 3921690, at *4 (Nev. Dist. Ct. Aug. 19, 2011) (holding that the "Supreme Court did not indicate that 'Dear Doctor' letters that were 'consistent and not contrary' to the labeling, were preempted").
Design Defect Claims
In most jurisdictions, plaintiffs are precluded from asserting design defect claims against pharmaceutical manufacturers because they have adopted Comment K to the Restatement (Second) of Torts, § 402A, which immunizes manufacturers of "unavoidably unsafe" products from design defect claims. See, e.g., Grinage, 2011 U.S. Dist. LEXIS 149667 at *15; Gross, 2011 U.S. Dist. LEXIS 134895 at *7. Despite Comment K, most plaintiffs still assert design defect claims in pharmaceutical product liability cases. Although Mensing only specifically addressed failure to warn claims, some courts have recently held that the same principles also impliedly preempt design defect claims against generic manufacturers. These decisions have expanded on Mensing's "duty of sameness," holding that federal law not only requires generic and brand-name pharmaceutical products to have identical labeling, but they must also share the same design, i.e., the same active ingredient, bioequivalence and safety and efficacy profile. Because generic manufacturers cannot unilaterally change the design of their generic drug products without FDA approval, these courts have held that design defect claims are also impliedly preempted under Mensing. See, e.g., In re Pamidronate, 2012 U.S. Dist. LEXIS 10901 at *11-12; In re Fosamax, 2011 U.S. Dist. LEXIS 135006 at *32-34; Stevens v. Pliva, Inc., No. 10-0886, 2011 U.S. Dist. LEXIS 147684, at *5-6 (W.D. La. Nov. 15, 2011). Along these same lines, a few courts have dismissed design defect claims because the brand-name manufacturer rather than the generic manufacturer that actually "designed" the product. Metz, 2011 U.S. Dist. LEXIS 121549 at *10; Fullington v. Pliva, Inc., No. 10-cv-236, 2011 U.S. Dist. LEXIS 142931, at *15-16 (E.D. Ark. Dec. 12, 2011).
Negligence, Warranty and Fraud Claims
Plaintiffs have not fared much better on their non-product liability claims. For example, several courts have dismissed claims which allege that the generic manufacturer was negligent or committed fraud in connection with the labeling, marketing, promotion or distribution of their products because such claims were essentially failure to warn claims. In re Pamidronate, 2012 U.S. Dist. LEXIS 10901 at *12-13; In re Fosamax, 2011 U.S. Dist. LEXIS 135006 at *40, 42-43; Grinage, 2011 U.S. Dist. LEXIS 149667 at *15; Gross, 2011 U.S. Dist. LEXIS 134895 at 22; Metz, 2011 U.S. Dist. LEXIS 121549 at *11; Del Valle, No. 11-cv-113 at pp. 8-9. Some courts have also dismissed express warranty claims on the same grounds. In re Pamidronate, 2012 U.S. Dist. LEXIS 10901 at *13-14; In re Fosamax, 2011 U.S. Dist. LEXIS 135006 at *42-43. Furthermore, claims that the defendant was negligent in designing or testing a product have also failed because they were akin to design defect claims which are also preempted. In re Fosamax, 2011 U.S. Dist. LEXIS 135006 at *41. Many courts have also dismissed implied warranty claims because they were just repeats of plaintiffs' failure to warn or design defect claims. In re Pamidronate, 2012 U.S. Dist. LEXIS 10901 at *14-15; In re Fosamax, 2011 U.S. Dist. LEXIS 135006 at *41-42; Grinage, 2011 U.S. Dist. LEXIS 149667 at *15; Gross, 2011 U.S. Dist. LEXIS 134895 at *19-20. But see Couick, 2012 U.S. Dist. LEXIS 3609 at *18-19 (refusing to dismiss plaintiff's implied warranty claim on preemption grounds because the claim did not exclusively relate to the product's labeling).
Post-Mensing, plaintiffs are trying to develop more creative arguments in order to maintain claims against generic manufacturers. For the most part, generic manufacturers have been successful in defeating these arguments and having cases dismissed in their entirety. Whether lawsuits against generic manufacturers will completely fade away still remains to be seen.
Beth S. Rose is the Chair of the Product Liability Practice Group at Sills Cummis & Gross P.C. She devotes her practice to the defense of pharmaceutical and medical device companies in mass tort litigation.
Vincent Lodato is a senior associate in the firm's product liability group and has extensive experience defending complex product liability matters. The views and opinions expressed in this article are those of the authors and do not necessarily reflect those of the firm or its clients.