Until only recently, brand pharmaceutical manufacturers have largely been left out in the cold when arguing that plaintiffs’ state-law tort claims should be impliedly preempted by federal law. Unlike their generic counterparts, absent extenuating circumstances, brand manufacturers have not been successful in arguing implied preemption of state-law claims based on either failure to warn/adequacy of warnings or design defect. In fact, just over a year ago (and some five months after the Bartlett decision), my colleague summed up the “scorecard” on implied preemption as follows:

• Implied conflict preemption for brand manufacturers? By and large, NO – unless the brand manufacturer can show clear evidence that the FDA considered, and rejected, proposed warnings on the same risks and injuries (Wyeth v. Levine¹);
• Implied conflict preemption for generic manufacturers based on a theory of failure to warn/adequacy of warnings? Generally, YES – because generic manufacturers must ask FDA for permission (and get it) before changing a label beyond that authorized for the brand version (PLIVA v. Mensing²); and
• Implied conflict preemption for generic manufacturers based on a theory of design defect? Generally, YES – under the rationale of Mensing, a generic manufacturer cannot unilaterally change the design of a product that was FDA-approved, and further, the manufacturer should not be forced to make a Hobson’s choice of ceasing sales of the product altogether to avoid conflict (Mutual Pharmaceuticals v. Bartlett³).⁴

In the immediate aftermath of the Supreme Court’s Bartlett decision, it could fairly be said that the preemption scorecard read 2-0 in favor of the generic manufacturers. However, in the roughly 18 months since Bartlett, brand prescription drug manufacturers have begun to make up some ground on the generic drug makers. While Bartlett did not affect a brand manufacturer’s chances of success on failure-to-warn/adequacy of warnings claims, brand manufacturers have begun to gain traction on implied preemption of design defect claims.

IMPLIED PREEMPTION OF FAILURE-TO-WARN/ADEQUACY OF WARNINGS CLAIMS.

Wyeth v. Levine remains the controlling authority on whether claims sounding in failure to warn/adequacy of warnings are impliedly preempted by federal law, and the answer remains, by and large, NO. Under Levine, a brand manufacturer must show “clear evidence that the FDA would not have approved a change to [the drug’s] label” in order to successfully argue that it was impossible for it to have complied with both federal and state law.[v] This “clear evidence” legal standard itself has remained unchanged in the years since Levine. Moreover, because the Supreme Court did not define or suggest the level of proof required to constitute “clear evidence,” lower courts have been left to determine what level of proof is necessary to satisfy this standard. Given this, in the wake of Levine, all that is “clear” about the “clear evidence” standard is that it is a highly fact-specific and demanding defense,⁵ and very few courts have found that a brand manufacturer has successfully demonstrated the requisite “clear evidence.” That being said, a couple of decisions have given brand manufacturers hope that it is possible to meet the “clear evidence” standard enunciated in Levine.

DOBBS V. WYETH

The first court to find implied preemption of failure-to-warn claims against a brand manufacturer was the U.S. District Court for the Western District of Oklahoma in Dobbs v. Wyeth.⁶ In Dobbs, the plaintiff sued brand manufacturer Wyeth for failure to warn of a risk of suicide associated with its antidepressant, Effexor, after her husband committed suicide while taking the drug.⁷ Ms. Dobbs alleged that the existing suicide warning on the Effexor label was insufficient to alert patients to the suicide risk associated with the drug.⁸

The District Court initially granted summary judgment in favor of Wyeth in 2008 finding that the plaintiff’s state-law failure-to-warn claims were preempted by FDA regulations.⁹ That decision was vacated on appeal in light of the Supreme Court’s intervening decision in Levine, and remanded for the trial court to reevaluate Wyeth’s defense based on the “clear evidence” standard enunciated in Levine.¹⁰ On remand, the District Court found that Wyeth met the clear evidence standard and again granted summary judgment to Wyeth.¹¹

Specifically, the court found that the FDA’s regulatory history with regard to the class of antidepressants including Effexor showed that the agency reviewed manufacturers’ reports from clinical trials and studies regarding suicidality, as well as a number of independent studies, and continually refused to enhance the suicidality warnings on these medications both before and after Mr. Dobbs’ death. The FDA’s decision was based on a finding that there was no scientific evidence to support a causal connection between these antidepressants and suicidality in adult patients.¹² Moreover, the court found that the FDA had approved a supplemental new drug application (sNDA) for Effexor and over a dozen new drug applications (NDAs) and sNDAs for other antidepressants with the very same suicide warnings both prior to and after Mr. Dobbs’ suicide.¹³ Finally, the court found it highly persuasive that the FDA had rejected a pediatric warning relating specifically to Effexor that was added by Wyeth under the CBE regulations after Mr. Dobbs’ death.¹⁴ All of these findings established “clear evidence” that the FDA would have rejected an expanded Effexor suicidality warning for patients of Mr. Dobbs’ age group prior to his suicide in 2002.

GLYNN V. MERCK

Similarly, in June 2013, the District Court for the District of New Jersey found that Merck had demonstrated “clear evidence” that the FDA would not have approved a stronger warning about Fosamax’s link to femur fractures and, therefore, held that the plaintiff’s state-law failure-to-warn claims were preempted.¹⁵ Prior to plaintiff’s injury, the FDA refused to approve a change to the Precautions section of the Fosamax label relating specifically to femur fractures through a “prior approval supplement” (PAS) initiated by Merck. This refusal established clear evidence that the FDA would not have approved a CBE seeking to add the same language prior to the injuries suffered by the plaintiff.¹⁶ Since the FDA would not have approved a CBE with the stronger warnings urged by plaintiff as the basis for failure-to-warn claims, the court held that the plaintiff’s claims were impliedly preempted.

UPDATED SCORECARD – FAILURE TO WARN/ADEQUACY OF WARNINGS

Despite favorable implied preemption decisions in Dobbs and Glynn, the deck certainly remains stacked against brand manufacturers when arguing preemption of state law failure-to-warn claims. To date, Dobbs and Glynn are the only favorable decisions for brand manufacturers on the “clear evidence” standard enunciated in Levine.¹⁷ On the other hand, numerous courts across the country have found that brand manufacturers failed to meet this demanding standard for various and sundry reasons.¹⁸ Therefore, since the score was last tallied on this topic, there has been no significant change: Implied Preemption of Failure-to- Warn/Adequacy of Warnings Claims – Generic manufacturers – Generally, YES; Brand manufacturers – By and large, NO.

IMPLIED PREEMPTION OF DESIGN DEFECT CLAIMS

While recent Supreme Court implied preemption jurisprudence creates disparate treatment of brand and generic pharmaceutical manufacturers on state law failure-to-warn/adequacy of warnings claims, this very same jurisprudence – specifically Bartlett – creates a more equal playing field for design defect claims. Soon after the Bartlett decision, commentators argued that Bartlett should essentially apply to preempt all design defect claims asserted against FDA-regulated products – both brand and generic.

While Bartlett involved claims against a generic manufacturer, the Supreme Court reasoned that under FDA regulations applicable to all prescription medications – brand or generic – all changes to a drug that affect its safety or efficacy require prior FDA approval. Thus, a manufacturer could not comply with a state law duty to render a drug safer by altering its composition without prior FDA approval, and design defect claims would be impliedly preempted. The following language from Bartlett may have opened the door for brand manufacturers to argue implied preemption of state law design defect claims: “Once a drug – whether generic or brand-name – is approved, the manufacturer is prohibited from making any major changes to the ‘qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application.’”¹⁹ In other words, because a drug redesign requires FDA approval, claims seeking such a redesign under state law are preempted because they are in conflict with federal laws that prohibit manufacturers from unilaterally altering a drug’s composition.²⁰

Calls for a broad application of the Bartlett to both brand and generic manufacturers have been answered – though not in favor of brand manufacturers in every instance.

THOMPSON V. ALLERGAN

The favorable application of Bartlett’s reasoning to brand manufacturers began some seven months later when the U.S. District Court for the Eastern District of Missouri held that Bartlett applied to the manufacturer of the brand name prescription ophthalmic medication, Restasis.²¹ The plaintiffs in this putative class action alleged that the defendants overfilled Restasis dispensers so that consumers were forced to purchase more of the medication than they could use, therefore paying higher prices than necessary.²² Upon consideration of defendant’s motion to dismiss, the court agreed that the plaintiffs’ claims were preempted because reducing the amount of medicine in each Restasis vial would constitute a “major change” in the specifications provided in the drug application previously approved by the FDA, thus requiring new FDA approval.²³ Based on this finding, the court dismissed the plaintiffs’ state law claims as impliedly preempted.²⁴

CASSEL V. ALZA CORP.

Only a little over one month later, the U.S. District Court for the Western District of Wisconsin found the exact opposite – that Bartlett is inapplicable to state law design defect claims against brand manufacturers. In Cassel, plaintiffs brought a design defect claim, among others, against the designers and manufacturers of the brand name “Duragesic Reservoir Patch” following the death of Teri Cassel by accidental overdose.²⁵ On summary judgment, defendants argued that plaintiffs’ design defect claims were impliedly preempted.²⁶ The court denied defendants’ motion for two reasons: (1) unlike in Bartlett, the defendants were not generic manufacturers, and thus their fentanyl patches were amenable to various designs; and (2) Bartlett was inapplicable to the facts of the case and plaintiffs’ claims because plaintiffs alleged that the defendants had a duty to employ an alternative design from the beginning, i.e. before FDA approval, as opposed to engaging in a redesign of the product after initial FDA approval of the product.²⁷ The court noted its concern that defendants’ argument would essentially foreclose all state law design defect claims against manufacturers of FDA-approved drugs, whether brand or generic, and determined that such a result was not contemplated by the Supreme Court in Bartlett.

AMOS V. BIOGEN IDEC INC.

In Amos, the U.S. District Court for the Western District of New York once again held that plaintiffs’ state law design defect claims were impliedly preempted under the reasoning in Bartlett.²⁸ While the plaintiffs conceded that their state law design defect claims were preempted by federal law, the court still considered defendants’ motion to dismiss the plaintiffs’ design defect claims, granting it with prejudice based upon the implied preemption analysis in Bartlett.²⁹

BOOKER V. JOHNSON & JOHNSON

Brand manufacturers obtained another positive implied preemption decision from the U.S. District Court for the Northern District of Ohio in Booker v. Johnson & Johnson.³⁰ In Booker, the plaintiff claimed that her daughter suffered pulmonary emboli and passed away due to her use of the Ortho Evra® birth control patch.³¹ After first determining that the plaintiff had sufficiently pled a claim for design defect under Georgia law, the court focused on whether such claims were nonetheless impliedly preempted under Bartlett. In short, the court determined that Bartlett governed the issue and that plaintiff’s design defect claims were therefore preempted.³² More specifically, the Court found that the essential inquiry in considering preemption of a design defect claim is whether the state law requires remedial action by the manufacturer.³³ Finding that Georgia law would indeed require the defendant to create an alternative design, thus changing the composition of the drug, the court held that the plaintiff’s design defect claims were preempted.³⁴

BROWN V. JOHNSON & JOHNSON

Another unfortunate decision for brand manufacturers came in December 2014 when the U.S. District Court for the Eastern District of Pennsylvania refused to dismiss the plaintiffs’ state law design defect claims against the manufacturer of brand-name, over-the-counter Children’s Motrin.³⁵ The court specifically cited to Bartlett but held that “[t]he Supreme Court has not addressed whether federal law can preempt state law design defect claims brought against manufacturers of brand-name or non-prescription drugs. I conclude that its preemption cases do not extend to the manufacturers of these products.”³⁶ Then, apparently borrowing from the Supreme Court’s reasoning from Levine, the court went on to find that the defendants failed to demonstrate that the FDA would have rejected a proposed change to Children’s Motrin’s chemical composition.³⁷

YATES V. ORTHO-MCNEIL PHARM., INC.

Most recently, in another Ortho Evra® birth control patch case, the District Court for the Northern District of Ohio again found that a state law design defect claim was impliedly preempted.³⁸ Importantly, the court explicitly held, contrary to the plaintiff’s assertion, that the language of Bartlett applies equally to brand and generic drugs.³⁹ The court cited Amos for the same proposition and specifically found that the court’s holding in Cassel was incorrect and inconsistent with the Supreme Court’s analysis in Bartlett.⁴⁰

UPDATED SCORECARD – DESIGN DEFECT:

Brand manufacturers have undoubtedly made up ground on generic manufacturers when it comes to design defect claims. Aside from a few outliers in Cassel and Brown, district courts have regularly held that plaintiffs’ state law design defect claims against brand manufacturers are impliedly preempted under Bartlett. The majority approach holds that Bartlett’s application mandates preemption for both brand and generic drug manufacturers. While there may not be uniformity, there certainly seems to be at least a favorable trend.

WHAT DOES THE FUTURE HOLD FOR THE SCORECARD?

As it relates to preemption of failure-to-warn claims, it seems unlikely that the score will change significantly going forward. Brand manufacturers will likely continue to have difficulty satisfying the requisite “clear evidence” standard enunciated in Levine. Nearly six years post-Levine, there remains limited case law finding implied preemption of state law failure-to-warn claims against brand manufacturers. To make matters more difficult, the fact-specific nature of the findings in these cases limits their overall utility for other brand manufacturers facing similar claims.

Finally, as previously discussed in this very publication, almost immediately following the Supreme Court’s decision in Bartlett, the FDA announced its intention to “create parity” between brand and generic manufacturers through federal rulemaking.⁴¹ It was initially anticipated that further information regarding this proposed rulemaking would be available in September 2013, but such was not the case. To date, there have been no further pronouncements from the FDA regarding this possible administrative action, and, at this point, it seems that the question is more “if” such rulemaking will ever occur as opposed to “when” it will occur. Therefore – despite the Supreme Court explicitly stating in Bartlett that “the Court would welcome Congress’ ‘explicit’ resolution on the difficult preemption questions that arise in the prescription drug context” so that the Court is not “left to divine Congress’ will from the duties the statute imposes”⁴² – at this point it does not appear likely that courts and litigants will have the benefit of such legislative action anytime in the near future. Without this, brand manufacturers (and their counsel) can only continue their attempts to further develop post-Bartlett implied preemption jurisprudence on a case-by-case basis.

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[i] Wyeth v. Levine, 555 U.S. 555 (2009).

[ii] PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (U.S. 2011).

[iii] Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013).

[iv] See Richelle Kidder, Is the Feeling Really “Mutual”?: The Supreme Court’s Continued Frustration with the Prescription Drug Legal Framework, Pro Te: Solutio, November 2013, at 15 (http://www.butlersnow.com/wp-content/uploads/2014/08/Pro-Te-Solutio-Vol-6-No-4.pdf).

[v] Levine, 555 U.S. at 571. Briefly, the Supreme Court’s reasoning in Levine was that because a manufacturer may make certain changes to its label before receiving the FDA’s approval (namely through the “changes being effected” (CBE) regulation) to “add or strengthen a contraindication, warning, precaution, or adverse reaction” or to “add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product,” it is not impossible for a brand manufacturer to comply with both its state-law duty to warn without violating federal law unless the brand manufacturer can show “clear evidence” that such label changes would not have been approved by the FDA.

[vi] Id. at 573.

[vii] Dobbs v. Wyeth, 797 F. Supp. 2d 1264 (W.D. Okla. 2011).

[viii] Id. at 1266.

[ix] Id.

[x] Id.

[xi] Id.

[xii] Id. at 1280.

[xiii] Id. at 1276-77.

[xiv] Id. at 1273.

[xv] Id. at 1276-77.

[xvi] In re: Fosamax (Alendronate Sodium) Prods. Liab. Litig.; Glynn v. Merck Sharp & Dohme Corp., 951 F. Supp. 2d 695 (D.N.J. 2013).

[xvii] Id. at 697-98; 703-04.

[xviii] Robinson v. McNeil Consumer Healthcare, 615 F.3d 861 (7th Cir. 2010) could be considered an additional favorable decision. However, Robinson discussed implied preemption only briefly and on a somewhat tangential matter. This case involved an appeal of the trial court’s refusal to allow the plaintiff to add a claim for breach of implied warranty on the eve of trial in a case involving claims that the plaintiff’s decedent was diagnosed with toxic epidermal necrosis (TEN) after taking defendant’s product Children’s Motrin. On appeal, the court held that the trial court’s refusal to allow the amendment was proper, in part, because such a claim would have been unlikely to succeed. The court cited Levine and held that a court cannot order a drug company to place on a label a warning if there is “clear evidence” that the FDA would not approve it. Finding that the FDA had previously refused to require a reference to SJS/TEN on the label of over-the-counter drugs containing ibuprofen, the court went on to comment that “it would be odd to think that McNeil had a legal duty to guarantee against a risk that the FDA thought not worth warning against.” Id. at 873

[xix] See, e.g., Mason v. SmithKline Beecham Corp., 596 F.3d 387 (7th Cir. 2010); Koho v. Forest Labs., Inc., 17 F. Supp. 3d 1109 (W.D. Wash. 2014); Hunt v. McNeil Consumer Healthcare, 6 F. Supp. 3d 694 (E.D. La. 2014); Dopson-Troutt v. Novartis Pharms. Corp., 975 F. Supp. 2d 1209 (M.D. Fla. 2013); Schedin v. Ortho-McNeil-Janssen Pharms., Inc., 808 F. Supp. 2d 1125 (D. Minn. 2011); Wolfe v. McNeil–PPC, Inc., 773 F. Supp. 2d 561 (E.D. Pa. 2011); Lofton v. McNeil Consumer & Spec. Pharm., 682 F. Supp. 2d 662 (N.D. Tex. 2010); Dorsett v. Sandoz, Inc., 699 F. Supp. 2d 1142 (C.D. Cal. 2010); Forst v. SmithKline Beecham Corp., 639 F. Supp. 2d 948 (E.D. Wis. 2009); Muzichuck v. Forest Labs., Inc., 2015 U.S. Dist. LEXIS 5440 (N.D. W. Va. Jan. 16, 2015); Brown v. Johnson & Johnson, 2014 U.S. Dist. LEXIS 173800 (E.D. Pa. Dec. 9, 2014); Allen v. Takeda Pharms. N. Am., Inc., 2014 U.S. Dist. LEXIS 1749 (W.D. La. Jan. 7, 2014); Wells v. Allergan, Inc., 2013 U.S. Dist. LEXIS 13191 (W.D. Okla. Jan. 31, 2013); Newman v. McNeil Consumer Healthcare, 2012 U.S. Dist. LEXIS 2153 (N.D. Ill. Jan. 9, 2012); Baumgardner v. Wyeth Pharms., 2010 U.S. Dist. LEXIS 90263 (W.D. Pa. Aug. 31, 2010); Aaron v. Wyeth, 2010 U.S. Dist. LEXIS 14581 (W.D. Pa. Feb. 19, 2010).

[xx] Bartlett, 133 S. Ct. at 2471 (quoting 21 C.F.R. § 314.70(b)(2)(i)).

[xxi] Id. at 2475, 2479.

[xxii] Thompson v. Allergan USA, Inc., 993 F. Supp. 2d 1007 (E.D. Mo. 2014).

[xxiii] Id. at 1009.

[xxiv] Id. at 1014.

[xxv] Id.

[xxvi] Cassel v. Alza Corp., 12 – cv-771-wmc, 2014 U.S. Dist. LEXIS 27924, at *1-*3 (W.D. Wis. Mar. 5, 2014).

[xxvii] Id. at *5.

[xxviii] Id. at *13-*14.

[xxix] Amos v. Biogen Idec Inc., No. 13-CV-6375T, 2014 WL 2882104, at *3 (W.D.N.Y. June 25, 2014).

[xxx] Id.

[xxxi] Booker v. Johnson & Johnson, Case No. 3:12 oe 40000, 2014 U.S. Dist. LEXIS 145442 (N.D. Ohio Oct. 10, 2014).

[xxxii] Id. at *1.

[xxxiii] Id. at *11.

[xxxiv] Id. at *10-*11 (citing Bartlett for the proposition that “[a]s the Supreme Court explained, when a state imposes a ‘duty to ensure that one’s products are not unreasonably dangerous,’ it also involves a duty to make one or several changes to the composition of the drug, which conflicts with federal law prohibiting alteration of an FDA-approved design.”)

[xxxv] Id. at *11.

[xxxvi] Brown v. Johnson & Johnson, Civ. No. 12-4929, 2014 U.S. Dist. LEXIS 173800 (E.D. Penn. Dec. 9, 2014).

[xxxvii] Id. at *5.

[xxxviii] Id.

[xxxix] Yates v. Ortho-McNeil Pharm., Inc., Case No. 3:09 oe 40023, 2015 U.S. Dist. LEXIS 2838 (N.D. Ohio Jan. 5, 2015).

[xl] Id. at *13 (citing Bartlett, 133 S. Ct. at 2471).

[xli] Id. at *14.

[xlii] Kidder, supra note 4.

[xliii] Bartlett, 133 S. Ct. at 2480.

Finis