Trio of Favorable Preemption Decisions for New Jersey Pharmaceutical Companies

A trio of recent preemption decisions – from the United States Supreme Court, the United States District Court for the District of New Jersey, and the Superior Court of New Jersey – are good news for pharmaceutical companies facing product liability suits in New Jersey.

First, in Mutual Pharmaceutical Co. v. Barlett, the United States Supreme Court issued an important ruling (copy available here) on several critical issues affecting product liability suits against generic pharmaceutical manufacturers.  Bartlett involved claims by a woman that alleged she suffered permanent and disfiguring injuries after ingesting a generic version of the nonsteroidal anti-inflammatory drug sulindac. 

Pursuant to the 2011 decision from the United States Supreme Court in Mensing v. PLIVA, the landmark case establishing that failure-to-warn claims against generic drug manufacturers are preempted by federal law, Bartlett was unable to proceed with a failure-to-warn claim against the manufacturer of the sulindac that she took.  As explained by the Mensing decision, such claims are preempted because generic drug manufacturers have a duty under federal law to provide the same warnings with their drugs as the FDA-approved warnings provided by the brand-name drug manufacturer, and because this so-called “duty of sameness” prohibits a generic drug maker from providing any new or different warnings.  Thus, any attempt under state law to require a generic drug manufacturer to provide different warnings than the FDA-approved brand-name drug label would impose a duty to violate federal law, which is preempted under the Supremacy Clause of the United States Constitution.

Notwithstanding her inability to assert a failure-to-warn claim against Mutual, however, Barlett was permitted to pursue a claim for a design defect, as the First Circuit found that such a claim was not explicitly preempted by Mensing and because it reasoned that Mutual could simply have decided not to sell its generic sulindac, and thus could have avoided a state-imposed duty to violate federal law by issuing a different label.

The First Circuit’s opinion sent shockwaves through the generic pharmaceutical industry, which had generally enjoyed wide success in securing the dismissal of product liability claims involving generic drugs in the wake of Mensing.  Mutual appealed the First Circuit’s ruling to the United States Supreme Court, and on June 24, 2013, the Court released its opinion rejecting the reasoning of the First Circuit.  In particular, the Court recognized that Mutual had a duty under federal law not only to provide the same warnings as the FDA-approved warnings accompanying the brand-name version of sulindac, but also a duty under federal law not to change the design of its generic sulindac.  The Court also ruled that the First Circuit’s “stop selling” rationale would “render … preemption a dead letter.”

The second important decision (copy available here) comes out of the Fosamax Products Liability MDL pending before Judge Pisano in the United States District Court for the District of New Jersey in a case captioned Glynn v. Merck Sharp & Dohme Corp.  Unlike the Barlett case, which involved a generic pharmaceutical, Glynn involved a brand-name drug – Fosamax – that the plaintiffs claimed had inadequate warnings about the risk of atypical femur facture.  Whereas the 2011 Mensing decision established that failure-to-warn claims agasint generic drug manufacturers are preempted, the 2009 opinion from the US Supreme Court in Wyeth v. Levine reached the contrary result in the context of brand-name drugs, finding that failure-to-warn claims are not preempted under federal law in the absence of “clear evidence” that the FDA would not have approved whatever labeling change a plaintiff might propose.  Levine thus largely squelched brand-name pharmaceutical companies’ ability to assert a successful preemption defense to failure-to-warn claims.

 In the Glynn case, however, Merck did assert such a defense, relying on evidence that it had sought FDA approval of a stronger warning about this risk before the plaintiff suffered her injury, but that FDA had rejected its proposed new warning.   After hearing oral argument on Merck’s motion to dismiss on this basis, Judge Pisano elected to proceed with a trial so that a fuller factual record on this issue could be developed.  A jury trial took place in April of this year, resulting in a jury verdict for Merck.  Afterwards, Judge Pisano found in an opinion dated June 27, 2013, that the evidence presented at trial indeed was sufficiently “clear evidence” that the FDA would not have approved the alternative warning proposed by Glynn, and on this basis found that Glynn’s failure-to-warn claims against Merck were indeed preempted.

Last but not least, the third opinion (copy available here) comes from Judge Carol Higbee of the Superior Court of New Jersey in the context of the centralized litigation pending before her involving Accutane and its generic form, isotretinoin.  In an opinion released on June 28, 2013, Judge Higbee ruled on the generic isotretinoin manufacturers’ motion to dismiss plaintiffs’ claims against them, finding all such claims to be preempted.  In particular, Judge Higbee determined that all of the plaintiffs’ claims against the generic defendants were based, ultimately, on an alleged failure-to-warn and that, if successful, the plaintiffs’ claims would have imposed a duty on the generic defendants to violate their federal-law “duty of sameness.”  Because such a claim is preempted by Mensing, Judge Higbee granted the generic defendants’ motion to dismiss and dismissed all of the plaintiffs’ claims as preempted.

While the pharmaceutical industry continues to face product liability suits in New Jersey (and nationwide), this trio of decisions should prove helpful to both brand-name and generic manufacturers by strengthening the preemption defense against such claims.

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