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From Health Law Daily, March 28, 2019

Preemption of failure to warn claims against drug giants in Eliquis® MDL affirmed

By Harold S. Berman, J.D.

No new information to thwart preemption was presented, the appellate panel found, adding that pre-service removal of Eliquis lawsuits to federal court was proper.

A New York federal district court’s dismissal of multiple suits alleging failure to warn and other product liability claims against Bristol-Meyers Squibb Company and Pfizer Inc was proper because the plaintiffs’ negligence and strict liability claims based on failure to warn were preempted by the FDC Act, the U.S. Court of Appeals for the Second Circuit ruled. In addition, the appellate court held that the removal of the suits from Delaware state court to federal court was appropriate even though the drug companies were Delaware corporate citizens, because the suits were removed after they were filed in state court but before either company was served. Therefore, removal did not run afoul of the forum defendant rule (Gibbons v. Bristol-Myers Squibb Co. March 26, 2019, Sullivan, R.).

Background. Bristol-Meyers Squibb and Pfizer together manufactured and distributed Eliquis®, a blood-thinning medication used to reduce the risk of stroke. However, the drug also increased patients’ risk of bleeding. Although the FDA approved Eliquis in 2012, the drug included warnings that users risked serious and even fatal bleeding.

Beginning in 2015, plaintiffs nationwide began suing the two drug companies, asserting product liability claims and alleging that they or their decedents suffered excessive bleeding after taking Eliquis, resulting in substantial injury or death. The plaintiffs generally contended that the injuries derived from the drug’s improper design and insufficient warning labels. Seventeen of the suits came before a federal district court in New York, and the court, ruling on an exemplar action, ultimately granted the companies’ motion to dismiss in part, concluding that most of the claims were preempted by the FDC Act and that the remaining claims did not meet the pleading threshold pursuant to federal procedural rules. The district court dismissed the design defect claim with prejudice, but granted leave to amend the remaining claims.

Eliquis product liability cases nationwide were then transferred to the New York district court. The plaintiffs in the exemplar action amended their complaint, which the court also dismissed. The court then gave the plaintiffs in the other pending Eliquis suits leave to amend their complaints and to show why their complaints should not be dismissed along with the exemplar action. Of the 68 pending actions, 19 plaintiffs attempted to show why dismissal was not warranted, but none were successful. The district court concluded that in all of the Eliquis actions, the FDC Act preempted claims premised on a design defect and failure to warn, and that all other claims either were preempted or failed to state an actionable claim.

However, at the time of the New York district court’s dismissal, over 30 of the Eliquis cases had not yet been transferred to New York, and were still pending in California. The California plaintiffs then refiled their cases in Delaware state court. The drug companies removed the actions to the Delaware federal district court and requested that the cases be transferred and consolidated into the New York actions. However, the plaintiffs asked the Delaware federal district court to remand their cases to state court, arguing that the companies’ corporate status as Delaware citizens precluded the court’s jurisdiction based on diversity. The Delaware district court denied the plaintiffs’ motions and, instead, transferred the cases for consolidation to the federal district court in New York, where they were dismissed.

Additional Eliquis plaintiffs then adopted a new strategy that entailed filing new suits in Delaware state court. When those suits also were removed to federal district court and ultimately transferred to New York, the new plaintiffs asked the New York federal court to remand the suits to Delaware state court. The New York court denied the remand motions and, consistent with the reasoning behind the earlier Eliquis suit dismissals, dismissed the 45 new suits. The plaintiffs in the new suits appealed, and their appeals were consolidated with earlier Eliquis suit appeals, of which 15 remained before the Second Circuit.

Removal. The appellate panel affirmed the removal of the suits from state court to Delaware federal district court, rejecting the appellants’ argument that the Delaware federal district court had no jurisdiction because the only basis for jurisdiction was diversity of citizenship and the drug companies were Delaware citizens. The drug companies removed each of the actions to federal court after suit was filed in state court, but before either company had been served. Under the forum defendant rule in 28 U.S.C. §1441(b)(2), an action may not be removed to federal court based only on diversity of citizenship once a home-state defendant has been "properly joined and served." Consequently, §1441(b)(2) did not apply until a home-state defendant was served according to state law, and the suit was removable to federal court before that service took place, provided that the federal court could assume jurisdiction.

Dismissal on preemption grounds. The panel also affirmed the district court’s dismissal of the Eliquis suits’ negligence and strict liability claims on the basis that the plaintiffs’ failure to warn claims were preempted by the FDC Act. To state a claim for failure to warn that is not preempted by the FDC Act, a plaintiff must plead a labeling deficiency that the company could have corrected without FDA approval, based on newly acquired information.

In the instant cases, the failure to warn claims were deficient because they contained only conclusory and vague allegations and did not plausibly allege any newly acquired information that could have justified changing the Eliquis label without approval by the U.S. Food and Drug Administration. The plaintiffs’ assertions that various studies confirmed problematic bleeding associated with using Eliquis provided no basis to conclude that the bleeding described in those studies presented a different kind of risk than what the company already had discussed with the FDA or were more severe than the bleeding risks of which the government already was aware.

The cases are Nos. 17-2638; 17-2642; 17-2643; 17-2648; 17-2661; 17-2667; 17-2677; 17-2687; 17-3765; 17-3867.

Attorneys: Lawrence R. Lassiter (Miller Weisbrod LLP) for Catherine Gibbons. Neal Kumar Katyal (Hogan Lovells US LLP) for Bristol-Myers Squibb Co. and Pfizer Inc.

Companies: Bristol-Myers Squibb Co.; Pfizer Inc.

MainStory: TopStory CaseDecisions FDCActNews DrugBiologicNews LabelingNews PreemptionNews PrescriptionDrugNews PLDrugNews ConnecticutNews NewYorkNews VermontNews

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