Health Law Daily Federal law does not preempt state law claims of failure-to-warn and design defect against Xarelto®
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Monday, July 24, 2017

Federal law does not preempt state law claims of failure-to-warn and design defect against Xarelto®

By Deborah Hammonds, J.D.

Finding sufficient facts existed to merit a jury determination, a federal district court rejected defendants’ argument that federal law preempted failure-to-warn and design defect claims under the Mississippi Products Liability Act. The court rejected the contention that federal law preempts the claims because they would be required to take actions they could not lawfully take without the FDA’s approval (In re: Xarelto (Rivaroxaban) Products Liability Litigation, July 21, 2017, Fallon, E.).

Multiple plaintiffs across the country filed suit against several pharmaceutical companies involving Xarelto®, an anti-coagulant used for a variety of blood-thinning medical purposes. Plaintiffs allege they or their family members suffered severe bleeding and other injuries due to Xareto’s allegedly defective design and inadequate warning label, among other issues. This is the third of four bellwether trials.

Defendants sought partial summary judgment on plaintiff’s failure-to-warn claims based on "impossibility" preemption principles. Writing that it was well aware of the divide among federal state courts on the issue of FDA preemption, the court refused to stretch the preemption doctrine beyond its existing borders, noting that doing so would free pharmaceutical companies from state common-law liability–and limit states’ constitutional right to protect its residents’ welfare–so long as manufacturers are selling a federally-approved drug. Because Congress has not provided a federal remedy for consumers harmed by unsafe or ineffective drugs, it has, evidently, determined that widely available state rights of action provide appropriate relief for injured consumers. Looking at the U.S. Supreme Court’s Wyeth v Levine, the court found Congress had demonstrated a clear intent to preserve the functions of both the FDA and state tort remedies.

While pharmaceutical companies generally cannot take unilateral action or alter an FDA-approved drug, the defendants’ argument took the preemption doctrine one step too far. The defendants relied on precedent related to generic drug manufacturers, which are more limited in their ability to make changes to their labels than manufacturers of name-brand drugs such as Xarelto. However, the preemption of claims against brand name drug manufacturers is not as clear. Neither Congress nor the Supreme Court has spoken directly on that issue. Until Congress or the Supreme Court does so, the court wrote that it is restrained to existing precedent. However, defendants could have strengthened their label post-approval as there are clear pathways which allow brand-name drug manufacturers to make changes without FDA approval. In any event, the court found there sufficient questions of fact existed to merit a jury determination of the issue.

The court also rejected was the contention that there was clear evidence the FDA would have refused to approve a similar label change under the changes being effected (CBE) regulation. The FDA and the defendants are required to give more than "passing attention" to the issue: there must be evidence the FDA intended to or would prohibit a defendant from strengthening warning. The defendants are responsible for their label and may have been able to include other data to support the need to update their label. Further, issues of fact remain as to whether the defendants could have warned doctors about the INRatio recall, either through the label or through other means. Finally, there were issues of fact as to whether the defendants could have added a warning about the test’s availability.

Finally, at the core of preemption analysis is congressional intent. In Levine, the Supreme Court determined that Congress had declined to limit the historical state police power over health and safety matters and had allowed for coexistence between state and federal regulation of prescription medications. In contrast to the express preemption clause found in the Medical Device Amendment Act within the FDCA, no such clause exists for branded prescription drugs. Noting it would not step into Congress’ shoes to create such a provision, the court denied the motions for partial summary judgment based on preemption principles.

The case is MDL No. 2592.

Attorneys: Leonard A. Davis (Herman, Herman & Katz, LLC) for Dora Mingo. Susan M. Sharko (Drinker, Biddle & Reath, LLP) for Janssen Pharmaceuticals, Inc.

Companies: Janssen Pharmaceuticals, Inc.; Janssen Research & Development, LLC; Janssen Ortho LLC; Johnson & Johnson; Bayer Pharma AG; Bayer Healthcare Pharmaceuticals Inc.

MainStory: TopStory CaseDecisions FDCActNews DrugBiologicNews PreemptionNews PLDrugNews LouisianaNews

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