By David Yucht, J.D.
New Jersey law provides that where a warning on a drug label was approved by the FDA, a rebuttable presumption exists that the warning is adequate.
A federal judge in New Jersey ruled an HIV patient’s claims against a drug manufacturer alleging it should have developed a drug using a safer active ingredient were not federally preempted. Consequently, the court refused to dismiss the patient’s design-defect and failure to warn claims. The court also denied the manufacturer’s motion to dismiss on state law grounds (Gaetano v. Gilead Sciences, Inc., March 26, 2021, McNulty, K.).
Truvada. An HIV patient was prescribed Truvada® until he began suffering from chronic pain. He sued Gilead Sciences, Inc, alleging New Jersey products liability claims that Gilead should have used a safer ingredient and that Gilead failed to warn about Truvada’s risks. In 2004, the FDA approved Truvada for the treatment of HIV. Truvada contains tenofovir disoproxil fumarate (TDF). Gilead had developed and sold other TDF-based drugs before marketing Truvada. According to the patient, Gilead’s research showed TDF caused bone and kidney problems. However, he alleged that Gilead’s labeling failed to warn doctors that patients should be monitored accordingly. Moreover, Gilead provided "stronger monitoring recommendations" in the European Union. Before TDF medications were introduced, Gilead discovered a similar active ingredient, tenofovir alafenamide fumarate (TAF) that did not pose the same risks as TDF. Yet Gilead discontinued its development of a TAF medication in 2004, to focus on gaining FDA approval for Truvada. Gilead moved to dismiss the complaint arguing that all claims were preempted by federal law and the failure-to-warn claim was precluded by state law.
Preemption-design defect. The court refused to dismiss the design defect claims on impossibility preemption grounds. Impossibility preemption applies where it is impossible for a drug manufacturer "to comply with both state and federal requirements." When faced with a claim of impossibility preemption, a court should first identify what changes to the drug or label the state-law claim would require, and then determine whether, under federal law, a manufacturer could unilaterally implement that change. If the manufacturer could do so, then federal law does not make it impossible to comply with a state-law duty, and preemption does not apply. Under federal law, a generic manufacturer is not permitted to change the drug or its label; even if state law imposes a duty to alter the drug’s composition. However, a brand-name manufacturer, such as Gilead, particularly during the pre-FDA-approval process, may make changes. Here, it appeared that the design-defect claim was not preempted. The allegation was Gilead should have designed Truvada differently from the outset. However, federal law does not dictate the way a manufacturer must initially design a drug.
Preemption-failure to warn. The court concluded that a claim the manufacturer should have proposed a stronger warning pre-approval was not preempted and it was premature to rule on preemption concerning post-approval failure to warn. A failure-to-warn claim requires that a manufacturer knew or should have known about a risk but failed to warn about that risk. Concerning the allegation that Gilead failed to prepare an adequate warning pre-approval, a drug manufacturer is required to present an adequate warning label to the FDA for approval. Gilead pointed to no federal law that would have prevented it from submitting a different warning label to the FDA prior to Truvada’s approval.
Concerning the post-approval claim, the FDA’s "changes being effected" (CBE) regulation allows a brand-name manufacturer to change a label without first obtaining FDA approval, subject to later review. The CBE provides that a labeling change must be based on "newly acquired information." The court noted because preemption is an affirmative defense dismissal is appropriate only when preemption is manifest on the face of the complaint. Some allegations here appeared to involve newly acquired information. For example, the patient alleged that from 2001 to 2007, Truvada labelling "failed to warn doctors that all patients should be monitored for adverse kidney effects," based on studies "that otherwise healthy individuals were experiencing adverse kidney events." The court could not infer the pertinent studies occurred pre-approval.
Failure to warn-presumption of adequacy. State law did not provide a basis for dismissal either. UnderNew Jersey law a warning approved by the FDA is presumably adequate. As applied to this case, the patient needed to plausibly allege that the presumption could be overcome. Here, the allegation about stronger warnings in the EU allowed an inference Gilead knew of harmful effects but did not disclose them in the US. Moreover, the complaint alleged Gilead deliberately downplayed risks and published studies understating the kidney problems associated with TDF drugs.
The case is No. 2:21-cv-01418-KM-JBC.
Attorneys: Ari G. Bernstein (Landel, Bernstein & Kalosieh, LLP) for Anthony Gaetano. Beth S. Rose (Sills Cummis & Gross PC) for Gilead Sciences, Inc.
Companies: Gilead Sciences, Inc.
MainStory: TopStory CaseDecisions FDCActNews DrugBiologicNews PreemptionNews PLDrugNews SafetyNews NewJerseyNews
Interested in submitting an article?
Submit your information to us today!Learn More
Health Law Daily: Breaking legal news at your fingertips
Sign up today for your free trial to this daily reporting service created by attorneys, for attorneys. Stay up to date on health legal matters with same-day coverage of breaking news, court decisions, legislation, and regulatory activity with easy access through email or mobile app.