In case you missed it, last week the U.S. Supreme Court denied generic drug manufacturer Pliva Inc.’s challenge to a 2014 Iowa Supreme Court decision that found the high court’s landmark Mensing ruling did not necessarily preempt failure-to-update labeling claims against generic-drug makers (Pliva, Inc. v. Huck, Docket No. 14-544, filed November 10, 2014, cert. denied March 30, 2015).
As our readers are probably aware, the 2011 Supreme Court decision in Pliva, Inc. v. Mensing foreclosed state law failure-to-warn claims against generic-drug manufacturers (if you need to catch up, the Monitor has been following this ruling and its implications over the last four years).
Last week’s Supreme Court order denying Pilva’s petition for certiorari came out of the July 2014 Iowa Supreme Court ruling in Huck v. Wyeth, Inc., which found that Mensing did not necessarily preempt failure-to-update labeling claims against generic-drug makers.
By way of background, the Iowa Supreme Court case involved the following facts. Plaintiff Theresa Huck was prescribed the brand name nausea drug Reglan to treat her acid reflux disease, but only ever ingested the generic metoclopramide version manufactured by Pliva. When Huck was prescribed the drug, the label contained warnings that the drug was not approved for therapy longer than 12 weeks and addressed possible side effects, one of which was tardive dyskinesia, a severe neurological disorder that, among other symptoms, leads to involuntary body movement. In 2004, five months after Huck began taking the drug, the Food and Drug Administration (FDA) approved an update to the brand name drug label that included a boldface warning concerning the 12-week threshold. Pliva did not update its generic label to include the new FDA warning.
Two years after the updated labeling, Huck stopped taking the medication and was diagnosed with tardive dyskinesia. Two years after her diagnosis, Huck filed suit against Pliva, the brand name manufacturers, and several physicians. Huck’s complaint asserted claims of products liability, fraud, and warranty violations. Specifically, she claimed that Pliva did not issue the stronger warnings that federal regulators had approved in 2004. All of the defendants eventually managed to obtain judgment in their favor, but through multiple challenges, Huck’s claims reached the Iowa Supreme Court.
Pliva argued that all of Huck’s claims against it were preempted because it was impossible for the generic manufacturer to comply with both federal law and state law requirements. In other words, Pliva argued that it was complying with FDA requirements and that Huck could not impose additional regulatory requirements on a drug that the FDA had already approved.
The Iowa Supreme Court agreed with Pliva for each of Huck’s claims except for those which turned on her allegation that the generic drug manufacturer was obligated to update its label to match the changed brand name drug label. The Iowa court found that Huck’s failure-to-update claim would have been preempted if she had framed it as Pliva’s failure to meet the Hatch-Waxman Act’s duty of sameness, which requires generic-drug labels to match that of their branded counterparts. However, Huck had framed her claim as a breach of a state law duty to warn about the potential risks of taking metoclopramide for more than 12 weeks. Importantly, the court found:
“Neither the federal duty of sameness nor the duty to report safety risks to the FDA are ‘critical element[s]’ of [Huck’s] state law claims. Federal law has limited the way in which she can frame her claim: she cannot raise a claim based on labeling that would require Pliva to unilaterally strengthen its label. She has managed to avoid that difficulty because Pliva did not include the additional 2004 approved language. In sum, Huck’s claims fit into a ‘narrow gap': she is suing for conduct that violates the FDCA, but she is not suing because the conduct violates the FDCA.”
The state high court thus held that Pliva was responsible for updating its label to match the brand name manufacturer’s label, and that Huck’s state common law tort claims on Pliva’s allegedly insufficient warnings were not preempted simply because the warnings were consistent with FDA labeling requirements for generic drugs. Significantly, the decision also let Wyeth and other branded drug makers off the hook, following numerous other rulings in holding that a pharmaceutical company cannot be liable for injuries alleged to have been caused by products it did not manufacture or distribute.
In its November 2014 petition for certiorari, Pliva’s question to the Supreme Court was whether the Iowa Supreme Court erred when it deepened an acknowledged circuit split among the federal and state appellate courts and held, contrary to various Supreme Court and other appellate court decisions, as well as the plain language of the federal Food, Drug, and Cosmetic Act (FDCA), that federal law does not bar state tort claims predicated on allegations that a generic drug manufacturer violated the FDCA by failing to immediately implement or otherwise disseminate notice of labeling changes that FDA approved for use on the generic drug product’s brand-name equivalent.
As noted above, last Monday the Supreme Court denied Pliva’s petition without elaboration: “The motion of Generic Pharmaceutical Association for leave to file a brief as amicus curiae is granted. The petition for a writ of certiorari is denied.”
That may not seem like much to talk about, but with nearly eight in 10 prescriptions filled by generic drugs today, any change in the way the preemption doctrine is applied to generic-drug makers could have an enormous impact on mass torts and pharmaceutical litigation. This is why even a two-sentence denial of certiorari by the Supreme Court dealing with only the potential for survival of a state law claim makes headlines here at the Monitor. Moreover, the FDA continues to examine whether generic-drug makers might someday be able to unilaterally change the warnings on their drugs, which could drastically change the legal landscape as well. As always, we will continue to keep you posted on these developments.