Long ago, when we first started representing the makers of prescription pharmaceuticals, it was said that people did not tend to sue over life-saving medications. Contraceptives, pain medications, obesity medications, diabetes medications, psychiatric medications, and many others were fair game, even if the risk-benefit calculus for an individual patient might involve major benefits on one side of the scale. Plaintiff lawyers would not waste their time, it was said, with medications to treat potentially terminal cancer or other conditions that would kill the patient absent effective treatment. Regardless of whether that old saw was ever true, dockets have been full for a while with cases about medications that are clearly life-saving. (Some of those plaintiffs also seek to prevent the defendants from properly characterizing their medicines as life-saving, but that is a different matter.)
AIDS used to be one of those conditions that came with a death sentence. Now, with dozens of medications, often combining different active ingredients, on the market since AZT was approved in 1987, the ability of the medical community to treat HIV, the virus that causes AIDS, is one of the great success stories of medicine. Dr. Fauci and others from NIAID who have been in the news over the past several months played an important role in this success, but so too have pharmaceutical companies. Not only can modern treatment regimens keep viral loads below detectable levels and make it so patients with HIV die of old age or unrelated conditions, but the advent of Pre-Exposure Prophylaxis with combinations of medications can prevent transmission in some instances, something unthinkable in the early days of the HIV/AIDS epidemic.
In Epstein v. Gilead Sciences, Inc., No. 19-81474-CIV-SINGHAL, 202 WL 4333011 (S.D. Fla. July 27, 2020) (Singhal, M.J.), these two trends intersected. The plaintiff claimed to have suffered kidney and bone damages from his use of the prescription drugs Viread and Atripla, a combination of Viread and two other active substances. In support, he asserted seven different state law claims, including that the drugs were defectively designed because Viread should have had tenofovir alafenamine instead of the tenofovir disproxil as its active ingredient, the drugs never should have been sold, and the drugs should have had different warnings about the risk of kidney and bone damage (of some sort). This brought us to another trend: implied preemption of design and warnings claims with branded prescription drugs. Leading up to and for a while after the terrible Levine decision there was not much hope of getting such design and warnings claims out on preemption, let alone on a motion to dismiss. But, after Mensing, Bartlett, Albrecht, and a bunch of cases along the way, things have changed for the better.
After noting the plaintiff's position that "no federal law prevented Gilead from designing its TDF Drugs to be safer before FDA approval and because Gilead could unilaterally change their label to make it stronger to comply with state law" and citing Albrecht, two cases, and the Supremacy Clause, this was the entirety of the Court's analysis:
Plaintiff's Complaint is premised on the allegations that: (1) Gilead should have designed Atripla and Viread with TAF instead of TDF, and thus, never should have sold Atripla and Viread; and/or (2) Gilead failed to adequately warn Plaintiff or his doctors about the bone and kidney risks associated with Atripla and Viread. Gilead argues these claims are preempted, because Gilead could not have marketed or sold medications containing this design change without first seeking and obtaining FDA approval. See 21 C.F.R. §314.7-(b)(2)(i) (defining "changes in the qualitative or quantitative formulation of the drug product" as "major changes" that "requir[e] supplement submission and approval prior to distribution of the product"). This Court agrees, it would have been impossible for Gilead to comply with both its state duties to change the products' labels and its federal duties not to make such changes without first obtaining FDA approval. See Mut. Pharm. Co., Inc. v. Bartlett, 570 U.S. 472, 475 (2013). Additionally, Plaintiff contends that TAF should have been used instead of TDF; however, the FDA approved Gilead's formula and any changes would have required further approval.
Id. at *2. As we said above, short and sweet. (Not like the path described here.) Also clearly right on the law. The narrow CBE exception that Levine latched onto and made something so much bigger did not apply here. (Peruse these posts, perhaps: this, this, and this.) Insisting that a drug should have had a different compound as its active ingredient is not really a design claim, but it definitely requires a few layers of FDA decisions that cannot be taken for granted. So, plaintiff's standard product liability claims were preempted.
Plaintiff asserted (and did not drop) state claim claims for fraud, express warranty, and implied warranty. The Defendant also moved to dismiss those on preemption, but the court only evaluated them on the adequacy of pleading, presumably because of the doctrine of constitutional avoidance. So, while the preempted claims were dismissed with prejudice, these three were dismissed without prejudice and the plaintiff was given a little time to try to amend. We do not know yet if he took a second swing, but, if he did, we expect to see another preemption order out of this case. Preferably, another one that is concise and correct like this one.
Originally published by Reed Smith, August 2020
This article is presented for informational purposes only and is not intended to constitute legal advice.
