Trial News

A California federal district court found that federal law does not preempt most claims brought by HIV patients against the pharmaceutical company Gilead over the toxicity of its drugs containing tenofovir disoproxil fumarate (TDF), denying Gilead’s motion to dismiss. The patients allege that Gilead failed to adequately warn them of the drugs’ toxicity, defectively designed the drugs, and violated state fraud and consumer protection laws by withholding safer drug designs. (Holley v. Gilead Sciences, Inc., 2019 WL 2077845 (N.D. Cal. May 10, 2019).)

Between 2001 and 2012, the FDA approved five drugs produced by Gilead that contain TDF for the treatment of HIV. One of these drugs, Viread, is also approved for the treatment of hepatitis B, while another, Truvada, is also approved for pre-exposure prophylaxis to reduce the risk of contracting HIV. Before the first TDF drug approval in 2001, Gilead was aware that TDF-based drugs posed a risk to patients’ kidneys and bones, and it had discovered tenofovir alafenamide fumarate (TAF), which provides the same therapeutic effect as TDF drugs. But TAF does this through a significantly smaller dose, reducing the risk of these side effects.

However, Gilead failed to obtain approval for TAF drugs until 2015 and obtained approval for Stribild, which contains a higher-than-required dose of TDF, in 2012. In addition, Gilead’s TDF drug labels did not indicate that kidney and bone damage could occur in patients without preexisting conditions and did not recommend a specific, frequent monitoring schedule for the assessment of patients’ kidney function.

In 2018, 140 plaintiffs from 31 states filed suit in California district court, alleging state law failure-to-warn, design defect, and fraud and consumer protection claims based on Gilead’s drug pre-approval warning submissions and post-approval drug labeling. The plaintiffs also allege Gilead was financially motivated to withhold the safer TAF drugs from the market for almost 15 years because the drugs were too similar to the TDF drugs and because Gilead “stood to gain by having two different periods of drug exclusivity: first for TDF drugs and later for TAF drugs.”

Gilead moved to dismiss the failure-to-warn and design defect claims, arguing that they are preempted under federal law. The court used the two-step analysis under Wyeth v. Levine to determine whether these claims are preempted. Under this analysis, the court first must look at whether a drug manufacturer could have taken action independently that would have complied with both state and federal law. Then, if independent action was possible, the court must look at whether there was “clear evidence” that the FDA would not have granted approval.

As to the plaintiffs’ design defect claims, the court found that no federal law prohibited Gilead from developing and seeking approval for safer TAF drugs rather than the TDF drugs. The court concluded that “Gilead could have independently complied with both state and federal law prior to submitting the TDF drugs for FDA approval” and that no “clear evidence” exists that the FDA would not have approved the TAF drugs.

In determining whether to dismiss the plaintiffs’ failure-to-warn claims, the court separately considered Gilead’s pre- and post-approval warnings. Regarding the pre-approval warnings, the court found that federal “labeling requirements provide only that a new drug application must contain certain proposed information” and “do not conflict with any state-law duties regarding adequacy of warnings.” Because Gilead could have complied with federal law while meeting state law warning requirements, the pre-approval claims are not preempted, the court said.

As to the post-approval failure-to-warn claims, the court looked to the date the specific TDF-containing product was introduced. This is because in 2008, the FDA adopted the “changes being effected” (CBE) regulation, which allows brand-name drug manufacturers to add to or strengthen a drug warning label before FDA approval of the label change only if the change is based on “newly acquired information.” Gilead was aware of the risks of the TDF drugs prior to their approval—so after the FDA adopted the CBE regulation, Gilead could not independently change drug labels because the information forming the basis for the change was not “newly acquired.” Accordingly, the court dismissed the post-approval claims for the two TDF drugs approved after 2008, while allowing claims for the three drugs approved before 2008 to move forward.

Gilead also argued that it had no duty to introduce TAF drugs at an earlier date, based on  AIDS Healthcare Foundation, Inc. v. Gilead Sci., Inc.  (2016 WL 3648623 (N.D. Cal. July 6, 2016) aff’d, 890 F.3d 986 (Fed. Cir. 2018).) In that case, the plaintiffs had argued that Gilead improperly bundled TAF with other ingredients for patent protection purposes, and the court found there was “no legal basis for concluding that Gilead had a duty to release TAF as a standalone product.” However, the court distinguished the current case, concluding that while in AIDS Healthcare “ Gilead owed no duty to its competitors [this] says nothing about any duties Gilead might owe to consumers under state tort law.”

Finally, the court turned to the plaintiffs’ fraud and consumer protection claims, which are based on Gilead’s alleged misrepresentations and omissions concerning the toxicity of the TDF drugs. Gilead argued that the plaintiffs’ state fraud claims do not meet the heightened pleading requirements of Federal Rule of Civil Procedure 9(b). The court agreed that the plaintiffs failed to meet requirements under Rule 9(b) to “state with particularity the circumstances” of fraud-based claims. “Whether Gilead acted unfairly by designing unreasonably dangerous drugs for financial gain does not require that Gilead also acted fraudulently.” However, the court found that the plaintiffs’ allegations that Gilead had withheld safer drug designs and failed to provide adequate warnings of the need for bone and kidney monitoring were “specific enough . . . to give defendants notice of the particular misconduct.” The court allowed these omissions-based claims to move forward.

Benjamin Crump, of Tallahassee, Fla., who represents the plaintiffs, said that the court’s “favorable motion is good for all plaintiffs who can now go forward with their claims against Gilead but especially for minority plaintiffs who have been deeply affected by the heinous actions of this pharmaceutical giant.” Crump noted that “according to the CDC, despite representing less than 13% of the U.S. population, in 2017 African-Americans made up 43% of new HIV diagnoses.”

Robert Hilliard, of Corpus Christi, Texas, who also represents the plaintiffs, said that “there are well over 100,000 people who will have been exposed to, and suffered some level of side effect, including death, from this needlessly dangerous Gilead drug” and that “as we begin a deep dive into the documents, we are discovering the mind-numbing depth of Gilead’s culpability.” Hilliard added that he “looks forward to trying this case and securing justice for these victims.”