Holley v. Gilead Sciences, Inc.

Background

The court had consolidated approximately 75 cases for pretrial purposes, involving more than 3,000 plaintiffs. The plaintiffs had taken one or more of Gilead’s TDF-containing drugs: Viread, Truvada, Atripla, Complera, and Stribild. They alleged that the drugs caused unnecessary kidney and bone damage because Gilead failed to provide adequate warnings and chose to develop TDF drugs instead of the allegedly safer TAF alternative.

The plaintiffs asserted state-law claims for design defect, failure to warn, negligence, fraud, breach of the implied warranty of merchantability, and violations of consumer-protection laws. Gilead moved for summary judgment on all claims involving common issues. Summary judgment is a decision without a trial when the moving party shows that no genuine dispute of important fact exists and that it is entitled to judgment under the law.

Design-defect claims

The court rejected Gilead’s argument that the plaintiffs’ design-defect claims were preempted by federal law. The plaintiffs challenged the TDF drugs that Gilead distributed and alleged that Gilead should have considered TAF as a safer alternative before seeking approval for the TDF drugs. The court concluded that the relevant state-law duties applied to the drugs that Gilead actually distributed, so the lack of FDA approval for TAF did not resolve the preemption question.

The court granted summary judgment to Gilead on design-defect claims based on strict liability in Massachusetts, North Carolina, Pennsylvania, Virginia, and Utah because the parties agreed those states do not recognize such claims for prescription drugs. The court also granted summary judgment to Gilead on the Alabama design-defect claims under both strict-liability and negligence theories, following authority that treated prescription-drug design-defect claims under Alabama law as challenges to the adequacy of warnings.

For the remaining jurisdictions, the court held that the plaintiffs had presented sufficient expert testimony and other evidence about TDF’s kidney and bone risks and TAF’s relative safety. The court rejected Gilead’s argument that the plaintiffs needed expert testimony specifically weighing TDF’s risks against its benefits. It also rejected Gilead’s argument that evidence of a reasonable alternative design could not defeat summary judgment. The court denied summary judgment on the remaining design-defect claims because a reasonable jury could find the evidence about TAF relevant to whether TDF was defectively designed.

Negligence claims

The court denied summary judgment on negligence claims based on an alleged design defect for the same reasons it denied judgment on the remaining design-defect claims. It rejected Gilead’s argument that a plaintiff cannot win on negligence without also proving strict liability, explaining that negligence and strict liability examine the case from different perspectives.

The court granted summary judgment to Gilead on Utah negligence claims based on an alleged duty to refrain from marketing a non-defective product when a safer model was available or to inform consumers that a safer model was available. The court declined to decide, without briefing about the specific duties recognized by each jurisdiction, which other negligence claims were supported by the applicable state laws. It stated that Gilead could renew those arguments in case-specific summary-judgment motions.

Failure-to-warn claims and federal preemption

The court held that the plaintiffs’ pre-approval failure-to-warn claims were not preempted. Gilead had argued that it could not provide an initial warning without FDA approval, but the court found that Gilead cited no federal law preventing it from proposing adequate warnings. FDA approval of a label did not conclusively establish that the manufacturer had satisfied its duty to provide adequate warnings.

The court granted summary judgment to Gilead on the post-approval failure-to-warn claims. The plaintiffs relied on the FDA’s “changes being effected” regulation, which can allow a manufacturer to strengthen certain warnings before receiving FDA approval when the manufacturer has newly acquired information. The court placed the burden on the plaintiffs to show that such information existed. It concluded that the plaintiffs had not shown that the information they identified differed from information already provided to the FDA. The plaintiffs therefore had not shown that Gilead could have changed its labels without first obtaining FDA approval.

Fraud claims

Only fraud claims based on omissions remained because earlier orders had dismissed fraud claims based on affirmative misrepresentations. The court held that fraud claims based on inadequate labeling were preempted for the same reasons as the post-approval warning claims.

The court held that claims based on omissions in promotional and marketing materials were not preempted to the extent they alleged that Gilead concealed safety information contained in FDA-approved labels without contradicting those labels. However, the court granted summary judgment to Gilead on claims concerning omissions about TAF clinical Study 1101 and Gilead’s reasons for delaying TAF development. The court assumed for purposes of the ruling that Gilead might have owed a duty to disclose the information, but found that the plaintiffs presented no evidence that the information was material—that is, important enough that it could have affected a reasonable person’s choice. The court noted that Study 1101 showed TAF had greater potency and a safety profile similar to TDF, not that TAF was safer than TDF.

Implied-warranty and consumer-protection claims

The court held that the implied-warranty and consumer-protection claims survived to the extent they were based on design-defect, negligence, and fraud claims that also survived. It granted summary judgment to Gilead on those claims to the extent they depended on failure-to-warn claims that the court found preempted.

The court rejected Gilead’s argument that FDA approval alone defeated the implied-warranty claims. It also declined to treat an earlier decision involving Gilead and competitors as dispositive of the plaintiffs’ consumer-protection claims, reasoning that duties owed to competitors do not resolve possible duties owed to consumers.

Disposition

The court granted in part and denied in part Gilead’s motion for summary judgment on common issues. It granted summary judgment on the specified state-law design-defect claims, the specified Utah negligence theory, the post-approval failure-to-warn claims, the specified fraud claims, and related implied-warranty and consumer-protection claims. It denied summary judgment on the remaining claims. The court did not rule on Gilead’s evidentiary objections because it did not rely on the disputed evidence.