Supreme Court To Clarify Whether Manufacturers Are Shielded From Failure-To-Warn Suits When FDA Rejects Label Warnings

Merck v. Albrecht will resolve interpretation of high court's landmark Wyeth v. Levine ruling and could shield companies from certain litigation; case involves adequacy of Fosamax labeling of bone fracture risk.

Pharmaceutical companies have a chance to eliminate a swath of product liability suits alleging they failed to adequately warn of a product's risk now that the US Supreme Court has agreed to review a case involving Merck & Co. Inc.'s osteoporosis drug Fosamax (alendronate).

In June 28 orders, the high court granted Merck's petition, Merck Sharp & Dohme Corp. v. Albrecht, challenging a Third Circuit decision that revived hundreds of complaints in multidistrict litigation. Merck asked the court to specify that a drug manufacturer cannot be subject to failure-to-warn claims about a risk associated with its product if it informs FDA about the risk and the agency rejects adding it to the labeling. (Also see "Does FDA Rejection Of Label Warning Shield Manufacturers From Tort Suits?" - Pink Sheet, 4 Dec, 2017.) The claims are brought under state laws.

The court asked the US Solicitor General to weigh in on the issue. He advised the court to take up the case and sided with Merck.

"The underlying issue – whether the meaning and effect of an FDA labeling decision present a question of law for courts to resolve or a question of fact for lay juries to determine – is significant," the Solicitor General stated in a May 22 brief. "The petition cleanly presents that issue in a context in which hundreds of separate cases asserting similar failure-to-warn claims turn on its proper resolution."

The Solicitor General said the US Court of Appeals for the Third Circuit erred in holding that a jury must decide whether FDA's declining to approve Merck's proposed revision of Fosamax labeling preempted state-law failure to warn claims. "Moreover, because FDA's decision here prevented petitioner from modifying the relevant labeling before late 2010 the court of appeals erred in rejecting petitioner's impossibility-preemption defense," he said. Impossibility preemption exists in situations where it is impossible for a private party to comply with both federal and state law.

What is 'Clear Evidence' FDA Would Not Approve Label Change?

At issue is the interpretation of the Supreme Court's landmark 2009 Wyeth v. Levine ruling, in which the court dismissed Wyeth's argument that FDA labeling regulations prevent companies from unilaterally adding a warning without prior FDA approval. The court also held that "absent clear evidence that the FDA would not have approved a change to" Wyeth's Phenergan label, it would "not conclude that it was impossible for Wyeth to comply with both federal and state requirements." (Also see "Pre-emption After Supreme Court Ruling May Depend On How FDA Weighs Risk" - Pink Sheet, 9 Mar, 2009.)

Merck says in its petition that it submitted data to FDA suggesting Fosamax may be associated with the risk of femur fractures and proposed a label warning, but the agency rejected the proposed addition, saying it was not supported by the data.

In May 2009, the agency approved adding the language solely to the Adverse Reactions section of the label. Almost a year later, FDA announced it would work with an outside task force to gather more information about the potential connection between bisphosphonate use and atypical femur fractures. In September 2010, the task force reported that there appeared to be an association and in October 2010, FDA directed manufacturers to revise the Precautions section of their labels.

Beginning in 2010, hundreds of Fosamax users sued Merck alleging the drug caused them to suffer thigh bone fractures and that the company failed to add an adequate warning of the risk to the label. The federal cases were consolidated in multidistrict litigation (MDL) for coordinated pre-trial proceedings in New Jersey district court. Merck won a jury verdict in April 2013 in the only MDL bellwether trial to date, Glynn v. Merck. And in June 2013 the court ruled that the plaintiffs' failure to warn claim was preempted by federal law.

The court concluded that there was "clear evidence that the FDA would not have approved a change to the Precautions section of the Fosamax label" before the September 2010 task force report.

In a March 2017 opinion, the US Court of Appeals for the Third Circuit vacated the MDL court's preemption ruling and remanded the appealed cases back to the MDL court. The Third Circuit held that the "clear evidence" standard in Wyeth "requires the factfinder to predict a highly probable outcome in a counterfactual world and, therefore, requires a court sitting in summary judgment to anticipate both the range of conclusions that a reasonable juror might reach and the certainty with which the juror would reach them."

In the Fosamax litigation, "plaintiffs have produced sufficient evidence for a reasonable jury to conclude that the FDA would have approved a properly-worded warning about the risk of thigh fractures – or at the very least, to conclude that the odds of FDA rejection were less than highly probable," the appeals court stated.

Two Pharma Cases On Docket For Next Term

The outcome of the case will affect numerous pharma product liability complaints. For example, the question of whether FDA rejection of a proposed label change preempts failure-to-warn claims is a crucial issue in Xarelto (rivaroxaban) multidistrict litigation.

Bayer AG and Johnson & Johnson are seeking Fifth Circuit review of pre-trial rulings by the judge overseeing the litigation that denied summary judgement motions on the ground that the plaintiffs' failure-to-warn and design-defect claims are preempted by federal law. (Also see "With 5-0 Winning Streak, Bayer And J&J Move To Eliminate Remaining Xarelto Litigation" - Pink Sheet, 22 Jun, 2018.)

They note in a recent filing that plaintiffs have cited only two cases where other courts have rejected a preemption defense on the ground that the manufacturer failed to press FDA after an initial rejection of proposed labeling. One of those cases is the Third Circuit's Fosamax ruling.

Merck's is the second pharma-related case the Supreme Court has added to its merits docket for the next term, which begins in October.

The other case, Helsinn Healthcare SA (Helsinn Group) v. Teva Pharmaceuticals USA Inc., addresses whether an inventor's sale of an invention to a third party that must keep the invention secret makes it unpatentable. (Also see "Does Sale Of Confidential Invention Prevent Its Patenting? US Supreme Court Will Review" - Pink Sheet, 25 Jun, 2018.)

The court has not yet decided whether to grant review of another high-profile pharma dispute, Gilead Sciences Inc. v. US ex rel. Campie. Gilead is asking the court to clarify how a False Claims Act complaint should be resolved when the government knows about a company's alleged misrepresentations about a product but continues to pay for it. (Also see "Gilead Asks Supreme Court To Restrict False Claims Act Cases" - Pink Sheet, 7 Jan, 2018.) 

The court asked the Solicitor General for its views on the case, and he has yet to submit a brief. (Also see "When Should False Claim Act Complaints Be Dismissed? US Supreme Court Wants Government's Views " - Pink Sheet, 16 Apr, 2018.)