MRK Merck and Co Inc

By Jess Bravin 

WASHINGTON -- Merck & Co. won a partial victory at the Supreme Court, with the justices unanimously ruling that a judge, rather than a jury, must determine whether federal regulators took steps that immunize the company from claims its osteoporosis drug Fosamax injured patients.

The court agreed with Merck that juries are less suited than judges to decide often technical questions of whether the Food and Drug Administration was provided sufficient information and refused to approve changes to the drug's warning label regarding potential injuries.

Still, the majority opinion, written by Justice Stephen Breyer, suggested Merck may have a difficult time proving its position before a judge. Three conservative justices disputed that implication in a concurrence that construed the facts more in sympathy with the Kenilworth, N.J., company.

Fosamax helps treat and prevent osteoporosis, a condition that can cause bone fractures in postmenopausal women, by adjusting the process by which the body replaces old bone cells. But evidence collected after the drug went on sale in 1995 indicated Fosamax also may increase the risk of a different class of bone damage known as atypical femoral fractures.

In 2011, Merck and the FDA agreed to revise the Fosamax label to reflect such risks; more than 500 people who took the drug before the label change and suffered atypical fractures sued, arguing that the company should have acted more quickly to warn physicians and patients of the risk.

Under Supreme Court precedents involving failure-to-warn claims, drugmakers are can't be sued for injuries if the FDA didn't let them revise the product's label. While the theoretical possibility of atypical fractures long had been known by both Merck and the FDA, the parties dispute whether the FDA was provided with adequate information to determine if a label update was warranted.

In 2017, the Third U.S. Circuit Court of Appeals, in Philadelphia, said that was a factual question to be decided at trial in the Trenton, N.J., federal district court where the claims were consolidated. Monday's opinion, however, said such issues were complicated legal matters best untangled by a judge.

"Judges are better suited than are juries to understand and to interpret agency decisions in light of the governing statutory and regulatory context," Justice Breyer wrote, joined by Justices Clarence Thomas, Ruth Bader Ginsburg, Sonia Sotomayor, Elena Kagan and Neil Gorsuch.

A drugmaker is immune from lawsuits only if it would be impossible to comply both with federal law regulating the product label and state law creating liability for failure to warn about potential injuries. Justice Breyer suggested that would be a high bar to pass.

"A drug manufacturer will not ordinarily be able to show that there is an actual conflict between state and federal law such that it was impossible to comply with both," he wrote.

Justice Thomas went further still, writing separately that Merck's argument "should fail as a matter of law" because the drugmaker identified "no statute, regulation, or other agency action...that would have prohibited it from complying with its alleged state-law duties."

The court's three other conservatives, while agreeing that a judge rather than jury should make the legal determination, wrote a separate concurring opinion accusing the majority of skewing the dispute in the plaintiffs' favor.

In response to the ruling, Merck said it "remains fully committed to defending these cases going forward and will continue to present evidence that it acted appropriately at all times in regard to the potential risk of atypical femur fractures."

Plaintiffs' lawyer David Frederick said Monday's "opinion makes clear that pre-emption can be established only by a formal FDA action prohibiting the manufacturer from changing its warning label."

Write to Jess Bravin at jess.bravin@wsj.com

(END) Dow Jones Newswires

May 20, 2019 18:36 ET (22:36 GMT)

Merck (NYSE:MRK)
Historical Stock Chart
Von Mär 2024 bis Apr 2024

Merck (NYSE:MRK)
Historical Stock Chart
Von Apr 2023 bis Apr 2024