Supreme Court puts Merck's FDA preemption argument up for another review

Merck
Merck's Fosamax pulled in more than $3 billion at peak, but the drug is now generic. (Merck)

Merck & Co.'s Fosamax fight has lasted for years—and now, thanks to a U.S. Supreme Court ruling Monday, Merck gets yet another chance to press its case.

At issue are hundreds of lawsuits claiming the company was too tardy with warnings about serious bone fractures linked to long-term use of the osteoporosis med. And central to Merck's argument is a legal question the entire pharma industry would like resolved in its favor: Whether FDA labeling decisions shield drugmakers from liability in state court.

In a unanimous decision, the high court sent the suits back to appeals court—and instructed that court to reweigh the issue with this in mind: The question is about the law, not the facts of the case. And that means a judge has to decide, not a jury. Previously, the appeals court had ruled that the preemption question should be decided in a jury trial.

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Though the ruling does give Merck a shot at persuading a judge to buy its preemption argument, Justice Stephen Breyer wrote that it'll be hard for Merck to prove its argument.

Merck wouldn't be liable if it shows it couldn't comply with federal and state law simultaneously, Breyer wrote in the majority opinion. But he went on to say that "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."

In a concurring opinion, though, three conservative justices seemed more positive about Merck's position.

Merck scored FDA approval for Fosamax way back in 1995, but it wasn’t until later that the company and regulators had strong evidence that long-term use of the drug could cause atypical femoral fractures, or painful fractures of the upper thighbone that require surgery, plus a rod and screws, to repair.

In one report, staff at a hospital started calling atypical femoral fractures the “Fosamax Fracture” because all patients who suffered the breaks—and who hadn’t been hit by a car—took Fosamax for more than 5 years, the Supreme Court opinion says. One patient took the drug for 10 years and one day felt her leg simply give out.

Fosamax works by slowing the breakdown of old bone cells to help postmenopausal women avoid bone fractures. At the same time, the drug may cause ordinary stress fractures to progress over time into serious breaks.

After patients sued Merck under state law for failing to warn about those risks, the company said the FDA's authority should preempt those claims.  With evidence of the fractures, Merck applied to change Fosamax’s FDA label in 2008, according to the court’s opinion. But the FDA rejected the company’s proposed warning specifying “stress fractures” as “inadequate," the opinion says.

RELATED: Merck wins Supreme Court hearing in pivotal Fosamax pre-emption case 

The agency allowed Merck to resubmit its labeling application, but the company withdrew it instead. A warning about atypical femoral fractures didn’t hit the drug’s label until 2011, after the FDA forced the change based on its own analysis, the Supreme Court opinion said.

The preemption issue has progressed through courts for years. Initially, the district court agreed with Merck's preemption argument and tossed the cases. But then an appeals court rejected that decision and revived the litigation. The appeals court said that “whether the FDA would have rejected a proposed label change is a question of fact that must be answered by a jury.” 

Product liability cases in pharma have long tussled over the issue of preemption, and Merck's case further irons out the Supreme Court's view on the issue. But Monday's result isn't the complete win Merck or other drugmakers might've hoped for, as the Supreme Court didn't decide FDA authority always overrides state law responsibility to warn.

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