Supreme Court tosses out ruling allowing lawsuits against drug manufacturer

The Supreme Court on Monday ordered a lower court to reconsider whether hundreds of lawsuits against a pharmaceutical company can move forward.

The justices unanimously ruled that the 3rd Circuit Court of Appeals should revisit its prior ruling allowing for the legal challenges against the drug manufacturer Merck & Co. Hundreds of individuals had filed suit against the company over the osteoporosis drug Fosamax, alleging that the firm failed to comply with state law by not quickly including a warning on the drug label that it could cause thigh-bone fractures.

The company had argued that the lawsuits were preempted by Food and Drug Administration (FDA) regulations on changing drug labels, claiming that the FDA would not have approved the change.

Merck pointed to the FDA rejecting their attempt in 2008 to add a warning about potential stress fractures as reason to believe they would also not approve a warning about the thigh-bone fractures.

Justice Stephen Breyer, who authored the court’s majority opinion, wrote that the court had already found that “clear evidence” of the FDA rejecting a change to a label was enough to overrule state laws requiring drugmakers to issue updated warnings on the risks of taking a medication.

The justices also found that a judge, not a jury, should make the ruling on whether the lawsuits can advance, as a judge would be more well-versed in how the authorities of federal agencies compare to state laws.

Justices Clarence Thomas and Samuel Alito each wrote concurring opinions in the case, reaching the same conclusion as the rest of the court but for differing reasons.

There was not enough evidence of the fractures to include a warning about the possible injury when the medication was first approved in 1995. The FDA eventually ordered the drugmaker in 2011 to update the label with the warning.

Tags drug labels Food and Drug Administration Supreme Court

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