Will the U.S. Supreme Court find Merck liable for failing to provide adequate warnings about Fosamax?

Fosamax is a prescription drug manufactured by mega-company Merck.  It was created to help treat osteoporosis and other diseases that cause bone loss.  Given that one in three women worldwide and one in five men over 50 will suffer from osteoporotic related fractures, Fosamax and other drugs like it are big business.  Fosamax claims that it will slow bone loss and improve bone density, but alarming evidence of the potential link between the drug and fractures has emerged. Now, thousands of Fosamax users have filed suit against Merck, claiming that the dangerous drug led them to suffer thigh bone fractures and the company failed to warn them of the risks.

As other claimants joined in the action against Merck, Merck sought dismissal of the claims.  Merck submitted evidence that it had notified the FDA back in 2008of a potential link between the drug and some bone fractures.  However, the FDA rejected its proposal to a warning label to the drug. It wasn’t until 2010 when the FDA ordered a revision of the labels to include a warning, which Merck did.

In federal court in New Jersey, Merck urged that the claims against it should be dismissed because the FDA rejected its proposed warning label, which it believes should exclude liability.  However, the 3rd Circuit ruled the case should proceed because the jury could find that the FDA would have accepted a properly worded warning concerning fracture risks.

The Supreme Court Takes Up the Case

Now, at the urging of President Trump, the U.S. Supreme Court has elected to hear the case. At issue will be the crucial question as to whether a pharmaceutical company can be liable for failing to warn drug users as to known risks when the FDA rejects its proposed warnings.  The issue is a crucial one that could have wide spread implications.

If the Supreme Court finds that Merck is relieved of liability, it could leave consumers crucially unprotected against potentially dangerous or defective drugs.  Individuals harmed by dangerous drugs that did not come with adequate warnings could be left without legal avenues, and product makers may further lose financial incentive to create comprehensive, up-to-date warnings.  On the other hand, most would agree that the FDA needs to be more proactive in issuing potentially lifesaving warnings when made aware of this need by drug makers. All of us should closely watch this case, which may have an impact on anyone who will ever take a prescription drug.