The future of consumers’ right to bring state law claims against pharmaceutical companies for injuries caused by their drugs hangs in the balance as the United States Supreme Court reviews the federal appellate court’s decision in Levine v. Wyeth. Hundreds of women had filed lawsuits against pharmaceutical giant, Merck, for bone fractures suffered after taking osteoporosis drug, Fosamax.
Diana Levine sued Wyeth (now owned by Pfizer) for failure to warn about the risks of bone fractures when taking Fosamax. A federal court ruled last year this case could proceed to trial, deciding that state courts were not barred by federal law from evaluating failure to warn claims.
Attorneys are watching over the case as it may affect what types of drug lawsuit cases can proceed in the future. The facts of this case include Wyeth and Pzifer having the FDA not approve the wording the corporations wanted to use on their label.
A ruling that preemption bars failure to warn cases in cases where the FDA has not approved specific wording could limit which drug side effects are viable claims. If a company tried to insert favorable language that begins to disclose warning but the FDA deems the warning incorrect, insufficient, or denies for any other reason, the corporation could claim it tried and should not be liable in a drug lawsuit.
A change in when preemption applies would require a drug lawyer investigating a hidden side effect case to dive deep into the label history, to see what the company tried to update through the history of the medication. If a drug manufacturer wanted to partially warn about a side effect and was denied it could provide a potential shield for liability.
The effects of a Supreme Court ruling should they rule in favor of drug manufacturers, would affect active failure to warn litigation as well as future litigation. A ruling today could be enforced in cases that were filed years ago and still in court, and could affect drug settlement ongoing negotiations. However, even a ruling in favor of pharmaceutical companies could only be used if they attempted to add language changes to the label to warn of side effect risks. Companies that refused to even attempt a warning label change after learning of side effects in current literature, from ongoing safety studies reviewing the medication, or from a failure to design safety data to capture these complications in the first place would not be protected.