The U.S. Supreme Court will consider a case next week that examines a legal strategy drugmakers use to defend themselves against patient lawsuits, according to STAT.
Merck Sharp & Dohme Corp. v. Doris Albrecht started as a class-action lawsuit brought by thousands of patients who used Fosamax, Merck's osteoporosis drug. Patients claim Merck failed to properly warn them about certain side effects, particularly that taking the drug may increase their risk of fracturing their femurs. In the lawsuit, patients argue that the drugmaker broke state "failure to warn" laws, which require companies to warn consumers about any dangers of their products.
Merck argues that it tried to warn patients by updating the drug label, but the FDA didn't allow it. Merck claims it's not responsible for patients who suffered bone fractures because the FDA blocked the proposed warnings from the label.
The Supreme Court will decide how companies can use this defense, commonly used by pharmaceutical companies to quickly resolve cases and avoid patient lawsuits.
"Regardless of the outcome of the case, this is going to be a very big deal, because [this defense is] a really important issue with respect to drug manufacturer liability," Patti Zettler, an associate professor at Atlanta-based Georgia State University College of Law who used to work in the FDA's office of chief counsel, told STAT.
The case will be watched closely by several industries, not just drugmakers, because it tackles the question of what happens when federal law and state law appear to be in conflict.