There is always some risk with medications, but consumers have the right to all information about the drugs they are taking in order to make an informed decision.
Suppose a pharmaceutical company discovers that one of its drugs causes a serious adverse event. The company files an application for a change to the drug label, but knowingly designs the change so the FDA won’t accept it — either by minimizing the risk of the adverse event or by not accurately reflecting the risk. The drug company could then claim it isn’t liable for not warning consumers about that adverse event because the FDA denied the label change. That is the case for millions of women taking Fosamax, a prescription drug used to treat or prevent osteoporosis.
Numerous lawsuits have been filed alleging that Merck, the drug manufacturer of Fosamax, knew the risks of the drug, yet failed to warn doctors and their patients. While Merck does not dispute the claims, the company argues that it can’t be held liable for violating any state “failure-to-warn” laws because in 2008 it proposed adding a warning label that was denied by the FDA. (Currently, Fosamax carries a warning of “atypical femoral fractures,” which was mandated by the FDA in 2010 after mounting evidence of a link to the drug).
A New Jersey federal court threw out the case, but plaintiffs argued that Merck misled the FDA by describing the heightened risk as a “stress fracture” (an incomplete bone break that is typically treated by rest and inactivity) rather than a “spontaneous fracture,” (a complete break to a normal bone, often resulting in surgery). After producing sufficient evidence that the FDA would have approved a properly-worded warning, the Philadelphia-based 3rd U.S. Circuit Court of Appeals allowed the claims to proceed to trial. That decision led to an appeal by Merck.
Backed by the Trump administration, Merck asked the U.S. Supreme Court to hear the case, saying the appeals court ruling puts drug companies in an impossible position. “Even if they cooperate with the FDA, share their safety data, and follow the agency’s direction to ‘hold off’ on adding label warnings, they still cannot escape costly, burdensome tort litigation complaining about those labels,” Merck said.
On Monday, the Supreme Court appeared sympathetic to Merck. If the Supreme Court allows Merck to circumvent the law, it would remove the motivation for pharmaceutical companies to provide the FDA with timely and transparent information. Such a ruling could also have far-reaching effects, even beyond the pharmaceutical industry.
I hope that the U.S. Supreme Court has the wisdom and compassion to realize that drug company immunity is a free pass to the drug industry to injure, maim and kill our citizens without regard to safety. The most important safety tool available to our citizens is the threat of a lawsuit against an offending drug manufacturer. The elimination of this vital tool will permit the industry to “self-regulate”. If we have learned anything from the country’s financial crisis, we have learned that self-regulation does not work. It is time for these companies to do a better job in research and testing before exposing Americans to potentially dangerous and life-threatening products and drugs.
If the Supreme Court votes the way the President wants them to, I strongly suggest that you write your federal congresspersons and senators and tell them to legislate against federal drug immunity.
Experienced attorney, lawsuit funding expert, certified civil mediator, and award-winning author of the Zachary Blake Betrayal Series. The series consists of "Betrayal of Faith", "Betrayal of Justice", and "Betrayal in Blue", with a fourth book due out in 2019. You can learn more about these topical political, legal thrillers at markmbello.com. Mark Bello is also a member of the State Bar of Michigan, a sustaining member of the Michigan Association for Justice, and a member of the American Association for Justice.