How would you feel if you were harmed by a medicine you took as prescribed and then learned that the drug company wasn’t liable — even though it knew about the risk and didn’t tell you or your doctor?
This is exactly what has happened in the case of Fosamax (alendronate), a drug used to treat bone-thinning osteoporosis and osteopenia. After it was approved by the Food and Drug Administration and women across the country began taking the drug, the FDA and its maker, Merck, started receiving reports about spontaneous fractures of the thigh bone among women taking the drug.
These fractures, dubbed “Fosamax fractures,” happen with no warning and usually require surgery. Although they are a rare side effect of the drug, millions of women have taken the drug. While the true number of Fosamax fractures isn’t known, about 500 women have sued Merck for failing to warn them about the risk of this painful and possibly debilitating side effect. These lawsuits are at the heart of a case, Merck, Sharp & Dohme Corp. v. Doris Albrecht, et al., that will be argued before the U.S. Supreme Court on Jan. 7, 2019.
MedShadow Foundation, the nonprofit organization I founded in 2012 to inform the public about the side effects of medicines, along with three former FDA officials, filed an amicus curiae brief in support of Albrecht, the defendant in the case. Such “friend of the court” briefs are filed by individuals or organizations that aren’t parties in a case.
Merck acknowledges that Fosamax caused these fractures and that the company knew about them. In 2008, Merck started the process to get the FDA’s permission to put a warning on the drug label — the inserts that come with all medicines, providing information such as instructions on how to take a drug, what it can be used for, and warnings. The FDA reviews and must approve any information on drug labels for accuracy. These labels are generally considered fair warning to users about possible side effects or adverse events and, in that way, provides legal protection for drug companies from being sued for causing them.
The FDA relies on manufacturers to update and make changes to drug labels throughout the lives of their drugs. That’s because approvals for new drugs are often based on small clinical trials of 1,000 or fewer people that normally last less than a year. Unusual or rare side effects and can’t be detected in such small, short-term trials. Once a drug is approved and thousands or millions of people are taking it, new side effects and adverse events can emerge.
The spontaneous fractures caused by Fosamax didn’t begin appearing until the drug had been on the market for five years. And these fractures aren’t the only significant bone problems linked to the drug. Cases of osteonecrosis (literally “bone death”) of the jaw, a painful condition where jaw bones become exposed, were reported by people taking Fosamax. In 2013, Merck agreed to pay $27.7 million to settle 1,140 lawsuits from individuals who alleged that Fosamax caused them to develop this condition.
Pharmaceutical companies have the best access to reports of adverse events, and they pay attention to updating drug labels as an important patient-protection safeguard.
When Merck applied to the FDA for a label change to reflect these fractures, the FDA rejected its request. Why? Because Merck described them as stress fractures, which are minor and quite different from far more serious spontaneous fractures. A stress fracture is an incomplete bone break that is generally treated by rest and inactivity. A spontaneous fracture is a complete break that occurs in a seemingly normal bone without any trauma and must often be repaired with surgery.
Although drug companies are responsible for updating labels, the FDA can require updates. In 2010, the FDA convened a panel to review the increasing number of reports of Fosamax-related spontaneous fractures. After reviewing the research, the panel found a clear connection between Fosamax and spontaneous thigh bone fractures. The FDA then ordered Merck to change the label.
The women suing Merck claim that the company failed to warn them about a known adverse event. Merck is claiming that the FDA did not allow the company to change the label, making it impossible for Merck to warn women or their doctors.
If Merck prevails, the disingenuous tactic it used for Fosamax could be replicated by other pharmaceutical companies and have far-reaching effects.
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.
If the Supreme Court allows drug companies to circumvent the law this way — which is what Merck is attempting to do in this case — it would remove the motivation for pharmaceutical companies to provide the FDA with timely and transparent information.
MedShadow Foundation is a small nonprofit with limited resources. Yet we have taken on the costly and time-consuming process of filing an amicus brief because we believe that pharmaceutical companies cannot be allowed to obscure the risks, side effects, and adverse events of drugs — or exaggerate their benefits.
The foundation’s mission is to protect quality of life by ensuring that people have all the known information about side effects before deciding to take a prescription or over-the-counter drug. Today, pharmaceutical companies are motivated to reveal previously unknown risks and warn the medical community so they can’t be sued for damages. The FDA and the law must maintain that obligation to protect people from unnecessary harm.
There will always be some risk with medicines, but consumers have the right to all the information about benefits and risks of drugs — whenever that information is discovered — so they can make informed decisions about their health and well-being.
Suzanne Robotti is the founder and president of MedShadow Foundation and the executive director of DES Action USA. She is also the consumer representative on the FDA’s Drug Safety and Risk Management Advisory Committee. MedShadow Foundation does not accept funding from pharmaceutical or medical device companies.