For many years, the manufacturer of Fosamax did not inform patients of a known, important adverse reaction to their drug: an atypical femoral fracture (AFF). The thigh bone (femur) can break spontaneously, with no warning and usually during a low-impact movement, like walking or standing up. These injuries usually require surgery. A class action lawsuit has been winding its way through the courts that addresses the question if those patients who experienced the AFF have the right to sue. This case about the claim that Merck failed to warn about AFF reaches past this suit to potentially change pharmaceutical companies’ relationship with the FDA. The case is Merck Sharp & Dohme Corp., V. Doris Albrecht, et.at. The case was scheduled to be heard in Philadelphia in the Court of Appeals for the Third Circuit on March 5th.
Three former officials of the FDA and MedShadow Foundation, of which I am founder and president, filed an amicus brief with this court and in the previous US Supreme Court hearing. These, and other facts in this article, are supported by the amicus brief filed with the Supreme Court:
An amicus brief can be filed by an individual, a group of individuals, or organizations that offer insight or a unique point of view that has bearing on the case.
Fosamax belongs to a class of drugs called “bisphosphonates,” which are commonly used to treat osteoporosis. Respondents in this case are patients who allege that Fosamax (alendronate sodium) caused them to suffer atypical femoral fractures, which are incapacitating fractures that result from little or no trauma in which the thigh bone often breaks in two.
There are several legal questions in this suit and many nuances to each of the questions it presents. From my courtside seat as a patients’-rights advocate (and not a lawyer), the most important issue is a patient’s right to be informed of and to understand the risks, along with the benefits, of any drug. Traditionally that information is included in the prescribing “label,” the written communication enclosed with the drug (and in several other places). In general, if a side effect or adverse reaction is listed on the label, patients’ ability to sue for damages is blocked. After all, they were warned and presumably felt the risk was worth the drug’s benefit. Additionally, if a drug company is specifically told by the FDA that the adverse risk does not need to be included on the label, the drug company is again protected from lawsuits by patients.
This case is about the women who experienced so-called “Fosamax fractures” and whether they have the right to sue Merck for “failure to warn.”
Fosamax was approved by the FDA in 1995 to treat osteoporosis. Records show that Merck, the manufacturer of Fosamax, received reports of atypical femoral fractures as early as 1999; and subsequent articles, case studies, and reports continued for several years. With this information, Merck could have added a warning through either of two processes without FDA permission as provided for in The Federal Food, Drug, and Cosmetic Act (outlined in the amicus curiae). But, Merck did not act for nine years.
In 2008, Merck was asked by the FDA to submit a proposed warning to be added to the label regarding these risky fractures. But the proposed warning submitted by Merck described a less serious stress fracture, which is very different from an atypical femoral fracture. The FDA’s response was clear: the agency could not approve the warning “in its present form.” Finally, about two years later in 2010, the FDA directed Merck to add three specifically worded paragraphs describing atypical femoral fractures to the “Warnings and Precautions” section of the label.
Merck is claiming that the FDA’s letter rejecting the proposed warning was a final letter which did not allow Merck to add the warning about atypical femoral fractures. The FDA does not agree.
Did Merck phrase the proposed warning about atypical femoral fractures in a way designed to be rejected by the FDA? Did the drug manufacturer hope to create protection from lawsuits that the FDA did not intend to give by poorly wording its first submission? If so, will other drug companies use the same tactic to avoid disclosing drug risks to patients and doctors?
Under FDA regulations, drug manufacturers bear the responsibility for the content of its label at all times. The FDA has provided at least two methods for pharmaceutical companies to add warnings to their drug labels before or pending FDA approval of the warning.
There are many additional nuances to the case that are not discussed here. The case may fail or prevail based on technical legal aspects. But there is a core value at stake here, that the Delaware courts, or the Supreme Court after this procedure, need to make clear: Patients have the right to know the risks and benefits of any drug they are prescribed, and the responsibility for that knowledge and message delivery lies with the manufacturer of said drug.
When Merck decided not to include that information on the label, they chose not to disclose to patients a known and severe adverse risk. Patients should have the right to sue in those cases. They were denied information that might have changed their decision to use or not use the drug. And in the future, drug manufacturers should not be able to use Merck’s tactic to avoid informed decision making.
Photo: putilich, Getty Images
