FDA Fail Leaves Patients in the Lurch

A look at the implications of a key court case that could have major consequences for the public’s ability to hold drug companies accountable.

THE TOPLINE

• A drug approved by the FDA to treat osteoporosis was proven to cause a serious type of fracture, yet years of court battles have resulted in no justice for those who suffered injuries.
• FDA negligence is part of the problem, as the agency could have mandated a label change reflecting the fracture risk.
• This shows the incompetence and hypocrisy at the FDA, that is too busy trying to take your supplements and homeopathic medicines away to be concerned with dangerous drugs it approves.

Imagine taking a medication that promises to protect your bones, only to discover that it causes them to break out of nowhere. For thousands of patients, this nightmare became a reality with alendronate (Fosamax), a drug meant to treat osteoporosis. Usually, patients harmed by a drug can sue the manufacturer and get at least some financial recompense for their injuries. But the legal battle over alendronate injuries highlights how broken and tilted towards drug companies our current system is.

Approved by the FDA in 1995, alendronate has been linked to a rare and devastating type of fracture. These atypical femoral fractures occur spontaneously in the femur and are not related to trauma. Designed to increase bone density by reducing bone turnover, the drug unexpectedly led to these fractures due to structural changes in the bone.

In 2011, about 1,000 plaintiffs who experienced these fractures sued Merck, the drug manufacturer. They claimed that from 1995 to 2011, the FDA-approved label for alendronate did not warn about this risk, despite Merck knowing about the problem. This type of lawsuit, known as a failure-to-warn claim, holds manufacturers responsible for updating labels with new adverse effect information. The lawsuit has dragged on for 13 years through various courts without resolution.

Merck has argued that federal law preempts the plaintiffs’ state law claims. For preemption to apply, two conditions must be met: Merck had to show it fully informed the FDA about the adverse effects, and the FDA had to explicitly reject a label change. Plaintiffs argue Merck never proposed a valid label change, making preemption invalid.

Here’s where things get shady. In 2008, Merck asked the FDA to update the label to warn about fractures. The FDA declined, citing disagreements over the label’s wording: Merck called the fractures “stress fractures.” Plaintiffs argue that the FDA rejected this label because it was inaccurate: referring to the injuries as stress fractures downplayed the seriousness of the atypical femoral fractures the drug caused, whereas stress fracturs are relatively minor. With no valid label change, the conditions for preemption are not met.

Merck has argued that the FDA declined its updated label because the agency was not persuaded by the evidence that atypical femoral fractures were caused by alendronate. Nonetheless, the FDA indicated it would accept a more accurate label, but Merck withdrew the request and never updated the label on its own.

In 2022, a District Court ruled in favor of Merck, stating the case was preempted. The plaintiffs appealed, and the case is now with the Third Circuit Court of Appeals.

This is a failure on multiple levels. That the drug company seems to have downplayed the risks of the drug in the updated label it proposed is nothing surprising. But the fact that the FDA stood with its hands in its pockets for years after that is unconscionable. This is made worse by the fact that, since 2007, the FDA has had the statutory authority to mandate label changes for safety based on new information. In alendronate’s case, the FDA delayed action until 2011, after many were harmed.

This case also highlights the hypocrisy at work in the FDA. Think about how the FDA would respond if a dietary supplement caused thousands of serious adverse events. Health food stores and clinics would probably be raided the next day, and then members of Congress like Senator Dick Durbin (D-IL) would introduce legislation to increase the FDA’s powers over supplements.

As we’ve seen, it’s a different story when FDA-approved drugs harm people. Remember, as ex-FDA official Dr. David Graham once said, the FDA sees Big Pharma as its client whose interests it represents? After all, the drug industry provides 45 percent of the FDA’s budget through the fees it pays to have the FDA approve drugs. This is regulatory capture at its worst, and one of the key reasons that we need to be so vigilant in protecting access to the natural health products that the FDA so often, and so illegitimately, attacks.