Last week’s Supreme Court decision in Wyeth v. Levine protected consumers’ longstanding right to take pharmaceutical companies to court for failing to properly warn patients and their doctors about the risks posed by the drugs they market. Unfortunately, people injured by faulty medical devices don’t have the same right following last year’s Riegel v. Medtronic decision.
Without the protection of the courts, patients with medical devices rely solely on the protections afforded by the FDA approval process. But last week, the Wall Street Journal‘s Alicia Mundy gave a glimpse at just how broken that process can be.
Mundy tracked the FDA approval of Menaflex, a small pad made of cow collagen that can be implanted in a torn meniscus to both patch the tear and promote tissue regrowth. The manufacturer, ReGen, originally submitted the device for FDA approval under normal procedures for new devices, but when the required clinical trials ran into snags (including criticism from FDA about conflicts-of-interest and data integrity), ReGen shifted course and asked FDA to approve the device under its 510(k) “fast track” process. For ReGen, that would mean they could get the device approved without having to finish the clinical trial. However, 510(k) approval is reserved for devices that are substantially similar to others already approved by the agency. FDA experts argued that Menaflex didn’t meet the criteria, and that’s when things got complicated. (Read the article for the full story of how members of New Jersey’s congressional delegation, Bush’s political appointees, and ReGen reshaped the device approval process to their liking, paving the way for Menaflex to be introduced to the market last month.)
The WSJ story probably only scratches the surface of the problems in FDA’s medical device regulation. In December, a group of FDA career employees sent a letter to congressional overseers, claiming that political interference is rampant in FDA’s device safety group. And GAO released a report in January suggesting that FDA is using the 510(k) approval process when it’s not warranted. The situation is so bad that former FDA head Andrew von Eschenbach said that the fast-track approval process “has gotten out of control” and the medical device approval process in general is in need of a complete overhaul.
The patients are the ones who lose from this broken process. The Riegel decision leaves medical device patients at the whims of the FDA’s politicized approval process. The only reason for eliminating tort law in Riegel was that Congress included language in the law governing medical device approvals that arguably preempted state tort law.
Some Members of Congress are attempting to rewrite that law to clarify that they do not intend for FDA approval of a medical device to displace state tort law. Representatives Frank Pallone and Henry Waxman, along with 65 co-sponsors, introduced H.R. 1346, the Medical Device Safety Act of 2009. (Disclaimer: CPR is a 501(c)(3); I’m not, and CPR isn’t, endorsing or criticizing the bill.)
Eliminating preemption is only part of the solution; we also need to improve the drug and device approval process to ensure that politics doesn’t negatively impact public health, and we need to improve FDA’s ability to take protective action after a drug or device has been approved.