Nothing’s “Knee-Jerk” About The Importance of Passing The Medical Device Act

The day after the landmark Wyeth decision came down, a bill was introduced in Congress to correct last years horrible Supreme Court decision, Riegel v. Medtronic (which immunized medical device manufacturers from liability for deaths and injuries caused by FDA-approved products).  As if we needed any more evidence that speedy passage of the bill was essential, the Wall Street Journal broke a story on Friday with a follow-up in today’s WSJ health blog that truly hammers the point home.

The device under scrutiny is called the “Menaflex,” and it’s made by RenGen Biologics.  It is a C-shaped device made from cow collagen that’s intended to encourage tissue growth and act as a shock absorber for a common knee injury (meniscus tears).   Apparently, the “efficacy” of this device is “in dispute,” according to the Journal.

But what makes the story so incredibly disturbing isn’t so much the ailment or the device, but the obscenely politicized process by which the Menaflex was granted fast-track FDA approval.  Suffice it to say, the tawdry tale is far too long to fit into the confines of our humble blog, but we’ll throw out a few samples—like these incriminating FDA emails suggesting special treatment was given to RenGen.

Other notable “low” lights include: the aforementioned "fast-track" approval process the FDA allowed Menaflex to undergo was meant to be strictly reserved for products that are similar to already-existing ones (and the Menaflex most certainly is not); admissions by former FDA head, Andrew von Eschenbach that the fast-track system “has gotten out of control” and “[w]e fumbled that process;” a supposedly neutral approval panel which included two employees of RenGen; a letter from RenGen asking that FDA staffers who had previously opposed Menaflex be excluded from the decision-making process; and a former FDA lab director who admits that the Menaflex affair “shows the FDA at its worst.”

FDA critic Senator Chuck Grassley (R-Iowa) is looking into the whole sordid matter, recently having drafted a letter to the FDA demanding to know what’s been happening.  In the meantime, though, this story is just one more reason (on a seemingly never-ending list of them) why the FDA should not be allowed to have the final word on device safety—and why the Medical Device Act of 2009 should be passed ASAP.

Comments

[Vicki Kimmick]

I am in support of the proposed Medical Device Safety Act of 2009:S. 540. Quality in health care, especially medical devices, is very important in today's society. If there is a defect in a medical device such as the Medtronic sprint Fidelis heart lead, a person should be able to take legal action at the state and local level. The public needs to have its rights restored in case of any issues with medical devices intended for human use. Our poulation of people are living longer and their rights need to be protected if a faulty medical device is used to correct their medical issue. Manufacturers of these devices need to be held responsible and correct the problem for any person affected and need to do so in a timely manner.