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Pro: Giving state courts jurisdiction in medical device cases is necessary to counter lax enforcement of Bush years

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Wayne Madsen
September 2, 2008
EDITOR’S NOTE: The writer is addressing the question, Should Congress permit states to override the FDA’s approval process by passing the Medical Safety Device Act?

It’s a sad fact that under the Bush administration, federal regulatory agencies have become nothing more than shills for the industries they are supposed to regulate for the public’s well-being.


One of the most vital—the U.S. Food and Drug Administration—unfortunately is particularly lax in ensuring the health and safety of those who take medication and rely on properly functioning medical devices.


To remedy this egregious situation swiftly, Sen. Ted Kennedy, D-Mass., and Rep. Frank Pallone, D-N.J., have introduced the Medical Device Safety Act of 2008.


The legislation would allow victims of faulty medical devices to sue for injuries in state courts even if the medical device had been approved for use by the FDA. Such legislation, it’s safe to say, would not have been needed had the FDA performed its traditional watchdog role and not become a virtual rubber stamp for the med-tech industry.


The Supreme Court recently ruled 8-1 that a federal law, the Medical Device Amendments of 1976, pre-empts state laws that provide for stricter standards for medical devices than does the federal statute.


In his majority opinion, Justice Antonin Scalia—no friend of the victims of corporate malfeasance and federal incompetence—wrote that state tort laws disrupted the “federal scheme” and that the FDA is the sole determining body to approve medical devices.


Scalia’s so-called scheme subjects patients to possible death or debilitating conditions resulting from faulty medical devices approved by the FDA, while denying them the recourse of seeking compensation for damages in state courts.


In that sense, Scalia’s use of the word “scheme” was right. Ironically, his “Alice in Wonderland” judicial interpretation means the corporate/FDA schemers cannot be held responsible for their actions.


Kennedy, of course, is keenly aware of the health risk posed by defective medical devices as he undergoes a battery of medical procedures for a brain tumor. From his hospital bed, he noted just how essential it is that manufacturers of medical devices “be held accountable when these products injure consumers.”


To no one’s surprise, the med-tech industry vigorously opposes the legislation precisely because it has been able to duck behind the FDA shield to deflect claims by patients harmed by medical device that didn’t live up to the government’s seal of approval.


The Alliance for Justice and Public Citizen, public advocacy groups that monitor the situation in the nation’s capital, have chronicled increasing numbers of patients grievously injured by faulty medical devices over the last decade. Among them: Trident prosthetic hips, Prodisc spinal implants, Medtronic and Guidant defibrillators, St. Jude’s Silzone-coated heart valves and Sulzer’s hip and knee implants.


Both groups say the Kennedy-Pallone bill would ensure safer products by allowing personal injury lawyers to file lawsuits against manufacturers at the state level. Even officials at the FDA, they observe, have questioned the agency’s ability to monitor and ensure the safety of medical devices.


Eight years of a “look-the-other-way” philosophy from the Bush White House has led to an almost total breakdown in federal regulatory agencies—often called “the fourth branch of government”—to carry out their mission of protecting American consumers.


Enactment of the Medical Device Safety Act of 2008 would be good first step toward rectifying the kind of lax enforcement that leads to disabling injuries and deaths for patients who put their trust in the miracles of modern medicine.


It’s high time Congress restored that trust by allowing plaintiffs’ lawyers and state courts to step in and clean up an area where the FDA now appears fear to tread.


Wayne Madsen is a contributing writer to the progressive Online Journal (www.onlinejournal.com). Readers may write to him c/o National Press Club, Front Desk, 529 14th St. NW, Washington, D.C. 20045.

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