Medical Device Makers Immunized from Lawsuit by Persons They Exploit


Medical Device Makers Regulation

It’s interesting to note the number of federal agency insiders stepping up to the plate during these final Bush hours, all wanting to spill the beans to President Elect Obama about the corruption and mismanagement found within the their agencies under the Bush Administration.

For some, their actions would be gallant, heroic even, if not for the fact that their silence over the last eight shameful years often caused unimaginable pain, suffering and in many cases, the death of Americans they were sworn to protect.

Center for Devices and Radiological Health

The latest group to shower the President Elect with their ‘truths and revelations’ was nine FDA scientists within the agency’s Center for Devices and Radiological Health, which is responsible for the approval of medical devices including, but not limited to heart defibrillators, valves and pacemakers, stents, hernia patches, implants, knee and hip prosthetics and radiological equipment, such as MRI machinery.

A letter signed by the scientists last week to Obama read in part, ”The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk.” The scientists further alleged in their letter that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.

You don’t say? Suppose that’s why so many American’s have been left to linger in painful suffering as a result of dangerously defective hernia patches known to have caused multiple deaths and debilitating, chronic infections with no cure in sight?

Intimidation? Intimidation led them to allow an unsuspecting and trusting public to agree to medical procedures said necessary to save their lives, only have their very lives literally destroyed and that of their family’s because known defective products were approved and used? Intimidation, which lead to their continued silence as deaths from such products were reported throughout the country, while the same products remain on hospital shelves even today? Intimidation lead them to remain silent last February as the Supreme Court discussed and ultimately passed 8 – 1, blanket immunity from law suits aimed at medical manufacturers if their defective product was approved by the same corrupt FDA – their agency – and later found to have known defects that weren’t revealed?

These scientists were directly or indirectly involved with purposeful deceit that has lead to the severe injury or death of countless thousands of Americans.

Special Interests

While the FDA scientists remained quite complacent and contained (by such intimidation) the Bush administration reversed longstanding federal policy and began arguing that if a medical device had received pre-market approval by the F.D.A., such approval should override a citizen’s right to seek damages for death or serious injury if the device was later determined to be defective. Today, for the first time in American history, anyone injured by these known defective devices like a defective knee replacement cannot bring suit against the manufacturer to recover their loss of medical care, disability, income, pain and suffering, or loss of life itself.

We know during the discovery phase of a trial, that a manufacturer is forced to release otherwise confidential material proving a known defect existed, or that unsupported claims of safety are exposed. The Supreme Court’s decision ensures that will never happen.

Where medical devices and new drugs are concerned, often such defects are hidden from the FDA at the time of approval and are only exposed during the course of litigation.

Worse yet, given the high level of conflict of interests found amongst FDA officials – some of whom stand to profit greatly in stock ownership from those companies seeking approval or from future job offers from these companies – FDA officials fail to aggressively and objectively scrutinize the safety of proposed devices and drugs. Even after a defect is discovered and an application filed for redesign, the FDA does little to remove the original, defective product from hospital shelves and physician offices – such as defective knee replacements.

Further, the FDA is a bureaucracy and not equipped to evaluate thoroughly all the medical products on the market.

If the scientists who have recently adopted a sense of conscience are to be believed (and I suspect they’re telling the truth…now), it is likely that many products like defective knee replacements have passed the FDA approval process with their help, despite the agency being fully aware of the risk of injury and/or death of patients.  As a result of the Supreme Court’s decision, the rights of those injured by known defective devices was stripped by the influence of the Bush Administration and one of America’s most powerful industries. Certainly, Americans were forsaken by the scientists who silently stood by as it happened.

I’d like to believe that we could all breathe a sigh of relief as the Obama administration takes shape, but this year the same Supreme Court justices will decide if blanket immunity should also be given to drug manufacturers when the FDA has approved a drug before it went to market.  We are predicting that the conservative Supreme Court will immunize the wealthiest companies in America (the pharmaceuticals) from any liability or responsibility for defective drugs that kill or destroy Americans.

Levine v. Wyeth Pharmaceuticals

In the case, Levine v. Wyeth Pharmaceuticals, the court will weigh the merits of the underfunded, understaffed and morally corrupt FDA’s ability to protect the public from ineffective, defective and, as proven time and time again, dangerous and deadly drugs to such a degree that once again, the rights of American citizens and their access to justice against billion dollar corporations will be destroyed.  If that happens, countless American health care consumers will have no recourse, no justice. This will also only serve to motivate the pharmaceutical companies to ignore safety in exchange for higher profits.

Clearly our legislators must be told that we, as citizens of Illinois, demand they join the efforts of Rep. Henry Waxman (D – Calif.) and others who are poised to take aggressive action in overhauling the FDA; a priority of Waxman under the Obama administration.

Chicago Injury Lawyer, Managing Partner and Lead Trial Attorney, Cliff Horwitz, welcomes your comments on this article and can be reached at (800)-985-1819.