Federal Regulatory Approval May Work Against the Public Interest

A recent ruling by the U.S. Supreme Court limiting medical device lawsuits is making it almost impossible for a consumer to sue a manufacturer of federally-approved medical devices. As hard as I try, I can't understand what our judicial system was thinking when they made this decision. Time and time again, we're told that certain laws and regulations have been enacted for our safety. In reality, the only conclusion that makes sense to me is that these rulings are intended to benefit some special interest group or business.

I hope I'm wrong, but I can't help but to think that this is the situation with the recent 8-1 decision by the U.S. Supreme Court against the estate of a patient who suffered serious injuries when a catheter burst during a medical procedure.

The decision rendered by the Supreme Court states that lawsuits are barred to the extent they would impose requirements that are different from federal requirements. Even the current Bush administration agrees with the ruling, saying state jury verdicts against medical device manufacturers would compel companies to alter product design or labels that had already received approval from the U.S. Food and Drug Administration (FDA).

This is absurd. If these government branches really believe what they are saying, a reality check is in order. Just because a company must substantiate the safety and effectiveness of a medical device before the FDA will approve it for the marketplace doesn't mean that the company and/or FDA is infallible. The FDA, with a shortage of funds and manpower, is certainly prone to make errors. Medical companies, in an effort to reach the marketplace first, are also susceptible to errors. In fact, over a recent three-month span, federal regulators responded to more than 100 safety problems regarding medical devices.

I wonder if the Supreme Court looked into these safety problems or even considered that just two months ago, the Washington Post reported that the FDA approved experiments with artificial blood substitutes after studies showed that the controversial products posed a clear risk of causing heart attacks and death. I wonder if the Court considered that one company pulled its defibrillation wires off the market because broken leads had resulted in five deaths, even though the risk of breakage is low and less than 1% have failed.

Perhaps if the real concern was public safety, a different decision would have been reached.

By no means am I lawsuit fanatic; however, I do believe people are entitled to fair, honest representation. It's wrong to tie the hands of this nation's citizens by not allowing them to seek compensation for personal injury or wrong doing.

The only winners here are special interest groups, federal agencies and major companies. While they get the rights to the profit well, the people get the proverbial shaft.