The Supreme Court Gets Ready to Rule on Patient Safety

That title seems a bit silly, doesn't it? Why would anyone have to rule on patient safety? Shouldn't patient safety be an obvious choice?

Of course not. Because -- you guessed it -- this is a patient safety vs money question. It's called pre-emption.

Specifically, during this session of the Supreme Court, based on Wyeth vs. Levine, the justices are being asked to rule that once the FDA has approved a drug, then a drug or medical device company can't be sued if the drug causes harm. In other words, the FDA approval pre-empts a patient's ability to file a lawsuit for any harm done by the drug or device.

Wyeth Laboratories is pursuing the ruling. Diana Levine was injected with a Wyeth drug which caused gangrene. As a result, she had to have her arm amputated. Wyeth doesn't want to be held responsible, because they claim the FDA already ruled the drug to be safe.

According to the Boston Globe:

In Wyeth v. Levine, the Bush administration has lined up on Wyeth's side, while Levine has support from the attorneys general of 47 states and the present and former editors of the New England Journal of Medicine. Two former FDA commissioners, David Kessler and Donald Kennedy, also have filed briefs for Levine. The FDA, they say, cannot "police the market on its own."

Here's the problem: we have learned during the past several years about how some drug companies have hidden problems from the FDA while seeking approval. For example, Vioxx trials showed the connections between Vioxx and deaths from heart problems. When Merck sought approval for Vioxx, it simply did not disclose those studies.

The FDA struggles with doing its job of protecting American citizens already. If the Supreme Court rules in favor of these drug and device companies, and gives them a pass on lawsuits once they get FDA approval, then it's like giving them free rein to manipulate the FDA and American citizens even further.

Profits at the cost of safety. One can only hope the justices see the folly, and potential deaths, in that.
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Photo © Getty Images, Mark Wilson