Diana Levine, a Vermont guitarist, lost her right arm below the elbow after she was injected with Phenergan, a medicine for nausea, and developed gangrene. She sued the manufacturer, Wyeth, arguing that the company had a duty to warn consumers that such injections could have devastating consequences. The courts in her state agreed, awarding her nearly $7 million.
But Wyeth appealed, countering that it was protected from such lawsuits. It argued that the FDA’s judgment could not, in effect, be overruled by a state court. FDA scientists had weighed the risks and benefits of Phenergan in approving the drug’s prescribing literature, or label, as a guide for doctors. The FDA was aware of risks associated with injecting some forms of Phenergan, but the label did not specifically warn about the technique used with Levine.
To say this decision will have broad-reaching consequences for consumers is an understatement.
If the Supreme Court extends the federal preemption clause of the U.S. Constitution to the FDA, then it would in essence take away a person’s right to a trial by jury if the product around which the lawsuit is based had been previously approved by the FDA.
That means the FDA would basically have the administrative authority to grant immunity to drug companies and medical device manufacturers; and I don’t think anyone in their right mind believes the FDA is remotely competent enough to handle that kind of responsibility.
Thankfully, doctors are beginning to speak out about the possible negative implications of the Supreme Court siding with the drug companies in this case.
In an Amicus brief submitted to the High Court, the New England Journal of Medicine noted that lawsuits serve as “a vital deterrent” against this and protect consumers if the drug companies don’t disclose drug-related risks. And they are absolutely right.
Federal preemption is one of the most important issues facing us right now – not only in prescription drug cases, but in other areas as well. If the FDA and other government agencies are granted the power of life and death – literally – then we could all be in a world of hurt. Literally.
I encourage everyone to contact their legislators in Washington about this important issue. To contact your Senator, click here. To contact your Congressman, click here.