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What to do when drugs cause unexpected health problems.

Posted Aug 01 2009 11:24pm
What to do when drugs cause unexpected health problems

In a rare court ruling that pleases me, the U.S. Supreme court upheld damages for a woman injured by one of Big Pharma’s drugs. And this decision is extremely important to you.

A Vermont woman received an intravenous injection of the drug Phenergan, which the FDA approved years ago. The drug found its way into her artery and caused gangrene. She lost her right arm. She brought suit claiming that the drug maker, Wyeth, should have had more stern warnings about injection of the drug on the label. The FDA approves of such warnings.

Here was the problem. The FDA might not go far enough in stressing a warning. An injury could occur that might not have otherwise happened if the label carried full disclosure of the known risks. Wyeth argued that since the FDA approved the label, the company should be immune from attack. The court held that such defense would apply only if the issue was presented to the FDA and the agency rejected the proposed warning.

This is welcome relief for consumers. Big Pharma tried to do an end run around you. If it won the case, you would have had no recourse if a drug with listed warnings injured you. However, now, if you feel that the warnings didn’t go far enough, the court says that you have the right to sue for damages incurred.

I am no fan of the FDA. It has presided over unprecedented drug scandals. But this decision gives us some hope for change. Warnings approved by the FDA don’t protect the company if a problem occurs that the drug company should have revealed to the FDA. We have a long way to go for parity on the sickness industry playing field. But at least this ruling protects your day in court for a drug-related injury.

Yours for better health and medical freedom,

Robert Jay Rowen, MD

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