What to do when drugs cause unexpected health problems

July 31, 2009

In a rare court ruling that pleases me, the U.S. Supreme court upheld

damages for a woman injured by one of Big Pharmaâ€™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

didnâ€™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 donâ€™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

Ref: _links.sfgate.com/ZGHW_ (http://links.sfgate.com/ZGHW) .

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