Justinian C. Lane, Esq.
Let Justice Be Done, Though the Heavens May Fall

Justinian Lane's Blog

Justinian's Blog

Thanks to litigation, two more unsafe drugs may be pulled off the market

One of the arguments for tort “reform” that really infuriates me is the argument that we should defer to the FDA’s “expert” judgment in approving drugs.  As they say, to err is human… and the FDA is very human.

WASHINGTON -(Dow Jones)- A Food and Drug Administration panel of medical experts narrowly recommended Friday pain pills commonly known as Darvon and Darvocet should be pulled off the market over concerns the drugs don't work very well and carry safety risks.

The panel narrowly said, in a 14 to 12 vote, the benefits of the decades-old drugs didn't outweigh the risks and they should be removed from the U.S. market. However, the FDA will make the final decision, and given the essentially split vote it's not clear the FDA will take the products off the market.

Sharon Hertz, the deputy director of FDA's anesthesia, analgesia and rheumatology products division, said the agency would also look at whether it could order post-market studies or change the drugs' labels.

The advisory panel meeting was prompted by a petition and then lawsuit from Public Citizen, a public-advocacy organization, that has asked the agency to remove the products from the market because there's little evidence the drugs are effective and they carry risks of death from heart problems.

Source: FDA Panel Narrowly Recommends Darvon Be Pulled Off Market

Thankfully, the type of lawsuit filed here isn’t at risk of being eliminated by the “reform” movement.  It’s a special type of lawsuit anyone can file against the government if the government fails to act.