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Drug Makers Vaccinate Themselves From Liability

Posted by Jane Akre
Thursday, September 18, 2008 10:55 PM EST
Category: Major Medical, Protecting Your Family
Tags: Federal Pre-emption, Federal Preemption, Tort Reform, Diana Levine, Wyeth, Dangerous Drugs, Defective and Dangerous Drugs, Dangerous Products

FDA publicly states federal preemption in the federal register.



IMAGE SOURCE: Diana Levine in recording studio of Charles Ellers/ Courtesy: Diana Levine & Charles Ellers Studios


Peppermint oil, Cocoa butter, pine needle oil.  Sounds like spa ingredients designed to lull you into a state of bliss.

You actually could fall asleep if you spend too much time buried in the Federal Register, but contained in a June volume (Vol. 73, No. 119) is a long list of over-the-counter (OTC) ingredients that the Food and Drug Administration (FDA) says are generally recognized as safe (GRAS), but the agency is not sure.

It’s what’s in the fine print that’s not a snooze.  The Food and Drug Administration (FDA) has gone beyond its statutory authority to give drug manufacturers complete immunity from lawsuits.

The proposed rule-changes subject the OTC ingredients to additional FDA approval before being used.

Once approved, makers of topical antimicrobials that contain ammonia, or blemish remedies with triclosan, or any of 21 wound care, impotency cures or medicated bath preparations, would no longer be held accountable should the ingredients eventually be found to cause harm.

“The FDA has done a 180-degree about face,” says Gerie Voss, American Association for Justice (AAJ) director of Regulatory Affairs to IB News.  “Even though their mission is to protect consumers, it’s more important to give protection to prescription drug manufacturers then their ability to hold them accountable.”

The FDA’s federal pre-emption provides a shield to drug manufacturers as the proposal clearly states, “FDA has determined that the proposed rule, if finalized as proposed, would have a preemptive effect on State law.”

Voss believes mineral oil opens the door for across- the-board federal pre-emption of drugs approved by the FDA, circumventing an injured consumer’s ability to bring an action in state count. 

In a letter to the FDA Commissioner, Andrew von Eschenbach, California Rep. Henry Waxman on Wednesday, asked how the FDA sets priorities and whether they include advising companies on how to promote and pre-empt products.   

In his letter, Rep. Waxman cites a June, 2007 email from then FDA chief Counsel Sheldon Bradshaw to Tevi Troy of Health and Human Services, which Waxman believes gives the appearance of a fast-track to the agenda.

Bradshaw is a lawyer who represents the food and drug industry.  Troy is the brother of Daniel Troy, former FDA counsel, now general counsel for GlaxoSmithKline, who has taken credit for the pre-emption language.  

Mother Jones’ Stephanie Mencimer recently profiled the revolving door between government and industry.

She reports that in 2001, Bush appointee Daniel Troy, “quietly advanced a legal revolution that is playing out in earnest in the U.S. Supreme Court this year. This revolution has the potential to affect the health and safety of the nation’s citizens for years to come, all while making Troy a rich man.”

The American Association for Justice (AAJ), a group representing trial lawyers who frequently face off with drug manufacturers over dangerous drugs such as Vioxx, is asking the FDA to revise the proposed preamble language to eliminate any reference to protections or pre-empting state law.  

“By giving drug manufacturer’s complete immunity from lawsuits through this small addition to a rule, there is little incentive for them to make sure the over-the counter drugs they market and sell are safe.  This puts consumers at risk,” said American Association for Justice (AAJ) President Les Weisbrod.   

Senator Edward Kennedy (D-MA) has introduced the Medical Device and Safety Act that would ensure dangerous medical device makers do not have immunity from product liability lawsuits.  The House introduced a similar bill in June.  

The next big showdown on pre-emption occurs November 3rd, Wyeth will cite pre-emption when it brings a notable challenge to the U.S. Supreme Court to attempt to overturn a favorable $6 million verdict to injured woman Diana Levine, who lost her arm after being injected with a Wyeth drug.

The editors of the New England Journal of Medicine and many others, including lawmakers and FDA employees, have filed a friend of the court brief in the Levine case, arguing that FDA rules have always complemented the civil justice system and pre-emption is not necessary.  # 

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