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Britney, Palin, Paris, and Pre-emption (Part One)

Posted by Jane Akre
Thursday, September 11, 2008 3:28 PM EST
Category: Major Medical, Protecting Your Family
Tags: Federal Pre-emption, Federal Preemption, Tort Reform, Pharmaceutical Companies, Dangerous Products, Dangerous Drugs, FDA and Prescription Drugs, Diana Levine

Celebrity often trumps issues in todays mainstream media



IMAGE SOURCE: Wikimedia Commons/ Palin/ author: Frank K. Anchorage/ Paris Hilton/ author: Peter Schafermeier/ Britney/ author: Middo09


Pre-emption may not be one of the hot topics in the news, among celebrity chat, or featured on your morning talk show, but it has the potential to impact your life more than any celebrity (maybe not more than a politician).

Pre-emption is the legal notion that if the Food and Drug Administration (FDA) approved a drug, you cannot successfully file a state lawsuit (lawsuits are generally filed in state courts) challenging the safety, efficacy or labeling of the drug. 

Why not?  Drug makers and increasingly the FDA argue that the FDA is the final word and state actions only interfere with that approval.

The Diana Levine case will be a major test of federal pre-emption when it is heard by the U.S. Supreme Court on November 3. 

In that case, Levine sued Wyeth arguing that the company had a duty to warn against injecting the drug Phenergan.

Levine, a musician, lost her right arm below the elbow after she was injected with the drug in an IV push and developed gangrene.  She was awarded nearly $7 million, but Wyeth appealed to the U.S. Supreme Court citing federal pre-emption.

Nine current and former editors  at the New England Journal of Medicine, along with 47 state attorneys general, and two former FDA commissioners have come out with a brief suggesting that the FDA cannot do an adequate job to protect Americans.

The FDA “is in no position” to guarantee drug safety is the message in a friend-of-the-court brief in support of Diane Levine.  

The Bush administration still supports Wyeth’s position.

It will be the next major decision in the U.S. Supreme Court on federal pre-emption since the Riegel v Medtronic landmark case was heard earlier this year.     

In that case, Charles Riegel was seriously injured when the balloon catheter used during an angioplasty burst during the operation.

Riegel and his wife sued Medtronic, the maker of the catheter. They claimed the company had violated state law duties not to market an unreasonable dangerous product and then to warn doctors and the public about it. 

The court ruled the 1976 federal law that gives the FDA the authority to regulate medical devices, also severely limits the rights of the injured to sue.

Since the Medtronic case, the Medical Device Safety Act of 2008 (HR 6381)  has been proposed to overrule the February decision in Riegel v Medtronic. The legislation would restore the traditional state common-law remedies for injuries and deaths caused by medical devices and drugs.

Think federal pre-emption is some lofty legal notion that doesn’t apply to you? Think again.

Federal pre-emption has creatively been applied to many situations blocking citizens from traditional remedies to redress.      

*SmithKlineBeecham argued that federal pre-emption should bar a lawsuit by a family whose teen committed suicide in 2002 after taking the drug Paxil.  

*Legislation signed into law by the Bush administration on December 30, 2005  allowed federal pre-emption of state laws banning mercury or thimerosal use in vaccines, even if its use is banned in the state.  

* The Office of the Comptroller of Currency issued a rule that would prevent most California consumer protection laws from applying to nationally chartered banks.

* The Supreme Court has rejected efforts by states to give patients the right to sue managed care companies arguing that the federal Employee Retirement Income Security Act (ERISA) pre-empts the right to sue.

* In California in 2002, then Governor Gray Davis signed a law reducing greenhouse gas emissions from passenger cars and light trucks.  The auto industry and federal government argued the proposal is pre-empted by federal authority to set fuel economy standards.

* DowAgrosciences argued that peanut farmers could not sue in Texas court over labeling requirements because federal law governing insecticides and herbicides pre-empted state law claims. 

*When Johnson & Johnson manufactured its Ortho Evra birth control patch with much more estrogen than standard birth control, more than 3,000 women sued after experiencing blood clots and strokes. The company argued federal pre-emption prevented the lawsuits. 

*The tobacco industry tried to dismiss liability lawsuits claiming that the Federal Trade Commission had sanctioned the use of descriptions such as “light’ and “low tar” cigarettes therefore pre-empting claims and they were not liable for deceptive marketing practices under RICO.

And on the horizon, expect the broad argument in support of pre-emption to be creatively applied by NHTSA governing the auto industry, by the Consumer Product Safety Commission (CPSC) over consumer products, and the Federal Railroad Administration governing rail-crossing accidents.

Alison Zieve, the attorney who represented Riegel, told IB News in a June interview, “There’s been a lot of it (pre-emption) since the early 1990s,” she said. “But until the Bush administration, it was really limited to arguing about the meaning of the pre-emption provisions.”

Why aren’t people getting it? 

Zieve said the fault is with consumer advocates (Zieve is with Public Citizen) and plaintiffs’ lawyers who have not translated the issue into language people can really understand.

“I went out for a drink and told the bartender what I was doing and he was shocked. Of course they can sue, he said.” 

How best to explain federal pre-emption?

Zieve calls it, “fighting for people’s right to sue manufacturers of products that cause injury; fighting to preserve the traditional rights to sue for compensation when you are injured by a product. There is no federal product liability law so it’s state torts when you are injured. Lots of people are hostile to tort suits. It makes it hard to preserve rights when people don’t think about them.”

An ad hoc group wants to know what you think about federal pre-emption in hopes of motivating public awareness and influence decision making this fall.   The group allegedly chose the web site Pharmalot, where much discussion on federal pre-emption has taken place, to post the petition. 

(Part Two -Why supporters think pre-emption is good for Americans, corporations, and a streamlined government.) #

1 Comment

Anonymous User
Posted by Rob
Tuesday, September 16, 2008 8:43 AM EST

Don't call it "preemption," call it the "corporate shield law against consumers."

Special interest groups of people (corporations) argue that they should not be held responsible for thier actions, unlike real people. The current administration has placed former corporate lobbyists and cronies at the helm of every regulatory body (FDA, Veteran's Administration, EPA, OSHA...) who have worked hard to unilaterally change the laws to eliminate corporate responsibility. The word "preemption" does not adequately describe what is going on here!

Comments for this article are closed.

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