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

Posted by Jane Akre
Thursday, September 11, 2008 10:34 PM EST
Category: Major Medical, Protecting Your Family
Tags: Federal Pre-emption, Federal Preemption, Tort Reform, FDA and Prescription Drugs, Dangerous Drugs, Drug Products, Defective Products, Medical Devices, Diana Levine

Federal pre-emption has more potentially to do with your life than celebrities of the hour, but few know about it.

(Part Two) Of A Special Series on Federal Pre-emption, see Part One



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

READERS*- What Do You Think? 


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. 

What is federal pre-emption? Injuryboard.com Part One covers some of the areas of consumer protection that are targeted by federal pre-emption - the concept that federal approval should prohibit state lawsuits challenging defective products or warnings.

The consumer versus corporation issue has the potential to impact every American, yet few hear about the issue on personality and celebrity saturated mainstream media. But debate is happening loud and furious in alternative media.

Dr. Doug Bremner puts it most colorfully this election season in his blog on the Huffington Post:

“While Americans sit mesmerized by Sarah Palin clapping into the microphone and rambling on about Greek Columns while her daughter wipes down her youngest child's hair with her own spit, they are utterly unaware of yet another attempt by the Republican machine to steal even more of their civil rights and liberties. As if the "Patriot" Act wasn't enough, the war mongerers now want to take away your civil rights in the form of redress in the event that you or your family are damaged by dangerous prescription drugs. And while the fear mongerers are hyping the "War on Drugs" and making chemical attacks against Columbian farmers, they aren't drawing attention to the fact that three times as many people die from "legal" prescription medications every year as from illegal drugs, and that the government is getting ready to remove your right to have any recourse for the harm that is done to you by a pharmaceutical company.”

Here is the petition, opposing federal pre-emption which can be signed and submitted electronically to Congress. 

The group chose the web site Pharmalot, which covers the drug industry and the pre-emption issue, to post the petition on this devisive issue. 

The petition states:

"Previous administrations and the FDA considered tort litigation to be an important part of an overall regulatory framework for drugs and devices; product-liability litigation by consumers was believed to complement the FDA's regulatory actions and enhance patient safety. ...

“In stripping patients of their right to seek redress through due process of law, preemption of common-law tort actions is not only unjust but will also result in the reduced safety of drugs and medical devices for the American people."  

The petition is the creation of “Americans for Drug and Device Accountability."  

Hank Greenspan, a social ethics lecturer at the University of Michigan Medical Center says it was organized by a diverse group of people "healthcare workers, patient advocates, policy analysts, and so on (but no lawyers, if anyone cares!). Politically, we are equally divided - from conservative Republicans to liberal Democrats. It is genuinely multi-party. And no one, by the way, is “anti-industry.”

“So it is about an issue, not about an individual or even individuals. What may be “newsworthy” is that, as far as I know, this is the first such petition on preemption that arose in an entirely grass roots, spontaneous way. The effort has no ties with any other group - be that Public Citizen, AAJ, AARP, etc. It is just citizens who are deeply concerned, acting on it.”

Not to be outdone, a reader of the web site Pharmalot in response has created his own petition in support of pre-emption. It too is an iPetition and submitted to Congress electronically.

It states that:

“We the undersigned support the doctrine of pharmaceutical preemption. Congress has given the FDA authority to regulate and maintain the adequacy of domestic pharmaceuticals. State courts consisting of lay juries should not be allowed to second-guess the decisions of well-trained medical staff employed by the FDA. Doing so undermines the scientific process and potentially undermines the future development of new medications. State courts are interested in the health of the individual involved in the lawsuit. The FDA is interested in the health of the nation. Preemption is an essential guard that protects the health of the populace from being overridden by the concerns of the health of a few individuals involved in high-profile lawsuits.”

The U.S. Chamber of Commerce is known to be a big supporter of federal pre-emption and the relief it potentially offers to industries it represents, as is the Pharmaceutical Research and Manufacturers of America (PhMRA), a trade group that represents the country’s leading pharmaceutical research and biotechnology companies which reached assets of $58.8 billion in 2007, it says.

According to a June 11, statement, PhRMA Senior Vice President Ken Johnson defines the other side of federal pre-emption:

“Federal preemption is not about providing blanket immunity for America’s pharmaceutical research companies. It is about allowing the Food and Drug Administration (FDA) to do its job to protect patients by overseeing drug warnings.

“Indeed, patients are best protected by a single, strong, uniform regulatory authority that is the sole arbiter of the benefits and risks of medicines. That is why Congress empowered the FDA to approve how that information is conveyed on the medicine’s label.”

While it may not be as exciting as Palin or Paris – the federal pre-emption debate is one you might hear more about in coming weeks as the November 3rd U.S. Supreme Court revisits the issue in the upcoming Levine case.   

But don't expect to hear the debate about the role of government and the rights of corporations and citizens on the mainstream media, which today on “Today” was busy with a story on a 13 pound Chihuahua, real estate bargains, “Food for your Face,” and Fashion Week, “Pumps Up the Volume”.  #


Anonymous User
Posted by HG
Friday, September 12, 2008 11:30 AM EST

Thanks for your covering all this. It could not be more important.

One clarification. It was Pharamlot's choice (for which we are grateful}, not ADDA's, that word about the petition was posted there.

Pharmalot is almost alone in is serious coverage of the preemption issue. We hope other voices will continue to join in.

Anonymous User
Posted by Jane Akre
Friday, September 12, 2008 11:37 AM EST

Thanks for the clarification. Ed does a great job on Pharmalot!

OKAY readers- do you care? Unfortunately this is one issue you're not going to see in your local newspaper or on the big networks, you'll have to do a little research on your own. OR you can wait until you want to sue a drug manufacturer that has just killed your family member, only to find out that no one will take your case because of federal pre-emption.

Do lawsuits deter reckless behavior by corporations? Or are they a waste of time?

Anonymous User
Posted by HG
Friday, September 12, 2008 3:25 PM EST

Ed does, indeed.

I hope your readers will respond. It is very clearly the hope of the pro-preemption folks that FDA preemption happens unnoticed, as it essentially did in the device arena. Beyond a scattering of editorials, neither media nor most political candidates (with as few noteable exceptions) have been willing to pick up the ball.

Among the several ironies is that preemption will be a disaster for industry itself, and I say this as a shareholder in both drug and device companies. How much more erosion of public trust can it - and all of us - afford?

Anonymous User
Posted by Jane Akre
Friday, September 12, 2008 3:48 PM EST

Okay HG-- What are the few notable exceptions? I looked for anything from the pol candidates and saw nothing from either camp on FP. Perhaps they don't get it either.

Time to revisit Howard Beale and "Mad As Hell" See it on YouTube here:

Incredibly Relevant! See it!!

Anonymous User
Posted by HG
Friday, September 12, 2008 11:51 PM EST

The following signed the amicus against preemption in the Levine case:

Senators Patrick J. Leahy, Edward M. Kennedy, Sheldon Whitehouse, Tom Harkin, Dianne Feinstein, Richard J. Durbin, Bernard Sanders, Russell D. Feingold, Representatives Henry A. Waxman, John Conyers, Jr., John D. Dingell, Frank Pallone, Jr., Bart Stupak, Zoe Lofgren, Linda Sánchez, Debbie Wasserman Schultz, Maxine Waters, and Peter Welch.

Kennedy is also the sponsor of the Senate Bill that would restore civil liability in the device arena post-Riegel. There are about twelve Senators who have signed on as co-sponsors, including Obama.

That said - with the very occasional exception of Waxman, Stupak, Kennedy, and Leahy - I am not aware of any of these folks being outspoken in a context that either media or public would "overhear." To that degree, the cliff we are about to go over might as well be on Mars.

So, yes, mad as hell.

Anonymous User
Posted by Jane Akre
Monday, September 15, 2008 2:33 PM EST

I haven't found any comments on federal pre-emption among the GOP. Might be a good question to pose during the upcoming debates. I wonder who / how many would have the "deer in the headlights " look?

Comments for this article are closed.

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