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Should The FDA Be The Final Word On Drug Safety?

Posted by Jane Akre
Friday, August 15, 2008 3:24 PM EST
Category: Major Medical, Protecting Your Family
Tags: Federal Preemption, Tort Reform, FDA and Prescription Drugs, Dangerous Drugs, Corporations, Drug Companies, Defective Drugs

Diana Levine's case will go before the U.S. Supreme Court in November, the decision potentially affects all Americans.



IMAGE SOURCE: Diana Levine on her birthday, 2003/ Courtesy: Diana Levine & Charles Ellers Studios


In April 2000, musician Diana Levine of Marshfield, Vermont was rushed to an emergency room with a severe migraine. It had happened before. She was given a painkiller then another medication to stop the nausea brought on by the drug.

The nausea medication, called Phenergan, was inadvertently injected into an artery which led to gangrene and eventually caused Levine to lose her right arm below the elbow.  Ed Silverman of Pharmalot interviewed Levine in February.

Levine filed a lawsuit against drug maker, Wyeth.

The drug’s labeling was inadequate for the particular method of administering the drug, the suit argued. She was awarded $6.8 million, an award that survived an appeal to the Vermont Supreme Court.

Generally, that’s the end of the story.

The plaintiff takes the money they recover, after paying attorney’s fees and the IRS, they then figure out how to remake their lives, pay any past and ongoing medical bells and move on. Rarely does a jury award mean one has struck the lottery jackpot.

But Wyeth, not content with the ruling, has appealed to an even higher court – the U.S. Supreme Court – which will hear the Levine case November 3.   

The outcome has the potential to impact millions of Americans who take prescription drugs or use FDA-approved medical devices.  

Wyeth reasons that since its drug (and the warning label) went through FDA approval, it should receive blanket immunity from state law claims challenging safety, efficacy or labeling.  

That is the reasoning behind federal preemption, an increasingly convenient way for drug makers to avert the cost of damages from a drug or medical device that causes harm.

The Levine case is being watched by many because it’s as much about preemption as it is about Wyeth. It’s about state rights versus federal rights, and ultimately it’s about the rights of citizens versus the rights of corporations.

Without the FDA mandate, chaos would prevail, some argue.  States (in the form of lawsuits) should not be allowed to challenge the wisdom and consistency of a federal binding standard for drug approvals. The FDA should be the final word on safety and effectiveness.

Wyeth argues in its brief, that it is impossible to comply with both state law and FDA requirements. Perhaps not surprisingly, the White House supports a federal preemption

A court challenge does nothing to prevent Wyeth from making a drug label clearer, Levine argued.  And what happens when the FDA is repeatedly shown to be incapable of keeping dangerous drugs and medical devices off the market?  Anti preemption sentiment argues that to take away the ability to hold corporations accountable could have cataclysmic consequences for public health and patients’ rights.  

The New England Journal of Medicine is against preemption, though many doctors feel it protects them from lawsuits. Also filing briefs against federal preemption are 47 state attorneys general, former FDA commissioners, members of Congress and constitutional experts, all urging the high court to uphold the $6.8 million ruling.

The question before the U.S. Supreme Court will be this – Whether the prescription drug labeling judgments imposed by the FDA under the federal Food, Drug and Cosmetic Act, preempts state-law product liability claims premised on the theory that different labeling judgments were necessary to make the drugs reasonably safe for use.

Levine tells Pharmalot about Wyeth that, “They should’ve taken responsibility for changing the label…. I just have to have faith. If people like me are denied the ability to sue a drug company, well, a drug company has a mind of its own. They know when something is dangerous and they can change it. Think of all the little clinics and emergency rooms that may know as a result of my case. Hopefully, that’ll lead to change. It’s a shame we have to take this upon ourselves. Why should I have to be the savior? It’s astonishing to me that the Supreme Court took this, but I’m going to make the best of it.”

Diana Levine’s case will set the future ground rules for lawsuits against an FDA approved drug or device. A loss in the high court and arguments will be made to the White House and Congress guaranteeing the right to sue, according to the Wall Street Journal legal blog

Many eyes are watching. Stay tuned. #


Anonymous User
Posted by Gene Strong
Friday, August 15, 2008 5:09 PM EST

The drug company should be made immune from

Anonymous User
Posted by Gene Strong
Friday, August 15, 2008 5:10 PM EST

The drug company should be made immune from all lawsuits by virtue of its FDA approval.

Anonymous User
Posted by Jane Akre
Friday, August 15, 2008 5:36 PM EST

I guess the question should be, do you trust the FDA? You realize that having a court system is part of living in our democracy - it is a right that Americans enjoy and unless they appreciate it, they could lose it.

Anonymous User
Posted by Joan M.Petty
Sunday, August 17, 2008 1:02 AM EST

I filed a CIVIL RICO Complaint on Merck for damages from Vioxx. I also had a case filed in Product Liability class action that will never go anywhere.
I learned from Judge Fallon's Order and Reason brief in the case Gomez v. Merck, where he stated why and reason there is no remedy for any person injured by a prescription drug. The Crux of these cases are 1962 Congress omitted when they amended the FDA & FDCA ACT Public Law, any remedy for a injury or death caused by a defective prescrioption drug and medical devise. This puts a sheild of protection for the drug manufacturing and puts the public at risk. The Drug Companies can experiment, torture, kill and injure with out being held criminally responsible. this is a violation of the United States Constitution. My RICO case is presently in the Appeal court 5th Circuit. I entend to appeal to the United States Supreme Court as a pro se litigant for Equial Rights of protection. I am a Vioxx Survivor and find that NO Federal Law, NO State Law can prosecute for a remendy for a death or injury for any individual injured or killed by a defective prescription drug or a medical devise. Preemption of the FDA FDCA ACt. Public LAW. for more information contact me on my e-mail address. My CIVIL RICO Complaint fits like a glove.

Anonymous User
Posted by Joan Petty
Wednesday, August 20, 2008 10:45 AM EST

Gene Strong: Congress created the FDA and the FDA takes its directions and Laws from the Congress. I agree, The FDA has no Authority to dictate to any Corporation. They are a Government Agency. On the other hand, If there is death and damages caused by a Corporation, That is where the law should provide a remedy for prosecution, Not the FDA. The FDA is a watch dog and has only "Power of Persuaion" No inforcement. If we have laws to provide for corporations to take responsibility for their actions.

Anonymous User
Posted by Joan M. Petty
Saturday, August 30, 2008 2:15 AM EST

Jane there is a group of Vioxx comments listed on a web called VPEG VIOXX Plaintiffs Education Group.
Look on YouTube at the video the walking wounded.
I think you will find it interesting.
Many people who took Vioxx are damaged goods now and can not enjoy their life to the fullest because of taking the Poisen Pill. There is a new book out also by TOm Neis, called the Poisen Pill, The inside story of Vioxx.

Comments for this article are closed.

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