Who is the FDA protecting: you or the pharmaceutical companies?

On March 4, 2009 the U.S. Supreme Court, in a 6-3 decision, found that FDA approval was not a complete defense to plaintiff Diane Levine's claim that Wyeth failed to adequately warn against a risk involved with the anti-nausea drug Phenergan.

As stated by Justice John Paul Stevens:

"Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness."

Wyeth v. Levine, No. 06-1249 (U.S. Sup. Ct.)

For background information and materials regarding the Wyeth v. Levine case, visit the Federal Preemption of Drug Injury Lawsuits page over at the Drug Injury Law web site.

Some Reasons To Support The Medical Device Safety Act Of 2009, And A Dissent
May 12 Hearing In Washington Begins The Debate About Whether The Medical Device Industry Should Have Total Immunity From Legal Liability
(Originally Posted by Tom Lamb at DrugInjuryWatch.com)

On May 12, 2009 the Health Subcommittee of the House Energy and Commerce Committee will have a hearing on the Medical Device Safety Act of 2009. This hearing is the first step to legislatively moving this important piece of legislation through the House of Representatives.

In more detail, the Medical Device Safety Act (S. 540/H.R. 1346) would address the Supreme Court's Riegel v. Medtronic decision and restore the ability of injured patients to hold negligent medical device manufacturers accountable when their products cause an injury or death.

The February 2008 Riegel decision by the Supreme Court serves to give total immunity to device manufacturers who fail to adequately warn patients about device risks. As a result of the Riegel decision, any patient who is injured by a faulty medical device cannot get legal compensation from the manufacturer who would be legally liable but for the federal preemption defense available to the company.

In Riegel, the device that failed was a Medtronic balloon catheter used in heart surgery. The patient in Riegel required additional surgery and eventually died. But the Supreme Court's decision allowed Medtronic to walk away and, accordingly, there was no corporate accountability in that case.

Looking beyond that one case, when patients with serious injuries are unable to hold the negligent manufacturer accountable, the patients and the taxpayers are left footing the bill. Where a patient has private health insurance, their insurance company would likely cover the additional surgery required, but this raises the cost of insurance for all of us. For Medicare or Medicaid-covered patients, the costs of the additional medical care are passed onto the taxpayers. And for patients who can no longer work, they may need additional taxpayer supported programs, such as Social Security disability.

Not only is this "bad" cost-shifting, this immunity does not encourage the manufacturer of the faulty device to fix the problem(s) with its product -- and the cycle continues.

The Medical Device Safety Act of 2009 would effectively reverse the Supreme Court's Riegel decision handed down last year.

If ultimately passed by the House and the Senate, and thereafter signed into law by the President, the Medical Device Safety Act would apply to cases brought on or after the date of enactment as well as to any cases that are still pending prior to the date of enactment.

For an article in support of this legislation, see this editorial published by The New England Journal of Medicine (NEJM), titled simply "The Medical Device Safety Act of 2009", which concludes in this manner:

"Patients and physicians deserve to be fully informed about the benefits and risks of medical devices, and the companies making the devices should be held accountable if they fail to achieve this standard. We urge Congress to swiftly pass this legislation and to allow lawsuits by injured patients, which have been an important part of the regulatory framework and very effective in keeping medical devices safe, to proceed in the courts. The critical issue of preemption, which directly affects the disclosure of risks and thus the safety of the nation's supply of medical devices and drugs, should properly be decided by officials elected by the people, with whom the responsibility for the health of the public rightfully resides."

To get a sense of what the medical device manufacturers will be asserting in Washington at next week's hearing, here is a May 6 press release about a brand new report by Ernst Berndt and Mark Trusheim of the Massachusetts Institute of Technology (MIT), which was funded by the Advanced Medical Technology Association: "Removing Medical Device Preemption Impacts Jobs, Health Care Costs, Patient Access".

So the stage is set. You can let us know what you think about the federal preemption of medical device lawsuits by submitting a Comment, below.

More importantly, you can contact your representatives in Washington and tell them whether or not a medical device manufacturer should have total immunity when its product seriously injures or kills a patient.

P.S. The Subcommittee on Health held its hearing on H.R. 1346, the Medical Device Safety Act of 2009 on Tuesday, May 12, 2009, as scheduled. Here is a list of the witnesses who testified:

David Vladeck, J.D., Professor of Law, Georgetown University Law Center

William H. Maisel, M.D., M.P.H., Director, Medical Device Safety Institute, Department of Medicine, Beth Israel Deaconess Medical Center, Boston

Gregory Curfman, M.D., Editor, New England Journal of Medicine

Bridget Robb, Gwynedd, Pennsylvania

Richard Cooper, Partner, Williams & Connolly LLP

Michael Kinsley, Seattle, Washington

Transcripts of their testimony and audio from the hearing are available, now.
(5/13/09)

Georgia May Introduce Preemption For Pharmaceutical Companies
January 2009

"Here are four compelling reasons why Gov. Sonny Perdue's proposal to create a liability-free haven for drugmakers threatens the welfare of Georgians - Vioxx, Rezulin, fen-phen and Bextra."

Thus begins an opinion piece which appeared in the Atlanta Journal Constitution on January 14, 2009. Following in the footsteps of Michigan, currently the only state which preempts pharmaceutical lawsuits, Georgia's governor purposes that drug companies be granted immunity from lawsuits involving FDA approved drugs. The incentive behind Purdue's idea is bringing pharmaceutical industry to the state.

"'This legislation will say that companies with a significant presence in Georgia will not be subject to product liability claims within this state if the FDA approved the medical device, drug or the labeling along with it,' said Perdue on Tuesday. 'The legislation will make Georgia an even more attractive environment for biotechnology companies.'" reported Maureen Downey.

However, citizens question whether taking away the protection and "common-law right" of consumers to hold pharmaceutical companies accountable for their products worth this potential industry growth. The simple fact is that, on its own, the FDA is not enough to keep pharmaceutical companies in line. After almost 3 years of manufacturing problems and out-of-spec pills, is the FDA finally making a decided effort to shut down Actavis, Inc., the manufacturers of the notorious double-dose Digitek pills.

In an article from the Center of Public Integrity:

"Five FDA inspections in 2006 and 2007 of three Actavis Totowa plants in New Jersey - two in Totowa and one in Little Falls - uncovered shoddy manufacturing practices and numerous 'longstanding' quality control and reporting violations dating back to 1999 in regard to various drugs produced by the firm. During an August 2006 inspection, the FDA said it was impossible for Actavis to reliably ensure that their pills even contained the drug they said they contained. In a warning letter dated February 1, 2007, the FDA wrote that there was no assurance that many of the company's drugs 'have the identity, strength, quality and purity that they purport to possess.' Record keeping by the company was equally poor. Company records had been altered or 'overwritten' and undesirable or 'out of specification' test results were simply discarded and replaced with newer test reports 'without any justification' for discarding the earlier results, according to the inspection report."

After all of these failed inspections and serious manufacturing flaws, the FDA took no poignant action until late last year when it finally pushed for Actavis to shut down it's facilities.

Further, is there even a good reason to believe that preemption fosters this kind of growth?

"In 1995, Michigan passed the broadest drug manufacturer shield law in the country. Have biotech companies flocked to the state? 'We have had some pharmaceutical companies pack up and leave since then,' says John LaMacchia, legislative aide to Michigan Democratic state Sen. John Gleason, who is fighting to repeal the immunity law. 'If we are supposed to be able to harbor these types of companies and provide them great opportunities, then why are they leaving?'"

The author of the opinion piece focused on Vioxx, a drug linked to numerous injuries and deaths. She urged others to recognize the dangers of taking away the consumer's ability to hold pharmaceutical companies accountable.

"Liability laws exert pressure on Big Pharma to maintain the highest safety standards and to act fast to yank products when problems arise. And when the FDA gets it wrong, the tort system offers insurance to harmed consumers that they can seek corrective justice."

Downey goes on to illustrate her point with a testimony from a Michigan resident all too familiar with the effects of preemption:

"...justice has been denied Leslie Richter of Lansing, Mich. Her husband, Richard, died of a heart attack in 2003 after taking Vioxx for arthritis for two years. Retired from General Motors after 31 years, Richard Richter was a fit and avid hunter when he suffered a stroke in 2002.

"'He worked really hard to walk again and get use of his left arm,' said his wife Tuesday in a telephone interview. 'Everything was going fine and then in January of 2003, he suffered a brain stem stroke.'

"He died 44 days later, leaving his family puzzled over how a robust 62-year-old died of a stroke. And then the news broke about Vioxx doubling the risk of stroke in longtime users. 'This whole time he was on Vioxx, even when he was in the hospital,' said Leslie Richter.

'In Michigan, people who are harmed have no recourse because of our law,' she said. 'We have become second-class citizens. People in Georgia need to be aware of what this could do to them.'"

Read the AJC article here.

For more information on Vioxx visit:

http://delicious.com/tjlpa/Vioxx

For Digitek visit:

http://squidoo.com/Digitek