The outcome of an upcoming Supreme Court case, Wyeth v. Levine, will answer whether the manufacturers of drugs should be sheltered from plaintiffs' lawsuits if the drug is approved by the FDA.

Makers of medical devices like implantable defibrillators might now be immune from legal liability any injury or death their product caused as long as it was FDA-approved. This situation resulted from an opinion issued by the U.S. Supreme Court on February 20, 2008, in the case Riegel v. Medtronic Inc. (No. 06-179).

From DrugInjuryWatch:

Read Patient Lawsuits Against Pharmaceutical Companies For Drug Injuries Might Be Prohibited In U.S. >>

Read Sprint Fidelis Recall Showed That FDA's Medical Device Safety System Is Flawed >>

It means if the Supreme Court rules in favor of the drug company in the Levine case, you would probably not be able to file a lawsuit against the manufacturer if you were hurt by a drug, even if that drug were later recalled.

It means that already, as a result of the Riegel ruling, federal preemption might prevent you from filing a lawsuit if you are injured or die because of a faulty medical device, such as Medtronic's Sprint Fidelis Heart Wire Lead.

It means that it doesn't matter what state you live in. It is that way because the Supreme Court said so.

Read an interview I had in March 2008, Drug Safety: A Lawyer's View on ClinPage.com

Read what others are saying >>

This can all be helped by legislation. Find your elected officials in the Congressional directory and tell them what you think. >>

"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://delicious.com/tjlpa/Digitek

http://squidoo.com/Digitek

On May 14, 2008 the House of Representative's Committee on Oversight and Government Reform had a hearing to explore the legal doctrine of federal preemption in the context of product liability lawsuits involving FDA-approved drugs and medical devices.

Should FDA Drug and Medical Device Regulation Bar State Liability Claims?

See the transcripts of testimony on their website: http://www.oversight.house.gov

Testimony included the following witnesses:

• Actor Dennis Quaid and his wife Kimberly, parents of newborn twins, Thomas Boone Quaid and Zoe Grace Quaid, who were victims of a heparin overdose;
• William Maisel, director of the Medical Device Safety Institute, Department of Medicine, Beth Israel Deaconess Medical Center, Boston;
• Aaron Kesselheim of the Harvard Medical School's Division of Pharmacoepidemiology; David Kessler, professor of pediatrics and epidemiology and biostatistics at the School of Medicine, University of California, San Francisco;
• David Vladeck, professor of law at the Georgetown University Law Center;
• Gregory Curfman, editor of the New England Journal of Medicine;
• Christine Ruther, president and chief engineer for C&R Engineering, Inc.; and,
• Utah State Representative David Clark (R) of the National Conference of State Legislatures.

Looking forward, in October 2008 (what will likely still be) the same Supreme Court hears oral arguments in the case Wyeth v. Levine, relating to the issue of whether the federal preemption doctrine ought to prohibit drug injury cases.

Let us know what you think about this federal preemption doctrine in the context of medical device and drug injury cases by submitting a Comment to this article, below, or by taking part in a poll on this issue -- "What if you were hurt by a drug and couldn't sue?" -- over on HeyMonkeyBrain!

Read the blog entry at DrugInjuryWatch.com.

In its next term, the US Supreme Court will hear Wyeth v. Levine, a case involving a Vermont woman who lost a hand and forearm to gangrene after being improperly injected with the drug Phenergan. At the trial of this lawsuit, Wyeth argued that its drug had met FDA labeling requirements and therefore the drug company should face no liability under state law. The trial court judge disagreed, and the jury in that case awarded $6.8 million in legal compensation to Levine for her injury. In October 2008, the Supreme Court will decide if lawsuits for injuries caused by FDA-approved drugs will be barred.

That would mean if you were to take an FDA-approved drug in the future and lose a hand and forearm, you may not be entitled to legal compensation from the drug company.

If you were one of the unlucky few who had Medtronic's Sprint Fidelis defibrillator heart wire lead and then the lead malfunctioned and shocked you or failed to stimulate the heart and killed you, it is now more difficult or perhaps impossible to successfully sue Medtronic due to an opinion issued by the U.S. Supreme Court on February 20, 2008, in the case Riegel v. Medtronic Inc. (No. 06-179).

As explained by New York Times reporter in her February 21, 2008 article, "Justices Shield Medical Devices From Lawsuits":

"The 8-to-1 decision [in the Riegel v. Medtronic case] was a victory for the Bush administration, which for years has sought broad authority to pre-empt tougher state regulation."

"In 2004, the administration reversed longstanding federal policy and began arguing that "premarket approval" of a new medical device by the F.D.A. overrides most claims for damages under state law. Because federal law makes no provision for damage suits against device makers, injured patients have turned to state law and have won substantial awards."

"The Bush administration will continue its push for pre-emption in another F.D.A. case that the court has accepted for its next term, on whether the agency’s approval of a drug, as opposed to a device, pre-empts personal injury suits. Drugs and medical devices are regulated under separate laws."

The prescription drug injury case referred to in that last paragraph is Wyeth v. Levine and in that case the Supreme Court will decide whether a patient should be able to sue a pharmaceutical company when there is a serious side effect that the company did not fully disclose, amongst other scenarios where currently the patient does have access to the court system here in the U.S.

nder the Supremacy Clause of the United States Constitution, where federal and state law directly and irreconcilably conflict, federal law prevails. Today, however, preemption is increasingly used as a weapon to undermine state laws protect the public health and safety, and to eliminate provisions allowing persons to take violators of these laws to court. The danger of preemption lies in its capacity to undermine consumer-friendly state or local laws and remedies that advance public health, safety, and other important public policy goals in favor of weaker federal laws that provide lesser or even no oversight of powerful actors like large corporations.

The public pays the price when these preemption arguments prevail.

This past year, the American public has been bombarded with news headlines of under-regulated products entering into the market and harming people.(13) As it becomes increasingly clear that federal agencies, constrained by inadequate budgets and industry-biased administrators, are not protecting the public, it is important that state and local authorities have the power to enact effective laws and regulations to protect their citizens.

After suffering serious injury when a balloon catheter burst while he was undergoing an angioplasty procedure, Charles Riegel and his wife sued the catheter’s manufacturer, Medtronic, Inc. Medtronic moved to dismiss the lawsuit, arguing that the Food, Drug, and Cosmetic Act expressly preempts state-law damages actions brought by patients who have been injured by medical devices that received pre-market approval from the Food and Drug Administration.

Read this blog entry in its entirety.

In his March 7, 2008 discussion in the Philadelphia Inquirer, Thomas R. Kline expressed concerns about the US Supreme Court granting legal immunity to device manufacturers when their products are made according to FDA specifications when, "It is a well-known scandal, however, that the FDA is nearly unable to perform its most basic tasks."

"Americans have always looked to our courts to vindicate our rights. Congress should move quickly to pass corrective legislation to restore and assure the fundamental right to seek both protection and compensation for defective devices and drugs, and assure that there is no further erosion in service and drug product safety. We should never be at the mercy of anyone who places profit over public safety. We should not be left undefended, without recourse, against the newly privileged class - device manufacturers."