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, http://www.druginjurylaw.com/TJLClinPageInterview.pdf

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

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.

In his March 7, 2008 discussion in the Philadelphia Enquirer, 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."

Read the article

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

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

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?

Committee on Oversight and Government Reform
Wednesday, May 14, 2008, 10:00 AM at 2154 Rayburn House Office Building.

Transcripts of this hearing are offered on the website from 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.


• Utah State Representative David Clark (R) of the National Conference of State Legislatures

For reasons I have written about previously, I believe that patients should not be pre-empted, or prohibited, from filing lawsuits against medical device and pharmaceutical companies.

Let us know what you think about this federal preemption doctrine in the context of medical device and drug injury cases by submitting Comments.

Read my blog entry about the hearing.