What if you were hurt by a drug and couldn't sue?

(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)

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.