Medical Device Safety Act Needs to Become Law

U.S. District Judge Richard Kyle dismissed a lawsuit brought against Medtronic, a company that produced defective defibrillators, and stated the only viable option for the 1,400 victims in the case is through legislative action.

The case involved heart defibrillators that are attached by defective Medtronic leads (the part of the defibrillator that attaches the device to the heart). This part routinely malfunctions and sends repeated shocks to patients, sometimes for hours on end, which leaves them seriously injured and virtually incapacitated until the device is shut off. 

The leads were eventually recalled in October of 2007, but this was seven months after Medtronic received reports by patients of the numerous problems associated with this medical device. Lawsuits were filed, but the decision by Judge Kyle crystallizes what needs to be happen next.

Judge Kyle even declared in his dismissal that "plaintiffs' remedy...lies with Congress and not with this Court" which means our elected representatives need to pass the Medical Device Safety Act (MDSA).

The MDSA would help ensure that consumers still have the right to hold irresponsible medical device manufacturers responsible for causing serious injuries to their customers.

The bill specifically states:

SEC. 2. LIABILITY UNDER STATE AND LOCAL REQUIREMENTS RESPECTING DEVICES.

(a) Amendment- Section 521 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360k) is amended by adding at the end the following:

‘(c) No Effect on Liability Under State Law- Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.'.

(b) Effective Date; Applicability- The amendment made by subsection (a) shall--

(1) take effect as if included in the enactment of the Medical Device Amendments of 1976 (Public Law 94-295); and

(2) apply to any civil action pending or filed on or after the date of enactment of this Act.

The bill would also clarify the intent of a U.S. Supreme Court case, Riegel v. Medtronic, that Judge Kyle used as a reason to dismiss the lawsuit, according to justice.org. The Supreme Court ruled that a medical-device manufacturer cannot be sued under state law by patients alleging harm from a device that received marketing approval from the Food and Drug Administration (FDA). Judge Kyle argued that the FDA approval of the defibrillator leads prevents the court from acting. This needs to change and the MDSA will provide that change.

The MDSA currently has 108 co-sponsors and is working its way through the Committee process. Hopefully, it will get to the floor for a vote and we can finally make this important piece of legislation a law. As the New England Journal of Medicine said:

"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."