State Law

U.S. Supreme Court Shields Medical Device Makers From Liability

By Ryan

   by Richard Cabelus

          At the outset of  tort litigation it is common practice for a plaintiffs? attorney to  sue all parties who were involved in the event which lead to their client?s damages. After all a good lawyer wants to keep all avenues of liability open, so that his client can recover, and hopefully be made whole for the injury he or she suffered.

Many times after the discovery process has run its course, various parties who were sued in the original complaint will be dropped from the suit, as the information obtained in discovery exculpated them from liability.

This scenario is even more commonplace in the complex realm of medical malpractice litigation. For example, a botched operation typically will lead to a negligence action against the doctor, perhaps an action in tort against the hospital as well for negligent supervision, and claims against the manufacturer of any sophisticated surgical equipment used in the procedure. If the discovery process is utilized properly, after the documents have been inspected, and depositions have been taken, the plaintiffs? attorney will be able to ?discover? the real culprit in the action, drop the other parties from suit, and lean on the remaining party in the hope of pretrial settlement.

Last Wednesday the United States Supreme Court corrupted this process, when they all but granted immunity to medical device manufactures from suit, so long as the device was FDA approved. The likely result of this holding will be that now that corporations have an FDA shield from liability,   plaintiffs? lawyers will seek novel ways to attempt to establish liability against doctors and hospitals. This in turn may lead to higher litigation costs for practitioners defending lawsuits and maybe even increased premiums down the road.

         In Riegel v. Medtronic, Inc., 2008 WL 440744 the Supreme Court held that so long as a new medical device receives pre-market approval from the Food and Drug Administration (FDA) the medical device manufacturer will be shielded from all state or common law claims for damages in the event the product is later found to be defective. The Court held that so long as the medical device was classified by the FDA as a Class III device, meaning the device is ?purported or represented to be for supporting or sustaining human life?? and was screened by the FDA and received their pre-market approval, all state or common law claims that differ from or add to the FDA?s pre-market requirements would be preempted by the Federal Food, Drug and Cosmetic Act.

           Examples of Class III devices are replacement heart valves, cerebella stimulators, and pacemaker plus generators. Other medical products like bandages, gloves, wheelchairs, surgical drapes?etc. are categorized as either a Class I or II device and do not receive preemption protection under the Court?s holding. The decision dramatically enhances the regulatory compliance defense for Class III medical devices that receive pre-market approval from the FDA. Therefore, any negligence, or implied warranty suit brought by an injured plaintiff regarding such devices would be dismissed as it is not a valid claim.

            There is also a further loophole regarding Class III devices in that they may still qualify for preemption, and be immune from suit, without even passing the FDA?s pre-market approval process so long as (1) the device was in use prior to the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act, codified as 21 U.S.C. § 360c et seq., and is therefore ?grandfathered-in?; or (2) if the new device is found by the FDA to be ?substantially equivalent? to another device exempt from pre-market approval, no pre-market approval of that device is required. Most new Class III medical devices come into the medical market by way of the second loophole. In 2005, 3,148 new Class III devices entered the market under the ?substantially equivalent? exception and now are immune from common law products liability. Only 32 devices underwent the FDA?s pre-market screening and approval. However, once a device does receive FDA approval, no changes can be made to the product without further FDA approval.

            Although state and common law claims which seek to add to or alter the FDA?s pre-market requirements are preempted under the statute, states are free to provide a damages remedy for claims premised on the violation of FDA regulations, as this is consistent with the federal requirement. Senator Ted Kennedy and Representative Henry Waxman are already working on a bill that would restore a patient?s common law right to sue and in effect overrule the Court?s holding.

            Another case to watch is Wyeth v. Levine which will be heard before the Supreme Court later this session and will address whether FDA approval of prescription drugs under the New Drug Approval process, preempts state law claims for failure to warn, or challenges to safety of efficacy. The Court has been unwilling to find preemption in the past for prescription drugs, but this recent holding will make this future case all the more interesting to watch.

Richard Cabelus is a thrid year law student at Suffolk University. Mr. Cabelus is a former high school history teacher and a former intern at the John F. Kennedy Library in Boston. Mr. Cabelus is presently working as a law clerk at Parker Scheer, a Boston based medical malpractice and products liability firm. In addition to being the first guest blogger here at www.aconnecticutlawblog.com , Rich is a longtime friend and is fast on his way to becoming a superb attorney.

Full post as published by A Connecticut Law Blog on March 04, 2008 (boomark / email).