Supreme Court Denies Certiorari in Stengel, Closing the Door on Federal Preemption of Medical Devices, Parker Waichman LLP Comments

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Parker Waichman LLP

Jun 27, 2014, 12:45 ET


Port Washington, NY (PRWEB) June 27, 2014 -- Parker Waichman LLP, a national law firm that has long been dedicated to protecting the rights of victims who have been injured by medical devices, comments on a Supreme Court decision that may put an end to the efforts of medical device maker, Medtronic, Inc. concerning the legal notion of preemption. Medtronic has been seeking to have a number of courts nationwide ensure that it not be sued over federal preemption on every claim involving devices that received Premarket Approval (PMA) by the U.S. Food and Drug Administration (FDA). The case is Stengel v. Medtronic, Inc., Docket Number 12-1351, filed May 14, 2013 in the United States Court of Appeals, Ninth Circuit.

The Supreme Court just denied certiorari—an order (or writ) by which a higher court reviews a lower court’s decision—to review the Court of Appeals’ ruling in the case of Stengel v. Medtronic, Inc., which is in Arizona from the Ninth Circuit Court of Appeals. The High Court found that Stengel’s failure-to-warn claims had not been preempted by the FDA’s supervision of medical devices. (Stengel v. Medtronic, Inc., Docket Number 12-1351, filed May 14, 2013 in the United States Court of Appeals, Ninth Circuit)

Medtronic sought to resolve the breach in its litigation strategy involving a number of preemption motions filed nationwide, and claimed that the Court’s denial of certiorari was meaningless due to its prior rulings in two earlier cases, namely Riegel and Buckman (Riegel v. Medtronic, Inc., Docket Number 06-179 in the United States Court of Appeals for the Second Circuit, Argued December 4, 2007—Decided February 20, 2008 and Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 349-50 (2001). In doing this, the medical device maker was able to avoid the views of the Solicitor General of the United States, which are views on which the High Court specifically sought prior to its denying review. In fact, in the Solicitor General’s brief to the Court, he indicated that Riegel was significantly different from Stengel because, in Riegel, the FDA granted preemption for claims and indicated that the device maker violated device-specific requirements. In Stengel, no specific preemption directives were noted concerning alleged violations of the agency’s general rules.

Medtronic had been using the preemption argument in a number of courts with minimal success, while mounting lawsuits rejected the review of applicable state law and statutes, including three Circuit Courts of Appeal that ruled in addition to the Ninth Circuit:

  • Hughes v. Boston Scientific Corporation: No. 09-60925, United States Court of Appeals, Fifth Circuit. January 21, 2011.
  • Bass v. Stryker Corporation: No. 11-10076., United States Court of Appeals, Fifth Circuit., January 31, 2012
  • Howard v. Sulzer Orthopedics, Inc.: No. 02-CV-0564-CVE-FHM, United States District Court, N.D. Oklahoma, June 21, 2011
  • Bausch v. Stryker Corp.: No. 09-3434, United States Court of Appeals, Seventh Circuit, decided December 23, 2010

In Bausch, the Supreme Court denied certiorari review and all of the Circuit Courts uniformly rejected Medtronic’s arguments—all holding that the Supreme Court in Riegel expressly held that where a medical device violates state tort law that parallels federal requirements rather than adding to them, the state law claim is not preempted and may be maintained.

“Given the Supreme Court’s recent denial, one would think that Medtronic may finally stop burdening the courts with frivolous preemption motions that do not have any legal basis,” said Gary Falkowitz, Managing Attorney for Parker Waichman LLP.

If the FDA has not specifically provided for a medical device to be preempted, it is not, according to Parker Waichman. General specifications are not sufficient. And, if a device does have specific preemption from the FDA, state court actions may be maintained if device makers simply seek redress for state claims that are parallel to, and do not seek to change, federal requirements.

“We are happy that the justice system seeks to put an end to Medtronic’s attempts at stopping lawsuits brought by individuals who have suffered from significant and life-changing injuries allegedly caused by medical devices,” said Gary Falkowitz, Managing Attorney at Parker Waichman.

Parker Waichman LLP offers free legal consultations to victims of injuries allegedly caused by medical devices. If you or a loved one experienced injuries as a result of a potentially defective medical device, please visit the Medical Devices pages at YourLawyer.com or call 1-800-LAW-INFO (1-800-529-4636).

Gary Falkowitz, Parker Waichman LLP, http://yourlawyer.com, +1 (800) 529-4636, [email protected]