The U.S. Solicitor General Has Urged the U.S. Supreme Court to Deny a Medtronic Inc. Petition in a Dispute Over its Pain Pump Device, Parker Waichman LLP Notes

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Medtronic is attempting to rely on the legal concept of preemption, which has been used by a number of medical device makers when arguing liability lawsuits filed over U.S. Food and Drug Administration- (FDA) approved devices.

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"We are hopeful that the Solicitor General’s brief will put an end to Medtronic’s attempts,” said Gary Falkowitz, Managing Attorney at Parker Waichman LLP.

A key issue in this case involves “failure-to-warn” claims that may be preempted by federal oversight of high-risk medical devices. Following the high court’s October request that it provide an opinion in a dispute filed by Richard Stengel of Arizona, the Solicitor General stepped in. Stengel alleged he was implanted with a Medtronic, Inc. pain pump, which caused him to develop a granuloma (inflammatory mass) around the area where the pain pump was inserted and removed, causing him to become paraplegic. Allegations also include that Medtronic became aware of the granuloma risk after the pain pump’s pre-market approval (PMA) was granted by the FDA; however, the device maker never revised the warning or submitted risk data to the agency. The case, filed in the U.S. Supreme Court on January 10, 2013, is Medtronic Inc. v. Richard Stengel et ux., case number 10-17755.

While the United States Supreme Court rarely seeks assistance, when it does, it does so through the Office of the Solicitor General of the United States. This so-called “Call for the View of the Solicitor General” is rare, only occurring in about one dozen cases annually. In most—approximately 80 percent—of these cases, the Solicitor General advises the Court against granting the position and the Court typically follows this suggestion.

“This is not the first time that Medtronic has attempted to utilize preemption in personal injury cases filed over claims that its medical device were associated with serious harm to patients. We are hopeful that the Solicitor General’s brief will put an end to Medtronic’s attempts,” said Gary Falkowitz, Managing Attorney at Parker Waichman LLP.

The Court was recently faced with this type of a petition in the highly publicized Stengel v. Medtronic, Inc. case, which was received from the U.S. Court of Appeals for the 11th Circuit, and which had held that the Stengels would be able to bring an action seeking damages from Medtronic for the alleged injuries and the subsequent death of Richard Stengel, allegedly due to the Medtronic pain pump. The Stengels alleged that Medtronic neglected to warn the medical community that the pain pump catheter, implanted in the area of Richard Stengel’s spine, might develop a granuloma, which could lead to collapse, permanent paraplegic injury, and death.

Medtronic relied on a portion of the 1976 Medical Device Amendment (MDA) to the Federal Food, Drug, and Cosmetic Act (FDCA), arguing that it was exempt from any lawsuit that challenged its medical device and noting that the Amendment preempted state laws meant to protect medical consumers. The 11th Circuit Court of Appeals disagreed and relied on a 2008 Supreme Court ruling Riegel v. Medtronic, Inc., in which the high court found that there could be no preemption of state protective laws where those laws parallel federal law and neither add, nor take away, from the federal regulatory scheme. In 2013, a Ninth Circuit panel ruled in favor of Stengel, finding that his claims parallel a federal law duty under the MDA, which bars such claims from being preempted. The 1976 Amendments outline the agency's oversight of medical devices, providing the FDA with authority over device labeling and production, and PMA for specific devices.

Although the U.S. agreed that Stengel's failure-to-warn claim is not preempted, its agreement was not related to the lower court’s reasons. "The court of appeals’ conclusion that respondents’ failure-to-warn claim is not expressly preempted is correct, but for a different and more basic reason than the court identified: The federal requirements relevant to respondents’ claim are not device-specific, and therefore, they do not have preemptive effect under Section 360k(a)," the U.S. said in its brief (Brief for Amicus Curiae filed May 2014, number 12-14252 in the Supreme Court of the United States). The response referred to a section of the FDCA that the high court found protects medical device makers if they have complied with federal law.

The U.S. also distinguished Stengel's case from the groundbreaking Riegel v. Medtronic case, in which the Supreme Court, in 2008, ruled that a company may not be sued under state law should a device that underwent the FDA's PMA cause injury. The Solicitor General argued that, in Riegel, PMA approval of the disputed device created preemptive requirements concerning the device’s labeling, production, and design. (Donna S. Riegel, individually and as administrator of the Estate of Charles R. Riegel, v. Medtronic, Inc., No, 06-179 filed in the Supreme Court of United States, Argued December 4, 2007; Decided February 20, 2008 and United States Court of Appeals, Second Circuit: Charles R. Riegel and Donna S. Riegel, v. Medtronic, Inc., Docket No. 04-0412-CV, decided: May 16, 2006)

At the invitation of the Court, the Solicitor General advised against granting review given that Medtronic’s medical device had not been entitled to preemption in the first instance. In fact, the federal requirements that the Stengels claimed were violated by Medtronic were not specific to the catheter device and involved device-specific requirements protected under preemption under the Amendment. Since that wasn’t the ruling in the Circuit Court of Appeals, the case was “not in a suitable posture for correcting that error.” When FDA requirements are stated in general terms, applying to all devices, those requirements cannot have a preemptive effect under the Medical Device Amendment.

The Supreme Court’s Solicitor General opined that, in the Stengel case, “in any tort claim predicated on a failure to report adverse events to FDA,” the claim may be presented “as a claim that the manufacturer should have discharged its state-law warning duties” by working to update its labeling to reflect the device maker’s updated knowledge that something was wrong. In this case, for example, the Justice may rely on the Solicitor General’s finding, which may stop Medtronic’s attempts to have the Supreme Court review the 11th Circuit’s opinion in favor of the Stengels.”

Parker Waichman LLP continues to offer free legal consultations to victims of injuries allegedly caused by Medtronic medical devices, including Medtronic’s pain pump. If you or a loved one suffered a serious complication or injury after receiving a Medtronic pain pump or other device, please contact our office or visit the firm’s Medtronic Pain Pump Injury page at yourlawyer.com. Free case evaluations are also available by calling 1-800-LAW-INFO (1-800-529-4636).

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