MINNEAPOLIS, MN, December 08, 2013 /24-7PressRelease/ -- Stuart L. Goldenberg, Senior Partner of the Minneapolis products liability and personal injury firm GoldenbergLaw, PLLC, will be speaking on "Recent Developments in Preemption for Drugs and Devices" at the 13th Annual Class Action/Complex Litigation Symposium in New Orleans, Louisiana on Friday, November 22nd, 2013.---
Preemption, a constitutional principle dictating that federal law supersedes conflicting state law, has been a hot-button issue lately in drug and device litigation. According to 21 U.S.C. § 360k, Class III medical device manufacturers can avoid personal injury lawsuits stemming from product defects, so long as the product in question was approved by the FDA's Premarket Approval ("PMA") process and comply with federal law.
In 2008, The Supreme Court granted Medtronic, Inc. immunity in lawsuits involving a heart catheter failure (Riegel v. Medtronic, Inc., 552 U.S. 312). The Court reasoned that the FDA (a federal agency) is solely responsible for regulating the safety of medical devices. Consequently, any state-law claims which conflict with rules made by the FDA are preempted, or in other words, barred by federal law.
Since then, there have been several lawsuits challenging the scope of this decision. GoldenbergLaw is one of several product liability firms around the country that is currently litigating many cases against Medtronic, stemming from Medtronic's alleged unlawful promotion of off-label uses of its product, Infuse Bone Graft. Medtronic argues that these claims are preempted under federal law, because Infuse was approved through the FDA's premarket approval process.
Attorney Goldenberg, a co-chair of the American Association for Justice (AAJ) Litigation Group for the Infuse Bone Graft litigation, argues that preemption does not protect manufacturers who violate federal law by promoting products for off-label uses they know to be unsafe. Mr. Goldenberg indicated that the argument is best encapsulated by a portion of the decision in Cabana v. Stryker Biotech, et al.,(Cal. Super. Aug. 20, 2012): "...while manufacturers who comply with federal law may be entitled to preemption, those who violate federal law are not entitled to preemption." .
The U.S. Senate investigated Medtronic's promotion of off-label uses of Infuse and concluded that Medtronic had been involved in editing and/or ghostwriting medical journal articles on Infuse, under-reporting adverse events, embellishing positive outcomes, and paying to doctors approximately $210 million in exchange for promoting Infuse for uses not approved by the FDA. (Milwaukee Wisconsin Journal Sentinel, June 2013).
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About GoldenbergLaw, PLLC
For over 29 years, the Minneapolis and St. Paul injury attorneys at GoldenbergLaw have assisted thousands of victims of negligence and fraud, including those injured by defective pharmaceutical drugs and medical devices. During this time, the firm has obtained more than $70 million dollars in verdicts and settlements for its clients.
Attorney Stuart Goldenberg, the firm's Senior Partner, has been named a Top Attorney by Law and Politics and a SuperLawyer by Minneapolis St. Paul Magazine every year since 1998. He is also an elected member of the Million Dollar Advocates Forum, and one of the Top 100 Lawyers selected by the American Trial Lawyers Association. Attorney Goldenberg's tenacity and skill in the courtroom, as well as his strong negotiation skills, have earned him accolades from both peers and independent sources throughout the region.
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