The Cincinnati appeals court's decision to review a lawsuit alleging that Medtronic made false claims to FDA portends a favorable decision for manufacturers, according to the Washington Legal Foundation.

The appellate court will reconsider a lower court decision that effectively allowed litigants to file, under state laws, product liability suits "second-guessing" FDA decisions, WLF states in a Sept. 30 release.

The protracted case involves two Medtronic pacemaker leads (models 4004 and 4004/M ), originally approved by FDA in the 1980s. In the mid-90s, Cincinnati attorneys Louis Gilligan and Gregory Utter filed a series of liability suits against Medtronic under Ohio law, alleging that the devices never should have been approved for sale because the company obtained approval by providing "fraudulent evidence" to FDA.

The claims were dismissed in 2000 by a circuit court, which argued that Congress did not intend to permit states to challenge FDA decisions. The Supreme Court's later Buckman decision, which asserted that intended use is FDA's exclusive territory, affirmed the circuit's reasoning, WLF maintains (¹ Also see "Supreme Court Leaves FDA To Its Own Devices In Regulating Fraud Claims" - Medtech Insight, 26 February, 2001., p. 3).

The lawyers launched a new suit against Medtronic, this time alleging that the company defrauded the federal government under the False Claims Act. The trial court denied Medtronic's motion to dismiss the case, holding that Buckman did not preclude the filing of fraud-on-the-FDA suits under the FCA.

WLF urged the appeals court to hear the case, arguing in a June 30 brief that permitting such suits to go forward would undermine FDA integrity. In light of the appellate court's reconsideration of the dismissal motion, the foundation plans to file an additional brief by late November, arguing that the trial court adopted an overly narrow Buckman interpretation.

To prevent quick proliferation of similar suits and "plaintiffs' lawyers running amuck," WLF Chief Counsel Richard Samp asserts that FDA must be "the sole arbiter of whether a medical product is...effective to be marketed." When a party believes that a manufacturer has defrauded FDA, individuals should bring the case to the agency to determine appropriate enforcement actions, Samp maintains.

Medtronic Fraud Case Review Casts Doubt On FDA Tort Challenges – WLF

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