On November 17, 2008, two whistleblowers filed a qui tam action against Medtronic, a medical device manufacturer, alleging off-label promotion of Cardioplate, a heart device. The U.S. District Court in Houston recently granted Medtronic a motion to dismiss the case. The device is FDA approved for ablating (removing) tissue to control bleeding during general surgery and to coagulate cardiac tissue during general surgery. According to the dismissed complaint, Medtronic promoted Cardioplate for the treatment of atrial fibrillation (fast and irregular heartbeat), a use not approved by the FDA as safe and effective.
Big Pharma and its proponents have since championed the dismissal. Whistleblowers Bennett and Boone were “industry insiders,” but did not have direct knowledge of Medtronic’s promotion practices; they were sales representatives not for Medtronic but for its competitors, such as Boston Scientific, Guidant, St. Jude Medical, and Endoscopic Technologies. Through their work and experience in the industry, however, they became familiar with the fraudulent practices utilized by Medtronic.
The court pointed to Franklin v. Parke-Davis as an example of a case in which a relator successfully identified the “who,” “what,” where,” “when,” and “how” of fraud. The relator in Parke-Davis identified the names of sales representatives engaged in off-label promotional efforts, the names of physicians receiving such efforts and submitting claims to Medicare and Medicaid for off-label prescriptions and the time period, as well as eleven misleading and fraudulent statements used by sales reps in off-label promotion. As a result of the court’s ruling, the whistleblowers have until October 29th to amend their complaint to conform with the court’s standards for pleading fraud.
In the interests of full disclosure: the sponsor of this website, Greene LLP, was responsible for the relator’s suit in Franklin v. Parke-Davis, cited by the Medtronic order referred to above.