We have written before about the virtues of Lone Pine orders, which require plaintiffs to produce elementary evidence supporting their claims, usually some prima face evidence of exposure, injury, and causation. These orders provide an excellent tool to eliminate the cases filed in any mass tort by people just hoping to cash in without having

Anybody with a pulse, a computer, and a connection to the internet has heard the warnings: be careful what you post on Facebook, MySpace, and other social network sites. That blow-by-blow account of your victory in the Tenth Intramural Beer Pong Championship can come back to haunt you. Those pictures of you clothed only with

Some lawyers in the East Coast and West Coast – you know who you are – tend to be dismissive of decisions from the middle of the country, referred to with disdain as “flyover country.” In our experience, the assumptions of the superiority of the coastal courts and the inferiority of landlocked courts are unwarranted.

Qui tam plaintiffs can make money under the False Claims Act if they can show that a defendant caused the submission of false claims to the government. As we have discussed before, some qui tam plaintiffs, usually former sales reps, have tried to turn allegations of off-label promotion into false claims cases. In United States ex rel. Bennett v. Medtronic, Inc., 2010 WL 3909447 at *1 (S.D. Tex. Sept. 30, 2010), the court considered “the question of when a manufacturer’s promotion of a medical device for an ‘off-label’ use may provide the basis for a qui tam action by private plaintiffs suing under the False Claims Act.” The court answered this question in a careful, thorough opinion, which we recommend to anyone interested in this area.

The relators in Bennett were not exactly classic whistleblowers. Bennett was a sales rep for Boston Scientific for all of four months and then filed five qui tam actions against seven medical device companies, including Medtronic. Fellow relator Boone had worked for a couple of device companies. Neither ever worked for Medtronic. They claimed that they were “industry insiders” with knowledge of unlawful activities by a company they never worked for. The government was not too impressed with their evidence and declined to intervene in their suit, which is a pretty good sign that the government didn’t feel that it had been defrauded.

The device at issue was Medtronic’s Cardioblate system, which the FDA had approved for ablating tissue to control bleeding and to coagulate cardiac tissue during general surgery. The relators claimed that Medtronic promoted the Cardioblate for the off-label use of surgical ablation to treat atrial fibrillation.

But off-label use or even promotion of off-label use does not amount to a False Claim Act violation, the court said. Off-label use of medical devices is an accepted medical practice and may be eligible for Medicare and Medicaid reimbursement if medically necessary. Id. at *3-5. Off-label promotion is unlawful, but does not amount to an FCA violation. Id. at *14, 28. An FCA violation requires a showing that the defendant caused the submission of false claims to the government. Id. at *2.


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Sometimes repeated litigation concerning a particular product can help establish legal standards applicable to all cases, especially if many people received the product and try to bring suits. Plaintiffs try one theory after another; courts reject most of those theories; and the resultant mosaic of decisions forms a comprehensive picture of which claims are viable

We have written several times before about the good and the bad pretrial rulings in Bartlett v. Mutual Pharmaceutical Co., No. 08-358 (D.N.H.). Faithful readers will recall that the plaintiff allegedly developed Stevens-Johnson Syndrome (SJS) after taking generic Sulindac, an NSAID. The court threw out the failure to warn claim because the provider never