We have reported periodically on rulings in the Aredia/Zometa litigation, including Daubert and summary judgment rulings by the MDL judge and choice of law rulings by Judge Arthur Spatt of the E.D.N.Y. in Deutsch v. Novartis Pharmaceuticals Corp., a case remanded for trial from the MDL. Judge Spatt has now decided Daubert motions in Deutsch and another remanded case, and his very long opinion is a bit like yesterday’s list of silly law songs : there is something in there for everyone. Deutsch v. Novartis Pharmaceuticals Corp., 2011 U.S. Dist. LEXIS 22755 (E.D.N.Y. March 8, 2011).
MDL rulings are law of the case. The MDL judge ruled on Daubert challenges to several plaintiffs’ experts. Novartis challenged those experts based both on arguments made to the MDL judge and on new arguments. Judge Spatt generally refused to consider the arguments previously decided by the MDL judge based on the law of the case doctrine, finding the doctrine particularly applicable when cases are transferred from an MDL. 2011 U.S. Dist. LEXIS 22755 at *18-21. “Reversing or otherwise undermining the decisions by the MDL court could lead to the type of inconsistent pretrial rulings that Congress sought to avoid [in the Multi-District Litigation Act], and therefore frustrate the very purpose of consolidation.” Id. at *21.
As a general matter, we agree that issues decided by the MDL judge should not be relitigated on remand. In Deutsch, however, the MDL rulings became the third rail, and anyone raising an argument that came within a few yards of an issue decided by the MDL court got zapped.

Continue Reading A Grab Bag Of Rule 702 Rulings In A Remanded Aredia/Zometa Case

Once a mass tort becomes widely publicized, sometimes based on a combination of a bad study, a verdict or two for plaintiffs, internet sites, and late night television ads, lots of plaintiffs come out of the woodwork, including plaintiffs with weak, late, or marginal claims. Those plaintiffs and the clever lawyers who assist them believe

It’s cold here in Philadelphia and in much of the country. Really cold, your-car-makes-weird-noises-you-start-it cold. When it’s this cold up here, people start fantasizing about moving to Florida and leaving their snow shovels, rock salt, hats, coats, gloves, and all that behind.
Is there a point to this about drug and device law, you may

The American Tort Reform Association released its annual judicial hellholes ranking, and Philadelphia is ranked as #1. The primary reason cited for this ranking was the performance of the Philadelphia Court of Common Pleas Complex Litigation Center, which handles mass torts and other big, complex cases.
In Philadelphia, where attytood is everything, we usually revel

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.

Continue Reading Off-label promotion by itself does not support a qui tam action