According to the FDA’s Office of Prescription Drug Promotion (“OPDP”), Marc Beer, the CEO of biopharmaceutical firm Aegerion Pharmaceuticals, overstepped his bounds when he allegedly made misleading statements about Aegerion’s cholesterol-lowering drug, Juxtapid™ on two televised appearances on CNBC. As a result, Aegerion received a warning letter earlier this month from OPDP, admonishing Beer for his transgressions, accusing the Company of misbranding Juxtapid™ and asking for corrective action. Although it makes business sense for Aegerion to “play ball” with the FDA and do whatever it takes to convince the agency that there was no intent to promote Juxtapid™ off-label, Beer’s comments are a reminder of the free speech issue embedded in any discussion about a drug or device product that falls outside the friendly confines of the product’s labeling. [Read more...]
Charges of off-label marketing and kickback payments to physicians and long-term care pharmacy provider Omnicare are behind a $2.2 billion settlement agreement between Johnson & Johnson (“J&J”) and the U.S. Department of Justice (DOJ), in which the global health care giant finally resolves criminal and civil liability involving Risperdal and two other prescription drugs. The eye-popping figure makes this the third largest health care fraud settlement in U.S. history. [Read more...]
A majority of plaintiffs seeking damages based on off-label promotion of Medtronic’s InFUSE Bone Graft system have been stopped in their tracks following several recent federal court decisions holding that such challenges were barred on preemption grounds. Indeed, with the exception of two district court cases out of the Ninth Circuit, these preemption rulings not only underscore the limits of off-label promotion arguments in medical device cases, but also show that courts remain skeptical about whether off-label promotion is illegal under federal law. [Read more...]
Allegations of misconduct continue to plague Big Pharma companies in China. Charges of bribery, corruption, off-label promotion, and inflated pricing now extend beyond GlaxoSmithKline (GSK) to Novartis, Eli Lilly, and Sanofi. While these companies react to coming under Chinese scrutiny — with Johnson & Johnson (J&J) reportedly taking “proactive” steps to strengthen its China unit – the Company that started it all (GSK) braces for major fines. [Read more...]
In what will likely be another adverse legal decision for Boston Scientific Corporation’s Neuromodulation subsidiary (“BSNC”) in its ongoing battle with two former billing services employees-turned whistleblowers, the medical device manufacturer’s latest attempt to derail a qui tam suit involves charges that the whistleblowers stole BSNC trade secrets, thus violating the terms of their employment agreements. Although there might one day be a case that truly tests the limits on how far an employee can go in taking her employer’s proprietary data to win the qui tam lottery, the current suit involving BSNC is probably not that case. [Read more...]
Two False Claims Act whistleblower lawsuits are being resolved as part of a $491 million settlement between Wyeth Pharmaceuticals, now a division of Pfizer, Inc., and the U.S. DOJ. This time around, Wyeth’s misconduct was based on off-label sales tactics for Rapamune®, an immunosuppressive drug that FDA approved for use in renal (kidney) transplant patients. Unfortunately for the pharmaceutical industry, Pfizer’s latest compliance woes are a stark reminder that off-label cases are anything but passé. [Read more...]
Yesterday we described the burgeoning bribery allegations against GSK’s China operations in a post titled “Enemy at the Gates: Bribery Charges in China Getting Worse for GSK.“ Apparently, GSK’s China woes are getting worse by the day. A Reuters article reports that the Chinese government has secured “confessions” from several GSK “executives” to bribery and tax violations. (Click http://www.reuters.com/article/2013/07/11/gsk-china-idUSL4N0FH21620130711 to read the Reuters story).
Allegations reported recently in the Wall Street Journal disclose that GSK Chinese staffers developed a plan, dubbed the “Vasily” program after famed World War II Russian sniper, Vasily Zaytsev, that targeted 48 doctors for payments and gifts in exchange for writing GSK drug prescriptions. Pharmarisc will be following this story and will report any significant developments in the case.
Recent news reports from the Wall Street Journal about an alleged bribery scheme at GlaxoSmithKline’s (GSK) China operations come on the heels of several arrests of GSK employees, including one foreign executive, on charges of “economic crimes.” The bribery scheme reportedly involved a plan to pay 48 Chinese doctors to push sales of Botox® and was dubbed the “Vasily” strategy after famed World War II Russian sniper, Vasily Zaytsev, who Jude Law portrayed in the 2001 film, Enemy at the Gates. A GSK whistleblower is the apparent source for the recent WSJ reports, as well as earlier reports submitted to the Company in January, and may also be responsible for the recent GSK arrests in China. Although GSK has stated that its internal investigation of the whistleblower’s January allegations found “no evidence of bribery or corruption,” the allegations in the recent WSJ reports are embarrassing and not likely to go away anytime soon. [Read more...]
ISTA Pharmaceuticals, Inc. (“ISTA”), a unit of eye care giant Bausch + Lomb (“B&L”), recently agreed to a $33.5 million Government settlement involving civil and criminal charges. The conduct underlying the settlement pre-dated B&L’s acquisition of ISTA in June, 2012 and underscores once again that when it comes to these kinds of settlements, it’s better for companies to play ball and let the Feds have their press release. [Read more...]
Pfizer, Inc., must pay a $142 million jury verdict to Kaiser Foundation Health Plan, Inc. (“Kaiser”) for “damages” related to the off-label promotion of Neurontin®, the First Circuit ruled last week. Unfortunately, for Pfizer and other companies that have pleaded guilty to misbranding violations based on off-label promotion, the First Circuit’s ruling could spell even more trouble ahead. [Read more...]