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...]
Ending anti-competitive “pay-for-delay” settlements is a top priority at the Federal Trade Commission, according to FTC Chairwoman Edith Ramirez. What that means for branded and generic drug makers seeking to settle their patent disputes short of all out litigation remains to be seen . . . but the early indications aren’t good. [Read more...]
Allegations of bribes, sexual favors, and inflated seminar expenses swirl around GSK as news of China’s high level police investigation continues to unfold on a daily basis. Four Chinese GSK executives have been arrested, one is being barred from leaving the country and the most recent reports indicate that up to six other big pharma companies are about to be taken down. Although the situation looks bad for GSK, the burgeoning Chinese bribery scandal will most likely ensnare other pharma companies sometime soon. [Read more...]
Fallout From Mensing/Bartlett: FDA Proposes Leveling The Labeling Playing Field Between Brandeds and Generics
In response to growing pressure from lawmakers and consumer groups, the FDA recently announced plans in a July 3, 2013 notice posted by the OMB to issue a rule in September that would allow generic drug makers to change their labeling based on new information. If approved and implemented, the new rule would effectively overrule the Supreme Court’s decisions in PLIVA, Inc. v Mensing and Mutual Pharmaceutical Co., Inc., v. Bartlett, enabling the plaintiffs’ mass tort bar to go after generic drug manufacturers for personal injuries caused by their products. [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...]
All companies should have internal written data protection protocols to address a security breach under state laws before a breach happens, writes my colleague, Donna A. Balaguer, in a recent article published in PharmaceuticalCompliance Monitor. Given the importance of data security to pharmaceutical companies, medical device suppliers, biotech / life science firms, hospitals, nursing homes, clinics, and other companies, Donna Balaguer’s article, titled “Managing State Security Breach Notification Laws,” is being reprinted for Pharmarisc readers.
In the last week of the its 2012-13 term, the Supreme Court spurned the First Circuit’s attempt to circumvent the Court’s 2011 decision in PLIVA, Inc. v. Mensing, which immunized generic manufacturers from liability based on state “failure to warn” claims on federal preemption grounds. In Mutual Pharmaceutical Co., Inc., v. Bartlett, the Court re-affirmed Mensing and ruled that design defect claims were also preempted, leaving consumers injured by generic drug products with no legal recourse . . . except for a possible “misbranding” claim against generic manufacturers or even a possible direct claim against the original pioneer manufacturer in some state courts. [Read more...]
Yesterday, the Supreme Court ruled that “large unexplained” reverse payments in Hatch-Waxman litigation settlements, even if within the “scope of the patent,” are subject to antitrust attack. In a long-awaited decision, the Court ruled 5-3 in Federal Trade Commission v. Actavis, Inc., et al., that so-called “pay-for-delay” settlement deals between pioneer drug manufacturers and their generic rivals are subject to antitrust ”rule of reason” analysis, but stopped short of applying a “quick look” approach that assumes patent invalidity. In so ruling, the Court threw open the litigation floodgates for plaintiffs’ lawyers of all stripes, made patent litigation settlements going forward less likely and more costly and may even discourage generic companies from challenging pioneer drug patents – defeating the very rationale for the ruling. [Read more...]