The office of the U.S. Attorney for the District of Massachusetts and the DoJ abandoned their civil and criminal probe into allegations of off-label marketing and concealed safety risks without finding evidence of wrongdoing, according to a press release.
Resorbable bone materials
Medtronic (NYSE:MDT) found itself at the center of another shareholder lawsuit accusing it of artificially boosting its stock price and forcing the company to repurchase more than $2.8 billion of its own shares at inflated rates.
MASSDEVICE ON CALL — Some hospitals paid thousands more than others for the same implantable medical devices, costs that might be passed on to federal Medicare programs, according to a new government report.
A lack of transparency in pricing may be preventing health care providers from making the best decisions regarding the technologies they purchase, sometimes amounting to thousands of dollars in differences paid for the same device, according to the report, published by the U.S. Government Accountability Office.
Federal prosecutors dropped all charges against former Stryker Biotech president Mark Philip today in a lawsuit charging him and a clutch of sales reps with illegally promoting the off-label use of 2 bone growth products and of lying to the FDA.
The feds dropped the Philip indictment after reviewing documents that had previously been withheld as privileged, assistant U.S. attorney Jeremy Sternberg said during a pretrial hearing today, according to Bloomberg.
After more than 5 months of haggling, a confidential Medtronic (NYSE:MDT) witness is still staunchly refusing to produce documents in a shareholder’s lawsuit accusing the company of using off-label promotion for its troubled Infuse bone growth protein to inflate share value.
MASSDEVICE ON CALL — BioMimetic Therapeutics (NSDQ:BMTI) cut 25% of its workers in hopes of saving some cash in focusing on getting FDA pre-market approval for its Augment bone graft.
The federal watchdog agency’s advisory panel recommended approving the treatment in May 2011, after releasing a dim summary of the pre-market approval application that sunk BMTI shares by more than 35%.
Federal prosecutors dropped all charges against the 2 remaining Stryker Biotech sales managers charged with illegal off-label promotion and of lying to the FDA.
Judge George O’Toole Jr. of the U.S. District Court for Massachusetts agreed to drop all criminal charges against Jeff Whitaker and William Heppner in a lawsuit charging Stryker Corp. (NYSE:SYK) subsidiary Stryker Biotech with illegally promoting off-label uses of its OP1 bone-growth products.
A Massachusetts federal judge has granted a request by former Stryker Biotech president Mark Philip to sever charges against him in an ongoing government case that alleges the company, along with former executives, committed conspiracy to defraud the FDA, conspiracy to commit wire fraud and wire fraud.
The decision by U.S. District Judge George O’Toole Jr. means Philip will be able to use communications he had with Stryker Biotech lawyers, which would otherwise fall under attorney-client privilege, in his defense.
Medtronic Inc.’s (NYSE:MDT) Infuse bone growth product created a stir this summer after an entire edition of the Spine Journal was devoted to problems with a slew of peer-reviewed articles by company-backed doctors.
The journal’s investigation found that 13 Medtronic-backed studies downplayed or omitted entirely evidence of safety risks from Infuse.