Justice Dept. probes St. Jude for potential False Claims, kickbacks violations
May 6, 2014 by Arezu Sarvestani
Minnesota medtech giant St. Jude Medical revealed a new Justice Dept. inquiry today, noting in its recent quarterly report that federal officials launched a probe into the company’s cardiac implant sales.
St. Jude last month received a Civil Investigative Demand from the Civil Division of the DoJ, stating that the department was looking into allegations that the company may have paid illegal kickbacks to encourage physicians to buy St. Jude’s cardiac devices. The company provided few other details, but said that it’s working with the DoJ to respond to the inquiry. Read more
More secret human studies uncovered in Myxo ring inquiry
May 5, 2014 by Arezu Sarvestani
A 7-year-old inquiry into controversial studies conducted at Northwestern University unearthed previously undisclosed human trials of an experimental valve repair device manufactured by Edwards Lifesciences.
The new information, uncovered by repeated inquiries from Sen. Chuck Grassley (R-Iowa), are tied to reports that the hospital permitted one of its star surgeons to implant patients with a device he invented himself, and that leadership decided to waive patients’ right to informed consent. Read more
Medtech manufacturer fleeced Stryker, says former exec | MassDevice.com On Call
May 6, 2014 by Arezu Sarvestani
MASSDEVICE ON CALL — Former Ferry Machine Corp. sales vice president Keriellen Mack told a court this week that her erstwhile employer ran a scheme to sell uncertified parts to orthopedics giant Stryker.
Mack claimed that Ferry was already on Stryker’s “no future business” list after CFO Louis Ferretti attempted to offer kickbacks to Stryker’s clients, Law360.com reported. After that Stryker refused to purchase any new parts from Ferry, ordering only parts it had already been purchasing. Read more
FDA morcellator warning spurs lawsuit against J&J | MassDevice.com On Call
May 7, 2014 by Arezu Sarvestani
MASSDEVICE ON CALL — Johnson & Johnson and its Ethicon subsidiary notched their 1st lawsuit since the company suspended sales of its laparoscopic power morcellators.
The devices were the subject of an FDA warning issued last month over concerns that morcellation, used to break apart uterine tissue or fibroids so that they can be removed through a small incision, may accidentally cause the spread of undetected cancers. Read more
NuVasive claims win in patent spat with Cadwell Labs
May 6, 2014 by Brad Perriello
NuVasive Inc. said today that Cadwell Laboratories agreed to settle a patent spat over neuromonitoring technology by exiting the lateral spine market and potentially paying 5% royalties to NuVasive for future products.
The settlement lays to rest the patent infringement lawsuit NuVasive filed against Cadwell in December 2012, which accused the diagnostic and monitoring products maker of infringing NuVasive’s integration of nerve monitoring technology during lateral approach spine surgery, according to a press release. Read more
