Earlier this year, I offended some when I wrote a story about Abbott Labs paying $1.5 billion to settle a Department of Justice investigation into off-label promotion. I wrote that off-label promotion was “apparently second nature” to device manufacturers and infuriated those who felt I was painting with too broad a brush and offering an […]
Swiss medical device manufacturer Synthes has received a warning letter from U.S. regulators taking issue with the company’s management of complaints over its devices and problems with orthopedic surgery devices. It said a review of its factory in West Chester, Pennsylvania between June and September 2011 revealed that some complaints “were not promptly reviewed, evaluated, […]
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
Synthes is back in court, this time as the plaintiff in a lawsuit against Stryker Corp. (NYSE: SYK) accusing the Michigan-based medical device company of trying to obtain “an improper competitive advantage.” The complaint, filed in federal court in Philadelphia, also singled out three former sales staff from Synthes’ San Francisco sales unit who resigned from […]
The sentencing of three of the four ex-directors of medical device manufacturer Synthes to terms ranging from five to nine months over the unauthorized use of bone cement in spinal surgery clinical trials in the case United States. v. Norian crisscrosses between regulatory issues and corporate responsibility. Synthes subsidiary Norian conducted a clinical trial using […]
Johnson & Johnson (NYSE:JNJ) is in talks to buy Synthes Inc. for $20 billion, according to a report in the Wall Street Journal. The Journal, citing anonymous sources with knowledge of the situation, reported late Friday that the New Brunswick, N.J.-based conglomerate had made an overture to buy the Swiss medical device giant in a […]
Efforts to rein in rapidly rising healthcare costs will require new team-based payment and delivery approaches, which would demand sacrifices from hospitals, doctors and insurers, according to the Boston Globe.
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Synthes Inc., the American division of the Swiss medical device maker, will plead guilty to federal criminal charges that its North American subsidiary Norian Corp. made an illegal end run around the Food & Drug Administration for clinical trials in which three patients died. The plea deal calls for the West Chester, Pennsylvania-based company to […]
Synthes USA slapped a former sales rep and Biomet Inc. with a lawsuit accusing them of colluding to steal customers from the sales rep's Ohio territory. The suit alleges that John Scott of Dublin, Ohio, conspired with Biomet to solicit and convert Synthes customers before leaving Synthes' employ.
The Food & Drug Administration issued warnings to Millipore Corp. and Cardiac Sciences Corp. and a Class I recall to Synthes USA. The FDA has concerns about one company's diagnostic equipment, and malfunctioning defibrillators and vertebral implants from the other two companies.