Stryker has filed a lawsuit in U.S. District Court complaining that the Departments of Justice and Health and Human Services are making unreasonable requests as part of a continued investigation into its sales practices, reports Dow Jones Newswires. Last year, Stryker was one of five orthopedics firms that settled with the government over allegations of improper payments to physicians. Like the others, it agreed to accept federal monitoring, but unlike the others, it did not have to pay a fine, ostensibly because it was the first to come forward. That hasn’t stopped the government from continuing to pursue the company, though. Earlier this year, the company received a subpoena seeking documents related to an investigation of whether it made false Medicare reimbursement claims and whether it violated anti-kickback laws and the Physician Self-Referral Law. The subpoena required “the production of voluminous documents including, but not limited to, documents pertaining to corporate structure, management, research, sales, marketing, personnel, and consultants far beyond (Stryker’s) Orthopedic Division and well outside any relationship to Medicare and Medicaid providers,” the company said. That, the lawsuit says, makes the request “oppressive and overly broad.”
Anaylsts believe that the investigation increases the chance that Stryker will have to pay a fine after all.
Thanks to demographic trends and sluggishness in other sectors, Investors Business Daily has bumped the medical products sector from No. 105 to No. 15 in rank among the 197 sectors that it tracks. Much of the jump is due to growth trends in the orthopedics and cardiology sectors, thanks to baby boomers wanting to age gracefully. In an article touting the strength of the device industry, IBD mentions Medtronic, NuVasive, and Stryker as positive examples. Sectors within the industry cited were joint replacements, back pain treatments, spinal implants, and cardiological and cardiovascular devices.
Wall Street is speculating that Zimmer wants to buy fellow orthopedics giant Smith & Nephew, reports Memphis Commercial Appeal. Smith & Nephew’s stock rose on the news. However, any deal would have to be approved by US and EU antitrust regulators, and since there are only five major players in the $11.6 billion market for artificial hips and knees, it’s not a certainty. (Zimmer has 25% of the market; Smith & Nephew, 11%.) Indeed, Biomet rejected Smith & Nephew’s $11.2 billion buyout offer in 2006 in part because of concerns about whether antitrust regulators would nix the deal.
Medtronic has sued NuVasive Inc., a rival in the spinal implants arena, claiming that it has infringed spine-related patents held by its unit Medtronic Sofamor Danek, the Associated Press reports. The suit involves 12 different patents. Medtronic has made huge investments in its spine business recently, most notably by acquiring Kyphon. NuVasive CEO Alex Lukianov called the suits an “attempt to intimidate NuVasive,” since it is a threat to the aforementioned investments.
Medtronic has filed suit against Abbott and Boston Scientific, claiming they infringed a patent covering a stent used in treatment of blood vessels, Bloomberg News reports. This comes a day after Boston Scientific sued Medtronic, claiming it infringed 10 patents covering grafts that repair aneurysms. And it comes on the heels of Medtronic’s $250 million victory over Boston Scientific in a case where it accused its competitor of infringing catheter patents. Boston Scientific is appealing that one, of course.
A defect in a stent delivery system that causes its tip to break off during surgery has led Boston Scientific Corp. (Maple Grove, MN) to recall its NexStent products. The recall was initiated by the company in June but was updated on FDA’s Web site yesterday. Potential dangers resulting from the detachment of the delivery system’s tip include increased time in surgery, vessel wall injury, stroke, and emergency surgery to remove the broken tip. The recall doesn’t apply to stents already implanted.
– From DeviceTalk.
There is not much advantage to implanting coronary stents instead of prescribing a regimen of drugs, diet, and exercise, according to a study published in the online edition of the New England Journal of Medicine and reported on by Bloomberg News. The study, tracking 2287 patients, was the second installment of a seven-year clinical investigation called Courage. It found some advantage to stenting in the first three years of treatment, but none thereafter.
Its first installment, published last year, said stents were no better than a drugs/diet/exercise regimen when it came to preventing deaths and heart attacks.
The research team concluded that stenting should only be used as a last resort when drugs, diet, and exercise have failed. An accompanying editorial questioned whether as many as one-third of the 1 million stents implanted in the United States each year are really necessary.
Analysts don’t think the news is going to be too damaging for the companies that make stents. The advantage in the first three years is a positive, and safety concerns have been addressed.
Disposable laparoscopic instruments aren’t designed for surgeons with small hands, especially females, according to a recent study. As more female surgeons enter the field, this becomes a challenge for them, and the problem will continue until manufacturers start making devices that aren’t a one-size-fits-all design. The study, published in a recent issue of Surgical Endoscopy, surveyed general surgery residents who were asked to rate their ease in using four disposable laparoscopic instruments. Women reported that they were more apt to use both hands with certain devices and found them to be “always awkward.” Regardless of gender, as the glove size increased, the surgeons had an easier time using the instruments with one hand. According to the study’s senior author, Peter Nichol, MD, half of the U.S. medical school population is women, yet device companies still design some instruments to only fit male surgeons. Instrument size can affect the length of time that it takes a surgeon to complete a procedure as well as his or her comfort in completing the surgery.
On Wednesday DePuy Inc. will start construction on a new training and research building at its Raynham, MA campus. The site houses the company’s spine, trauma, neurosurgery, and sports medicine businesses, and the 70,000 sq-ft expansion is scheduled for completion by some time next year. Equipped with a 200-seat auditorium, operating rooms, labs, advanced equipment, and classrooms, the DePuy Education and Research Center will be the largest of its kind on the East Coast, according to the company. It will provide hands-on training and education for nearly 3000 surgeons and healthcare professionals annually. About 300 medical education and training programs are slated for its first year. The center will be the East Coast training hub for all the DePuy Companies, including DePuy Spine and DePuy Orthopaedics.Â
Ortho giant Smith & Nephew plc has commenced legal action against the former owners of Plus Orthopedics Holding AG, which it bought for $889 million last year, Bloomberg reports. Smith & Nephew shut down much of Plus’ operations in Greece after it discovered that questionable sales practices were occurring. The measure cost Smith & Nephew $19 million in revenue and $9 million in profit in the second quarter of this year. In an unrelated matter, the Securities and Exchange Commission is investigating whether Plus violated the Foreign Corrupt Practices Act. Plus makes artificial hips, knees, and small joints.
Smith & Nephew’s CFO said the revelations mean that Plus is worth less than Smith & Nephew paid for it, and so it will be seeking “substantial” recompensation from the former Plus owners in court.
