The Business Of Law

Another medical device case type that we’ve been watching has to do with Calaxo Osteonconductive Interference Screws, also known simply as the Calaxo Screw. These devices are used to repair knee ligaments and promote bone growth most often after ACL repair or reconstruction. ACL injuries are common in many athletics including football, soccer, ice hockey and downhill skiing.

The Calaxo Screw was supposed to be an innovative product because it’s made of a bioabsorbably polymer, so that unlike conventional screws used to reattach ligaments, it could be reabsorbed by the body 12 months after surgery.

The problem is that the Calaxo Screw has been linked to graft failure and premature material degeneration. Symptoms include swelling, fluid build-up around the knee redness around the joint, loss of flexibility in the knee area, screw fragmentation, and localized joint pain. These side effects often require additional surgery to remove dead or infected tissue.

From 2006 to 2009, more than 300 adverse effects related to Calaxo Screws were reported to the FDA, and in August 2007, the manufacturer Smith & Nephew voluntarily recalled 68,000 units implanted worldwide. Some of the product was also recalled in October 2007 in the U.K.

There have been several suits filed alleging failure to warn patients about possible side effects. We’ll be monitoring the case, and may engage in a marketing effort targeting potential litigants who may have been given one of these screwed up screws as part of their surgery.

I’m catching up on some of the news that broke over the summer, and one of the interesting stories was about bioengineered proteins usined during spinal fusion procedures to correct neck pain. These substances sold by either Medtronic or Stryker are not technically approved for neck procedures, but Doctor’s are not prevented from using them for that. A new study however suggests that patients whose treatment included the proteins had more complications than patients who didn’t.

According to a study in the Journal of the American Medical Association, (subscription required) researchers at Boston’s Brigham and Women’s Hospital found that patients who received the proteins during treatment for lower or middle back pain had increased complications after the procedures, and in some cases those complications may have been underreported because they did not occur until after patients left the hospital. Check out a very good New York Times story on the subject here.

While the study is fairly new, we at Sokolove have been following the complications associated with off-label use of these proteins going back more than a year. In fact, the FDA has received dozens of complaints over the past four years of neck swelling and breathing problems in patients given the product for neck pain.

Last July the problem became so accute that the FDA issued a Public Health Notificiation indicating the life-threatening complications associated with the proteins. In December and January, the first lawsuits were filed.

As ever, we’re monitoring the situation and looking for affiliates who are interested in potential leads in this area. If you’re interested in partnering with us on marketing efforts, shoot me a note.