Medtronic Infuse Class Action Lawsuit Says Company Misled Investors
On June 27, a Medtronic Infuse class action lawsuit was filed by stockholders alleging that misleading statements about the safety and efficacy of Infuse led them to buy stock in the company at inflated prices. The plaintiffs claim that they bought the stock because they believed that Infuse was a safe and effective bone graft product, based on information provided by the company to the public and to government regulatory agencies. When information later surfaced showing that Medtronic may have covered up Infuse bone graft problems, company stock prices plummeted and investors lost money as a result.
Infuse bone grafts
When a patient must undergo bone surgery, the traditional method often involved removing some bone tissue from one part of the patient’s body and grafting it into the surgical site. Often, the bone tissue was taken from the hip. The removal of bone tissue from the hip or another body part can result in numerous complications and side effects, including pain, infection, and a lengthy recovery period.
Medtronic introduced Infuse in 2002 with FDA approval and marketed it to patients as a better alternative to bone removal and grafting. Instead of using bone tissue, Infuse contains a protein that causes the body to grow new bone. The Infuse bone graft is placed at the surgical site and the new bone grows into the implant over time. Infuse is approved for use in spinal surgery in the lower back, for tibial fractures, and for two dental procedures.
Infuse bone graft problems
Although initial studies certified the safety and efficacy of Infuse, it was later revealed that Medtronic may have influenced the results of the study by paying a total of $210 million to researchers investigating the product. Congressional investigators found that the company appeared to have deliberately removed or left out information about the risks and side effects of Infuse, which include back and leg pain, extra unwanted bone growth, male sterility, and infection. Infuse has also been linked to a higher risk of cancer.
Recent studies reviewed all data on clinical trials of Infuse and found that in addition to producing side effects and a possibly increased cancer risk, Infuse is also no more effective than traditional bone graft surgery. Some researchers claim that in light of this information, the balance of risk and reward no longer favors the use of Infuse bone grafts.
In addition to these problems, Medtronic has also been accused of marketing Infuse for off-label uses. The product has not been approved for these uses, and in some cases, patients receiving Infuse off-label have experienced more severe side effects or complications than patients who received Infuse for approved surgeries.
Medtronic Infuse bone class action lawsuit
According to the Medtronic Infuse class action lawsuit, many stockholders bought Medtronic stock at inflated prices due to the false information available about Infuse and then lost money when the truth about Infuse came to light. The West Virginia Pipe Trades Health & Welfare Fund filed the complaint on behalf of all such stockholders. The complaint says prices were elevated between December 8, 2010 and August 3, 2011. Stock prices dropped over $10 per share between May 18, 2011 and August 4, 2011 as a result of a series of academic papers and news articles addressing the problems with Infuse.
- Bloomberg - Medtronic’s Infuse No Better Than Bone Graft With Risk http://www.bloomberg.com/news/2013-06-17/medtronic-s-infuse-benefits-equal-bone-graft-with-risk.html
- FDA, Public Health Notification Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062000.htm