An Infuse investors’ class action lawsuit filed by a shareholder against Medtronic Inc. was allowed to proceed by U.S. District Judge John Tunheim.

This decision by the Minneapolis federal judge may have created a huge complication in Medtronic’s recent acquisition of the Irish medical device company Covidien, an acquisition that reportedly cost Medtronic $43 million dollars.

According to the Infuse investors’ class action lawsuit, Medtronic attempted to cover up the adverse Infuse side effects by allegedly paying off doctors hired by the medical company to perform research on the Infuse product and other Medtronic officials. The company also allegedly pushed doctors to perform surgeries with off-label Infuse use, which has allegedly injured thousands of patients across the United States.

The stockholders and investors acting as the named plaintiffs in this Infuse investors’ class action lawsuit claim Medtronic CEO William Hawkins attempted to hide reports that the U.S. Food and Drug Administration (FDA) refused to approve Amplify, the next generation version of Infuse. The plaintiffs also allege Hawkins downplayed the side effects of Infuse to the FDA, doctors, consumers, and investors alike.

It is predicted that if this Infuse investors’ class action lawsuit makes it to a jury trial and if that jury finds that Medtronic knew of and purposefully covered up dangerous Infuse side effects, then the preemption legal argument the medical company has used to avoid thousands of Infuse personal injury lawsuits may be torn apart.

A question central to this Infuse investors’ class action lawsuit is whether Medtronic and company officials intentionally deceived stockholders and investors by allegedly falsifying Infuse side effects research reports performed by medical experts that Medtronic allegedly paid $210 million over a 14-year period. The plaintiffs allege Medtronic, with full knowledge of the Infuse side effects, purposefully edited medical research studies to highlight Infuse’s success rates in spinal surgery recovery, while simultaneously occluding the harmful and sometimes fatal Infuse side effects.

Infuse Bone Graft System

The Infuse Bone Graft System is a synthetic protein mixed with bovine collagen that when injected into a surgical area, facilitates and encourages bone growth of affected joints and bones. The Infuse Bone Graft System, designed and manufactured by Medtronic Inc., has been a popular choice in graft surgeries across the nation, especially when surgeons perform spinal fusion procedures because it is less invasive compared to traditional bone graft surgery.

At the site of implantation, Infuse is designed to replace damaged bone matter in joints and other parts of the body, while providing relief to suffering patients. Since the 2002 FDA approval of this Medtronic product, more than 100,000 patients have been implanted with an Infuse bone graft.

While Infuse has become the popular surgeons choice for spinal fusion surgeries, recent reports have demonstrated that there exist many risks with using the Infuse Bone Graft System.

Some side effects of using the Infuse bone graft product for label and off-label use include:

• Infection
• Male sterility
• Bone and nerve damage
• Urinary problems
• Increased risk of cancer

Patients who allege they experience painful and long-lasting side effects of Infuse after a spinal fusion surgery have filed Infuse lawsuits or joined Infuse class action lawsuits.