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People are on edge about the sharp rise in malpractice insurance premiums. Many physicians have limited their clinical services or have even relocated to more equitable practice environments. Because of this, physicians in crisis states are concerned about whether to remain where they are or perhaps consider a move to a non-crisis state offering lower malpractice rates. “

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Medical device makers are protected from personal injury lawsuits by a 2008 Supreme Court ruling—only a narrow space exists for plaintiffs to file ” lawsuits alleging violations of state-law requirements that are the equivalent, or parallel, to federal law requirements. But lawyers for people injured by medical devices are trying out a new strategy to get around the restriction.

The 2008 case, Riegel v. Medtronic, saw the high court rule that federal law barred most state law claims over a medical device that has gone through the Food and Drug Administration’s review process and received premarket approval. But in a new string of suits, hundreds of plaintiffs who were injured by Medtronic Inc’s Infuse Bone Graft device are claiming the company illegally promoted the device for uses not approved by the FDA—the off-label promotion is a parallel claim, meaning their lawsuits are not barred by federal law.

Minneapolis-based device maker Medtronic has been served with three hundred lawsuits; nine hundred more cases are in the investigation stage, according to the American Association for Justice, the largest plaintiff trial lawyers’ organization. The faulty device, Infuse, uses a collagen sponge soaked with a genetically engineered protein to promote bone growth and treat degenerative disc disease in the lower spine. Infuse was granted FDA premarket approval in 2002; the agency stated the protein had to be used in conjunction with a titanium cage. Also, FDA approval was limited to a certain type of spinal surgery, performed through the abdomen rather than the back or other entry points. “


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