Medical Devices Protected From Lawsuits

Medical device makers are protected from personal injury lawsuits by a 2008 Supreme Court ruling—only a narrow space exists for plaintiffs to file medical malpractice 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.

But, because frontal spine surgery was rare, Medtronic paid industry specialists to promote the use of Infuse for other types of surgeries even though FDA officials had expressed concerns about the dangers of such off-label uses—this is documented in a Senate Finance Committee report from October 2012, which discovered the company paid physician consultants to write medical journal articles, and the company shaped the content.

Patricia Caplinger, a Missouri woman, had the spinal device implanted through her back in 2010 to correct a degenerative disc condition—since it was inserted from behind, Infuse caused unwanted bone growth around her spinal cord, compressing her nerves and requiring additional surgeries. She sued Medtronic in 2012 in Oklahoma federal court, accusing the company of numerous state-law tort violations, including failing to warn about the dangers of off-label uses, and Medtronic successfully filed to dismiss the suit, in February 2013. Caplinger appealed the decision to the 10th U.S. Circuit Court of Appeals, where her case is pending.

If you or someone you care for has suffered an injury as a result of negligence, you have options. First and foremost contact an attorney almost all of them offer a free consultation. This is a typical proposal “We are a Chicago injury law firm representing individuals and families who have suffered an injury or loss due to an accident. Our law firm will handle your personal injury case quickly, will advise you every step of the way, and will not hesitate to go to trial for you. Lastly, we do not get paid attorney’s fees unless we win your case. Our no-fee promise is that simple. Therefore, you have nothing to risk when you hire us–just the opportunity to seek justice.

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