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Baum Hedlund Defeats Preemption in Another Medtronic Infuse Case

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The Los Angeles law firm of Baum Hedlund Aristei & Goldman has defeated preemption (immunity) for the second time in a case against medical device maker Medtronic, Inc.

On July 18, 2013, the Honorable Eileen Mary Brewer of the Circuit Court of Cook County, Illinois denied Medtronic’s motion to dismiss a product liability and medical malpractice lawsuit filed by Baum Hedlund on behalf of plaintiff Karl Sanda. Mr. Sanda, of Illinois, claims that the off-label use of a Medtronic Infuse bone growth product during spine surgery caused him to suffer permanent and debilitating injuries. The judge’s favorable ruling will allow Mr. Sanda’s case to move forward.

Mr. Sanda’s lawsuit (case number 2013-L-000305) alleges negligence, strict liability, breach of warranty, and willful-wanton conduct causes of action against Medtronic and negligence causes of action against Northwestern Memorial Hospital, Northwestern Orthopedic Institute, LLC, and Mark T. Nolden, M.D.

Dr. Mark Nolden diagnosed Karl Sanda with advanced subaxial cervical spondylosis and degenerative cervical stenosis from C-2 through C-7 of the cervical spine. On January 10, 2011, Dr. Nolden operated on Mr. Sanda, performing a spinal procedure that fuses the cervical vertebral body with the sacrum. The operation removes the center of the diseased disc and surgically implants a medical device containing a genetically engineered protein designed to stimulate bone growth over time in order to “fuse.”

According to Mr. Sanda, Dr. Nolden performed this procedure following an off-label protocol. “Off-label” refers to the use of a medication or medical device for an indication or purpose not expressly approved by the U.S. Food and Drug Administration (FDA). In this case, Mr. Sanda claims Dr. Nolden used Medtronic’s Infuse Bone Graft in the cervical spine, an indication for which the bone growth product is not FDA-approved.

The complaint states that Dr. Nolden failed to inform Mr. Sanda that Medtronic’s Infuse Bone Graft would be used during his surgery and that Infuse had only received limited FDA approval for very specific procedures.

Dr. Nolden also failed to inform his patient that the use of Infuse could result in dangerous and unwanted bone growth, seroma, paralysis, bone migration, bone resorption, and swelling of the neck and throat tissue, which can result in compression of the airway and difficulty swallowing, according to the lawsuit’s allegations. In addition to failing to inform Mr. Sanda about all the risks involved with this procedure, Dr. Nolden never discussed safer alternative methods of surgery with his patient, the lawsuit states.

Nearly a week after his surgery, Mr. Sanda was forced to endure an emergency corrective surgery after he developed a life-threatening seroma, a tumorlike collection of serum in the tissues. As a result of these Infuse-induced adverse events, Mr. Sanda has become partially paralyzed and lives in permanent pain. He has never recovered from his Infuse-induced adverse reactions.

Medtronic was unsuccessful in trying to get Mr. Sanda’s case against the company thrown out. In her ruling, Cook County Circuit Court Eileen Mary Brewer said she applied a two-part test.  First, to determine whether the FDA has imposed device-specific requirements for Infuse, and second, whether the state requirements that relate to Infuse’s safety and effectiveness constitute requirements different from or in addition to the federal requirements. Judge Brewer found that the FDA has imposed device-specific requirements for Infuse, but not for off-label use. Additionally, Judge Brewer found that state requirements for Infuse run parallel to federal requirements, not in addition to them.

Judge Brewer also relied on a previous case that ruled against a medical device maker seeking preemption. She quoted the rationale provided in a ruling by the Seventh Circuit Court of Appeal, which stated, “the idea that Congress would have granted civil immunity to medical device manufacturers for their violation of federal law that hurt patients is, to say the least, counter-intuitive.”

This represents the second time a judge has cleared the way for a Baum Hedlund client to have their day in court against Medtronic. In what has been determined to be the first time a law firm has defeated preemption in a Medtronic Infuse case, a California judge denied a motion filed by Medtronic last year in an attempt to toss a similar case involving the off-label marketing of Infuse. In that case, plaintiff April Cabana sued Medtronic, among other defendants, after a back surgery involving the off-label use of Infuse resulted in debilitating and permanent injuries to her spine.

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