Repeated assurances from a Medtronic, Inc. representative that an implanted spinal cord stimulator was safe for use in light of a patient’s latex and rubber allergies were enough to support a fraud claim, but her manufacturing defect, design defect, and failure to warn claims were preempted, a federal district court in Michigan held (Canary v. Medtronic, Inc., April 18, 2017, Edmunds, N.).
Surgery. After the patient suffered spinal injuries during a car accident, she considered an implantable spinal cord stimulator to alleviate her chronic pain. She met with her doctors and a Medtronic representative on several occasions, and told the representative that she was allergic to latex and rubber and had experienced allergic reactions to materials used in prior spinal fusion surgeries. She asked whether other patients had allergic reactions to any of the materials in the stimulator, but was assured that none had and that those allergies did not prevent the implantation.
The patient decided on a trial run with the stimulator, which lasted less than 24 hours, during which most of the device remained outside of her body and was activated for six hours. Following the trial, she met with her physician and the Medtronic representative twice more before the stimulator was permanently implanted. During both meetings, she expressed her concerns again about allergic reactions and each time was assured that no patients had reported allergic reactions and those allergies did not preclude use of the device. The stimulator was activated a few days after the procedure, and within five hours the patient experienced itching where the lead and battery were placed. Her allergic reaction continued with hives, and became progressively worse until she was admitted to the hospital. While she was in the hospital, she called the representative and was informed that other patients had experienced allergic reactions to the device.
The patient brought product liability and fraud claims against Medtronic, alleging that the device had design and manufacturing defects, the company had failed to provide the patient with adequate warnings, and its representatives made misrepresentations about the safety of the device. Medtronic moved to dismiss, arguing that the product liability claims were preempted and her misrepresentation and fraud claims were not adequately pleaded.
Preemption. The products liability claims alleging design defect, manufacturing defect, and failure to warn were preempted by federal law. The court first rejected Medtronic’s argument that these claims were expressly preempted on the ground that the FDA’s current good manufacturing practice (CGMP) regulations were inherently too generic to serve as the basis for a parallel product liability claim. However, rather than citing specific CGMPs that Medtronic allegedly had violated, the patient simply recited a "laundry list" of CGMPs to which Medtronic allegedly was subject; these allegations that Medtronic had violated FDA regulations were vague and conclusory.
A CGMP that requires the removal of potentially harmful manufacturing material did not assist the patient; while the commentary accompanying the definition of manufacturing material cited allergic proteins in natural rubber latex as an example of a "concomitant constituent" that must be removed at the conclusion of the manufacturing process, the silicone rubber in her spinal cord stimulator was not a residue or impurity not intended to be present in the finished device but was one of the materials composing the device. As a result, she had not alleged a violation of an FDA regulation or a CGMP that could support a parallel product liability claim that could avoid preemption. Even if she had, the court observed, this alleged violation would have saved only her manufacturing defect claim, not her design defect or failure to warn claims.
Fraud. Medtronic opposed the fraud claim for failure to allege that its representative made statements with false or reckless disregard for the truth. The court disagreed, noting that the allegations that the patient was repeatedly assured that allergic reactions had not been observed until after her surgery supports a plausible inference that the representative knew that these assurances were false, or that she recklessly provided these assurances. The fraud claim will proceed.
The case is No. 16-11742.
Attorneys: Daniel B. Lambert (Lambert & Lambert PLC) for Janet Canary. Matthew J. Lund (Pepper Hamilton LLP) and Ronald Clifton Merrell (Greenberg Traurig LLP) for Medtronic, Inc.
Companies: Medtronic, Inc.
MainStory: TopStory PreemptionNews WarningsNews DesignManufacturingNews MedicalDevicesNews MichiganNews
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