By Jeffrey H. Brochin, J.D.
State law claims for manufacturing defects based on allegations of a manufacturer’s failure to comply with device-specific PMA specifications were parallel state claims that survived federal preemption.
A federal district court in Missouri has denied motions to dismiss filed by Medtronic, Inc., the manufacturer of the SynchroMed II infusion pump, in a strict liability-manufacturing defect case brought by a patient who was severely injured when the infusion pump failed. Federal preemption did not apply as a bar to her case because she pleaded not only particularized violations of Current Good Manufacturing Practices (CGMPs) as detailed by the Food and Drug Administration’s (FDA) numerous warning letters to Medtronic, but also that the manufacture of her device was in violation of the premarket approval (PMA) specifications, which resulted in a defective device whose manufacture was not approved by the FDA. State law claims based on allegations of a manufacturer’s failure to comply with device-specific PMA specifications survive preemption (Sullivan v. Medtronic, Inc., October 30, 2020, Perry, K.).
Infusion pump failure led to drug withdrawal. In 2005, a patient who suffered from cerebral palsy and spastic quadriplegia had a SynchroMed device implanted to reduce her muscle spasticity. The device administered programmed amounts of her medication, baclofen, and remained in place until August 29, 2011, when it was surgically removed due to having reached the end of its service life. It was replaced by the SynchroMed II. On March 5, 2015, the patient began to experience stiffness and the sensation that bugs were crawling on her, and the device’s alarm began to beep. She alleged that the motor in her pump was stalling, seizing, or otherwise failing to deliver baclofen medication as programmed, resulting in baclofen withdrawal.
The next day she was taken to the emergency room and was admitted with a diagnosis of acute withdrawal secondary to baclofen pump failure, with symptoms of tremors, pruritus, shortness of breath, tachycardia, elevated blood pressure, and hyperthermia. Doctors initiated drug withdrawal protocol, and a Medtronic representative who examined her pump at the hospital confirmed that it was not functioning. Her doctors recommended "urgent replacement" and, on March 7, 2015, she underwent pump replacement surgery. She filed suit against Medtronic claiming strict liability-manufacturing defect and other claims. Medtronic moved to dismiss based on federal preemption, which for the reasons stated below the court denied.
Premarket approval. The device was originally granted FDA approval in 1988 under the Medical Device Amendments (MDA) as a Class III medical device and underwent a rigorous, comprehensive inquiry for premarket approval. An applicant seeking PMA for a Class III device must supply information to the FDA, including a description of the device, clinical safety trials, methods of product testing, design of the device, and manufacturing controls, outcome evaluation, and proposed labeling. The FDA does not conduct independent testing on a medical device in a PMA application, and following PMA, an applicant must comply with certain FDA requirements and federal regulations, and also must comply with specifications imposed during the PMA process for the device.
Long history of warnings. Starting in 2006, the FDA issued Medtronic a series of warning letters identifying federal manufacturing and quality control violations at its manufacturing plants with respect to SynchroMed. On April 27, 2015, the U.S. Department of Justice and the U.S. Department of Health and Human Services filed a complaint requesting a permanent injunction, leading to a court-ordered consent decree imposing a moratorium on the manufacture, sale, and distribution of SynchroMed. Since receiving PMA, SynchroMed has been subject to at least 72 recalls. The warning letters issued by the FDA identified "significant deviations" from CGMPs committed by Medtronic while manufacturing SynchroMed, and, due to the deviations, SynchroMed was found to be "adulterated" or "misbranded." The FDA also notified Medtronic on multiple occasions that the violations might be symptomatic of serious underlying problems in Medtronic’s manufacturing and Quality Assurance systems.
State claims survive preemption. Medtronic argued that the claims were expressly preempted by the federal MDA, which barred the patient’s state claims from proceeding, and it further asserted that she did not plead facts plausibly establishing that Medtronic violated federal requirements in the manufacture of her specific pump thereby causing her specific injury, and that her claims sought to impose state law requirements "different from, or in addition to," federal device requirements, triggering preemption.
However, the court pointed out that the patient pleaded claims for manufacturing defects, not design defects, and that those claims were parallel state claims that survived preemption. She adequately alleged that the SynchroMed implanted in her body was defective in that it was manufactured in violation of the PMA and the CGMPs as set out in detail in her first amended complaint, and that those manufacturing defects caused her device to fail. She not only pleaded particularized violations of CGMPs as detailed by the FDA’s numerous warning letters to Medtronic (which detailed the factual bases for such violations), but also that the manufacture of her device was in violation of the PMA specifications, which resulted in a defective device whose manufacture was not approved by the FDA. State law claims based on allegations of a manufacturer’s failure to comply with device-specific PMA specifications survive preemption.
Based on the foregoing, the court denied Medtronic’s motion to dismiss.
The case is No. 4:20-cv-00344-CDP.
Attorneys: Ellen A. Presby (Van Wey, Presby & Williams, PLLC) for Carissa Sullivan. Brandon D. Cox (Greenberg Traurig, LLP) for Medtronic, Inc., Medtronic USA, Inc., Medtronic Puerto Rico Operations Co. and Medtronic Logistics, LLC.
Companies: Medtronic, Inc.; Medtronic USA, Inc.; Medtronic Puerto Rico Operations Co.; Medtronic Logistics, LLC
MainStory: TopStory PreemptionNews MedicalDevicesNews DesignManufacturingNews WarningsNews MissouriNews
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