Sacramento, CAA Medtronic SynchroMed Infusion pump lawsuit brought by a plaintiff who without doubt suffered as the result of an allegedly defective medical device, saw his case lost due to legal precedent and various legal roadblocks that preempted his claims and assertions under a Medical Device Amendment (MDA) to the Food, Drug, and Cosmetic Act (FDCA).
The plaintiff in the Medtronic SynchromMed Impantable Infusion pump lawsuit is Michael Martin, who brought his action against Medtronic (Michael Martin v. Medtronic, Inc. et al., Case No. 1:15-cv-00994-DAD-MJS in US District Court for the Eastern District of California). The case represented the plaintiff’s second amended complaint after the Court granted the defendant’s petition to dismiss Martin’s first complaint. The Court, however, left the door open for the plaintiff to amend, which he did.
According to his second amended complaint as described in US Official News (10/16/17), Martin was diagnosed with Lumbar Spondylosis and Lumbar Degenerative Disc Disease in 2004. On February 4, 2008, the plaintiff was implanted with a Medtronic SynchroMed II Implantable Infusion System consisting of a pump (model no. 8637-20, serial no. NGP315748H) and a catheter (model no. 8709SC, serial no. N132467011).
In November 2008, during a trip to Arizona, Martin became seriously ill and was bedridden for two weeks. He sought medical attention when he returned home, and over the next five years, Martin underwent extensive diagnostic testing to determine the source of his illness. That testing is alleged to have left Martin with blurred vision, inability to walk, abdominal pain, and severe nausea, for four to five days each week. During this time, Martin alleges to have experienced symptoms consistent with severe withdrawal-overdose cycles involving opioid medication prescribed to treat pain stemming from his Lumbar Spondylosis and Lumbar Degenerative Disc Disease.
The plaintiff alleges that Medtronic et al were aware that these symptoms were caused by his defective SynchroMed II device, even as Martin’s medical providers were unable to determine the cause.
On July 12, 2013, after Medtronic agreed to allow for a pump replacement, Martin underwent a surgical procedure whereby his original SynchroMed II device was removed and replaced with a new SynchroMed II device. During the procedure, the operating doctor discovered disintegration of material connecting the original pump and the catheter, as well as broken pieces and leakage of fluids around the pump-catheter connection site. Martin’s medical records indicate that such leakage caused the plaintiff’s medication to flow directly into a pocket where the pump is located.
As a direct result of this failure, Martin alleged he experienced pump-induced cycles of overdose and withdrawal: a temporary build-up of medication in the pocket caused overdose symptoms, followed by withdrawal symptoms as the pump emptied.
Martin alleged he suffered physical and emotional injuries, including lost time with his children.
Plaintiff documents filed with the Court noted the SynchroMed II device was first approved through a pre-market approval process in 1988, by the US Food and Drug Administration.
Medtronic moved to dismiss the plaintiff’s second amended complaint on grounds that each of Martin’s state law claims is preempted by the medical device amendment to the FDCA. Medtronic also held that Martin’s second amended complaint failed to adequately allege facts to support his plausible claims for relief, even if such claims were not preempted.
As to Martin’s allegations towards breach of express warranty claims, the Court noted that State law claims based on breach of express warranty can survive preemption under the MDA only to the extent that they seek to impose liability for misleading warranties voluntarily made outside the label.
In spite of Martin’s claims of documented pain and suffering, as well as the deficiencies of the Medtronic II device found during the replacement procedure, the Court granted Medtronic’s motion to dismiss, and the case was closed.
It is not known if he has the opportunity, or the willingness to appeal.
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