Medtronic lawyers at Pintas & Mullins Law Firm report on a recent lawsuit filed against Medtronic Inc., by a man who believes his paralysis was caused by the company’s pain pump. The case was appealed to the U.S. Supreme Court after the Ninth Circuit ruled in favor of the plaintiff.
The Arizona plaintiff, Richard Stengel, was implanted with the Medtronic pain pump to provide medication infusions into his spine. Over time, the pain pump caused him to suffer an inflammatory condition, which ultimately rendered him a paraplegic (complete paralysis of the lower half of the body). He sued Medtronic for failure-to-warn, and in January 2013, the Ninth Circuit ruled in his favor.
Deep-pocketed Medtronic appealed, and is now asking for the federal government’s opinion on the matter; in response, SCOTUS released an order seeking the views of the U.S. Solicitor General. The task of the Solicitor General is to oversee and conduct litigation in the high court, deciding the merits of cases to determine whether the court will take them on.
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At the center of this dispute is Stengel’s failure-to-warn claim, which Medtronic believes is preempted by federal law, thus rendering his case inarguable. The federal government supervises the design, manufacture and selling of high-risk medical devices like internal pain pumps via the FDA’s Medical Device Amendments.
Specifically, Medtronic cited the 2001 decision in Buckman Company v. Plaintiffs’ Legal Committee, which concerned FDA fraud. Plaintiffs in that case argued that their injuries were directly caused by the use of orthopedic bone screws in their spines. They claimed that Buckman falsely represented the orthopedic screws to the FDA in order to gain approval. Had the company not made such fraudulent representations, plaintiffs argued, the FDA would not have approved the screws and they would never have been injured.
The Ninth Circuit ruled that Stengel’s claims closely related to federal laws, and that his lawsuit may move forward because it does not implicate the federal premarket approval process, as Buckman did. Instead, the court decided, Stengel’s claim was based on Arizona state law which seeks to protect the health and safety of citizens by expecting manufacturers to demonstrate reasonable care.
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Further, Stengel claims that Medtronic was negligent under Arizona law for failing to report adverse event information to the FDA. Medtronic says it is up to the federal government, not individual plaintiffs, to file lawsuits about failure to comply to such requirements.
Another medical pump manufactured by Medtronic, the Paradigm Insulin Pump (pictured above), has also had its own extensive FDA drama. Starting in April 2013, the company suffered a string of mishaps involving the device, including several recalls (of the MiniMed Paradigm Insulin Infusion Sets and Infusion Set Reservoirs) and FDA safety alerts.
The insulin pumps were recalled because their support caps could become detached and protrude from the pump, resulting in damage to internal electronics and preventing the pumps from working properly. In June 2013, the MiniMed Paradigms were again recalled due to problems with the pump’s tubing. If insulin or any other fluid comes in contact with the tubing connector it can block the vents that allow the pump to function properly.
When the vents are blocked too much or too little insulin is delivered, causing extreme changes in glucose levels, which in diabetics is extremely dangerous and often fatal. One month after this recall Medtronic sent out emergency medical device recall notices alerting patients of problems with the MMT-326A and MMT-332A Reservoirs, which are used with the Paradigm Insulin Pumps. If you were seriously injured as a result of a defective Medtronic device, and would like more information on your legal options, contact our firm for a free, no-obligation consultation.