Products Liability Law Daily Warnings and design allegations keep claim alive against GE for MRI contrast agent
Friday, March 27, 2020

Warnings and design allegations keep claim alive against GE for MRI contrast agent

By Leah S. Poniatowski, J.D.

Despite dismissal of strict liability-based claims, remaining allegations corresponded to state product liability law.

A patient who was injected with a contrast agent for MRI imaging and developed physical ailments thereafter successfully alleged claims for failure to warn and unreasonably dangerous design, a federal court in Louisiana ruled. However, the strict liability and remaining claims were not correctly pleaded, meriting dismissal on the manufacturer’s motion for summary judgment (Lewis v. GE Hea lthcare, Inc., March 25, 2020, Doughty, T.).

The patient stated that as part of several magnetic resonance imaging tests, he was given injections of Omniscan, a gadolinium-based contrast agent ("GBCA") manufactured by General Electric Company and GE Healthcare, Inc., GE Healthcare AS (collectively, "GEHC"); and distributed by McKesson. He alleged that he developed Gadolinium Deposition Disease ("GDD"), a disease that occurs in patients who have received a GBCA, with symptoms consistent with the toxic effects of retained gadolinium. He filed a lawsuit against GEHC and McKesson, contending that they failed to warn healthcare providers of the risk of GBCA in patients with normal kidney function and that they knew or should have known the risks. Specifically, he asserted causes of action for: strict liability-failure to warn; negligence; negligent misrepresentation; negligence per se; breach of express warranty; breach of implied warranty; fraudulent misrepresentation and concealment; and civil battery.

Summary judgment motions. McKesson and GEHC filed separate motions for summary judgment. McKesson argued that the patient failed to meet the requisite pleading standards and his failure to warn claims were barred by federal preemption. The court agreed that the strict liability-based claims should be dismissed, but denied summary judgment on the breach of implied warranty claim. GEHC asserted in the present action that the patient’s claims could only be remedied under the Louisiana Products Liability Act (LPLA), and even if asserted under the Act, they were insufficiently pleaded.

Louisiana Products Liability Act. The court explained that the LPLA provides the exclusive path to recovering against a liable manufacturer for damages caused by their product and that courts routinely dismiss claims that do not arise under the Act. In the present case, the majority of the patient’s claims were not cognizable under the LPLA. The court determined that the strict liability, negligence, negligent misrepresentation, breach of implied warranty, fraudulent misrepresentation and concealment, and civil battery claims were dismissed. Additionally, the patient’s negligence per se claim was dismissed because Louisiana does not recognize claims for violations of the federal Food, Drug & Cosmetic Act or other federal law with respect to the Food & Drug Administration.

However, the court remarked, the patient’s claims do not fail for not correctly specifying the legal theory under which the claim arises as courts are guided to examine the substance of the claim. Thus, according to the patient’s reply brief, he asserted claims for failure to warn, breach of express warranty, and unreasonably dangerous design, which were recognized under the LPLA.

Failure to warn. The court concluded that the patient asserted an adequate claim for failure to warn pursuant to the LPLA. According to the LPLA, a product is unreasonably dangerous if it leaves the manufacturer’s control with a characteristic capable of causing damage, and that the manufacturer failed to use reasonable care to warn of the danger. The patient presented evidence that GBCAs have been known to cause injury to patients with normal renal functioning for several decades and GEHC eventually corrected its label in 2012 to warn of gadolinium retention in patients with kidney disease or injury, and in 2018 to include patients with normal kidney function. Thus, the patient presented sufficient evidence to support the inference that GEHC failed to provide an adequate warning.

Unreasonably dangerous design. However, the patient’s claim for unreasonably dangerous design was inadequate. The court found that he did not provide an alternative design for Omniscan, which was necessary to support the claim. Further, he did not include a proposed pleading with his request for leave to amend his complaint.

Breach of express warranty. The court found that the patient met his pleading burden with respect to his claim for breach of express warranty.

The case is No. 5:19-CV-00490.

Attorneys: Amanda Lynn Washington (McGlynn Glisson & Mouton) for Rickey Lewis. Michael D. Fisse (Daigle Fisse & Kessenich) for G E Healthcare Inc. and General Electric Co.

Companies: G E Healthcare Inc.; General Electric Co.

MainStory: TopStory WarningsNews DesignManufacturingNews CausationNews DrugsNews LouisianaNews

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