Earlier this month, the Texas court of appeals ruled that personal injury claims against a medical device manufacturer accused of promoting off-label uses of the device are not subject to the same requirements state law imposes on health care liability claims.
The Third Court of Appeals in Austin said Verticor Ltd., which manufactures the Eclipse Sphere device, cannot avoid a patient’s claim that the company solicited a doctor to do an off-label surgery implanting Verticor’s Eclipse Sphere device into his spine to treat a herniated disc, Law360 reports.
Verticor had argued that the claims should have been dismissed when the plaintiff did not meet requirements under tort reform measures that require expert reports and impose damages caps on lawsuits designated as health care liability claims.
But in its ruling, the court said there is no bright-line rule that product manufacturers can never be considered health care providers under the Texas Medical Liability Act. The reality is not as simple as the all-or-nothing arguments made by the two sides, the court said. Texas law does not categorically exclude medical device manufacturers from being considered health care providers, Law360 reports, but, mere manufacture and sale of a medical device also does constitute the provision of health care under the law. The court ruled that Verticor was not entitled to the protections Texas law grants to health care providers because the company did not show evidence it had any involvement in the plaintiffs care or treatment, or was licensed to be involved in the care or treatment beyond manufacturing the Eclipse Shield that was used in the surgery. Verticor has not demonstrated “conclusively” that it is a health care provider under the Texas health care law, the court said.
The plaintiff sued both Verticor and the surgeon, James Hansen, for damages. The patient experienced complications following implantation of the Eclipse Sphere. The patient alleged that the doctor was negligent in performing what he says was an off-label and experimental procedure for which the doctor did not obtain informed consent. The plaintiff filed expert reports supporting his health care liability claim against Hansen, according to Law360.
The plaintiff also alleged that the doctor and Verticor engaged in a fraudulent scheme in which Verticor paid kickbacks to the doctor to induce off-label uses of the device. The Eclipse Sphere was approved by the Food and Drug Administration (FDA) solely for use in lumbar intervertebral fusion procedures and was never intended for “motion-sparing, nonfusion” procedures like the one performed on him. The plaintiff alleges that Verticor did not adequately disclose the FDA warning.
The patient sought damages based on strict product liability for marketing defect, negligent marketing of the device, and breach of the implied warranty of merchantability, according to the court opinion. Verticor is expected to appeal the ruling to the Texas Supreme Court, Law360 reports.