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Texas Appeals Court Rules Medical Device Claims not Barred under Tort Reform Law

Filed November 20th, 2015 Fran Kelley

In a ruling earlier this month, the Third Court of Appeals in Austin, Texas ruled that personal injury claims against a medical device manufacturer accused of promoting off-label uses of one of its devices are not subject to the same requirements imposed on health care liability claims.

The court said Verticor Ltd., which manufactures the Eclipse Sphere device used in the plaintiff’s spinal surgery, cannot avoid the man’s claim that the company solicited a doctor to implant the Eclipse Sphere into his spine in an unapproved use, Law360 reports.

Verticor argued that the claims should have been dismissed because the plaintiff did not meet requirements under tort reform measures that require expert reports and also impose damages caps on lawsuits designated as health care liability claims. But the court ruled that there is no bright-line rule under which product manufacturers can never be considered health care providers under the Texas Medical Liability Act. The court said the reality is more complicated that the all-or-nothing arguments being made by the two sides. Medical device manufacturers are not categorically excluded from being considered health care providers under Texas law, according to Law360, although mere manufacture and sale of a medical device also does constitute 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 Verticor did not show evidence of any involvement in the care or treatment of the plaintiff, or involvement beyond manufacturing the Eclipse Shield that was used in the surgery. The court said Verticor has not demonstrated “conclusively” that it is a health care provider under the Texas health care law.

The man who filed the lawsuit is suing both Verticor and Dr. James Hansen, the surgeon. He is seeking damages for complications following the implantation of the Eclipse Sphere for treatment of a herniated disc. He alleges that the doctor was negligent in performing an off-label and experimental procedure for which Hansen did not obtain informed consent. The plaintiff filed expert reports supporting his health care liability claim against Hansen, according to Law360.

The suit further alleges that the doctor and Verticor engaged in a fraudulent scheme in which Verticor paid kickbacks to the doctor to induce him to engage in off-label uses of the Eclipse Sphere. The Food and Drug Administration (FDA) approved the Eclipse Sphere solely for use in lumbar intervertebral fusion procedures. The device was never intended for “motion-sparing, nonfusion” procedures like the one performed on the plaintiff, and the plaintiff alleges that Verticor did not adequately disclose the FDA warning.

The patient sought damages based on strict product liability, negligent marketing of the device, and breach of the implied warranty of merchantability, according to the appeals court opinion. Verticor is expected to appeal the ruling to the Texas Supreme Court, Law360 reports.

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