Texas Tort Reform Law Does Not Bar Medical Device Claims, Appeals Court Rules

Texas’s Third Court of Appeals in Austin ruled this month 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 surgery, cannot avoid the man’s claim that the company solicited a doctor to implant the Eclipse Sphere into his spine to treat a herniated disc, an unapproved use, Law360 reports.

The manufacturer 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.

The court ruled that 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 more complicated that the all-or-nothing arguments made by the opposing sides. 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 appeals court ruled that Verticor was not entitled to the protections granted to health care providers under Texas law because Verticor did not show evidence of any involvement in the plaintiff’s 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 man who filed the lawsuit is suing both Verticor and his surgeon, James Hansen. He is seeking damages for complications following implantation of the Eclipse Sphere. He alleges that the doctor was negligent in performing 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 suit also 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 device. 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. Law360 reports that Verticor is expected to appeal the ruling to the Texas Supreme Court.

from Parker Waichman http://www.yourlawyer.com/blog/texas-tort-reform-law-does-not-bar-medical-device-claims-appeals-court-rules/