Texas Tort Reforms Don’t Bar Medical Device Claims
Law360, Dallas (November 13, 2015, 5:00 PM ET) — In a case of first impression, a Texas appeals court on Friday said personal injury claims against the manufacturer of a medical device accused of promoting off-label uses with kickbacks to doctors aren’t subject to the same requirements Texas imposes on health care liability claims.
The Third Court of Appeals in Austin said manufacturer Verticor Ltd. can’t avoid a patient’s claim 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. Verticor had argued plaintiff Michael Wood’s claims triggered tort reform measures that require expert reports and impose damages caps on lawsuits designated as health care liability claims, and that his case against the company should have been dismissed when he didn’t meet those requirements.
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 but that reality is more complicated than the diametrically opposed all-or-nothing arguments made by the parties. Texas law doesn’t categorically exclude medical device manufacturers from being considered health care providers, but the mere manufacture and sale of a medical device also does not ipso facto constitute the provision of health care under the act, the court held.
But because Verticor didn’t show evidence it had any involvement in Wood’s care or treatment, or was licensed to be involved in his care or treatment beyond manufacturing the Eclipse Shield that was used, the company was not entitled to the protections the TMLA gives to health care providers, the court held.
“Without more, Verticor has not raised a fact issue, let alone demonstrated conclusively, that it is a ‘health care provider’ under the TMLA,” the court said.
Wood sued both Verticor and surgeon James Hansen for damages after complications arose following the implantation of the Eclipse Sphere. Wood alleged Hansen acted with professional negligence and gross negligence in performing what he says was an off-label and experimental procedure for which he did not obtain Wood’s informed consent — and he filed expert reports supporting his health care liability claim against Hansen.
Wood also alleged both defendants engaged in a fraudulent scheme in which Verticor paid Hansen kickbacks to induce his off-label uses of the device. Wood said the Eclipse Sphere was approved by the Food and Drug Administration solely for use in lumbar intervertebral fusion procedures and was never intended for “motion-sparing, nonfusion” procedures like the one performed on him, and that Verticor didn’t disclose the FDA warning adequately.
He sought damages based on theories of strict product liability for marketing defect, negligent marketing of the device and breach of the implied warranty of merchantability, according to the opinion.
“Defendants like Verticor keep pushing the boundaries on the tort reform laws to shield their unscrupulous actions,” Jeff Meyerson of The Meyerson Law Firm PC, an attorney for Wood, said on Friday. “We are glad the court made a well-reasoned decision and we can finally proceed to trial.”
Meyerson said Verticor “shouldn’t take up the court’s time with further appeals” because the ruling draws a clear line.
“While we respect the court of appeals opinion, it’s clear they missed the point, and we are looking at an appeal to the Supreme Court of Texas,” David Chamberlain of Chamberlain McHaney, who represents Verticor, said on Friday.
Verticor is represented by David Chamberlain, Cathy Kyle and David Campbell of Chamberlain McHaney.
Wood is represented by Jeff Meyerson and Mark McLean of The Meyerson Law Firm PC.
The case is Verticor Ltd. v. Wood, case number 03-14-00277-CV, in the Texas Court of Appeals for the Third District.
–Editing by Aaron Pelc.