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From Products Liability Law Daily, November 13, 2015

Medical device manufacturer not 'health care provider' under Texas Medical Liability Act

By John W. Scanlan, J.D.

The manufacturer of a spine implant device was not a “health care provider” for purposes of the Texas Medical Liability Act, a Texas court of appeals ruled in an issue of first impression that permitted a patient’s claims against the manufacturer to go forward (Verticor, Ltd. v. Wood, November 13, 2015, Pemberton, B.).

Background. A man with a herniated disc in his lumbar region underwent surgery to have an “Eclipse Sphere” device implanted to treat it. After complications developed, the patient filed suit in Texas state court against his surgeon and against Verticor, Ltd., the manufacturer of the device. He brought claims for strict liability for marketing defect, negligent marketing of the device, breach of the implied warranty of merchantability, and fraud against Verticor, alleging that the FDA had approved the device only for use in lumbar intervertebral fusion procedures, not the “motion-sparing, non-fusion” procedure that his surgeon had used, and that the company had solicited his surgeon to perform this off-label use.

In its answer, Verticor asserted that it was a “health care provider” under Texas law, and that the patient’s claims were “healthcare liability claims” (HCLCs) under the Texas Medical Liability Act (TMLA). The TMLA imposes a requirement that a plaintiff must serve one or more expert reports upon each physician or health care provider against whom a liability claim is brought, or have his claims dismissed. The patient in this case had served an expert report upon his surgeon, but not upon Verticor. The patient moved for partial summary judgment, asking the court to rule that Verticor was not a health care provider as defined by the TMLA, and that his claims were not HCLCs. The trial court granted this motion, and subsequently denied Verticor’s motion for reconsideration and its motion to dismiss on the ground that the patient had not served it with the expert report required by the TMLA. Verticor appealed.

Health care provider/device manufacturer. The appellate court affirmed the trial court because Verticor could not establish that it was a “health care provider” under the TMLA. Verticor based its argument on evidence that it holds a “device manufacturer” license from the state of Texas, asserting that it is thus licensed to provide health care. Verticor conceded that it had no involvement in the patient’s care or treatment beyond manufacturing the Eclipse Sphere and placing it into the stream of commerce.

The TMLA defines “health care” to mean “any act or treatment performed or furnished, or that should have been performed or furnished, by any health care provider for, to, or on behalf of a patient during the patient’s medical care, treatment, or confinement.” This language defines “health care” in terms of “acts” and “treatments” provided to patients rather than products or things. The court observed that this understanding is consistent with the common usage of “health care” as being associated with medical intervention or assistance. The Act went on to define “health care provider” as a person or entity that is duly “licensed, certified, registered, or chartered by the State of Texas to provide health care.” A non-exclusive list of health care provider exemplars listed in the Act showed that the state legislature had in mind trained professionals as well as health care institutions such as hospitals and nursing homes. While the court would not go so far as to say that a medical device manufacturer can never be a “health care provider” under the TMLA, it agreed with the patient that the cases relied upon by Verticor were distinguishable from the present case because they involved manufacturers that had been licensed not only to make medical devices but also to provide acts or treatment that would qualify as “health care” under the TMLA. As a result, the court concluded that Verticor had not raised a fact issue that it was a “health care provider” under the TMLA.

The case is No. 03-14-00277-CV.

Attorneys: Jeff M. Meyerson (The Meyerson Law Firm, P.C.) for Michael Wood. Catherine L. Kyle (Chamberlain McHaney) and David J. Campbell (DuBois, Bryant & Campbell, L.L.P.) for Verticor, Ltd.

Companies: Verticor, Ltd.

MainStory: TopStory SCLIssuesNews MedicalDevicesNews TexasNews

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