In Verticor, Ltd. v. Wood, an appellate court considered whether personal injury lawsuits against a medical device manufacturer count as health care liability claims for the purposes of the Texas Medical Liability Act (TMLA). The case arose when a surgeon treated a herniated disc in the plaintiff’s lumbar spine by using a device called the “Eclipse Sphere,” which was manufactured by the defendant. After suffering complications, the plaintiff sued the doctor and the manufacturer.
The plaintiff argued that the surgeon had used the device in a non-fusion procedure, although it was only approved by the FDA for use in fusion procedures in the lumbar region. The FDA had also required that the device’s packaging and manuals include a warning about how its safety in non-fusion procedures hadn’t been established yet.
The plaintiff argued that the doctor was professionally and grossly negligent in using the device in an off-label, experimental fashion and not getting his informed consent for it. He also claimed that the manufacturer had solicited the off-label use, alleging strict liability theories of failure to warn, negligent marketing, a breach of the implied warranty of merchantability, and fraud. The manufacturer claimed as an affirmative defense that it is a health care provider as defined by the TMLA.