Off-Label Lawsuit is Not Barred. The Third Court of Appeals in Austin has ruled that an off-label lawsuit is not barred by Texas tort reforms, Law 360 reports. The court found that the lawsuit, which accuses manufacturer Verticor Ltd. of paying kickbacks for off-label use of a medical device, is not subject to the same rules the state uses to govern health care liability claims.
The suit was filed on behalf of a man who was implanted with Verticor’s Eclipse Shield to treat a herniated disc. The lawsuit alleges Verticor paid the surgeon to implant the device off-label, and that the experimental procedure was done without the plaintiff’s consent.
Pharmaceutical companies are not permitted to promote drugs off-label
When a drug or a medical device is used off-label, it means it is being used a manner not approved by the U.S. Food and Drug Administration (FDA). Pharmaceutical companies are not permitted to promote drugs off-label, although physicians can prescribe for unapproved uses at their discretion.
In this case, Verticor contended that the lawsuit triggered tort reform measures that would limit the plaintiff’s maximum compensation and also require expert reports. These rules apply to lawsuits designated as health care liability claims, and Verticor argued that the case should have been dismissed for failing to meet the requirement.
The court ruled that the company is not protected under the Texas Medical Liability Act because it has not proven itself to be a health care provider. “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 stated, according to Law360.