Bespoke makes us think of tailoring, which makes us think of London’s Savile Row, which makes us think of Annie’s You’re Never Fully Dressed Without a Smile (“who cares what they’re wearing on Main Street or Savile Row”).  Which as it turns out is perfect for today’s case about a plaintiff who wanted the court to recognize a custom-tailored cause of action against the manufacturer of Invisalign teeth aligners.

Plaintiff in Adair v. Align Technology, Inc., 2024 U.S. Dist. LEXIS 233300 (W.D. Tex. Dec. 27, 2024), consulted a dentist to have her teeth realigned.  Her dentist prescribed Invisalign aligners and performed imaging to monitor her progress.  In other words, at all times plaintiff’s dentist was responsible for choosing the size of the aligners and overseeing plaintiff’s care.  Plaintiff alleges the aligners pushed her teeth too far forward and that she will need to undergo additional treatment to correct the problem.  Id. at *1. 

Plaintiff sued the manufacturer of the aligners claiming it was negligent in providing “inappropriate” aligners and in failing to read or properly read her dental images.  Id. at *2.  However, under Texas law a products liability claim sounding in negligence turns on whether the manufacturer used ordinary care in “design and production” of the product.  Id. at *4.  Texas does not impose on medical product manufacturers a duty to assure the product is being properly used by the physician.  So, plaintiffs were asking the court to “craft a new duty tailored specifically to this case.”  Id. at *5. The court refused. 

 Applying the recognized duty to the facts, the court found plaintiff failed to connect her alleged injury to either defendant’s design or production of the aligners.  The images plaintiff alleges defendant should have reviewed were taken during her treatment, long after the aligners were designed and produced, and therefore had no bearing on that process.  Id. at *5-6.   Plaintiff’s complaint was dismissed but given an opportunity to move for leave to amend. 

This is a useful case for the general proposition that prescription medical product manufacturers have no duty to supervise how doctors use their products.  And, that products liability claims belong on Main St. and not Savile Row.