[Drug and Device Law] Guest Post - First Contact - 3D Printing Meets the Learned Intermediary Rule
Here is a guest post on an interesting case. It's the first decision that we're aware of in which a 3D printed medical device (or any 3D printed product) has been the subject of litigation that involves product liability principles. This post is submitted by Matt Jacobson of Reed Smith, who is particularly interested in 3D printing issues. As always our guest blogger gets all the credit, and any blame, for the analysis that follows.
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October 21, 2015, the day Marty McFly, Doc, and their flux capacitor-charged Delorean arrived in the future. The future was filed with flat screen TVs, self-lacing shoes, flying cars, cold fusion, Pepsi Perfect, and, of course, hover boards. While the future is only a week away now, in the 1980s, when Back to the Future, Part II hit movie theaters, it seemed like a long way off. However, a surprising amount of Back to the Future tech and non-tech (the Cubs are in the playoffs after all) are now part of our everydaylives—flying cars and cold fusion, not so much. One thing, the movie did not predict was 3D printing. 3D printing is turning science fiction into reality, and as the technology continues to develop, we may soon realize the future really is here.
This blog is not a stranger to 3D printing, as we have posted about it here, here, and here. But as the writers of Back to the Future could not actually predict the future, neither can we predict how courts will handle 3D printed medical devices. A glimpse into that future may be found in Buckley v. Align Technology, Inc., No. 5:13-cv-02812-EJD, 2015 U.S. Dist. LEXIS 133388 (N.D. Cal. Sept 29, 2015)—which, as far as we can find, is the first even semi-product liability case dealing with a 3D printed product.
The 3D printed product is Invisalign braces, which are a series of custom-made aligners that are used to treat misalignment of teeth (or the technical term malocclusion). Invisalign braces are only available through a prescription by a dentist.
Plaintiff alleged that her dentist took dental impressions of her teeth who sent them to Align (the company that markets and sells Invisalign) to be evaluated and approved. Align then 3D printed the aligners for plaintiff. After wearing the aligners for almost 2 years, her malocclusion, which was caused by worn down teeth, did not improve. Plaintiff filed a complaint against Align centered on the allegation that “Align falsely advertised, misled and deceived her and other consumers into believing that the Invisalign aligners could treat their malocclusions.” Id. at *3. Plaintiff quickly amended her complaint and Align moved to dismiss. The court granted the motion with leave to amend and plaintiff filed a second amended complaint. Plaintiff’s third shot is the subject of the court’s opinion and alleged various causes of action, including violation of the Magnuson-Moss Warranty Act, breach of warranty, unjust enrichment, money had and received, violation of California consumer protection statues, and negligent misrepresentation. She claimed the fraudulent misrepresentations could be found in Invisalign brochures in the dentist’s office and on Invisalign’s website. Align again moved to dismiss.
Because this is a drug and device law blog, we will focus on what interested us first about the case (although the court found it was an additional basis for dismissal)—the learned intermediary doctrine. As regular readers of this blog will know, the learned intermediary doctrine holds that “in the case of prescription drugs, the duty to warn runs to the physician, not to the patient.” Id. at *10. In attempting to prevent dismissal, plaintiff contended that Align medically evaluated her dental impressions before they ultimately 3D printed her custom aligners, and therefore had a duty to warn her directly. The court was not fooled by this contention and found that
[t]he Invisalign aligners are prescribed exclusively by the dentist, and are custom-manufactured by Align . . . It appears, thus that Align stands in the position of a manufacture not a medical evaluator. As such, Align has a duty to warn the dentist about any dangerous side effects pertaining to the Invisalign treatment, but has no duty to directly warn Plaintiff.
Id. at *10-11. The learned intermediary doctrine barred plaintiff’s claims, to the extent they were based on failure to warn, because the complaint did not allege that Align had failed to warn plaintiff’s dentist.
The complaint also failed because the underlying fraud allegations did not meet the heightened pleading standard in Rule 9(b). Although, plaintiff alleged that she relied on representations in a product brochure, she provided “no specific allegation as to what information Align conveyed to her that was false or misleading.” Id. at *7. Plaintiff also claimed to have relied on Invisalign’s website, which provided that Invisalign treats “serious malocclusion.” Id. at *8. This was not good enough, as there was no indication of what types of “serious malocclusion” Invisalign can fix or that it can fix worn down teeth. Id. “Instead, the Invisalign system’s instructions for use provide that the system is unable to treat ‘[t]ooth malocclusion requiring surgical correction,’ which is precisely the type of malocclusion Plaintiff alleges she has.” Id. Plaintiff had not identified any false or misleading statements and therefore the lawsuit “failed to adequately state any claim.” Id. at *9.
As if that were not enough, the court also found the money had and received claim (a type of unjust enrichment) alternatively failed, because plaintiff used the product for almost two years and thus it was “unclear how Align is indebted to Plaintiff, or how it has unjustly enriched from Plaintiff’s payment.” Id. at *12. Plaintiff struck out and the court dismissed her lawsuit with prejudice.
Great Scott! What a good result. The court treated the 3D printed product like any other medical device. Although 3D printing manufactures may play more of a role in customizing and fitting medical devices to specific patients, they are still manufacturers, after all, and it appears, at least in California, that the learned intermediary doctrine applies. This may be a glimpse into the future, but only time will tell, how courts will treat 3D printed medical devices in the confines of current product liability law—especially when someone other than a traditional manufacturer actually operates the 3D printer.
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Posted By Bexis to Drug and Device Law at 10/15/2015 08:00:00 AM --
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