Products Liability Law Daily Wrap Up, WARNINGS ISSUES—MEDICAL DEVICES—D.N.H.: California consumer protection claim against mesh product manufacturer moves forward, (May 20, 2021)

By Elena Eyber, J.D.

The patient’s claim under New Hampshire law was dismissed, however.

The federal district court in New Hampshire granted a medical device manufacturer’s summary judgment motion as to a patient’s New Hampshire Consumer Protection Act (NHCPA) claim and denied the motion as to the patient’s California Consumer Legal Remedies Act (CCLRA) claim. The court explained that a consumer who receives misrepresentations of goods or false advertising outside of New Hampshire cannot state a claim under the NHCPA. However, the patient’s CCLRA claim survived summary judgment in light of the surgeon’s testimony that he would have been less likely to choose the manufacturer’s product had the manufacturer warned him about its risks, and in the absence of material evidence regarding the basis for the hospital’s decision to purchase the mesh product (Luna v. Atrium Medical Corp., May 14, 2021, McCafferty, L.).

Procedural history. The patient asserted that Atrium Medical Corp. designed, manufactured, and sold an unreasonably dangerous surgical mesh product intended for permanent implantation in the human body in connection with hernia repair surgeries. The patient alleged that she suffered injury after undergoing umbilical hernia repair surgery using Atrium’s surgical mesh product. Atrium filed a motion for summary judgment seeking dismissal of the patient’s claims for violation of New Hampshire and California consumer protection laws.

NHCPA claim. Atrium argued that the patient lacked standing to bring her NHCPA claim because the alleged misrepresentations or false advertising would have been received in California, where the patient’s care providers were located. The patient did not dispute that the care providers made the decisions to purchase and use the surgical mesh product in California. As a matter of law, therefore, it was immaterial that Atrium may have made misrepresentations or falsely advertised the mesh product in New Hampshire. The court held that a consumer who receives misrepresentations of goods or false advertising outside of New Hampshire cannot state a claim under the NHCPA. Thus, the court granted Atrium’s motion for summary judgment as to the patient’s NHCPA claim.

CCLRA claim. Atrium asserted that the patient lacked standing to pursue her CCLRA claim because she could not prove the element of reliance. Atrium argued that the patient could not have relied on any false representations because she did not make the decision to use the mesh product and did not see any advertising or representation regarding the product prior to her surgery. The court explained that the learned intermediary doctrine holds that a manufacturer’s duty to warn regarding the risks associated with a product runs to a patient’s treating physician (or other learned intermediary) rather than directly to the patient.

The patient’s implanting surgeon did not consider any advertising or affirmative representations regarding the mesh product before making the decision to use it in the patient’s surgery. However, a jury could reasonably find, on the basis of the surgeon’s testimony, that he usually received information on a particular mesh from manufacturers’ sales representatives and that Atrium had opportunities to convey any reasonably necessary warnings regarding the product to the surgeon prior to the surgery. A jury also could reasonably find both that Atrium failed to warn the surgeon regarding any increased infection risk and that the surgeon relied on that omission when he elected to use the surgical mesh product. Moreover, the surgeon did not make the decision to purchase the mesh product for the use of surgeons at the hospital. When the surgeon decided whether to use a surgical mesh product for a specific surgery, he relied in part on a "risk-benefit analysis" that he assumed was performed by someone at the hospital at the time the product was originally purchased.

Accordingly, in light of the surgeon’s testimony that he would have been less likely to choose Atrium’s product had Atrium warned him about its risks, and in the absence of material evidence regarding the basis for the hospital’s decision to purchase the mesh product, the court could not find that Atrium established its entitlement to summary judgment, and denied Atrium’s motion as to the patient’s CCLRA claim.

The case is No. 1:16-cv-00372-LM.

Attorneys: Adam M. Evans (Brenes Law Group, PC) for Martha Luna. Katherine A. Armstrong (Dechert LLP) for Atrium Medical Corp.

Companies: Atrium Medical Corp.

Cases: CourtDecisions MedicalDevicesNews WarningsNews NewHampshireNews