Cosh v. Atrium Medical Corporation

Background

Tina M. Cosh and Lester A. Cosh sued Atrium Medical Corporation. They alleged that Tina Cosh suffered injuries after Dr. Moaz W. Albulfaraj used Atrium’s ProLite Mesh during hernia-repair surgery on February 5, 2015. About six weeks later, she underwent another surgery to treat a nonhealing wound and remove the infected mesh. The plaintiffs alleged that she experienced stomach pain after the surgeries that she had not experienced before the mesh was implanted.

The plaintiffs’ Second Amended Complaint asserted strict-liability claims for design defect, manufacturing defect, and failure to warn; negligence; breach of warranty; punitive damages; negligent misrepresentation; consumer fraud; and loss of consortium. They did not replead claims for fraudulent misrepresentation or unjust enrichment that had appeared in the earlier amended complaint. The court had previously dismissed the First Amended Complaint in its entirety.

Legal Standard

Atrium moved to dismiss under Rule 12(b)(6), which tests whether a complaint states a legally sufficient claim. The court accepted well-pleaded factual allegations as true for purposes of the motion and considered whether they plausibly showed that Atrium was liable. The court did not weigh evidence that might be presented at trial.

Reasons for Dismissal

Design defect. Under New York law, a design-defect claim requires allegations that the product posed a substantial likelihood of harm, that a safer alternative design was technically and economically feasible, and that the defective design substantially caused the injury. The court held that the plaintiffs’ proposed alternatives—including different materials, a heavyweight small-pore mesh, a non-woven mesh, and hemp—did not cure the earlier pleading deficiency. The plaintiffs did not allege facts showing that the proposed mesh designs were technically and economically feasible and safer. The court also said that proposing materials that would effectively avoid use of the product did not satisfy the alternative-design requirement.

Manufacturing defect. A manufacturing-defect claim requires a specific product unit to have been made defective by a manufacturing mishap, improper workmanship, or defective materials, and requires a connection between that defect and the injury. The plaintiffs added allegations about Food and Drug Administration complaints, a warning letter, and a consent decree involving Atrium’s manufacturing facility. The court held that these allegations did not identify a deviation, workmanship problem, or defective material in the specific mesh implanted in Tina Cosh. The court also found it unclear how the cited violations affected ProLite Mesh or whether they could have caused her complications.

Failure to warn. The plaintiffs alleged that Atrium represented that ProLite Mesh was safe and effective and failed to disclose various risks and manufacturing-related information. The court held that they still did not identify specific statements supporting the alleged representations. It also held that the warnings the plaintiffs claimed were missing merely reframed the design- and manufacturing-defect allegations that the court had already found insufficient.

Negligent misrepresentation. The plaintiffs added allegations that hundreds of adverse events involving ProLite Mesh had been reported to the Food and Drug Administration and that Atrium failed to investigate them. The court held that these allegations did not address the earlier deficiencies concerning what false representations were made or what representations Tina Cosh or her physician relied on.

Remaining claims. The court dismissed the consumer-fraud, punitive-damages, breach-of-warranty, and loss-of-consortium claims for the same reasons given in its earlier decision because the Second Amended Complaint added no facts addressing those deficiencies.

Disposition

The court granted Atrium’s motion to dismiss. It dismissed the case in its entirety and directed the clerk to close the case. The opinion does not state that the dismissal was with or without prejudice.