January 25, 2017
A New Orleans federal judge has dismissed a suit by a man who says he was injured when his implanted Coloplast Corp. penile prosthesis malfunctioned and then stopped working.
U.S. District Judge Sarah S. Vance of the Eastern District of Louisiana granted Coloplast’s motion to dismiss the suit, holding that Stephen Parra’s causes of action for manufacturing/design defect and failure to warn are preempted by the Medical Device Amendments, 21 U.S.C.A. § 360k, to the Food, Drug and Cosmetic Act, 21 U.S.C.A. § 301.
Judge Vance further held that Parra’s breach-of-express-warranty claim against Coloplast lacked the detail required for her to determine if the claim, asserted under the Louisiana Products Liability Act, La. Stat. Ann. § 9:2800.51, is federally preempted.
Parra filed suit in April 2016, claiming the Titan inflatable penile prosthesis he had received a year earlier caused him pain and began operating sporadically soon afterward. Parra says the system is designed replicate an erection by releasing fluid from a reservoir inserted in the abdomen through silicone tubing and into two cylinders implanted in the penis.
Parra claimed in his suit that his device will likely require surgical removal because it soon began to cause him pain and inflate spontaneously. He said the malfunction centered on the system’s locking valve, which is designed to control the flow of fluid between the reservoir and the penile cylinders.
Parra said the fluid has since been drained from the implant and he now has permanent nerve damage and other injuries requiring future surgeries.
In October 2016, Coloplast moved for dismissal, saying Parra’s claims are federally preempted. It added that even if the court decided the claims were not preempted, it should find that Parra did not provide enough detail to support them.
Judge Vance agreed, dismissing the suit with prejudice.
She said that in asserting his manufacturing design/defect claim, Parra “makes no mention of anything that went wrong in the manufacturing process and similarly mentions no violation of any federal design or manufacturing requirements.”
Parra’s failure-to-warn claim, the judge said, does not reference the Food and Drug Administration-approved warnings for the Titan prosthesis or allege that Coloplast deviated from them.
The judge ruled that Parra’s breach-of-express-warranty claim lacked the requisite factual allegations “to raise a right to relief above the speculative level.”