Penis-Implant Warranty Suit Given Another Shot


     (CN) - A man who had to replace his inflatable penile implant after the first one leaked must amend his warranty and contract claims, a federal judge ruled.
     John Starks says a urologist first fitted him for a Titan OTR Inflatable Penile Implant at Hahnemann University Hospital in Philadelphia nearly four years ago.
     After the implant "malfunctioned, leaked, and 'otherwise would not operate' in January 2012, however, Starks allegedly underwent another surgery to remove the implant and have another penile device implanted at Lankenau Medical Center. The surgeon who implanted the first device said a leak had caused it to malfunction, according to the complaint.
     Starks says his new surgeon described the first implant's malfunction as a result of "a break in the tubing of the right corporal cylinder."
     He sued the Titan's manufacturer, Coloplast Corp., for negligence, strict products liability, breach of warranty claims, and breach of contract.
     It is not the first time Coloplast has faced such claims. In February 2012, a different federal judge in Philadelphia advanced claims from a man who said his first Coloplast prosthesis was defective, and the replacement pump stopped inflating after a "blowout."
     Starks meanwhile noted in his complaint that his first surgeon had received a patient guide titled "Straight Talk about Erectile Dysfunction," which said that "Coloplast will replace the inflatable implant, or any component, for any reason during the lifetime of the patient."
     In addition to the additional medical bills, Starks said he has suffered from post-surgical pain and suffering; extra scar tissue; loss of life's pleasures, including sex; embarrassment and humiliation; and impairments of his bodily functions.
     U.S. District Judge Mary McLaughlin dismissed Starks' claims for breach of contract and breach of warranty with leave to amend on Feb. 13.
     "Starks has failed to allege any affirmation of fact or promise made by Coloplast that relates to the [Titan] implant that would amount to an express warranty," McLaughlin wrote. "Additionally, Starks has not pleaded any details regarding the content of any express warranty, how it was made, that it became the basis of the bargain, or that it was directed to Starks."
     The Coloplast advertisement referencing its "lifetime replacement policy" does not suffice to show that the company had a "contract" with Starks, according to the judgment.
     "The court agrees with Coloplast that Starks does not adequately allege the elements of a cause of action for breach of contract," McLaughlin wrote. "Rather, Starks 'mislabels snippets from an advertising brochure mailed to a third party.' The 'Straight Talk' document attached at Exhibit A does discuss a lifetime replacement policy, but it is not clear to the court that the brochure sets forth the terms of any agreement between the parties. For example, the document is not signed or dated. Starks has also not alleged that there was any offer and acceptance between Coloplast and himself. Therefore, Starks fails to state a claim for breach of contract."
     Starks has 30 days to amend those claims.
     McLaughlin tossed the remaining claims with prejudice, finding that the "broad references" Starks made to federal regulations did not sufficiently support his negligence claim.
     The strict liability claims, meanwhile, are "even more general than his allegations of negligence and do not plead 'a violation of FDA regulations,'" according to the ruling. "He alleged that Coloplast 'manufactured, distributed, assembled ... tested, inspected, sold and placed into the stream of commerce a penile implant which it defectively designed' and 'which malfunctioned and was unreasonably dangerous.' Starks did not assert that Coloplast has in any way failed to conform to the FDA requirements prescribed by its premarket approval or that Coloplast deviated from or violated any of the FDA's federal statutes or regulations."
     McLaughlin also found that the Medical Device Amendments of 1976 pre-empts the implied warranty claims, which "relate to standards that are different from, or in addition to, the federal requirements."