Jon Campisi Feb. 20, 2014, 3:38pm


A federal judge in Philadelphia has dismissed a lawsuit against Coloplast

Corp. that was brought by a man who claims his penile implant malfunctioned.

U.S. District Judge Mary A. McLaughlin granted the medical device manufacturer’s motion to dismiss the litigation initiated by John Starks, who claims he sustained injuries due to a defective Titan OTR Inflatable Penile Implant.

Starks, who initially filed his complaint in May 2013 at the Philadelphia Court of Common Pleas – it was removed by the defense to federal court two months later – claimed that the penile implant, which was surgically placed in his body in the spring of 2010 by a urologist at Hahnemann University Hospital in Philadelphia, ultimately stopped working and even leaked internally.

The plaintiff ended up having to undergo a second surgery in March 2012 to remove the defective implant and replace it with another penile device.

Coloplast petitioned the court to dismiss the litigation in July 2013, arguing that the plaintiff’s claims are preempted by federal law.

Starks sued for negligence, strict liability, breach of implied and express warranties, and breach of contract.

In her Feb. 18 order, McLaughlin dismissed the plaintiff’s breach of express warranty and breach of contract claims without prejudice, allowing 30 days by which to file an amended complaint with regard to these two counts only.

The judge also dismissed the negligence, strict liability and breach of implied warranty claims, albeit with prejudice.

On the breach of contract claim, the judge wrote in her memorandum that she agreed with Coloplast that Starks did not adequately allege the elements of such a cause of action, but rather the plaintiff “mis-labels snippets from an advertising brochure mailed to a third party.”

Starks had alleged that when he received the penile implant in 2010, he and the defendant had a contract in which Coloplast promised to replace the implant throughout the plaintiff’s lifetime.

The judge, however, determined the “contract” to merely be an excerpt from an advertising brochure.

Pennsylvania law, McLaughlin wrote, requires that a plaintiff suing for breach of contract to establish the existence of a contract, including its essential terms, a breach of a duty imposed by the contract, and resultant damages.

The judge wrote that the brochure referenced by Starks does not set forth any terms between the parties, and is not signed or dated.

Starks also didn’t allege that there was any offer and acceptance of a contract between himself and Coloplast.

On the breach of express warranty claim, Starks asserted that Coloplast assured him that the implant was in good, working condition, and of good materials.

The judge noted that under state law, a breach of express warranty claim is not preempted by the Medical Device Amendments of 1976, since express warranty claims arise out of the representations or promises of the seller.

McLaughlin determined that Starks failed to allege any affirmation of fact or promise made by Coloplast that relates to the Trident implant that would amount to an express warranty.

“Additionally, Starks has not plead 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 judicial memorandum states. “Therefore, Starks has not set forth the elements of a breach of express warranty cause of action.”

Like the breach of contract claim, however, McLaughlin gave Starks the opportunity to file an amended breach of express warranty claim.

McLaughlin dismissed the breach of implied warranty claim with prejudice, ruling that that count in the suit is preempted by the Medical Device Amendments, which require new Class III devices to undergo a rigorous premarket approval process, according to the judge’s memorandum.

Class III medical devices includes the likes of replacement heart valves, implanted cerebella stimulators and pacemaker pulse generators.

Such devices receive the most oversight by the federal Food and Drug Administration, and as such are often preempted by the premarket approval process when it comes to civil litigation.

In her memorandum, McLaughlin wrote that state common law claims against manufacturers of such medical devices that are approved through the FDA process are subject to federal preemption.

In the end, McLaughlin also determined that the plaintiff’s negligence and strict liability claims were preempted by federal law in this particular case.

On the latter, McLaughlin wrote that Starks did not assert that Coloplast has in any way failed to conform to the FDA requirements prescribed by its premarket approval process or that the defendant deviated from or violated any of the FDA’s federal statutes or regulations.

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