Product liability claim against penile implant manufacturer can proceed, judge rules

By Jon Campisi | Mar 13, 2012

A federal judge in Philadelphia has allowed a strict liability claim over an alleged defective penile implant to proceed against the device’s manufacturer, while simultaneously dismissing a negligence claim against the company.

In a Feb. 27 order, U.S. District Judge Cynthia M. Rufe granted a motion for summary judgment that was filed by Minnesota-based Coloplast Corp. on the negligence claim against the company that was initiated by Eric Banks, a Philadelphia man who alleges the penile device he had surgically implanted to treat his erectile dysfunction malfunctioned.

In his lawsuit, which was originally filed in June 2010 at Philadelphia’s Common Pleas Court and later transferred to U.S. District Court, Banks claimed that the inflatable penile device that he had had implanted during a December 2007 surgery at Albert Einstein Medical Center in Philadelphia had to be surgically removed in September 2008 after the device began experiencing difficulties deflating properly.

The lawsuit claimed that as a result of the malfunction, Banks experienced an inability to work, an inability to sit for a prolonged period of time and a lack of sexual activity.

The complaint accused Coloplast of negligence for failing to properly design the prosthesis to ensure its durability and safety, failing to adequately evaluate and test the device, and failing to properly inspect the prosthesis before placing into the stream of commerce.

The suit also contained a count of strict liability, with the plaintiff arguing that the prosthesis was sold in a defective, dangerous and/or hazardous condition, and that it was “unfit for implantation into the human body.”

According to background information contained within Rufe’s ruling, Banks had the Coloplast device removed in June 2009, less than a year after it was initially removed and re-implanted, and had it replaced by a similar product designed by a different manufacturer.

This came after Banks experienced a “blowout,” or tear in the pump portion of the device. While Banks sought medical attention the first time around because the device wouldn’t deflate, the second time he consulted doctors because the device would no longer inflate.

After the Coloplast device was removed, Banks’ doctors photographed the damaged pump on the prosthesis.

The present whereabouts of the Coloplast device, however, aren’t known at this time.

In its motion for summary judgment, Coloplast argued that its defense was “irreparably prejudiced by Plaintiff’s failure to preserve the prosthetic device. As Coloplast cannot examine the device, it cannot determine the nature and cause of any defects in the device.”

The judge disagreed, however, writing that courts have held that when a device or product is unavailable, circumstantial evidence may be used to prove strict liability.

In this case, the circumstantial evidence presented by Banks included the malfunction of the product, the timing of the malfunction and the elimination of certain other possible causes.

“The Court will not enter summary judgment simply because Plaintiff has failed to preserve the implant,” Rufe wrote. “Rather, the Court will assess the merits of the claim.”

Rufe noted that evidence provided by Banks demonstrated that he visited his doctor and had multiple surgeries in order to correct the problem, efforts that prove Banks believed he had been implanted with a defective product.

“A reasonable jury could conclude that the timing of both problems gives rise to the inference that the device was defective when it left Coloplast’s control,” the ruling states. “There is no record evidence indicating that abnormal or unintended use led to the malfunction.”

The judge dismissed Coloplast’s argument that because the device was implanted by a surgical team, it’s possible that the malfunctions were the result of improper surgical implantation.

“Coloplast’s argument merely raises a genuine issue of material fact as to when and how the defect occurred; it does not support an entry of summary judgment in Coloplast’s favor,” Rufe wrote. “A reasonable jury could determine, without an expert opinion, whether the defect was preexisting or caused by the medical provider.”

Rufe did, however, agree to dismiss the negligence claim against Coloplast, writing that Banks failed to meet his burden of proof with regard to each of his theories of negligence, which included negligent failure to adequately warn doctors and consumers of the risks or dangers of the penile prosthesis, negligent design and manufacture of the product, and negligence per se.

One of the reasons for the dismissal of the negligence count was that Banks failed to submit an expert’s report, something that is usually required to determine the adequacy of warnings provided to the medical community by a product’s manufacturer.

“To proceed on this claim, Plaintiff would need to produce an expert opinion, as the penile prosthetic industry’s standard of care is beyond the knowledge and experience of a lay juror,” Rufe wrote.

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