Most of the claims brought by a man whose penile implant broke two years after it was put in were preempted by U.S. law governing medical devices, a federal judge has ruled, dismissing those claims with prejudice.
U.S. District Judge Mary A. McLaughlin of the Eastern District of Pennsylvania granted the motions to dismiss filed by Coloplast, the maker of the device, on the negligence, strict liability, and breach of implied warranty claims with prejudice. She dismissed the claims of breach of express warranty and breach of contract claims without prejudice.
“State common-law claims against manufacturers of medical devices that are approved through premarket approval are subject to federal preemption,” McLaughlin said in her opinion in Starks v. Coloplast.
“The Supreme Court determined that the Medical Device Amendments’ express preemption clause ‘bars common-law claims challenging the safety and effectiveness of a medical device given premarket approval by the’” U.S. Food and Drug Administration, the judge said, quoting from the high court’s 2008 opinion in Riegel v. Medtronic.
In that opinion, the Supreme Court established a two-part test to determine if a given claim is preempted. Applying that test, McLaughlin found that most of the claims brought by John Starks against Coloplast would be preempted.
The law that preempts Starks’ claims is the Medical Device Amendments of 1976, which requires that certain new medical devices filed with the FDA go through a process called premarket approval. The judge characterized it as “rigorous.”
It involves a detailed review of scientific and clinical data, McLaughlin said, which means the FDA spends an average of 1,200 hours reviewing each application.
“The FDA is required to weigh ‘any probable benefit to health from the use of the device against any probable risk of injury or illness from such use,’” McLaughlin said, quoting from the statute. “The FDA may approve devices that pose significant risks to the patient if they also offer large benefits,” she said.
The devices that are required to go through the premarket approval process are those in Class III—the FDA has three categories of medical devices based on their level of risk with Class III having the most oversight by the agency.
The implant at issue, the Titan OTR Inflatable Penile Implant, is a Class III device, as are replacement heart valves, implanted cerebellar stimulators, and pacemakers, according to the opinion.
The penile implant is described in a footnote of the opinion as “a device that consists of two inflatable cylinders implanted in the penis, connected to a reservoir filled with radiopaque fluid implanted in the abdomen, and a subcutaneous manual pump implanted in the scrotum. When the cylinders are inflated, they provide rigidity to the penis. Such devices are used in the treatment of erectile impotence.”
The Titan implant, which was called the Mentor Alpha I Inflatable Penile Prosthesis when it was introduced, finished the premarket approval process in 2000, according to the opinion.
The device had three FDA-approved changes between 2002 and 2008.
Starks had a Titan implant put in on March 15, 2010, and two years later, in January 2012, the device stopped working and began to leak, according to the opinion. Starks had a second surgery in March 2012 to have the implant removed and a replacement put in. He filed suit a year later.
When the U.S. Supreme Court considered the Medical Device Amendments’ preemption clause in Riegel, which dealt with a Class III catheter, it decided that the strict liability claim, breach of implied warranty claim, and negligence claims were preempted by the law.
In that opinion, the U.S. Supreme Court “established a two-part test for determining whether a claim is preempted,” McLaughlin said. “First, a court must determine whether the federal government has established requirements applicable to the medical device. Second, a court must determine whether the state common-law claims impose requirements that are ‘different from, or in addition to’ those imposed by federal law,” she said.
Most of the claims brought by Starks were preempted under that test, the judge found.
(Copies of the 21-page opinion in Starks v. Coloplast, PICS No. 14-0253, are available from The Legal Intelligencer. Please call the Pennsylvania Instant Case Service at 800-276-PICS to order or for information.) •