Lawsuit seeks $4 million from maker of implant

April 11, 1993|By Darren M. Allen | Darren M. Allen,Staff Writer

A Westminster man who says his penile implant failed to work and eventually ruptured is suing the device's maker for $4 million.

Eugene Duvall, 62, a retired Washington police officer, suffered "economic and psychological loss as well as severe humiliation" because of the malfunctioning Surgitek Uni-Flate 1000, he said in an eight-count negligence suit filed in Carroll County Circuit Court.

A doctor surgically inserted the $7,200 device in March 1990, the suit says. Four months later, Mr. Duvall tried to use the device, but it"was not working as it should," the suit says.

He returned to his doctor, who could not make adjustments to make the implant work. The nonfunctioning implant ruptured, causing Mr. Duvall to have two strokes and to suffer continuous pain in his groin, the suit claims.

The device was removed and replaced with another type of implant Dec. 23, 1992. The lawsuit says Mr. Duvall still is recovering from that surgery and has not been able to resume marital relations with his wife, Patricia Sue, since 1990. She is a plaintiff in the lawsuit.

"This is a growing problem that many men are ashamed to come forward about," said Baltimore attorney David B. Shapiro, who represents Mr. Duvall. "My client has suffered immensely from this . . . product."

Surgitek offered to pay for a replacement, but Mr. Duvall decided to get a device from another company.

Nancy Coleman, a spokeswoman for Surgitek's parent company, Bristol-Myers Squibb Co., declined to comment on the lawsuit or on the Uni-Flate 1000.

Mr. Duvall's experience is becoming more common nationwide, according to the Food and Drug Administration.

FDA spokeswoman Sharon Snyder said last week that the agency has received more than 6,500 complaints nationwide about penile implants since 1984.

In the coming months, the agency is proposing to require manufacturers of penile implants to submit information to support safety claims.

The FDA hopes to avoid much-publicized problems such as those experienced with silicone breast implants in 1991, when ,, XTC the agency halted their use after revelations that the implants could leak and become hazardous to women.

"We want to gather the information on these devices and ensure their safety," Ms. Snyder said.

Ms. Snyder said the FDA has received 1,719 complaints about the Uni-Flate 1000 since 1989. But agency officials in Baltimore said that no complaints against the Uni-Flate or any implant had been recorded in Maryland.

Several people have won implant lawsuits, including an Oregon couple awarded $1 million after a jury determined that a doctor erroneously inserted one that caused the man to contract

gangrene.

Last year, a Louisiana man sued Surgitek for $1.6 million over its Flexi-Flate device. That case, which claims that more than 500 men have experienced problems with the Flexi-Flate, is still pending in U.S. District Court in Baton Rouge.

Penile implants are one of several ways to treat impotence, a condition affecting an estimated 100,000 men in the Baltimore metropolitan area and 12 million men nationwide, health officials said.

When they work the way they're supposed to, implants allow men to lead active sex lives. When they don't work, as Mr. Duvall asserts in his suit, the results are devastating.

Mr. Duvall has "suffered from depression over the fact that he has had no sex with his wife, not to mention the permanent nature of his condition," the suit says.

"It's been a drain financially and emotionally," Mrs. Duvall said. "We've lost years we can't get back."

Mr. Duvall claims in the suit that Surgitek knew of problems with the Uni-Flate, and that the device "was dangerously defective and improperly checked" before it was marketed to the public.

Had Mr. Duvall known of the product's history of rupture and malfunction, he "may not have selected said device for insertion into his body," the suit says.

The Duvalls are asking for damages based on negligence, breach of warranty, defective product design, defective product manufacture and loss of consortium.

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