Class actions filed against penile implant maker.

Plaintiffs' attorneys in California, South Carolina, and Minnesota have filed separate class action suits against a maker of penile implants on behalf of men who have been injured by the devices. The suits seek compensatory and punitive damages against American Medical Systems, Inc. (AMS), the largest U.S. manufacturer of inflatable penile implants.

Penile implants are used by men who have difficulty getting and maintaining an erection. The product manufactured by AMS consists of a cylinder or tube inserted into the penis, a pump positioned in the scrotum, and a reservoir of fluid implanted in the abdomen. When the user manually exercises the pump, fluid is drawn into the cylinder. After sex, the fluid is pumped back into the reservoir.

A large number of the implants have failed to operate properly and have had to be surgically removed. According to Dan Bolton of San Francisco, who filed one of the recent class actions, "The failure rate of penile implants may be in excess of 30 percent, and likely significantly higher." (King v. American Medical Systems, Inc., No. C94 1808 CAL (N.D. Cal. filed May 20, 1994).) Attorney Steven Fabbro of San Francisco joined Bolton in bringing the suit.

"The purpose of this suit is to hold AMS accountable for an unsafe product that is poorly designed and prone to failure," Bolton said. His complaint states that AMS "knew at all times that their penile implants would not last very long after implantation in the human body." Dangers of the devices, he said, include infection, extrusion, leakage, multiple failures, immune problems, scarring, loss of sensation, pain, and disfigurement.

Fabbro said, "The manufacturers of these defective products have benefited far too long from a conspiracy of silence due to the sensitive nature of the product." AMS has frequently settled suits under protective orders that kept information about the product failures secret.

A class action was also filed in Charleston, South Carolina, by attorney A. Hoyt Rowell III. (Turner v. American Medical Systems, Inc., No. 2:94 1313 2 (D.S.C. amended complaint filed June 2, 1994).) He was joined by Lewis Saul of Bethesda, Maryland; J. Michael Papantonio of Pensacola, Florida; and William Morton of Atlanta, chair of ATLA's Penile Implant Litigation Group.

This suit claims that AMS "intentionally withheld information concerning potential dangers resulting from the installation and use" of the product. Like the other actions, the suit identifies a class consisting of all men who had penile implants installed in their bodies. The class also includes spouses "who suffered a loss of consortium as a direct and proximate result" of the product failure.

A third class action has been filed by attorney Roger Brosnahan in Minneapolis. (Pipia v. American Medical Systems, Inc., No. 4-94-521 (D. Minn. filed June 16, 1994).)

AMS is headquartered in Minnetonka, Minnesota. The company is a subsidiary of Pfizer, Inc., a Delaware corporation with its principal place of business in New York state.

Bolton said the class action was necessary because the damages suffered by individual members of the class may be relatively small in comparison with the large expenses likely to be incurred in establishing liability and causation. The expense would make it impractical for individuals to pursue separate litigation to vindicate their rights.

"In the absense of a class action," he said, "the defendants will retain the benefits of their wrongdoing."

Bolton, with the support of the other attorneys, has petitioned for a multidistrict litigation (MDL) order. The Judicial Panel on Multidistrict Litigation in Washington, D.C., has given AMS through July to answer the complaints, after which a hearing may be held to determine the need for an MDL order.

"There is no way of knowing if that will happen," conceded Rowell. "And if it is approved, no one has any idea what court might be assigned."