To Sue or Not to Sue in Implant Cases - Medical Malpractice Law & Strategy - March 1, 1992

By: Leslie Nicholson
Medical Malpractice Law & Strategy
March 1992

SEVERAL possible strategies have emerged in the proliferating silicone breast implant litigation, and one concerns whether to name the implanting/treating physician as a defendant along with the implant manufacturer. Reaction to the strategy has been mixed. However, a report earlier this month in The Wall Street Journal may convert some skeptics; it suggests surgeons were given many reasons to be concerned about the implants' safety long before the recent explosion of scrutiny and disclosure of potentially incriminating documents from manufacturers.

An obvious reason for suing a physician in breast implant litigation is for substantive malpractice - e.g., failing to treat infections following implantation or performing the wrong procedure. Another basis for doing so involves informed-consent/failure-to-warn issues- especially, some attorneys say, if it will avoid an "empty chair" if an implant maker raises a "learned intermediary" defense.

However, there is some disagreement over what constitutes malpractice in this area, and even more disagreement on the extent of doctors' liability for not informing patients of the risks. Furthermore, there may be procedural bars that make filing malpractice claims impractical.

"Doctors are a responsible party for patients' injuries and should be held responsible for their share of the problem," says Karen Koskoff of Bridgeport, Conn., who has named doctors as co-defendants in most of the implant suits she has filed in state court.

In two of her cases, the women went in for breast lifts and ended up with implants they didn't know they would be getting; in another, the surgeon removed so much during a breast reduction that he had to insert an implant. Additionally, in every case, "there is clearly a lack of informed consent," she says; although the implant package inserts were "by no means adequate," none of the plaintiffs even received the information the inserts contained. She also believes many doctors may have minimized the fact that implants interfere with mammograms for breast cancer.

Some attorneys contend that reliance on the closed-capsulatomy technique of breaking up scar tissue that can form around the implants (it can cause the implant to rupture) may be malpractice. However, it may be difficult to prove that the procedure constitutes substandard care. Ernie Hornsby of Dothan, Ala.'s Farmer, Price, Smith, Hornsby & Weatherford and Ralph Knowles of Atlanta's Doffermyre, Shields, Canfield & Knowles discovered this when a doctor they were suing for rupturing both the plaintiff's implants during a closed capsulatomy was exonerated at trial.

Ms. Koskoff also has included doctors in product liability claims because of their role as "distributors" of a product. If suing a physician under the product statute is upheld as proper, "it's unlikely his malpractice insurer will cover a claim against him (this isn't malpractice for the care and treatment of a patient)," says Ms. Koskoff, explaining her rationale. "Thus, it makes the doctor vulnerable and may get him to force the insurer to settle."

Another reason cited for suing doctors is to head off the possibility that the manufacturer will raise a learned-intermediary defense. Ms. Koskoff confronted such a situation in an earlier suit involving a polyurethane-coated breast implant. Messrs. Hornsby and Knowles saw how it resulted in a defense victory in a California case tried two months before their's. Richard B. Garrett of Montgomery, Ala.'s Rushton, Stakely, Johnston & Garrett, who defended the doctor in the Hornsby/Knowles suit, said the co-defendant implant company did argue, albeit unsuccessfully, that it had indeed warned doctors against closed capsulatomies.

Skeptics' Reservations

Skeptics contend that based on the revelations in documents that are just now being disclosed by implant manufacturers, it is likely that informed-consent claims won't wash. "Doctors just didn't know," says Kenneth B. Moll of Chicago. "These could be seen as frivolous lawsuits." And although former implant maker Heyer-Schulte Corp. sent a letter to doctors in 1976 cautioning against performing closed capsulatomies, "the medical literature was actually recommending doing the non-invasive procedure," he points out.

However, a March 12 Wall Street Journal article- "Informed Consent? Plastic Surgeons Had Warnings on Safety of Silicone Implants" - reveals evidence that "over the past two decades, plastic surgeon...saw and ignored red flags in this lucrative branch of their speciality...[and] failed to alert women to possible health risks reported by several sources, including professional journals, manufacturers and some of their own patients." Among the experts who reportedly warned surgeons about possible problems with the implants, only to be "rejected and condemned," are Frank Vassey, a Florida rheumatologist; Melvin Silverstein, an oncologist at the Breast Center in Van Nuys, Calif.; and James Rudy, an engineer and former president of Heyer-Schulte.

Clearly, a lot of research must be done before a surgeon can be named as a defendant, proponents acknowledge. Furthermore, "In most states, there are lots of roadblocks to suing doctors," says Mr. Knowles-e.g., special pleading requirements, statutes of limitations, caps on compensatory and punitive damages, and mandatory review panels.

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