RICHARD RAWLS : Attorney, Palmieri, Tyler, Wiener, Wilhelm & Waldron

An individual sues a manufacturer for product liability and it’s considered David vs. Goliath. That has happened with silicone-gel breast implant makers who were hit with a flood of lawsuits from women blaming the product for causing serious illnesses. Yet Irvine attorney Richard Rawls, who last summer successfully defended McGhan Medical Corp. and 3M in a trial in Hawaii, says it’s hardly as simple as victim vs. villain. Scientists disagree over the issue, said Rawls, who recently talked to Times correspondent Ted Johnson.

*

Why do you believe the jury decided in favor of your clients, McGhan Medical Corp. and 3M?

They simply did not accept (the plaintiffs’ arguments) that these breast implants had caused injuries to that particular woman. If you talk to people in the scientific community, you’ll find a great deal of skepticism over the claims that silicone is causing all of these things. What evidence does exist to date shows that there is not a relationship.

In December, a jury in Houston awarded $25 million to a woman who sued Bristol-Myers Squibb Co. How was that case different?

There were some documents in the manufacturer’s files that the plaintiff’s lawyers in Houston were able to pull out and distort, take them out of context, and make them sound like the manufacturer was not concerned about the safety of its products. You can piece together in any situation a story that sounds bad. Obviously there are different lawyers trying the case, and from what I’ve seen in videotape and what I’ve read in reference to the trial, they may have not been aggressive enough in taking on the plaintiffs’ witnesses. One witness was Dr. Nir Kossovsky. He’s a very impressive guy, he’s very knowledgeable, but I think he will even admit that all he has really done is postulate a theory that silicone might be causing these illnesses. I sat through a deposition with Dr. Kossovsky (last week) and heard him agree on the record that his theory has not been generally accepted in the scientific community and there are people disagreeing with him. That is essentially how I took him on in Hawaii.

Do you concern yourself with your client’s image?

That’s really not my job as a lawyer representing a company that makes products. But I truly believe that when I get up in front of a jury that, in the context in which they were operating, my client did the appropriate things. Historically, silicone has always been regarded as one of the least reactive materials available for implantation in the human body. In 1983, someone came along and said that maybe silicone was causing these diseases. And when some doctors started reporting in the literature that they had patients with some of these diseases and they had breast implants too, eventually you got enough information to justify somebody taking a closer look at the issue.

How did you counter the emotional pull that the plaintiff had in her testimony?

The American people are a very compassionate people. Unfortunately there is the risk that when a jury sees that a plaintiff has had a tough time of it, they may overlook the evidence in their rush to do something to help that person. It’s a difficult thing to combat. What I did in the case in Hawaii is I tried to also make the jury see the human side of the company. We had the woman who has been in charge of the production of these implants for the entire time. We were able to show all these people have been working at this company for 15 or 16 years, making these products, doing the best they can. They’re good people, and they aren’t out there to hurt somebody. By humanizing the defense, I think that helped the jury set aside some of the compassion they may have felt for the plaintiff and focus on the causation question.

Still, should doctors inform patients about the risks when some scientists have questioned the safety of a product?

If the scientific community is saying right now, “We don’t know whether silicone has any immunological implications for women,” and the doctor has a patient there wanting to know about breast implants and risks, it’s a doctor’s judgment call. Much of that information you want to convey to the patient. But you don’t necessarily want to convey false information that may discourage her from doing something that is perhaps very important. For example, a woman who has had a mastectomy, whose life might be improved by a breast implant.

How do you defend manufacturers in light of the Food and Drug Administration restrictions on implants?

In a general sense, contrary to what a lot of people may be thinking, the FDA has not said that breast implants are unsafe. They have basically said, “We want more documentation of their safety, and until we get that, we’re going to have a limited use program.” Under certain circumstances, gel-filled breast implants are available, and with the FDA’s blessing. Unfortunately, it can be taken out of context, which it often is, and it can be made to sound more serious than it is.

Are other lawsuits involving silicone products in the works?

It’s in virtually all kinds of surgical tubing, what is used to coat syringes. It’s used in a variety of the antacids, in gel formulations. The reality is we have probably all have been exposed to significant amounts of silicone throughout the course of our lives. I don’t think this litigation will necessarily stop with breast implants. People are already talking in the discovery procedure, “Well, we want all the silicone studies that you have done involving all of the implants.” I’m not sure that is really a good thing for any of us.

Is there a chance that medical device manufacturers will be scared away from putting new products on the market?

It does raise questions of: “Do I really want to get myself involved in a product that might end up costing more in the long run than I could ever hope of making out of that product?” It could have a chilling effect and definitely impede the development of new and novel ideas.

On the $25-million verdict against Bristol-Myers Squibb Co. . . .

“The lawyers in that case were interviewed on TV. Now every woman in America thinks her breast implant case is worth $25 million.”

On what it takes to defend a manufacturer in a trial. . .

“If you can set aside all of the compassion and prejudices, and get the jury to look at it objectively, you will have a chance at winning.”

On whether manufacturers will be reluctant to market new products. . .

“They may find that the profit would be minimal on it compared to the exposure they face in case something allegedly goes wrong with that product.”

On witnesses who claim a company is at fault. . .

“It’s really not an issue of company conduct. It’s an issue of whether silicone is causing all of these things that women are complaining about.”