Tag Archives: proof

Amongst the many interesting topics that Paul Offit’s Autism’s False Prophets brings up are how science is perceived in the media, received by the public, and judged in the courtroom.

For reference, Offit brings up the fiasco of the 1990s lawsuits against the makers of silicone implants.

Kristin E. Schleiter writes an excellent paper about the history of silicone implants and the litigation that followed them in Silicone Breast Implant Litigation in the AMA Journal of Ethics.

Breast implants, she says, were first introduced in the 1960s. In 1976, the FDA was granted the power to regulate them as medical devices, but did not specifically do so until 1988. Prior to that, in 1984, Maria Stern won [the first case against an implant manufacturer totaling] “$211,000 in compensatory damages and $1.5 million in punitive damages from silicone breast implant manufacturer Dow Corning after claiming that her breast implants caused autoimmune disease.” This was the first, but not last case to bring implants to court. In the 1990s public opinion was against the makers of breast implants and thousands of suits were filed against their makers.

A natural progression

-Schleiter’s paper goes through a list of important individual and class action cases that I don’t feel the need to repeat here, however it is a fascinating read.

In the midst of these lawsuits, the attorney, “John O’Connor, relied on PR and sympathy to win [his case representing client, Pamela Johnson]. O’Connor hired a public relations firm that gave interviews to Phil Donahue and 60 Minutes, and the trial was broadcast in its entirety on Court TV. At trial, O’Connor set up a rebuttable presumption, asking the jury to hold MEC liable unless the company could prove that they knew their implants were safe at the time they marketed them. “

That is, it doesn’t matter whether the implants caused damage, but instead, whether the company, MEC, could prove them to be safe.

In the wake of litigation, studies began appearing showing the lack of any connection between breast implants and negative health outcomes.

Schleiter provides a list of papers reviewing the safety or danger linked to implants consolidated here:

•  Plastic and Reconstructive Surgery published a study that found no increase in the incidence of breast cancer in women who had received breast implants
• The New England Journal of Medicine soon followed with a study that concluded that breast implants did not substantially increase a woman’s risk for breast cancer
• In 1994- New England Journal of Medicine published a study by Mayo Clinic epidemiologists that found no increased risk of connective tissue disease in women with silicone gel breast implants
• In 1995, the Journal followed with yet another study—this one larger and more refined—that found no association between implants and connective tissue disorders.
• In 1997, the American Academy of Neurology reviewed existing silicone gel breast implant studies and concluded that there was no link between the implants and neurological disorders
• Also in 1997 Journal of the National Cancer Institute published a review of studies and concluded that breast implants did not cause breast cancer

However, billions of dollars had already been awarded or settled upon and Dow Corning was forced into Bankruptcy.

With respect to Offit’s book, the question arises, “How should science be settled in court?” It’s tempting to say that the cases should prompt investigations that statistically determine the culpability of, in this case, breast implant manufacturers. But that leads directly to one of the core problems that raised the specter of a MMR / Autism connection. Andrew Wakefield’s paper was intended to do just that – provide scientific evidence to help determine a case. In that case, the British government provided $30M to a law firm in order to fund their investigation. But that’s not proper either. To begin with an outcome in mind, i.e. “MMR shots cause autism” and then try to uncover evidence to support that idea is putting the cart in front of the horse. It’s OK to ask, “Does MMR vaccination cause autism?” and then look for the answer, but starting with the answer in mind – No.

For those in my Pathophysiology class, consider, as you read these next chapters, how these questions should be answered. If you were in the position to outline how cases involving questions of science / healthcare should be handled in court, how would you do it? Are these questions any different from the other questions that courts have to address?