By Michael J. Sacopulos, JD

In recent weeks, our European friends have both a monetary policy crisis lurking and a nasty public health situation to deal with. Over the past year, tens of thousands of European women have received substandard breast implants, produced by the French firm, PIP (Poly Implant Protheses). These implants are prone to ruptures; worse the silicone in these implants is industrial grade, not medical grade silicone. Although the evidence of adverse outcome is at best weak, the governments of the United Kingdom, France, Germany and the Czech Republic have advised women with PIP implants to get them removed. However, the Austrian government has declared that there is no evidence to support the removal of these implants. Questions of whether PIP implants should be removed, and if so, who should pay the cost of removal are being asked against a backdrop of panic. Without doubt, the PIP implant situation is a mess.

Some of you may be reminded of the movie Groundhog Day. You have that feeling that those of us here in the United States have been through a silicone implant public health scare before. The better cultural reference is Chapter 66 out of Moby Dick. Remember? After much effort, a dead Sperm Whale is lashed the side of The Pequod one evening. It is to be processed by the crew the next evening. What happens next is horrific. Huge numbers of sharks come and shred the whale carcass. Some of the crew try to kill off sharks with wailing-spades but this in It won’t be long before you can substitute PIP and those associated with its implants for Melville’s dead whale. Rest assured, the litigators are coming to feed. In a bloodletting that will take place across the sea, PIP and its business associates will be attacked and devoured from all angles.

The first action against Dow-Corning for a ruptured implant came in 1977. The plaintiff received a $170,000 settlement. Amidst the FDA involvement and congressional hearings the lawsuits kept coming. A month long trial in 1984 resulted in a $1.7 million dollar judgment against Dow-Corning. By 1991, 137 individual lawsuits had been filed against Dow-Corning.Shortly thereafter a class-action lawsuit was filed. By December 1992, a litigation frenzy was in high gear and 3,558 suits had been filed against Dow-Corning. One year later that number increased to 12,359. In June of 1994, the Mayo Clinic published a study in the New England Journal of Medicine which found no increased risk of disease or disorder in women with silicone implants. By December of 1994, 19,092 individual lawsuits have been filed. So much for the Mayo Clinic and the New England Journal of Medicine. In 1995, the American College of Rheumatology offered up a statement saying that the evidence was compelling that “implants did not cause systemic disease." In May of 1995, facing more than 20,000 lawsuits, Dow was bleeding out. Dow-Corning filed for Chapter 11 bankruptcy. Knowing that Dow-Corning was not long for this world, plaintiff attorneys had begun filing suit against its parent company Dow Chemical. In October 1995, Dow Chemical had about 18,000 implant lawsuits pending against them, and by late 1998, Dow agreed to a $3.2 billion dollar settlement. The claimants were to receive anywhere between $2,000 to $250,000. Months later the Institute of Medicine released a 400-page report stating that silicone implants do not cause any major disease such as lupus or rheumatory arthritis.Too late. The damage was done.

I am uncertain of many things. I don’t know whether the industrial grade silicone in the PIP implants will prove harmful. I don’t know the tort laws in the Czech Republic. Perhaps Germany will reverse its opinion and join with Austria by stating that there is no evidence to support removing PIP implants. Who knows? But there are several things I feel confident about:

1) PIP is carrion;

2) Women with PIP implants will receive uneven and unfair compensation related to their implants;

3) Science and medicine will not link PIP to any illness or disease prior to the tidal wave of litigation that is in the process of commencing; and

4) Business associates of PIP will be collateral damage.

 The PIP story will be much like Moby Dick. We might not know all the parts of the story but we are clear on how it ends. For now it seems that we are at the part of the story where Melville states “But in the foamy confusion of their mixed and struggling hosts, the marksman could not always hit their mark; and this brought about new revelations of the incredible ferocity of the foe." Aye, aye Captain.

About the Author

Michael J. Sacopulos is a Partner with Sacopulos, Johnson & Sacopulos, in Terre Haute, Indiana. His core expertise is in medical malpractice defense and third party payment disputes. Sacopulos may be reached at [email protected].