Recently, a panel that advises the Food and Drug Administration on regulatory policies related to women’s health met just outside of Washington to review the latest in medical science and technological advancements.
Almost all medical devices work as intended, but some patient outcomes are not optimal. Unfortunately, some will discard patients’ well-being and exploit those rare occurrences for personal gain.
Recently, some trial lawyers appear to have taken advantage of one vulnerable group, leaving thousands of women having undergone perhaps unnecessary surgeries and many facing painful side effects from them.
What began with class action settlements to support the removal of silicone breast implants in the mid-1990s has spread to the removal of vaginal mesh implants used to help women cope with urinary tract issues. Research ultimately determined that silicone breast implants were safe, and the FDA again cleared them for use in the United States, but not before lawyers squeezed more than $3 billion in settlement money out of manufacturers.
Trial lawyers are now using the same approach on women who have received pelvic mesh.
Marketers — yes, marketers — identify women who have had mesh implants, with a special focus on those with limited means or little or no insurance. They approach these women with what must seem like a tremendous offer: They will set up an appointment for surgery to remove the mesh implant, recruit a doctor to perform it, arrange for a hotel for the woman and her family during the surgery and recovery, and even set up a loan to pay for it all — which doesn’t need to be repaid unless there’s a legal settlement.
Trial lawyers, in turn, work with activist groups and even create their own groups, all to mount opposition campaigns to medical devices, further driving up costs.
What could go wrong? Unfortunately, plenty.
First, an entire cottage industry now needs patients to keep its wheels of commerce turning.
Second, the cost of the surgery is often inflated to drive up the reimbursement. Doctors who perform the surgery may not know or care if it is actually needed — $14,000 per day for surgeons buys a lot of acquiescence. And the loan comes at interest rates so high that patients — the victims here — may end up owing thousands of dollars to the finance companies that underwrote these potentially unnecessary surgeries.
Oh, and the organizations that control and disburse the money defendants pay into funds to address patient needs? They’re in on it, too.
It has gotten so bad that the U.S. attorney’s office for the Eastern District of New York has begun to look into it. Last September, the New York Times reported prosecutors had issued subpoenas “seeking information about whether women had been tricked into undergoing unnecessary surgery and whether doctors or others had received improper payments.”
The idea, the Times reported, was to rack up a large number of women who had undergone surgery to remove mesh implants to then convince juries to award large settlements against the manufacturers.
It told the story of a woman in Arkansas who had had some problems with her mesh implant but had not sought medical treatment. One day, she got a call from a woman who said her mesh implant was defective, and if she didn’t get it removed, she could die.
This call was not from a doctor, but from a phone solicitor with no medical training, no meaningful information on the woman’s condition, and who certainly was not able to provide diagnosis over the phone. But just days later, the woman was on an operating table in Orlando, with her husband and children staying in a nearby hotel, and suddenly thousands of dollars in debt.
Her surgery led to further problems — swelling in her legs and her stomach seized up, leaving her unable to control her bladder, which ultimately confines her to home most of the time.
According to Reuters, about half the affected patients go for surgery, but that half receives 90 percent of the settlement money. So naturally, trial lawyers seek to get as many women into surgery as possible.
America’s legal system was set up to help people receive compensation when products or services they bought do not perform as expected. Large settlements that enable firms to address thousands of lawsuits at once work only if the payments go to the right people in the right amounts.
A side industry has sprung up dedicated to siphoning off as much of that money as possible to lawyers, lenders and activists. We all pay for these parasites through higher premiums and less access to medical devices. The women involved pay with mental, physical and financial suffering.
In short, it’s worth it to everyone to stop this abuse.
Brian McNicoll is a columnist who has worked as a newspaper writer, editor and columnist, as a senior writer for The Heritage Foundation and as director of communications for the House Committee on Oversight and Government Reform.
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