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Boston Scientific faces nearly 300 lawsuits so far over problems with mesh implants
2012 May 5
by Jon Chesto
When Sheila Roach was admitted for surgery in May 2008 to treat pelvic discomfort and urinary incontinence, she had no idea that the solution would be more painful than the problem.
But that’s exactly what Roach says happened, based on the lawsuit she filed against Boston Scientific on Tuesday in Boston federal court. The Modesto, Calif., resident blames a mid-urethral sling system made by the company for debilitating pain and infections – symptoms that continued or worsened after an attempt at corrective surgery in 2010.
Similar stories are repeatedly unfolding in court papers, as the pile of lawsuits grows against Boston Scientific and several rival manufacturers. In each case, vaginal mesh inserts were used to help with incontinence or a condition known as pelvic organ prolapse.
The wave of litigation poses a multimillion-dollar problem for Natick-based Boston Scientific and other medical device makers. The federal cases against Boston Scientific are being consolidated in Charleston, West Virginia, with similar suits against C.R. Bard, Johnson & Johnson and American Medical Systems.
Harry Bell, a Charleston lawyer on a steering committee for the plaintiffs, says nearly 1,300 federal suits citing vaginal mesh problems have been filed against the four companies, including nearly 170 naming Boston Scientific. Here in Massachusetts, another 100-plus suits against Boston Scientific are piling up in Middlesex County under the oversight of Judge Diane Kottmyer.
To some extent, the suits are being fueled by a U.S. Food and Drug Administration reversal last year. In July, the FDA stated that adverse events involving surgical mesh are not rare, contrary to its stance in 2008. The agency also ruled that vaginal mesh used in pelvic organ prolapse repair is no more effective than traditional, non-mesh repair. The FDA found that about 10 percent of women with transvaginal mesh inserts for pelvic repair experienced erosion of the mesh within 12 months of surgery.
Boston Scientific declines to comment on the litigation, other than saying the company believes that transvaginal placement of mesh for incontinence and pelvic organ prolapse remains an important treatment option for patients. The company says it continues to work with the FDA to ensure that appropriate information about the mesh products is provided to patients and their doctors.
Time and again, however, the plaintiffs are questioning whether they were adequately informed of the potential risks. In Sheila Roach’s case, she accuses the company of consistently underreporting problems and withholding information about the problems with its pelvic mesh products. Her lawsuit claims the company hid important facts from the FDA, doctors and patients.
Michael Appel, a Boston lawyer who provides local counsel in state suits against Boston Scientific, says plaintiffs are suing in a Middlesex courtroom with the hopes that a state case could be resolved more quickly than a federal one. In Massachusetts and at the federal level, Appel says, certain bellwether cases will be identified to pave the way for similar suits to be resolved. In the state cases, Appel says both sides reached an agreement for how discovery will be handled – an agreement that should be approved by Kottmyer soon.
Appel says the horrific problems described in these suits are drawing attention to the way the FDA originally approved these devices for sale. The vaginal mesh implants were treated by the FDA as Class II devices, meaning they didn’t need thorough clinical human trials to prove their safety before they were put on the market. To get clearance, the manufacturers just needed to show that the surgical mesh products were similar to devices that had already been cleared by the FDA.
The surgical mesh problem is one of several factors behind a new trend at the FDA to give medical devices additional scrutiny, says Bruce Jackson, an analyst at Northland Securities. Generally speaking, Jackson says, it’s taking longer for companies like Boston Scientific to get clearance for medical devices. There’s a flip side, though: Smaller firms may simply find it easier to sell themselves to giants like Boston Scientific rather than deal with all the paperwork on their own.
Analysts downplay the financial impact these mesh lawsuits could have on Boston Scientific. Litigation is a fact of life for the medical device industry, and the vaginal mesh business represented less than 5 percent of the $7.6 billion in revenue that Boston Scientific reported last year.
Shares in Boston Scientific were pounded after its 2006 acquisition of Guidant Corp., partly because of the lingering medical issues with Guidant implants, and they never recovered. The company’s stock now trades at around $6 a share, down from $16 a share five years ago.
Morningstar analyst Debbie Wang says the lawsuits’ impact on Boston Scientific’s bottom line will be modest, at most. She says the company’s bigger problem is that it failed to keep pace with innovation in recent years, partly because of the distractions caused by the Guidant merger.
When Boston Scientific shareholders gather next Tuesday in the Financial District for the company’s annual meeting, they’ll be hoping that the rough times are in the past. But the still-ongoing flood of lawsuits over the mesh implants serves as a reminder that the medical device business is never completely pain-free.