Few people outside of public health advocates and consumer groups used to pay much attention to the Food and Drug Administration's confusing, shadowy process for approving medical devices to the market. When patients find themselves suffering after a surgery that was supposed to help them -- like, say, a hip implant -- they often find that their doctors are at a loss and their only recourse is in the courts.
That's how Dallas District Court Judge Ken Molberg ended up overseeing two trials in six months over a device called vaginal mesh, which doctors have been using to treat prolapsed organs and incontinence in aging women before they understood all of the potentially horrific side effects. The earlier mesh trial, as I detailed in a May feature story, resulted in the jury awarding a woman named Linda Batiste $1.2 million from Johnson & Johnson. The second trial, currently under way, is against Boston Scientific, which, like J&J, appears highly disinterested in research that might hurt its bottom line.
The case, filed by a woman named Martha Salazar, targets the company's Obtryx sling, one of several types of mesh slings Boston Scientific has sold. In an email her attorneys showed jurors last week, Boston Scientific employees discussed a research paper that revealed some of the negative side effects caused by the sling. The employees decided against showing the research to their doctor customers.
"I don't feel that this paper would useful to the sales force, in terms of helping defend business or selling more slings," a Boston Scientific employee wrote to another in sales. "It actually is a fairly negative outcome in terms of our Obtryx sling."
Outside the presence of the jury, attorneys for Boston Scientific argued that they should be able to tell jurors that the Obtryx was approved by the FDA.
"The FDA did no such thing," Molberg responded. He said that the product was grandfathered in but not cleared. "The FDA did not approve this product," he added.
Molberg was referencing the FDA's process for fast tracking new devices to the market, called the 510(k) process. Devices supposedly "cleared" under that process don't actually undergo any safety testing. Rather, manufacturers simply find another product already on the market and argue that their new device is "substantially equivalent" to the older one.
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Many companies have stretched the limit of what that substantial equivalence actually means. The Consumers Union reports that 78 percent of high-risk medical devices are sold through that fast-tracking process, a percentage the group argues is much too high.
While the FDA in 2011 acknowledged that complications from some of the mesh surgeries are "not rare," it has yet to issue a formal recall or make major changes to how it regulates devices. On its own website, the FDA continues to describe the 510(k) process as a "clearance."
But Molberg disagreed with that characterization. "It's that word, 'cleared.' It's bothersome," the judge told the attorneys.
The trial continues this week.