I'm not one for lawsuits. Too often I believe they are frivolous, and the only people who benefit are the lawyers. But today's blog post addresses an exception to that rule. For what I know about it, this one is necessary and will send a very important message.
I was contacted a few weeks ago by Angela, a woman who faces her fourth surgery due to life-ruining outcomes from a product that was left inside her during a previous surgery. The product, called Mentor's OB Tape, was introduced in 2004 as a product to help women with incontinence problems. Shortly after it was introduced, problems were documented; infections, discharge, any number of simply ugly side effects were reported.
There are thousands of women worldwide who have developed these horrible side effects from the same product, and many feel as if their lives have been ruined. Angela's next surgery will search and destroy the parts of the tape that have not only integrated with her body, but may also have migrated away from the site where it was sewn in. She is in constant pain, and contends with more problems every day.
Here's part of the reason why a lawsuit is so necessary. Despite the fact that those problems arose within just months of the tape being implanted in women, the company never recalled the product. Instead, it simply and quietly pulled the original product from distribution, and replaced it with another. If the women and their doctors didn't begin consulting with each other, no one would have ever realized it was a problem with the manufacturer.
Further, the way the manufacturer achieved FDA approval is suspect. In its application to the FDA, it stated that there were no substantial differences between Mentor OB Tape and other, similar products; therefore it should be approved. However, as the tape was released to the marketplace, its materials heralded a new and improved product. (It should be noted that the inventor now resides in France. I do not know whether he lived there to begin with, or whether he escaped to France... trying to avoid litigation, perhaps?)
What we know is that the FDA has had the wool pulled over its eyes by any number of medical and drug manufacturers -- not just the Mentor's OB Tape people, but by pharma companies -- think Vioxx, Rezulin, and others. But we need to blame the FDA, too. They aren't minding the store. They aren't requiring these manufacturers to come clean.
So yes, I believe that a lawsuit against the developer and manufacturer of Mentor's OB Tape is worthwhile, both for the message it will send to medical and pharmaceutical manufacturers, and perhaps to help shore up the obvious changes need to the FDA's approval procedures.
Once again, the almightly dollar is far more important to these companies than the lives of the people they ruin. What's one woman's lifetime of pain when compared to happy stockholders?
If you have interest in the progress of this lawsuit, or would like to hear what Angela has to say, you'll want to take a look at her blog.
As for my personal opinion -- I hope that if the lawsuit goes to trial, the judge is a woman.
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