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By Felix Adamo/ The Californian
BY COURTENAY EDELHART Californian staff writer email@example.com
In the first of hundreds of such cases poised to go to trial nationwide, a Bakersfield woman has won a $3.6 million judgment against a medical device manufacturer after an implant left her incontinent, in chronic pain and unable to have intercourse.
At issue is a surgical mesh implanted through the vagina to treat urinary incontinence and pelvic organ prolapse, or POP. That's when the muscles and ligaments supporting a woman's pelvic organs weaken, which can allow organs to slip out of place. The condition is common among older women and those who've undergone hysterectomies.
The traditional treatment is exercise to strengthen the pelvic muscles or, if that fails, crafting together a support system out of the woman's own tissue.
But in recent years, physicians have begun using synthetic support systems, which can be implanted faster and are, therefore, more lucrative. The U.S. Food and Drug Administration has warned doctors about synthetic meshes, noting the possibility of severe complications after implantation.
Christine Scott, 53, of Bakersfield, had an anterior and posterior synthetic support system made by C.R. Bard Inc., implanted in her body in 2008 to treat occasional urinary incontinence. Bard markets its transvaginal surgical mesh under the name Avaulta Plus Biosynthetic Support System.
Scott sued Bard in January 2009, after learning that in October 2008 the FDA issued a warning letter to doctors about "rare" but "serious" complications in some patients.
TROUBLE FROM THE START
Problems for Scott began immediately after surgery, she testified in a jury trial in Kern County Superior Court before Judge William Palmer. For five months, she could only urinate with a catheter. Since then, she's had eight additional surgeries and nine other procedures to deal with ongoing internal damage from the mesh system, which remains in her body and cannot be removed safely, she said.
A jury returned a verdict in favor of Scott late Friday.
"My heart just dropped," she said Monday of her reaction to the verdict. "My husband was with me and we just kept squeezing hands. I thought, 'I have a voice. I have a voice.'"
During the more than four years the case was in litigation, Scott was under a court order to not talk about it.
An attorney for Murray Hill, N.J.-based Bard said the company is disappointed and will appeal.
"Throughout the case we clearly have empathized with Mrs. Scott's injuries," said Michael Brown. "We just don't feel that they were the result of the Avaulta Plus product or the conduct of our company."
The product can be used "safely and effectively when used properly and when used with the right patient," he said.
Bard issued a statement Monday saying, "We intend to appeal this verdict, and we will continue to vigorously defend against all other lawsuits regarding this product."
There are hundreds of lawsuits pending against transvaginal surgical mesh makers, but the Bakersfield case was the first to go to trial. Consequently, defendants in the lawsuits were watching closely.
It's common in large-scale personal injury litigation for both sides to see how the first few trials go before deciding how to dispose of the rest of them, said Stephen Sugarman, a professor of law at the University of California, Berkeley.
"Both sides are treating each jury case as an experiment," he said. "They see what works and what doesn't before a jury. If they have a bad witness, they switch them out. After a while, a pattern emerges."
If there are enough wins -- as in, say, the tobacco lawsuits against cigarette makers -- defendants might conclude they have a dangerous product, but not so dangerous that the adversities outweigh the benefits, Sugarman said.
Conversely, if they lose a lot, they might pull the product and try to settle as painlessly as possible, he said.
Bard is no longer selling the Avaulta Plus in the United States, but continues to sell it in other countries. Johnson and Johnson, which sold a similar product, is pulling its vaginal mesh off the market worldwide.
The product remains cleared for use by the FDA, but the government has imposed 88 postmarket study orders on 33 manufacturers of meshes used to treat POP; and 11 postmarket study orders on seven manufacturers of single-incision mini-slings used to treat incontinence. In that surgery, synthetic material such as mesh creates a pelvic sling or hammock around the bladder neck and urethra.
A postmarket study is a study on the safety and efficacy of a drug or medical device after it is already in widespread use.
Scott testified at trial about the physical and emotional toll she said the mesh has caused. At one point, she was so distraught she considered taking her own life.
Her psychologist, Community Counseling and Psychological Services chief executive Dean Haddock, testified about the counseling Scott has received to date and said he anticipated she would need ongoing therapy for the rest of her life.
Both sides presented expert witness testimony with opposing takes on the safety of the surgery.
Some women have had meshes implanted without any problems.
Others have suffered a recurrence of the issue the surgery was intended to correct, infection, internal bleeding, vaginal scarring and pain.
In Scott's case, the mesh has eroded, broken apart and become inextricably intertwined with surrounding tissue, causing cuts, infections and abscesses. It cannot be removed because it's now tangled up with vital pelvic organs, and bits of it are tearing up her insides like shrapnel from a bomb.
In an interview after the trial, Scott said she suffers from incontinence, can no longer make love to her husband because parts of the implant are poking through her vagina, and is in pain so severe she can't even sit down without a regimen of pain-mitigating shots.
Scott said her husband "is a saint" for not leaving her, but she knows of other women with similar complications who have gone through a divorce and become shut-ins, too embarrassed by frequent trips to the bathroom and the possibility of an accident to go out in public.
Scott didn't eat or drink before she testified last week because she didn't want to risk any problems while she was on the stand, she said.
Now that Scott is freed from her court-ordered silence, she wants to form a support group for similarly afflicted women and become an advocate, warning others about potential complications from the device.
Her life "became hell" after the implant, she said. "Nobody else should have to go through this."
Scott's attorney, Eugene Lorenz, said they want to get the word out that these devices were implanted in women without any human clinical trials. The only testing was in animals and cadavers, he said.
It was the hope of becoming a voice for women that gave his client the determination to persevere through a years-long legal battle with a much better-funded adversary, Lorenz added.
"The money is nice, but it's not going to restore her health," he said.