Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Friday, February 27, 2015

Patient's sin is to rely on surgeon's advice! Surgical mesh trial.


BY COURTENAY EDELHART The Bakersfield Californian cedelhart@bakersfield.com  Thursday, Feb 26 2015 05:47 PM  FiDA highlight
A jury of three women and nine men began deliberating late Thursday in a transvaginal mesh trial brought by a Bakersfield woman and her husband, a case that has garnered national attention.
Coleen Perry, 52, of Bakersfield, filed a lawsuit against New Brunswick, N.J.-based Johnson & Johnson and its wholly owned subsidiary, Ethicon Inc., over complications from a medical device implanted in her in March 2011 to treat stress-induced incontinence, or brief urination with coughing, sneezing, laughter or other exertion.

There has been a tidal wave of lawsuits over synthetic surgical meshes implanted through the vagina since the U.S. Food and Drug Administration issued a notification in 2008 that it had received high numbers of complaints about them. Three years later the FDA issued an advisory about serious complications.
In 2012, a jury awarded Christine Scott, also of Bakersfield, $3.6 million in a similar case against C.R. Bard Inc., which manufactures a rival device designed to treat the same condition.
Both women said after the implants, their incontinence did not improve, and they were left with chronic pain that had ruined their ability to have comfortable intercourse.
Perry is seeking at least $17.2 million for past and future medical expenses, pain and suffering and punitive damages.
Perry testified that her husband's penis has been left with abrasions by portions of the mesh that poked through her vaginal wall. She's had a follow-up surgery to remove the part that was sticking out, but the entire mesh cannot be removed because it is permanently intertwined with natural tissue.
Her attorneys argued that Johnson & Johnson knew it had a defective product and concealed those defects from doctors, consumers and the FDA, pointing to internal memos and emails in which employees cited concerns that went unheeded.
Johnson & Johnson said those emails had been "cherry picked" and produced other emails in which those same employees said they were reassured by testing.
Attorney William Gage asked jurors not to read too much into the exchange, saying it was a normal part of the development process.
"If your medical device company is not vigorously debating the safety of a medical device, we've got a real problem," he said.
Gage also said it was a coincidence that language describing the mesh as light weight was removed from a company website during the trial, putting a witness on the stand who said the website overhaul had been planned months ago and the timing was coincidental.
Over the course of the eight-week trial in Kern County Superior Court, Perry's lawyers argued that the company's laser-cut mesh was sharper and heavier than others on the market and therefore more prone to erosion and shrinkage.
Gage said no medical device is entirely without risk and Perry signed an informed consent form acknowledging a risk of erosion, among other things, prior to surgery. Moreover, he argued, she had a host of other medical conditions and procedures that likely were the source of her symptoms.
Perry's attorneys called that a red herring and put Dr. Hung Luu, who did the original surgery on Perry, on the stand. Luu started out as a defendant but was later removed as a party to the case, and testified that he would not have implanted the device had he known it was heavy (which Johnson and Johnson disputes) and had a lot of problems. Luu said he is no longer using the mesh in his practice.
The informed consent Perry signed wasn't actually informed, attorney Rich Freese argued, because all the facts weren't available to Perry or her doctor when Perry agreed to the surgery.

"Coleen relied on her doctor, and Dr. Luu was relying on Johnson & Johnson and Ethicon," he said. "That was Coleen's sin."

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