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ethicon 5/17
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Mesh Rally Rescheduled Around Edwards v. Ethicon Trial in August
May 16, 2016 | Mesh Medical Device News Desk
By Jane Akre
The case of Edwards v. Ethicon (Case No. 2:12-cv-09972), filed in multidistrict litigation in Charleston, WV, which was scheduled for June 3 for jury selection with the opening scheduled for June 6 Monday, has been rescheduled. Again. -
ProPublica Wants to Raise Awareness on Medical Harm
May 17, 2016 | Mesh Medical Device News Desk
By Jane Akre
...Of the 1,000 stories collected so far, surgical, infection and device problems lead the types of harm. Disability and death sometimes result. Many readers of Mesh News Desk already know their injuries are not being acknowledged by their health care providers.
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Mesh Rally Rescheduled Around Edwards v. Ethicon Trial in August
May 16, 2016 | Mesh Medical Device News Desk
By Jane Akre
The case of Edwards v. Ethicon (Case No. 2:12-cv-09972), filed in multidistrict litigation in Charleston, WV, which was scheduled for June 3 for jury selection with the opening scheduled for June 6 Monday, has been rescheduled. Again.
Now the case of Edwards v. Ethicon is set to be heard in federal court before Judge Joseph Goodwin with jury selection scheduled for Friday, August 12 and opening arguments on Monday, August 15th. There is also a slight change the opening arguments could begin on Friday if jury selection goes smoothly so if you want to watch the case, it is advisable to be there then.
MAM RALLY
As a result, the mesh rally scheduled for June has also be rescheduled. Women and their families impacted by mesh plan to be in Charleston for a dinner and rally Friday night and a presence Monday morning.
MAM or Mesh Awareness Movement brought awareness to the mesh issue in 2015 when a couple dozen folks from around the southeast, showed up in front of the Robert C. Byrd courthouse to raise awareness of mesh complications. Too often the media has ignored this story, even Charleston WV media, including the CBS station, for example, which is a stone’s throw away right next door to the courthouse. But the media turned out in June 2015 and there were several stories as a result.
EDWARDS V ETHICON
The defendant corporation is Ethicon, a division of Johnson & Johnson, the manufacturer facing the largest number of mesh cases consolidated in this federal court among seven manufacturers. Tonya and Gary Edwards of Georgia are the plaintiffs.
This is the fifth delay for this trial as both sides seem to be inching toward settlements, with J&J/Ethicon still, at least publicly, planning to fight each plaintiff in court.
Ms. Edwards was implanted with a TVT-O by Dr. Harold Wittcoff. Court documents show Ethicon attorneys, Christy Jones and Dave Thomas, want to exclude the expert opinion of Dr. John T. Steege, who would testify TVT-O was defective and caused her present day pain. Defense used Dr. Elizabeth Kavaler, previously seen in the Gross trial, to issue an expert report as well as Dr. Stanley Zaslau.
The TVT-O has already been found to be defective in this same courtroom before Judge Joseph Goodwin in the Huskey v. Ethicon trial. See the background story here. Also in the Linda Batiste case in Dallas in April 2014, the jury concluded the TVT-O made by Ethicon was defective and awarded Ms. Batiste $1.2 million. See the story here.
MAM RALLIES GETTING STRONG
Last June 2, Mesh Awareness Movement (MAM) brought women and their families from Kentucky, Ohio, Pennsylvania, Florida and beyond to join in solidarity and send a message that pelvic mesh should not be allowed to continue to injure unsuspecting women and that mesh manufacturers need to financially care for the women they’ve harmed.
A dinner is planned Friday, August 12 with the rally beginning 8 am Friday morning in front of the Robert C. Byrd federal courthouse.
Pelvic mesh, used to shore up pelvic organs, was never approved for safety or efficacy by the U.S. Food and Drug Administration. Instead it was approved for sale by the FDA 510(k) approval process that does not require any clinical trials. Assurances of safety rely on the integrity of the manufacturer.
Litigation was consolidated in federal court in Charleston by the Judicial Panel on Multidistrict Litigation in January 2012.
Since then, seven manufacturers now face more than 90,000 lawsuit alleging they sold defective transvaginal mesh which was promoted to doctors as part of an aggressive, yet deceptive campaign. The plaintiffs allege defective manufacturing instructions to doctors and a breach of warranty, negligence, fraud, and more. They are asking for punitive damages.
Only American Medical Systems (AMS) has offered mass settlements to women, though many women tell MND their settlement amount is as low as $5,000 after legal fees are paid and any existing liens.
As of April 27, 2016, there were 90,131 cases consolidated in the Charleston court before Judge Goodwin, the largest mass tort ever assembled in one courtroom. They include:
C.R. Bard 13,429
AMS 20,155
Boston Sci 20,830
Ethicon 32,672
Coloplast 2,425
Cook 487
Neomedic 133
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ProPublica Wants to Raise Awareness on Medical Harm
May 17, 2016 | Mesh Medical Device News Desk
By Jane Akre
The numbers of patients harmed by mainstream medicine keeps rising. First reported in November 1999 by the Institute of Medicine (IOM) “To Err is Human” concluded there are about 98,000 patient deaths each year from preventable medical errors. The Journal of Patient Safetyin September 2013, reported the preventable harm to patients led to more than 400,000 patient deaths.
The San Francisco Chronicle did an extensive report in 2009, Dead by Mistake (which has since disappeared from its website), that found most hospitals and states have failed to adopt the recommended steps in the IOM report to keep patients safe. One of the steps was a mandatory nationwide reporting system.
In the latest accounting, the British Medical Journal (here) in May 2016 reports medical errors that are not captured by code are not captured. If they were, medical errors would be the third leading cause of death at 251,000 annually in the U.S. conservatively, the data suggests. We spend money on cancer and heart disease but do not even recognize the third leading cause of death, says researcher, Martin Makary in a radio interview.
That is where good journalism comes in and you can help.
ProPublica
ProPublica, journalism in the public interest, is connecting more than 1,000 stories from patients harmed across the U.S. Patients feel abandoned and they are not getting the answers they deserve. What’s worse, without acknowledging there is a problem, it is bound to happen again. The first step to correcting a problem is to understand its scope, including medical providers, hospitals and doctors.
Of the 1,000 stories collected so far, surgical, infection and device problems lead the types of harm. Disability and death sometimes result. Many readers of Mesh News Desk already know their injuries are not being acknowledged by their health care providers.
Unfortunately, the vast majority of medical providers and facility didn’t acknowledge the harm done in the reports collected so far. Overwhelmingly, they do not apologize and the medical establishment does not face any consequences.
The head in the sand approach to medicine does not work.
Marshall Allen, who covers patient safety for ProPublica tells MND, “The information remains confidential unless people give us permission to share it. If we have permission, we share the patient stories with other journalists who might want to cover these topics or with researchers who want to study the reports from patients who have been harmed. There are places in the questionnaire where people can opt-in to allow us to share the info.”
The Problem
Instead, the majority of hospitals still do not provide patients with information on hospital error. When the IOM and the Chronicle reports on patient preventable medical harm were issued, then President Bill Clinton sought legislation requiring hospitals make reports on its errors public. Instead the American Medical Association and the American Hospital Association opposed the push lobbying to derail it.
Legal settlements require a gag order so details of malpractice are not revealed. Unlike airline crashes, where there are lessons learned, medical errors hide behind a wall of silence.
About ProPublica
ProPublica is a nonprofit newsroom that exists through foundation support, a small amount of advertising and donations. It opened its doors in 2008.
It mission is investigative journalism with a staff of about 45 and headquartered in Manhattan, it serves the public at a time when journalism is suffering in its search for new business models.
According to its website:
“ProPublica is an independent, non-profit newsroom that produces investigative journalism in the public interest. Our work focuses exclusively on truly important stories, stories with “moral force.” We do this by producing journalism that shines a light on exploitation of the weak by the strong and on the failures of those with power to vindicate the trust placed in them.
“Investigative journalism is at risk. Many news organizations have increasingly come to see it as a luxury. Today’s investigative reporters lack resources: Time and budget constraints are curbing the ability of journalists not specifically designated “investigative” to do this kind of reporting in addition to their regular beats. New models are, therefore, necessary to carry forward some of the great work of journalism in the public interest that is such an integral part of self-government, and thus an important bulwark of our democracy.”
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