1. Plaintiffs Attorneys dumbed down trial strategy despite significant scientific expert evidence and knowledge to the contrary resulted in anemic, lethargic settlements for thousands of women in @ETHICON MDL 02327. Ambiguity remains.
DO PLAINTIFFS ATTORNEYS
PURPOSELY FAIL THEIR
#MESH INJURED WOMEN CLIENTS?
Hundreds of thousands of women are at risk from unsafe surgical procedures using synthetic surgical mesh in the female pelvis and reproductive system for serious permanent disabling injuries because Plaintiff's Attorneys litigated women's health.
2. Plaintiffs Attorneys did not integrate all the causes of the harm from transvaginal mesh procedures in their dumbed down trial strategy. The procedure, synthetic surgical mesh and trocar combined in the female pelvis and reproductive system are catastrophic along with comorbidities, age, concomitant procedures, again catastrophic. These complications are not even mentioned as a basis of injury in the pathetic settlements.
3. The Dumbed Down Trial Strategy used was a limited concept of large vs. small pore size which is difficult to prove and does not integrate the myriad physical and chemical properties of polypropylene synthetic surgical mesh and wound healing, critical to the understanding of mesh injury. Most important physical property: the polypropylene synthetic surgical mesh shrinks itself due to inherent manufacturing defects.
Synthetic Surgical Mesh remains on the market. Why?
1. Plaintiffs Attorneys,
2. the American Urogynecological Society (AUGS)
3. the American College of Obstetrics and Gynecology (ACOG)
4. the International Urogynecological Association (IUGA)
4. the International Urogynecological Association (IUGA)
5. Doctors: Dr. John Miklos and Dr. G. Willy Davila
6. Hospitals: the Cleveland Clinic and the Mayo Clinic
7. the United States Food and Drug Administration’s Center for Devices and Radiological Health (FDA’s CDRH)
8. the director of the CDRH, Dr. Jeffrey Shuren, and David Krause, and other top officials at the FDA and
9. Johnson & Johnson and its wholly owned subsidiary Ethicon, Inc
Kept mesh on the market by a series of events.
The events listed below culminated in a disaster for #MESH injured women. Plaintiff’s attorneys "proved" (perhaps "lied" is the operative word) abdominal sacral colpopexy was a better, safer alternative procedure to Pelvic Organ Prolapse (POP) repair by Transvaginal Surgical Implantation with synthetic surgical mesh in bellwether trials in the U.S. District Court for the Southern District of West Virginia.
January 2012: The FDA’s CDRH issues 522 orders to 33 companies for 99 products they must begin clinical trials testing their synthetic surgical mesh products for safety and efficacy. J&J/Ethicon NEVER started the studies as mandated In June 2012 J&J/Ethicon removed the prolift from the market (not recalled) just stopped selling when the inventory ran out.
April 2012: Dr. John Miklos and Dr. Robert Moore hold doctor conference in Atlanta. Henry Garrard III is only attorney speaker on the agenda. Topic of Garrard speech: how doctors can avoid legal liability when implanting mesh.
April 12, 2012 Mass Torts Made Perfect Panel
Abdominal Sacral Colpopexy recommended as trial strategy to a nationwide audience of 500 - 1,000 Trial Lawyers attending the conference
Pelvic Mesh: How to Represent the Victims
Robert Price, Levin Papantonio Thomas Mitchell Rafferty & Proctor
Amy Eskin, Hersh & Hersh
Henry Garrard, Blasingame Burch Garrard Ashley
Lana Keeton, Truth in Medicine
April 27, 2012 Lana Keeton sends e-mail notification letter to all Plaintiff’s Attorneys known to her to represent #MESH injured women in the MultiDistrict Litigation in the Southern District of West Virginia warning of the significant dangers of Abdominal Sacral Colpopexy including clinical trials showing there IS NO "LEVEL ONE EVIDENCE" OF SAFETY OF ABDOMINAL SACRAL COLPOPEXY BUT HUGE PERCENTAGE OF FURTHER COMPLICATIONS
May 2012 Johnson and Johnson’s Ethicon will stop selling 5 of their transvaginal mesh products. Only the TVT Secur was removed and the rest of the TVT bladder sling meshes remained on the market.
GYNECARE ProliftTM Pelvic Floor Repair System
GYNECARE Prolift +MTM Pelvic Floor Repair System
GYNECARE ProsimaTM Pelvic Floor Repair System
GYNECARE GYNEMESH MTM Partially Absorbable Mesh
GYNECARE TVT SecurTM System (not all TVT products)
Ethicon also notified FDA's Office of Surveillance and Biometrics of their intention to make a labeling change to the Indication for Use for GYNECARE GYNEMESH PS Nonabsorbable PROLENE Soft Mesh indicating it for abdominal (open or laparoscopic) use only.
With approval of the labeling change by the FDA, the 522 orders for their products were placed on hold and eventually terminated since the orders were applicable to transvaginally placed POP mesh products only. Sales continued in the US and globally under the then current indication until regulatory approval of the labeling change was obtained in each country.
June 2012: Johnson and Johnson’s Ethicon send letter to Judge Joseph Goodwin they are removing 5 of their transvaginal mesh products from market
September 2012: J&J RECEIVED> > The applied for approval of label changes for indication for use to Abdominal Sacral Colpopexy was eventually signed by Dr. Ben Fisher at the FDA’s CDRH
This Very neat package NEVER publicized Kept Mesh on the Market for use in the Female Pelvis and Reproductive System. This, in my opinion, is a crime against women. It PRESERVES:
a. Use of mesh for abdominal sacral colpopexy by doctors
b. The mesh profits for Johnson & Johnson’s Ethicon Gynemesh
c. Injury to hundreds of thousands of women patients
There is NO LEVEL ONE (1) EVIDENCE of success
of abdominal sacral colpopexy despite decades of use.
CONSPIRACY OR COINCIDENCE?