Preview Newsletter
Ethicon 6/29
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No More Tears as J&J Readies for Pelvic Mesh Trials
Jun 28, 2016 | Mesh Medical Device News Desk
What has happened to pelvic mesh trials? For a while the defective product pelvic mesh trials were scheduled in rapid succession. -
Couple accuses medical device manufacturers of negligence
Jun 28, 2016 | The Louisiana Record
A Texas couple is suing Johnson & Johnson, alleging negligence in manufacturing a defective mesh device. -
Canadian Coverage of Mesh Complications Continues
Jun 28, 2016 | Mesh Medical Device News Desk
Canadian Television news recently did a report on Canadian women living with the aftereffects of painful pelvic mesh.
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No More Tears as J&J Readies for Pelvic Mesh Trials
Jun 28, 2016 | Mesh Medical Device News Desk
What has happened to pelvic mesh trials?
For a while the defective product pelvic mesh trials were scheduled in rapid succession.
Trials were conducted naming the major defendants – Ethicon, Boston Scientific, C.R. Bard and were held in federal court in Charleston WV, Massachusetts, Dallas, in California and New Jersey. In the majority of cases, the verdicts for and jury awards to the plaintiffs ran into the millions of dollars.
Then settlements began, quietly, covertly and much too slowly.
AMS began settling cases when it faced financial trouble and a sale to Endo. C.R. Bard announced some settlements as did Boston Scientific. But four years after formation of the federal multidistrict litigation in Charleston, WV, where 93,000 cases are consolidated and waiting for trials – litigation has largely stopped.
Judge Joseph Goodwin
Judge Joseph Goodwin hoped to push both sides toward settlement and promised neither would like his future rulings.
The settlement dollars have been slow to be issued or so paltry that after legal fees and liens are paid, may not cover even one year much less a lifetime of medical care that may be needed.
Women have died, become homeless and are running out of options.
Besides one reported settlement, Johnson & Johnson continues to hold out and vows to continue in court.
That may change as defense and plaintiffs are in a head-on collision course to another succession of trials beginning in August.
NO MORE TEARS Johnson & Johnson Ahead
Beginning in August and through the rest of this year and into next, J&J and its Ethicon division will face a barrage of trials.
Most are filed in Philadelphia in the Court of Common Pleas. Ten cases are set for trial, according to the docket and the plaintiffs are represented byKline & Specter of Philadelphia.
More on the Philadelphia trials in a moment, but the next pelvic mesh trial is set for federal court in Charleston WV.August 12, 2016
EDWARDS V ETHICON, (Case No. 2:12-cv-09972), Friday, August 12 is jury selection, trial commences Monday, August 15, 2016, 8:30 a.m. Pretrial conference July 21, 2016 to explore any final options such as settlement.
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. Ms T. Edwards of Georgia, and her husband are the plaintiffs.
This is the fifth delay for this trial. Attorneys are Mark Mueller, John Fabry, Breanne Vandermeer for Ms. Edwards and Christy Jones and Dave Thomas for Ethicon.
Ms. Edwards was implanted with a TVT-O by Dr. Harold Wittcoff. Court documents show Ethicon attorneys, 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. A list of exhibits includes the Patent by De Leval, an email chain including Piet Hinoul involving an IFU rewrite, an email chain about TVT complaints alleging brittle mesh and blue shi*, and a list of hundreds of other exhibits, many seen in other Ethicon trials. The case was filed December 31, 2012.
This trial is limited to six days writes Judge Goodwin in a June 12, 2015 order. Edwards v. EthiconComplaint here.
BACKGROUND – 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.Meanwhile, Waves of cases will be heard in groups and are currently on a pre-trial schedule heading for trial in Charleston federal court.
MULLINS V. .JOHNSON & JOHNSON/ ETHICON , (Case No.2:12-CV-02952), Mullins completion of pretrial should be June 30, 2016 and a trial date can then be set according to Judge Goodwin’s order of March 15. PTO #217.
Mullins complaint, July 11, 2012, U.S. District Court, Southern District WV. Background story on MNDhere.This is a trial of 37 plaintiffs appearing at one time before Judge Goodwin in Charleston, WV. All of the plaintiffs had been implanted with Johnson & Johnson’s TVT (transvaginal tape) and all are from West Virginia. Even though different implanting doctors are involved, the injuries are similar enough to consolidate them into one case before Judge Goodwin in this multidistrict litigation.
As of now, deposition is set for Dr. Dionysios Veronikis, M.D. for July 11, 2016 as pertaining to his treatment of four women, and the deposition of Dr. Jerry G. Blaivas, M.D. on July 7th in New York City, related to two plaintiffs.
In a filing June 27, 2016, plaintiffs ask to amend the original complaint and include spoliation, which is recognized under West Virginia law to be a stand-alone issue.
J&J purportedly destroyed hundreds of thousands of documents that were related to mesh litigation before any trials were heard. Plaintiffs have since determined that more instances of purported spoliation have occurred since it was first revealed.
See the background story on Mesh News Desk hereand here.
On Monday, Judge Joseph Goodwin granted plaintiffs’Motion for Leave and to Amend the Complaint to add spoliation issue. Document 821. Plaintiffs want to depose Ronald L Rink who oversaw the human resources files and documents that were part of the Ethicon Global Production.
This consolidated case will focus on design defect. Defective warning, breach of warranty may be added to this case. The Defendant wants the plaintiffs to have to prove a safer design alternative design existed as part of a design defect claim.
You may recall that pre-trial order #214 had to do with the parameters set for the Defense to conduct the medical examinations of the women in Wave One. See the story here.
ALSO NEXT UP Boston Scientific- Dallas
Figueroa v Boston Scientific, September 12, 2016, 8:30 am, (DC-13-03145),
Dallas, Texas, before Judge Ken Molberg. This case is in settlement mode, though has not settled yet and is still on the docket. Ms. Y. Figueroa is also suing the doctor Celso Hernandez MD and Baylor Surgicare at Mansfield LLC. Dallas., June 4, 2011 she was implanted with a Solyx SIS pelvic mesh for incontinence by Dr. Hernandez for SUI. Proxy Biomedical Ltc. An Irish company, Manufactures PP mesh component but is not subject to the jurisdiction of this court.PART TWO- PHILADELPHIA IS THE STAGE FOR 10 UPCOMING PELVIC MESH TRIALS INVOLVING DEFENDANT J&J
http://www.meshmedicaldevicenewsdesk.com/canadian-coverage-mesh-complications-continues/
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Couple accuses medical device manufacturers of negligence
Jun 28, 2016 | The Louisiana Record
A Texas couple is suing Johnson & Johnson, alleging negligence in manufacturing a defective mesh device.
Martha M. Stevenson and James Stevenson filed a lawsuit June 10 in U.S. District Court for the Western District of Louisiana against Johnson & Johnson and Ethicon Inc., alleging violation of the Louisiana Products Liability Act and breach of warranty.
According to the complaint, since Feb. 7, 2007, Martha M. Stevenson has undergone five revision surgeries in an attempt to correct problems with the defective mesh, a part of the Gynecare system, previously inserted in her body to correct urinary incontinence and pelvic organ prolapse.
As a result of the defective system, the suit says, she was caused to suffer pain and suffering, urinary incontinence, erosion of mesh inside her, scarring, emotional distress, loss of enjoyment of life and medical expenses. James Stevenson says he has suffered a loss of consortium.
The plaintiffs allege the defendants defectively created, designed, manufactured, tested, formulated advertised, marketed, promoted and sold the Gynecare system, failed to provide adequate warnings and failed to comply with industry standards.
The Stevensons seek a trial by jury, compensatory damages, attorney fees, legal costs, interest and any other relief to which they are entitled. They are represented by attorneys Maury A. Herman, James C. Klick, Joseph A. Kott, Mikalia M. Kott and Alexandra E. Faia of Herman, Herman & Katz LLC in New Orleans.
http://louisianarecord.com/stories/510940058-couple-accuses-medical-device-manufacturers-of-negligence
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Canadian Coverage of Mesh Complications Continues
Jun 28, 2016 | Mesh Medical Device News Desk
Canadian Television news recently did a report on Canadian women living with the aftereffects of painful pelvic mesh.
The video features Chrissy Brajcic, 40, of Windsor Ontario who has been hospitalized with repeated infections, nausea, vomit and pain even though her removal of pelvic mesh was more than one year ago. Brajcic has pelvic mesh implanted to treat incontinence following the birth of her two children.
“It feels like I’m dying from the inside and I’ve lost all sense of normalcy in my life,” she says. Brajcic has been hospitalized twice monthly for infections and each one is more severe. She says she’s becoming resistant to antibiotics treatments and Brajcic says her future is uncertain.
What’s worse is that her infections don’t appear to be responding to antibiotics. She says her goal is to take all mesh implants off the market.
Diane Fichter of British Columbia says doctors have also run out of antibiotics to treat her repeated infections. She was implanted to treat prolapse and incontinence seven years ago and has undergone one revision. Intervenous antibiotics have caused anaphylactic shock, nausea and vomiting.
Avis Favaro of CTV News has been one of the few reporters who has done repeated stories on the mesh controversy. See a 2013 story here and see the latest story here.
After a series of reports in 2012 she told Mesh News Desk
“This was one of the most troubling stories producer Elizabeth St. Philip and I worked on this year.
The story began as a small piece about two women in Ontario planning to sue the makers of a mesh used to treat their incontinence. They claimed the devices had left them in pain and the implants could not be removed.
We were unprepared for the flood of phone calls and emails from women with similar implants and even more horrific stories of suffering. Some left us in tears.
There are now an estimated 600 women in Canada who are seeking to be part of various lawsuits against transvaginal mesh products. We’ll likely hear more on this story in 2013.”
Canadian Lawsuits
Canadian lawyer, Paul Miller of Will Davidson law firm, has partnered with U.S firms to settle Canadian cases. He has obtained $2.3 million for 20 Canadian clients and is settling both AMS and CR Bard cases.
Miller tells Lawyers & Settlements that the Canadian government is now approving claims for women to have mesh removal surgeries in the U.S., something that wasn’t done four years ago. See the background story on Mesh News Desk.
Siskinds LLP, a law firm in Toronto, is also taking transvaginal mesh cases.
In February 2010, Health Canada issued a safety warning about polypropylene pelvic mesh.
“Reported complications associated with the use of transvaginally-placed mesh for the treatment of SUI and POP include erosion (vaginal, urethral), pain including dyspareunia, infection as well as perforations and other injuries to adjacent organs including the bowel, bladder and blood vessels. Risk factors associated with these complications are not completely understood but may relate to both patient-specific factors such as age, overall health status, estrogen status and a history of previous surgery in the area as well as procedure-specific factors such as surgical technique and route of mesh placement. Required treatment for these adverse events varies depending on the complication but can involve surgical intervention including complete mesh removal.”
http://www.meshmedicaldevicenewsdesk.com/canadian-coverage-mesh-complications-continues/
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