Preview Newsletter
Suntech Media Scan for February 9, 2015
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Judge: Come To An Agreement Over Transvaginal Mesh in Two Days, or Else The Barrage of Lawsuits Will Commence
Feb 6, 2015 | Fierce Medical Devices
By Varun Saxena
U.S. District Judge Joseph Goodwin once again pled for a comprehensive settlement between 7 devicemakers and the plaintiffs in the 70,000 lawsuits they face over potentially dangerous transvaginal mesh. -
Judge Goodwin Predicts Rocky Path if Pelvic Mesh Cases Don’t Settle
Feb 6, 2015 | Mesh Medical Device News Desk
By Jane Akre
“This is the rocky path,” Judge Joseph Goodwin forecast to a full courtroom Thursday and Friday, if there are not settlements forthcoming among the 72,000 pelvic mesh cases consolidated in his Charleston, West Virginia federal courtroom. -
Plaintiff on the Stand in Perry v. Ethicon Pelvic Mesh Trial
Feb 8, 2015 | Mesh Medical Device News Desk
By Jane Akre
Coleen Perry took the stand in her pelvic mesh defective product case against Ethicon on Wednesday, February 4.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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Feb 6, 2015 | Fierce Medical Devices
By Varun Saxena
U.S. District Judge Joseph Goodwin once again pled for a comprehensive settlement between 7 devicemakers and the plaintiffs in the 70,000 lawsuits they face over potentially dangerous transvaginal mesh.
In a last-ditch effort to avoid decades of trials and millions of dollars in legal fees, his West Virginia court launched two days of discussions between the companies and the plaintiffs' lead lawyers, Reuters reports. Unless a compromise is reached, the lawsuits will be sent to trial, he said, according to the article.
This is not Goodwin's first attempt at achieving a settlement. In December 2014, he said during a hearing that he could not "imagine a corporation facing potentially billions of dollars in verdicts wouldn't find it advisable to try to achieve a settlement for a much lesser sum" and pointed to other "rather large" verdicts from similar cases. These include awards to two sets of four women worth $18.5 million and $26.7 million for suits filed against Boston Scientific's ($BSX) for its vaginal mesh product.[
Since Goodwin's December plea, Johnson & Johnson ($JNJ) has agreed to settle more than 100 product liability lawsuits regarding pelvic mesh products sold by itsMentor subsidiary, but that's only a tiny piece of the pie for that company, not to mention all of the industry players ensnared in the legal fight.
Two of the manufacturers have already heeded the judge's advice and arrived at a comprehensive settlement. Endo ($ENDP) agreed in October of last year to pay an additional $400 million to settle "substantially all" of the remaining claims related to its vaginal mesh implants. And Danish device maker Coloplast paid $16 million to settle lawsuits claiming it injured women with vaginal mesh inserts in March 2014.
As early as 2008, the FDA issued a warning against vaginal mesh implants. It stated: "The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia."
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Judge Goodwin Predicts Rocky Path if Pelvic Mesh Cases Don’t Settle
Feb 6, 2015 | Mesh Medical Device News Desk
By Jane Akre
“This is the rocky path,” Judge Joseph Goodwin forecast to a full courtroom Thursday and Friday, if there are not settlements forthcoming among the 72,000 pelvic mesh cases consolidated in his Charleston, West Virginia federal courtroom.
The federal judge wants faster action in bringing the thousands of product liability lawsuits to resolution and said “I’m going to kick it into high gear and ask that you do the same,” reports Reuters.
In attendance were lawyers for both plaintiffs and defendant mesh manufacturers, executives, risk managers and settlement teams who had been called to a mandatory gathering of both sides involved in pelvic mesh litigation. Knowing there is no way the courts can possibly try every single lawsuit filed, Judge Goodwin promised cases will be set for trial, there will be no delays, no excuses and there will be an increased number of resolutions.
Judge Goodwin has received support from the Fourth Circuit which has assigned him three additional law clerks so they can keep up with the fast-tracked paperwork. The rulings will be fair and the deadlines will be firm, he promises. Lawyers from both sides will need to manage their conflicts.
So far defendant companies- Ethicon (Johnson & Johnson), Boston Scientific and C.R. Bard have faced millions in losses at trial, most recently a $73 million verdict for a woman implanted with a pelvic mesh made by Boston Scientific. The women claim permanent pelvic injuries from defectively designed mesh implants used to reinforce pelvic organs.
The corporations still claim their devices are safe and effective even as they quietly remove them from market (Prolift, Pinnacle) and secretly settle cases.
Reuters reports lawyers for three companies said they are ready to prepare hundreds of cases for trial.
Representatives from each defendant corporation reported their progress to Judge Goodwin. Held up as an example is American Medical Systems, purchased by Endo International, which has set aside up to $1.6 billion to settle 20,000 pelvic mesh lawsuits.
Danish company Coloplast A/S has also settled a substantial chunk of the nearly 2,000 mesh lawsuits it is facing. Cook Medical says it is ready to go to trial over its cases.
Judge Goodwin warned that each side needs to face reality and put aside their preconceived thoughts. Multimillion dollar settlements are unlikely and both sides will experience losses, reports one court watcher.
Cases will be consolidated according to liability and/or damages and you can expect to see multiple plaintiffs in one courtroom as happened last November in two trials – one federal case in Miami and another one in Charleston. Plaintiffs were successful in both trials. Four plaintiffs implanted with the Boston Scientific Pinnacle mesh were awarded $26.7 million while $18.5 million went to four women injured by the Boston Scientific Obtryx mesh .
After court Thursday, there was a mandated social gathering paid by each side inside the courthouse and attended by about 100. The purpose was transparent- get both sides talking and for about two hours that is what they did.
By Friday, Judge Goodwin had representatives from each MDL meeting privately in his chambers including lawyers, executives and risk managers. #
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Plaintiff on the Stand in Perry v. Ethicon Pelvic Mesh Trial
Feb 8, 2015 | Mesh Medical Device News Desk
By Jane Akre
Thanks to Courtroom View Network for access to live streaming video of the Perry v. Ethicon trial. Mesh News Desk is prevented from showing any plaintiffs or evidence or from quoting directly from the case.
Coleen Perry took the stand in her pelvic mesh defective product case against Ethicon on Wednesday, February 4.
She is an attractive woman, about 50 years old, with light blonde hair cut in wavy layers. She is wearing a sleeveless print dress and does not appear to be overweight as was alluded to in the opening statement by the defense counsel. She speaks clearly, is friendly and gives complete answers to one of her attorneys, Peter de la Cerda (Edwards & de la Cerda.)
Ms. Perry experienced incontinence and went to consult with Dr. Singh in her home town of Tehachapi, California, 35 miles east/ southeast of Bakersfield, California where this trial is being held.
Case 1:13-cv-00729-AWI-JLT
Judge Lorna Brumfield, Metropolitan Division, Superior Court of California, Kern Co.
The complaint (Perry Petition PDF) lists seven causes of action, including Failure to Warn, Design Defect, Negligence, and Loss of Consortium.
Pain Never Goes Away
Peter de la Cerda
The plaintiff says she was never given patient information about the TVT-Abbrevo, one of the TVT family of polypropylene meshes made by Ethicon, a division of Johnson & Johnson. Under questioning, Ms. Perry said she did not understand the sling could cause lifelong mesh erosion, pelvic and vaginal pain, or painful intercourse. Had she known, would she have agreed to the sling implant? No, said Ms. Perry.
The surgery was performed March 2011 by Dr. Luu, a Bakersfield, CA colleague of Dr. Singh. She was told she would be healed in eight weeks. Instead, Ms. Perry told jurors that the pain never went away and intercourse was painful. Her husband was injured by what felt like shards of glass. Mesh had eroded through the vaginal wall she was told by her doctor and she’d need a mesh removal which occurred in October 2011.
Dr. Luu told her by removing the mesh and cleaning up scar tissue it would help with her pain. But the October 2011 surgery did not alleviate the pain.
Around the same time, Ms. Perry went to a medical doctor who used natural treatments and alterations in diet instead of pharmaceuticals as part of a complimentary medicine treatment. Primarily Ms. Perry wanted to lose weight, get her hormonal irregularities under control including night sweats, digestive problems and diarrhea. She did not go in for the pelvic pain. With a positive outcome, Ms. Perry had written a letter commending her doctor on her renewed hormonal health and related problems and began walking again.
Kim Schmid, Ethicon attorney
In opening arguments, defense attorney Kim Schmid, told jurors that Ms. Perry felt so well after her mesh removal that she wrote a glowing letter to her doctor and had taken up exercise again. But under questioning from her attorney, Ms. Perry said that improvement in her health did not include her pelvic issues which were not even addressed by the alternative practitioner.
Car Accident
In June 2013 she and her husband, a Los Angeles firefighter, were in a car wreck. A taxi ran a stop sign and broadsided them and sent them into another car. The couple’s car was totaled and they were hospitalized. She sustained injuries in her neck, and under questioning by J&J attorney Kim Schmid, Ms. Perry emphasized the pain was in her neck, not her pelvis.
After her husband retired, the couple prepared a trip to Hawaii. She said she wasn’t going to let the pain stop her from enjoying the trip of a lifetime with her husband. She was in pain but she decided she was going to push through it. The couple agreed to join in the activity chosen by each. Since she loves gardening and flowers, they went to gardens. Her husband picked zip lining, and his wife joined him. Before the jury, defense counsel referred to a photo that showed Ms. Perry zip lining that had been presented during her deposition.
Mr. de la Cerda established Ms. Perry now had a chance to explain the photo in its proper context.
Present Pelvic Pain
The degree of her vaginal pain today depends on whether it’s a good or bad day, said Ms. Perry. Some days it feels like her tissue is tearing and stretched like its coming apart, pain she’s had since the original surgery. It’s an everyday occurrence and part of her life. In terms of rating her pain, on the lower end of the scale it’s a 3. She has days where it is more moderate depending on her activity. Then there are days when she has to lay down. It’s always there, she said. Bending, lifting, housecleaning, doing the laundry, any movement can make it worse. Every aspect of intercourse is painful and sometimes the pain causes her to see stars and is impossible to finish, she said tearing up.
How has it affected her relationship with her husband? She said she feels like damaged goods because of a decision which has ruined everything. She twirls a tissue as she described pulling away from her husband, afraid a touch might lead to a request she cannot fulfill. It is devastating, she said as she dabs her eyes and is now crying fully.
She doesn’t like to take pain medication and instead refrains from social activities that may be embarrassing due to incontinence.
The defense asked Ms. Perry about her treatment with Dr. M. Tom Margolis who had been referred to consult on the Perry case. A Dr. Flynn would be the expert doctor for the defense and Ms. Perry had to be subjected to a pelvic exam by him as well. Attorney Schmid established even though Dr. Flynn worked for Ethicon he did nothing wrong or inappropriate. Ms. Perry agreed.
Kim Schmid then went through Ms. Perry’s work history establishing that she did not work outside the home from 1994 to 1996. She had attended interior design school, cosmetology school and had worked part time at a winery and in catering.
The defense needs to establish what is meant by a loss of income when the jury deliberates by showing she was not earning a full-time salary.
Past Medical History
Dragging out many documents from her past history, Kim Schmid, the attorney for Ethicon, attempted to show that Ms. Perry suffered health complications before her mesh implant in March 2011. Presenting questionnaires from medical facilities where she had been a patient, the defense established Ms. Perry had high cholesterol and had been prescribed Lipitor. She stopped taking the statin drug because of a fear of the side effects. Defense also talked to her about her history of high blood pressure she had before her multiple pelvic surgeries (she often reminds the jury) and a history of fainting and seizures, difficulty breathing, seasonal allergies, asthma.
Under her alternative care doctor, Dr. Mather, Ms. Perry said she is off all prescriptions and feels better with those problems, which she emphasized are separate from her ongoing pelvic pain.
The case began January 26th and is predicted to take three weeks, however there was no trial last Thursday or Friday.
The plaintiffs are represented by Wagstaff & Cartmell LLP, Richard A. Freese of Freese & Goss, Stewart Albertson of Albertson & Davidson LLP and by Peter De La Cerda of Edwards & De La Cerda PLLC.
Ethicon is represented by Bowman and Brooke LLP, William Gage and Burt Snell of Butler Snow LLP and by Soo Lin and Joshua Wes of Tucker Ellis LLP. #
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