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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Showing posts with label Judge Goodwin. Show all posts
Showing posts with label Judge Goodwin. Show all posts

Monday, June 30, 2014

Catastrophically harmed by surgical mesh? Justice in settlements?


By: Austin Kirk | Published: June 25th, 2014
As hundreds of Coloplast mesh lawsuits continue to move forward through the federal court system, the parties are continuing to make progress in settlement negotiations to resolve the litigation, according to a recent court update.
Coloplast Corp. currently faces nearly 1,500 federal transvaginal mesh and bladder sling lawsuits, which have all been consolidated for pretrial proceedings before U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia as part of an MDL, or multidistrict litigation.
All of the complaints involve similar allegations that women suffered severe and debilitating complications after receiving Coloplast mesh for surgical repair of pelvic organ prolapse (POP) or female stress urinary incontinence (SUI), where the mesh eroded through the vagina, caused infections or other injury.
According to a pretrial order (PDF) issued by Judge Goodwin on June 16, “substantial progress” has been made toward settling the Coloplast cases and a follow up status conference has been scheduled for August 7, at which time the parties will meet with Judge Goodwin in chambers to provide an updated report.
In March, it was reported that a Coloplast mesh settlement was reached to resolve about 400 cases for $16 million.
In addition to lawsuits against Coloplast, Judge Goodwin is also presiding over thousands of similar cases brought against manufacturers of other transvaginal mesh products, including C.R. Bard, American Medical Systems (AMS), Ethicon, Boston Scientific, Cook Medical and Neomedic.
Endo Health Systems reported last month that it has agreed to pay $830 million to settle AMS mesh lawsuits brought by about 22,000 women, making it the largest settlement reported to date in the litigation.
C.R. Bard has also reached a number of individual settlements involving cases that were scheduled to come up for trial, but no global settlement agreement has been reached.
Vaginal Mesh Litigation Update
According to the latest case list (PDF) released by the U.S. Judicial Panel on Multidistrict Litigation (JPML) on June 16, Judge Goodwin is currently presiding over 17,812 AMS mesh lawsuits, 18,176 Ethicon mesh lawsuits, 12,004 Boston Scientific mesh lawsuits, 8,555 Bard Avaulta mesh lawsuits, 1,468 Coloplast mesh lawsuits, 195 Cook Medical mesh lawsuits and about 52 Neomedic mesh lawsuits.
The combined total of 58,262 vaginal mesh claims pending in the federal court system represents a nearly 35% increase in the number of cases pending since March 2014, when the U.S. JPML reported that a combined total of 43,173 cases were centralized before Judge Goodwin. In addition, thousands of other cases are pending in various state court systems throughout the country.
As part of the coordinated pretrial proceedings in federal court, Judge Goodwin has scheduled a series of early trial dates involving several of the manufacturers. Known as “bellwether” cases, such test trials are designed to help the parties gauge how juries may respond to certain evidence and testimony that may be repeated throughout the litigation.
In August, a trial involving a lawsuit filed against Ethicon by Jo Huskey is scheduled to go before a federal jury. Huskey alleges that she suffered injuries after receiving an Ethicon TVT-O bladder sling for stress urinary incontinence.
Later this year, a combined trial involving 11 Boston Scientific mesh cases is set to go before a jury starting in October 2014. That case involves women who experienced problems after receiving a Boston Scientific Obtryx sling for repair of stress urinary incontinence.
Last year, a series of three Bard Avaulta trials were set for trial in the MDL, with the first case going before a federal jury in July 2013, involving a lawsuit filed by Donna Cisson. That trial resulted in a $2 million damage award against Bard, including punitive damages designed to punish the company for the actions during the manufacture and sale of the product. The second and third trials were each settled shortly before they were set to begin, with terms of the deals withheld.
Given the lack of progress towards settling additional cases by some manufacturers, Judge Goodwin recently ordered that a second wave of Bard Avaulta cases and Boston Scientific mesh cases be prepared for trial, with hundreds of cases going through case-specific discovery over the remainder of this year so that they can be trial-ready by early 2015.
If the manufacturers fail to reach vaginal mesh settlements to resolve the majority of cases against them, they could face hundreds of individual trial dates scheduled throughout the country next year.
Related Articles


- See more at: http://www.aboutlawsuits.com/coloplast-mesh-settlement-update-66621/#sthash.6t8X8Wjf.dpuf

Tuesday, February 18, 2014

Texas woman first in bellwether surgical mesh trial.

Read the ruling here.
NewJersey.com ruling article here.


http://www.charlestondailymail.com/policebrfs/201402120147
Wednesday February 12, 2014
Trial against pelvic mesh manufacturers ongoing

Daily Mail Staff
CHARLESTON, W.Va. -- A Johnson & Johnson president of North American businesses was the latest to testify in one of several cases against the manufacturers of pelvic mesh.
Trial began Monday in the case brought by women who say the mesh used to treat stress urinary incontinence led to pain and permanent injury because of its defective design.
Carolyn Lewis, Kenneth Lewis, Augistina Brown-Singletary, Andre Singletary-Smith, Karin Harrison, Robert Harrison, Patricia Headrick, Darrell Headrick, Katie Uszler, Nick Uszler, Kelly Young and Kenneth Young originally filed the lawsuit in July 2012 in the Northern District of Texas.
Lewis received surgery in 2009, where doctors implanted the TVT, or transvaginal tape. The lawsuit alleges because of the defective design of the product, Lewis experienced pain when she emptied her bladder and during sex.
Defendants in the case are Johnson & Johnson, Ethicon Inc., Ethicon Women's Health and Urology, Gynecare and American Medical Systems Inc. This is the first case against Ethicon.
Attorneys for the companies said the plaintiffs never complained about problems from the mesh until after they filed the lawsuit and said the product was not defective.
U.S. District Judge Joseph Goodwin is overseeing the consolidation of more than 26,000 similar cases alleging injury from plastic mesh devices used to treat bladder and other organ weaknesses.
Laura Angelini, who has served in several marketing positions at Johnson & Johnson and Ethicon, appeared in a pre-recorded video deposition.
In her video testimony, Angelini agreed with the attorney, saying a Swedish company and the inventor of the TVT signed an agreement that later led to the company being the exclusive supplier of the tape. She said the inventor was a 20 percent shareholder in the company.
Angelini said the TVT initially was launched in Europe and was launched in the U.S. in late 1998. She agreed the type of mesh was used in hernia repair.
In Monday's opening statements, Lewis' attorney, Thomas Cartmell, alleged Ethicon used mesh to treat hernias but problems caused by the heavy nature of the product and small pores required surgeries to remove it.
Cartmell said a Swedish inventor later contacted Ethicon saying he used the old mesh to treat stress urinary incontinence and experienced no complications.
In her video testimony, Angelini said the Swedish company and the inventor signed an agreement where his company would be the exclusive supplier of the TVT.
Under the agreement, Agenlini agreed Johnson & Johnson would pay $400,000 to the company if it received acceptable clinical trial results.
In her opening statements, Christy Jones, an attorney representing the mesh manufacturers, said there were several studies on the transvaginal tape, not just those conducted by the inventor.
She said those studies have shown the tape is effective to treat stress urinary incontinence and said it was deemed the gold standard to treat this condition.
In the video, the attorney read off the agreement, saying Johnson & Johnson would pay $20 million for the TVT and a second installment of $2 million. If 140,000 units of TVT were sold, then Johnson & Johnson would pay another $2 million to the seller.
Angelini agreed that if all payments were made, that would total more than $24 million for the TVT device.
The video also showed an email from Angelini in response to her colleagues in the U.S. The attorney asked if she wrote they should spin it to more of a safety aspect than the complications and asked if she had influenced the title of a medical presentation.
Angelini responded that she provided her perspective to provide a more balanced position to show the safety data they had.
Goodwin dismissed the jury early Wednesday and told them to come back at 9 a.m. today. According to the court calendar, the trial is scheduled to last through Feb. 25.
Contact writer Andrea Lannom at Andrea.Lan...@dailymailwv.com or 304-348-5148. Follow her at www.twitter.com/AndreaLannom.