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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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.




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