Tag Archive > Medical Devices

Avaulta Transvaginal Mesh Lawsuit Trial Begins Today

admin » 09 July 2013 » In Legal News, Mass Tort » No Comments

The first of four bellwether trials regarding C.R. Bard transvaginal mesh lawsuits began today in the U.S. District Court in the Southern District of West Virginia, with the plaintiff of the first transvaginal mesh multi-district litigation trial alleging to have suffered injuries from C.R. Bard’s Avaulta transvaginal mesh device. The woman claims that the transvaginal mesh device was made from a resin-based plastic not suitable to be implanted in the human body.

Transvaginal mesh has been commonly used to treat urinary incontinence and pelvic organ prolapse in women. However, transvaginal mesh devices are currently facing scrutiny for the numerous health problems associated with the implantation of the transvaginal mesh device in the body. Shrinkage of the transvaginal mesh device due to the body’s natural foreign body response after implantation can ultimately lead to the destruction of nerves, tissue, and organs surrounding the transvaginal mesh device.

“Multi-district litigation trials are important in encouraging defendants to recognize the damage and harm that their products have caused and compensate all victims of their defective devices accordingly. If C.R. Bard should learn anything from the past, it would be the need for their company to have performed adequate testing and to convey proper warnings. In the absence of an effort to protect public safety, they should be found liable for the harm that they produce” said Robert Price, a transvaginal mesh attorney with the law firm of Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor, P.A.

Thousands of women implanted with faulty transvaginal mesh devices have filed lawsuits against C.R. Bard and other manufacturers of defective transvaginal mesh products. In June 2012, a woman was awarded a $5.5 million verdict by a California jury for injuries she suffered from an Avaulta transvaginal mesh device.

An Atlantic County, New Jersey jury ruled against Johnson & Johnson with an $11.11 million verdict, in which the plaintiff was awarded $3.35 million in compensatory and $7.76 million in punitive damages from injuries she suffered from ProLift, a recalled transvaginal mesh device manufactured by Ethicon, a subsidiary of Johnson & Johnson.

“Often times, the manufacturers of these faulty transvaginal mesh devices are aware of the serious health risks associated with their products,” commented Daniel Nigh, a transvaginal mesh attorney also with the law firm of Levin, Papantonio. “However, companies such as C.R. Bard and Johnson and Johnson failed to warn consumers of the risks and continued to market their products as safe and effective. Now, they are being held accountable for their negligence.”


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Medtronic gets FDA warning on heart implant unit

admin » 18 November 2009 » In Defective Products, FDA » No Comments

Medtronic gets FDA warning on heart implant unit

Medtronic said Wednesday it is responding to a warning letter from the Food and Drug Administration about procedures at the Minnesota headquarters of its heart implants division.


Medtronic said the FDA inspected the Mounds View, Minn., location in August. It found problems with Medtronic’s procedures for preventing and identifying problems with its devices, documenting those problems, and the speed with which it informs the FDA of any issues. The agency also cited problems with Medtronic’s quality control for suppliers.

Medtronic is the world’s largest medical device maker, and the cardiac rhythm disease management unit is its largest business. It makes surgically implanted devices for rapid, slow, and irregular heartbeats, and systems that monitor how those products are working.


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