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C.R. Bard, a medical technologies developer, manufacturer and marketer commonly referred to simply as Bard, has reached a settlement in the second lawsuit trial of the multidistrict litigation for its transvaginal mesh product. The amount of this second settlement has not been made public.
Bard agreed to settle the claims made by Wanda Queen of North Carolina, who stated that Bard’s Avaulta-branded vaginal mesh device caused her severe pain and forced her to undergo six surgeries.
The announcement comes approximately one week after a federal jury found Bard had failed to warn consumers of the potential health hazards associated with its transvaginal mesh product and awarded $2 million in damages to a Georgia woman. According to court records, the product was also the Avaulta-branded vaginal mesh device.
Thousands of other similar transvaginal mesh claims against Bard are currently pending. Results of these trials could indicate positive potential for other claimants injured by Bard’s transvaginal mesh product.
Transvaginal mesh has been associated with many harmful health complications. The Food and Drug Administration (FDA) has issued Public Health Notifications about the serious complications and side effects linked to surgical mesh.
Specifically, the FDA has stated that serious complications associated with the use of transvaginal mesh for the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are common. The FDA has pointed out that it is not proven that using transvaginal mesh for POP is more effective than using non-mesh repair in patients with POP. For this reason, using transvaginal mesh may actually expose patients to greater risk of health problems.1
Serious complications linked to transvaginal mesh include:
- Erosion through vaginal epithelium
- Urinary problems
- Recurrence of prolapse and/or incontinence
- Bowel, bladder and blood vessel perforation during insertion
- Vaginal scarring
- Mesh erosion causing discomfort, pain and/or dyspareunia
Januvia is a once-daily medication prescribed to help lower blood sugar levels in patients with type 2 diabetes. Also known by the name Sitagliptin, the medication can be used in combination with other diabetes drugs to treat type 2 diabetes, but is not prescribed to treat type 1 diabetes.
A New Jersey jury has ruled Johnson & Johnson must pay $11.1 million to Linda Gross, of South Dakota, for her injuries resulting from the company’s transvaginal mesh implant product. The jury awarded Gross $3.35 million in compensatory damages and $7.76 million in punitive damages, resulting in a total verdict of $11.1 million.
Gross, 47, underwent 18 corrective surgeries after the device was implanted and suffered numerous debilitating side-effects. The jury ruled that Ethicon, a subsidiary of J&J and manufacturer of the device, failed to properly warn Gross of the risks associated with the transvaginal mesh implant and made fraudulent misrepresentations about its benefits.
The case is Gross v. Gyncare Inc., Atl-L-6966-10, Superior Court of Atlantic County, New Jersey (Atlantic City). The suit alleged failure to warn and fraudulent misrepresentation of the dangers associated with the Gyncare Prolift vaginal mesh product.
Gross filed her suit after she underwent surgery to install the transvaginal mesh medical device to treat pelvic prolapse. She spoke with her doctor and read a brochure supplied by Ethicon, leading her to believe there was little risk and that the mesh could be removed easily.
Instead, the mesh implant lead to a series of complications and problems, Gross testified, including mesh erosion, scar tissue, inflammation, hardening of the mesh, pain while sitting and 20 prescriptions for medications to help her with pelvic problems.
In August 2012, Johnson & Johnson stopped selling four types of mesh devices, including the Gyncare Prolift because, according to the company, the products “lacked commercial viability”.
This is the second verdict related to the dangers associated with transvaginal mesh implants. The ruling could have an impact on the other lawsuits against other manufacturers of similar products.
Owes $7.76 Million in Punitives in Vaginal Mesh Case
Bloomberg, Feb. 28, 2013
awards $3.35 million in vaginal mesh case against J&J
Reuters, Feb. 25, 2013
Bloomberg Businessweek, Feb. 25, 2013 Comments (2)
Three studies have determined women who take the cholesterol-lowering drug Lipitor have an increased risk of developing Type 2 Diabetes. In one study published by The Archives of Internal Medicine, the risk for older women was as high as 48 percent compared to women who do not take Lipitor.
As a result of the new research, the Food and Drug Administration issued a health warning in January 2012 requiring the labels of Lipitor and other statins to include the increased risk for diabetes.
“The announcement, medication label change and health advisory by the FDA were long overdue and have brought this important public health issue to light,” wrote Dr. Eric J. Topol, a professor of genomics at the Scripps Research Institute, in a New York Times article.
Lipitor works by preventing an enzyme in the liver from creating low density lipids (LDLs), a type of cholesterol that blocks the arteries. The drug essentially blocks the production of this cholesterol thereby reducing the user’s cholesterol level and risk of heart disease.
The attorneys at the Simmons Firm are currently investigating the legal rights of those who develop diabetes after taking Lipitor.For more information about the research surrounding Lipitor and diabetes, click here. Comments (0)
There's been a critical development surrounding the safety of vaginal mesh implants. According to a letter filed yesterday with U.S. District Judge Joseph R. Goodwin in Charleston, West Virginia, who is overseeing the litigation, Johnson & Johnson’s Ethicon will stop selling four of its vaginal mesh implants. This comes after 600 women filed suit, alleging the products caused serious internal injuries. A representative of Ethicon said sales of the devices will cease throughout the world.
According to the letter, Ethicon has asked the FDA for 120 days to end sales so it can “notify its customers and provide those hospitals and surgeons with sufficient time to select alternative treatment options for their patients,” and “Ethicon will also discontinue or revise, as appropriate, all marketing materials during this time.”
Complications associated with transvaginal mesh include infection, painful sexual intercourse, urinary problems, and overall discomfort and bleeding, all caused by the mesh eroding through tissue or the skim contracting too tightly around the device.
The FDA estimates that about 100,000 women a year with pelvic organ prolapsed are treated with the plastic mesh. The irony is that the medical condition can most often be treated without mesh and thereby avoiding the increased risked associated with the medical device.
“There are clear risks associated with the transvaginal placement of mesh to treat POP,” said Dr. William Maisel, chief scientist of the FDA division that oversees medical devices, in a TVM press release. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant -- complete removal may not be possible and may not result in complete resolution of complications.”Comments (0)
Three multidistrict litigations involving the risks of transvaginal mesh were consolidated this past week into a single MDL before Chief Judge Joseph R. Goodwin the U.S. District Court for the Southern District of West Virginia. The MDLs were filed against Boston Scientific, American Medical Systems and Johnson & Johnson’s Ethicon Inc.
Judge Goodwin was already handling another MDL involving Avaulta transvaginal mesh against C.R. Bard. Consolidating so many similar MDLs before one judge is very unusual. However it will benefit our clients to have a streamlined process overseen by the same judge, regardless of which company manufactured their defective TVM implant.
Transvaginal surgical mesh is a medical device that is generally used to repair weakened or damaged tissue in urogynecology procedures, including repair of pelvic organ prolapsed and stress urinary incontinence.
Every year approximately 100,000 women diagnosed with pelvic organ prolapsed are treated with surgically implanted transvaginal mesh. In July, the FDA released a warning about TVM, saying not only do women have a high risk of complications associated with implanting transvaginal mesh, but that the surgery may not be more effective when compared to traditional non-mesh repair.
As a result, the FDA has required the above manufactures to conduct additional studies to investigate the serious complications now becoming associated with the use of transvaginal surgical mesh.Learn more about transvaginal surgical mesh. Comments (0)
A November 23, 2011, Cleveland.com article reports that the state of Ohio will receive a $22.8 million settlement from the Merck, the manufacturer of the recalled drug Vioxx. This is according to an announcement made on November 22 by the U.S. Justice Department.
The article also reports that Ohio’s Attorney General Mike DeWine made a statement regarding the resolution saying that this settlement should serve as a reminder to drug manufacturers that they should represent their products truthfully.
The allegations made against Merck claimed that the manufacturer made false statements about the safety of Vioxx and also marketed the drug as a treatment for rheumatoid arthritis before getting regulatory approvals.
To resolve these allegations, Merck made an agreement with the federal government to pay a total of $950 million to 43 states and the District of Columbia but says the settlement does not constitute an admission of liability or wrongdoing.
The article can be read in full detail at http://www.cleveland.com/healthfit/index.ssf/2011/11/ohio_to_get_228m_from_vioxx_se.html.
Vioxx is a nonsteroidal anti-inflammatory drug (NSAID) that works to reduce inflammation, pain and fever in the body. Many defective drug lawsuits were filed over Vioxx’s link to heart attack and stroke. Finally, the drug was recalled in September 2004.
While the 2004 recall and recent settlement does serve as a victory in the war against pharmaceutical negligence and greed, it does not compare to the human lives lost.Comments (1)
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