Jury Rules Against Johnson & Johnson, Awards $11.1 Million to Woman for Transvaginal Mesh Injury

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.

Related Articles

J&J Owes $7.76 Million in Punitives in Vaginal Mesh Case
Bloomberg, Feb. 28, 2013

Jury awards $3.35 million in vaginal mesh case against J&J
Reuters, Feb. 25, 2013

J&J Failed to Warn of Vaginal Mesh Risks, Jury Says
Bloomberg Businessweek, Feb. 25, 2013 Comments (1)

Research Finds Female Lipitor Users Have Increased Risk of Diabetes

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)

Transvaginal Mesh Update: Johnson & Johnson to Stop Mesh Implant Sales

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.”

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Transvaginal Mesh Lawsuits Consolidated Before Same Judge

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)

Vioxx Settlement in Ohio

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.

About Vioxx

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.

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DePuy Pinnacle Hip Implant Product Problems Result in More Lawsuits

DePuy Pinnacle hip lawsuits are now being filed by consumers who say that they have had to have revision surgery to remove their implants after experiencing problems with the metal-on-metal hip replacement.

The Pinnacle hip replacements, like the previously recalled ASR hip replacements, are metal on metal products. According to the suits filed, Pinnacle products have the same problems as their ASR counter parts. DePuy Orthopaedics, a subsidiary of Johnson & Johnson, issued a voluntarily recall of 90,000 ASR Hip replacement products last fall with additional products in the ASR family being recalled as recently as March 2011.

The metal-on-metal (MoM) products were designed in the hopes that they would last longer then other types of hip replacement devices, such as ceramic on ceramic or metal on polyethylene. But that wasn’t the case. Metal-on-metal hip replacement systems have additional risks compared with other hip replacement systems, according to the FDA. The friction caused by movement has been shown to release metal particles into the blood, causing multiple problems.

The main concern is when the metal ions damage the tissue surrounding the hip area, causing the implant to loosen and fail. This can cause severe pain and require a risky revision surgery where the old device is replaced with a new one. Some people might also experience metal poisoning.

DePuy Pinnacle hip replacement devices haven’t been recalled. The FDA recommends patients who have had MoM hip implants like DePuy Pinnacle or ASR hip implants should be aware of potential symptoms that might occur after surgery and indicate their device has failed. These include:

• Pain in the groin, hip or leg
• Swelling at or near the hip joint
• A limp or change in walking ability

It you or a loved one are experiencing these symptoms and have had a MoM hip implant, you should contact your orthopaedic surgeon for further evaluation. Then, also consider contacting an experienced defective medical device attorney about your DePuy Pinnacle or ASR hip implant.

As an advocate for consumer and patient rights, our experienced Pharmaceutical attorneys are currently investigating claims on behalf of patients injured by DePuy and its hip replacement products.  Follow the links to learn more about DePuy Hip Implants and the Simmons Law Firm’s pharmaceutical injury litigation practice. Comments (0)

Consumers continue to be placed at risk as pharmaceutical companies race to market

The FDA recalls & warnings of 2010 reads like a who’s who list in big pharmaceutical companies. It includes household brand names like Tylenol, Johnson & Johnson’s DePuy hip implants, heartburn pills Prilosec OTC & Nexium, Bayer’s Yaz Birth Control, and smoking-cessation drug Chantix.

In early 2010, the Simmons firm claimed a national leadership role in the on-going Yaz litigation when the cases were consolidated and centralized to the Southern District of Illinois in East St. Louis. More than 70 women suffered serious injuries after taking Yaz or Yasmine, a previously popular birth control bill, including heart attacks, pulmonary embolisms, gallbladder disease and sudden death, according to the FDA.

The firm also claimed a leadership spot on the committee to manage national litigation regarding the Chantix cases. Chantix, a drug used to help people overcome their smoking addictions, was linked to suicidal thoughts and actions, as well as behavior and mood disorders, as early as 2008. FDA officials warned that those taking the drug should stop immediately should they experience those behaviors.

Probably the most visual recall thanks to extensive coverage by the media here & here were the Tylenol recalls. The only good news is if you missed the recall of liquid children Tylenol & Motrin when it happened, there’s nothing to be unsure about. Don’t use it! According to Tylenol’s website, they don’t anticipate stocking shelves with safe infant & children’s liquid medicine until the spring.

As the year progressed, so did the FDA’s warnings with the news that long-term use of heartburn pills increased people’s risk of fracturing their wrists, hips and spine. Millions of people this past year bought over the counter versions of Nexium and Prilosec OTC to treat their long-term heartburn. The popular use of antacid drugs motivated FDA officials to re-label the prescription and over the counter versions to warn consumers of the dangers of long-term use longer than a year.

The fall brought yet another recall. An unpublished study revealed new data showing defects in DePuy Orthopaedic hip implants that caused an unexpected increase in the rate of second surgeries needed. The recall involves the ASR XL Acetabular System and DePuy ASR Hip Resurfacing System. At least 12 to 13 percent of patients who received either the Acetabular System or the Hip Resurfacing System have required follow-up surgeries and five-year revisions.

The year ended with the FDA pulling Darvon and Darvocet, or propoxyphene, from retailers' shelves because research found it can cause serious heart rhythm abnormalities. European regulatory agencies had banned the popular pain killer drug more than a year ago, while the U.S. medical community has raised concerns about the drug since it was first approved 1957.

As an advocate for consumers’ rights, the Simmons law firm will continue to keep you updated on the FDA’s investigations and its findings as we continue into 2011. Click here to read more about the Simmons pharmaceutical division. Comments (0)