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.

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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)

FDA Pulls Darvon, Darvocet from Market for Heart Risks

The maker of the pain killer medicine known as Darvon and Darvocet, or propoxyphene, announced last week it will stop making the popular drugs because it can cause serious heart rhythm abnormalities, according to a new study.

Xanodyne Pharmaceuticals Inc. agreed to the ban Darvocet, Darvon and its generic versions at the request of the Food & Drug Administration. The new ban brings the drug in line with European regulatory agencies that banned the drug more than a year ago.

The new study indicates that even when Darvon or Darvocet is taken at the recommended dosages, “there were significant changes to the electrical activity of the heart.” The new findings outweigh the potential benefit, the FDA said in a statement.

While it’s good the FDA is finally pulling Darvon and Darvocet from the market, it’s disconcerting that it’s taken this long for it to do so. In 2009, an FDA committee voted 14-12 against the continued making of propoxyphene products but noted additional information would be helpful. The FDA required the drug maker to conduct the study, and its results confirm concerns the medical community has raised about the drug since it was first approved by the FDA in 1957.

"We recommend to physicians stop prescribing the drugs. As for patients, do not stop taking it, but we urge you to contact your health care professional. Do not delay," Gerald Dal Pan, director of the FDA's Office of Surveillance and Epidemiology, told CNN last week.

Since 2009, more than 10 million patients have been prescribed some form of propoxyphene, according to the FDA. The Simmons law firm is currently investigating claims on behalf of those patients injured due to taking Darvon, Darvocet or the generic versions of propoxyphene. Click here to learn more about the Simmons pharmaceutical injury division.
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Doctors on Pharma Payroll Not Always Experts, New Investigation Finds

Do you promise to tell the truth, the whole truth and nothing but the truth, so help you God?

It’s a simple, but significant act on which our entire judicial system rests. When anyone takes the stand – defendant, witness or expert – they have a duty to tell the truth without prejudice.

This is especially necessary when experts testify. If experts are misleading, it can cause our legal system to fail. This happens more than you might think.

An investigation called “Dollars for Docs” by ProPublica has discovered that the experts hired by drug companies to educate consumers and doctors about the pros and cons of their drugs were not always experts. The investigation found that hundreds of these “so called” experts have been accused of professional misconduct, disciplined by state boards or lacked credentials as researchers or specialists, as reported by NPR.

Learn more about the database ProPublica created that lists the pays outs seven drug companies made to doctors.

Companies that hired these drug experts include some well known brands: Johnson & Johnson, Merk, Pfizer, Lilly, Cephalon, AstraZeneca, GlaxoSmithKline.

“Without question the public should care,” Dr. Joseph Ross, a professor of medicine at Yale told reporters. “You would never want your kid learning from a bad teacher. Why would you want your doctor learning from a bad doctor, someone who hasn’t displayed good judgment in the past?”

I would add, would you want one of these “so-called” experts to testify in court, to swear to tell the whole truth and nothing but the truth, when their very title is based not on their expertise, but on how many paid presentations they gave for the drug companies? Comments (0)

Hip Implants Recalled by Johnson and Johnson DePuy

According to the Wall Street Journal and other news sources, Johnson & Johnson's orthopaedic-device unit, DePuy Orthopaedics, Inc., announced recalls of some hip-replacement devices due to data on the rate of second surgeries needed. The voluntary recall came amid a string of quality-control problems at its non-prescription drug operations. Patients are being advised to visit their surgeons to evaluate their implant performance, which DePuy said should be done annually in any case.

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 Hip Resurfacing System has been available since 2003 for use outside the U.S., whereas the Acetabular System has been in use in the U.S. and worldwide since 2004. Both systems have been highly preferred by surgeons in cases of young patients because of the initially reduced chance of dislocation provided by both devices.

New, unpublished data showed a five-year revision rate being much higher than previously reported. One in eight patients needed a second surgery, according to data compiled from the National Joint Registry of England and Wales. Females saw the highest rates. Prior post-market data had shown lower revision rates and that its ASR hip was performing "in line with other devices in its class."

David Floyd, president of DePuy Orthopaedics, said the company is "committed to paying for the cost of doctor visits, tests and procedures associated with the recall." The company said in a statement that it "intends to cover reasonable and customary costs of monitoring and treatment for services, including revision surgeries.

As an advocate for consumers’ rights, the Simmons law firm will keep you updated on the FDA committee’s recommendations. Click here to read more about the Simmons pharmaceutical division. Comments (0)