Commentary and insight about the complex legal, medical and social issues surrounding pharmaceutical litigation.

Research Finds Female Lipitor Users Have Increased Risk of Diabetes

February 5, 2013

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)

Expert Testifies DePuy's Metal-on-Metal Hip Implant Has High Failure Rate

January 29, 2013

Dr. John A. Baron, a professor at Geisel School of Medicine at Dartmouth, testified Monday that the DePuy ASR metal-on-metal hip implants had a 22 percent failure rate within five years. He based his opinion on studies from Sweden, Australia and the United Kingdom, according to a LAW360 article about the trial.

He told the jury that this number is “striking” and “extraordinarily high” since the average rate of failure for hip implants is around 4 percent at five years.

The case is the first of thousands in the nation to go to trial. It alleges that Johnson & Johnson failed to warn consumers and their doctors about the dangers associated with the DePuy metal-on-metal hip replacements. Within five years, the implant has failed thousands of patients causing pain, swelling and problem walking.

More serious problems related to the medical device’s failure include:

  • Metal poisoning from microscopic particles released by wear on the implant
  • Loosening caused when the implant does not stay attached to the bone
  • Fracture(s) where the bone around the implant may have broken
  • Dislocation caused when the two parts of the implant that move against each other becoming misaligned
DePuy Orthopaedics, a subsidiary of Johnson & Johnson, issued a voluntary recall of its ASR hip implant devices in 2010. For more information about the recalls and the legal rights of patients, click here. Comments (0)

Continued Meningitis Cases Have Doctors Baffled

December 21, 2012

More than one month ago, fungal meningitis cases began appearing from the use of tainted steroid injections, resulting in a total of 37 deaths. The 42-day risk period for contracting fungal meningitis from these injections ended on November 7, but new cases of meningitis and infections continue to develop. Some of these new cases appear to be in individuals previously treated and sent home.

Since December 12, the Centers for Disease Control have reported 39 new spinal infections that are not meningitis, five new cases that are meningitis, and three new joint infections. 

“Here’s the perplexing issue,” said Dr. Tom Chiller, deputy chief of the Centers of Disease Control and Prevention’s mycotic disease branch, in an ABC News article. “Why are we getting people that early on who are presenting with rip-roaring meningitis, but now, they’re presenting 100 days later with focal infections only? Why the difference? We don’t know.”

Previously, an investigation by the FDA revealed that about one-quarter of the steroid vials in an NECC bin contained a “greenish black foreign matter”, as disclosed in an FDA report released on October 26. This report also identified rooms where sterile products were produced that had mold or bacterial growth.

Approximately 14,000 people received injections that were tainted and produced by a New England Compounding Center in Massachusetts, which later recalled all of its products and shut down for the remainder of the year.

“We hope we’re nearing the end of this,” Chiller said.

Read the full ABC News article here: http://abcnews.go.com/Health/fungal-meningitis-cases-spinal-infections-baffle-doctors/story?id=17937366#.UNHNS6zqR4t 

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FDA Requires Labels of Drospirenone Birth Control, Like Yaz, to Include Increased Blood Clot Risk Warning

April 10, 2012

The requirements levied against Bayer and its popular birth control Yaz became stricter today. The Food & Drug Administration has issued a safety alert regarding birth control that contains drospirenone, like Yaz and Yasmine, saying that they may be associated with a higher risk for blood clots than other progestin-containing pills.

As a result, Bayer must revise all labels of Yaz and Yasmin to include this FDA warning. Specifically, the labels must include that some epidemiological studies reported as high as a three-fold increase in the risk of blood clots while other epidemiological studies found no additional risk. 

While the labels being updated is a move in the right direction, the warning is watered down by the second half which acknowledges the studies conducted by Bayer which found no additional risk. As a member of the Yaz Multidistrct Litigation Steering Committee and an attorney representing hundreds of women injured due to Yaz and Yasmin, I have seen the harm this drug has caused thousands of woman first-hand.

Thousands lawsuits have been filed against Bayer over Yaz/Yasmin. More than 267 deaths have been linked to drospirenone-containing pills and similar birth controls, according to an FDA study. Plus, it can cause numerous other serious medical problems like stroke, heart attack, kidney failure and gall bladder problems.

Perhaps the FDA recognized including both study results sends consumers a mixed message because it has also required that the label include a summary of the FDA-funded study of the blood clot risk. The FDA study confirmed that women who take contraceptives that contain drospirenone are 75 percent more likely to suffer serious side effects from blood clots compared to older birth control methods.

While the FDA did not include the summary wording that would go on the label in its wording, hopefully it will be enough for women to fully understand the risks.

As one of the firms handling the national cases against Bayer, the Simmons Law Firm and its experienced pharmaceutical attorneys are in a position to help victims of contraceptives.  Learn more in our Yaz/Yasmin section.

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FDA to Review Popular Birth Control Pill Yaz

June 3, 2011

Women who take birth control know doing so comes with a risk of blood clots, especially if they’re a smoker over 35. However, two new studies by the British Medical Journal found that women who take contraceptives like Bayer’s Yaz or Yasmin have a two to threefold higher risk of blood clots.

As a result of the findings, the Food & Drug Administration issued a statement Tuesday saying it’s conducting a new safety review of birth control pills that contain drospirenone, the hormone that’s alleged to increase blood clot risk. The results of their investigation should be released later this summer.

Drospirenone, in addition to Yaz and Yasmin, is also used in Ocella, Beyaz, and Safyral. For a complete list, click here.

Despite the new findings, Bayer continues to insist its oral contraceptives are safe, according to the NYTimes. Yet, nearly 7,000 lawsuits filed against the company tell a different story. Approximately 200 reported deaths have been linked to Yaz/Yasmine and numerous other serious medical problems such as stroke, heart attack, kidney failure and gall bladder problems.

As one of the firms handling the national cases against Bayer, the Simmons Law Firm and its experienced pharmaceutical attorneys are in a position to help United States victims of contraceptives.  Learn more in our Yaz/Yasmin section. Comments (0)

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

January 4, 2011

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

November 24, 2010

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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