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

Low Testosterone Diagnosis: Are Current Testing Methods Substantial?

Since 2000, the number of American men taking testosterone replacement therapy has quadrupled. More than 5 million prescriptions were written for testosterone therapy in 2011 alone.

Men experience a decline in natural testosterone production as they age. This can cause less than desirable health effects such as declining sex drive, erectile dysfunction, decreased bone density, lower muscle mass and fatigue and depression. Because of this, more and more men are turning to prescription low T treatments to ease the symptoms.

Some experts are beginning to worry about the extent to which testosterone treatments are prescribed. Many believe there is a failure to get adequate testing from certified medical experts in the area of hormone therapy. This can create a dangerous path for men taking low T treatments who might not necessarily need them or be properly monitored while taking the prescription.

How Doctors Diagnose Patients with Low Testosterone

When a patient gets tested for low testosterone levels, they will generally have a morning office visit because this is the time of day testosterone levels are highest. A blood test is performed. The doctor may also use hormone or genetic testing to check for low testosterone levels.

Some health experts believe more should be done to prevent unnecessary testosterone use. They recommend that doctors perform a physical exam in addition to blood and hormone testing to check for physical symptoms of low testosterone.

“A mildly low level of testosterone alone, without any signs or symptoms, typically does not require treatment,” said Dr. Todd Nippoldt, of the Mayo Clinic in a Chicago Tribune article. “Follow-up tests and exams can usually show if a medical condition may be contributing to low testosterone. If an underlying medical condition is identified, treatment for that disorder may be all you need to bring your testosterone level back into the normal range.”

Patients should be aware of the recent link between testosterone replacement therapy and risk of heart problems and stroke. Several studies have linked low T treatments to increased risk of stroke, heart attack and death among men. The U.S. Food and Drug Administration (FDA) is currently investigating this link.

Learn more about testosterone therapy and its associated health dangers, or contact an experienced testosterone lawyer at the Simmons Firm today.

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Louisiana Jury Orders Actos Manufacturer to Pay $9 Billion

April 11, 2014

Takeda Pharmaceutical Co. and Eli Lilly & Co. have been ordered to pay a total of $9 billion in punitive damages in connection to the diabetes drug Actos. A Louisiana jury found that the companies did not disclose the proper information about cancer risks associated with Actos.

Based in Japan, Takeda is the manufacturer of Actos, a prescription medication for the treatment of type 2 diabetes. Eli Lilly & Co. helped to promote the drug. Both companies are accused of failing to warn consumers about the increased risk of bladder cancer linked to Actos.

Actos had previously been a major seller for Takeda until its patent expired in 2011 and it began facing generic competition. Additionally, sale of Actos was suspended in both Germany and France in 2011 due to its connection to increased cancer risk.

Takeda executives failed to provide clear warnings about the associated cancer risk for seven years, Bloomberg reports. Research definitively showed Actos’ link to bladder cancer wasn’t an accident or oversight, yet the company did not issue a warning to consumers.

More than 2,700 Actos lawsuits have been consolidated before the U.S. District Judge Rebecca Doherty in Louisiana, the Bloomberg article states.

The Simmons Firm has been actively litigating claims that the diabetes drug Actos has led to an increased risk of bladder cancer. If you have questions, please contact our attorneys today.

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Consolidation of Lipitor Lawsuits to Streamline Process

March 14, 2014

Currently 56 personal injury claims regarding Lipitor have been filed. More than 170 similar federal cases are pending in more than 40 districts before 100 different judges. As a result, the U.S. Judicial Panel on Multidistrict Litigation has ordered the consolidation of all federal Lipitor lawsuits.

One of the reasons for the consolidation is that the cases share similar facts based on common allegations. The cases all allege that use of Lipitor has led to the development of type 2 diabetes among women.

A previous request to consolidate the lawsuits in Sept. 2013 was denied. However, this most recent request was approved on Feb. 18, 2014. Pzifer, the manufacturer of Lipitor, fought against the consolidation efforts, as it will contribute to an accelerated litigation process.

“The MDL will allow the cases of women injured by Lipitor to have streamlined discovery and contribute to an expedited legal process,” said attorney Trent Miracle of the Simmons Law Firm in a press release. “I’m looking forward to continue working on behalf of those injured by Lipitor to ensure they receive the justice they deserve.”

Since the consolidation will lead to a smoother lawsuit process, there comes the question of whether or not Lipitor claims will spike. There has been a steady increase in the sales of Lipitor since 1998 when 13 million patients took the drug. By 2004 more than 40 million Lipitor prescriptions were written and by 2011, Lipitor was the best-selling drug in the world.

Several medical studies have directly linked Lipitor use among women to an increased risk of developing type 2 diabetes. The popular cholesterol medication, also known by the name atorvastatin, is a member of the statin class of hypolipidemics.

Learn more about Lipitor lawsuits or contact a pharmaceutical lawyer today to see if you have a case.

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C.R. Bard Reaches Settlement in Second Lawsuit Trial Over its Transvaginal Mesh Product

August 26, 2013

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
  • Infection
  • Pain
  • 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

Read more about the C.R. Bard settlement or transvaginal mesh lawsuits now.

1 http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm

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Study Finds Januvia May Damage Pancreas

April 29, 2013

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 recent study conducted by researchers at the University of California found evidence that Januvia can increase the rate of pre-cancerous changes in the pancreas of diabetic patients. Specifically, Januvia is linked to pancreatic cell growth and damage that has the potential to become malignant. 
 
“These findings are in accord with the rapidly increasing number of reports to the U.S. Food and Drug Administration of pancreatic cancer in patients using these drugs compared with diabetics using other drugs,” reported Public Citizen, a Washington-based public advocacy group, in a Bloomberg article
 
In a similar study published in the March 2013 edition of the American Diabetes Association journal Diabetes, results showed a 40 percent increase in pancreatic cells and cell damage among 20 diabetics. Out of the 20 study participants, eight were being treated with incretin therapy such as Januvia, while 12 were treated with other diabetes treatment. 
 
Medical professionals have raised concerns about diabetes treatments that may harm the pancreas and lead to dangerous health complications. Complaints concerning serious side effects caused by Januvia were first reported to the FDA in 2009. 
 
Januvia remains a multi-billion dollar pharmaceutical for its manufacturer, Merck. It generated approximately $4.1 billion in 2012 worldwide sales, according to the Bloomberg article. 
 
Learn more about the serious side effects and reported health complications associated with Januvia, along with information on Januvia lawsuits here.
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Jury Rules Against Johnson & Johnson, Awards $11.1 Million to Woman for Transvaginal Mesh Injury

March 1, 2013

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 (2)

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)