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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Pharmaceutical News Wrap Up: March 2014

March 31, 2014

Here at the Simmons Firm, our pharmaceutical lawyers strive to keep you caught up on the latest pharmaceutical news. Below is a short list of some of the most recent headlines concerning FDA recalls, approvals and warning label changes, medical studies and other pharmaceutical news taking place across the country and world.

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Takeda Pharmaceuticals Intentionally Destroyed Actos Files, Bloomberg Reports

March 19, 2014

The Osaka, Japan-based pharmaceutical company Takeda said they cannot find files pertaining to the development, marketing and sale of Actos that were compiled by 46 different employees, according to a recent Bloomberg news report. The company admitted to U.S. District Judge Rebecca Doherty that even though executives warned employees to retain Actos-related materials, some files were deleted from company computers.

Because of this, Judge Doherty ruled Asia’s largest drug maker must let a jury hear claims that it intentionally destroyed Actos files. Lawyers of a former Actos user will tell jurors about the document destruction during the on-going trial. The ex-Actos user is suing the company over his development of bladder cancer since taking the drug.

Actos, a type 2 diabetes medication, has been linked to an increased risk of bladder cancer, especially among patients who use the drug for longer than one year. Many former Actos users contend that Takeda researchers ignored or downplayed the serious health concerns associated with the drug’s cancer-causing potential. They also believe researchers misled U.S. regulators about its health risks.

Takeda’s sales for Actos peaked in March 2011 at $4.5 billion. Actos sales made up 27 percent of Takeda’s total revenue at the time, according to the Bloomberg article.

The Simmons Firm lawyers are actively investigating claims that Actos use has led to the development of bladder cancer. If you or your loved one has been injured by Actos and has since been diagnosed with bladder cancer, the manufacturer may have failed in its duty to label the product appropriately.

Contact us today to see if you are eligible to file an Actos lawsuit, or learn more about Actos and bladder cancer today.

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Former Yaz User Shares Her Story of Unspoken Side Effects

The hormonal birth control Yaz has been linked to dangerous side effects including blood clots, stroke, heart attack, kidney failure, cardiac arrhythmia, pulmonary embolism and even death. Hannah Kohlman, a former Yaz user, experienced some of these severe side effects which put her in the hospital and almost ended her life.

Six months after starting to take the birth control, Hannah began experiencing symptoms she thought were associated with asthma, like rapid exhaustion while climbing stairs, sleepiness and being constantly short of breath. Her coworkers told her she appeared very pale.

One morning Hannah woke up with chest pains, which she thought were a pulled muscle in her chest. The next day she had severe chest pain, a racing heart and difficulty breathing. She collapsed on the floor before gradually pulling herself to her phone, which she used to call for help before losing consciousness.

Hannah woke up in the hospital where she was told her blood pressure was less than half of what a normal adult’s blood pressure should be. A CT scan found two major blood clots blocking two of her arteries in her heart – one was blocked 100 percent and the other was blocked 75 percent.

She spent the next week in intensive care with 24-hour surveillance monitors. Doctors were worried her clots would move to her heart and cause a heart attack or move to her brain and cause a stroke. She was later released from the hospital, but suffered from chest pains for the next six months and is dealing with increased risk of blood clots for the remainder of her life.

Doctors told Hannah the only cause of the blood clots was Yaz, her contraceptive pill. Hannah states she had no knowledge of the serious side effects of Yaz such as pulmonary embolism and blood clots. She had always lived a healthy, active life and thought blood clots only happened to unhealthy people.

“If I had been even slightly aware of the negative side effects, I never would have started taking [Yaz] in the first place,” Hannah said. “I hope by sharing my story it inspires other young healthy women to educate themselves on some of the potential side effects from taking common and popular contraceptive pills such as Yaz.”

The Simmons Firm is dedicated to helping individuals who have been harmed by drugs such as Yaz. If you are interested in learning more about Yaz side effects or would like to speak to one of our Yaz lawyers, please contact us 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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FDA Runs First Widespread Quality & Safety Evaluation on Generic Drugs

March 7, 2014

FDA Runs First Widespread Quality and Safety Evaluation on Generic Drugs

More than 80 percent of prescription drugs in the U.S. are being tested by the Food and Drug Administration (FDA) in its first widespread safety and quality evaluation. The effort will examine generic drugs such as heart medications, ADHD treatments, immunosuppressants, anti-seizure drugs and antidepressants. The evaluation will cost $20 million. It is funded through new fees collected from the generic pharmaceutical industry Congress approved in 2012.

The decision to run this first widespread test is a result of growing concerns over the quality of medications imported from other countries. The evaluation will run through 2017 and will involve dozens of academic centers across the country. Such academic centers participating in the evaluation include Duke University, the University of Michigan, John Hopkins University, the University of Maryland, Brigham & Women’s Hospital and the University of Florida, among others.

While testing has been conducted on a periodic basis, this new evaluation reflects the FDA’s recent emphasis on the quality of “copycat drugs”, according to a Bloomberg article. Medical professionals have also become more concerned about the quality of medications manufactured overseas.

For example, a 2013 study from a Boston-based researcher found numerous problems in copies of Lipitor made outside of the United States. Manufactured by Pfizer, brand drug Lipitor lost its patent protection in November 2011, opening it up to generic competition. Up until that point, the cholesterol medication had been the world’s top-selling drug. The FDA will be reviewing the Lipitor study as part of its new safety evaluation.

Additionally, recent medical studies have linked Lipitor to a dangerous risk of diabetes in women who take the medication. In 2012, the FDA required Pfizer to update Lipitor’s warning label to inform consumers of the increased risk of developing type 2 diabetes.

If you or someone you love took Lipitor and is now dealing with diabetes, take the first step and contact our experienced Lipitor lawyers today.

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