The attorneys at Alexander, Corder & Shelly, P.C. are pursuing claims against several drug manufacturers, which are outlined below. If you think you have a claim, contact one of our attorneys today.

XARELTO

Because Xarelto’s manufacturers, Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) and Bayer AG, might not have adequately warned consumers about the potential risks associated with Xarelto, users of the drug might be eligible for compensation by filing a Xarelto lawsuit if the following occurred while taking the drug as directed:

  • Intracranial hemorrhages
  • Epidural hematoma
  • Gastrointestinal hemorrhages
  • Retinal hemorrhages
  • Adrenal bleeding
  • Stroke
  • Wrongful death

Xarelto Bleeding Problems
In 2011, the U.S. Food and Drug Administration (FDA) first approved Xarelto (rivaroxoaban), and it is indicated to reduce the risk of strokes, deep vein thrombosis (DVT), pulmonary embolism (PE), and blood clots in patients who have undergone hip or knee replacement surgery. Despite at least three attempts, it has not been approved to reduce blood clots in patients with coronary artery disease.

Like similar “blood thinners,” Xarelto carries the risk of internal bleeding side effects. However, Xarelto internal bleeding side effects cannot be controlled or reversed by physicians, making the drug more dangerous than other, conventional anticoagulants like warfarin (Coumadin). The added dangers have contributed to Xarelto lawsuits.

TRANSVAGINAL MESH

Since 2005, the FDA has received over 1,000 reports from nine surgical mesh manufacturers of serious, life-threatening complications associated with surgical mesh devices used to repair Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Typically, the mesh devices are placed “transvaginally” utilizing tools that assist in giving the patient a minimally invasive procedure.

The FDA has stated that the most frequently reported complications have included the following: 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, and a number of other possible serious, life-threatening side effects.

The U.S. Food and Drug Administration recently issued an updated safety communication warning health care providers and patients that surgical placement of mesh through the vagina to repair pelvic organ prolapse may expose patients to greater risk than other surgical options.

LIPITOR

The U.S. Food and Drug Administration (FDA) has warned that individuals who take Lipitor (atorvastatin) to lower their cholesterol may have a higher risk of type-2 diabetes. Recent studies have found that the risk of Lipitor and type-2 diabetes is especially high for post-menopausal women and people with other risk-factors for diabetes. Unfortunately, many people who took Lipitor and developed type-2 diabetes have now filed lawsuits alleging that they were never properly warned about the potential risk.

What is Lipitor?
Lipitor (Atorvastatin Calcium), a product of Pfizer Pharmaceuticals, is a pharmaceutical that is used for the treatment of high cholesterol. Lipitor is commonly referred to as a statin, and is similar to other medications such as Crestor, Levacor, Zochor, and Provochol. Lipitor was approved by the Food and Drug Administration (FDA) for consumer usage in 1996. At that time, there were little known side effects that were associated with the drug.

By 2009, the FDA issued new prescribing guidelines for the medication due to the increased risk of muscular damage when using the product. In 2011, additional warnings were placed on the drug because of possible liver damage associated with use. In January 2012, a study found that women, especially those who were post-menopausal, had a significant increase in the chance of getting Type II Diabetes when using the product.

Lipitor and Diabetes
Medical researchers studied thousands of people who took statin drugs, including Lipitor. The statistics showed that people taking Lipitor were more likely to become diabetic than people who did not take the drug. Scientists do not yet know exactly how Lipitor and other statin drugs cause diabetes. However, the increased risk seems clear.

The increased risk varies depending on the population that the scientists were studying. In some studies, the increased risk was as much as 28 percent. In others, it was only 9 percent. An increased risk means that a higher percentage of people who take the statin drug will get diabetes than those who do not. It does not mean that everyone who takes the drug will become diabetic.

The scientific articles showing the increased risk appeared in the medical journals called The Lancet and JAMA Internal Medicine. Those are two of the most highly regarded publications for doctors. The evidence has been accumulating since at least 2008.

  • In 2008, medical researchers noticed that some patients who took the statin drug called Crestor had higher levels of sugar in their blood.
  • In 2010, medical scientists confirmed that the increased risk of diabetes existed for people who took Lipitor.
  • In January 2012, research showed the increased risk to women who had gone through menopause.

In 2012, the FDA required the drug manufacturers to disclose the increased risk of diabetes in the information that is provided to patients with their prescription.

FDA Safety Warning for Lipitor and Type-2 Diabetes:

In July 2012, the U.S. Food and Drug Administration (FDA) updated the warnings on Lipitor to warn about increases in blood-sugar levels, which may increase the risk of type-2 diabetes. The FDA conclusions were based on several studies linking the entire statin class of drugs to new-onset diabetes (especially in post-menopausal women).

The FDA added warning:

“Based on clinical trial meta-analyses and epidemiological data from the published literature, information concerning an effect of statins on incident diabetes and increases in HbA1c and/or fasting plasma glucose was added to statin labels.”

Lipitor Raises Risk of Type-2 Diabetes:

Cholesterol lowering medications in the statin class, including Lipitor (atorvastatin), are popular for reducing the levels of dangerous Low-Density Lipoprotein (LDL) or “bad cholesterol.” Studies have shown that this also reduces the risk of heart attacks and strokes in patients who already have cardiovascular disease.

Unfortunately, recent studies have also raised serious concerns about Lipitor and type-2 diabetes. A new study confirms that Lipitor can increase blood-sugar levels, which may also increase the risk of type-2 diabetes. The risk is particularly high among post-menopausal women and people who have other risk-factors for diabetes, such as:

  • Post-menopausal women
  • Problems controlling blood sugar
  • High blood pressure
  • High triglycerides in the blood
  • Low daily activity levels
  • Excess weight
  • Family history of type-2 diabetes

LOW TESTOSTERONE THERAPY

New research has been found that testosterone treatments for men could cause an increased risk of stroke, heart attack or even death. Men with signs of heart problems were more likely to suffer a stroke, heart attack or die compared to healthy men who didn’t take testosterone supplements, according to the study, which followed 8,700 men taking testosterone for three years.

What is Low Testosterone therapy?
Testosterone therapy or low T treatment is prescribed to men to combat the natural decline in testosterone as they age. It helps improve sex drive, strengthen bone density and build muscle mass.
In 2011, more than 5 million prescriptions for testosterone were written in the United States, according to news reports. Testosterone therapy is most often administered as a gel, patch or injection. The following products treat low testosterone:

  • Androgel
  • Androderm
  • Axirom
  • Bio-T-Gel
  • Delatestryl
  • Depo-Testosterone
  • Fortesta
  • Striant
  • Testim
  • Testopel

Testosterone Therapy Heart Attack and Stroke Research
A study conducted by a group of researchers at the National Cancer Institute revealed that some men have an increased risk of suffering heart attacks while using prescription testosterone therapies. The study of approximately 56,000 patients found that men over the age of 65, as well as patients younger than 65 with a history of heart disease, had twice the rate of heart attacks in the three months after beginning testosterone therapy when compared to the year prior to treatment. The study also addressed whether these men were at a greater risk for cardiac problems due to an increase in libido caused by higher testosterone levels. When the study compared these men to a separate group of patients taking Viagra and Cialis, the men on the erectile dysfunction drugs patients did not experience more heart attacks.

Another study published in the Journal of the American Medical Association (JAMA) had similar results, finding that older men had a 29% increase in stroke, heart attack and death when undergoing testosterone therapy. Further supporting the link between testosterone therapy and heart risks, a 2009 federally-funded research study intended to address whether testosterone gels could help older men build muscle was stopped after researchers noticed that some of the study’s participants were suffering heart attacks and other cardiac problems.

FDA Investigating Heart, Stroke Risk for Testosterone Products
On January 31, 2014, the FDA announced it would be investigating the risk of heart attack, stroke and death in men using prescription testosterone products. The agency made the announcement after reviewing the study conducted at the National Cancer Institute, as well as the study published in JAMA.

The FDA recommended that while patients should not stop using these products without first talking to their doctors, healthcare professionals should consider whether the benefits of testosterone treatment outweigh its risks. The agency said it would communicate its final conclusions on the products after it has evaluated data from the two studies and other available information.