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The History of Risperdal in the Pharmaceutical Marketplace

Also known by the generic name risperidone, Risperdal is a powerful, anti-psychotic medication prescribed to treat schizophrenia, autism and bipolar disorders in adults. Its manufacturer, Johnson & Johnson (J&J), has recently been making headlines, especially in the Huffington Post, where its story has been the subject of a 57,000-word series by Steven Brill. The series discusses the tumultuous journey of Risperdal and J&J, which paid more than $2 billion in government penalties due to marketing several drugs, including Risperdal, for off label uses.

The investigative news series shows that $2 billion in penalties, for J&J, is a small price to pay for a profit of about $30 billion in Risperdal sales since 1994.

The problem comes from the fact that J&J earned a majority of its profit from wrongfully marketing the drug to a target audience that was not approved by the U.S. Food & Drug Administration: children.

Multiple studies had shown the risk of gynecomastia (male breasts) among children taking the drug. One study found that Risperdal led 5.5 percent of boys to develop large breasts – but the company covered up this information and continued to market Risperdal off-label to adolescents and children.

While the drug was approved for adolescent use in 2007, Risperdal was allegedly marketed before it was approved for adolescent use by the FDA.… Read the rest


Is Testosterone Replacement Therapy Safe? What You Need to Know

Did you know that testosterone is the most important sex hormone for men? It impacts multiple areas of health – including sex drive, energy, bone and muscle health, fertility and more. Below, we answer some commonly asked questions concerning testosterone and various treatment methods.

How does testosterone deficiency happen?

Learn about testosterone lawsuits.

Learn about testosterone lawsuits.

A decline in testosterone is a natural part of aging for most men – so it’s normal to witness minor side effects from a decline in this important hormone. [Click to Tweet] When decreased testosterone does not occur as a normal part of aging, it can be caused by a number of health conditions and disorders.

How does testosterone deficiency affect a man’s health?

Natural decline in testosterone typically has minor effects on a man’s health. Such side effects include a drop in sex drive, low sperm count, fatigue, moodiness and more.

What are the safety concerns associated with testosterone replacement therapy?

Not only have several studies linked testosterone replacement treatments to an increased risk of heart attack, stroke or death, some experts say testosterone treatments are marketed to fix a problem that’s not necessarily a problem needing fixed. [Click to Tweet] For example, testosterone marketing may tell a man that if he feels tired, testosterone replacement therapy can give him more energy.… Read the rest


Past Zofran Studies Showed Signs of Toxicity in Pregnant Animals

Zofran, a potent anti-nausea medication that was often prescribed off-label for women during pregnancy, has been linked to an increased risk of causing birth defects. While many medications like Zofran lack conclusive data on their effects on unborn humans, Zofran was studied in pregnant rats and rabbits. Results revealed that the drug’s active ingredient, ondansetron, could cross the placental barrier in mammals.


Contact our Zofran lawyers.

These studies were conducted in the 1980s, prior to Zofran’s FDA approval. It’s important to note that animal studies are never assumed to predict the outcome for human patients, but physiology is very similar across a variety of mammals. The study results may not prove that Zofran directly causes harm to a human fetus, but it does show that Zofran’s ingredients can travel in a pregnant female’s blood and enter her unborn child.

In 1991, GlaxoSmithKline, the pharmaceutical manufacturer of Zofran, submitted the study results to the U.S. Food and Drug Administration (FDA) during its initial application for approval. Reports showed that the company reported no harm to the fetus in the animal study, but there were signs of “toxicity, premature births, intrauterine fetal deaths, and incomplete bone growth.”

Again, animal studies do not necessarily predict similar outcomes with human studies.… Read the rest


Real Faces of Zofran Birth Defects: Arianah’s Story

You may be familiar with Zofran, an anti-nausea medication that is often prescribed off-label for women during pregnancy. Zofran has been linked to causing birth defects such as cleft lip, cleft palate, heart defects and more. When pharmaceutical companies rush their products to market without thorough research, everyday consumers like you and me are the ones who are harmed. However, this information tends to sink in more after we’ve seen and heard the stories of the real faces of Zofran birth defects –children like Arianah.

zofran lawsuitsValley News Live, a news station in North Dakota, recently featured the story of Arianah, a little girl with a heart defect. The two-year-old is facing major heart surgery that could have easily been prevented.

When Arianah’s mother Kylee Riesen was pregnant with her, Riesen suffered from severe morning sickness. Doctors prescribed Zofran, which, at the time, was only approved by the U.S. Food and Drug Administration (FDA) for use in chemotherapy patients to ease nausea. Throughout her pregnancy, Riesen continued to take the drug not knowing its risk of causing birth defects.

Two years later, Arianah is now preparing for open heart surgery to repair her heart defect. The family will have to travel out of town for the surgery, and they will have to stay there for about a month.… Read the rest


Johnson & Johnson Ordered to Pay $5.7 Million in California Transvaginal Mesh Trial

Pharmaceutical company Johnson & Johnson (J&J) was ordered to pay $5.7 million to the plaintiff in its first trial related to injuries from TVT Abbrevo, a transvaginal mesh device. A California jury found the company liable for problems connected to the design of TVT Abbrevo. Additionally, the jury found that J&J failed to warn consumers of its risks.

According to Reuters, this verdict is the fourth win for plaintiffs suing J&J and its Ethicon Inc. unit for transvaginal mesh products. In total, more than 36,000 lawsuits have been filed against the company and its transvaginal mesh devices.

Abbrevo is one of Ethicon’s newer transvaginal mesh products and was approved by the U.S. Food and Drug Administration (FDA) in 2010. The device was approved to treat stress urinary incontinence.

Along with many other transvaginal mesh devices, however, Abbrevo has caused serious injuries among women, including erosion of the device through the vaginal epithelium and other parts of the body. This can cause intense pain and lasting negative effects.

Other transvaginal mesh complications include:

  • Erosion through vaginal epithelium (the tissue inside the vagina)
  • 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 (painful intercourse)

A total of seven companies are facing transvaginal mesh lawsuits filed by women and their loved ones who have been seriously injured.… Read the rest

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