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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


Pharmaceutical News Wrap Up: March 2015

Interested in the latest pharmaceutical news? Simmons Hanly Conroy’s pharmaceutical attorneys understand the importance of staying up to date, which is why we’re providing the list of recent news stories below. Read about U.S. Food and Drug Administration (FDA) recalls, approvals and warning label changes, medical studies and other pharmaceutical news that took place in the month of March.

  • Drugs using testosterone will label heart risks
    pharmaceutical newsAs mentioned by Simmons Hanly Conroy attorneys earlier this month, the FDA has ordered testosterone manufacturers to update the labels to include warnings of increased risk of heart attacks and strokes. The update also describes how testosterone should not be prescribed to treat symptoms in men brought about by natural aging.
  • Statins increase risk of type 2 diabetes, study suggests
    A new study discovered that statins (drugs used to lower blood cholesterol) increase risk of type 2 diabetes by 46 percent. Researchers found that this is a result of decreases in insulin sensitivity and secretion.
  • FDA adds alcohol and seizure warnings to Pfizer’s quit-smoking pill
    The popular smoking cessation drug Chantix now flaunts a new safety alert warning from the FDA. The label warns consumers about its risk of seizures and dangers of taking the drug with alcohol.
Read the rest

Pelvic Organ Prolapse Patients: Follow FDA's Precautions For TVM Surgery

Pelvic organ prolapse (POP), caused by the weakening of the tissues that hold pelvic organs, may be experienced by 30-50 percent of women. Despite its controversial results, transvaginal surgical mesh is the primary treatment for pelvic organ prolapse. Unfortunately, pelvic organ prolapse repair with surgical mesh can sometimes lead to complications and additional surgeries without much added benefit. Some of the transvaginal mesh (TVM) side effects include:

  • transvaginalmeshMesh erosion
  • Pain
  • Organ perforation
  • Urinary problems

Before pursuing transvaginal mesh lawsuits, patients should read about the precautions they can take to avoid dangerous complications, as recommended by the U.S. Food and Drug Administration (FDA).

  1. Ask About All of Your POP Options
    Transvaginal mesh is not always the best option. In fact, a review of scientific research has shown that treatment of POP with surgical mesh repair does not decrease symptoms or improve the patient’s quality of life more than options without mesh. If your surgeon does insist on using mesh, make sure to understand his or her reasons for doing so.
  2. Practice Consistent Post-Surgery Care
    Routine checkups and follow up care are vital to a healthy recovery from pelvic organ prolapse treatment. By staying aware of your body and keeping your doctors informed, you can catch surgical mesh side effects before they advance.
Read the rest

The Ovarian Cancer Risk Factor You May Not Know

Ovarian cancer is one of the most common cancers among women. According to the American Cancer Society, an average woman’s risk of developing ovarian cancer is 1 in 75. Approximately 21,290 women receive an ovarian cancer diagnosis every year.

ovarian cancer risk factorHowever, there are certain risk factors that can increase a woman’s chances of developing ovarian cancer. Some of the risk factors are uncontrollable, while others can be avoided. Below is a short list of some of the most common ovarian cancer risk factors:

  • Increased age
  • Obesity
  • Pregnancy after age 35
  • Reproductive difficulties (never carrying a pregnancy to term)
  • Fertility drugsAndrogens (male hormones)
  • Estrogen therapy and hormone therapy
  • Family and/or personal history of ovarian, breast or colorectal cancer
  • High-fat diets

There is one ovarian cancer risk factor that many women may not know. Talcum powder, which can be found in baby powder, body and facial powders, deodorant powders and other cosmetic products, has been linked to an increased ovarian cancer risk. When applied directly to the genital area or on sanitary napkins, studies have shown that cancer-causing components from the powder may reach the ovaries.

Specifically, one study found a possible 30 percent increased risk of ovarian cancer with the perineal or genital use of talcum powder.… Read the rest

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