Articles Posted in Pharmaceutical Litigation

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DSC08554-b morguefile username dodgertonskillhauseIn Estate of Hoholek v. AbbVie, Inc., a man apparently used testosterone replacement therapy medication prior to his death. Later, the man’s estate and his spouse filed a lawsuit against the manufacturer of the drug, its parent company, and two unnamed doctors in an Indiana court. Since the corporate defendants were based in Delaware and Illinois, the medical product manufacturers successfully removed the case to the Northern District of Indiana in Hammond based on diversity of citizenship. A federal court may normally exercise diversity jurisdiction where the defendant in a lawsuit hails from a different state than the plaintiff, and the amount in controversy exceeds $75,000.

After the case was removed to federal court, the defendants filed a motion to stay the proceedings and withdraw appearances made by certain counsel. In addition, the drug companies asked the court to provide them with more time to respond to the plaintiffs’ complaint. According to the defendants, the plaintiffs’ case was similar to that of nearly 500 other individuals involved in ongoing multidistrict litigation (“MDL”) over testosterone replacement therapy. In general, MDL is a unique legal proceeding designed to promote judicial economy by combining complex lawsuits with overlapping issues that are pending across federal districts into a single case. A few days after the case was removed to federal court, the ongoing action was conditionally transferred to the MDL.

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In order to make important government health data available to consumers, the U.S. Food and Drug Administration (FDA) launched a new initiative in June of this year.

OpenFDA offers not only information, but programming opportunities to developers who wish to build accessibility to government data into their projects and apps. While initially providing readily usable data to researchers and consumers, the site plans to include large sets of additional data previously difficult for the public to access.

The FDA is phasing in the site with an initial project that includes information on:

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Although codeine is familiar to many consumers, it is not safe for pediatric patients.

Earlier this year, a study published in the journal Pediatrics looked at prescribing patterns for the drug codeine. The journal article reviewed data from 2001 to 2010 for children ages three to 17 admitted to emergency rooms.

Many parents are familiar with codeine as a component in cough syrup. Most caregivers do not question prescription of the medication for a child when sick. They should.

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In response to more than 4,000 legal claims concerning the side effects of the blood thinner Pradaxa, the manufacturer agreed to settle in May.

Manufactured by Boehringer Ingelheim (BI), Pradaxa is the brand name for dabigatran etexilate mesylate. Approved in 2010, Pradaxa follows in the successful footsteps of the drug Wayfarin without the dietary or testing concerns of that drug.

Blood thinners are widely used in the United States to treat and prevent blood clots and strokes. In May of this year, the U.S. Food and Drug Administration (FDA) released a study comparing the efficacy and effects of wayfarin and Praxada. Review of medical records of more than 130,000 Medicare patients, aged 65 and older, resulted in findings that include:

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As a medical patient, being informed about potentially dangerous pharmaceutical products or medical devices can prevent you from suffering injury or risking death. Unfortunately, just because the Federal Drug Administration (FDA) initially approves a product for market release does not mean that severe adverse side effects are non-existent for some patients. All too often, adverse side effects do not become apparent until several years after the products’ release. In many cases, the manufacturer is liable.

In some instances, companies reevaluate and recall their dangerous products at a later time. This typically occurs after discovering initial research was inadequate to uncover relevant risks about the drug or medical device. It also occurs after patients suffer injury and send adverse event reports to the FDA.

The following are potentially dangerous medical devices where the companies either recalled the products themselves, were warned by the FDA about violations or continue to face numerous lawsuits based on harm experienced by consumers:

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The Infuse Bone Graft, which is manufactured by Medtronic, is used during back surgery to stimulate bone growth and to replace damaged spinal discs in the lumbar spine. The Infuse Bone Graft is an alternative to harvesting a bone graft from the patient’s hip. Although it is not approved for other uses, the Infuse Bone Graft has been used off-label for procedures on the cervical spine.

However, since its introduction, there have been some concerns about the use of the Infuse Bone Graft:

  • Off-label use of the Infuse Bone Graft in the cervical spine has been linked to some serious complications between two and 14 days after the surgery, including:
    • Difficulty speaking, swallowing or breathing
    • Nerve damage
    • Airway compression
    • Respiratory depression
    • Need for respiratory support, insertion of feeding tubes, anti-inflammatory medications, tracheotomies, and additional surgery
    • Death
  • Two independent studies published in the Annals of Internal Medicine found that the Infuse Bone Graft does not work any better than a bone graft and carries certain side effects, including the increased risk of cancer. The studies acknowledge that the Infuse Bone Graft is less invasive than a bone graft, which can require an additional surgery, but there are concerns about the cancer risk and other side effects.

The use of the Infuse Bone Graft can present some serious complications. If your doctor used the Infuse Bone Graft and you are now experiencing side effects, speak to an Indiana law firm that handles pharmaceutical litigation.

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For many women, childbearing and age cause pelvic discomfort and incontinence. Seeking relief, some women opted for a surgical solution that brought only pain. In August 2013, a federal jury agreed with a Georgia woman that the medical device she received was defective.

Pelvic organ prolapse (POP) is a relatively common condition caused by relaxation of the pelvic floor and organs. Serious pain, urine leakage and sexual difficulties often result. While pelvic exercises help, they may not solve the problem. Women whose doctors offered them a vaginal mesh transplant were told the slinglike device would support their internal organs and restore quality of life.

The U.S. Food and Drug Administration (FDA) warns of possible risks of vaginal mesh, including the following:

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More choice is good for business. This has been a mantra for the marketing industry. When several new-generation birth control pills appeared on the market during the past decade, the drug manufacturers promoted the benefits of having newer — and better — contraceptive options. In doing so, they may have misrepresented the safety of these products, which can have life-threatening side effects.

In late 2011, the Food and Drug Administration (FDA) convened a hearing about the safety of some newer oral contraceptives, including Yaz and Yasmine, both products of Bayer Pharmaceuticals. The FDA had already instructed the company to stop running ads that made unsupported, distorted claims. The hearing was concerned with the fact that women using Yaz or Yasmine had a 74 percent higher risk for blood clots. Blood clots can cause serious or deadly conditions such as:

  • Strokes
  • Heart attacks
  • Deep vein thrombosis
  • Pulmonary embolism

The FDA panel agreed that Bayer had not provided adequate labeling information. But the panel did not recommend that these products be withdrawn, even though consumer groups and women’s health advocates had urged that they do so. With Yaz and Yasmine still on the market, thousands of women have been harmed or suffered fatalities.

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Intrauterine devices, or IUDs, are a widely used birth control method. Made of copper, which acts as a spermicide, IUDs are inserted into the uterus transvaginally. They can remain in place for up to 10 years or until the woman wishes it to be removed. As of 2000, American women have had the choice of a hormonal IUD, a plastic device that slowly releases the hormone levonorgestrel. Marketed by Bayer Pharmaceuticals under the name Mirena, this device must be replaced after five years.

The original advertising campaign for Mirena emphasized that it was a low-hormone product that provided convenient, reliable protection against pregnancy. Unfortunately, the company downplayed the risks and potential complications. The Food and Drug Administration has received more than 45,000 reports of adverse events associated with Mirena, including:

  • Device embedded in uterine wall
  • Uterine perforation
  • Migration from uterus
  • Intestinal damage
  • Vaginal hemorrhage
  • Ectopic pregnancy
  • Pelvic inflammatory disease
  • Expulsion

The serious complications that occur when the device becomes embedded in the uterine wall or travels through the uterine wall into the abdominal cavity. This may require surgical removal of the device or even total hysterectomy. Some complications can cause permanent infertility.

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Making decisions about contraception is one of the most important and intimate healthcare concerns for women and their families. Women want birth control that is reliable and safe, with a minimum of dangerous or uncomfortable side effects.

NuvaRing, a flexible vaginal ring that a woman can insert herself, promised to be just that. However, the manufacturer failed to warn about potential serious side effects, and many women have suffered injury and death as a result.

The NuvaRing works by releasing the hormones estrogen and progestin. While the dose of the hormones is low, it uses a form of progestin known as desogestrel, an ingredient common in third-generation combination birth control pills. This synthetic hormone is known to increase the risk of blood clots.