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Defective Drugs

Dangerous side effects and birth defects the drug companies may or should have been aware of.

Medical Devices

We get consumers compensation for medical expenses, lost wages, and pain and suffering for defective medical devices.

Defective Products

Products liability is the area of law that requires designers, manufacturers and suppliers to pay for injuries to consumers caused by defects and hazards in the products they market.

Class Action

What is Xarelto?

Xarelto (rivaroxaban) is one of the newest blood thinners on the market and is manufactured by Bayer and marketed in the U.S. by Janssen Pharmaceuticals. Xarelto is an anticoagulant (blood thinner) that prevents the formation of blood clots. Xarelto is used to prevent or treat a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism). A DVT can occur after certain types of surgery. Xarelto is also used in people with atrial fibrillation (a heart rhythm disorder) to lower the risk of stroke caused by a blood clot.

Why are lawsuits being filed?

The most dangerous side effect for people who take Xarelto is uncontrollable bleeding. Unlike traditional anticoagulants (e.g. warfarin, Coumadin) whose blood-thinning effects can be reversed using vitamin K, there is no remedy available for Xarelto. Former Xarelto users say they were not appropriately warned about the medication’s risk. Sometimes, filing a lawsuit is the only way to hold drug companies accountable for manufacturing dangerous drugs and to get compensation for financial loss and emotional injuries.

FDA and Xarelto

At a January 2014 meeting, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted unanimously that Johnson & Johnson and Bayer have failed to show that the benefits outweigh the potential risks when using Xarelto for the prevention of thrombotic cardiovascular events. Less than one year after the drug was introduced into the marketplace, at least 350 “serious, disabling or fatal” Xarelto-related injuries were reported to the FDA, according to a report from the Institute for Safe Medication Practices.

What is Mirena?

Mirena is an intrauterine device (IUD) that is inserted in the uterus and prevents pregnancy by releasing a medication known as levonorgestrel. Mirena may remain in the body for up to 5 years.

Why are lawsuits being filed?

Hundreds of lawsuits are claiming that Mirena punctured or migrated away from the uterus. In some women, Mirena can cause life-threatening ectopic pregnancy (pregnancy that occurs outside the uterus), perforation of the uterine wall, and a serious condition known as pelvic inflammatory disease (PID). Women who have sustained injuries from Mirena are pursuing legal action against Bayer Pharmaceuticals, claiming the device is defective and seeking compensation for medical expenses, lost wages, and pain and suffering.

FDA and Mirena

The FDA sent Bayer a warning letter in March of 2009. The FDA was concerned that online advertisements (specifically, sponsored links on search engines like Google) were misleading because they “fail to communicate any risk information.” Furthermore, because the ads did not clearly state that Mirena is only recommended for women who have had a child, the ads falsely imply that Mirena is safe for any woman.

What is Zofran?

Zofran (ondansetron) is a powerful anti-nausea drug that is approved to treat chemotherapy and surgery patients. It was approved by the FDA in 1991 and is marketed by GlaxoSmithKline. Although it is not approved for use by pregnant women, Zofran is sometimes prescribed off-label to treat morning sickness during pregnancy, including a severe form called hyperemesis gravidarum.

Why are lawsuits being filed?

New research links Zofran to an increased risk of birth defects. Zofran is sometimes prescribed to treat morning sickness during pregnancy, yet this risk is not mentioned on the drug’s warning label. This has led to Zofran lawsuits accusing the drug maker of illegally marketing Zofran for morning sickness and negligently failing to warn consumers and the medical community about the true risks of Zofran pregnancy use.

Potential Zofran birth defects found in recent studies include:

  • Cleft lip and cleft palate (2.4-fold increased risk)
  • Heart defects (doubled risk)
  • Kidney defects
  • Musculoskeletal defects
  • Poor fetal growth
  • Fetal death (Note: the baby’s death must have been related to a birth defect to be eligible)

FDA and Zofran

Based on recent studies regarding the association between Zofran use in early pregnancy and congenital cardiac malformations and oral clefts (cleft lip and palate), the FDA has cautioned against its use in pregnancy. There are also potential maternal risks associated with taking Zofran especially in pregnant women with electrolyte imbalance due to severe nausea and vomiting. These risks include the Serotonin Syndrome, which is a triad of cognitive or behavioral changes including confusion, agitation, autonomic instability, and neuromuscular changes. Therefore Zofran should not be taken during pregnancy.

What is AndroGel?

One of the most-used medical products to treat low testosterone is AndroGel. Made and marketed in the United States by AbbVie Inc., AndroGel is prescribed as a testosterone-replacement drug, mostly to men whose bodies fail to produce sufficient amounts of the male hormone. The drug was developed by Brussells-based pharmaceutical company, Solvay Pharmaceuticals. The FDA approved it in 2011 for use by men diagnosed with testosterone deficiency.

Why are lawsuits being filed?

One of the most dangerous side effects of AndroGel is its link to cardiovascular problems like heart attacks and strokes. Recently, a number of studies revealed that men using testosterone drugs are at increased risk of heart attack and stroke. Individuals claim that Abbott knew or should have known of these risks and failed to warn the public. As a result of a heart attack or stroke from AndroGel, men could be left with substantial medical expenses and an overall decreased quality of life.

FDA and AndroGel

FDA is requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. FDA is also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. FDA cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.

What is Zimmer?

Every year, more than 1.1 million people in the United States have hip or knee replacement surgery. Device makers market these products as solutions to pain and limited mobility. Some of these devices have failed or been linked to serious injuries. Consumers suffer injuries that increase their pain and restrict their mobility more than they experienced before the implant. Some also experience emotional suffering over financial burdens resulting from defective devices.

Why are lawsuits being filed?

Hip implant class action lawsuit settlements could result in thousands of dollars for affected Americans. Hundreds of Zimmer hip replacement lawsuits have been filed by patients suffering severe complications from the metal-on-metal Zimmer Durom Cup hip replacement system, including:

  • Failure of the metal on metal hip implant requiring early replacement
  • Dislocated Hip
  • Leaking of toxic substances in your bloodstream from your hip implant like chromium or cobalt
  • Cancer
  • Degenerative Heart Disease or Cardiomyopathy
  • Loss of bone strength or structure which can result in bone fractures
  • Tissue death for any tissue surrounding the implant
  • Non-cancerous tumors or pseudotumors around the hip implant
  • Cobalt poisoning
  • Metallosis or metal poisoning due to chromium or cobalt particles from the hip implant leaking into nearby tissue or the patient’s bloodstream

In addition, designing a knee replacement device is crucial to the safety and effectiveness of these devices. Some recent devices, like NexGen implants, can be used with or without cement. The uncemented technique allows the bone to fuse into the implant. Unfortunately, some consumers with uncemented devices have experienced loosening of the joint and other complications. A prominent surgeon formerly employed by Zimmer has also concluded that a NexGen model was not stable and could fail prematurely.

FDA and Zimmer

On July 22, 2008, the FDA announced a voluntary recall of the Zimmer Acetabular Durom Cup because the instructions for use/surgical technique instructions were inadequate. The FDA has received numerous reports of adverse side effects associated with the metal-on-metal Zimmer hip implant, which tends to prematurely fail due to acetabular cup loosening.

What and IVC Filter?

Interior vena cava filters, also known as IVC filters, are used to treat people at risk for pulmonary embolism (blocked main artery of the lung or one of its branches). C.R. Bard is a manufacturer of two types of IVC filters, but the company is facing several class action lawsuits after nearly 1,000 adverse reports of pieces of the device breaking off.

Why are lawsuits being filed?

Although the filters were designed to prevent the life-threatening pulmonary embolism, they actually have life-threatening side effects. In a report released in 2010, the FDA received more than 900 reports of adverse events associated with IVC filters.

The adverse events listed in the FDA report include:

  • 70 filter perforations
  • 328 device migrations
  • 56 filter fractures
  • 146 embolization. The components of the device became detached.

FDA and IVC Filter

The FDA released a 2010 warning that the filters pose risks of filter fracture, device migration and organ perforation and should be removed as soon as the patient’s risk for blood clots subsides. Shortly after the FDA’s warning, lawsuits across the country were filed amid claims the filters caused harm – and even death – to patients who received them.

What is Invokana?

Invokana was the first member of a new class of diabetes drugs introduced in the U.S., known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. The medication works by inhibiting some kidney functions to increase the amount of sugar excreted in the urine. This was designed to increase glucose production and lower blood glucose levels among diabetics.

Why are lawsuits being filed?

Diabetic ketoacidosis is a condition that generally affects type-1 diabetes and is accompanied by high blood sugar levels. Multiple patients have filed Invokana diabetic ketoacidosis lawsuits against Johnson & Johnson, claiming that the drug maker knew or should have known of the high risk of diabetic ketoacidosis associated with their diabetes medication but failed to provide adequate warning in an effort to protect their own profits. If you or a loved one suffered serious Invokana side effects or side effects from Farxiga, Jardiance or another SGLT2 inhibitor drug, you may be owed substantial compensation for medical expenses and other damages.

FDA and Invokana

In May 2015, the FDA issued an Invokana warning about serious risks associated with sodium-glucose co-transporter 2 (SGLT2) inhibiting diabetes drugs, indicating that the medication may cause patients to experience high levels of acid to accumulate in the blood; known as diabetic ketoacidosis.

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