In the US, the Food and Drug Administration (FDA), does a good job at screening medications before they reach the market as either over the counter or prescription products. Notwithstanding, throughout time there have been many medications that reach consumers, cause serious issues, and are then recalled in order to protect the public. Sometimes defects come to light after the medication has spent years on the market. Lawsuits arise when manufacturers or distributors of defective drugs are guilty of:

  1. Failure to warn consumers through improper labeling
  2. Drug design defects causing dangerous side effects
  3. Drug manufacturing defects causing tainted or diluted medication

Failure to Warn Consumers through Improper Labeling – Zofran (Ondansetron)

An example of a drug manufacturer failing to label their medication correctly is the nausea medication, Zofran. Zofran was developed, and FDA approved, for the use of minimizing nausea symptoms in cancer patients being treated by chemotherapy. It was then prescribed to women across the country as a way to reduce morning sickness.

Problems arose when children born to women who were treated with Zofran were born with defects, including a cleft palate. Some studies suggest that the risk of a child being born with a cleft palate doubled in mothers who took Zofran.

Zofran was never approved by the FDA. The manufactures, GlaxoSmithKline failed to warn consumers of the dangers of Zofran and allowed the drug to continue to be prescribed to pregnant women.

Drug Design Defects – Xarelto (Rivaroxaban)

The manufacturer of the popular blood thinning medication, Xarelto, Bayer is accused of designing the drug with dangerous side effects and failing to disclose those side effects to consumers.

Designed and approved by the FDA, Xarelto is effective in thinning blood in patients susceptible to blood clots. Some consumers, however, reported uncontrollable bleeding episodes. These episodes resulted in hospitalization and in some tragic cases, death. A $775 million settlement was reached in 2019.

Drug Manufacturing Defects – Avapro (Irbesartan)

Avapro is an effective treatment for those suffering from high blood pressure. In 2018 the FDA released a voluntary recall of the medication due to an impurity, NDEA, in the medication due to manufacturing by Aurobindo Pharma Limited.

While to date no injuries or deaths have been reported by consumers taking Avapro, anything of that nature could be grounds for a lawsuit against the manufacturer for distributing a tainted medication.

Help from an Experienced Attorney

Lawsuits against drug manufacturers or distributors are usually complex. There are legal pitfalls that make it exceedingly difficult for a person to go after a major drug company on their own. That’s where an experienced attorney steps in. At Craig Swapp & Associates our attorneys have the necessary experience in defective drug cases to help victims to fair compensation.

If you or a loved one has suffered an injury of any kind because of a defective drug, you may be eligible for financial compensation. For more information on defective drug, cases visit our page Give us a call at 1-800-404-9000 for a free consultation and take the first steps to financial compensation.

Written By: Ryan Swapp     Legal Review By: Craig Swapp