Defective Drugs and Side Effects

Before a newly developed drug can be sold commercially, it must first endure an exhaustive clinical trial process through which it is tested for safety, toxicity, side effects and efficacy. The final phase of any drug clinical trial revolves around Food and Drug Administration (FDA) approval, clearing it for distribution.

FDA approval does not void a drug manufacturer's liability for defects or severe side effects that are caused as a result of using their drugs. Drug manufacturers are required to take comprehensive measures to ensure that their products are safe. Failure to disclose any side effects, defects, or other such complications associated with their drugs is negligent and grounds for legal action. The purpose of the clinical trial process is to test the drug across a wide variety of populations so as to monitor sporadic issues affecting specific groups (gender, age, race, etc.)

Although the final phase of any drug clinical trial revolves around long-term studies designed to monitor the effects of continued use of the drug, latent effects can present themselves after FDA approval of the drug and after it has been widely distributed and used.

The following FDA approved drugs have recently garnered a great deal of attention resulting from harmful defects and side effects that have been affecting significant numbers of people.

Fleet Phospho-soda

Avandia

Several over-the-counter Fleet laxative products have been recalled by C. B. Fleet Company after the Food and Drug Administration (FDA) received more than 20 reports of kidney injury caused by the products, including acute phosphate nephropathy — a serious type of renal damage.

The controversy surrounding popular diabetes drug Avandia continues to grow as new information comes out regarding GlaxoSmithKline's knowledge of Avandia heart risk.

Trasylol

Levaquin

Bayer Pharmaceuticals Corp. issued a worldwide suspension of the production and marketing of Trasylol on November 5, 2007, following increased evidence of a heightened risk of death.

A leading antibacterial drug has come under increased scrutiny by the Food and Drug Administration following reports of serious injuries to tendons and ligaments linked with its use.

If a drug manufacturer learns of a potential serious side effect caused by its drug, it has a responsibility to notify the physicians who prescribe the drugs in order to protect the safety of the patients. If a drug manufacturer does not provide the proper notifications and patients are harmed by its drug, the harmed patients may be entitled to compensation. The lawyers of Aylstock, Witkin, Kreis & Overholtz are experts in handling cases of negligence by large drug companies. They have successfully represented and obtained substantial compensation for a number of patients who have been harmed by drugs. If you or a loved one has been harmed by a defective drug, contact us at (888) 255-AWKO (2956) for a case evaluation.