Dangerous Drugs and Defective Medical Products

In recent decades, it seems like there was a rash of litigation and major class action lawsuits involving defective medical devices and pharmaceutical products. Within this context, it seems reasonable to ask why, with all of the money that is poured into this nation's health care industry, and with the lengthy approval process imposed by the Food and Drug Administration (FDA), we are nonetheless confronted with dangerous drugs and defective medical products.

A defective drug may carry significant health risks, and may even be fatal. The failure of a medical device can also cause injury or death, and the implant of a defective medical device (such as a heart valve, knee joint or pacemaker) may require another major surgery to replace the defective device - sometimes at a greater risk to the patient or with a lower chance of success than the original surgery.

Why Do Dangerous Medical Products Reach the Market

One part of the problem is the inevitability of human error. Some cases involve defects in medical devices resulting from errors in the manufacturing process, or in quality control procedures. While the technology used to manufacture and inspect medical products has advanced significantly, no matter how much care is exercised, human error can always creep into safety systems.

Unfortunately, as long as profits are at stake, there will also always be some companies which are willing to forego certain safety advances in favor of fattening their corporate profits.

The cost of developing, patenting, and obtaining government approval for a medical device or for a new drug can be staggering. Delays in approval can shave years off of the life of a patent, and after a patent expires the profits associated with a new drug or medical device are severely diminished by competition from generic products. This can create a significant temptation to hide negative information about a potentially lucrative drug or device, so as to obtain government approval and to bring the product to market.

At the same time, there may also be considerable pressure on the FDA to approve a new drug or device. Drug companies lobby hard for "reforms" in the FDA's procedures meant to speed the approval process, so they can start profiting from their new drugs.

This is not to say that there is not room for improvement in the FDA's procedures, or in the time it can take to bring a valuable new drug to market, or that drug manufacturers wish to bring defective products to market. But when things go wrong as a result of expedited approval or concealed dangers, the consequences for consumers can be catastrophic.

Pharmaceutical Product Liability Case Studies:

In recent decades, many medications and medical devices have become the subject of product liability claims and litigation. In some cases the products were determined to be reasonably safe, while other cases involved defects that posed significant risk to consumers, some with lethal consequences. Examples of medications that were the subject of product liability claims include:

  • Accutane: An acne medication alleged to trigger depression and possible suicidal behavior.

  • Baycol: A dangerous cholesterol drug, whose manufacturer reportedly suppressed information about known dangers.

  • Bextra: A Cox-2 NSAID pain medication similar in many respects to Vioxx.

  • Crestor: A statin medication, similar to Baycol, alleged to carry an undue risk to patients.

  • Celebrex: Another NSAID pain medication similar in many respects to Vioxx.

  • Fen Phen: A combination of drugs prescribed for weight loss. Manufacturers allegedly suppressed information about known dangers.

  • Prempro and Premarin: Hormone replacement therapy medications.

  • Rezulin: A dangerous diabetes drug which received "fast track" approval by the FDA.

  • Serzone: An antidepressant medication associated with liver disease.

  • Vioxx: A medication, voluntarily recalled by its manufacturer, used to relieve osteoarthritis symptoms, acute pain, menstrual pain.

  • Zyprexa: An antipsychotic medication associated with heightened risk of diabetes, hyperglycemia, and ketoacidosis.

Examples of claims alleging defects in medical products and devices include:

  • Guidant Ancure Endograft device: a medical device for treating aortic aneurisms, problems with which led to the criminal conviction of the manufacturer.

  • Guidant Defibrillator: an implanted heart defibrillator which is alleged to been unsafe due to an electrical defect.

State Product Liability Laws

Due to the significant variation in the law governing liability over defective products, when selecting a lawyer, it is usually a good idea to seek representation from a lawyer with experience handling this type of case.

Copyright © 2003 Aaron Larson, All rights reserved. No portion of this article may be reproduced without the express written permission of the copyright holder. If you use a quotation, excerpt or paraphrase of this article, except as otherwise authorized in writing by the author of the article you must cite this article as a source for your work and include a link back to the original article from any online materials that incorporate or are derived from the content of this article.

This article was last reviewed or amended on Apr 26, 2018.