Each year, thousands of Americans rely on medications to treat a wide variety of illnesses. Most of today’s medicine work as advertised and have manageable side effects, but occasionally we learn about drugs that are unreasonably dangerous. Some pharmaceutical companies will do everything in their power to mislead the public and hide crucial safety information to protect their bottom line. The pharmaceutical industry is a booming business in the United States. Pharmaceutical companies spend about $19 billion a year advertising their drugs to physicians and to the public. This is twice as much as they spend on drug safety research. Unsafe medications may include prescription medications, prescribed by a physician and filled at a pharmacy; over-the-counter medications available without a prescription; and medications administered by health care providers in a hospital, surgical or other clinical setting.

RESPONSIBILITY OF THE FDA

The Food and Drug Administration (FDA) is responsible for ensuring the safety of the millions of consumers who use the multitudinous treatments that are prescribed for their ailments. Thousands of medicines are brought before the agency, however, and it is impossible for the FDA to completely prevent the sale of medicines that have harmful side effects. As pharmaceutical companies overload the system by rushing medicines to market without adequate research or trials to support their safe use, many medicines end up falling through the cracks and into the hands of people who are led to believe they are safe. Unfortunately, it is often not until many people have been harmed that pharmaceutical companies can be held responsible for reckless practices and the disregard of their customers’ health. Pharmaceutical companies have an obligation to manufacture safe products, to provide adequate warnings, and to alert the public to known risks and dangers. When drug makers fail to honor their responsibilities, they are liable to the individuals and families they harm. Examples of when a manufacturer may be held liable include:

  • TAINTED OR CONTAMINATED DRUGS
  • INADEQUATE WARNINGS
  • FALSE & MISLEADING ADVERTISINGS
  • NEGLIGENCE
  • FDA APPROVAL BASED OFF FALSIFIED TEST RESULTS

MARKET WITHDRAWAL VS. RECALL 

A drug is removed from the market when its risks outweigh its benefits. This typically occurs when a safety hazard cannot be corrected, such as when it is discovered that the drug can cause serious side effects that were not known at the time of approval. However, completely removing a unique product from the market could be very dangerous to people who depend on the drug. So, decisions to remove products from the market are made very carefully, especially if people would be in danger without the product. Manufacturers may decide to simply withdraw a drug from the market. These “market withdrawals” (sometimes called “product withdrawals”) are not recalls, since existing drugs on the market do not have to be returned. Instead, the manufacturer simply stops distributing a drug. This gradually removes a drug from the market by cutting off its supply. Market withdrawals tend to be business decisions. A manufacturer may conclude that falling sales revenue makes selling a drug unprofitable, or that a rise in product liability lawsuits has damaged the brand and is hurting the company’s public image. Ceasing to sell a drug can remove it from the market without attracting the attention of an actual recall.


DO YOU HAVE QUESTIONS ABOUT INJURIES RELATED TO A DANGEROUS DRUG?

If you or a loved one have been affected by the use of a potentially dangerous drug, we encourage you to consult with our team as soon as possible. With our extensive knowledge and expertise, you can rest assured that should you choose to work with us, you will have legal representation that you can trust. All initial consultations are free, and we don’t charge any up-front fees for representation. We handle all fees on a contingency basis, meaning that unless we’re successful, you don’t have to pay us. Please contact Fulmer Sill at (405)510.0077 for a free consultation.