10 Little Known Facts about Product Liability for Pharmaceutical Drugs

We all depend on government oversight to keep pharmaceuticals safe; however, pharmaceuticals are susceptible to defects just like any other product. There’s a good chance you’re not well-versed in pharmaceutical defects, so here are some facts about product liability for pharmaceutical drugs:

Product Liability for Pharmaceutical Drugs

1. The largest drug recall since the FDA started monitoring recalls was the 1997 Fen-Phen recall that occurred after the product had been on the market for an astounding 24 years. The popular weight loss drug was found to cause heart problems, which led to as many as 50,000 consumers filing suit against Wyeth-Ayerst Laboratories. Between awards to plaintiffs and legal costs thought to exceed $21 billion, the Fen-Phen recall has the dubious honor of being one of the most expensive product liability lawsuits in history.
2. The FDA classifies recalls according to the potential harm as follows:
   • Class I Recall – a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
   • Class II Recall – a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
   • Class III Recall – a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
3. University researchers found that the FDA failed to send notifications for one in five of the most serious recalls through its two electronic systems used to alert doctors and the public.
4. There were as many drug recalls in 2013 and 2014 as the previous ten years combined.
5. In the fourth quarter of 2013, 21.3 million units were recalled, compared to 3.1 million in the same quarter of 2012.
6. The dramatic increase in recalls are predominately Class II recalls, making up 75-80 percent of all recalls for the past three years.
7. Compounding pharmacies were responsible for a sizeable portion of the increased recalls in 2013 and 2014, due in large part to an FDA crack-down following a deadly outbreak of fungal meningitis which killed more than 60 people.
8. All drug recalls can be found in the FDA’s weekly Enforcement Report.
9. The pharmaceutical industry is worth more money than the gross domestic product (GDP) of entire countries, including Belgium, Sweden and Switzerland, according to statistics from the World Bank.
10. Vaccines are the new trend in pharmaceutical product liability cases, as the number of new vaccines on the market steadily increases in the United States. Non-pandemic vaccine injuries fall under the “National Childhood Vaccine Injury Act of 1986,” which is a no-fault federal vaccine injury compensation program.

When defective drugs result in injury to consumers, or even death in some cases, the injured person or their surviving family members may be entitled to compensation. If you believe you have been injured by defective pharmaceutical in Atlanta, contact the prescription drug liability lawyers in Atlanta at Harris Lowry Manton LLP to discuss your legal options.

Harris Lowry Manton LLP

Harris Lowry Manton LLP is a dedicated full-service trial law firm. Our Georgia personal injury lawyers fight for the injured throughout every step of the legal process. We explain how litigation works from the moment you come into one of our offices in Atlanta or Savannah until your case is solved. Our legal team has achieved remarkable success because we leave no stone unturned when investigating our client’ claims and what should have been done to prevent their injuries. We file claims against all responsible parties — not just the most obvious one.

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