Drug recalls occur when a medicine is pulled out from the market because it has been found to be either faulty or potentially hazardous to health. These recalls can be conducted as the manufacturer’s own initiative, by FDA request, or by an FDA order under statutory authority. Drug recalls are considered to be common all over America. It has been found that over the years many drugs have managed to hoodwink the FDA and found their way into the market. Using such drugs has proven to be harmful and even fatal. Once the news of such tragic incidents reaches the public, the FDA is forced to change the policies and recall the drug from the market due to public pressure. Legal experts are generally hired by victims and their families for procuring the due compensation. Mentioned below are few of the most infamous American drug recalls from the recent past.
1. Diethylstilbestrol (DES)
This drug was prescribed by doctors to women for the prevention of miscarriage and other pregnancy-related complications. However, in 1975, after over 30 years of being in the market, its use was linked to a rare tumor in the daughters of the women who had consumed it. As a result, the FDA banned the prescription and use of this drug among women as no problems were reported to occur in the sons of the consumers.
DES lawsuits led to a legal breakthrough in the form of products liability awards that heavily influenced the approach of courts and the FDA toward the oversight of drugs. The damages incurred by the manufacturers is unknown but is estimated to be steep.
2. Fenfluramine/Phentermine (Fen-Phen)
This is one of the most infamous instances of drug recall, occurring in 1997 after 27 years of the drug being on the market. This immensely popular weight-loss drug became the bane of its users, with several developing heart diseases and other serious pulmonary side effects, and was called back by the FDA. The manufacturers reportedly suffered huge losses in damages, with the legal expenses and product liability awards costing them over $21 billion.
3. Terfenadine (Seldane)
Manufactured in 1985 to treat allergies without causing drowsiness, Seldane was called back by the FDA in 1997 after being in the market for 13 years. It was found to be linked to cases of cardiac arrhythmia (abnormal electrical activity in the heart) in the users. Following that was the introduction of Allegra, an antiallergin like Seldane except for the side effects, to mitigate its damages. The exact financial damages incurred are not clear, but it was reported that in addition to legal expenses and awards, the manufacturer also lost its huge market share to other drugs.
4. Phenylpropanolamine (PPA)
This multipurpose drug seemed like a miracle medicine, being prescribed for everything from dieting to treating common cold and flu, and even psychological disorders. Sound too good to be true? It was—it was recalled in 2000 after being in the market for at least 60 years, following an analysis by Yale University linking it to cardiac arrest and stroke among its users, particularly women. The FDA later estimated that around 200‒500 strokes per year could have been prevented had PPA been replaced with another no-risk drug.
An interesting fact here is that PPA wasn’t formally approved by the FDA, i.e., for decades it remained neither fully banned nor fully recommended for use. The financial damage it brought the manufacturers remains to be uncertain but is estimated to be in the millions.
5. Cerivastatin (Baycol)
This drug was prescribed to patients with high cholesterol. However, it was recalled in 2001 because it was connected to rhabdomyolysis, a serious muscular disorder that clogs kidneys with protein from dying tissues. Consumption of Baycol was found to have resulted in more than 100,000 deaths, with many lawsuits filed against the manufacturer. The legal damages reportedly amounted to $1.2 billion.
6. Rofecoxib (Vioxx)
Prescribed as a painkiller to patients suffering from arthritis, this drug was found to be responsible for accelerating the risk of heart attack and stroke among its users. It was prescribed to more than 20 million people within a span of five years, before being pulled out in the year 2004. Besides the manufacturer, the FDA too came under heavy criticism for approving this drug. Settling the damages cost the manufacturer $4.8 billion, with around $1 billion being legal expenses.
7. Valdecoxib (Bextra)
Like Vioxx, Bextra too was prescribed to treat arthritis and other inflammatory disorders. It was removed from the market in 2005, with only one year in the market, amid similar apprehensions, i.e., increased risk of heart attack and stroke. In some cases, it was also found to cause a terminal skin condition. The damages incurred by the manufacturer amounted to over $2 billion, with an additional fine of $1.19 billion for admission of criminal wrongdoing, with “intent to defraud or mislead” in relation to promotion of the drug.
It is clear that drug manufacturers, the FDA, and other responsible authorities need to step up their efforts to create quicker and increased awareness about recalled/banned drugs among doctors, pharmacists, and the public. Only then can this history be prevented from repeating itself.
Dan Brown is one of the principal partners and attorney at Brown & Brown Law Office based in St. Louis, MO. He has successfully handled thousands of personal injury and workers’ compensation cases. The firm represents individuals from Missouri who are suffering from personal injury, DUI charges, and workers’ compensation.
Disclaimer: The views expressed here are those of the author and not representative of American Laboratory.