December 20th, 2010
This year’s recall of certain types of Tylenol and Motrin by Johnson & Johnson (NYSE: JNJ), which began in January, brought back memories of the 1982 Tylenol recall. It affected as many as 21 million packages which were in circulation at the time. Johnson & Johnson’s reaction set the bar for other companies. It did not spare any expense to protect the public from what turned out to be a tiny number of tainted products.
Recalls are commonplace now. And, they are not just for drugs. Recent incidents include children’s beds and toys with high lead content. However, it is still the huge recalls of prescription drugs that garner the most headlines because they often harm the largest numbers of people. These recalls can also cost large pharmaceutical companies billions of dollars.
Many dangerous drugs have slipped past the FDA and found their way into the marketplace. When the agency approves a dangerous drug, there can be a number of consequences, often times tragic. Once news of a tragedy reaches the public, pressure mounts for FDA policy to change, as happened after the Thalidomide controversy in the 1960s.
Prior to 1962, there was no mechanism in the US to approve drugs before they went to market. Although the 1906 Food and Drugs Act required drugs to be accurately and honestly labeled, that was largely the extent of the oversight. In 1961, it was determined that Thalidomide caused horrifying birth defects. It is estimated that between 10,000 to 20,000 people were affected in what is considered to be among the worst medical disasters in history. Thalidomide prompted Congress to act, and the Kefauver-Harris Drug Amendments were passed in 1962, granting oversight of drugs to the FDA and compelling manufacturers to prove that their drugs are safe for public consumption.
Each of the drugs or group of drugs on this list drew a strong reaction from the public. In some cases, such as DES and PPA, what is shocking is how long the drugs were on the market before their devastating side effects were acknowledged. In others, the amount of money the drug company paid in settlements was so huge it drew public attention and ire. Still others were surprising because of the fraudulent manner in which they reached the market. This is a list of the worst drug recalls since the FDA became responsible for approving drugs in 1962.
Information for this article about litigation was obtained from the US Department of Justice and from LexisNexis. Facts about the history of each recall and statistics citing numbers of injuries or deaths were obtained from the archives of The New York Times, The Los Angeles Times, The Washington Post and USA Today.
1) Fenfluramine/phentermine (Fen-Phen)
Recalled: 1997 (after 24 years on the market)
Financial damage: Awards to victims close to $14 billion, making it one of the most costly products liability cases in history.
Fen-Phen’s was a hugely popular weight loss drug, its popularity peaking in the 90’s. It is estimated that as many as 6.5 million people took it to help fight obesity. After consumers began experiencing heart disease and other pulmonary problems, the FDA set the recall in motion. American Lawyer reported that more than 50,000 Fen-Phen victims have filed suits against Fen-Phen’s maker Wyeth, and legal expenses combined with awards may have exceeded $21 billion. Lengthy time in the marketplace combined with the severity of both the public reaction and the significant awards granted to its victims make its impact unprecedented.
2) Diethylstilbestrol (DES)
Maker: Multiple manufacturers (DES was never patented as it was created with British public funds)
Recalled: 1975 (after 37 years on the market)
Financial damage: Steep, but difficult to quantify because each manufacturer paid out legal damages correlated with its respective market share (a new way of awarding damages in these cases).
DES was prescribed for more than thirty years to prevent miscarriages and other complications during pregnancy. It was not until 1971 before it was connected to a rare tumor that kept appearing in the daughters of women who had taken it. The FDA only banned DES prescriptions to women because no such problems have been found in men. In fact, it can still be prescribed to men to treat estrogen deficiency. Litigation over DES led to a landmark products liability award that heavily influenced how both courts and the FDA approach oversight of drugs with multiple manufacturers.
3) Cerivastatin (Baycol)
Recalled: 2001 (after four years on the market)
Financial damage: Litigation-related damages totaled $1.2 billion
Baycol, prescribed to patients as a treatment for high cholesterol, is reportedly responsible for more than 100,000 deaths and about as many lawsuits. It was connected to a severe muscle disorder known as rhabdomyolysis, which clogs the kidneys with protein from dying muscle tissue.