Drug recalls, while vital and necessary, often induce panic in the general public. To be clear, it is best that drug makers err on the side of caution when considering whether or not to take a drug of the market. Unfortunately, there have been plenty of incidents over the years when drug makers had an indication that their products were dangerous yet they refused to take them out of circulation. In many cases, this led to countless deaths that could have been avoided. Now, pharmaceuticals companies are often action with more caution as you can see below. Here are six major drug recalls in U.S. history.
Fen-Phen was hailed as a miracle diet drug that helped people lose weight quickly. The drug did get results for many of its users but also had a dangerous side effect. Fen-Phen caused valve damage and hypertension that damaged the hearts of thousands of users. Patients suffered heart attacks and many needed surgery to repair their valves. Many patients suffered long-term heart damage that still remains with them. Many others died from ailments that included heart attacks. Wyeth Pharmaceuticals, the maker of Fen-Phen, spent tens of millions of dollars in advertising even though it knew that there may be issues with the drug. Fen-Phen ultimately became one of the largest mass tort litigations in history. The maker of the drug set aside over $20 billion to pay settlements and fines and the amount paid out to date is over $13 billion.
Valsartan is a widely-used class of medications that are used to treat high blood pressure and heart disease. The drug is manufactured overseas in China and India and was taken by millions of patients. There was an impurity discovered in the drug after the manufacturing process was changed. Specifically, a contaminant called NDMA was found in medications containing Valsartan. NDMA is a carcinogen when patients are exposed to it at certain levels. Although the level of NDMA contained in Valsartan was initially reported to be low, the effects on patients remain to be seen. After the impurity was discovered, the FDA announced a voluntary recall from several makers of the drug. This soon spread as dozens of drugmakers pulled their products that contained Valsartan from the market. These companies are now facing thousands of lawsuits from patients who are claiming that they were affected by the tainted drugs. Given the millions of people who took the drug, this could turn out to be a large mass tort.
The popular heartburn drug is used by tens of millions of people and, as a result, was one of the biggest drug recalls in history. The problem with Zantac is similar to that of Valsartan, although the cause is slightly different. Zantac was also found to contain levels of NDMA. Initially, these levels were reported to be lower, but subsequent tests have begun to call the initial test results into question. The problem with Zantac is that the main component of the drug is inherently unstable. As a result, ranitidine can break down and become NDMA on its own without any intervention. In other words, the drug itself can potentially be a carcinogen. This issue just arose in September 2019 so the exact effects will take some time to materialize. Still, Zantac has the potential to become one of the larger pharmaceutical torts of all time depending on how potent the carcinogen is.
Vioxx was a pain medication that was widely used for five years. The drug was so prominent that many Americans identified the product by the Olympians that endorsed it. However, Vioxx presented a significant risk of a cardiac event in those who took it. Merck knew of the possible dangers of this drug but did not disclose them to the general public. As a result, as many as 140,000 people experienced cardiac events or developed heart disease. Some estimated that roughly a third of the heart attacks were fatal so Vioxx was responsible for as many as 50,000 deaths in only five years. Even the independent investigation commissioned by Merck found that the sales force acted in an overzealous manner to sell the drug in spite of the risks. Nonetheless, the FDA allowed the drug to return to the market since it did not accept the evidence that Vioxx led to heart attacks. After winning many of the early cases at trial, Merck settled approximately 27,000 lawsuits for a total of $4.85 billion.
This was one of the first and biggest drug recalls ever. The drug was used to treat morning sickness in pregnant women and reduce their nausea. However, Thalidomide was a ticking time bomb, and it caused serious birth defects in thousands of newborns around the world. The problem was worse around the world than it was in the U.S. thanks to the FDA which had refused to approve the drug until there were more studies. Still, thousands of women received the drug as part of a clinical testing program and there was a handful of babies born in the U.S. with birth defects. However, this is a small fraction of the up to 20,000 babied worldwide that were born with defects and missing limbs due to the effect of Thalidomide.
Although only a handful of people were affected, Tylenol experienced a recall in 1982 that caused mass hysteria among the public. Several people died from taking Tylenol tablets that were laced with cyanide. The deaths were concentrated in the Chicago metro area. Nobody knows who was responsible for coating the Tylenol with poison as the perpetrator was never caught. The FBI has surmised that someone was tampering with the product when it was on the store shelves. As a result of the poisoning, roughly 31 million tablets of Tylenol were taken off the market. The biggest problem was not so much the original tampering but the fact that there was a multitude of copycat incidents following the initial criminal act. Approximately 270 different copycat incidents were reported, further jeopardizing the American public. These acts including lacing Tylenol tablets with hazards such as rat poison and hydrochloric acid.