The FDA requires that every pharmaceutical company publicly state the potential hazards and side effects their products might cause. It's why every pharmaceutical commercial ends with an absurd list of caveats and symptoms. "X may cause nausea, vertigo, moodiness, constipation," and so on in increasing severity.
But the reason for listing side effects in commercials is simple: drug companies, in return for advertising their medications directly to consumers, must also to warn users of the hazardous—and sometimes deadly—side effects of their products. These warning requirements keep pharmaceutical ads honest about their product's risks.
Regardless, sometimes a pharmaceutical company fails to disclose possible side effects—often to improve profitability. When that happens, the people who put their health in the company's hands pay the highest cost. Our nation's history of drug recalls is an enlightening look at what happens when companies either fail to document or disclose the various side effects caused by their medications.
These are some of the most significant and impactful drug recalls in history.
The first recall we're covering is perhaps the most transformative recall in FDA history. Thalidomide, also sold as Immunoprin, was manufactured by Chemie Grünenthal in 1954 and prescribed as a sedative. It was eventually given to pregnant women for morning sickness. Thalidomide was sold throughout the world as an over-the-counter drug throughout the late 1950s.
However, in 1961, the drug was found to be the cause of about 10,000 to 20,000 severe birth defects. According to the National Institutes of Health, this crisis was the “biggest man-made medical disaster ever.” Though the drug was never approved for sale in the United States, physicians prescribed the drug to approximately 20,000 women during a clinical testing program.
After the crisis, Congress added the Kefauver-Harris Drug Amendments to the law, providing the FDA with the power to oversee drugs and require manufacturers to document their products' side effects.
Grünenthal later received criminal charges for negligent homicide and injury.
Diethylstilbestrol (DES), 1971
Physicians prescribed diethylstilbestrol to pregnant women for over three decades to help prevent miscarriages and other complications during pregnancy. At the time, the medical community believed that some women did not produce enough estrogen for safe delivery, so DES could compensate for this problem. Even though research revealed that DES was not effective in 1953, doctors continued to prescribe it. Then, in 1971, the FDA issued a Drug Bulletin warning physicians that DES caused a rare form of vaginal cancer to girls exposed to DES while in the womb.
Those suffering from complications caused by DES were able to secure a landmark product liability case in 1980. As part of the settlement, the Supreme Court of California ordered all DES manufacturers to pay a settlement proportionate to their share of the drug’s market while it was being sold.
Pfizer manufactured and marketed Bextra as an anti-inflammatory drug. Physicians prescribed the drug to treat inflammatory disorders and arthritis. However, researchers found that the drug was to blame for heart and stomach problems and could cause severe skin conditions. But that was far from the whole story.
Researchers learned that one of the skin conditions caused by Bextra was Stevens-Johnson syndrome (SJS), a reaction that causes blistering on the skin and internal organs. SJS has a high fatality rate, with 1 in 10 cases resulting in death. Some SJS cases result in toxic epidermal necrolysis, which has a 50% fatality rate.
In response, the FDA blocked the sale of Bextra in 2005.
Vioxx, also known as Rofecoxib, was a painkiller often prescribed to treat arthritis pain. More than 20 million people used the drug at its peak, earning $2.5 billion in annual sales for Merck & Co.
Then researchers discovered Vioxx increased the chance of heart attack and stroke. One Vioxx report estimated that up to 140,000 people suffered from coronary heart disease after taking it. Merck voluntarily recalled Vioxx in 2004.
However, subsequent reports suggested that both Merck and the FDA had ignored evidence of dangerous side effects for years before Vioxx was recalled. In 2006, Merck sponsored a report on Vioxx, which many criticized for being self-serving. The company spent $21 million for legal help to publish the report, which determined that Merck acted in good faith.
Eventually, Merck settled all Vioxx-related litigation for $4.8 billion. The Vioxx recall is considered one of the largest drug recalls in United States history.
Fenfluramine/phentermine, stylized for sale as Fen-Phen, was once just one of many “miracle” weight-loss pills. It was manufactured in an earlier form as fenfluramine by Wyeth in the 1970s and generated modest sales numbers.
Then Wyeth added phentermine, and everything changed.
An aggressive advertising campaign in the 1990s caused the drug’s popularity to suddenly soar. An estimated 6.5 million people bought Fen-Phen for weight loss.
But the widespread use of Fen-Phen led to reports that people were suffering serious lung problems, specifically pulmonary hypertension. After a young woman died from taking Fen-Phen for a month, the Boston Herald publicized growing concern that Fen-Phen had serious, undisclosed side effects. The FDA recalled the drug, and someone eventually revealed that a Wyeth official expressed concerns that the company was undercounting cases of pulmonary hypertension as early as 1994.
To date, over 50,000 victims have filed suit against Wyeth; the company lost an estimated $21 billion to legal defenses and damages for Fen-Phen.
What Should You Do After Suffering from a Drug’s Side Effects?
If you are suffering from the side effects of a drug that was supposed to help you, it’s time to contact a defective drug lawyer from Handler, Henning & Rosenberg LLC. Our attorneys have been fighting for clients since 1922, and we’ve won tens of millions of dollars for them over the last nine decades. We’ve helped clients recover damages from a variety of harmful drugs, so we have the experience and resources need to fight for your recovery.
Call our Pennsylvania defective drug attorneys today at (888) 498-3023 today for a free consultation of your case. You can be certain that our help is affordable because we only collect a fee if we win results!