Painkiller Vioxx was hugely popular when it first came on the market in 1999. Made by Merck, Vioxx was supposed to be the next great solution to arthritis pain, and it did work. Millions of people took the drug and felt some of the relief they needed from chronic pain. Unfortunately, it took just a few years for the risks of this medication to come out and to lead to the recall of Vioxx.
Merck ended up paying out billions of dollars in settlements for the damage that Vioxx caused. The company marketed the drug heavily and made a lot of money on it, but it turned out to cause heart attacks and people lost their lives. Patients and their loved ones began lawsuits to help bring Merck to justice, accusing the company of hiding information about the side effects and risks of taking Vioxx. It is no longer available, and many plaintiffs one, facing Merck to pay big for its mistakes.
Vioxx and the Risk of Heart Attack
The U.S. Food and Drug Administration (FDA) first approved Vioxx in 1999. The generic drug is called rofecoxib and the FDA approved it for the treatment of chronic pain. It was mostly designed to treat the pain associated with arthritis, but was prescribed for some other types of pain as well. Rofecoxib belongs to a class of drugs called non-steroidal anti-inflammatory drug, or NSAID.
Although it is in the same class as well-known painkillers like ibuprofen, rofecoxib works differently. It targets an enzyme called COX-2, which causes inflammation. By inhibiting this enzyme, Vioxx reduces inflammation, and consequently, pain. Merck brought Vioxx out and marketed it as a safer alternative to other painkillers used to treat chronic pain.
As with other types of NSAIDs, Vioxx’s most common side effect was gastrointestinal distress. Drugs like these can cause stomach upset, pain, and even bleeding, but for many the risks of this were outweighed by the benefits. Also, this was a well-known side effect, not anything that Merck tried to hide about its new wonder drug.
There was, however, a troubling complication that later many would accuse Merck of covering up as it promoted Vioxx as a safe alternative. In clinical trials Merck found that Vioxx increased the risk that a patient would experience an adverse cardiovascular event, a heart attack or a stroke. The FDA eventually found out about this risk and in 2002 required that it be included on the label. This meant that for three years patients had been taking Vioxx without knowing of the risk it posed to them. And, with the warning now made public, Merck continued to market Vioxx as safe.
Merck certainly fought hard to make Vioxx seem safe and to keep it earning billions of dollars in revenue, but eventually had to give up and issue a recall. This happened in 2004 and rofecoxib is no longer on the market in any form. Merck could no longer keep Vioxx going after a study proved it could be dangerous.
In one of these studies, Merck was using rofecoxib to find out if it could be used to treat colon polyps. The doctors working on the study found that those patients taking the drug form 18 months or more were at an increased risk for having a heart attack. In another study that wasn’t concluded until after Vioxx was recalled, researchers actually found that the drug could cause a heart attack much earlier, as soon as two weeks after someone started taking it.
Once more information about Vioxx became public, the number of lawsuits against Merck exploded. It wasn’t just that the company had sold a drug that turned out to be harmful; there was evidence of unethical and possibly illegal marketing practices. When a company does this, it lends credence to the lawsuits and in the case of Vioxx probably helped plaintiffs to get more compensation.
The findings came out in senate hearings. The U.S. Senate Finance Committee listened to witnesses who testified as to what Merck knew and what it hid in the case of Vioxx. These witnesses came forward to testify that Merck knew that Vioxx could cause heart attacks and strokes and that the company knew about it early on in the process of creating and testing the drug.
Witnesses also stated that Merck did everything possible to hide that information, to make it seem less serious, and even to design the trials of the drug so that the chances of the information becoming public would be lessened. Knowing the risks and still marketing a drug, especially while making claims that it is safer than alternatives is highly unethical and could be considered illegal.
Vioxx Class Action Lawsuit
The biggest Vioxx lawsuit was a class action that represented thousands of people who died from a heart attack or stroke while taking Vioxx. Merck fought the accusations and never admitted to any wrongdoing, but ultimately agreed to a $4.85 billion settlement to be split among the families of those whose loved ones died. Merck was able to successfully deny any settlement money to several thousand cases, but the majority did receive monetary damages.
Criminal, Federal, and State Fines
Merck also had to pay out for criminal fines and fines to the federal government after the senate hearings. The company was found to have engaged in illegal marketing practices. It was also accused of colluding with the FDA to hide the dangers of Vioxx from the public. The result of those hearings was a $321 million criminal fine, $426 million paid to the federal government, and $202 million to be split between all states and the District of Columbia.
In addition to the big class action lawsuit and senate hearings, Merck faced a number of multidistrict litigation cases and individual lawsuits over Vioxx. An early lawsuit, brought by a family in Texas who lost a loved one to the painkiller, ended in a settlement worth $235 million. Out of the 16 multidistrict litigations, Merck actually won eleven of them and did not have to pay out in those cases.
Merck was even sued by its shareholders who claimed they lost billions of dollars because of the mistakes the company made and the outright deceit used in marketing Vioxx. The shareholders were only able to win $12 million in legal fees, but the pressure they put on the company led to significant changes in how Merck is managed. One of those changes was the hiring of a chief medical officer in charge of safety and marketing of products.