In September of 2004, when Merck voluntarily removed their prescription pain medication, Vioxx, from the market, Product Liability Law once again moved into the realm of everyday news. Lawyers for everyday people took on one of the world’s largest drug companies.

The battles are still raging. In May 1999, Merck receive Food and Drug Administration (FDA) approval to sell a new non-steroidal anti-inflammatory drug (NSAID). It had gone through the standard FDA approval process and it sounded like this would be a good drug for people with osteoarthritis, without some of the stomach side effects seen in some other drugs then on the market. In fact, it was the Vigor Trial, started in January 1999, that was designed to show the relative the lack of gastrointestinal problems caused by Vioxx (as compared to naproxen), that showed the problems associated with increased cardiovascular disease. By this time, thousands of people had been taking Vioxx for longer than 18 months, some much longer.

Trials completed after the completion of the approval process indicated that people who had been taking Vioxx for less than 18 months faced no increased risk for cardiovascular disease, while those who took it longer than 18 months did face an increased risk.

The important thing here is increased risk. Not everyone who took Vioxx for more than 18 months had heart attacks, just more of them than those taking naproxen. This is why lawyers get involved. Science could not tell you which of the patients taking Vioxx were going to, or did, have a heart attack due to taking Vioxx. Nor could they tell you who would die from that Vioxx caused heart attack. They could only state that there was an increased risk for the population of people who took the medication for more than 18 months.

Some people would have had heart attacks anyway, even if they hadn’t been taking Vioxx. Product liability law generally holds that people that are hurt by using a product, in accordance with appropriate directions, should be compensated for their injuries. Science couldn’t tell you who was hurt by Vioxx, so it is up to the courts to decide. Lawyers representing individuals who thought that they or their family had been harmed by Vioxx, argued with lawyers from Merck.

The juries and judges listened to the arguments and made decisions; sometimes they agreed with Merck and sometimes agreeing with the patients. As more and more cases are completed, a body of law, or rules, is being made. Patients who meet certain conditions about how long and how much Vioxx they took, and what other cardiac risk factors they had before they started taking Vioxx, and how long after they stopped taking Vioxx before they had their heart attack, will be considered to have had that heart attack legally caused by Vioxx. They will get a settlement.

Those that don’t fit those conditions would have, legally, gotten that heart attack anyway and will not get money from Merck and Merck’s insurance companies. Remember, we are talking about legally caused, not scientifically proved to have been caused. Will everyone who had a heart attack caused by Vioxx be compensated for their pain or death? No one knows, because no one knows for sure which heart attacks were caused by the drug and which ones would have happened anyway. The lawyers for both sides, and the judges and juries, are trying to ensure that most of the people hurt by this drug are compensated. At the same time the system is trying to protect Merck from paying unnecessary damages to people that they did not hurt.

It is not a perfect system, but it is one that works most of the time. It tries to serve the greater good.0n Nov. 9, Merck & Co., after long insisting it would never settle the 27,000 Vioxx cases filed against it, turned an about face and agreed to a global settlement in which it will pay $4.85 billion to resolve the bulk of these cases.

Two of the lawyers who were instrumental in bringing this about join us to discuss the settlement on the latest episode of the legal-affairs podcast Lawyer2Lawyer. My co-host J. Craig Williams and I discuss the terms of the settlement and its implications with: Thomas V. Girardi of Girardi & Keese, one of the six attorneys who made up the plaintiffs’ negotiating committee. Leigh O’Dell, a member of the Vioxx litigation team at the law firm Beasley Allen, whose partner Andy D. Birchfield Jr. was also a member of the plaintiffs’ negotiating team. We invited representatives of Merck and also of the Defense Research Institute to appear on the program, but they declined.

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