Duract Lawsuit

Duract is the brand name of bromfenac. It was a nonsteroidal anti-inflammatory drug (NSAID), or painkiller, that was withdrawn from the market in 1998.

What Went Wrong with Duract?

Wyeth-Ayerst Laboratories, a division of American Home Products Corporation, manufactured Duract. While it was used as a prescription medication in 1997 and 1998, it caused a dozen cases of serious liver failure. Eight consumers of Duract needed liver transplants, and four others died after using the drug. All the people had medical issues with the drug and had taken it for more than 10 days. It was not supposed to be taken for more than 10 days.

The federal Food and Drug Administration (FDA) and Wyeth-Ayerst Laboratories advised patients who had taken Duract for longer than 10 days to stop taking it immediately. All patients who were taking the medication were advised to consult their doctors.

During the 11 months that Duract was on the market, it was prescribed to 2.5 million people, according to the manufacturer, Wyeth-Ayerst. The problem with Duract was that it was supposed to be taken for 10 days only. Taking the drug for the recommended period only was safe. Using it for longer caused significant problems.

However, reportedly 15 percent of the prescriptions that doctors wrote were for longer than 10 days. Doctors wrote prescriptions for longer than 10 days even though the label had a clear warning that the medication was not supposed to be used for more than 10 days.

The problem is that other medications in the same class as Duract, i.e., NSAIDs, are, and were then, frequently used for more than 10 days by consumers. Some were and are still quite safe and sold over the counter without a prescription.

People are accustomed to taking them to treat chronic conditions such as arthritis and bursitis. Experts say that it is not unusual for people to take these medications for weeks or months. This might have explained why doctors prescribed Duract for longer than 10 days

It was noted that when the situation with Duract developed, the long-term and short-term effects of Duract had been studied in 2,500 patients. When patients in the studies looking at the long-term effects exhibited evidence of dangerously high liver enzymes, their liver functions returned to normal when they stopped taking the drug.

What about the Warnings for Duract?

Reportedly, within 8 months of Duract’s introduction to the market, Wyeth-Ayerst had received three reports of patients who had suffered injury after taking the medication for over 10 days. The FDA asked the manufacturer to add a black box warning label to the packages in which Duract was sold. This was meant to emphasize the warning that the drug should not be taken for more than 10 days.

Unfortunately, after the black box warning was added, the FDA received more reports of patients having liver issues, and four deaths were reported. At this point, it was decided that the risks were not worth the benefit of the drug. The FDA asked the manufacturer to take Duract off the market, and it did so.

The FDA’s system for tracking negative reactions to drugs approved for use was criticized. These are problems that might not be detected during clinical trials because only a small number of people participate in these trials. Once a drug is approved, it is usually used by a larger number of people, and this is when problems begin to appear.

Some experts argued that the system for detecting problems after a drug has been approved does not work effectively, partly because too few employees at the FDA are devoted to this task. They claim that the fact that patients died after doctors were warned about the problem with Duract proves the system is inadequate.

Is Duract Available Today?

Duract is no longer available on the market today and has not been available since 1998. Many other painkillers are available on the market now, both over-the-counter and with a prescription from a doctor. A person can use these to treat pain. If a person suffers from pain and an over-the-counter medication does not relieve it, they should consult their doctor about how it can be treated.

Because the medication has not been available for over 20 years, it is highly unlikely that a person would have suffered injury from using Duract in the recent past. If a person took Duract long ago when it was still on the market and did not have a problem, they probably have nothing to worry about in connection with Duract.

The serious liver issues some people experience only occur while taking the drug or within a few days after stopping. So a person should not have problems now connected with having taken Duract many years ago, assuming they did not experience problems when they took Duract.

So, if a person feels well today, even if they took Duract long ago, they probably do not need to do anything. There have not been reports of delayed problems to the knowledge of the FDA.

What Remedies Are Available for Duract Injuries?

A person injured by prescription medication may have several options when seeking a remedy. They might file a civil lawsuit if they have suffered a significant injury. One possible lawsuit would be an action for medical malpractice.

As noted above, doctors wrote prescriptions for Duract that directed patients to take it for more than 10 days. It was noted on the label that Duract should be taken for only 10 days. So prescribing the medication for more than 10 days would be a prescription error for the doctor.

A pharmacist who dispensed a quantity of Duract pills that would last a patient longer than 10 days could also be sued for their error. A pharmacist should also know that Duract should be taken for 10 days only and would be liable if they dispensed a prescription that could have lasted more than 10 days. This would be a medical error on the part of the pharmacist.

Another option for the person injured by Duract or another prescription medication would be a lawsuit for strict product liability. In a strict product liability claim, a person who a product has injured must prove that the product was defective and that the defect caused them harm.

The facts regarding Duract suggest that the defect in Duract was a design defect. It was an NSAID that could be used for only 10 days before causing serious injury. This would make it unique among NSAIDS on the market. People would not expect another NSAID to have such a limitation.

Rather, consumers were conditioned to think they could use an NSAID long-term. Even doctors who prescribed the drug failed to follow the warning regarding the 10-day limitation on use. This was especially unfortunate in light of the health problems that a person could suffer after 10 days of use. Arguably, this was a defect in the design of the medication.

Or a person might claim that Duract had a warning defect because the warning regarding the fact that users should have been limited to 10 days was not added until after the drug had already been on the market for almost a year. The facts do not suggest that a manufacturing defect was involved in the case of Duract.

Any of these lawsuits would result in an award of compensatory damages to cover the person’s economic and non-economic damages. These would include such losses as income loss, the cost of medical treatment, and pain and suffering.

Of course, a person who a prescription drug has injured should always report their experience to the FDA.

Do I Need a Lawyer for Help with My Duract Issue?

If you took Duract in 1997 or 1998, you should consult your doctor if you are concerned that it may have caused your health problems. If you believe you have been injured by taking Duract or any other medication, you should consult a class action lawyer.

Your lawyer can arrange to have a medical expert review your case to determine if a medication has harmed you. Your lawyer can advise you on protecting your rights and seeking a remedy.