Darvon and Darvocet Recall

Wednesday, December 7, 2022

Darvon and Darvocet Recall

Written by Malman Law, reviewed by Steve J. Malman.

Darvon and Darvocet are pharmaceutical products that have been known to cause serious health complications. The dangers of these drugs were debated for over 30 years before the Food and Drug Administration (FDA) pulled them off the market in 2010.

Since the 2010 recall, many lawsuits have been filed by patients who suffered side effects, most notably heart rhythm abnormalities, known as arrhythmia.

If you or a loved one were prescribed Darvon or Darvocet and have suffered side effects, you may be entitled to compensation. Contact Malman Law to discuss your case with a Chicago product liability attorney today.

What Are Darvon and Darvocet?

Darvon and Darvocet are both brand-name drugs that are made with propoxyphene. Propoxyphene is an opioid pain reliever. Darvocet also contains acetaminophen, which is the active ingredient in Tylenol. Xanodyne Pharmaceuticals, Inc. manufactured Darvon and Darvocet through 2010.

Both drugs are prescribed to treat mild to moderate pain. These painkillers were approved by the FDA in 1957, but have been riddled with safety concerns ever since.

Side Effects of Darvon and Darvocet

In July 2009, the FDA announced an ongoing safety review of propoxyphene. The FDA asked for overdose risk and cardiac effect warnings to be placed on each prescription.

On November 19, 2010, the Food and Drug Administration issued a drug recall, pulling propoxyphene off the shelves. At the time the drugs were banned, an estimated 10 million Americans were taking propoxyphene.

Propoxyphene can cause a variety of side effects:

  • Vomiting;
  • Severe abdominal pain;
  • Confusion, unusual thoughts or behavior;
  • Seizures or convulsions; and
  • Yellowing of the skin or eyes (jaundice).

The FDA found that both Darvon and Darvocet could be toxic to the heart, even when prescribed at therapeutic doses. The drug has been shown to affect the electrical activity of the heart, which can be seen on an electrocardiogram. These electrical activity changes even required some patients to need a pacemaker. Findings have also shown that continued use of propoxyphene has been linked to an increase in heart attacks.

In addition to heart arrhythmia, lightheadedness, dizziness, and heart palpitations are also presented in patients. Although these side effects are not long-term and will normally disappear once you stop taking the drug, users are at risk of fatal heart complications.

An experienced dangerous drug lawyer will be able to assess your case and gather the necessary evidence to prove your injuries are related to the use of propoxyphene.

FDA Recall Classifications

A recall is a method of removing drug products that are in violation of laws overseen by the FDA. The FDA uses three levels of classifications for recalls.

The three recall classifications are (listed from serious to mild):

  • Class I – exposure to a drug could cause serious health complications or death;
  • Class II – exposure to a drug may cause temporary or health implications that can be treated or in which the chances of serious health complications are unlikely; and
  • Class III – exposure to a drug is not likely to cause serious health complications.

The Darvon and Darvocet recall was categorized in Class II since the FDA concluded that the medications did not pose an immediate threat of serious health complications or death, but could still be detrimental to a user’s health.

At the time of recall, the FDA determined that the drug’s benefits no longer justified the risks.

Who Can You Sue for Damages?

If you took either Darvon or Darvocet, you might be eligible to receive compensation if you suffered side effects from either medication. In most drug side effect lawsuits, you can either recover compensation from the pharmaceutical company or drug manufacturer.

Additionally, if your physician did not give you an adequate briefing on the risks of taking the medications, you may be entitled to recover damages from your doctor.

Can You Always Sue a Pharmaceutical Company or Drug Manufacturer?

In March of 2009, the United States Supreme Court ruled that a patient is allowed to sue a pharmaceutical company if they suffered injuries after taking a prescribed medication. This even includes if the drug manufacturer puts a warning label on their bottles.

Statute of Limitations for Drug Injury Lawsuits

According to the Illinois Code of Civil Procedure (735 ILCS 5/13-202), you generally have two years to file a personal injury lawsuit, which would include filing a suit against a drug company.

The statute specifies that legal action must be started “…within two years after the cause of action accrued….” The cause of action would be the date on which a person of reasonable intelligence would have known or should have known that they suffered an injury.

There are many exceptions to the statute of limitations in drug side effect litigation cases. If you have suffered a complication from taking a prescription drug, it is important that you don’t wait to contact an attorney.

Compensation for Your Injuries

If you have suffered injuries from taking an unsafe drug, like propoxyphene, you may be entitled to special (economic) or general (non-economic) damages.

Damages are a legal remedy that an injured party requests in order to compensate them for any losses or injuries they sustained.

Special damages include any monetary losses you have sustained as a result of taking a dangerous drug.

Examples of special damages:

  • Lost wages
  • Diminished earning capacity (future lost wages)
  • Past and future medical bills
  • Cost of medical equipment
  • Homemaker services

In contrast, general damages describe non-monetary losses that you have suffered. This includes losses that do not come with a price tag but affect your quality of life.

Examples of general damages:

  • Pain and suffering
  • Mental anguish
  • Physical impairment
  • Loss of enjoyment of life
  • Lowered quality of life

It is always beneficial to discuss your specific case with an attorney to find out what type of compensation you should request from the party responsible for your suffering.

A Chicago Product Liability Attorney Advocating for You

At Malman Law, we know that your health is not something that you should take for granted. We have recovered millions of dollars for our clients. Contact us today to schedule your free, no-obligation consultation.

Steve Malman

Malman Law’s founder Attorney Steven Malman has over 30 years of experience handling personal injury, nursing home, medical malpractice, truck accidents, car accidents, premises liability, construction, and workers’ compensation cases in Chicago, IL.

Years of experience: +30 years
Justia Profile: Steve Malman
Illinois Registration Status: Active and authorized to practice law—Last Registered Year: 2024

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This page has been written, edited, and reviewed by a team of legal writers following our comprehensive editorial guidelines. This page was approved by President and Founder, Steven J. Malman who has more than 20 years of legal experience as a personal injury attorney.

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