Darvon, Darvocet Wrongful Death Lawsuit Filed Over Sudden Heart Death

  • Written by: Staff Writers

A wrongful death lawsuit over Darvocet has been filed by the widow of a Tennessee man who died due to sudden heart problems that were allegedly caused by the recently recalled painkillers. 

Cornelius Kellehar died on November 2, just days before the FDA issued a Darvon and Darvocet recall, according to a complaint filed by his wife, Mary Ann Kellehar, on January 13 in the U.S. District Court for the Western District of Tennessee against Xanodyne Pharmaceuticals.

Kellehar was prescribed Darvon and Darvocet on July 30, 2010, for pain management. He used the painkillers until he died due to sudden heart problems, according to the lawsuit.

The complaint alleges that the manufacturer, Xanodyne Pharmaceuticals, knew or should have known that Darvon and Darvocet side effects increase the risk of potentially fatal heart rhythm problems and failed to warn doctors and patients about potential health risks. 

Darvon was first introduced in 1957, containing propoxyphene to relieve mild to moderate post-surgical pain. Before the recall, it was most commonly prescribed as Darvocet, which combines the active ingredient in Darvon with acetaminophen, the active ingredient in Tylenol.

Darvocet was one of the 25 most commonly prescribed medications, which has been prescribed to more than 22 million people. In 2009 alone, 10 million people received a prescription for some kind of propoxyphene-based drug.

A recall of Darvocet and Darvon was issued on November 19, after the FDA determined that propoxyphene-based painkillers may increase the risk of fatal heart rhythm abnormalities, including heart arrythmia.

Some say that there have been warning signs that Darvon and Darvocet caused heart problems and an increased risk of death for decades. In 1978, the FDA was petitioned to issue a Darvocet and Darvon recall. A second petition was filed in 2006, which included indication that the medication may cause heart rhythm abnormalities. In 2009, an FDA advisory panel also recommended that the drugs be recalled due to the risks of suicide, overdose and heart rhythm problems.

However, the FDA allowed the painkillers to remain on the market while the manufacturer conducted additional studies to review the impact of Darvon and Darvocet on the heart. After preliminary results from this study showed that Darvon and Darvocet cause cardiac rhythm abnormalities in otherwise healthy volunteers when used at the maximum approved dose, federal regulators determined that the risk of sudden heart death from Darvocet and Darvon outweighed any potential benefits provided by the drugs over other available painkillers.

Since the recall, a growing number of individuals throughout the United States have filed a Darvon lawsuit or Darvocet lawsuit against Xanodyne Pharmaceuticals as a result of sudden and sometimes fatal heart problems that were allegedly caused by the drugs.

Last month, a Motion was filed with the U.S. Judicial Panel on Multidistrict Litigation seeking to have the Darvon and Darvocet litigation centralized before one judge for pretrial proceedings as part of a multidistrict litigation, or MDL. Xanodyne Pharmaceuticals has opposed the consolidation, saying that the health issues of each plaintiff represent significant differences from one case to the other. The MDL Panel will likely hear oral arguments on the Motion in March.

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  1. Lynn Reply

    I read no where anything pertaining as to whether these people were taking name brand Darvocet or generic – I truly believe this needs to be clarified. I’ve taken Darvocet since it came out for a broken back, for menstral cramps, for surgical pain, for fibromyalgia, and for osteoporosis – over 50 years of taking it – it was the one and only painkiller that my doctors found I could take due to severe drug allergies. I never had a problem at all until I was given generic Darvocet – which made me sick to my stomach, nervous, and felt like my heart was going to jump out of my body. A feeling I have never had with brand name Darvocet. Why is there nothing in any of the reports as to whether these problems are from namebrand or generic?

  2. judy Reply


  3. Joseph Reply

    I took Darvocet on a regular basis for many years after a orthopedic injury. At the age of 30 I had several heart attacks suddenly during this time,but it was inconclusive as to the cause. I had no heart disease, as validated by a heart cath. I no longer take the drug but now have to live with the damage caused.

  4. Susan Reply

    This website does mention both the generic and trade name Darvocet recalls:
    Just to inform you a medication that I have been taking for pain, management after spinal reconstructive surgery resulting in chronic intractable pain for an instability of my lumbar spine after an on the job injury, recently began distribution in a generic form. With a generic medication the only requirement is that the actual active drug is the same but binders and cutters that are included in the manufacturing of the medication DO NOT have to be the same and this is where costs are cut on generic medications, but using less expensive additives. Within 24 hours I began to feel affects from the generic medication after never having a problem with the Trade Name for 3 yrs. I began taking the medication on a Friday and saw my primary care doctor on the following Tuesday, only 4 days on the generic. I had all the signs and symptoms of the beginning of anaphalactic shock (shock caused by an allergic reaction which can be fatal). I had heart palpatations, an extemely low blood pressure, severe nausea, dizziness and other symptoms, all due to the generic.
    Now, FDA regulations state that, “if there is a generic medication and your doctor does not check the no substitution box, the pharmacist filling the prescription MUST dispense the generic.” This is where my problem came into play because my pain mgt. doctor was not informed by the FDA that a generic was released BUT the pharmacy had the generic and due to FDA regulations had to give me the generic.
    If you have any questions about anything you are prescibed by your doctor, start by asking the pharmacist and if your questions are not answered to your satisfaction then speak to the doctor prescribing the medication. To no surprise there is a breakdown in information between the approval of generic medications and doctors being notified that a generic has been released. ASK QUESTIONS, it is your health and your life!

  5. claire Reply

    I heard about the class action filed against darvecet and wish join on behalf of my father Russell Thomas who died from the side effects and was a very horrific painful death. He went from being a very strong man to complete bed ridden and writhing in pain. After his passing I saw the literature in his car on the side effects and he had every single one of them.My mother is still living at 93 and would like her to have something for all her pain and suffering as we both took care of him. PLEASE put me in touch with the lawyers handling the class action.

  6. Barbara Reply

    2008 35 year old son died. autopsy showed accidental overdose of Darvocet. Heart disease He had trench fever disease which damaged heart, having a triple bypass and valve replacement in 2007. Much pain from complications. VA subscribed these pain killers for which he had an addiction. He was a healthy young man, athletic and body builder prior to illness. Four years have passed. Our hearts are still broken.

  7. Dianne Reply

    1906 W Enerald Bend CT

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