Darvocet Mass Tort Could Be Massive

Newport, KYWith the removal last November of Darvon and Darvocet from pharmacy shelves after some 50 years on the market, those conversant with the issue in the legal community are anticipating a huge response from former patients with a history of Darvocet side effects. A major mass tort could be on the horizon, with some attorneys reportedly fielding as many as 1,000 calls in one day from concerned patients.

Some have noted the Darvon and Darvocet file has the potential to equal fen-phen in terms of scope. The latter was an infamous combination diet drug that was hugely popular amongst Americans trying to shed unwanted pounds, until it was found to be harmful and was pulled from the market.

As has happened with the Darvon medication. The latter is known generically as propoxyphene. Darvocet is the combination of acetaminophen and propoxyphene. And Darvon has had quite a history and an impact on patients—given that it dates back to 1957.

However, as long as the drug has been around, concern over Darvon (and subsequently Darvocet) has been an issue for almost as long.

It was more than three decades ago, in 1978, that Public Citizen, the consumer advocacy group founded by Ralph Nader, first raised a red flag over Darvocet, asking the US Food and Drug Administration (FDA) to either ban the drug outright or tighten restrictions on its use. Public Citizen cited research that identified the potential for heart risk.

The FDA responded by categorizing Darvon as a controlled substance, but went no further.

In 2006, after the phased withdrawal of Darvon and Darvocet from the UK, Canada and Japan, Public Citizen went after the FDA again on the same issue, urging an immediate phased removal of all medications containing propoxyphene.

The January 23 issue of Missouri Lawyers Media reports that an FDA advisory panel did, indeed, vote to withdraw approval of the drug (albeit narrowly). However, the federal drug watchdog decided to reject the panel's recommendation and instead allowed propoxyphene to remain on the market pending further study.

Almost five years later, in November of last year, the FDA urged the withdrawal of all propoxyphene drugs after irrefutable evidence from the manufacturer of Darvon and Darvocet, Xanodyne, showing propoxyphene as harmful to the heart—even in healthy people.

To that end, Kristine Esposito, the plaintiff named in one of the first lawsuits filed, was 31 when she suffered a potentially life-threatening arrhythmic cardiac event. Esposito had been taking Darvocet for about a week to combat abdominal pain. Prior to the episode, Esposito was healthy with no pre-existing heart ailments.

Studies have shown that even when the drug is taken at prescribed levels, a metabolite of propoxyphene called norpropoxyphene causes an irregular heartbeat. The condition, called QT prolongation, is commonly associated with arrhythmia. The difference is that arrhythmia patients are already under surveillance by a cardiologist, whereas an otherwise healthy patient simply prescribed Darvon or Darvocet for pain is not.

There is even some dispute reported as to the efficacy and effectiveness of Darvon and Darvocet when compared to taking a more common over-the-counter (OTC) medication for pain.

And even though it took the FDA almost five years to finally ask for a ban on propoxyphene after similar market withdrawals in other countries, some pharmacists and formularies appear to have caught on a long time ago. The Springfield News-Leader on January 5 noted that the pharmacy at Skaggs Community Health Center ceased the stocking of Darvon and Darvocet for hospital patients in 2007.

Bob Campbell, the pharmacy director, was quoted as saying, "The reports have been out there for a long time that it hasn't been real effective in treating pain and there were side effects," Campbell said. "We just felt it was time to pull it off our formulary."

Ditto with the Family Pharmacy chain, which stopped recommending propoxyphene for nursing home patients with whom Family Pharmacy worked, due to the Darvon and Darvocet side effects the drugs were having on elderly patients. Lynn Morris, the president and owner of the chain, said "We took [propoxyphene] out of all the emergency boxes at our nursing homes several years ago."

Eli Lilly originally brought the drug to market, before selling propoxyphene to AAI Pharmaceuticals in 2002, according to Missouri Lawyers Media. When AAI faced bankruptcy in 2005, it was sold to Xanodyne.

A Darvocet lawsuit would likely name Eli Lilly, as well as the manufacturers of generic propoxyphene. It has been reported that attorneys have petitioned the federal multidistrict litigation (MDL) panel to consolidate cases in either New York or Louisiana. The Esposito lawsuit was filed late in 2010 in US District Court for the Eastern District of New York. Arguments for an MDL are expected as early as March 2011. One of the judges proposed for potential MDL consolidation is the Honorable Jack E. Weinstein of the Eastern District of New York, who is currently presiding over the Esposito case. The manufacturers of propoxyphene have countered with Judge Danny C. Reeves, who presides over the Eastern District of Kentucky.

Xanodyne Pharmaceuticals, the manufacturer of Darvon and Darvocet, is based in Newport, Kentucky.