BOSTON, Mass. — Plaintiffs’ personal injury attorneys are gearing up to initiate an onslaught of litigation against makers of the popular painkillers Darvon and Darvocet.
After the voluntary withdrawal of the drugs from the market following a recommendation by the Food and Drug Administration in November, lawyers are predicting a major mass tort and some are working around the clock fielding calls from potential plaintiffs.
“The numbers are astronomical. It has the potential to be as big as fen-phen,” said Jerrold Parker of Parker Waichman Alonso in Port Washington, N.Y.
Since the recall a month ago, Matthew McCauley, also an attorney at Parker Alonso Waichman, has received 1,000 calls per day.
While many of those calls are simply from nervous people who took the drug without any ill effects, lawyers are still in the process of weeding through the chaff.
McCauley filed one of the first lawsuits over the drugs on Dec. 10 on behalf of 31-year-old Kristine Esposito, who suffered a potentially life-threatening arrhythmic cardiac event after taking Darvocet for a week for abdominal pain.
Two other suits have been filed in federal court in Louisiana, including a class action.
If the drug’s popularity is any indicator, the number of filings could be huge. The FDA estimated 10 million prescriptions for the medications in 2009 alone, for everything from minor aches to post-surgery pain relief.
The heart condition Darvon and Darvocet allegedly cause is unpredictable and asymptomatic, and it can be fatal.
“This is large-scale litigation with numerous wrongful death cases,” said Matthew Sill of Sill & Medley in Oklahoma City, who expects to file cases in the coming weeks.
Lawyers have petitioned for the federal multidistrict litigation panel to consolidate cases either in New York or in Louisiana, the two states where so far the only complaints have been filed. The panel could decide whether and where to consolidate the cases as early as January, or at its next meeting in March.
The active ingredient in the brand name products Darvon and Darvocet is the generic drug propoxyphene.
Darvon contains pure propoxyphene and Darvocet is a combination of propoxyphene and acetaminophen.
The current manufacturer named as a defendant in the lawsuits is Xanodyne Pharmaceuticals, based in Newport, Ky. According to Parker, his firm plans to amend its complaint to add Eli Lilly, which pioneered the drug, as a defendant along with the many generic makers. (In 2002, Eli Lilly sold the drug to AAI Pharmaceuticals, which went bankrupt and was purchased by Xanodyne in 2005.)
The suits claim strict products liability and negligence. They also claim that the drug makers failed to warn doctors and patients about the risks of propoxyphene to the heart.
According to plaintiffs’ attorneys, studies have shown that even when the drug is taken at prescribed levels, a metabolite of propoxyphene called norpropoxyphene causes an irregular heartbeat. This condition, called QT prolongation, lengthens the time between the Q wave and T waves, which are two of five electrical impulses that measure the regularity of a heartbeat.
According to McCauley, there are no symptoms of QT prolongation; in some patients it will go away, but in others it will lead to a potentially lethal rapid heartbeat called ventricular tachycardia.
“QT prolongation [caused by] medications is not new — a lot of anti-arrhythmics cause QT prolongation. The difference is those medications are prescribed by cardiologists who are already monitoring your heart. When you give somebody Darvocet or Darvon, you don’t have a cardiologist looking after you,” said McCauley.
As for general causation, McCauley alleges that QT prolongation is a “signature” injury caused by propoxyphene and only a few other drugs, including methadone and some antibiotics.
Specific causation, however, is likely to be hotly disputed.
“I definitely think causation issues are going to be a major hurdle. … There has to be more scientific opinions on these claims to make sure they have the proof necessary in federal court to overcome … future Daubert motions,” said James T. Capretz of Capretz & Associates in Newport Beach, Calif., who will be speaking on a panel about the litigation in January.
Plaintiffs’ attorneys claim that the manufacturers had ample evidence to show the drug’s dangers, including the latest study leading to the FDA’s decision.
Parker contends not only that the risks outweigh the benefits, but that the drug had no benefit that could not be solved with an existing alternative.
“Not only was this drug extremely dangerous but it had zero efficacy. If you took aspirin or Tylenol, it probably would have been more effective than Darvocet,” said Parker.
Attorneys representing Xanodyne did not respond to calls for comment.
50+ years on the market
Propoxyphene was first approved in 1957 and removed over 50 years later. Complaints about the drug go back more than three decades.
In 1978, Public Citizen filed its first complaint with the FDA, asking the agency to ban the drug or tighten restrictions on its use, based on research into heart risks associated with it.
While the drug was not banned at that time, it was categorized as a controlled substance.
In 2005, the British government ordered the phased withdrawal of propoxyphene from the market. Canada and Japan soon followed suit.
With the new research from Europe, Public Citizen filed a second petition with the FDA in February 2006 urging immediate phased removal of all products containing propoxyphene.
An FDA advisory committee voted narrowly to withdraw approval of the drug, but the agency rejected those recommendations and let it remain on the market pending further study.
Because the FDA never responded to Public Citizen’s petition, the organization filed a lawsuit in federal court in 2008 under the Administrative Procedure Act, challenging the unreasonable delay.
The FDA denied that petition.
“They responded, saying, ‘Even though the advisory committee said to ban it, we’re denying the petition at this time but we’re continuing to study it,’“ said Michael Kirkpatrick, an attorney at Public Citizen Litigation Group in Washington, D.C.
In another quirky twist, Public Citizen’s motion to reconsider its petition in light of new studies showing propoxyphene’s link to heart risks was still pending in November when the FDA announced its recommendation that the drug be withdrawn.