Ready, Set . . . SUE!

It was recently announced that Xanodyne, the makers of Darvocet and related (propoxyphene-containing products) products have voluntarily recalled them from the market based upon mounting evidence that there is a direct correlation between Propoxyphene and certain cardiac arrhythmias and changes in the electrocardiogram (ECG). The issue of this relationship has been building for some time, with the EU taking the first steps regarding recall. Now, everyone is awaiting the first lawsuit against Xanodyne and others (generic manufacturers) which would quickly escalate into a Class Action.

It will be fun to watch, as law firms advertise for clients to place themselves into position to become “class counsel” and thus receive the lion’s share of the fee, and huge numbers of the [more than] 30 million users of these products come out of the woodwork to get their share of the pie. We need to stop for a moment, though, and ask whether anyone did anything wrong and, if so, what?

There are two issues to be dealt with before a decision about a lawsuit should be made. Propoxyphene and the products that contain it has been on the market for decades; and is probably one of the most prescribed medium strength analgesics in the country. If Xanodyne knew of the problem before marketing the product, AND withheld such knowledge from the FDA to obtain approval, they are definitely liable and should be responsible for reasonable damages (including punitive damages). Did they know? I don’t know yet, and neither does anyone I’ve read about. Then, if they knew about the ECG changes but not the connection with arrhythmias, they would not be liable as long as this was disclosed (See recent Supreme Court Decisions).

Finally, and here is the hardest part of all’ even if we believe them to be liable, what are the damages and how can you prove it. The ECG changes described in the reports can lead to a variety of irregular heart rhythms; some benign, some leading to sudden death. How do we prove what happened to a specific individual and its relationship to propoxyphene? If we cannot prove that relationship, there is no case.

Let’s not rush to judgment. If you believe you’ve been injured by this drug, by all means talk with your doctor and, if you wish, with a lawyer that handles both health care law and medical malpractice law. If there is a case, they will find it (try to go to a firm, like ours, who has a doctor/lawyer in their firm). Do not be surprised, however, if your “case” is rejected; most are. Ultimately, though, we’ll have to find out what happened before we can successfully litigate the issue, so bring your cases but bring your patience as well.