Darvocet Litigation Likely to Feel Effect of Generic Drug Decision

For any given lawsuit, its chances at succeeding or failing to win in court are heavily influenced by the decisions made about similar types of cases in the past. For the scores of Darvon and Darvocet lawsuits set to reach trial during 2011, this means paying close attention to the after effects of an important generic drug decision made this past January.
In the case of Gaeta v. Perrigo, an individual in California alleged that the maker of a generic form of ibuprofen should be held liable for her child having experienced liver failure as a result of a dangerous interaction between the ibuprofen and an anesthetic previously consumed.
There was no warning of this dangerous interaction on the label of the generic ibuprofen simply because the brand-name version of the drug omitted such a warning. As established by current federal law, generic drugmakers are not responsible for furnishing these warnings. This practice is commonly known as “generic preemption.”
Gaeta lost her case in 2005 when a lower court ruled in favor of Perrigo Pharmaceuticals, the defendant. But the plaintiff didn’t lose hope. Later, in 2009, in an unrelated case, a decision was made related to the anti-nausea medication Phenergan. This made it possible for Gaeta to appeal her lawsuit to a higher court.
Finally on January 24, 2011, at the United States Court of Appeals of the 9th Circuit, Judge David R. Thompson overturned the 2005 ruling against Gaeta. He claimed that the duty to provide a warning, which was mandated by state law, superceded any contradictory federal law. This decision was highly publicized and is expected to have a significant impact on future litigation related to the generic pharmaceutical industry.

Expected Impact of Decision on Darvon Litigation

Based on the ruling made in January 2011, companies such as Perrigo Pharmaceuticals, as well as the drugmakers responsible for generic forms of Darvon and Darvocet, would now be liable for the accuracy and completeness of their products’ warning labels, regardless of what the label on the brand name version looks like.
The manufacturer of the brand-name medications Darvon (propoxyphene) and the very popular Darvocet (propoxyphene plus acetaminophen) is Xanodyne Pharmaceuticals. Xanodyne had not modified the warning labels on these two prescription painkillers during the months leading up to the Darvocet recall in November 2010, even though severe cardiac side effects had been linked to both. During this time, the warning labels on all the generic versions of propoxyphene (there are several) matched those of Darvon and Darvocet.
In the wake of January’s landmark ruling in the case of Gaeta v. Perrigo, there are many who hope that all companies responsible for the production and sale of generic propoxyphene medications will be found liable through Darvon litigation. It is thought that going forward, generic drugmakers will no longer be able to use the defense that they were only ‘following the leader.’