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Last year in a land mark decision, the US Supreme Court ruled that generic drugmakers are not required to change warning labels even when alerted to new serious and potentially deadly side effects.

The decision came in response to lawsuits by two women who claimed labeling changes could have been made under state law and without FDA approval. With that sweeping ruling, thousands of lawsuits against generic manufacturers, were thrown instantly into limbo.

What it meant was that lawsuits against brand name YAZ could go ahead but the lawsuits against generic YAZ was thrown into jeopardy. Similar fates awaited the lawsuits against the generic versions of Fosamax, Accutane, Reglan, to name but afew.

How can this be, you ask? Welcome to the Alice in Wonderland crazy FDA and federal rules. Under present FDA regulations, generic drugmakers cannot update drug labeling, even if they know of a potential risk not mentioned in the brand name labeling.

Brand-name drugmakers, can update warnings and precautions on medical product labeling before obtaining FDA approval. The generic drugmaker is required only to match its labeling to brand-name labeling. What this means if you got injured by brand name drug you have a case, if you were unfortunate enough to have taken the identical drug but it was a generic and you got the same injuries, you are out of luck. Heads you lose, tails you lose.

This disparate cynical outcome was wryly noted by the author of the Supreme Court opinion, his message was take it up with Congress. "We don't make the law, we only enforce them."

Darvon and Darvocet Hearing

This week, arguments were heard in Kentucky over this ruling in connection with numerous lawsuits that were filed against generic manufacturers of the Darvon and Darvocet painkillers. The manufacturers included Watson Pharmaceuticals, Mylan Laboratories and Teva Pharmaceuticals.

Generic drugmakers say this would require them to provide labeling that is different from what appears on labeling of the brand-name drug. Generic manufacturers were ecstatic over the Supreme Court ruling and they won the argument that federal law preempts state law and are using this in the Darvon and Darvocet litigation.

In the Darvon and Darvocet litigation, the plaintiffs say that the generic drugmakers would not have violated federal law if they simply recalled the products, given deadly safety issues. Preemption, in other words, is not an issue.

Darvon and Darvocet History

In early 2009, an FDA advisory panel recommended withdrawal over cardiac risks, but a few months later, the agency added a Black Box warning. In November 2010, the FDA asked all manufacturers recall their drugs after the results of a clinical trial found serious and fatal heart rhythm abnormalities.

This occurred more than a year after the European Medicines Agency recommended that the drugs be withdrawn and a lawsuit filed against the FDA by Public Citizen.

Plaintiffs allege that the generic defendants knew their product was unreasonably dangerous and should have voluntarily withdrawn it from the market. The “plaintiffs here contend that the defendants should have stopped selling propoxyphene. Federal law did not require the generic defendants to continue to sell propoxyphene, so it was not impossible for them to comply with their state law duty to do so.”

The plaintiffs also allege that two of the generic defendants, Mylan and Watson, appear to have served as holders of the ‘reference listed drug’ for propoxyphene and could have added new warnings to their label through what is known as the changes being effected, or CBE process for label changes without obtaining prior FDA approval.

The generic form of Darvocet accounted for up to 98 percent of the market before the withdrawal in late 2010. The plaintiffs contend this left thousands of patients of having their lawsuits dismissed because they took the generic version of the drug instead of the brand name version.

Implications for YAZ Generics

Yaz and Yasmin have been implicated in the formation of blood clots, a condition known as venous thrombo-embolism (VTE). The FDA recently found that Yaz and Yasmin side effects increased the risk of blood clots 74% when compared to older birth control pills that use levonorgestrel as a progestin instead of drospirenone. A number of other independent studies have shown an increased risk of blood clots from Yaz and Yasmin as well.

Finally, after a 3 year struggle, Bayer the manufacturer of these brand name contraceptives, has agreed to settle the lawsuits.

Generic versions of Yaz and Yasmin are also now available from other manufacturers, including Ocella, Gianvi, Loryna, Safyral, Syeda and Zarah. Under the present US Supreme Court ruling, they are not considered liable for venous thrombo-embolism, deep vein thrombosis and pulmonary embolism injuries. The outcome of this current generic Darvocet litigation will have wide ranging implications for the genric YAZ battle.

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