Published June 4, 2012 on LawsuitInformation.org
The Mensing Ruling refers to a ruling by the Supreme Court in the case of Pliva, Inc., et al. v. Mensing which essentially protected generic manufacturers from lawsuits for failure to warn about any side effects of their products beyond the warnings contained on the warning label of the name Brand product of which they are a “copy”.
The ruling does not effect the Yaz Lawsuit or the Yazmin Lawsuit however, it may effect women who took Generics of Yaz and Yazmin even if those generics were sold under brand names.
Yaz Lawsuit not covered under Mensing
Although the Mensing Ruling does not effect the maker of the Brand Name Drugs Yaz and Yasmin from Facing a Yaz Lawsuit or a Yasmin Lawsuit, the Mensing ruling may effect women who took “Branded Generics like Occela, Safyral, Gianvi, Loryna and others. Although all of the drugs were sold under brand names, they were considered generics. This selling of Generics under a brand name would seem to be a contradiction.
The term “Brand and Generic” are terms used to distinguish a “Brand Name” product from a “Generic” copy of that same brand. This contradiction would not be relevant to the Yaz Lawsuit and other drugs listed by the FDA containing Drospirenone if it were not for a ruling commonly known as the “Mensing Ruling” in which the supreme court ruled that the manufacturer of a generic drug could not be held liable for side effects from that drug so long as the generic manufacturer placed the same warning on their generic version of the drug as was placed on the brand name version of the drug.
This ruling does not effect the Yaz Lawsuit or the Yasmin Lawsuit however, the Mensing ruling may effect those who took one of the “Branded Generics” as those may be protected under the Mensing ruling despite the fact that they were sold under Brand Names.
Yaz Lawsuit and Senate Bill
Although the law may never pass, Legislation was presented before the Senate, The Senate bill, S. 2295m titled the “Patient Safety and Generic Labeling Improvement Act” which would allow generic drug manufacturers to put additional warning labels on their products beyond those of the Name Brand of which they are a copy. The Mensing ruling was largely based on the fact that generic manufacturers are not allowed to place warnings on their products beyond or different than those placed on the Brand Name of which they were a copy.
The high court’s reasoning in the Mensing case was largely based on the logic that if a generic manufacturer was not allowed to place a warning on their products that went further than or differed from the Brand Names warnings then they could not be held liable for failing to warn the public of a potential risk associated with their product that was not covered in the warning label of the product.
The Senate Bill was introduced in April 2012 and has to go through a long process before becoming law if it ever does. Until then, individuals that take Generic drugs may have no recourse if they suffer severe side effects from a generic drug that were not covered on the warning label. As previously stated, Yaz and Yasmin, the drugs that are subject to the Yaz Lawsuit and Yasmin Lawsuit, were both sold as Brand Name Drugs therefore, the Mensing ruling nor the Senate Bill effect the Yaz Lawsuit or Yasmin Lawsuit in anyway what so ever.
There may be arguments regarding whether some of the other “Branded Generics” should be afforded the protection of the Mensing ruling considering the fact that these drugs were in fact “Branded” with names like Ocella. It is reasonable to assume that a person taking a drug that has a brand name would believe they are taking a Brand Name drug vs a generic drug. Whether or not this consumer confusion created by generics being sold under brand names will come into play in the over all birth control pill lawsuit is yet to be seen regardless, at least those women who took Yaz and Yasmin will still be able to file a Yaz Lawsuit or a Yazmin Lawsuit without any concern of their suit being tossed out due to the Mensing ruling.References: Pharmaceutical litigation, Yaz/Yasmin