New York, NY 2/21/2010 12:30:05 AM
Chaffin Luhana, In Response to New Information About the FDA's Role in GSK's Decision to Withdraw Super Poligrip From the Market, Encourages the FDA to Step Up Pressure on P&G
Chaffin Luhana encourages the FDA to force The Procter & Gamble Company ("P&G") to follow GlaxoSmithKline's (NYSE:GSK) lead to remove zinc from its popular Fixodent denture cream since P&G has shown no willingness to do so on its own.
"One of the questions that we have been asking ourselves in the denture cream cases," said Roopal Luhana, a partner at Chaffin Luhana, is "where is the FDA" and WFAA's Susan St. James seems to have the answer. WFAA reporter Susan St. James of Channel 8 in Texas, who has been reporting on zinc in denture cream for an extended period, is reporting that Channel 8 spoke to an FDA representative this week, after GSK reported on Thursday that it would stop selling Super Poligrip with zinc. St. James reports that the FDA has been working "with two major producers of denture adhesives" on the zinc issue since 2009 and that "GSK developed their recent actions, as contained in their press release, in response to [the FDA's] concerns and business forces."
While the FDA apparently did not identify the other "major producer" to St. James as The Procter & Gamble Company ("P&G"), which manufacturers Fixodent, "we think it is safe to assume that it is P&G since P&G is the only other major producer of a denture cream with zinc besides GSK and because P&G's Fixodent is the other denture cream with zinc that is in the medical case reports identified in the Nations and Hedera medical journal articles published in the last two years," said Roopal Luhana.
St. James reports that in 2009, the FDA "began assembling the facts and developing means to address the risk" of "potential zinc overload" from denture creams with zinc. St. James further reports that the FDA said it is "working with other manufacturers so they can address the risk as well" and importantly, reports that the FDA is "considering the need for a new classification regulation for denture adhesives containing zinc."
Denture creams have enjoyed status as Class I medical devices in the United States for decades. A Class I device is suppose to "present minimal potential for harm to the user" according to FDA regulations. However, "we believe products like Fixodent present significant potential harm to the user as shown by the fact that people like Donald Kimball, who is a client of ours, are so impaired physically from Fixodent that they must now use wheelchairs, walkers or canes for mobility," said Eric Chaffin. "It is hard to believe at this point, based on the reports to the FDA and the medical literature" that the FDA can allow Fixodent to continue as a Class I device. Since last fall, "GSK first put a new product warning on Super Poligrip and is now withdrawing Super Poligrip with zinc from the market. P&G, on the other hand, has done nothing to protect consumers. The last time we checked, Fixodent's packaging still did not identify zinc as an ingredient," said Eric Chaffin.
"All we have seen from P&G regarding Fixodent in response to the zinc issue is arguments like zinc is 'good' for you and that Fixodent contains 'half the amount of zinc' as Super Poligrip," said Chaffin. "P&G's arguments ring hollow, however, considering P&G knows from, among other things, the medical literature and also the medical records produced for the plaintiffs suing P&G for zinc poisoning in state and federal courts that consumers are using large enough amounts of Fixodent that they are being poisoned and horrifically injured," said Chaffin. P&G's continued denials and failure to act on consumer safety is "outrageous, especially considering P&G does not identify zinc as an ingredient in Fixodent on its packaging." "We think that P&G's conduct is outrageous, warrants punitive damages and we look forward to proving it in court," said Chaffin, who recently won a motion against P&G in Philadelphia that will allow plaintiffs to continue to pursue punitive damages claims against P&G relating to zinc in Fixodent. Regarding that punitive damages ruling, Chaffin stated, "P&G is trying to set itself apart in this litigation from GSK, but that makes no sense to us on the facts and the law." "P&G's approach to the zinc issue also makes no sense considering P&G's marketing messages, like those in its 'Thank you, Mom' campaign running during the Olympics. As one of my clients recently remarked, I guess the thank you only applies to moms who don't use Fixodent," said Eric Chaffin. "If the FDA takes a look at the injuries to these people and the amount of Fixodent consumers use, we believe that there is no way the FDA will allow P&G or any other company to continue to maintain denture creams with zinc as Class I devices. We just hope the FDA does it sooner than later since years have now passed since the first denture cream zinc poisoning case reports."
Chaffin Luhana is a boutique plaintiffs-only law firm with a national trial practice focused on representing plaintiffs in mass tort, securities, consumer fraud and whistleblower cases in federal and state courts across the country. The founding partners, Eric Chaffin and Roopal Luhana, have an established record of success and leadership in the national plaintiffs' bar and they pride themselves in providing clients with unsurpassed professional legal services designed to achieve the specific goals of their families.
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