LOS ANGELES - Pharmacy chain CVS and the makers of acne medicine Proactiv and similar products have defeated a collection of lawsuits over claims the medication can break down to produce the carcinogenic chemical benzene, as a federal judge said the plaintiffs' claims must end because those claims improperly are asking the courts to ignore federal law and undermine federal regulators' determinations that the medications are "safe and effective."
The three class actions were lodged this spring in Los Angeles federal court by attorneys with the firms of Wisner Baum LLP, of Los Angeles.
The lawsuits rely heavily on findings published by Valisure, a controversial private laboratory whose research has reportedly fueled tens of thousands of lawsuits against medication makers in courts across the country.
Valisure's work, for instance, has undergirded the flood of lawsuits nationwide against the makers of heartburn medication Zantac and its generic equivalent, ranitidine.
And more recently, Valisure's work has led to a blizzard of lawsuits against the makers of acne medications containing the medication known as benzoyl peroxide.
In both instances, Valisure has been faulted for its methods. In the Zantac research, for instance, Valisure said it showed the active ingredient in that medication broke down to create a carcinogen known as NDMA. However, it achieved those results only when it heated the medication to 266 degrees Fahrenheit in an artificial stomach or exposed Zantac to salt levels fatal to humans.
In the case of the acne medications, Valisure heated them to 170 degrees Fahrenheit for extended periods, asserting such conditions were a reasonable approximation of what might occur in shipping containers or inside a hot vehicle.
Valisure has presented those findings to the federal Food and Drug Administration in the form of a citizen petition. Those petitions have not been acted upon.
However, in the meantime, the citizen petitions were seized by trial lawyers to launch lawsuits against the companies that make those medications.
In the acne medicine cases, the plaintiffs claim the companies should pay because they allegedly have sold products they know are "adulterated" with benzene and pose a danger to those using the products, and have allegedly failed to disclose that risk to the public.
In his Sept. 19 ruling, however, Judge Blumenfeld said those claims cannot hold up in court, because they directly conflict with federal medication safety and labeling laws.
The judge noted products containing benzoyl peroxide (BPO) have been approved for over the counter use by the FDA.
And the judge said the makers of the acne medications have complied with all of the labeling and warning requirements set by the FDA for the medications' so-called "monograph."
"Plaintiffs contend that it is misleading for Defendants not to include in their label a warning about the risks of benzene," Blumenfeld wrote. "But the monograph sets forth in detail the exact warnings that must be on the labels of OTC (over the counter) acne drug products, including warnings that are only necessary for the subset containing BPO.
"Those warnings do not include any mention of benzene or its risks. Given that the FDA has specifically identified the warnings that must be provided when an acne drug contains BPO, Plaintiffs’ contention that the presence of BPO requires a warning about benzene seeks to impose an additional labeling requirement that is not identical to the FDA’s requirements and is therefore preempted by (federal law)," the judge wrote.
Further, despite the plaintiffs' assertions that their lawsuit centers on a dispute over labeling, the judge noted the plaintiffs have repeatedly argued the acne medications are "inherently" dangerous.
"Not only is that argument inconsistent with the FDA's approval of BPO, it also contradicts the central theory of their (complaint) (i.e., false advertising or failure to warn) because no additional warning could transform a criminally adulterated drug into a legal, commercial product," the judge wrote.
"... In sum, Plaintiffs seek to require Defendants to make disclosures not required under (federal law) that would conflict with the FDA's conclusion that BPO is safe and effective," the judge said. "Because Plaintiffs' claims would impose requirements that differ from and are in addition to those in (federal law), they are preempted..."
The judge dismissed the lawsuits with prejudice, meaning the plaintiffs will not be allowed to amend their complaints and try again in district court. They can appeal.
The defendants have been represented in the action by attorneys Rick L. Shackleford and Daniell K. Newman, of Greenberg Traurig, of Los Angeles; Katie A. Stricklin, of WFBM LLP, of Irvine; David S. Kurtzer-Ellenbogen, Paul E. Boehm and Jessica Bodger Rydstrom, of Williams & Connolly LLP, of Washington, D.C.; and Sonya D. Winner, Andrew Soukup and Zachary R. Glassner, of Covington & Burling LLP, of Los Angeles, San Francisco and Washington, D.C.
Plaintiffs are represented by attorneys R. Brent Wisner and Stephanie Sherman, of Wisner Baum LLP, of Los Angeles.
A spokesperson for the Wisner Baum firm did not respond to a request for comment from The Record.