The U.S. Food and Drug Administration is right to crack down on products that make false claims or cause harm, but it shouldn't have forced Zicam — a proven, effective cold remedy with no demonstrated links to harm — off the market.
Like every other Zicam addict, I was unnerved on the day back in June when the FDA announced that the nasal-gel cold remedy poses a "serious risk" of causing loss of the sense of smell. How could a product that I had successfully and safely used for years be so dangerous? As a trial lawyer, I couldn't help but dig into the issue — one that worries me as we enter cold and flu season — and was appalled to learn that the FDA had no science to back up its action and that the suggestion that Zicam causes smell loss has been uniformly rejected as the product of junk science in at least 10 lawsuits since 2004.
The FDA's warning letter was no help. The FDA's conclusion was primarily based on a few hundred complaints of smell loss out of 35 million Zicam units sold since 1999 and vague references to a "significant and growing body of evidence."
JUDGES REJECTED THIS EVIDENCEBut I also figured that, if Zicam is such a health hazard, the "evidence" that it causes smell loss must have been the focus of litigation. And, sure enough, it has. But in all of the published cases involving claims against Zicam's maker, Matrixx Industries Inc., the "body of evidence" underlying the smell-loss claim consistently has been thrown out of court. In fact, no plaintiff has ever won a products liability case against Matrixx because the company has demonstrated time and again that there is no causal link between the use of Zicam and impairment of smell.
In seven of the cases, the scientific evidence offered to prove Zicam causes smell loss consisted of the testimony of Dr. Bruce Jafek, a professor of otolaryngology at the University of Colorado School of Medicine. Yet the judges in all seven cases did not allow Jafek to testify that Zicam use causes smell loss, and they dismissed the lawsuits.
A look at Jafek's methodology shows why. He opined that Zicam can reach the nose's smell receptor. But 20 years earlier, he had written that the smell receptor is "almost anatomically inaccessible." To overcome this contradiction, Jafek performed an experiment that one judge mockingly described as placing "a Zicam bottle far up the nostril of one half of a defrosted, septum-less cadaver head." This was neither a sufficient scientific experiment nor the way the product is supposed to be used, as any dedicated Zicam user knows.
The FDA also asserted that evidence in scientific literature (none of which the FDA identified) showed that various zinc salts can damage the smell function. Again, the courts thought little of this "evidence." The scientific literature cited in the Zicam cases involved antiquated polio prevention experiments performed in the 1930s that tested zinc sulfate, not zinc gluconate, the active ingredient in Zicam. No scientific literature nor any experiments cited by the FDA or offered in any of the Zicam cases demonstrated that the two forms of zinc had an identical chemical effect or that the specific form in Zicam causes smell loss.
In contrast, in the only Zicam case to actually go to trial, three experts testified that it was extremely unlikely that any gel would reach the nose's smell receptor. They also testified that, in four clinical studies involving Zicam, no one reported loss of smell and that the plaintiff's loss of smell was related to a viral upper respiratory infection and/or chronic sinusitis, not Zicam. The jury verdict exonerating Zicam was affirmed by the California Court of Appeal this past April. Inexplicably, the FDA made no mention of this evidence.
Nor did the FDA acknowledge that, when allegations of smell loss arose in early 2004, Matrixx assembled a panel of multidisciplinary experts who concluded that "the cumulative scientific evidence does not support the allegation that Zicam cold remedy can be associated with smell and taste disorders."
The FDA also questioned Zicam's effectiveness. Surely millions of satisfied Zicam users like me would testify that Zicam works wonders in stopping a cold in its tracks. But even the Council of Better Business Bureaus determined that Zicam's claims were substantiated by competent and reliable scientific evidence.
The FDA has a history of approving or leaving on the market drugs with much more serious side effects, making its urgency regarding Zicam even more mystifying. William Hemelt, Matrixx' president, said that "the FDA decided to take this action without notifying us first," adding that, had "we had the opportunity to sit down with the FDA beforehand, we are confident that the FDA would have agreed that the scientific data clearly demonstrated the safety of our products." Deprived of that opportunity, Matrixx has already incurred more than $30 million in charges relating to Zicam's recall and the taint the FDA has now given it. Moreover, the publicity generated by the FDA's action has spawned a new litigation feeding frenzy.
To be sure, the FDA is our drug-safety watchdog. But it shouldn't ban a product and scare the public based on evidence that one judge likened to "the never-never land of conjecture and wishful thinking."
C. Dana Hobart, a partner at Hennigan Bennett & Dorman in Los Angeles, specializes in the litigation of complex commercial cases and debtor/creditor business relations. He can be reached at hobartd@hbdlawyers.com.
