WASHINGTON (Legal Newsline) - It could've been the next pot of gold for plaintiff lawyers, but the Food and Drug Administration says it's bogus.
The FDA has again rejected the findings of product-testing lab Valisure, which is responsible for tens of thousands of Zantac lawsuits despite criticism from the agency. Valisure dialed up the Zantac playbook, which previously led to a multibillion-dollar settlement, by super-heating acne medicine to produce benzene.
It then submitted its findings to the FDA as plaintiff lawyers put the Valisure study in a flurry of lawsuits against defendants like Walmart, L'Oreal and Target. The same day Valisure announced its citizen petition with the FDA, Bloomberg and CNN ran stories on it. The lawsuits came a couple of days later, with one woman filing five in one day.
"The regular use of Valisure data in simultaneously filed citizen petitions and lawsuits certainly suggests a connection with the plaintiffs' bar," said Rachel Turow, of counsel at Skadden Arps on FDA regulatory issues.
"We see similar patterns like this with other consumer protection groups and the plaintiffs' bar, but the timing and nature of the data use in this instance suggests a particularly close relationship."
Valisure uses its own methods to find out what happens when products like Zantac are heated to extreme temperatures. In the case of acne medication, it claims benzoyl peroxide turns into cancer-causing benzene.
Around 30 lawsuits followed Valisure's testing on the acne medication. But they are in jeopardy now, after the FDA tested 95 acne drugs and found only six lots with with small problems, all nearing their expiration dates.
"Even with daily use of these products for decades, the risk of a person developing cancer because of exposure to benzene found in these products is very low," the FDA wrote.
The FDA went on to warn labs like Valisure to use validated testing methods, saying Valisure's processes may result in much higher reported levels of contaminants like benzene.
"FDA has continued to raise concern that use of unvalidated testing methods by third-party laboratories can produce inaccurate results leading to consumer confusion," the FDA said.
Valisure heated acne medicines to 170 degrees Fahrenheit and found "concerningly high levels of benzene in only 18 days." Valisure said the temperature was a reasonable estimation of what might occur in a shipping container or a hot car.
It was a similar process that produced NDMA in the heartburn medicine Zantac. Valisure created an artificial stomach, heated it to 266 degrees and exposed it to a level of salt that would kill a human.
And though the FDA similarly rejected those findings, lawsuits pressed on. A federal judge in Florida dismissed about 50,000 lawsuits after finding Valisure's methods didn't fit expert witness standards, but judges in Delaware and California reached the opposite conclusion and allowed lawsuits there to proceed.
That green light caused a massive spike in advertising for lawyers trying to find Zantac clients. The research firm X Ante found trial lawyers went from $3,000 on Zantac ads in May, then after the Delaware ruling that figure went up to $1.8 million in June and July.
In Philadelphia, plaintiffs asked a judge with a reputation for keeping "junk science" out of his courtroom to recuse himself from handling pretrial matters for more than 400 cases, but he refused, leading to an appeal.
As of August, there were 28 cases over acne medicine that, while not alleging any physical injury, said consumers would not have paid as much for them, or not bought them at all, had they been warned of the risk of benzene.
There are at least 12 different defendants. One woman - Lucinda O'Dea - filed five lawsuits in one day, but they were against five separate companies regarding five different products.
The panel that creates multidistrict litigation proceedings refused to group them all together, then earlier this year refused to consolidate six cases against L'Oreal.
In September, a Los Angeles federal judge found three lawsuits against the makers of Proactiv and other medications were barred by federal drug safety law since the FDA had given approval.
The FDA's March 11 findings won't help other plaintiffs' cases, unless they are suing over the six products out of 95 to have slightly elevated benzene levels. They are La Roche-Posay Effaclar Duo Dual Action Acne Treatment, Walgreens' Tinted Acne Treatment Cream and Acne Control Cleanser, Proactiv's Emergency Blemish Relief Cream and Skin Smoothing Exfoliator and SLMD Benzoyl Peroxide Acne Lotion.
Those companies volunteered to recall the lot numbers of those tested products, while the maker of Zapzyt Acne Treatment Gel recalled it after conducting its own testing.
Of course, reprimands from the FDA didn't stop the Zantac judges in Delaware and California from letting those cases proceed. Trial lawyers paid $2 million to a second lab to produce similar results as Valisure's, which medical experts then cited to conclude Zantac can cause cancer.
The FDA said Valisure's methods on Zantac were unreliable. Though the Florida judge took that to heart, the Delaware judge downplayed the significance, which led to GlaxoSmithKline settling some 80,000 state-court lawsuits last year for $2.2 billion.
Valisure CEO David Light started the company following his time at Yale University and a prison stint for possessing an illegal cache of weapons.
"There are other consumer publications that do their own testing and that have plaintiffs' lawyers pushing their theories," said Turow, a former regulatory counsel at the FDA who has held in-house jobs at major pharmaceutical manufacturers.
"However, I have not seen them being publicly criticized by FDA since many of them do not submit their results to the agency.
"FDA's testing should trump Valisure's testing, so I would expect FDA's declaration that the products are safe to be protective for defendants in (acne medicine) cases."