Personal injury attorneys are important for holding businesses accountable for negligence that harms other people.Without them, businesses could put profits above consumer safety. But who holds these same attorneys accountable for their own negligence? That remains to be seen.
If you watch much television, you’ve very familiar with the numerous ads of personal injury law firms announcing “new information that reveals Drug X may cause cancer in some individuals,” by a “non-attorney spokesman.” Just call the number on the screen if you have been affected because “you may be entitled to significant compensation.”
Ads of this type have been making such claims about the popular heartburn medication Zantac (ranitidine) for several years now. The Wall Street Journal editorial board just exposed these claims are false according to a federal judge who dismissed the claims.
A few years ago, the small laboratory Valisure generated headlines after purportedly finding astronomical levels of the cancer-causing chemical NDMA in Zantac. The Food and Drug Administration’s daily limit for NDMA is 96 nanograms, and Valisure claimed to have found levels exceeding 3,000,000 nanograms! Such an outrageous claim should have been questioned by the tort attorneys, but instead they jumped on the bandwagon and started their relentless advertising campaign seeking clients.
On the same day that Valisure announced a “Citizen Petition” with the FDA urging a recall of ranitidine, numerous lawsuits were filed against drug manufacturers. This timing strongly suggests coordination between plaintiff attorneys and Valisure. The FDA investigated and initiated a recall after finding NDMA in some pills that exceeded 96 nanograms.
Fast forward to today when federal Judge Robin Rosenberg notes in her 341-page ruling, the FDA limit is “conservative” – equivalent to a meal of grilled meat. “If one were to consume 96 ng. of NDMA every day, for 70 years in succession, the risk of cancer would be 1 in 100,000 or 0.001%,” and “even the highest-tested pill (by the FDA) showed NDMA at a tiny fraction of the level reported by Valisure.”
Naturally, this important context was left out of lawsuits and press reports. The same is true of the fact that the FDA found Valisure’s lab equipment actually created NDMA! Judge Rosenberg’s report details that Valisure heated the ranitidine to 266 degrees Fahrenheit – far beyond the roughly 98 degrees found in the human body – to achieve its test result of 3,000,000 ng. When Valisure tested ranitidine at 98 degrees, it found no NDMA. The extremely high temperature may have caused ranitidine to degrade into NDMA. One has to wonder why this didn’t end their investigation of ranitidine right then.
Rather than stop, however, they also tested ranitidine’s reaction with salt in an artificial stomach, which resulted in NDMA levels exceeding 300,000 ng. But the enormous levels of salt in the test might have been enough to kill a human being alone. Clearly, the laboratory was determined to find something wrong, regardless of how artificial the tests.
When Valisure tested ranitidine with salt concentrations approximating what a human could safely ingest, it detected no NDMA. But plaintiff attorneys were not deterred. They also relied on a Stanford University study that reported to find NDMA levels in ranitidine exceeding 47,000 ng. That study was later retracted by its authors after the lab equipment was found to have created the NDMA.
Judge Rosenberg writes, “There is no scientist outside this litigation who concluded ranitidine causes cancer, and the Plaintiff’s scientists within this litigation systemically utilized unreliable methodologies with a lack of documentation on how experiments were conducted, a lack of substantiation for analytical leaps, a lack of statistically significant data, and a lack of internally consistent, objective, science-based standards for the evenhanded evaluation of data.” For the record, Judge Rosenberg was appointed by President Barack Obama.
How big is this decision?
Judge Rosenberg’s decision dismisses some 50,000 lawsuits! The investment firm of Morgan Stanley had estimated potential damages against the various drug makers could reach $45 billion if the lawsuits had been successful. The WSJ editors say, “Drug makers have had to spend tens of millions of dollars to defend themselves and face tens of thousands of more lawsuits in state courts. And progressives complain about high drug costs?”
The remaining question concerns the relationship between Valisure and the plaintiff attorneys filing these cases. WSJ says, “Valisure’s role in the Zantac and other consumer lawsuits deserves more scrutiny. Its report that the diabetes drug metformin contained high levels of NDMA also triggered a blizzard of lawsuits. Valisure made headlines again in recent months after reporting scary-high levels of the carcinogen benzene in sunscreens and dry shampoos.”
The FDA has sent Valisure an eight-page letter criticizing its data controls, equipment and failure to “establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods.” This should serve as a warning the next time Valisure, or any other laboratory, makes claims about the safety of any drug or chemical in common usage. The public should ask the question, “Cui Bono – who benefits?”
