Starting with Z – the antacid, Zantac
In early October, Glaxo Smith Kline (GSK) settled 83% of its remaining Zantac cases, some 80,000 claims, for $2.2 billion. Simultaneously, they announced a proposed settlement with Valisure, a private laboratory that had instigated a whistleblower suit [1] containing dozens of scurrilous (if not causal or legally relevant) allegations against GSK. True, a day later, GSK’s stock increased. But GSK just announced third-quarter earnings, and that report wasn’t pretty.
While these whistleblower (qui tam) cases invite additional vigilance in complying with government regulation, they also invite individuals to harass corporations – raising claims that inflame a jury’s ire and generate punitive damages -- with little or no legal relevance in themselves. But courts are clamping down. Perhaps if GSK had waited, they might have prevailed in dismissing the Valisure case (although the embarrassing allegations would have floated around in the interim).
Status of Qui Tam Cases
On September 30, Florida judge Kathryn Kimball Mizelle (the judge who rejected CDC authority to order masking in interstate transit) ruled that an individual not appointed by the government has no “power to seek daunting monetary penalties against private parties on behalf of the United States in federal court” and rejected the False Claims Act (FCA) of relator-plaintiff, Clarissa Zafirov.
Referencing Zafirov in language that could well be applied to Valisure, the court ruled that allowing private individuals to sue on behalf of the government under the FCA is, essentially, unconstitutional, holding that:
“[N]o one—not the President, not a department head, and not a court of law—appointed [Zafirov to the office of relator. Instead, relying on an idiosyncratic provision of the False Claims Act, Zafirov appointed herself. This she may not do.”
Putting a kibosh on mushrooming False Claims litigation, which, of late, has generated tremendous awards and funneled litigation finance, the court ruled:
“This …. qui tam provision encourages litigation—so much so that private relators bring the majority of FCA actions…. Because a relator may sell portions of her interest in an FCA action to third parties, including firms that specialize in litigation funding… the government might not know who is involved in FCA enforcement.”
We will likely see more challenges in qui tam cases. Whether this will restrain Valisure, which seems to delight in bringing them, remains to be seen.
The Zantac litigation is not over
Over 70,000 Zantac cases are still pending in various state courts, primarily Delaware. Along with GSK, the major producers are other manufacturers who have signaled either ambivalence or negative approaches to mass settlements – the ultimate goal of the plaintiffs’ bar (which has no wish to try tens of thousands of cases individually).
In June, Delaware’s Judge Vivian Medinilla, handling the state mass tort Zantac docket, ruled that the plaintiff’s experts’ testimony was admissible as relevant and reliable under the Daubert criteria. This ruling directly contradicts a similar motion made in the Florida federal mass tort action, where Judge Robin Rosenberg rejected similar evidence two years ago. At the end of August, the Delaware Supreme Court granted permission for an interlocutory (i.e., intermediate) appeal. This decision is a breakthrough for the defendants since interlocutory appeals are rarely heard, with judges preferring to await final case resolution before addressing appellate issues piecemeal.
On October 7, the defendants submitted their briefs, arguing:
“Plaintiffs’ experts failed to establish a clear ‘threshold dose’ at which ranitidine or NDMA could be considered a cancer risk, and that they relied too much on studies unrelated to how people actually use ranitidine, such as NDMA exposure from food or industrial sources.”
Recall that no one claims Zantac (ranitidine) itself is harmful. The claim is that under certain (arguably contorted and hence irrelevant) conditions, Zantac can break down into NDMA, a recognized probable carcinogen. But as the defense lawyers remind us, “the dose makes the poison,” we have yet to be introduced to a precise threshold level found when Zantac degrades, nor has a critical threshold dose when NDMA becomes carcinogenic been identified, let alone proven.
Oral arguments are scheduled for December 11.
California Dreamin’
Thus far, the plaintiffs’ Zantac win record isn’t anything to brag about. Most cases have either been dismissed by Judge Rosenberg, decided in favor of the defendants, or ended in hung juries, which are considered “wins” by the defense since they force the plaintiffs to significantly lower their settlement demand or go through the entire exercise of trial all over again, having essentially wasted weeks in trying the hung case.
Cases are still being brought in state courts. In early October, a new trial commenced in California, which is usually a favorable venue for plaintiffs.
The defendant in that case, Boehringer Ingelheim, argues “that the plaintiff’s cancer was caused not by Zantac and suggested the more likely cause was secondhand smoke from his father and his weight at the time of diagnosis.”
But the plaintiffs are hopeful, claiming, “This is a bladder cancer case, arguably the cancer with the strongest link to NDMA.”
So, does that mean the other cancers aren’t strongly related to NDMA?
Valsartan Recall Class Action Lawsuit Investigation
Not willing to let a good theory die, the plaintiff’s bar recently initiated a class action claiming four fairly common cardiovascular medicines, including Valsartan and Losartan, are similarly carcinogenic. Again, these drugs are not dangerous themselves, but like Zantac, the claim is they degrade to the nasty and ubiquitous NDMA. To date, some 1200 claims have been consolidated in New Jersey, with the first bellwether case set to begin in the coming weeks. These cases are not personal injury claims but allege economic loss based on violation of regulatory standards.
Nevertheless, personal injury cases are beginning to trickle in, with the plaintiffs claiming that, like Zantac:
“The U.S. Food and Drug Administration (FDA) recalled the blood pressure medication valsartan, which is used on its own and in several combination drugs…. after some batches of the drug were found to contain N-nitrosodimethylamine, or NDMA, a probable human carcinogen.”
Unlike Zantac, however, the Valsartan recall was limited to specific lots (although smoking guns of alleged fraud in research exist). Nevertheless, in early October, the estate of a Missouri woman sued Mylan Laboratories, seeking punitive damages and wrongful death for negligence in failing to warn and alleging that Valsartan and Irbesartan caused multiple myeloma and, ultimately, the woman’s death. For now, that’s the lone case in the litigation wilderness, but the plaintiffs’ bar is investigating whether a future class action for personal injury claims is warranted.
Ending with A for Amlodipine
Among the drugs of interest to the plaintiffs for alleged breakdown into NDMA is amlodipine, a calcium channel blocker used to treat angina (chest pain), which, along with Valsartan, has been partially recalled by the FDA.
However, the conditions and amounts of NDMA generated from the degradation of these drugs, i.e., the dose, have not yet been disclosed in litigation.
As to storage, according to WebMD:
“Valsartan should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C), for shorter periods of time, such as when transporting it. Store in a cool, dry place, in a tightly closed container.”
Anyone using these drugs just might want to take extra care in protecting them from higher temperatures, just in case….
[1] As I have previously discussed, the whistleblower suit claimed that GSK cheated the government by knowingly marketing an adulterated drug for which it received federal payments. Posturing itself as a surrogate for the federal government and some two dozen states that declined to take part in the litigation, Valisure sought damages for violation of the False Claims Act (FCA), which “proscribes fraudulent claims for payment from the United States and the withholding of payments owed to the United States.” As the party bringing that action, the relator, Valisure, would be entitled to at least 30% of a favorable verdict. GSK was the major Zantac manufacturer. Others included Pfizer, Boehringer Ingelheim, Sanofi, and Patheon, who didn’t partake in the settlement and weren’t named in the whistleblower action.
