Judge Denise Cote of the U.S. District Court for the Southern District of New York, who is supervising the Eliquis MDL, ordered all plaintiffs to show cause by May 23 why her dismissal of one case should not be applied to all cases.
The case is In Re: Eliquis [Apixaban] Products Liability Litigation, MDL 2754, No. 17-md-2754, Charlie Utts, et al. v. Bristol-Myers Squibb Company, et al., No. 16-5668, S.D. N.Y., 2017).
On May 8 the judge dismissed the Utts case, one of 49 cases brought against Bristol-Myers Squibb Company and Pfizer Inc. over their Eliquis anticoagulant, ruling that the plaintiff’s state-law claims were preempted by federal law.
On May 9, Judge Cote gave plaintiffs until May 23 to file amended complaints “and to show cause in a memorandum no longer than 20 pages why the amended complaint should not be dismissed based on the analysis in the May 8 Utts Opinion.” Future lawsuits transferred into the MDL will have 14 days to provide the same information, the judge said.
The judge added that “it is unlikely that the plaintiffs in any of these actions will have a further opportunity to amend.” She said the defendants will file a reply or replies by June 20, “at which point the motions to dismiss each action will be considered fully submitted.”
Plaintiff Charlie Utts of California was diagnosed with atrial fibrillation and prescribed Eliquis by his doctor. After taking Eliquis, he suffered severe gastrointestinal bleeding and was hospitalized in July 2014 for about three weeks to undergo blood transfusions and several rounds of dialysis. He and his wife filed suit in 2016.
Eliquis — the brand name of the prescription medicine apixaban — is a blood-thinning medication used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Eliquis belongs to a class of drugs known as novel oral anticoagulants (“NOACs”). It does not have a known antidote or reversal agent. Unlike anticoagulant medications such as warfarin, NOACs, including Eliquis, do not require periodic blood testing or impose dietary restrictions on users.
The plaintiffs argued that despite there being no antidote for uncontrolled bleeding while taking Eliquis, the dosage recommendation was not individually tailored and that Bristol-Myers and Pfizer did not recommend constant monitoring of blood clotting times in patients.
Showing off her homework in an 85-page opinion, Judge Cote also rejected all nine scientific articles or documents cited by the plaintiffs to create a plausible claim that the Eliquis labeling fails to adequately warn of the risk of excessive bleeding. “The information contained in this literature does not constitute ‘newly acquired information’ under the FDA’s regulation,” the opinion says.
Well-Known to FDA
“These two complaints concern features of the design of the drug that were well known to the FDA [Food and Drug Administration] when it approved the drug,” Judge Cote wrote.
“Faced with the fact that, as of today, there is no research or clinical experience to suggest that any changes to the Eliquis label’s disclosures related to a risk of excessive bleeding are warranted, the plaintiffs argue vehemently that the motion to dismiss should be denied and that they should be permitted to conduct discovery to try to locate evidence in the defendants’ files that might support their failure to warn claims,” the judge continued.
“They emphasize that there is substantial ongoing litigation over the earlier drugs in the class of drugs to which Eliquis belongs,” the judge continued. “But, the ability of other plaintiffs in other litigation over other drugs to survive a motion to dismiss does not relieve the plaintiffs of the requirements imposed by Rule 12(b)[Fed. R. Civ. P., 12(b)]. Accordingly, the claims in the [second amended complaint], which reduced to their essence are attacks on the design of this drug, will be dismissed.”
The Uttses are represented by Hunter J. Shkolnik and Nicholas Farnolo of Napoli Shkolnik in Melville, N.Y.