CHARLESTON, W.Va. – Double doses of Digitek heart medicine didn't kill anybody, but national class action and wrongful death litigation over the drug keeps growing.
Litigation started last year after discovery of 20 double-thick tablets at a pill factory prompted the U. S. Food and Drug Administration to recall Digitek shipments.
Regulators apparently caught all the bad tablets, for after 15 months of mass litigation the 21st bad pill still hasn't turned up.
The FDA trumpets the recall as proof of its high standards and asserts that "harm to patients was very unlikely."
A New Jersey judge mocked the double-thick pill, calling it a quark, and ominously referred to whispers in the wind.
In consolidated proceedings before U. S. District Judge Joseph Goodwin in Charleston, W.Va., lawyers caught with empty claims have dismissed at least 31 cases, including a case from Beaumont and one from Houston.
One lawyer admitted what defendants Actavis Totowa and Mylan Pharmaceuticals suspect in most cases: that the client didn't take the drug.
In another case Goodwin refused to sign a dismissal order until someone explained to him what the plaintiff received through settlement.
The defense answered the next day that the plaintiff received nothing.
Since then each dismissal notice has stated that the plaintiff received nothing.
Two of 10 plaintiffs that Goodwin chose for his first trial group have dropped out.
Defense attorney Richard Dean of Cleveland, Ohio, told Goodwin in September that Actavis and Mylan paid more than $100,000 for research to expose worthless claims.
He wrote that death certificates of three plaintiffs blamed a hip fracture, end stage heart disease and internal bleeding with profound anemia.
"It has become increasingly clear that the publicity of the recall and the aggressive advertising in follow up to the recall is at the root of this litigation, not actual evidence of ingestion of a defective product," he wrote.
He wrote that "many plaintiffs' counsel had no medical records in their possession when they filed suit that established high digoxin levels."
He wrote, "In even more cases (likely over a majority) there is simply no evidence of digoxin toxicity reflected by the medical records collected to date."
He wrote that "depletion of insurance proceeds by defense costs incurred by defending meritless cases is an interest that all parties and this court should recognize."
In response, plaintiff lawyer Fred Thompson of Motley Rice in Mount Pleasant, S.C., hailed the dismissals as "an effort to self police cases."
But disposal of a few dozen empty cases hardly matters among hundreds before Goodwin and more arriving each week.
The U. S. Judicial Panel on Multi District Litigation picked Goodwin to preside over Digitek suits from federal courts around the nation.
Litigation started last year with the recall in progress.
In New Jersey, lawyer Arnold Levin of New York City asked U. S. District Judge Joseph Greenaway to notify all Digitek consumers that they should keep the pills.
That alarmed FDA and stirred the consumer litigation office of the U. S. Department of Justice to warn Greenaway that if patients kept the pills, they might swallow them.
"FDA does not have any information that would indicate that another notice at this time would add any benefit to the public health, and is concerned that it might confuse patients and potentially lead to adverse consequences," trial attorney Alan Phelps wrote.
Levin persisted in pleading with Greenaway to put his judgment above FDA's, but Greenaway declined the honor.
"This responsibility clearly lies within the realm of the FDA's authority," he wrote.
The multi district panel transferred that suit and other federal cases to Goodwin, but similar cases proceeded in state courts.
In March, at a hearing before Superior Court Judge Jonathan Harris in Hackensack, N.J., a lawyer vaguely referred to tests that found pills out of specification.
Defense lawyer Dean said, "No plaintiff's lawyer has provided that to us."
He said he went to offices of about 20 plaintiff lawyers on an informal basis, outside of New Jersey, to weigh and measure tablets.
Judge Harris asked Dean if he ever saw a double-thick tablet, and Dean said he had not.
Harris said, "Is that like the upside down plane on the stamp, if you find it?"
Dean said, "Yes, you have won. You have won the big prize."
Harris said, "Have any plaintiff's counsel seen this elusive double-thick tablet or do you know of any experts who have, or doctors, or pharmacists, or is it the quark?"
Michael M. Weinkowitz of Philadelphia said, "Your honor, I'm not aware of any."
On the spot he changed the theory of the litigation.
"Double thick from our perspective is a red herring," he said.
"A pill can have more than or less than the amount of the active ingredient in digoxin even if it's not twice as thick," he said.
He asked why pills were recalled, what testing was done, and what they found.
Harris said it sounded like a fishing expedition, and he stretched the point.
"Oh my god, you have Coumadin poisoning," he said.
"Now I want to go into the Coumadin plant. I want to check all of their warfarin specifications," he said.
"It sounds absurd and silly, but I think you would want a little bit more than you've got here," he said.
"I'm not suggesting you are acting in bad faith but you know, a lot of whispers are in the wind in this thing," he said.
In West Virginia, whispers turned into words on paper.
In July, Actavis and Mylan moved for an order requiring plaintiffs to admit or deny that they sued without necessary information.
Magistrate Judge Mary Stanley granted the motion on Aug. 11.
Since then lawyer Peter Miller of Orange, Va., has dismissed eight suits.
Danny Becnel of Reserve, La., has dropped five suits he filed with Matthew Moreland of his firm and Barry Hill of Wheeling, W.Va.
Teresa Toriseva, formerly Hill's partner, has dropped four suits.
David Peterson of Kansas City, Kans.; Maria Tejedor of Orlando, Fla.; Cara Luther of Los Angeles; and Ashley Ownby of Cleveland, Tenn., each dismissed two.
Ownby wrote for Reba Moore that, "After plaintiff counsel has reviewed the medical records, it appears the plaintiff Moore did not take any medication that is the subject of the present pending action."
Cyndi Rusnak of Houston; Mark Lanier of New York and Houston; James O'Callahan of Los Angeles; Stephen Nolan of Baltimore; Christopher Kirchmer of Beaumont, Texas; Harry Bell of Charleston; and David Hill of Memphis each dismissed a suit.
Scott Weinstein of Fort Myers, Fla., dismissed one suit and may soon dismiss more, for according to Dean his firm filed six suits with no medical records.
In Texas, about two dozen suits filed in state court are being handled by Orange County District Judge Buddy Hahn.