Goodwin ends final two Digitek cases

By Steve Korris | Nov 11, 2011


CHARLESTON – Like dust specks, U.S. District Judge Joseph Goodwin blew away the last two cases in nationwide litigation over heart medicine Digitek on Nov. 3.

"The plaintiffs' theory comes down to an attempt to use speculation about a defect to prove causation and speculation about causation to prove a defect," he wrote.

He granted summary judgment to drug maker Actavis and distributor Mylan in two wrongful death suits that outlasted last year's settlement of about 5,000 claims.

He rejected reports of doctors whose opinions changed after plaintiffs hired them.

Before finishing off the final pair, he composed a colorful history of the litigation.

"The trouble started with a plant worker who spotted a couple of double thick Digitek pills," he wrote.

He wrote that a massive visual search of an entire batch found 18 more.

"The total of 20 tablets never made it to the market of course," he wrote.

He wrote that they represented 0.0004 percent of the batch.

"Thousands of plaintiffs alleged that double thick tablets hit the market and injured consumers," he wrote.

"Not one of them produced a double thick tablet," he wrote.

He wrote that Digitek's active ingredient, digoxin, is tricky to manage.

"Taking too little has no effect. Taking too much can kill you," he wrote. "Keeping the drug in the helpful range proves tough at times and people die as a result."

He wrote that the Food and Drug Administration recalled 680 million pills in 2008. He wrote that in 2009, FDA found that "harm to patients is very unlikely."

He wrote that FDA regulates everything from employee qualifications and labeling to lab testing prior to distribution.

"These and other FDA enforced preventative regulations are policed through regulatory actions and not lawsuits," he wrote.

He wrote that in the only verified report of a thick tablet leaving Actavis and entering the market, the tablet was made in 2003. He wrote that in September 2010, lead counsel executed a settlement agreement.

He didn't summarize the agreement, but prior records show Actavis and Mylan settled about 3,000 federal suits for $10 million and about 2,000 state suits for $3 million.

On the first wrongful death case, he wrote that Daniel McCornack of San Luis Obispo, Calif., had a long history of fibrillation.

He wrote that he took digoxin for more than 10 years without incident. He wrote that his regular tested levels never exceeded the therapeutic range. He wrote that he died in 2008, on a family camping trip.

He wrote that Santa Cruz County coroner Richard Mason performed an autopsy and listed the cause as cardiac arrest due to heart disorders and obesity. He wrote that Mason changed the death certificate 15 months later, to list digoxin toxicity as a cause of death.

"Dr. Mason had been retained by plaintiffs at the time the death certificate was changed," he wrote.

In the other case, he wrote that Mimi Rivera-Vega of Houston, Texas, was obese.

"It is undisputed that she was in terrible health," he wrote.

He wrote that she got an implantable defibrillator in 2005. He wrote that she had 11 heart related hospital admissions in two years. He wrote that she had a bariatric procedure in 2007.

He wrote that in 2008, she skipped her Lasix for days and was admitted again. He wrote that physician Reynolds Delgado kept her on digoxin during hospitalization and discharge.

"This is important because Dr. Delgado would not give a patient digoxin if he thought it was causing harm," he wrote.

He wrote that she had a heart transplant on Sept. 2, 2008, and died on Sept. 28, 2008. He wrote that Delgado attributed death to congestive heart failure and cardiomyopathy.

He wrote that Delgado never changed her death certificate or reported an adverse event. He wrote that Delgado later expressed an opinion that she took defective tablets.

"Dr. Delgado's change of opinion as to Mrs. Vega's cause of death occurred after he was contacted by the plaintiffs' lawyers," he wrote. "He first expressed his digoxin related theory of death to the plaintiffs' counsel and not Mrs. Vega's family."

Goodwin struck a declaration Delgado signed and one that physician David Bliesner signed for McCornack's family.

He wrote that they tried to change opinions in violation of federal procedures.

He also struck an affidavit from a nurse who swore she saw a double thick pill.

"The alleged pill was never produced much less tested," he wrote.

He wrote that McCornack's family tested six tablets and all were within specification.

"They have at least 90 others in hand," he wrote.

He wrote that any fugitive pills had to make it past internal controls at the plant. He wrote that they had to slip by the distributor's repackaging processes.

"Third come the pharmacists and their technicians nationwide," he wrote. "Fourth, if the patient was hospitalized, there would have been a nurse intermediary who delivered the drug."

He wrote that he reviewed the record in the light most favorable to plaintiffs.

"I have taken all reasonable inferences in their column," he wrote. "I find that there is completely lacking a cogent argument or genuine issues of material fact on the questions of defect and its cause of resulting harm."

Don Ernst of San Luis Obispo represented McCornack's family.

Jimmy Williamson, Cyndi Rusnak and Michael Kerensky, all of Williamson and Rusnak in Houston, represented Rivera-Vega's family.

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