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On November, 14, 2008, U.S. Attorneys in New Jersey filed a lawsuit seeking a shutdown of three Actavis Inc. plants until they are brought into compliance with testing, manufacturing laws and FDA regulations. The complaint requests that the court prevent Actavis Inc., Actavis Totowa, and executives Sigurdur Olafsson and Douglas Boothe from being involved in the making of drugs until the company is brought into compliance with FDA requirements for testing, quality control and test response, and ceases selling unapproved and misbranded drugs.

The suit filed by U.S. Attorney Christopher Christie, along with the Department of Justice’s Officer of Consumer Litigation. It states that since early 2006, Actavis’ facilities in Totowa and Little Falls, New Jersey have repeatedly failed inspections by the FDA, the company has not made the necessary improvements.
Actavis Inc. and Actavis Totowa LLC are units of Iceland-based Actavis Group.

In a press release, Actavis said the company has focused on complying with the FDA since May and believes it will meet and exceed the agency’s requirements. The company said it invited FDA inspectors back to its facilities in October, but so far, the agency has not made a return visit.

The FDA investigated the two facilities in Totowa and one in Little Falls a total of five times between January 2006 and May 2008.

In April, Actavis recalled its heart drug Digitek because some tablets may have been twice as thick as they were supposed to be, which would have doubled the dose and created a greater risk of side effects. The drug was sold under different names by Mylan Inc. and UDL Laboratories Inc.

In the inspections, the FDA found the company kept incomplete lab records of its testing data, and failed to verify that its testing methods matched up with actual conditions under which the products would be used. It also did not investigate unusual test results, didn’t follow its own stability testing procedures, and didn’t make sure test samples met its specifications.

Further, the FDA said Actavis’ quality control unit didn’t follow its written procedures and check that all issues were resolved before the drugs were sold. The violations continued in further inspections.

The company also made drugs in the Little Falls facility that had not been approved by the FDA, according to the suit.

On October 2, 2008, a state agency said that almost 100 pharmacists and the hospitals they work for face fines for failing to remove Heparin, a blood thinner from their shelves after a federal recall last winter.

The recalled drug Heparin was found 94 times in inspections of all 533 hospitals in California, and at least 16 hospitals administered the drug to patients, according to the state Board of Pharmacy. Fines range from $2,500 to $5,000.

“This was really an alert that the recall system doesn’t work,” Virginia Herold, head of the state’s pharmacy board, told The Associated Press.

Regulators have not released the full list of hospitals involved. However, documents obtained by the Daily Journal show newborns were allegedly given heparin at the University of California San Francisco Medical Center and Children’s Hospital of Central California in Madera. Both hospitals are appealing the charges.

Heparin, which is often used in premature children to prevent blood clots, has come under scrutiny because of accidental life-threatening overdoses given to babies, including actor Dennis Quaid’s newborn twins at a Los Angeles hospital last November. Fourteen other babies received accidental heparin overdoses in July at a hospital in Corpus Christi, Texas.

The FDA issued a drug recall in February because “a higher than usual number” of patients reported adverse effects to heparin, which include chest pain, dizziness and headache.

The state’s Department of Public Health has also launched an investigation to determine whether recalled Heparin, Digitex and Procrit caused harm to any patients.

No link has been found, though a state health official said the state will try to ensure recalled drugs are taken out of hospitals.

“Our actions are to act as both a partner and an enforcer to look at what kinds of system breakdowns are taking place, to make sure we don’t have a reoccurrence of this in the future,” Kathleen Billingsley, deputy director of the state’s Center for Healthcare Quality, told the AP.

In March, the state Board of Pharmacy voted 12-0 to give drug makers, wholesalers and pharmacies until Jan. 1, 2011, to start electronically tracking drugs from factory to patient. The electronic tracking system has been delayed a number of times since 2004, when a recall of 175,000 bottles of fake Lipitor, the cholesterol drug, led state regulators to require tracking.

Herold said although it’s unclear whether the tracking system would have prevented this incident, it will give pharmacists a better idea of what is on their shelves.

Additionally, the Oakbrook Terrace, Ill.-based Joint Commission, an independent, not-for-profit organization health quality group, issued a safety alert asking hospitals nationwide to adopt stricter measures to prevent errors involving blood thinners, including Heparin.

On August 29, 2008, the United States Judicial Panel on Multidistrict Litigation ordered that all federal lawsuits related to defective, double strength Digitek (also known as Digoxin) be moved to the U.S. District Court for the Southern District of West Virginia.

The action comes after an April 2008 recall on all lots of the prescription drug after discovery that some tablets twice as thick as normal contained double the appropriate amount of medication.

At least 60 lawsuits have been filed in federal courts across the country. Defendants include Actavis Totowa, LLC, Actavis, Inc., Actavis Elizabeth, LLC, Actavis US, Mylan, Inc., Mylan Pharmaceuticals, Inc., Mylan Laboratories, Inc., Mylan Bertek Pharmaceuticals and UDL Laboratories, Inc.

Seventeen of the pending federal suits have been filed in the Southern and Northern District of West Virginia. The other pending cases come from Cleveland, Ohio; New Orleans, La.; Chicago, Ill.; Philadelphia, Pa.; Ft. Myers, Fla.; and Kansas City, Mo. At the time of the transfer order, potentially another 50 “related actions” had been filed.

A motion has been filed regarding overdose cases filed in West Virginia state courts too. If granted, the cases would be consolidated under one state court judge.

Under federal court procedures, the purposes of transferring all cases to one judge for pretrial rulings eliminates duplicative discovery and inconsistent pretrial rulings. Unlike a “class action,” where all suit are tried together, the Multi District Litigation (MDL) relates to pre-trial actions only. If a resolution or settlement is not reached, the cases go back to their respective districts for trial.

Judge John G. Heyburn II, chairman of the Panel on Multidistrict Litigation wrote of the Digitek cases: “On the basis of the papers filed and the hearing session held, we find that the actions in this litigation involve common questions of fact, and centralization in the Southern District of West Virginia will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation. All actions share factual questions relating to the manufacture and sale by defendants of allegedly adulterated Digitek, which was recalled in April 2008.”

The combined cases will be assigned to Judge Joseph R. Goodwin, who the order described as an “experienced MDL transferee judge with a docket that will allow him to devote the needed attention to these cases.”

Mylan Pharmaceuticals, Inc. has its principal place of business in Morgantown, W.Va. It is a leader in developing, manufacturing and marketing generic pharmaceutical products.

The drug is used to treat atrial fibrillation, atrial flutter and heart failure. Ingestion of a toxic amount of the drug can result in visual changes, palpitations, irregular pulse, cold sweats and digitalis toxicity (which results from a build up of the drug in the body).