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On November 6, 2008, the government seized 11 lots of contaminated Heparin, a widely used blood thinner, from a company in Cincinnati as part of a broader effort to ensure tainted Heparin from China doesn’t harm patients.

U.S. Marshals seized the Heparin at the request of the FDA, according to a press release. The FDA said the products from Cincinnati-based Celsus Laboratories Inc. were contaminated with over-sulfated chondroitin sulfate, a substance that mimics heparin’s blood-thinning activity. The company’s products were made from material imported from China.

Earlier this year, the FDA said contaminated Heparin from facilities in China was linked to 81 deaths in the U.S. and hundreds of allergic reactions. Baxter International Inc. is the largest supplier of Heparin. The FDA later said it received reports of 11 deaths and other adverse events associated with medical devices that contain Heparin.

The FDA’s handling of the contamination scandal has drawn criticism and sparked congressional inquiry. The agency has been working to prevent contaminated forms of the blood-thinner from getting to patients.

“This action will help prevent this contaminated heparin from finding its way into the marketplace,” said Mike Chappell, acting associate commissioner for regulatory affairs, in a statement.

The agency has initiated 13 recalls of contaminated products that contain Heparin.

In April and May, the agency alerted Celsus Laboratories that it wasn’t effectively recalling the contaminated Heparin, and that’s why it asked U.S. Marshals to seize the company’s products.

The FDA said companies who may have purchased Heparin from Celsus should contact the company to determine whether the heparin they purchased was from the seized lots. The FDA has notified Japanese, Canadian, Australian, European Union and other international authorities of shipments of contaminated heparin from Celsus.

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 September 24, 2008, a regulatory group instructed hospitals to adopt firm measures to prevent errors involving blood thinners including Heparin mistakes that have been made nearly 60,000 times and led to dozens of deaths in recent years.

The Joint Commission issued a safety alert saying hospitals need to adopt prevention measures that could include bar-coding technology for medicines or computerized drug orders. It advised hospitals to more closely monitor patients on these drugs and make sure that adult-strength Heparin is stored nowhere near children’s units.

The alert said 28 deaths are among 32 reports of drug errors involving blood thinners that it received between 1997 and last year.

“We know that there are many more (deaths) and that’s the reason for issuing this alert,” said Dr. Mark Chassin, president of the Oakbrook Terrace, Illinois based commission.

Recent errors include accidental life-threatening Heparin overdoses given to actor Dennis Quaid’s newborn twins at a Los Angeles hospital last November. In July, 14 babies received accidental Heparin overdoses at a hospital in Corpus Christi, Texas.

Commission investigators will make unannounced visits to make sure hospitals are adopting strict measures to prevent blood thinner errors, and those who fail to do so could see their accreditation revoked, Chassin said.

The commission is a private group that sets hospital standards and accredits most of the nation’s hospitals. Accreditation brings prestige and federal dollars.

A total of 59,316 medication errors involving blood thinners were reported between 2001 and 2006 to a database run by U.S. Pharmacopeia, a group that sets drug standards, the alert said. Nearly 3 percent, or roughly 1,700, resulted in patient harm or death, the commission said.

Blood thinners are particularly tricky to use because too much can cause hard-to-control bleeding internally and from everybody opening; too little can result in life-threatening blood clots, Chassin said.

Heparin is usually given intravenously. Warfarin, another blood thinner cited in the alert, is available in pills patients can take at home but can cause bad reactions when mixed with other medicines.

The recommendations “absolutely” will make a difference and hospitals will pay attention, said James Conway, senior vice president of the nonprofit Institute for Healthcare Improvement in Cambridge, Massachusetts.