Injuryboard Commentary - Heparin

Investigation Of Contaminated Heparin Syringes Highlights Medication Safety Issues

Wayne Parsons — Mon, 09 Nov 2009 14:44:50 GMT

Heparin is a biological compound often used as an anticoagulant, administered to patients through a pre-prepared syringe. It minimizes the danger of such diseases as deep-vein thrombosis, pulmonary embolism and NSTEMI. Since its commercialization in 1936, Heparin has saved countless lives; a recent investigation in the Archive of Internal Medicine, however, suggests that Heparin injections have been responsible for a recent outbreak of bloodstream infections.

To be fair, the problem doesn’t lie with the heparin itself – it lies with the manner in which it is packaged and prepared. Approximately a year ago, the Centers for Disease Control and Prevention (CDC) began examining incidents of bloodstream infections in health care facilities around the country. The infections took the form of Serratia marcescens, a fairly common bacteria that can often be found it people’s bathrooms and can, in especially serious situations, cause illnesses like meningitis and pneumonia. It appeared that the infection incidences corresponded with the source of the needles; a subsequent factory investigation revealed that manufacturer was not adhering to FDA standards. The company (whose name has been withheld) closed down all medical production and issued a voluntary recall. The dangerous needles are no longer on the market, but their existence has taught us some important lessons about drug regulation.

The authors of the investigation conclude that “close collaboration among federal agencies, public health authorities and clinicians was critical to the identification of the cause of this outbreak.” Furthermore, they suggest several preventative methods for the future. First, original manufacturer should label all of their products; currently, intermediary companies put their names on medical merchandise, making it difficult to trace equipment to its starting point. Second, since not all batches of the syringes contained infectious material, investigations must contain both epidemiologic and laboratory components (in case laboratory tests happen to use uncontaminated specimens). Most importantly, we must support the FDA. With the current trend towards medical globalization and the dangers it holds, it is more important than ever to sufficiently staff and fund this safety organization.

Originally posted at InjuryBoard by Wayne Parsons

Justice In Texas Points Out The Injustice Of The Law

Mike Bryant — Tue, 28 Jul 2009 09:50:00 GMT

The first week of July in Harris County, Texas, a man who lost his leg from mid-thigh down, part of his right foot and all of his fingers received a verdict of $10 million. The man was injured after an allergic reaction to Heprin. Under the present law in Texas, he would have really received $250,000. The product of tort reform caps that Steve Lombardi has covered extensively here at the Injuryboard. But, because he was "lucky" enough to be horrible manipulated before the law was imposed he was able to receive a little justice.

Look at this case and do you see a frivolous claim? Was the law really meant to stop this sort of case from getting to court? Absolutely not. It was championed with talk of stopping frivolous claims and stopping scummy lawyers. And instead it created a haven for bad doctors, protects bad medicine and most of all saves Insurance companies money.

This case will hopefully open some eyes, or at the very least provide evidence for why other states shouldn't steal the rights of the consumer. Justice needs to be available for everyone. Congratulations, that at least there was still a place for someone to be protected in Texas.

Originally posted at InjuryBoard by Mike Bryant

Jury Awards 10 million in Heparin Case

Beth Janicek — Sat, 04 Jul 2009 13:50:37 GMT

In Houston, Texas, a jury recently awarded 10 million in a medical malpractice case against Methodist Hospital and the doctors who treated John German. He sustained an amputation of his left leg above the knee, all the toes on his right foot and all of his fingers following heart surgery. The lawsuit claimed the hospital nurses failed to properly monitor him after he had been administered Heparin. He had a reaction commonly referred to as HIT, heparin-induced thrombocytopenia. The hospital claimed the nurses had not done anything wrong and had helped save Mr. German’s life. Apparently, the jury did not agree.

The jury award will help provide for the extensive medical care Mr German will have in the future.

As he stated,” It’s like closing a painful chapter in my life, even though I have to live every day like this.”

The hospital intends to appeal the case. Hopefully, the verdict will stand on appeal. I have blogged in the past about the devastating damages which result from HIT and the importance of the medical community to be vigilant in monitoring patients following heart procedures. This Texas jury has sent that message to the medical community.

Originally posted at InjuryBoard by Beth Janicek

FDA’s Lax Investigation Leads to Shipment of Contaminated Syringes

Greg Webb — Wed, 01 Jul 2009 08:00:00 GMT

Natalie Fullerton’s parents were thrilled to see their year-old daughter recover from a double-lung transplant. Her father dutifully used fluid-filled syringes to clean a tube that doctors had implanted in her chest to deliver intravenous medication. Despite his fear, bacteria infected the toddler’s blood and she was rushed to the hospital. Four months later, Natalie died in her mother’s arms.

The syringes Mr. Fullerton had been using were part of a contaminated lot made in a factory owned by Lake Zurich businessman Dushyant Patel. That batch and another have since been linked to 4 deaths and 162 illnesses across the country. Inspection reports and other documents show that the U.S. Food and Drug Administration missed several opportunities to prevent the tainted syringes from being used.

Three months before the prefilled syringes were shipped in October 2007, an FDA inspector investigated reports of red, brown, and black particles floating in syringes. She reported that the North Carolina plant managers had a plan to deal with rust, but did not note that the plant had switched to an unreliable sterilization tactic. When the FDA learned a week later that a distributor had recalled 1.3 million syringes, it should have conducted a thorough inspection of the plant, according to its operations manual. An FDA spokeswoman reports that this didn’t happen because the agency is so understaffed that it no longer follows the policy unless the recalled product poses a reasonable probability of serious injuries or death.

Federal prosecutors zeroed in on AM2PAT President Patel. An indictment on fraud, conspiracy, and other charges alleges that his firm produced syringes laced with bacteria and lied about performing sterility tests. Two employees, one a plant manager, were sentenced in February to 4 ½ years in prison for fraud and allowing tainted drugs into the marketplace. Authorities believe that Patel fled to India and are seeking to extradite him.

Patel bought a share of the North Carolina business and took over as president in 2001. Prosecutors allege that the operation was a fraud from the start, and that the firm’s application to make syringes incorporated fake data for a test to establish shelf life of the syringes. Unaware, the FDA gave Patel permission to start production in 2003.

The firm bought empty syringes and filled them with saline or heparin, solutions designed to prevent blood clots from forming in catheters. AM2PAT then sold the syringes to distributors who marketed them to hospitals and pharmacies, earnings nearly $7 million in profits in its last two years. In March 2005, a pharmacist reported finding orange sediment floating in one syringe and spotting an inch-long hair in another. An FDA inspector spent six days in the Raleigh plant three months later, noting nine significant violations, some of which could have an adverse effect on product quality. Shortly after, the FDA sent a warning letter, but it reported in January 2006 that Patel had either fixed or promised to address the major problems. New complaints were lodged in the spring and summer of 2007, including an AM2PAT employee who claimed that management was not adhering to appropriate clean-room temperatures during manufacturing.

The FDA’s Atlanta branch scheduled an inspection for June 26, 2007, but the plant was shuttered when the inspector arrived in Raleigh. By the time an inspector located the new plant, B. Braun Medical had recalled more than 1 million syringes following reports of particles floating in the saline. Six weeks after the inspection, the FDA issued a news release on the B. Braun recall’s finding that the particles were medical-grade silicone, which is capable of causing brain damage or a deadly clot. The FDA now admits that, until reports of injuries mounted, its Philadelphia office did not communicate information about the recall to its Atlanta office.

Toward the end of October 2007, the plant shipped the contaminated heparin-filled syringes. Authorities now link four deaths to the contamination. After the CDC linked the syringes, two investigators and a microbiologist interviewed workers, dug through records, examined equipment, and studied quality control in the factory. Patel had apparently concluded that the white particles that spurred the recall were caused by the failure of a standard sterilization process involving radiation. He adopted “UV light” sterilization, which the FDA says is a non-traditional technique. An employee also told investigators that the company kept two sets of records: one revealing rushed shipments of syringes that hadn’t completed sterilization tests and another fraudulently indicating that the plant was holding syringes on-site for two weeks while chemists conducted sterility tests. Patel responded that someone was sabotaging his records.

Gordon Harnack, a consultant who helps companies prepare for inspections, reviewed more than 120 pages of FDA reports on the AM2PAT plant and concluded that inspectors didn’t look deep enough, even as contamination problems became apparent. Although the syringe case has not received the attention that followed deaths from salmonella-laden peanut paste, consumer advocates say that both breakdowns are the result of a shift from aggressive enforcement to FDA partnership with the industries it is meant to oversee.

In response, FDA Commissioner Margaret Hamburg has pledged to make product safety a top priority. She said that she believes that it is critical for the FDA to take an aggressive approach to inspections and to maintain vigilance in ensuring that manufacturers comply with regulatory, legal, and moral obligation to provide safe products. FDA spokeswoman Siobhan DeLancey had previously defended the agency’s actions, saying that they had inspected the plant multiple times on a relatively low number of complaints and that the agency worked hard to prosecute the plant managers once reports of infections came in. This prosecution came too late for the Fullerton family, however, and many affected individuals have filed lawsuits in Cook County.

Originally posted at InjuryBoard by Greg Webb

Heparin Product Investigated In Deaths

Greg Webb — Wed, 20 May 2009 08:00:00 GMT

Baxter International Inc. has admitted medical care providers at a hospital in Delaware, as well as United States health officials, are investigating whether the deaths of two patients were caused by a brand of heparin blood thinners that Baxter sells in pre-mixed intravenous bags. Officials at the Beebe Medical Center in Delaware have suspended the use of Baxter’s heparin, a diluted form contained in pre-mixed bags used for a variety of blood thinning purposes, due to adverse reactions reported in five patients, such as internal bleeding in the brain.

These pre-mixed bags are different from the vials of heparin that were recalled last year. For example, the bags came from a United States manufacturer unlike the dangerous heparin that came from the China-based supply chain; in this incident, the active ingredients were supplied by Pfizer Inc. Results of product testing from the Food and Drug Administration (FDA) and Baxter have revealed no problems and Baxter claims no similar incidents have been reported. The FDA further believes the situation was an isolated incident.

Originally posted at InjuryBoard by Greg Webb

Two Die at Delaware Hospital After Taking Heparin

Beth Janicek — Fri, 15 May 2009 11:57:02 GMT

Medical care providers at a Delaware Hospital and U.S. health officials are investigating the deaths of two patients that may have been related to a brand of heparin blood thinner Baxter Internal Inc. The U.S. Food and Drug Administration said that the situation “appears to be an isolated incident.”

Although there is no specific evidence tying heparin to the illnesses, use of Baxter’s heparin has been suspended at Beebe Medical Center where adverse reactions were reported in five patients. Erin Gardiner, Baxter spokeswoman said that they “have not received any similar reports of adverse events from any other hospital regarding this widely-used product.

Last year after roughly 80 deaths were linked to contaminated heparin, Baxter recalled the medicine from several companies. Heparin is used largely before kidney dialysis and before major surgeries such as heart operations. The heparin used in these patients at Beebe Medical Center came in pre-mixed bags and was not the same product sold in vials that was part of the global recall last year. The heparin came from a North American derived bulk material supplied by Pfizer and not from the heparin Baxter claimed was altered in the China-based supply. Pfizer, based in New York, has not received any other reports of adverse reactions from heparin.

The two patients in Delaware, a 71-year old man and a 64-year old woman, did not have severe hypertension, or low blood pressure like the earlier cases. The symptoms involved intracranial bleeding. Wallace Hudson, Beebe Medical Center spokesman said, “We are not pointing fingers at Baxter. We don’t know what’s going on, but heparin is the only commonality that we were able to see ourselves.”

The hospital informed Baxter on Friday that the patients had become ill, and the company immediately contacted the Food and Drug Administration. The FDA sent medical teams to Delaware, and an FDA agent drove samples of the heparin bags directly to an agency laboratory in Queens, NY. The FDA spokeswoman, Karen Riley said, “Results of product testing to date by FDA and Baxter have not revealed any problems.”

Heparin has caused a flurry of litigation involving contaminated heparin and the allergic reaction, heparin induced thrombocytopenia, HIT. The injuries have been devastating. Our office is currently handling heparin related cases and would be happy to answer any questions.

Originally posted at InjuryBoard by Beth Janicek

Deadly Heparin? Drug Investigated in Two Deaths

Bret Hanna — Thu, 14 May 2009 23:43:16 GMT

A hospital in Delaware and the Federal Drug Administration are investigating two deaths and other complications that may be related to the use of the anti-coagulant heparin according to a report in the Chicago Tribune. The Beebe Medical Center in Lewes, Delaware, is investigating adverse reactions from the use of heparin in five patients. Meanwhile, the facility has suspended the use of the drug pending the results of the investigation. An independent laboratory is conducting the investigation.

Baxter International manufactures the the commonly used blood thinner which has had a checkered safety track record. Baxter issued a vast recall of a form of the drug distributed in vial form last year after a number of complications were reported from its administration, including the widely publicized case involving twins born to actor Dennis Quaid and his wife, Kimberly Buffington. The heparin at issue in the Beebe Medical Center cases was administered in pre-mixed bags and is a different product than that involved in the recall.

Baxter claims that the recalled product was the result of the use of an adulterated product from a Chinese supplier referred to as oversulfated chondroitin sulfate. The heparin at issue in the current investigation was formulated with active ingredients supplied by North American based Pfizer, Inc. Such active ingredients are generally described as being derived from pig intestines.

Originally posted at InjuryBoard by Bret Hanna

Another scare with Heparin by Baxter International

David Mittleman — Tue, 12 May 2009 11:15:26 GMT

It appears as though another Baxter International product may be implicated in patient’s injuries. United States health officials are investigating whether or not the deaths of two patients in a Delaware hospital are linked to a brand of heparin blood thinner sold by Baxter in intravenous bags.

The Beebe Medical Center in Lewes, Delaware, has suspended the use of Baxter’s heparin, following complications, including bleeding of the brain, with five patients.

This current scare comes on the heels of a larger recall of Baxter heparin that occurred last year.

Originally posted at InjuryBoard by David Mittleman

Blood Thinner Heparin Suspected in Deaths of Two Delaware Patients

Camryn Hansen — Mon, 11 May 2009 22:01:31 GMT

In a Delaware hospital, two patients have died and one is severely ill after taking heparin, the popular blood thinner manufactured by Baxter International. There is worry that the drug may be contaminated…again.

Last year, contaminated heparin made from raw drug stock originating in China killed 81 people. There was speculation that the contamination had been deliberate, but the FDA could not confirm this.

Heparin is a drug derived predominantly from pig intestines. The heparin currently under scrutiny comes from North American-derived bulk material supplied by Pfizer.

Pfizer, based in New York, said it hasn't received any other reports of adverse reactions from heparin. It supplies the active ingredient for Baxter heparin, manufactured in Ohio. A spokesman for Pfizer said the company gets bulk material from both North America and China, but that "Baxter believes the lot used in Delaware used North American raw materials."

Baxter spokeswoman Erin Gardiner said that, unlike the earlier cases, the Delaware patients didn't have severe hypotension, or low blood pressure. The current symptoms involve intracranial bleeding, she said.

"We are not pointing fingers at Baxter," said Beebe Medical Center spokesman Wallace Hudson. "We don't know what's going on, but heparin is the only commonality that we were able to see ourselves." -The Wall Street Journal

Upon discovering the illness of the three patients, Delaware’s Beebe Medical Center immediately contacted the FDA. Medical teams were sent to Delaware to have the suspect heparin analyzed at a lab in Queens, New York. So far, the FDA has said that this seems to be an isolated incident, and that no contaminants have been detected in the heparin.

Originally posted at InjuryBoard by Camryn Hansen

FDA: We Need to Protect the Public Health

Paul Kiesel — Wed, 04 Feb 2009 20:27:43 GMT

From U.S. News and World Report:

WEDNESDAY, Feb. 4 (HealthDay News) -- In a continuing effort to prevent counterfeit and adulterated medications from reaching American consumers, the U.S. Food and Drug Administration is adopting stricter standards for heparin and glycerin -- two widely used drug products at the center of recent contamination episodes.

The new standards were created by the U.S. Pharmacopeia (USP) Convention, a nonprofit health organization that sets public standards for prescription and over-the-counter medicines and other health-care products made or sold in the United States.

"These are ongoing changes for our standards for heparin, and for glycerin that might be contaminated with toxins called ethylene glycol and diethylene glycol," said USP Chief Science Officer Dr. Darrell R. Abernethy. "The reason is to protect the public health."

Starting in November 2007, there were hundreds of severe reactions among patients receiving heparin, a blood thinner, and most were patients on kidney dialysis. Some 200 people died from the reactions, Abernethy said.

"There was almost certainly a contaminate put in the heparin in China that caused these reactions," he said. "It was done in such a clever, devious way that it passed our standards."

The contaminated heparin from China was tainted with over-sulfated chondroitin sulfate, which is made from the dietary supplement chondroitin and mimics heparin's blood-thinning properties, Abernethy explained.

The USP had to fix the standard so that adulterated heparin would not be allowed to come into the United States, Abernethy said. In a first step, the USP did a "quick fix" last year, which dealt with the immediate problem from China.

Now, there will be a permanent change in the standard that takes effect in August. After that time, manufacturers and importers of heparin will have to use the new standard to test their products before they can be sold in the United States. The new standard includes a specific chemical identification of heparin that spots the chemicals in the heparin more precisely than was done before, Abernethy said.

Glycerin is a chemical used to sweeten products such as toothpaste and pancake syrup, while ethylene glycol and diethylene glycol are poisonous. Switching ethylene glycol, which is used in antifreeze, as a cheap substitute for glycerin goes back as far as 1937 when more than 107 people were killed in the United States by ethylene glycol used as a liquid base for an antibiotic, Abernethy said.

Recently, there have been cases of ethylene glycol or diethylene glycol contamination in toothpaste from China found in the United States and Panama. The latest case occurred in November, when 34 Nigerian children died after being given a tainted teething drug, according to the FDA.

With that background, the FDA asked the USP to improve the standard for glycerin, to exclude ethylene glycol or diethylene glycol from glycerin, Abernethy said.

Before this change, manufacturers were only required to spot test their products for these chemicals. Now manufacturers will have to test for these chemicals in all the glycerin that comes into their plants, Abernethy said. The new standard takes effect in May.

"The approach that the FDA is using to enforce these standards for heparin and glycerin means that these impurities should not happen again," Abernethy said.

Dr. David L. Katz, director of the Yale University School of Medicine's Prevention Research Center, said he wasn't convinced that these new standards will keep all tainted drugs or other products out of the country.

"In a world of global commerce, perfect defenses against tainted or adulterated drugs are achievable, but at costs few would be willing to pay," Katz said. "It would require high-volume inspection, strict quality-control standards, and a massively costly surveillance effort to let the good products through, while unfailingly filtering out the bad."

"Are higher quality standards and more scrutiny for heparin and glycerin a perfect defense against drug adulteration? Surely not," Katz said. "But they are a good step in the right direction."

Originally posted at InjuryBoard by Paul Kiesel