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The Heparin DisasterWednesday, July 30, 2008 FDA Tells Chicago Tribune That It Can Only “Conclusively” Link 3 Fatalities So Far to Contaminated Heparin
Today the Chicago Tribune reported that the FDA has only been able so far to "conclusively link" three fatalities to contaminated heparin manufactured by Baxter. (07/30/08 Chicago Tribune: Heparin Taint Tied to Deaths.)
According to the article, in an interview Tuesday with the Tribune, the FDA said it completed its review of 93 death reports related to heparin that the agency received from January 1 to March 31, 2008. (07/30/08 Chicago Tribune: Heparin Taint Tied to Deaths.) Of the 10 reports of death from severe shock known as anaphylaxis or hypotension, three of those could be traced to lot numbers of Baxter products that tested positive for oversulfated chondroitin sulfate (“OSCS”). Heparin lot numbers were not known for the other seven deaths from anaphylaxis or hypotension, so the FDA could not determine whether those 7 patients received heparin contaminated with the substance. Of the remaining 83 reports, 13 were described as "potential complications of heparin use" such as bleeding; and 25 cases were due to causes unrelated to heparin use such as pneumonia, sepsis and kidney failure. (07/30/08 Chicago Tribune: Heparin Taint Tied to Deaths.) In the remaining 45 deaths, FDA spokeswoman Janet Woodcock stated, "clinical information in the adverse-event reports is insufficient to specify the cause of death with clinical certainty,” and that the FDA was missing information from providers or others who filled out the reports to make an adequate determination. She also added, "While some of these [reports] appear definitely related [to contaminated heparin] many are still in the gray zone…We have looked over all of these death reports and a number of them were probably not related to the contaminated heparin." While it is good that the FDA has finally conclusively linked some of the deaths, many questions are still unanswered. The top five questions that immediately jump out to me are as follows: 1) If additional information is needed to determine whether additional deaths are related, why isn’t this information being gathered or at least requested from the providers or others who filled out the reports to make an adequate determination? For example, we have filed multiple adverse-event reports of clients, but to date WE HAVE NEVER BEEN CONTACTED BY THE FDA REGARDING THESE REPORTS, NEVER BEEN ADVISED OF THE STATUS OF THEIR INVESTIGATION, OR TOLD THAT ADDITIONAL INFORMATION IS NEEDED. 2) Is the FDA relying on death certificates to determine cause of death? If so, this analysis is suspect, as many individuals died before the public recall and before the medical community learned of the contaminated heparin. As such, a medical provider would not have known or appreciated that their patient could have died from an anaphylactic reaction from contaminated heparin. 3) Is the FDA investigating or supporting scientific studies to determine whether the contaminate, OSCS, and its resulting symptoms can cause or contribute to other complications leading to death, such as heart failure? To date, the FDA admits that it has limited knowledge “since the contaminant was only recently discovered.” (See FDA Questions and Answers, updated 7/3/08.) For example, the FDA admittedly does not know whether there are any long term health effects of the contaminant. (See FDA Questions and Answers, updated 7/3/08.) With the New England Journal of Medicine article (that had severely restricted testing parameters) being the only scientific study published to date regarding the effects of OSCS, it may be too quick to report that the only deaths caused by that contaminate are those from anaphylaxis or hypotension. 4) Why has the FDA failed to analyze any of the reports that were filed after March 31, 2008? Or if they have analyzed them, why have they failed to report on them? 5) Why did it take an interview with the Chicago Tribune to ferret out this important information? Baxter, SPL and the FDA have each admittedly failed the American public with respect to Heparin. As such, it is in their best interests to minimize the national disaster that they allowed to occur. It is no wonder, therefore, that they are quick to try to limit the number of deaths. Speculation is worthless. What we need is science. We implore the scientific community to not accept the FDA’s and drug companies’ unfounded conjectures at face value, but to test and study this contaminate further. Only then will we reach the truth… something that the victims of this disaster and their loved ones deserve. Labels: Baxter, Baxter Heparin, China, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, nightline, OSCS, oversulfated chondroitin sulfate, Scientific Protein Labs, SPL
Thursday, July 24, 2008 FDA links 149 deaths to contaminated Heparin
The FDA recently increased the number of reported deaths in which one or more allergic / hypotensive symptoms occurred in correlation to the receipt of heparin to 149 deaths.
Here is the table from the FDA Report:
A review of this table shows a significant spike in events for the months of November 2007 through March of 2008. There is no doubt but that this spike is the result of deaths caused by the contaminant oversulfated chondroitin sulfate (OSCS), which was intentionally added to the raw heparin in China. While there have been a few deaths related to products sold by other manufacturers, the overwhelming majority of the deaths arose from the administration of heparin manufactured and sold by Baxter. There is also no question but that this table significantly underestimates the actual number of people who died from the contaminated heparin. The FDA adverse events reports only capture a relatively small percentage of the actual number of adverse events. According to the FDA: "A small percentage of adverse reactions are reported to Centers for Deisease Control and Prevetnion and FDA by health care professionals and industry." Therefore the actual number of deaths attibutable to the contaminated heparin is much larger. Labels: Baxter, China, Chinese, dialysis, FDA, Heparin, heparin attorney, heparin lawsuit, heparin lawyer, nightline, oversulfated chondroitin sulfate
Wednesday, July 23, 2008 Baxter Announces Profits up 26%
Last Thursday, Baxter announced net income of $544 million for its second quarter ending on June 30, 2008, or 85 cents per share, due to higher sales of biotech drugs and vaccines. This is up from $431 million, or 65 cents per share, in the same period last year. (7/17/08 CNBC: “Biotech, Overseas Sales Push Baxter 2Q Profit Rise.”)
In response, Baxter shares rose $2.08, or 3.2 percent, to end at $67.96, and hit an all-time high of $69.66 earlier in the session. (7/17/08 CNBC: “Baxter Shares Hit High on 2Q Profit Growth.”) In boasting of the company’s success during Thursday’s earnings release, Chairman and Chief Executive Officer Robert Parkinson, Jr., did not mention heparin or the increasing death count linked to its contaminated drug, nor did Baxter bother mentioning how much of these increased profits were a result of foreign manufacturing of drug or drug components in countries with lax regulation and cheaper production costs. Labels: Baxter, Baxter Heparin, China, contamination, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, nightline, Parkinson
Saturday, July 19, 2008 Chinese Authorities Still Doubt Deaths are a Result of Contaminated Heparin
According to Chinese news, the Chinese Ministry of Health announced Friday that despite its “joint investigation” with U.S. drug authorities, it could still not conclude that the multiple U.S. deaths were a result of contaminated heparin sold by Baxter, who bought the raw ingredient supplied by SPL from its facility in China, SPL Changzhou. (07/18/08 China View News: “Cause of deaths still in doubt after Sino-U.S. Investigation on Blood Thinner.”)
As you may recall, China’s drug agency reported the same inability to link the reported deaths in May of this year. (See our May 7, 2008 Blog: China Points the Finger at Baxter and the FDA.”) At that time, the inability of China and the U.S. FDA to cooperate was evident. Chinese officials claimed that Baxter and the FDA failed to provide them with medical records, medical histories, and information on Baxter's manufacturing practices. The Chinese also complained that they had not been given samples of the contaminated product. The FDA complained that it was not provided records from Changzhou Techpool Pharmaceutical Co. (“CZTP”), a company who supplied SPL Changzhou with raw heparin and may have been a source for the contaminant. U.S. researchers confirmed the link between the adverse events, including death, and the contaminant, OSCS, since at least April 23, 2008, when the results of the first study were reported in an article published online by the New England Journal of Medicine entitled, “Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact System.” As reported on the FDA website, “The contaminant activates chemicals in the body called enzymes. These enzymes cause the body to make inflammatory mediators (chemicals that are released by immune cells). Inflammatory mediators can lead to some of the symptoms such as low blood pressure, abdominal symptoms and shortness of breath.” (FDA: Questions and Answers re Heparin.) It seems, therefore, that the two agencies are still failing to cooperate and exchange pertinent information. Maybe someone should give the Chinese Ministry of Health a copy of the New England Journal of Medicine article. Labels: Baxter, Baxter Heparin, Changzhou, China, Chinese, FDA, Heparin, heparin lawsuit, heparin lawyer, MDL, nightline, OSCS, over sulfated chondroitin sulfate, oversulfated chondroitin sulfate, SPL
Tuesday, July 1, 2008 Congress Demands Documentation Supporting the FDA’s Change in Position Regarding Preemption of Product Liability LawsuitsOn June 26, 2008, Congressman and Chairman of the House of Representatives’ Committee on Oversight and Government Reform, Henry A. Waxman, sent a letter to the FDA Commissioner demanding production of documents that explain why under the Bush Administration, the FDA changed its position regarding whether FDA regulation should bar liability claims. (To view this letter, click here.) Prior to the Bush Administration, the FDA had a long-standing position that despite its regulation of medical drugs and devices, “product liability lawsuits in state court complement the agency’s regulation of drugs and medical devices, providing an important additional layer of consumer protection against unsafe products.” (See 06/26/08 Letter to Eschenbach.) As such, the FDA did not interfere or challenge the constitutional right of innocent Americans injured by defective products to hold the drug companies responsible in a court of law. On May 14, 2008, the House of Representatives Committee on Oversight and Government Reform, held a hearing on the issue of preemption of state liability claims related to FDA-approved drugs and medical devices. (We have previously blogged on this hearing and the problem with preemption. See prior blogs, “Should FDA Drug and Medical Device Regulation Bar State Liability Claims?” (05/14/08); “FDA Needs Subpoena Power” (05/21/08); “The Preemption Problem” (06/04/08); “Draft Bill Regarding Preemption To Be Introduced” (06/13/08)). Despite the FDA’s long-standing position regarding preemption, the current FDA Deputy Commissioner for Policy, Randall Lutter, testified at the hearing that under the Bush Administration the FDA reversed its position and calls such suits a “challenge” to the agency that have “detrimental effects on the public health.” (For a transcript of this hearing, click here. For a video, click here.) As such, under the Bush Administration, the FDA now sides with drug manufacturers. They argue that regardless of any misconduct or failures on behalf of the drug companies, Americans injured by defective drugs should be stripped of their constitutional right to a trial by jury for most, if not all, legal claims, where the drugs are regulated or approved by the FDA, giving negligent drug companies almost complete immunity. Ironically, this position comes amidst the heparin disaster, wherein the FDA has admitted that it does not have the resources, authority and capability to ensure product safety. (See 04/29/08 Video of House of Representatives’ Subcommittee on Oversight and Investigations Hearing, “The Heparin Disaster: Chinese Counterfeits and American Failures; 04/22/08 Video of House of Representatives’ Subcommittee on Oversight and Investigations Hearing, “FDA’s Foreign Drug Inspection Program: Weaknesses Place Americans at Risk.”) Indeed, the FDA currently does not even have subpoena power, which would allow the FDA to demand certain documents from companies who have sold contaminated drugs. Without this ability, the agency is powerless to obtain internal company documents that a company itself chooses to withhold. (See prior blog, “FDA Needs Subpoena Power” (05/21/08)). The June 26, 2008 letter asks that the requested information/documents be produced by July 11, 2008. Labels: Baxter, China, Chinese, Eschenbach, FDA, Heparin, heparin attorney, heparin lawsuit, heparin lawyer, House Committee on Oversight and Government Reform, Lutter, MDL, nightline, preemption, Scientific Protein, Waxman
Tuesday, June 24, 2008 Why Didn’t the Contaminated Heparin Affect Everyone Receiving It?Much is yet to be learned regarding the contaminate found in the recalled heparin, oversulfated chondroitin sulfate (“OSCS”). However, the first and only study published to date since the January 2008 heparin recall does shed some light on the relationship between the contaminate and the severe reactions, sometimes fatal, experienced by many Americans. (“Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact System,” N. Engl. J. Med. 358:23, pgs. 2457-2467, June 5, 2008, available for a charge on the New England Journal of Medicine Website.) One of the issues addressed in this article is a question that we are often asked by our clients, why weren’t all patients who received tainted heparin from a particular lot affected? In order to investigate this and related issues concerning the biologic link between the contaminant and the reported reactions, the researchers conducted animal testing. (6/5/08 N. Engl. J. Med. article, pg. 2464.) Pigs were chosen because unlike rabbits, horses and rats, only the pig plasma supported an appropriate level of response to the OSCS contaminated heparin, but not the uncontaminated control heparin. (This also may explain why early attempts by Baxter to provoke an allergic response with suspect lots of heparin failed. See Baxter 03/19/08 Press Update and 6/5/08 N. Engl. J. Med. article, pg. 2464.) The pigs were given a single intravenous dose (5 mg per kilogram) of OSCS-contaminated heparin, uncontaminated heparin, or other substances. (06/05/08 N. Engl. J. Med. article, pg. 2466.) They were then monitored for 60 minutes. Two of six pigs treated with OSCS-contaminated heparin had at least a 30% drop in blood pressure over the first 30 minutes after infusion. One animal remained in a hypotensive state for more than 15 minutes. In contrast, none of the four animals treated with uncontaminated heparin showed any substantive changes in blood pressure. (Additionally, three pigs were given pure synthetic OSCS. All three of these pigs “showed a profound drop in blood pressure [maximal decrease, 45 to 59%] and a concurrent increase in heart rate within minutes after infusion.”) Interestingly, while not all pigs who received OSCS-contaminated heparin exhibited clinical signs, the researchers found that “induction of kallikrein activity [kallikrein is an enzyme present in blood plasma and other body fluids which can lead to the generation of bradykinin that in turn, impacts the blood vessels leading to hypotension and other symptoms] was evident in all animals that received OSCS-contaminated heparin, even when no substantive changes in blood pressure were observed.” (06/05/08 N. Engl. J. Med. article, pg. 2466, with explanation and emphasis added by Zoll, Kranz & Borgess, LLC.) Based on these findings, the researchers concluded as follows: “These findings suggest that activation of kallikrein does not always manifest as clinical symptoms, perhaps because of individual variations in control mechanism that regulate bradykinin activity…. The finding that hypotension did not develop in all animals treated with OSCS-contaminated heparin, even at a relatively high dose, is consistent with the observation that the majority of patients who received contaminated heparin did not experience an adverse event. However, it is important to note that all animals treated with OSCS-contaminated heparin showed evidence of kallikrein activation in vivo, even in the absence of clinical signs. Patients undergoing dialysis who are also receiving heparin therapy are already at high risk for hypotension because of their exposure to the dialysis membrane, which can also activate the contact system, and their treatment with angiotensin-converting-enzyme inhibitors, which inhibit bradykinin degradation. Exposure to OSCS-contaminated heparin may further increase the risk and could potentially trigger an adverse event.” (06/05/08 N. Engl. J. Med. article, pg. 2467.) Thus, the scientific evidence to date suggests that while some patients may not exhibit clinical signs after receiving OSCS, this does not necessarily lead to the conclusion that those patients were “unaffected” by the OSCS, particularly those patients, including dialysis patients, who are already at greater risk. Hopefully, researchers will continue to investigate the relationship between OSCS and the reported reactions, so that the families of those who have lost loved ones can understand how and why this happened, and continue to hope that it can and will be prevented in the future. Labels: Baxter, China, dialysis, Heparin, heparin attorney, heparin lawsuit, heparin lawyer, MDL, nightline, OSCS, oversulfated chondroitin sulfate, SPL
Friday, June 20, 2008 The FDA China Inspections
The US FDA inspected, or rather attempted to inspect, three heparin manufacturing facilities between February 20th and February 29, 2008. The first facility was that of Changzhous SPL Company, Ltd., ("CZ-SPL") a wholly owned subsidiary of SPL. All of the CZ-SPL product was shipped to Baxter.
This inspection lasted 6 days. This was the first time the FDA had ever inspected the facility, in violation of FDA policy. The inspection found that the process validation for the purification of Heparin Crude was inadequate . It further found a number of other deficiences, including:
The second inspection began February 27, 2008. This inspection was of a facility located right next door to CZ-SPL. The neighboring factory is known as Changzhou Techpool Pharmaceutical Co. Ltd. ("CT"). CT is 45% owned by CZ-SPL. All of the product made by CT is sold to CZ - SPL. Importantly, the plant is not registered with the Chinese FDA because it does not make product for consumption in China. Nor is it registered with or inspected by the US FDA. The inspection lasted only 2 days. On both days the company refused to give the FDA copies of basic documents, including raw material crude specification, test methods, cards, certificates of analysis, blend records, and inventory records. The FDA did take photographs, which we are seeking to obtain. The third inspection was even less successful. This inspection began the afternoon of February 28th and ended the next day when the FDA inspection team was refused reentry into the facility. This facility was located in Hangzhou, China. The name of the firm was Hangzhou Ruihua Biochemical Products Co. Ltd. This firm was a manufacturer and tester of crude heparin that was sold to CZ-SPL for further processing. A photograph of Dr. Wang, the general manager of CZ-SPL and an officer of SPL hung in the entryway of the facility. The firm refused to provide copies of any records and no samples were collected. The firm is not regulated or inspected by the Chinese FDA or the US FDA. The owner of the firm, Mr. Ruihua, admitted that the firm had been unable to meet the needs of CZ-SPL because there was not enough heparin available. He indicated that CZ-SPL was his sole customer. Ruiha collects raw heparin from the countryside and nearby provinces. The workshops are all on a list provided by CZ-SPL. However Mr. Ruiha refused to provide any documents, refused to permit the FDA to inspect the laboratory, refused to provide a list of the workshops from which they get the raw heparin, and would not even state the Provinces in which the workshops were located. On April 21, 2008 the FDA issued a warning letter, which held that the deficiencies and deviations from current good manufacturing processes were so severe that CZ-SPL was barred from shipping product into the United States. Labels: Baxter, Changzhou, China, Chinese, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, MDL, MDL; Multi-District Litigation, nightline, OSCS, Scientific Protein, Scientific Protein Labs, SPL
Tuesday, June 17, 2008 Heparin Death Reports Nearly DoubleThe FDA issued an updated report yeseterday on the number of deaths reported after heparin administration that occurred and were submitted to the FDA from January 1, 2007 through May 31, 2008. (See FDA 06/17/08 “Information on Adverse Event Reports and Heparin.”) According to the FDA, as of May 31, 2008, there have been 246 reports of death in patients receiving heparin since January 1, 2007. Out of the 246 reported deaths, 149 of the reports included one or more allergic symptoms or symptoms of hypotension. This report is nearly double the FDA's earlier report in April 2008, which advised of 131 reported deaths, with 81 of those reports including one or more allergic symptoms or symptoms of hypotension. The FDA's Center for Devices and Radiological Health (CDRH) has also recently reported 11 deaths and 86 injuries since January 1, 2008, which have been linked to use of medical devices containing heparin. (06/03/08 FDA web update: "Questions and Answers on Heparin, Medical Devices and In-vitro Diagnostic Assays.") The heparin in the majority of these medical devices was found to be contaminated with OSCS. Labels: Baxter, CDRH, China, Chinese, FDA, Heparin, heparin attorney, heparin lawsuit, heparin lawyer, MDL, nightline, OSCS, over sulfated chondroitin sulfate, Scientific Protein Labs
Wednesday, June 11, 2008 Heparin Timeline with Web-Links Now Available
Zoll, Kranz & Borgess, LLC has just posted a detailed timeline relevant to the Heparin recall and subsequent litigation. This timeline created solely by Zoll, Kranz & Borgess, also features web-links to almost a hundred articles, videos, and other documents, including public documents from Baxter, SPL and the FDA. Please visit this timeline by clicking here.
Labels: Baxter, Changzhou, China, Chinese, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, Heparin Timeline, MDL, MDL; Multi-District Litigation, nightline, OSCS, Scientific Protein, SPL
Wednesday, June 4, 2008 The Preemption ProblemBaxter, along with other drug manufacturers, continues to advocate for complete immunity from the majority of suits involving unsafe medical drugs under a legal concept called “federal preemption.” (See Baxter’s “Response to Preemption Discussion to Quaid’s Lawsuit.” See also testimony of Dennis and Kimberly Quaid at the Committee on Oversight and Government Reform’s 5/14/08 hearing, “Should FDA Drug and Medical Device Regulation Bar State Liability Claims?” The full transcript and video of this hearing is available by clicking here.) Baxter and other drug manufacturers argue that regardless of misconduct or failures on their part, Americans injured by defective drugs should be stripped of their constitutional right to a trial by jury for most, if not all, legal claims, where the drugs are regulated or approved by the FDA. This argument is not only legally and ethically problematic, but is based on the flawed assumption that the FDA has the resources, authority, and capability to ensure product safety. Unfortunately, as the heparin debacle as reminded us, such is not the case. Since the contaminated heparin recall, the significant shortcomings in the FDA’s ability to protect this county against unsafe drugs and medical devices, has been on the forefront of the news media, as well as the agenda of Congress. Reports exposing the depth of the problem continue. This week USA Today published an article entitled “Drug Companies Drain Scientific Brains from FDA,” which reports that the FDA continues to lose its most experienced scientific minds to major drug companies with more financial resources. This has led to staffing problems for the agency, which has a turnover rate twice that of other agencies. A previous study conducted by USA Today and reported in an article entitled “FDA Advisers Tied to Industry,” found that “more than half of the experts hired to advise the government on the safety and effectiveness of medicine had financial relationships with the pharmaceutical companies that will be helped or hurt by their decisions.” With their undeniable influence at this and other levels of our government, it is no wonder that drug companies have gained support for federal preemption of medical drug and device lawsuits. It is also no wonder that Americans continue to die from unsafe drugs and medical devices. Yet, our constitution gives every-day Americans injured through no fault of their own, a powerful weapon against corporate corruption and greed, the right to a jury trial. In a United States court of law, a regular American can hold even the wealthiest and most powerful corporation accountable. Attempts by Baxter and others to sacrifice that constitutional right for protection of its corporate profits, should be not be permitted. Labels: Baxter, China, Dennis Quaid, FDA, Heparin, heparin attorney, heparin lawsuit, heparin lawyer, House Committee on Oversight and Government Reform, MDL, MDL; Multi-District Litigation, nightline, OSCS, over sulfated chondroitin sulfate, preemption, Scientific Protein Labs
Wednesday, May 21, 2008 FDA NEEDS SUBPOENA POWER At the April 29, 2008 hearing entitled, “The Heparin Disaster: Chinese Counterfeits and American Failures,” Rep. Bart Stupak, Chairman of the investigations panel of the House Commerce Committee, asked FDA representatives if the FDA needs subpoena authority. This subpoena power would give the FDA the power to demand certain documents from companies who have sold contaminated drugs, such as Baxter and SPL. Without this ability, the agency is powerless to obtain internal company documents that a company itself chooses to withhold. Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, and Deborah Autor, Director of the FDA’s Office of Compliance, replied that this power “would be very helpful.” Last week, Stupak followed up on his inquiry, sending a letter to the FDA Chief, Andrew C. von Eschenbach, M.D. This letter emphasized the importance of giving the FDA subpoena power and asked the FDA Chief to stand by the statement of Dr. Woodcock and Ms. Autor. (Wall Street Journal, 5/20/08, “Rep. Stupak Nudges FDA Toward Subpoena Power.”) As noted by Stupak, the FDA is one of the few Federal agencies that lack subpoena power. In his letter, Stupak writes, “An integral part of ensuring the FDA can protect the American people is equipping the Agency with proper resources and enforcement authority it currently lacks….In some cases, the FDA does no testing of its own, and in making decisions it must rely entirely on the test results submitted by manufacturers. Without subpoena power, the only way the FDA can ensure it has the information it needs it to threaten criminal prosecution by the Justice Department if it finds critical data is withheld.” After six years of debate whether Congress should give the FDA subpoena power, the most recent heparin disaster and the FDA’s inability to fully investigate what went wrong, should signal the importance and need to immediately provide this power. Stupak is correct. Without the ability to obtain all documents necessary for a full and fair investigation, we will likely never know the full truth as to how fake heparin was allowed to be sold and injected into hundreds of Americans. More importantly, we cannot ensure that it will not happen again. -Submitted by Pamela A. Borgess Labels: Baxter, China, FDA, Heparin, heparin attorney, heparin lawsuit, heparin lawyer, House Committee on Oversight and Government Reform, MDL, MDL; Multi-District Litigation, OSCS, over sulfated chondroitin sulfate, SPL, Stupak
Friday, May 16, 2008 Promises of Safety
On Monday, during an interview with The Associated Press, U.S. Health and Human Services Secretary, Mike Leavitt, represented that the heparin in the United States is now safe in light of tighter testing and controls. (5/12/08 Chicago Tribune Article: “U.S. Health Secretary: Chinese Heparin Now Safe.”) He discussed the additional guidelines regarding quality and safety that exporters must now meet. I hope he is right. I hope that after months of Americans dying from contaminated heparin, import alerts at the borders and proper testing, heparin and all drugs coming into the United States are now safe. (Although based on the evidence presented to the U.S. House Commerce Committee on Energy and Commerce at the April 29, 2008 hearing entitled, “The Heparin Disaster: Chinese Counterfeits and American Failures,” I doubt this is the case.) But what about what is on our shelves already? Unfortunately, just a week ago, the FDA stepped up its heparin alert to hundreds of hospitals, medical societies and pharmaceutical organizations after learning that some medical facilities still had contaminated heparin among their supplies. (5/9/08 Wall Street Journal, “FDA Issues Update Heparin Alerts to Medical Facilities.”) The notice to the facilities read, "Please help FDA spread the word about recalls of injectable heparin products and heparin flush solutions that may be contaminated with oversulfated chondroitin sulfate (OSCS). Affected heparin products have been found in medical care facilities in one state since the recall announcement…Although product recall instructions were widely distributed, they may not have been fully acted upon at all sites where heparin is used.” Indeed, many manufacturers and distributors of medical products containing or coated with heparin have only recently begun to identify and recall products containing the contaminant, as requested by the FDA last month. For example, on Monday, Atrium Medical Corporation recalled selected lots of HYDRAGLIDE™ Brand Heparin-Coated Thoracic Drainage Catheters that were manufactured with heparin that was contaminated with OSCS. Likewise, on May 7, 2008, Medtronic, Inc. recalled selected products with a “Carmeda BioActive surface” that were manufactured with heparin found to have been contaminated with OSCS. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. This delayed response is unfortunately consistent with the experience of our clients, some of whom we believe received recalled heparin after the date of recall, or who never received notice of the recall from their pharmacy or medical facility. Authorities must continue to focus not only on what is being imported, but what is already within our borders. A blanket promise of safety to the unsuspecting American public should only be made when it is certain that it is a promise that can be kept. -Submitted by Pamela A. Borgess Labels: Atrium, Baxter, Changzhou, China, Chinese, FDA, Heparin, heparin attorney, heparin lawsuit, heparin lawyer, Leavitt, MDL, MDL; Multi-District Litigation, Medtronic, OSCS, over sulfated chondroitin sulfate, oversulfated chondroitin sulfate
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