|
|
|
|
|
The Heparin DisasterThursday, May 14, 2009 Bad Chinese Heparin Supplier Cited by FDA AgainDespite the deaths of hundreds of Americans last year from tainted Chinese heparin, Scientific Protein Laboratories (“SPL”) has still not cleaned up its act and has been cited again this month for violating safety regulations. SPL supplied the component ingredients in the bad heparin, called “active pharmaceutical ingredients” ("API") to Baxter from its facility in China. However, despite Baxter and SPL's representations to the public that they were taking great care to assure the safety of their drugs, both companies knew that the Chinese facility had never been inspected by the FDA or any other governmental agency. Last year, upon investigating the cause of the deaths, the FDA discovered the existence of the Chinese facility. When the International Compliance Team for the U.S. FDA performed an inspection of the Chinese facility from February 20 – 26, 2008, multiple and severe violations were found, including, but not limited to, the lack of any assurances that the processing steps used to manufacture heparin were capable of effectively removing impurities. As a result, the FDA issued a “Form 483” to SPL last year. A Form 483 is referred to as “Notice of Inspectional Observations.” The 483 is issued by an FDA field investigator after an on-site inspection of a facility and documents significant and serious violations from regulations called “Good Manufacturing Practices” (“GMP”) regulations. These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations protect the consumer from purchasing a product which is ineffective, dangerous or contaminated. After hundreds of Americans died from bad heparin supplied by its facility, you would think that SPL (who is now being defended by Baxter in the ongoing litigation), would have learned its lesson. You would think that the company would insist that its facilities strictly adhere to safety regulations to avoid something like this happening again. Unfortunately, such is not the case. The FDA recently issued another Form 483 for SPL’s United States plant in Waunakee, Wisc. (See May 13, 2009, FDAnews Drug Daily Bulletin “Scientific Protein Laboratories Gets Form 483 for Heparin Plant,” Vo. 6 No. 93.) The FDA cited six violations of GMP regulations, including for example, incorrect or inadequate data and reports, and failure to follow safety protocols, including the cleaning of tanks used in the manufacture of heparin. SPL’s ongoing and callous disregard for safety procedures is an absolute insult to every victim of the heparin disaster. The fact that Baxter is defending this company and asking that both itself and SPL not be held responsible for the deaths of innocent men, women and children, is likewise sickening. These companies must be held responsible. There must be consequences when companies balatantly ignore safety regulations, thereby sacrifing human lives for corporate profit. If not, as evidenced by SPL's refusal to learn from the heparin tragedy, history is bound to repeat itself. Labels: Baxter, Baxter Heparin, Chinese heparin, FDA, Heparin, heparin attorney, Heparin Class Action, heparin disaster, heparin lawsuit, heparin lawyer, Scientific Protein, SPL
Tuesday, February 17, 2009 FDA Scientists Report Corruption to President ObamaLast month, a group of nine FDA scientists wrote to the Obama transition team reporting widespread managerial misconduct in a division of the Food and Drug Administration. Specifically, in a letter written on FDA Center for Devices and Radiological Health letterhead, the FDA scientists complained that agency managers use intimidation to suppress scientific debate, leading to the approval of questionable medical devices that may not be safe for the American public. Various quotes from the letter provided to The Associated Press by a Congressional official, include: -"The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk." -"[Top FDA officials] committed the most outrageous misconduct by ordering, coercing and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along." -"Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts." -"Managers have ordered, intimidated, and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid." -"Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around." This letter continues to confirm that the FDA, whose duty is to protect the safety of the American public, is in desperate need of repair. It also reflects the power of large medical drug and device companies, who care more about profits than people, to influence the highest levels of government. We continue to support lawmakers who are seeking to overhaul the current FDA and once again restore confidence in the agency, so that catastrophic failures such as the heparin debacle will not happen again. Labels: Baxter, Baxter Heparin, CDRH, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, OSCS, Scientific Protein
Monday, January 5, 2009 Heparin Debacle Tops Chicago Tribune’s Top 10 Local Business Stories of 2008On December 31, 2008, the Chicago Tribune reported on the top 10 local business stories of 2008. Heparin contaminated with oversulfated chondroitin sulfate (“OSCS”) that was manufactured and sold by Baxter Healthcare Corporation and Scientific Protein Laboratories, topped this list. (See 12/31/08 Chicago Tribune Article, “Top 10 Local Business Stories of 2008.) As more and more scientific literature continues to be published linking the contaminate to the hundreds of reported deaths and other adverse events, we expect and hope that this will remain an important public concern this year, particularly for those families who still are awaiting answers whether their loved ones were in fact victims of the tainted heparin. Labels: Baxter, Baxter Heparin, China, contamination, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, OSCS, over sulfated chondroitin sulfate, Scientific Protein
Tuesday, November 25, 2008 Another Step Closer to Synthetic Heparin
Today, scientists at the University of North Carolina at Chapel Hill announced that they have discovered how to customize a key human enzyme responsible for producing heparin. (See NewsWise, “Scientists Teach Enzyme to Make Synthetic Heparin in More Varieties.") This important announcement brings researchers closer to developing a more effective synthetic anticoagulant, rather than using raw natural heparin from pigs. As a result, it would shorten the drug chain and make it less susceptible to contamination. This is important because as learned from the heparin debacle, companies such as Baxter and Scientific Protein Laboratories, who are more interested in saving a buck by purchasing product from China rather than protecting the American public, cannot be trusted to ensure the safety of their drug. As stated by Jian Liu, Ph.D., associate professor in the school’s medicinal chemistry and natural products division, “The pig stuff has served us well for 50 years and is very inexpensive, but if we cannot control the supply chain, we cannot ensure the safety of the drug.”
Labels: Baxter, Baxter Heparin, China, contamination, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, Liu, OSCS, Scientific Protein, synthetic heparin
Friday, September 26, 2008 The Joint Commission Warns of Heparin Dosing Errors
On September 24, 2008, the Joint Commission, an independent, not-for-profit organization that accredits and certifies more than 15,000 health care organizations and programs in the United States, issued a heparin safety alert. (See JOINT COMMISSION WEBSITE: 9/24/08 Sentinel Event Alert, “Preventing errors relating to commonly used anticoagulants.”)
According to this report, “anticoagulants have been identified as one of the top five drug types associated with patient safety incidents in the United States.” (Id.) From January 1997 through December 2007, the Joint Commission reported that there 446 medication-related sentinel events (9.3 percent of all events) reported in their event database, with 7.2 percent (32) of these involving anticoagulants; of those, two-thirds (21) involve heparin. (Id. See also the illustrative chart on the Joint Commission Website.) Further, according to the United States Pharmacopeia MEDMARX database, there were a total of 59,316 medication errors related to anticoagulants reported to their database from 2001 to 2006 (these data do not include errors involving heparin lock flush). (Id.) According to the report, “nearly 60 percent of these errors reached the patient and nearly 3 percent resulted in harm or death.” (Id.) Further, “performance error (e.g., administration) is the most common cause of adverse events relating to anticoagulant medications.” (Id.) The Joint Commission explained in its report that “heparin and warfarin in particular have narrow therapeutic ranges and a high potential for complications, so there is a greater risk of patient harm.” (Id.) It also listed the following factors which also contribute to medication errors involving anticoagulants: • Lack of standardization for the naming, labeling and packaging of anticoagulants creates confusion. For example, heparin flush syringes have been confused with LMW heparin syringes. In addition, other, lesser-known anticoagulant drug names exist (e.g., enoxaparin, dalteparin, tinzaparin) and are used less commonly, which can result in duplicate medication orders and erroneous dosing. • Keeping current with different dosing regimens for various patient populations, newer assay methods, the expanding lists of drug interactions, and the potential reversal strategies can be a challenge for providers—especially those who infrequently prescribe or administer anticoagulants. • The specific and individualized instructions and monitoring information (for example, dose adjustments, lab values, changing patient condition) that accompany the prescribing and administration of anticoagulants may fail to get documented or communicated during transfers and hand-offs. • Neonates and other pediatric patients are problematic to treat, specifically because the medications are formulated and packaged primarily for adults. (Id.) The Joint Commission offers suggestions on how to reduce these dangers. What is missing from the report is the danger of contamination and the lack of updated and appropriate testing for imported drugs, which unfortunately, may have claimed as many lives in a just few months, as dosage errors have claimed in the past ten years. Labels: Baxter, Baxter Heparin, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, imported drugs, Joint Commission, OSCS, safety alert, Scientific Protein, USP
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
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
Friday, June 13, 2008 Draft Bill Regarding Preemption To Be Introduced
On February 20, 2008, the United States Supreme Court severely curbed the rights of injured victims in the case of Riegel v. Medtronic, which held that the Federal Food, Drug and Cosmetic Act (FDCA) preempts state-law claims seeking damages for injuries caused by medical devices with premarket approval from the FDA. (The problems with preemption have been discussed previously on this blog including, “The Preemption Problem” and “Should FDA Drug and Medical Device Regulation Bar State Liability Claims?”)
However, as reported in the 6/10/08 FDA news Device Daily Bulletin, prominent lawmakers are now seeking to introduce a bill in the next few weeks that would render this harsh U.S. Supreme Court decision moot. (FDAnews Device Daily Bulletin, Vol 5 No. 113, “Device Preemption Ruling Threatened by Draft Bill.”) This important bill would add a subsection to the FDCA stating, “Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.” The draft bill is sponsored by Congressmen Pallone and Waxman and is available at: www.fdanews.com/ext/files/FinalBill.pdf. As this legislation is critical to ensuring the accountability of medical drug and device manufacturers for the safety of their products, we support this new bill. Labels: Baxter, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, MDL, MDL; Multi-District Litigation, nightline, Pallone, preemption, Scientific Protein, Scientific Protein Labs, SPL, Waxman
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
|
Links
Previous PostsArchives
Subscribe to
|
|
©
2006-2009 Zoll, Kranz and Borgess, Attorneys at Law (419) 841-9623 pamela@toledolaw.com |
Disclaimer Blogger Template by: Web Design |
