The Heparin Disaster
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The Heparin Disaster



Friday, July 10, 2009  

What Exactly is an MDL?

We are commonly asked by clients, referring attorneys and the media what is an MDL and how does it work? Therefore, the purpose of this blog is to help answer those questions.
Q. What is an MDL?

You may have heard of the Vioxx, Bextra, Celebrex and Heparin "MDLs" in the media recently. So what exactly is an "MDL"? MDL is an abbreviation for Multidistrict Litigation. It is not the same thing as a class action.

In a class action, one or more people or entities, called “Class Representatives,” sue on behalf of people who have similar claims. These latter people, called the “Class” or “Class Members,” are not individually named in the suit. For example, one person might sue on behalf of thousands of other people who were overcharged for a product as a result of an illegal price-fixing conspiracy, or by a member of a company for illegal hiring or salary practices. In a class action, if the named plaintiff (the “Class Representative”) wins at trial or resolves his/her claims, then all of the claims of the un-named Class members are likewise resolved, with the exception of those that exclude themselves from the Class.

Multidistrict litigation is very different from a class action. Although MDLs may involve a host of categories, such as airplane crashes, train wrecks, hotel fires, asbestos, fraud, and price fixing, many MDLs involve defective medical drugs and devices. To explain how multidistrict litigation works, it is easiest to give an example. Assume that a dangerous drug has just been pulled from market because it was contaminated or manufactured improperly, resulting in hundreds of injuries and/or deaths. As the news of the disaster spreads, attorneys begin filing suits all across the country on behalf of the victims. If enough suits involving the drug are filed in federal court against the same drug company, a federal court, the drug company and/or a plaintiff’s lawyer might ask the Judicial Panel on Multidistrict Litigation to “consolidate” all of the cases in an “MDL” before a single judge.

Although the Clerk of the Judicial Panel on Multidistrict Litigation is permanently stationed in Washington, D.C., the panel meets in different cities in the United States on a periodic basis to review requests that cases be consolidated. After an MDL request is made, a hearing will be held to determine whether to create the MDL proceeding.

If the panel agrees after the hearing to create an MDL, it will also decide where the MDL will be located. The judge who gets all the federal cases assigned to him is known as the "transferee judge." The judges throughout the United States who send cases to the MDL judge are known as the "transferor judges" or "transferor courts." The panel’s selection of the transferee court that is in charge of the MDL may affect the outcome of the litigation. There are friendly jurisdictions and not-so-friendly ones. Parties try to influence the panel by proposing various transferee courts.

Generally, the transferee court (also called the “MDL court”) will then set standing orders or pretrial orders informing the lawyers involved of the ground rules, deadlines and procedures that the Court expects the litigants to follow. Although there may be hundreds or even thousands of cases in an MDL, if the Court makes a ruling, it generally applies to all of the cases. Indeed, this is one of the purposes of the MDL, as it is much more efficient to have one ruling on a general issue than possibly hundreds of conflicting rulings by many judges across the United States on the exact same issue.

Typically hierarchies of plaintiff “executive” and/or “steering” committees made of leading and experienced drug litigation lawyers, such as our firm, are then appointed. These committees are often referred to simply as the “PEC” and/or the “PSC.” These PEC and/or PSC are responsible for representing all the claimants in the MDL and managing the substance of the litigation.
Under the supervision and direction of the PEC and/or PSC, volunteer lawyers will assist in reviewing documents, taking depositions, writing briefs, and developing and prosecuting the common aspects of the litigation. Ultimately, they prepare and provide to all MDL plaintiffs a trial package consisting of depositions, documents and other materials that the plaintiff’s attorney will need to take his or her case to trial.

In an MDL, all of the information-gathering and investigation is done at the same time on behalf of all of the plaintiffs. This is referred to as the “discovery” process and is designed to obtain the basic facts of the case. The MDL Judge also rules on discovery disputes and decides critical issues, including whether there is sufficient evidence for the claims to proceed to a jury trial.

During and/or at the conclusion of this process, the MDL Judge often works with both sides in an attempt to reach a global settlement (which if successful, is often a matrix based on various factors involved in each specific case and decided by neutral masters or arbiters who have experience in this area). To assist in trying to reach a settlement, the MDL Judge may even have a few jury trials on cases that were actually filed in his or her own court. Some MDL cases are settled individually, others as a group. Each claimant is typically free to accept or reject the award, but if they accept it, then they give up their claim and release the drug company of any further liability.

It is important to understand, however, that a settlement does not always occur in an MDL. If settlement cannot be reached, each of the cases is sent back for trial, to the court where it was originally filed. The only cases that would not be remanded are those cases originally filed in the court with the MDL Judge is seated. Unlike a class action where there is only one trial, MDL cases are tried individually. That is, each plaintiff gets his or her day in court.

Q. What experience does Zoll, Kranz & Borgess, LLC have with MDLs?

Our firm has been recognized on a national level for its work in MDLs. On February 14, 2008, Zoll, Kranz & Borgess, LLC was the first law firm in the nation to file suit against Baxter Healthcare Corporation and other related companies regarding contaminated batches of its drug, Heparin, and is now leading Heparin MDL 1953 in its position as Liaison Counsel and Chair of the Plaintiffs’ Executive Committee. In April of 2008, the firm was honored to have three of its clients speak before Congress at an investigational hearing on tainted Heparin entitled, “The Heparin Disaster: Chinese Counterfeits and American Failures.” Their stories have also been featured in news media, including on ABC Nightly News, Nightline, CNN, Bloomberg News and in Time Magazine.

Zoll, Kranz & Borgess, LLC was also one of the first firms to file suit this year regarding the birth control drugs, YASMIN and YAZ, and will likely also seek a leadership role in any national litigation.

Other MDL involvement includes, but is not limited to, the Plaintiffs’ Steering Committee for In Re: Yamaha Motor Corp. Rhino ATV, MDL No. 2016, acting as special counsel on behalf of Plaintiffs in In re: Inter-Op Hip Prosthesis Liability Litigation (Sulzer) MDL Docket No. 01-CV-9000, on the Discovery Committee in In re: Vioxx® Products Liability Litigation MDL Docket No. 1657, and involvement in Ford Crown Victoria, Bextra/Celebrex, and other mass tort litigation projects.

Q. What are the pros and cons of multi-district litigation?

Suing a billion dollar drug company with almost unlimited resources who will fight at every turn is expensive. A single victim would unlikely be able to finance such litigation alone. The combination of claims in a single forum increases the plaintiffs’ leverage by permitting counsel to pool their resources and to work for the plaintiffs’ common benefit. Thus, one purpose of an MDL is to make it cheaper for individual plaintiffs by spreading the costs of information gathering and trial preparation among hundreds or even thousands of plaintiffs. Although Zoll, Kranz & Borgess, LLC does not require its clients to reimburse it for costs if the case does not result in settlement or a favorable verdict, if there is a settlement or favorable verdict, costs come out of the settlement or verdict amount and an assessment is paid to the MDL. Thus, an MDL allows each plaintiff’s costs to be substantially reduced and avoids one client bearing a disproportionate share of the costs that benefit all such clients.

An MDL also promotes efficiency and consistency of rulings. Instead of 10, 100 or 1,000 cases pending in different courts across the county, the litigation is coordinated and important decisions are made by a single court saving substantial time and expenses.

However, there are disadvantages, too. The primary disadvantage is the length of time it takes to resolve an MDL. Although certainly litigation can resolve at any point, MDL litigation can often drag out for 4-5 years, or even more. Thus, MDL claimants should not have an expectation of a quick or guaranteed resolution of their case.

Q. Can a lawyer avoid having a case consolidated under multidistrict litigation rules?

Most plaintiff attorneys filing a case in state court against an out-of-state drug manufacturer may have no choice but to become part of an MDL proceeding, as the case will likely be pulled to federal court by the drug manufacturer.

However, if the attorney believes it is in his or her client’s best interests, there may be some appropriate state jurisdictions that may avoid being pulled into the MDL. (Although in an effort to be fair to the MDL lawyers who expend substantial time and effort for common-benefit work, some state court judges may order assessments in non-MDL cases to be paid to the MDL regardless.)

In every litigation, Zoll, Kranz & Borgess, LLC carefully considers all federal and state jurisdictional options to determine which is in their clients’ best interests.
If you have further questions or concerns about MDLs, please do not hesitate to contact us at our toll-free number (888) 841-9623 or or via email to pamela@toledolaw.com. (If you choose to correspond via email, please keep in mind that sometimes spam filters or computer problems block correspondence. Therefore, if you do not receive a response to your email by the next business day, please call us.)

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Monday, October 13, 2008  

Boston Globe Editorial on Preemption

A recent editorial, “No Haven for Dangerous Drugs,” published in the Boston Globe emphasizes the importance of a case often discussed in this blog, Wyeth v. Levine (06-1249), which deals with federal preemption of state drug labeling law and is set to be argued before the U.S. Supreme Court on November 3, 2008.

The Boston Globe Editorial highlights the importance of the issue of preemption in our present times. Given the increasing number of dangerous and defective pharmaceutical drugs and medical devices, such as tainted heparin, and the significant number of Congressional Hearings exposing the shortcomings and clear limitations of the U.S. FDA, barring any claim simply because it received FDA approval is a mistake. Indeed, as noted in the editorial, the U.S. FDA itself is among the many groups who support the argument that federal preemption should not bar a victim’s right to redress.

This editorial is worth reading and is available by clicking here.

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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.

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Friday, July 4, 2008  

THE HISTORY OF HEPARIN


Scientists have long realized the need to deal with clotting when disturbing blood flow during dialysis or other procedures. In 1913, John Abel, a pharmacologist at Johns Hopkins University, reported the first successful performance of dialysis in a dog using “hirudin,” an anticoagulant extracted from leeches. (Mark J. Acierno, Vera Maeckelbergh “Continuous Renal Replacement Therapy,” Compendium, May 2008, Vol. 30, No. 5; Research Defence Society Website, “Anticoagulants,” (2008)). This early anticoagulant was unsuitable for human use, however, as it was expensive, difficult to extract and purify, and caused severe heart and lung problems, as well as allergic reactions. (Research Defence Society Website, “Anticoagulants.”)

Heparin, one of the oldest drugs currently still in widespread clinical use, was discovered in 1916 by a second-year medical student, Jay McLean (1890-1957), and his Professor of Pharmacology, William Henry Howell (1860-1945) at Johns Hopkins University in Baltimore. (Wikipedia: Heparin; Rutty, Christopher, Health Heritage Research Services, “Miracle Blood Lubricant: Connaught and the Story of Heparin, 1928-1937.”)

Allthough “the first description of heparin has been clouded in controversy,” it is reported that McLean, working under the direction of Howell, was investigating pro-coagulant preparations, when he isolated a fat-soluble phosphatide anti-coagulant from liver cells from dogs, (hence its name hepar or "ηπαρ," which is Greek for "liver"). (“Practical Haemodialysis Began with Cellophane and Heparin: The Crucial Role of William Thalhimer (1884-1961),” Nephrol. Dial. Transplant (200) 15: 1086-1091; Wikipedia: Heparin.)

Although it appears that “Howell initially seemed not to have welcomed this discovery, perhaps because [he] disagreed with [McLean’s] theories of coagulation,” most historians believe that McLean’s work lead to Howell’s later isolation of a water-soluble polysaccharide anticoagulant in the early 1920s. (“Practical Haemodialysis Began with Cellophane and Heparin: The Crucial Role of William Thalhimer (1884-1961),” Nephrol. Dial. Transplant (200) 15: 1086-1091; Wikipedia: Heparin.)

This early heparin, however, was expensive, toxic and not practically applied by doctors until the early 1930s when a research team lead by Dr. Charles H. Best at Connaught Medical Research Laboratories, (then part of the University of Toronoto), developed a method to make it into a “purified, plentiful and inexpensive supply safe for human use.” (Rutty, Christopher, Health Heritage Research Services, “Miracle Blood Lubricant: Connaught and the Story of Heparin, 1928-1937;” Wikipedia: Heparin.)

In 1928, Best, the head of University of Toronto’s Physiology Department and an Associate Director of Connaught, “decided to break the heparin stalemate and explore its practical value.” (Rutty, Christopher, Health Heritage Research Services, “Miracle Blood Lubricant: Connaught and the Story of Heparin, 1928-1937.”) Best then expanded his team in 1929 to include Drs. Arthur F. Charles (1905-1972), an organic chemist, David A. Scott (1892-1971), a scientist closely involved with insulin production, and Dr. Gordon Murray (1896-1976), a prominent surgeon at Toronto General Hospital. (Id.)

Charles and Scott turned to beef liver because it was cheaper than dog liver and readily available from local slaughterhouses. (Id.) When the price of beef liver increased, they turned to beef lung and intestines. (Id.) In conjunction with Murray’s experimental surgeries on animals using the more potent heparin, the team succeeded in purifying and then crystallizing heparin into a standardized dry form that could be administered in a salt solution. (Id.)

In May of 1935, the first human trials began and “by 1937, it was clear that Connaught's heparin was a safe, easily-available, and effective blood anticoagulant.” (Wikipedia: Heparin.)

FDA first approved heparin drug products for sale within the U.S. in the 1940s. (04/14/08 USP Press Release.)

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Tuesday, July 1, 2008  

Congress Demands Documentation Supporting the FDA’s Change in Position Regarding Preemption of Product Liability Lawsuits

On 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.

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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.

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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:
  • process changes included removal of Heparin Crude quality attributes based on ease of procurement without adequate raw material evaluation.
  • No impurity profile had been established.
  • A discontinued workshop's crude heparin was included in lots sold to SPL.
  • Equipment was not cleaned.
The report states that, beginning in June of 2007, CZ-SPL started testing incoming lots by Polymerase Chain Reaction (PCR) for species verification. In other words, because SPL was worried about counterfeit sheep product being substituted for pig product, it started doing a basic PCR analysis. As a result of the inspection, the FDA issued a Form 483 report.

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.

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Thursday, June 19, 2008  

FDA revises information on Heparin

The FDA has updated its website FDA Questions and Answers on Heparin

The latest version contains new questions and answers about Heparin and its uses, further details on the FDA investigation, and describes the contaminant, oversulfated chondroitin sulfate (OSCS) and its effect on the human body.

For example, the new article adds the following question and answer:

18. Why does the contaminant cause serious adverse events? (new question and answer added 6/18/2008)

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. This mechanism can explain many of the serious adverse events that occurred immediately after patients were given the contaminated heparin.


Tomorrow I will write about the FDA inspections of the Chinese facilities.

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Tuesday, June 17, 2008  

Heparin Death Reports Nearly Double

The 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.

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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.

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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.

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Friday, June 6, 2008  

Heparin MDL Sent to Toledo, Ohio

On May 29, 2008, Zoll, Kranz & Borgess, LLC argued before the United States Judicial Panel on Multi-District Litigation that the Heparin Products Liability Litigation be transferred to the Northern District of Ohio, before the Honorable Chief Judge James G. Carr. Other districts, including the Southern District of Illinois, District of New Jersey, Southern District of Florida, the District of Puerto Rico, and the Northern District of California, were suggested by Baxter Healthcare Corp., Scientific Protein Laboratories, LLC, and other parties.

Today the United States Judicial Panel on Multi-District Litigation issued a transfer order, transferring the Heparin Multi-District Litigation MDL No. 1953 to the Northern District of Ohio, before the Honorable Chief Judge James G. Carr.

A copy of the decision is available by clicking here.
Any inquiry regarding this or any other Heparin matter may be directed to either David Zoll or Pamela Borgess at (419) 841-9623.

We have invited all Plaintiff attorneys from across the nation to meet with us and organize for this important litigation. We are committed to working for the common benefit of all Plaintiffs in this action.

Update: Link to story in Toledo Blade

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Wednesday, June 4, 2008  

The Preemption Problem

Baxter, 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.

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Monday, June 2, 2008  

SPL story in Wisconsin State Journal

The Saturday, May 31, 2008 edition of the Wisconsin State Journal ran a story on Scientific Protein Labs, the supplier of the contaminated heparin to Baxter. (SPL was formerly a division of Oscar Mayer, the hot dog company.) The story is worth reading for several reasons.

First, it describes the process involved in processing pig intestines into the raw sugar powder used to make heparin. This powder is called the api, or active pharmaceutical ingredient. Here in the United States, SPL controls its supply by actually processing the pig intestines. One 22 ton semi load of pig guts is processed down into just six pounds of heparin powder.

In China, SPL - Changzhou (SPL-CZL), an SPL joint venture, bought processed pig guts, rather than act as the parent company and purchase the raw pig guts. SPL-CZL purchased the material after some processing had been done. SPL - CZL then shipped the heparin powder in bags from China to Wisconsin. SPL did not even open the bags in Wisconsin, but simply forwarded them to Baxter's Cherry Hill, New Jersey plant. These bags contained material that had been "cut" with a counterfeit product that mimicked heparin. Up to 30% or more of the material was actually oversulfated chondroitin sulfate (OSCS).

What is new in this article is the admission that Baxter bought all of its raw heparin only from the China operation. The raw heparin that is made by SPL from domestic pigs is all sold to Sanofi Aventis, another drug company.

All of SPL's heparin was made in the United States until 2004, when it acquired the China operations. In China SPL purchases its raw materials from two different companies, and each of them obtain the processed raw material from 10 other workshops, which do the initial processing of the pig intestines. So the supply chain of SPL is much different than that here in the United States, a fact which should have been known by Baxter.

The most critical admission in the latest article is the admission by SPL that it feared suppliers would try to sell it counterfeit products because of the blue ear pig disease that was ravaging the pig supply in China. It started testing its incoming supplies to make sure that sheep intestines weren't being substituted. But amazingly it never utilized the common test of NMR until after it was too late.

It didn't even own an NMR machine.

CEO Strunce stated that he has learned a lesson. "The lesson is that you have to be constantly vigilant."

Mr. Strunce, that lesson was taught in drug manufacturing 101. You must have missed that class.

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Friday, May 30, 2008  

Where will the cases go? MDL update

Yesterday I had the honor to present oral argument before the United States Judicial Panel on Multidistrict Litigation. This is a very distinguished panel of Federal Judges from around the country who meet once a month to decide if particular groups of cases should be consolidated before a single judge for purposes of discovery, and, if so, to decide which judge should hear the cases.

The Court sat yesterday in Asheville, North Carolina to decide several dozen matters. One of them was MDL 1953, the Heparin Disaster cases. The first attorney to argue asked the cases be transferred to San Francisco, even though there as yet are no cases pending there, because San Fran is closest to China, where some of the discovery needs to be done.

I argued second for Toledo. My reasons included the following:

Toledo has the best resources and is most convenient, and we were the first to file, had the most cases, and it would be best not to have the cases heard in Baxter's back yard of Illinios.

I pointed out that Chief Judge Jim Carr has the time, experience, dedication and resources to resolve these cases in a fair and expeditious manner, pointed out that our Toledo courthouse has state of the art equipment in the clerk's office and courtroom, run by tech savvy skilled personnel.

I indicated that Baxter's claim that all the witnesses were in either New Jersey or Illinois was really incorrect. The main issue in this case isn't what Baxter or SPL did, but what they didn't do. Why they failed to perform critical customary testing of incoming raw material for purity, and why they relied on Chinese subcontractors to perform this critical purity testing without documentation. NMR analysis is a basic fundamental test that is done for purity. It should have been used for Heparin.

Finally I concluded that Toledo was centrally located and convenient to the entire country. I pointed out that the federal courthouse in Toledo was only 45 minutes from Detroit Metro, which has a state of the art Northwest hub with connections throughout the world, and that it is much easier to drive from Detroit Metro to the Toledo courthouse than to go from OHare to downtown Chicago. I ended by mentioning that Northwest has just announced a new nonstop flight from Detroit to Shanghai, China.

After my argument other attorneys argued for Puerto Rico, Illinois and New Jersey. I am cautiously optimistic that the cases may be referred here. I expect a decision within thirty days.

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Friday, May 23, 2008  

HEPARIN FEDERAL FILINGS UPDATE

To date there are twenty-four (24) heparin cases filed in Federal District Courts across the country. This number includes our seven (7) cases which are filed in the United States District Court for the Northern District of Ohio, Western Division. We expect to file additional cases shortly. Other Federal District Courts include:

· U.S. Dist. Ct., Southern District of Florida (1 case)
· U.S. Dist. Ct., Middle District of Florida (1 case)
· U.S. Dist. Ct., District of New Jersey (2 cases)
· U.S. Dist. Ct., Eastern District of Texas (2 cases)
· U.S. Dist. Ct., Northern District of Illinois (4 cases)
· U.S. Dist. Ct., Western District of Pennsylvania (1 case)
· U.S. Dist. Ct., Eastern District of Louisiana (1 case)
· U.S. Dist. Ct., District of Puerto Rico (3 cases)
· U.S. Dist. Ct., Eastern District of Tennessee (1 case)
· U.S. Dist. Ct., Eastern District of Pennsylvania (1 case)

There may be several other cases filed in state courts.

At the present time, the federal cases are being considered for multi-district litigation. Multidistrict litigation (“MDL”) is a procedure utilized in the federal court system to transfer to one federal judge all pending civil cases of a similar type, such as the heparin cases, filed throughout the United States. A panel of seven federal judges that are appointed by the Chief Justice of the United States Supreme Court decide on whether the cases should be transferred.

The judge who gets all the federal cases assigned to him is known as the "transferee judge." The judges from throughout the United States who send cases to the MDL judge are know as the "transferor judges" or "transferor courts."

At a hearing scheduled on May 29, 2008 in Asheville, North Carolina, we will be arguing that all of the federal cases should be transferred here to Toledo on the basis that our federal court has the time, resources and experience to handle the MDL and Toledo is conveniently and centrally located. Other attorneys are seeking a transfer to courts in Illinois, New Jersey, Pennsylvania, Florida and Puerto Rico. We hope to have a decision in the next few months.


-Submitted by Pamela A. Borgess

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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

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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

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Wednesday, May 14, 2008  

Should FDA Drug and Medical Device Regulation Bar State Liability Claims?

A hearing today before the House Committee on Oversight and Government Reform will address the question of immunity for drug companies. The drug companies want complete protection from lawsuits even when they fail to properly manufacture, market or package their drugs.

But a formerFood and Drug Administration commissioner told Congress today that FDA approval of a drug or medical device shouldn't bar suits against the product's manufacturer, saying the agency's lack of resources diminishes its ability to detect emerging risks.

"Even if the FDA's funding were doubled or tripled, its resources and ability to detect emerging risks on the thousands of marketed drugs and devices would still be dwarfed" by the resources of drug companies, according to David Kessler, FDA commissioner from 1990 to February 1997.

The Bush administration has followed a two-pronged strategy for protecting big pharma. First, seek legal immunity in the Supreme Court for companies on the basis that the FDA's approval amounts to a "preemption" of the rights of individuals injured or killed by the defective drugs to purse claims under state laws.

Second, the Bush administration intentionally underfunds the FDA, thereby preventing it from performing its obligation of inspection and enforcement.

Actor Dennis Quaid also testified today. His six-month-old twins, Thomas Boone and Zoe Grace, were accidentally given adult-doses of the blood thinner heparin in November 2007 because the product looked similar to another drug used to flush IV lines. The overdose of heparin was potentially lethal, but Quaid's children fully recovered.

Quaid said in opening testimony that the similarity of heparin to Hep-Lock, a weaker blood thinner used to flush IV lines, also led to the deaths of three infants in Indianapolis in 2006. Both Hep-Lock and heparin are made by Baxter International Inc. (BAX).

Quaid sued Baxter in November 2007, and the Deerfield, Ill., company has moved to dismiss the case, relying on the preemption doctrine.

Quaid said a federal ban on lawsuits "would relieve drug companies of their responsibility to make products as safe as possible, and especially to correct drug problems when they are most often discovered - years after their drugs are on the market."

Quaid and the former FDA Commissioner are right. Both the FDA and the manufacturers have absolute non-delegable duties to insure our drugs are safe. The preemption doctrine significantly diminishes the safety of our drugs, permitting companies to hide behind the fallacy that FDA approval amounts to a guarantee of safety.

We have learned the hard way that the FDA does not and cannot protect us from defective drugs. Drug companies that fail to perform their duties should be held to the same standard as every other corporation or person in America, and required to make good the harm caused by their breach of duty.

You can watch the hearing on C-Span here: Hearing: Should FDA Drug and Medical Device Regulation Bar State Liability Claims?

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Monday, May 12, 2008  

What is the status of the Litigation?

Most of the Heparin cases have been either filed in or removed to federal court. The federal court system has jurisdiction over the cases because of diversity of citizenship between the Plaintiffs and Defendants.

A motion has been filed to consolidate all of the federal cases into a single case for purposes of discovery and related proceedings. This motion will be heard on May 29, 2008 before a special panel of federal judges who will sit in Asheville, North Carolina.

The Judicial Panel on Multi-District Litigation ("MDL") has two issues to decide. First, they must decide if the cases should all be consolidated. It is highly probably that they will agree that the cases should be consolidated. In fact no one has opposed the motion to consolidate so far.

The second issue for the Panel to decide is to which District the cases should be sent. So far there have been a number of options presented to the panel. Baxter and SPL have argued that the cases should be decided in the home districts of Baxter, namely, New Jersey or Illinois. We have argued that the cases should be sent to the Northern District of Ohio. At the hearing I will present the argument for Ohio while other attorneys will request the panel to send the cases to Pennsylvania, Florida or Puerto Rico.

I expect that the panel will act quickly on this matter. I do believe there is a fair chance that the cases will be sent to our district.

Once the cases are assigned to a particular judge the parties will begin the discovery process. This involves obtaining copies of all relevant documents and taking the depositions of the Baxter and SPL employees and officers, as well as experts in the relevant fields of specialty.

Other MDL's have resulted in settlements. For example, we have recently worked on the Vioxx and Sulzer Hip MDLs which resulted in negotiation of a universal settlement. At this stage, though, the primary goal is to lock in the liability of SPL and Baxter for this tragedy. Once the evidence has established their irrevocable responsibility we can start to focus on the other issues.

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Friday, May 9, 2008  

NMR would have detected OSCS

One of the key issues in the Heparin Disaster litigation is whether Baxter and SPL should have taken reasonable steps to insure the safety and purity of the raw materials used in the finished heparin product.

We now know that a test called NMR Spectroscopy can easily distinguish over sufated chondroitin sulfate ("OSCS") contaminated heparin from the real thing. So what is NMR Spectroscopy?

According to Wikipedia:


Nuclear magnetic resonance spectroscopy, most commonly known as NMR, is the name given to a technique which exploits the magnetic properties of certain nuclei. This phenomenon and its origins are detailed in a separate section on nuclear magnetic resonance. The most important applications for the organic chemist are proton NMR and carbon-13 NMR spectroscopy. In principle, NMR is applicable to any nucleus possessing spin.

Many types of information can be obtained from an NMR spectrum. Much like using infrared spectroscopy to identify functional groups, analysis of a 1D NMR spectrum provides information on the number and type of chemical entities in a molecule.

The impact of NMR spectroscopy on the natural sciences has been substantial. It can, among other things, be used to study mixtures of analytes, to understand dynamic effects such as change in temperature and reaction mechanisms, and is an invaluable tool in understanding protein and nucleic acid structure and function. It can be applied to a wide variety of samples, both in the solution and the solid state.
Over the past 50 years NMR has become the preeminent technique for analysis of organic compounds. Here is a very good explanation (with pictures!) as to how NMR works from an undergraduate level course in Organic Chemistry at Michigan State University:

NMR Spectroscopy

While the science and theory maybe complex to a layman, NMR has been around a long time and is a very common analysis method taught at the undergraduate level. We intend to find out from Baxter and SPL why they failed to use this common test method in the analysis of raw materials from unknown sources before inclusion in such an important and sensitive product as heparin.

We continue to investigate cases from patients or their families around the country who have been killed or injured by this counterfeit product.

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Thursday, May 8, 2008  

Baxter CEO questioned by Shareholders

Baxter held its annual meeting yesterday in Chicago. According to press reports:

Although the hourlong meeting focused on Baxter's record sales last year and rising share price, about 15 minutes was devoted to the heparin imbroglio. One investor wondered whether Baxter has taken steps to "close the loopholes" in its supply chain to make sure such a situation did not happen again.

Parkinson acknowledged "challenges associated with managing the supply chain," but that Baxter and other companies were making changes for the better.

Parkinson said Baxter and other companies get heparin's raw ingredient from China because "that's where the pig population is," adding that the Chinese supply of hogs is five times larger than in the U.S.


Well it wasn't the Chinese pigs that added oversulphated chondroitin sulphate (OSCS) to their intestines. It was someone looking to substitue a counterfeit product that was 100 times cheaper than Chinese raw heparan made from pig intestines. Someplace between the workshop that received the raw intestines and the bottling of the finished heparin, someone substituted counterfeit OSCS.

We have obtained a translated copy of a Chinese patent for the manufacture of OSCS. The Chinese patent was filed December 20, 2005 by Shandong University in Shandong China. This patent claims that OSCS can be cheaply manufactured using the claimed technique and the resulting OSCS product "has anticoagulant activity of 10 IU/mg," "anti-inflammatory and pain killing activity," and "inhibits tumor growth and metastasis."

It doesn't take a great leap of imagination to figure out that this or a similar product might be used as a substitute for heparin, particularly when disease in China had caused a sharp increase in the price of the raw product.

I commend the responsible Baxter shareholders who are challenging their company to act responsibly and "close the loopholes" that let this counterfeit product into the Baxter products.

All manufacturers of food and drug products owe a non-delegable duty to the consumers to insure the safety of their products, even if this means they have to use only those raw materials that can be securely monitored.

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Wednesday, May 7, 2008  

China Points the Finger at Baxter and the FDA

The director of China's "FDA" told a press conference that Baxter had failed to cooperate with Chinese experts sent to the U.S. to investigate the Heparin Disaster. The director, Jin Shauhong, also claimed that there was no "confirmed" link between the Over Sulfated Chondroitin Sulfate ("OSCS") and the deaths of patients in the United States.

Chinese representatives 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. Baxter now says it will give the Chinese samples of the product to test.

The FDA tried to inspect the Changzhou Techpool Pharmaceutical Co. ("CZTP") in Changzhou, China on February 27, 28 and 29, 2008. This company supplied SPL Changzhou with raw heparin and may have been a source for the contaminant.

During those inspections the FDA was accompanied by a representative of the U.S. Embassy from Beijing. This facility was NOT regulated by the Chinese because it did not sell any product within China. Instead its products were all made for export; therefore neither the Chinese nor the FDA inspected this plant.

Changzhou SPL, a defendant in the cases we have filed, owns 45% of CZTP. During the FDA inspection CZTP refused to provide the FDA with records for review.

Now the Chinese are complaining that U.S. companies are not cooperating with them in their investigation. What a surprise.

This illustrates a number of critical shortcomings in our drug system. First, as admitted by the FDA last week, the FDA is woefully underfunded and unable to inspect foreign manufacturers. Second, the manufacturers themselves cannot be relied upon to self-regulate their suppliers. Third, China and the United States have been unable to cooperate with each other to insure that good manufacturing practices are followed throughout the chain.

The only regulation that is truly reliable is that obtained by our common law. Companies that fail to insure the safety of ingredients in their products must be held strictly accountable for all injuries and deaths they cause. They must be held strictly accountable.

SPL used to be called Oscar Mayer. It used the small intestines of American grown hogs to make the raw heparin. There was no adulteration by counterfeit heparin because Oscar Mayer was an American company with a reputation to protect and a business to run. It would be unthinkable.

Yet somewhere along the way, through free trade agreements, the drive for ever higher shareholder return, corporate profits, deregulation, and business - friendly agencies we have lost our way. As we go through the documents and take the depositions of these corporate officers we are going to learn a lot more. And it isn't going to be a pretty picture.

By the way, if the Chinese are really worried about the relationship between the counterfeit heparin and the injuries and deaths, I suggest they read the recent article in the New England Journal of Medicine. We have a link to it on our web site. Maybe we should translate it into Mandarin.

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Tuesday, May 6, 2008  

The Heparin Disaster


On February 14, 2008, Zoll, Kranz & Borgess, LLC was the first law firm in the nation to file suit against Baxter Healthcare Corporation and other related companies regarding contaminated batches of its drug, Heparin. We are continuing to lead the way with multiple cases filed in federal court and have ongoing investigations into possible cases both in and outside Ohio.


Recently, our law firm was honored when three of our clients, Leroy Hubley, Colleen Hubley and Johanna Staples, were invited by the U.S. House Commerce Committee on Energy and Commerce (one of the oldest standing committees of the U.S. House of Representatives) to speak on April 29, 2008, at a hearing entitled, “The Heparin Disaster: Chinese Counterfeits and American Failures.”


Please contact our law office by phone at 419-841-9623 or by email at pamela@toledolaw.com if you or someone close to you may have been given heparin during dialysis or during any other procedure, and experienced any of the following symptoms or death:


  • Oral swelling

  • Abdominal pain

  • Burning sensation

  • Chest pain

  • Diarrhea

  • Dizziness

  • Drug ineffectiveness

  • Painful, difficult, or disturbed digestion

  • Dyspnea [unpleasant or uncomfortable breathing]

  • Erythema [redness of the skin]

  • Flushing

  • Headache

  • Hyperhidrosis [excessive sweating]

  • Hypoesthesia [reduced sense of touch or sensation]

  • Increased lacrimation [production, secretion, and shedding of tears]

  • Loss of consciousness

  • Malaise [general discomfort or uneasiness]

  • Nausea

  • Pallor

  • Palpitations

  • Paresthesia [tingling, pricking, or numbness of a person's skin]

  • Pharyngeal edema [swelling in throat]

  • Restlessness

  • Vomiting/retching

  • Shortness of breath

  • Stomach discomfort

  • Tachycardia [rapid beating of the heart]

  • Thirst

  • Trismus [Inability to open the mouth fully]

  • Unresponsiveness to stimuli

  • Severe hypotension [abnormally low blood pressure]

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