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The Heparin DisasterMonday, January 18, 2010 Heparin Contamination was no Accident
Two years ago this month Baxter first recognized it had been selling contaminated heparin. We now know that this contamination was intentional, sophisticated, and deadly. Heparin is a sugar molecule, one of several glycosaminoglycans (GAGs) found naturally in the lining of the intestine of pigs. The contaminant also was a GAG. In fact, the contaminant may have been a combination of GAGs, all of which are found in crude heparin, the starting material for heparin.
Crude heparin consists of 4 GAGs, namely Dermatan Sulfate (DS), Chondroitin Sulfate (CS), Heparan Sulfate (HS) and Heparin. Responsible manufacturers have known of the requirement to test for the DS and CS to make sure their heparin is pure. If Baxter or its supplier, SPL, had been performing simple tests which were then in existence, they would have known and realized that their heparin was full of impurities. These impurities, the contaminants, were easily distinguishable from heparin; yet Baxter failed to perform any testing to insure its heparin was free of common GAG impurities. The contaminants included Chondroitin Sulfate which had been "sulfated", or chemically modified, to make it have anti coagulation properties. Heparin is an anticoagulant. So one of the purposes of adding the contaminant was to increase the anticoagulation properties. The recipe for the contamination had been published by Robert Lindhardt in 1997 in a scientific journal, along with claims that this oversulfated chondroitin sulfated product had value as a heparin like compound: It is possible that the anticoagulant activity can behttp://www-heparin.rpi.edu/ Unfortunately Baxter was too busy counting the profits from its cheap Chinese heparin to pay attention to what it was selling. Some one with a college education who was able to read scientific literature figured out that a cheap substitute for heparin could be made from the by product produced during the manufacture of heparin. All that had to be done was to follow the recipe published in 1997. There are basically 2 classes of GAGs found in crude heparin. Heparin itself contains glucosamine. The contaminants included heparin byproducts that contain galactosamine. DS and CS both are galactosamines. Therefore the simple tests that had been used for decades to make sure the heparin had been properly purified to remove all of the galactosamine-containing GAGs would have also detected the contamination. Recently published studies indicate that the contaminant was made from byproduct generated during the manufacture of heparin itself. http://ash.confex.com/ash/2009/webprogram/Paper17902.html Neither the FDA nor the USP wants to admit that the contamination was a result of their inability to perform basic inspections and to require basic purity tests. However the failures of these organizations does not relieve Baxter or its supplier from responsibility. The identity of the individuals and organizations responsible for intentionally contaminating Baxter's heparin remain a secret. But the list of suspects is actually pretty short. The FDA has still not finalized its investigation. Either the FDA has abandoned the hunt or they are closing in on the responsible party. Meanwhile our civil justice system continues to grind ahead. Sooner or later Baxter and SPL will be held accountable. There are currently about 750 claims for death or permanent injury pending in federal and state courts. Hundreds more died without their survivors realizing they were victims of corporate greed. The final chapter has yet to be written. Labels: Baxter Heparin, Heparin, Heparin Class Action, heparin disaster, SPL
Thursday, December 24, 2009 Hope for the HolidaysAs the holiday season quickly approaches, we remember the victims of the heparin tragedy that occurred almost two years ago this winter. In a season that is supposed to be filled with joy and peace, many of our clients still struggle with the emptiness left from the loss of their loved one, as well as frustration from Baxter’s ongoing refusal to acknowledge and take responsibility for the harm it caused these families. However, the holiday season is one that is filled with hope. While taking on a powerful billion dollar drug company is not an easy or quick task, there is an amazing team of attorneys, doctors, scientists and other victim advocates, who are working every day to expose Baxter’s lies and to hold it accountable for its decision to put corporate profits over people’s lives. We will not waiver or tire in our quest for truth and justice for the hundreds who lost their lives. As Martin Luther King, Jr. said, “True peace is not merely the absence of tension: it is the presence of justice.” As our important fight continues, we wish all of the families hope, strength and perseverance this holiday season. Labels: Baxter, Baxter Heparin, contaminated heparin, contamination, Heparin, heparin attorney, Heparin Class Action, heparin disaster, heparin lawyer; heparin safety, OSCS, Scientific Protein Labs, SPL
Tuesday, December 8, 2009 Heparin Cases continue to be Filed
As the two year anniversary of the discovery of the Heparin Disaster approaches more and more cases are being filed. At this point it appears that there will most likely be 700 - 1000 cases filed on behalf of those who literally lost life and limb as a result of the failure of Baxter Health Care to understand the product it was selling.
Many clients and other lawyers are interested in understanding what a typical case looks like. 1. Method of Administration. About 90% of the cases involve Intravenous administration of the heparin, while the other 10% of victims received their heparin subcutaneously. Typically a subcutaneous injection will, understandably, not involve as sudden or initally severe reaction as the reaction from a bolus intravenous dose, but the results can be just as fatal. 2. Purpose of Administration. About 85-90% of affected patients received heparin for preventive, or prophylactic, purposes, while therapuetic purposes accounted for 10-15% of the injuries. These can be further broken down to Dialysis patients (70-75%) and cardiac patients (10-15%). 3. Type of Injury. About 80% of the injuries involve Contact / Complement Anaphylactoid-type Reaction constellation of symptoms. These include the following: i. Hypotension (drop in blood pressure) ii. Diarrhea iii. Nausea iv. Vomiting Another 15% involve Heparin Induced Thrombocytopenia (HIT). 5% of the cases are so called "Supra-additive Effect" cases, involving bleed out cases or other coagulation issues. 4. Degree of harm. Death is the injury in 75% of the cases. Of those not involving death, most are Serious Permanent Injury (mostly HIT) (15%). 5. Time Frame. The large majority of cases occurred after September 15, 2007 and prior to April 15, 2008. If you believe a client or loved one died during this time frame from symptoms described here, while undergoing dialysis or cardiac surgery, you should immediately seek skilled review of the medical file. You can reach us during regular hours toll free at 888-841-9623. Or you can email me at david@toledolaw.com or our heparin paralegal Serenity at serenity@toledolaw.com. Labels: contaminated heparin, Heparin, heparin attorney, heparin injury, heparin lawsuit, heparin lawyer
Friday, October 16, 2009 Heparin Disaster Lawyer Update
The Heparin Litigation continues to move ahead, in spite of the efforts of Baxter and SPL to avoid responsibility for their misdeeds. Recently I took the deposition of Dr. Francois Lebel, Vice President for Baxter. Next week we depose Ted Roseman, a former Baxter official also involved in the heparin investigation.
The overriding principle of the litigation so far has been the refusal of Baxter to accept responsibility for its product, and the refusal of Baxter to admit the obvious: that their contaminated heparin killed hundreds of people. A recently published article on contaminated heparin authored by one of Baxter's own experts, Robert Linhardt, stated: The presence of OSCS within heparin likely led to clinical manifestations, most prevalently, hypotension and abdominal pain, leading to the deaths of several dozens of patients.The actual FDA count, which is only a fraction of the actual number, is well over 100 deaths associated with the contaminated heparin. Yet Baxter continues to deny that anyone died or became ill from their contaminated product. They claim they have no responsibility because their product met the then current specifications. Other manufacturers were performing tests for purity and did in fact detect the contamination, saving the lives of their customers. Yet Baxter claims it had no duty to do so. Published literature shows that at least since 1989 the existence of contaminants such as dermatan sulfate in heparin were known and identified through NMR analysis. For years the literature has encouraged NMR analysis of heparin. But Baxter never tested any of its heparin by NMR. Other recent articles and research by Dr. Fareed of Loyola and others have established that the contaminated heparin contained more contaminants than just oversulfated chondroitin sulfate (OSCS), and in fact that the contamination was done intentionally and by someone with a high level of knowledge about heparin anticoagulation properties and molecular structure. The Lindhardt article quoted above was based on research done by Baxter in an effort by Baxter to prove that their supplier, SPL, did not manufacture the contaminant from heparin byproduct. Heparin byproduct is the waste material generated in the refining of heparin crude into heparin API (active pharmaceutical ingredient). Heparin byproduct, like the heparin crude, contains a number of glycosaminoglycans (GAGs). These sugar molecules include heparin, heparan sulfate (HS), dermatan sulfate (DS) and chondroitin sulfate (CS). Some scientists have found evidence of all of these heparin byproducts in various lots of contaminated heparin, often in an oversulfated form. The oversulfated forms are not found in nature. Rather they are created by chemical sulfation. It is also possible, and indeed likely, that the sulfation step was followed by a desulfation step, thus making the number of sulfation units on the various sulfated GAGs more uniform. This step would have made the contaminant even more difficult to detect, and may even assist in more uniform anticoagulation. As pointed out by Dr. Lindhardt and his coauthors (see page 5 of the article) partially sulfonated GAGs, especially heparan sulfate, are difficult to detect and separate from heparin, even using modern detection techniques. These experts should know. Some of them hold patents on the sulfation / desulfation of GAGs. Labels: Baxter Heparin, Chinese heparin, Heparin, heparin attorney, Heparin Class Action, heparin disaster, heparin lawsuit, heparin lawyer
Wednesday, September 9, 2009 ZKB Partner to Moderate AAJ Seminar
The American Association for Justice has honored our firm, by asking one of our partners and drug litigation attorneys, Pamela A. Borgess, to act as moderator for their annual “Litigating Toxic Tort, Pharmaceutical and Medical Cases” Seminar to be held on September 24-25, 2009 in Las Vegas at the Palazzo Hotel. Ms. Borgess will also present an update on the ongoing litigation involving the tainted Chinese heparin that killed hundreds of Americans in 2007 and 2008.
This well-regarded seminar is attended by Plaintiff Attorneys from across the country, who come to get inside information on innovative trial techniques, strategies, and practices that leading attorneys have used to take on industry giants. Agenda highlights also include the latest updates on hot topics such as Hydroxycut, Paxil Birth Defects and Avandia; Electronic Discovery, and new topics such as "Facebook and Other Social Networking—What They'll Find Out About Your Client." Attendees will also learn how to access and maximize the necessary resources to go up against negligent companies. Plaintiff Attorneys who are interested in this seminar can get more information and register at www.justice.org/education/pharmaseminaror by calling AAJ Education at 800-622-1791 or 202-965-3500, ext. 612.
Wednesday, August 12, 2009 Conflict of Interest at the FDA
The Wall Street Journal reported today that the FDA was investigating conflict of interest allegations from a Momenta competitor, Amphastar.
The investigation of Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, stems from an ethics complaint filed by Amphastar Pharmaceuticals Inc., a California company that says it has been delayed in its six-year effort to win approval for a generic version of Lovenox, a multi-billion-dollar blood thinner.Last February Woodcock co-authored a paper with Momenta scientists claiming that OSCS was the contaminant in heparin. It has never been made clear why Woodcock selected Momenta scientists to the special task force. The papers have been challenged as lacking scientific rigor and leave many questions unanswered. There may be a lot more to this story and a lot more questions need to be asked. Contaminated heparin killed many people. There are many questions which no one has answered (or even asked) but which we are and will address in the litigation. There are millions of people exposed to this contamination. Many of them died and have claims that have not been filed. Most of their families probably do not even realize their loved ones were exposed to this contaminant. The statute of limitations is rapidly approaching for many people. The worst contamination was in heparin released after September 15, 2007. If you had a loved one who died after this date while on dialysis or while undergoing heart surgery you should immediately contact us or some other experienced attorney involved in the heparin litigation. If you are an attorney with a client who died while undergoing dialysis or heart surgery between October 2007 and April of 2008 feel free to contact me at david@toledolaw.com. Or call toll free 888-841-9623. Labels: Chinese heparin, FDA, Heparin, heparin attorney, Heparin Class Action, heparin disaster, Janet Woodcock, momenta
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.) Labels: Baxter, contamination, Heparin, heparin attorney, Heparin Class Action, heparin disaster, heparin lawsuit, heparin lawyer, MDL, multidistrict litigation, Ocella, Yasmin, YAZ
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