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The Heparin DisasterA running commentary on the contaminated heparin disaster caused by Baxter Healthcare's distribution of contaminated heparin from Scientific Protein Lab's API, and the deaths and injuries resulting therefrom.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
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
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
Wednesday, December 10, 2008 CDC REPORT IN NEJM FURTHER SUPPORTS LINK BETWEEN OSCS-CONTAMINATED HEPARIN AND DEATHS
The Centers for Disease Control and Prevention (“CDC”) recently issued a final report in the New England Journal of Medicine (“NEJM”) that confirms a definite link between the man-made contaminant found in heparin, (i.e. over-sulfated chondroitin sulfate, [“OSCS”]) and the patients who experienced reactions. Blossom, David, etc., “Outbreak of Adverse Reactions Associated with Contaminated Heparin,” N. ENGL. J. MED. 359:25, 2674-2684 (December 18, 2008), (available at http://content.nejm.org/cgi/content/full/NEJMoa0806450.)
The CDC was the first to investigate suspected reactions among hospital patients given heparin in November of 2007. Before the contaminant was discovered, the CDC collected data on possible reactions occurring from November 19, 2007 through January 31, 2008 that met its case definition (i.e. development of symptoms within one hour after administration of heparin or the initiation of a hemodialysis session). (In its report, the CDC explained that it used this early case definition as an attempt to reduce misclassification, but recognized that in light of what is being discovered about the contaminate, “some true cases may have been misclassified as noncases.”) The study did not report or investigate the long term effects of contaminated heparin, the cumulative effect of receiving multiple contaminated doses, delayed onset of symptoms, or the contaminate’s effect on other conditions such as heparin induced thrombocytopenia (“HIT”). Instead, the report simply confirmed that the “reported clinical features” of the limited cases it investigated “further support the conclusion that contamination of heparin with OSCS was the cause of the outbreak.” Labels: Baxter, Baxter Heparin, CDC, China, contamination, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, OSCS, oversulfated chondroitin sulfate
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
Sunday, November 23, 2008 Questions Raised Over FDA's Investigation of Heparin DeathsIn a letter to the Government Accountability Office (GAO) dated November 19, 2008, Rep. Joe Barton questioned the adequacy of the FDA's ongoing investigation and evaluation of the recent heparin deaths, casting doubt on whether the FDA in fact has used all available postmarket surveillance tools when determining the likelihood that contaminated heparin caused patient fatalities. Specifically the letter states, “Based on the available information …there is a serious and potentially troubling question about whether FDA availed itself [of] all of its tools to conduct comprehensive surveillance of heparin deaths.” The letter also questions "whether [the] FDA has confounding or conflicting information about Heparin death cases that has not been made public." A copy of this letter is available by clicking here. As first described in our July 30, 2008 blog, we also have questions concerning the conclusions reached by the FDA as reported to the Chicago Tribune and Nightline. For example, is the FDA investigating or supporting scientific studies to determine whether the contaminate, OSCS, and its resulting symptoms can cause, contribute to, or leave an individual susceptible to other complications leading to death, such as heart failure? (To date, the FDA admits that it has limited knowledge “since the contaminant was only recently discovered” and that all effects are not yet known. (See FDA Questions and Answers, updated 7/3/08.)) Without such studies, the FDA's conclusions may be premature. Likewise, if the FDA requires additional information to determine whether additional deaths are related, why isn’t this information being gathered or at least requested from the providers or others who filled out the reports to make an adequate determination? For example, as we stated in our July blog, while we have filed multiple adverse-event reports of clients, to date WE HAVE NEVER BEEN CONTACTED BY THE FDA REGARDING THESE REPORTS, NEVER BEEN ADVISED OF THE STATUS OF THEIR INVESTIGATION, OR TOLD THAT ADDITIONAL INFORMATION IS NEEDED. We have been contacted, however, by many caring lawmakers, journalists, and scientists who have not forgotten the victims of the heparin disaster. We commend and support their ongoing efforts to obtain answers and accountability from the FDA, Baxter and SPL. Labels: Baxter, Baxter Heparin, China, Chinese, contamination, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, Hubley, nightline, OSCS, SPL
Thursday, November 6, 2008 Reports of Serious Injuries and Death Linked to Medications Hits a Record High
On October 23, 2008, The Institute for Safe Medication Practice, (a nonprofit group that educates the healthcare community about safe medication practices), issued a report on the number of serious injuries and death reported to the U.S. Food and Drug Administration in the first quarter of 2008. (See Inst. For Safe Med. Practices: 10/23/08, “Quarter Watch: 2008 Q 1.”)
According to this report, the number of reports of serious injuries and death linked to medications hit a record high. In the first three months of 2008, there were 20,745 new cases of serious injury and 4,824 reports of death. This total was 38% higher than the average for the previous four quarters, and the highest for any quarter. Death cases also accounted for a larger share with 23% for the first quarter of 2008 as compared to a historical average of 16%. This represented a 2.6 fold increase from the previous quarter and the highest number of deaths in a calendar quarter since 2004. Two drugs accounted for a disproportionate share, including Chantix, a new anti-smoking drug from Pfizer, Inc. (with 1001 cases of serious injury and 50 deaths), and Heparin imported from China, (with 779 cases of serious injury and 102 deaths). (The FDA has actually reported receiving 238 reports of death from contaminated heparin over a longer period, but 102 represent the first quarter.) Even scarier for the American public is the fact that because reporting is voluntary, these reports represent “only a small fraction of the adverse drug events that occur.” Id. at 1. As concluded by the Institute, “While prescription drugs bring great benefits to millions of patients and most are used safely, these data show the need for additional progress to better manage the risks to patients….It also underlines the importance of the nation’s system for assuring drug product stability and purity. The scale of injury--hundreds of deaths or serious injuries in a short period—underlines the importance of strengthening oversight of drug manufacture abroad.” Id. at 4. Labels: Baxter, Baxter Heparin, Chantix, China, contamination, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, Institute for Safe Medication Practice, SPL
Tuesday, September 16, 2008 Spiked Baby Formula: Yet Another Warning To U.S. Companies
On Monday, Chinese health officials raised the total number of infants sickened by Sanlu brand milk powder to more than 1,200. (09/15/08 USA TODAY, “Tainted Milk Sickens More than 1,200 Babies in China.”)
The formula was spiked with the industrial chemical, melamine, a contaminate that causes kidney stones (which are otherwise rare in infants). (Id. See also 9/12/08 FDA PRESS RELEASE, “FDA Issues Health Information Advisory on Infant Formula.”) Like the Heparin scandal, the contamination was intentional and a result of corporate greed. Specifically, Chinese investigators say melamine was added to make the milk seem higher in protein and thus, fool quality tests after water was added to fraudulently increase the milk's volume. (Id.) Unlike the Heparin tragedy, however, it appears that Americans might have missed this latest batch of contaminated products manufactured in China. The FDA has indicated “that there is no known threat of contamination” as “no Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States.” (9/12/08 FDA PRESS RELEASE, “FDA Issues Health Information Advisory on Infant Formula.”) Yet, the FDA has not completed its current investigation as to whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community. (Id.) Regardless, this latest contamination is another example of why drugs and other products manufactured in poorly regulated foreign countries cannot be blindly accepted as pure. It should continue to serve as a warning to large U.S. companies who buy these cheaper products and pass them on to the unsuspecting American public…A warning, which unfortunately, was ignored by the big drug company, Baxter, in the heparin disaster that killed numerous Americans. Labels: Baxter, Baxter Heparin, China, Chinese, contamination, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, import safety, OSCS, oversulfated chondroitin sulfate, SPL
Wednesday, July 23, 2008 Baxter Announces Profits up 26%
Last Thursday, Baxter announced net income of $544 million for its second quarter ending on June 30, 2008, or 85 cents per share, due to higher sales of biotech drugs and vaccines. This is up from $431 million, or 65 cents per share, in the same period last year. (7/17/08 CNBC: “Biotech, Overseas Sales Push Baxter 2Q Profit Rise.”)
In response, Baxter shares rose $2.08, or 3.2 percent, to end at $67.96, and hit an all-time high of $69.66 earlier in the session. (7/17/08 CNBC: “Baxter Shares Hit High on 2Q Profit Growth.”) In boasting of the company’s success during Thursday’s earnings release, Chairman and Chief Executive Officer Robert Parkinson, Jr., did not mention heparin or the increasing death count linked to its contaminated drug, nor did Baxter bother mentioning how much of these increased profits were a result of foreign manufacturing of drug or drug components in countries with lax regulation and cheaper production costs. Labels: Baxter, Baxter Heparin, China, contamination, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, nightline, Parkinson
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