The Heparin Disaster

Heparin Contamination was no Accident

2010-01-18T07:53:00.005-05:00

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 be
further increased by appropriate refinement of the
modification procedure for N-deacetylation–N-desulfonation
w26x of fully O-sulfonated chondroitin
sulfate. These possibilities point to new practically
feasible routes for the generation of heparin-like
compounds with various pharmacologically relevant
biological activities.

http://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.

Hope for the Holidays

2009-12-24T11:21:00.004-05:00

As 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.

Heparin Cases continue to be Filed

2009-12-08T20:14:00.005-05:00

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.

Heparin Disaster Lawyer Update

2009-10-16T15:22:00.003-04:00

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.

ZKB Partner to Moderate AAJ Seminar

2009-09-09T08:59:00.002-04:00

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.

**Open Only to Plaintiff Attorneys**

Conflict of Interest at the FDA

2009-08-12T19:10:00.007-04:00

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.

What Exactly is an MDL?

2009-07-10T17:28:00.003-04:00

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.)

Bad Chinese Heparin Supplier Cited by FDA Again

2009-05-14T10:21:00.004-04:00

Despite the deaths of hundreds of Americans last year from tainted Chinese heparin, Scientific Protein Laboratories (“SPL”) has still not cleaned up its act and has been cited again this month for violating safety regulations.

SPL supplied the component ingredients in the bad heparin, called “active pharmaceutical ingredients” ("API") to Baxter from its facility in China. However, despite Baxter and SPL's representations to the public that they were taking great care to assure the safety of their drugs, both companies knew that the Chinese facility had never been inspected by the FDA or any other governmental agency.

Last year, upon investigating the cause of the deaths, the FDA discovered the existence of the Chinese facility. When the International Compliance Team for the U.S. FDA performed an inspection of the Chinese facility from February 20 – 26, 2008, multiple and severe violations were found, including, but not limited to, the lack of any assurances that the processing steps used to manufacture heparin were capable of effectively removing impurities.

As a result, the FDA issued a “Form 483” to SPL last year. A Form 483 is referred to as “Notice of Inspectional Observations.” The 483 is issued by an FDA field investigator after an on-site inspection of a facility and documents significant and serious violations from regulations called “Good Manufacturing Practices” (“GMP”) regulations. These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations protect the consumer from purchasing a product which is ineffective, dangerous or contaminated.

After hundreds of Americans died from bad heparin supplied by its facility, you would think that SPL (who is now being defended by Baxter in the ongoing litigation), would have learned its lesson. You would think that the company would insist that its facilities strictly adhere to safety regulations to avoid something like this happening again. Unfortunately, such is not the case.

The FDA recently issued another Form 483 for SPL’s United States plant in Waunakee, Wisc. (See May 13, 2009, FDAnews Drug Daily Bulletin “Scientific Protein Laboratories Gets Form 483 for Heparin Plant,” Vo. 6 No. 93.) The FDA cited six violations of GMP regulations, including for example, incorrect or inadequate data and reports, and failure to follow safety protocols, including the cleaning of tanks used in the manufacture of heparin.

SPL’s ongoing and callous disregard for safety procedures is an absolute insult to every victim of the heparin disaster. The fact that Baxter is defending this company and asking that both itself and SPL not be held responsible for the deaths of innocent men, women and children, is likewise sickening. These companies must be held responsible. There must be consequences when companies balatantly ignore safety regulations, thereby sacrifing human lives for corporate profit. If not, as evidenced by SPL's refusal to learn from the heparin tragedy, history is bound to repeat itself.

The Games Drug Companies Play

2009-05-08T09:44:00.004-04:00

Elsevier, the publisher of many medical journals relied upon by experts in drug litigation, made a chilling announcement yesterday:

Philadelphia, PA, 7 May 2009 - Elsevier, one of the world’s leading publishers of scientific, technical, and medical (STM) information products and services, announced today that Michael Hansen, CEO of Elsevier’s Health Sciences Division, issued the following statement in light of recent allegations of improper Australia based sponsored journal publication practices between 2000 and 2005:

“Elsevier prides itself on operating its business in the most ethical, honest and transparent manner possible. We have been stewards of the scientific record for more than 125 years and we take our role in advancing medical and scientific research seriously.

It has recently come to my attention that from 2000 to 2005, our Australia office published a series of sponsored article compilation publications, on behalf of pharmaceutical clients, that were made to look like journals and lacked the proper disclosures. This was an unacceptable practice, and we regret that it took place.

We are currently conducting an internal review but believe this was an isolated practice from a past period in time. It does not reflect the way we operate today. The individuals involved in the project have long since left the company. I have affirmed our business practices as they relate to what defines a journal and the proper use of disclosure language with our employees to ensure this does not happen again.

We will continue to partner with all scientists and clinical investigators, including those in the pharmaceutical industry, to help communicate the findings of high-quality, peer-reviewed medical research. We have strict disclosure rules in place so that readers are aware of any financial interests behind a specific article or journal, or when entire compilation products are created for pharmaceutical marketing purposes.

I understand this issue has troubled our communities of authors, editors, customers and employees. But I can assure all that the integrity of Elsevier’s publications and business practices remains intact.”

The AP reported that "Those publications included one titled The Australasian Journal of Bone and Joint Medicine, which heavily favored Merck & Co.'s osteoporosis drug Fosamax and the painkiller Vioxx."

Why is this so troubling? For a number of reasons. First, because it shows how invidious the big drug companies are in pushing their products, even when they know or have reason to know that those drugs have dangers which have not been fully disclosed.

Second, because medical journals are used by expert witnesses in cases such as the Heparin Litigation to support claims or oppose claims that a particular drug causes harm, or that it has been improperly marketed or lacked necessary warnings.

In essence the drug companies use their massive propaganda machine to push doctors into prescribing their drugs and to prevent those who are injured or killed by the drugs to obtain fair compensation.

In Vioxx Merk paid out over $4.6 billion to settle the cases, even after they had succeeded in defending many of the cases at trial. Articles in medical journals about the efficacy of Vioxx and the risks of harm were relied upon by experts for both sides in those trials.

Similarly, in the Heparin Litigation, many of the articles that have been written to date on contaminated heparin include authors whom we know are on the payroll of Baxter. We have made that discovery from a review of the confidential documents produced by Baxter, even though the articles themselves fail to make those disclosures.

The truth can only be learned through vigorous, demanding and diligent review of documents and careful depositions of witnesses. It is possible that this latest revelation could lead to further challenges of the Vioxx settlement, particularly if any experts relied upon the challenged articles in their testimony.

We will continue to vigorously pursue Baxter and the other defendants to hold them responsible for the harm caused by the dirty Chinese Heparin they sold across the continent. On Monday we have a hearing to determine a trial schedule. The papers we filed yesterday asked the Court to set the first cases for trial in the Spring of 2010.

FDA Pushed for Answers Regarding Bad Chinese Heparin

2009-05-06T15:35:00.003-04:00

Like many Americans, including the families of hundreds of innocent victims killed from tainted Chinese heparin last year, Rep. Joe Barton, (R- Texas) is dissatisfied with the lack of information from the FDA regarding the heparin debacle.

Barton, (the ranking member on the House Energy and Commerce Committee), has asked the investigative arm of Congress, the Government Accountability Office, to investigate the FDA’s response to the heparin debacle. He has also sent a letter to Acting FDA Commissioner Joshua Sharfstein, demanding that the FDA turn over any databases relating to their investigation. (See 05/06/09 Article from NASDAQ, Jared A. Favole, “Rep. Barton Presses FDA for Information about Tainted Heparin.”)

An unidentified staffer for the Energy and Commerce Committee is quoted as saying, “We don’t seem to be any further along a year later from understanding [the heparin debacle]. What are they doing about it? Is this an acceptable practice in China?”

Last year, Barton also sent a letter to the former FDA Commissioner, Dr. Andrew von Eschenbach, seeking answers on why the agency took six months to confiscate 11 tainted batches of heparin from Celsus Laboratories (located in Cincinnati, Ohio) even though an inspection in April found that the company's recall was inadequate. (See Dec. 15, 2008 Blog, “Rep. Barton Questions FDA’s Six Month Delay in Seizure of Tainted Heparin.”) At the time, FDA officials said they could not give details because of "an ongoing investigation."

While we applaud these continuing efforts by Congress to get answers for the victims of the tragedy, similar inquiry should also be made of the responsible drug companies, including Baxter. It was Baxter who decided to purchase the cheaper, bad Chinese heparin from a Chinese plant that it knew had not been inspected by the FDA. Why? Corporate Greed. While the FDA certainly has a duty to provide information to the American public, we should not loose sight that it is ultimately the drug companies, including Baxter, who are responsible for ensuring the safety of their supply chains.

Barton wants the FDA to respond to his letter within two weeks. We will continue to keep you updated as to any response from the FDA.

Baxter Files its Trial Proposal - Seeks to delay trials until 2011

2009-05-04T13:46:00.006-04:00

Late last week Baxter filed a Scheduling Proposal with Chief Judge James G. Carr here in Toledo, seeking to delay any trial in the Heparin Disaster litigation until June 1, 2011. We will be filing our response later this week, and will present argument on the issue in a hearing set for May 11th in Cleveland.

In our filing we will try to push for a quick trial date so that the victims of the Heparin Disaster will get their day in court sooner rather than later.

Sadly the goal of Baxter and other big pharma companies whose drugs cause harm typically follow this same pattern of delay: Delay the date of reckoning, delay the date of payment as long as possible, and then pay as little as possible to those you have injured. The only tool we have to bring these big companies to justice is the hammer of a jury trial. So it is our task to prepare for that trial as quickly and diligently as possible.

While we now have received a million pages of documents from Baxter and SPL, almost all have been marked confidential. This prevents us from sharing the content of those documents until the time of trial.

What we can say is that there is nothing good in these documents for Baxter or SPL.

Once trials begin they will be primarily wrongful death cases. The most serious harm caused by the contaminated heparin were wrongful deaths of people who were undergoing dialysis therapy or heart surgery between October 1, 2007 and April 1, 2008. We expect that most of the early trials will focus on cases that meet these criteria.

If you lost a loved one during this period of time who was undergoing dialysis or heart surgery you should immediately seek legal counsel. Some states have one year statutes of limitation while other states may have 2 years, which means that if a claim isn't filed promptly it can be time barred.

Baxter Releases Live Avian Flu Virus

2009-04-29T19:26:00.006-04:00

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Baxter International, the company that brought us contaminated Chinese heparin, has struck again. The Toronto Sun reported earlier this year that it released live flu virus material in Austria.

The World Health Organization is closely monitoring the situation. The contaminated product was a mix of H3N2 seasonal flu viruses and unlabelled H5N1 live avian flu viruses. The viruses could have combined to create an even more dangerous hybrid.

People familiar with biosecurity rules are dismayed by evidence that human H3N2 and avian H5N1 viruses somehow co-mingled in the Orth-Donau facility. That is a dangerous practice that should not be allowed to happen, a number of experts insisted.

Accidental release of a mixture of live H5N1 and H3N2 viruses could have resulted in dire consequences.

While H5N1 doesn’t easily infect people, H3N2 viruses do. If someone exposed to a mixture of the two had been simultaneously infected with both strains, he or she could have served as an incubator for a hybrid virus able to transmit easily to and among people.

That mixing process, called reassortment, is one of two ways pandemic viruses are created.

Amazingly, Baxter refused to reveal information about how the accident happened because of fear of revealing “trade secrets.” According to the Toronto Sun:

Earlier this week [Baxter spokesman Christopher] Bona called the mistake the result of a combination of “just the process itself, (and) technical and human error in this procedure.”

He said he couldn’t reveal more information because it would give away proprietary information about Baxter’s production process.

The cavalier attitude of Baxter towards the release of live flu virus is the same attitude we see in the Heparin case. Baxter failed to secure its supply lines, failed to adequately test, failed to adequately inspect, and when the contamination was discovery, failed to perform an adequate recall. In its quest to grasp the low hanging fruits and profits it ignores the safety of those it should be protecting. It is the same attitude that has plagued Baxter for decades.

For some very interesting history of Baxter International, go to Wikipedia and read the history of Baxter International.

Grassley, Kennedy Introduce Bill to Protect Against Contaminated Imported Drugs

2009-04-27T10:13:00.006-04:00

Sens. Chuck Grassley (R-Iowa) and Edward Kennedy (D-Mass.) introduced new legislation in Congress last week that would broaden the FDA’s inspection and enforcement authority with respect to foreign drugs and medical devices. To view the press release on the proposed legislation, click here.

This legislation, referred to as “The Drug and Device Accountability Act of 2009,” would give the FDA money to conduct foreign drug plant inspections. As stated by Sen. Grassley, “An increasing number of drugs and ingredients for pharmaceuticals are being manufactured in other countries, yet studies show the FDA doesn’t know how many foreign plants are subject to inspection, and the FDA conducts relatively few foreign inspections each year. Our legislation is a practical solution to beefing up the FDA’s inspection work, both domestically and abroad, and holding the FDA accountable for its review of medical devices, where questions have been raised about the agency’s work.”

The proposed legislation would also give the FDA the power to detain products from foreign plants when inspectors believe that a drug, (such as the dirty Chinese heparin that recently killed hundreds of Americans), has been adulterated. This is important because the FDA currently has no alternative, but to rely on the overworked and unfunded U.S. Customs to handle the actual seizure of suspect imported goods.

The bill would also give the FDA the power to issue subpoenas allowing the agency to obtain internal business records from careless drug manufacturers who ship production of their drugs overseas in order to increase corporate profit and avoid regulation meant to protect the American public. As discussed previously in our May 21, 2008 blog, “FDA Needs Subpoena Power,” without this ability, the agency is powerless to obtain internal business records from a negligent company who has allowed contaminated drugs to be sold, (such as Baxter who sold the dirty Chinese heparin from a foreign plant that Baxter knew had never been inspected by the FDA or any other governmental agency).

The FDA is one of the few Federal agencies that currently lacks subpoena power. As previously noted by Rep. Bart Stupak, (Chairman of the investigations panel of the House Commerce Committee), in a letter last year to the former FDA Chief, “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.”

Finally, the proposed legislation would also require certification of applications for drugs and devices needing FDA approval and establish civil and criminal penalties for false or misleading certifications.

To fund the new powers, the bill would levy fees on plant inspections, thus putting the cost on the drug manufacturers who decide to send production overseas.

This regulation would likely have prevented the Heparin debacle and saved the lives of hundreds of innocent Americans. As such, we commend and support this important legislation.

Sherrod Brown speaks out for Heparin Victims

2009-04-23T15:23:00.005-04:00

Ohio Senator Sherrod Brown struck a blow for victims of dirty Chinese Heparin yesterday in a speech in our nation's capital. Speaking before the Washington International Trade Association and the George Washington University Elliot School for International Relations, Senator Brown decried the importation of cheap drugs:

Our enormous trade deficit has resulted in our nation not only importing goods and services, but also importing the dangerous safety standards of our trading partners.
In Toledo, Ohio, patients died after taking contaminated Heparin to treat their heart conditions. The manufacturer of Heparin had outsourced the making of the drug, and as a result, did not know where the contamination occurred.
The patients in Toledo, or the factory workers in Reynosa, or the meatpackers in Nebraska illustrate that continuing our trade direction is not a ringing endorsement of our trade agenda. Their stories represent a continuation of a policy of broken promises. [Link to full text of speech]

I discussed the Heparin Disaster with Senator Brown last year in Toledo. He clearly heard the concerns of the victims of big pharma. Senator Brown understands that the big corporations like Baxter Healthcare put profits over people.

We have now received about one million pages of documents from Baxter. These documents show that Baxter went to China for its heparin because it could save a few dollars on its raw material costs. Baxter knew the Chinese facility had never been inspected by the FDA. It knew that there were no inspections being performed on the heparin workshops and consolidators.

Baxter showed reckless indifference even after the contamination was brought to light. We are now learning that Baxter was being criticized by the FDA in September of 2008 for an inadequate recall.

The more we learn, the worse the story. We will continue to uncover the unsavory details and fight in the courtroom for the victims. We ask you to all support Senator Brown as he fights for us in the halls of Congress.

Two Chinese Heparin Suppliers Cited by FDA

2009-04-19T21:11:00.002-04:00

The FDA just cited two Chinese-based drug suppliers, Qingdao Jiulong Biopharmaceuticals Co. and Shanghai No. 1 Biochemical & Pharmaceutical Co, who manufactured and sold at least 19 lots of contaminated heparin to the U.S. in 2008, despite the fact that the heparin was supposed to be quarantined. (See 04/18/09 Wall Street Journal Article, “FDA Cites Two Chinese Heparin Makers.”) To read the FDA’s letter to Qingdao click here. To read the FDA’s letter to Shanghai No. 1 click here.

The heparin was tainted with over-sulfated chondroitin sulfate (“OSCS”), the same contaminate that has been linked with numerous U.S. deaths.

During the FDA’s inspection of these companies, the FDA found “significant deviations from U.S. current good manufacturing practices (CGMP) requirements in the manufacture of drugs.” Further, one of the drug suppliers, Shanghai No. I Biochemical, was also was found to have lied to the FDA about the manufacture of its heparin. Specifically, the FDA found that the Chinese drug supplier “used two other manufacturers to produce heparin sodium, failed to notify FDA of this manufacturing arrangement, and affirmatively represented that ‘no contract firms are involved in the manufacturing of the drug substance, Heparin Sodium USP, that is the subject of th[e] Drug Master File.’”

PREEMPTION REJECTED!!

2009-03-04T12:05:00.005-05:00

As addressed periodically on this blog, powerful drug companies such as Baxter, have advocated for complete immunity from the majority of suits involving unsafe medical drugs and devices under a legal concept called “preemption.” Specifically, they have argued 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.

It looked like for a time, the drug companies were winning in this battle against victims harmed by their defective drugs. This was particularly true a little over a year ago in February 2008, when 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 harsh effects of this decision are now being sought to be reversed in a bill sponsored by Congressmen Pallone and Waxman.)

The United States Supreme Court then accepted a case, Wyeth v. Levine, that involved the labeling of a medical drug. Until this morning, the case had not been decided.
In the case, Diana Levine, a professional musician, went to the hospital to treat a migraine headache. However, after being injected with a drug manufactured by Wyeth, she was left with injuries that led quickly to the amputation of her right arm, harming her profession and lifelong passion to be a musician. The drug, Phenergan, was given to Ms. Levine using a method of administration that was permissible under Wyeth’s label instructions. However, Wyeth knew for decades that this method increased risk of contact with arteries and serious injuries, and specifically chose not to warn the medical community and the public of this danger.

After a trial in the case, a Vermont jury agreed with Levine's claim that Wyeth failed to provide a strong and clear warning about the risks of quickly injecting the drug into a vein. However, the drug company appealed and, backed by the Bush administration, argued that since the FDA had approved the drug’s labeling instructions, victims such as Ms. Levine are barred (i.e. “preempted”) from being able to hold them accountable, even where the company knew its warnings were not adequate.

In a 6-3 decision released this morning, the United States Supreme Court rejected Wyeth's claim that federal approval of its drug should have shielded the drug company from lawsuits like the one filed by Ms. Levine.

This is an important victory, particularly for the injured Americans who will not be denied their constitutional to seek and obtain justice in a court of law.

A copy of the decision is available by clicking here.

FDA Scientists Report Corruption to President Obama

2009-02-17T17:21:00.004-05:00

Last month, a group of nine FDA scientists wrote to the Obama transition team reporting widespread managerial misconduct in a division of the Food and Drug Administration. Specifically, in a letter written on FDA Center for Devices and Radiological Health letterhead, the FDA scientists complained that agency managers use intimidation to suppress scientific debate, leading to the approval of questionable medical devices that may not be safe for the American public.

Various quotes from the letter provided to The Associated Press by a Congressional official, include:

-"The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk."

-"[Top FDA officials] committed the most outrageous misconduct by ordering, coercing and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along."

-"Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts."

-"Managers have ordered, intimidated, and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid."

-"Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around."

This letter continues to confirm that the FDA, whose duty is to protect the safety of the American public, is in desperate need of repair. It also reflects the power of large medical drug and device companies, who care more about profits than people, to influence the highest levels of government. We continue to support lawmakers who are seeking to overhaul the current FDA and once again restore confidence in the agency, so that catastrophic failures such as the heparin debacle will not happen again.

New York Times Reports on Concern Over Drugs Produced Abroad

2009-01-21T15:21:00.003-05:00

According to a recent article in the New York Times, "experts and lawmakers are growing more and more concerned that the nation is far too reliant on medicine from abroad, and they are calling for a law that would require that certain drugs be made or stockpiled in the United States." (Gardiner Harris, The New York Times 01/19/09 “Drug Making’s Move Abroad Stirs Concerns.”)

In recent years, pharmaceutical companies like Baxter (who sold the majority of contaminated heparin that resulted in numerous U.S. deaths), have imported drugs and/or shipped production oversees in order to increase corporate profit and avoid regulation. Of the 1,154 pharmaceutical plants mentioned in generic drug applications to the FDA in 2007, the article reports that only 13 percent were in the United States. Forty-three percent were in China, and 39 percent were in India.

The article further reports that since drug makers often view their supply chains as trade secrets, the true source of a drug’s ingredients can be difficult or impossible to discover. Indeed, the FDA cannot even identify how many foreign entities ship drugs into the U.S.

As a result, and as made clear from the recent heparin contamination, oversees drug production with little or no government oversight, leaves Americans at risk for tainted drugs. We continue to support Ohio Senator Sherrod Brown, (who has held hearings on this issue), and other lawmakers who remain dedicated to ensuring that America’s drug supply is safe.

Heparin Debacle Tops Chicago Tribune’s Top 10 Local Business Stories of 2008

2009-01-05T10:10:00.004-05:00

On 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.

WORLDFOCUS NEWS STORY ON CONTAMINATED HEPARIN

2008-12-17T16:53:00.006-05:00

Today, Worldfocus editorial consultant Peter Eisner, the former deputy foreign editor of The Washington Post, reported on the deadly contamination of U.S. drugs produced overseas, including heparin.

This news program tells the story of a young couple, Alex and Ann Oryschak, whose infant son, Julien, may have been one of the hundreds of victims who died in late 2007 and early 2008 from tainted heparin that was produced overseas. Producing drugs overseas not only allows powerful drug companies, like Baxter (who sold much of the contaminated heparin), to fly under the FDA radar and avoid government regulation and oversight, but it is cheaper. However, when safety is sacrificed in order to increase corporate profits, there is still a price to be paid. It is Julien Oryschak, Bonnie Hubley, Randy Hubley, Dennis Staples, and the hundreds of others who have lost their lives, who have borne that cost.

We thank reporters like Knut Royce, Peter Eisner, legislators like Representative Bart Stupak, and others, who, like our firm, fight to publicly expose the dirty secrets of the drug industry and effectuate real change.

To view this latest news report by Worldfocus, click here. Also be sure to read Knut Royce's detailed story posted here.

Rep. Barton Questions FDA’s Six Month Delay in Seizure of Tainted Heparin

2008-12-15T17:08:00.002-05:00

On December 10, 2008, U.S. Rep. Joe Barton, (Republican on the House Energy and Commerce Committee), wrote to the Food and Drug Commissioner, Andrew von Eschenbach, asking for information about the six month delay in the FDA’s seizure of contaminated lots of heparin from a manufacturer in Cincinnati, Ohio, Celsus Laboratories Inc.

In November, U.S. Marshalls seized 11 contaminated lots of the blood thinner heparin from Celsus after an April inspection found that the company wasn't properly recalling the product.

The text of the Barton letter states as follows:

The FDA’s management of the heparin issue continues to be of great interest to me and others on the Committee on Energy and Commerce. I commend you for your recent seizure of contaminated heparin from a manufacturer in Cincinnati, Ohio.

However, your November 6, 2008, announcement accompanying the enforcement action indicates that you twice previously informed the manufacturer (during an April 2008 inspection and again in a May 8, 2008, letter) that the company’s actions regarding the contaminated heparin were insufficient to assure an effective recall. I am concerned about this six-month delay between FDA informing the company of its insufficiencies and FDA taking enforcement action, and respectfully request your response to the following:

1. Why did FDA wait until November 2008 to seize the contaminated lots?

2. When was the recommendation to seize this contaminated heparin first made? Who made
it? Was it a written recommendation? Please provide supporting records as appropriate.

3. Please provide all FDA regulations, policies and/or guidances that govern the standards for authorizing this type of seizure.

4. Please list the names, titles, and offices of the FDA officials involved in the recommendation for the seizure of the contaminated heparin.

5. Please list the names, titles, and offices of the FDA officials involved in the decision on whether to approve the recommendation for seizure.

The letter than requested a response in the next four weeks. We will continue to keep you updated.

CDC REPORT IN NEJM FURTHER SUPPORTS LINK BETWEEN OSCS-CONTAMINATED HEPARIN AND DEATHS

2008-12-10T16:51:00.003-05:00

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.”

Washington Post Reports on Needed FDA Overhaul

2008-11-26T18:18:00.004-05:00

The Washington Post reported today that former officials, members of Congress, watchdog groups and various government reports are calling for an overhaul of the FDA, which “desperately needs an infusion of strong leadership, money, technology and personnel -- and perhaps a major restructuring.” (11/26/08 Washington Post, “Ailing FDA May Need a Major Overhaul, Officials and Groups Say.”)

The article is worth the read and discusses some of the FDA’s recent failures to monitor imported drugs and consumer products, including contaminated heparin, toothpaste, and pet food from China. As similarly opined in this blog recently, the article also discusses the view that more needs to be done than simply starting to open offices overseas, including sharply boosting inspections abroad, developing strict new regulatory standards, and updating and integrating the FDA's computer systems. To read a copy of this article, click here.

Another Step Closer to Synthetic Heparin

2008-11-25T16:36:00.002-05:00

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.”