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.

Labels: Baxter Heparin, Heparin, Heparin Class Action, heparin disaster, SPL

Labels: Baxter, Baxter Heparin, contaminated heparin, contamination, Heparin, heparin attorney, Heparin Class Action, heparin disaster, heparin lawyer; heparin safety, OSCS, Scientific Protein Labs, SPL

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

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

Labels: Baxter, contamination, Heparin, heparin attorney, Heparin Class Action, heparin disaster, heparin lawsuit, heparin lawyer, MDL, multidistrict litigation, Ocella, Yasmin, YAZ

Labels: Baxter, Baxter Heparin, Chinese heparin, FDA, Heparin, heparin attorney, Heparin Class Action, heparin disaster, heparin lawsuit, heparin lawyer, Scientific Protein, SPL

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.

Labels: Baxter, Baxter Heparin, Heparin, heparin attorney, Heparin Class Action, heparin disaster, heparin lawyer, OSCS, over sulfated chondroitin sulfate, vioxx

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.

Labels: Barton, Baxter, Baxter Heparin, Celsus, Chinese, Chinese heparin, Eschenbach, FDA, Heparin, heparin attorney, Heparin Class Action, heparin disaster, heparin lawsuit, heparin lawyer, OSCS, Sharfstein

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.

Labels: Baxter, Baxter Heparin, Heparin, heparin attorney, Heparin Class Action, heparin disaster, heparin lawyer

Labels: Baxter, Baxter Heparin, China, Chinese, Chinese heparin, FDA, Grassley, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, Kennedy, OSCS, Stupak

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.

Labels: Baxter, FDA, Heparin, Heparin Class Action, heparin lawsuit, Sherrod Brown

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.’”

Labels: Baxter, Baxter Heparin, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, OSCS, over sulfated chondroitin sulfate

Labels: Baxter, Baxter Heparin, CDRH, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, OSCS, Scientific Protein

Labels: Baxter, Baxter Heparin, China, contamination, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, OSCS, over sulfated chondroitin sulfate, Scientific Protein

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.

Labels: Barton, Baxter, Baxter Heparin, Celsus, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, von Eschenbach

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

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.

Labels: Baxter, Baxter Heparin, China, Chinese, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, SPL

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

Labels: Baxter, Baxter Heparin, China, Chinese, contamination, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, Hubley, nightline, OSCS, SPL

In response to the ongoing public outcry for protection from imported drugs and other products, the U.S. Food and Drug Administration is finally taking some action. This week, the FDA is opening three offices in China. (11/17/08, Washington Post, “FDA to open China Offices After Product Scares.”) The first office will be opened in Beijing on Wednesday, followed by one in Guangzhou and another in Shanghai. According to Health and Human Services (HHS) Secretary Mike Leavitt,13 employees will be assigned to work in the FDA offices in China, but he has not said what their role will be.

While this is certainly a good first step, it is only a baby-step. There are thousands of foreign companies who ship drugs into the United States, let alone other consumer products. Thus, additional presence and regulation is needed. Last year the FDA reported that it only had resources to inspect foreign pharmaceutical companies every 13 years. (U.S. Government Accountability Office, Drug Safety: Preliminary Findings Suggest Weakness in FDA’s Program for Inspecting Foreign Drug Manufacturer. Statement of Marcia Crosse, Director of Health Care, before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives, November 1, 2007.) It is unclear how much of an impact that three offices with only 13 employees, who must deal with multiple consumer products, (not just pharmaceuticals), will have on the undisputed inability of the FDA to ensure product safety of foreign products.

As often discussed on this blog, this inability to protect the American public underscores why preemption of lawsuits is wrong. Drug and medical device companies argue that Americans injured by defective drugs or medical devices should be barred from bringing suit, because the FDA can adequately protect the American public. The heparin disaster has made it clear that this assumption is inherently flawed.

Indeed, as also reported in this week's news, the House Committee on Oversight and Government Reform released a report showing "that historically the Food and Drug Administration has not sought to preempt state law claims, and that the agency 'viewed lawsuits brought by persons injured by a drug as a valuable complement to the agency's regulatory efforts.'" (11/17/08 Lawyers USA, "Report: FDA Staff Objected to Preemption Policies.") However, during the Bush administration the FDA made a dramatic reversal, adding preemption language to drug regulations. This language has now become "a cornerstone of drug industry preemption arguments."

According to the report, "key career officials" objected to the regulatory changes. The officials "repeatedly warned that the central factual justifications for the agency's new positions were false."

The American Association for Justice ("AAJ") "blasted the FDA over the report, noting that the findings were similar to those in an AAJ report released earlier this month." Geri Voss, Director of Regulatory Affairs at AAJ, said, "In a gift to big negligent corporations, the Bush Administration overrode the advice of career professionals, ignored the agency's history of respect for litigation and put consumer safety on the backburner." For a full copy of “Get Out of Jail Free: A Historical Perspective of How the Bush Administration Helps Corporations Escape Accountability” go to: www.justice.org/getoutofjailfree.

Labels: AAJ, Baxter, Baxter Heparin, China, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, House Committee on Oversight and Government Reform, imported drugs

Labels: Baxter, Baxter Heparin, China, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, Hubley, Johanna Staples, Leroy Hubley, OSCS, Time

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

On September 24, 2008, the Joint Commission, an independent, not-for-profit organization that accredits and certifies more than 15,000 health care organizations and programs in the United States, issued a heparin safety alert. (See JOINT COMMISSION WEBSITE: 9/24/08 Sentinel Event Alert, “Preventing errors relating to commonly used anticoagulants.”)

According to this report, “anticoagulants have been identified as one of the top five drug types associated with patient safety incidents in the United States.” (Id.) From January 1997 through December 2007, the Joint Commission reported that there 446 medication-related sentinel events (9.3 percent of all events) reported in their event database, with 7.2 percent (32) of these involving anticoagulants; of those, two-thirds (21) involve heparin. (Id. See also the illustrative chart on the Joint Commission Website.) Further, according to the United States Pharmacopeia MEDMARX database, there were a total of 59,316 medication errors related to anticoagulants reported to their database from 2001 to 2006 (these data do not include errors involving heparin lock flush). (Id.) According to the report, “nearly 60 percent of these errors reached the patient and nearly 3 percent resulted in harm or death.” (Id.) Further, “performance error (e.g., administration) is the most common cause of adverse events relating to anticoagulant medications.” (Id.)

The Joint Commission explained in its report that “heparin and warfarin in particular have narrow therapeutic ranges and a high potential for complications, so there is a greater risk of patient harm.” (Id.) It also listed the following factors which also contribute to medication errors involving anticoagulants:

• Lack of standardization for the naming, labeling and packaging of anticoagulants creates confusion. For example, heparin flush syringes have been confused with LMW heparin syringes. In addition, other, lesser-known anticoagulant drug names exist (e.g., enoxaparin, dalteparin, tinzaparin) and are used less commonly, which can result in duplicate medication orders and erroneous dosing.
• Keeping current with different dosing regimens for various patient populations, newer assay methods, the expanding lists of drug interactions, and the potential reversal strategies can be a challenge for providers—especially those who infrequently prescribe or administer anticoagulants.
• The specific and individualized instructions and monitoring information (for example, dose adjustments, lab values, changing patient condition) that accompany the prescribing and administration of anticoagulants may fail to get documented or communicated during transfers and hand-offs.
• Neonates and other pediatric patients are problematic to treat, specifically because the medications are formulated and packaged primarily for adults.

(Id.) The Joint Commission offers suggestions on how to reduce these dangers.

What is missing from the report is the danger of contamination and the lack of updated and appropriate testing for imported drugs, which unfortunately, may have claimed as many lives in a just few months, as dosage errors have claimed in the past ten years.

Labels: Baxter, Baxter Heparin, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, imported drugs, Joint Commission, OSCS, safety alert, Scientific Protein, USP

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

Recently, the New England Journal of Medicine (NEJM) voiced strong opposition to preemption of cases involving defective medical devices and drugs, which would strip Americans injured by defective medical devices or drugs of their constitutional right to a trial by jury for most, if not all, legal claims, where the drugs or medical devices are regulated or approved by the FDA.

In an Amicus Brief filed in a case pending before the United States Supreme Court, Wyeth v. Levine, the NEJM editors wrote that the “FDA alone simply lacks the ability to serve as the sole guarantor of drug safety'’ and that without the discoveries made by plaintiff’s lawyers as a result of defective drug lawsuits, “the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct.'’

A copy of this compelling brief is available by clicking here. In addition, the recent NEJM article, “Why Doctors Should Worry about Preemption,” is available on the NEJM’s website, by clicking here.

Labels: Baxter, Baxter Heparin, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, OSCS, preemption, SPL

Last week, the Los Angeles Daily Journal reported that the California Pharmacy Board will be citing and fining 94 California hospitals and the head pharmacist at each facility for not removing (and in some cases actually dispensing) contaminated heparin from their hospital pharmacies. (George, Los Angeles Daily Journal, 8/20)

This failure is inexcusable, as these institutions have been warned in writing on numerous occasions, including, for example, the FDA’s April 25, 2008 “Update to Healthcare Facilities and Healthcare Professionals about Heparin and Heparin-Containing Medical Products.”

Patients receiving heparin therefore, should remain cognizant of the recall and demand assurances from their health-care providers that they have complied with the recall.

Labels: Baxter Heparin, california hospitals, FDA, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, SPL

At the American Chemical Society’s national meeting on August 17, 2008, Robert J. Linhardt, a chemist with Rensselaer Polytechnic Institute (“RPI”) in Troy, New York, reported ongoing advances toward developing a safer, fully-synthetic version of heparin. (Am. Chem. Society 09/17/08 Press Release, “Chemists move closer toward developing safer, fully-synthetic form of heparin.”) Specifically, Linhardt said his team from RPI, along with the assistance of Jian Liu at the University of North Carolina, has been able to produce a tiny amount of synthetic heparin. (Id.) The researchers claim that this creation is the largest dose of heparin ever created in a lab. (RPI Website: “Researchers Create Safer Alternative to Heparin.”)

According to the American Chemical Society’s press release, researchers have been trying for years to develop heparin production methods. (Am. Chem. Society 09/17/08 Press Release, “Chemists move closer toward developing safer, fully-synthetic form of heparin.”) In 2003, the first so-called total synthesis of heparin was developed at the Massachusetts Institute of Technology (MIT). However, the result was not practical as it only produced minute batches of heparin — less than 0.000000035 ounces at a time. (Id.)

Linhardt, together with Jian Liu, discovered the synthetic “recipe” for heparin in 2006. (RPI Website: “Researchers Create Safer Alternative to Heparin.”) Since that time, they have worked to piece together the various molecules and grow a complex carbohydrate that is naturally created in the body in the lab. (Id.)

RPI claims that larger amount of fully synthetic heparin could be ready for use in patients in five years. (Id.)

Labels: Baxter, Baxter Heparin, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, Linhardt, Liu, synthetic heparin

Sens. Edward Kennedy (D-Mass.) and Patrick Leahy (D-Vt.) have followed the lead of House lawmakers and introduced a Senate counterpart of the Medical Device Safety Act of 2008 to ensure individuals are not prevented from seeking legal recourse against devicemakers selling defective products under state tort laws. (FDAnews Device Daily Bulletin, Aug. 12, 2008, Vol. 5, No. 157, “Senators Introduce Their Version of Anti-Preemption Bill." See also 08/01/08 Statement of Senator Leahy.)

The bill seeks to reverse the United States Supreme Court’s February 20, 2008 decision in Reigel v. Medtronic in which the Supreme Court severely curbed the rights of injured victims. Specifically, this harsh decision 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.

Baxter and other drug manufacturers argue that Riegel should be even further expanded to include medical drugs. They argue that regardless of misconduct or failures on their part, Americans injured by defective drugs or medical devices should be stripped of their constitutional right to a trial by jury for most, if not all, legal claims, where the drugs or medical devices are regulated or approved by the FDA.

As discussed in previous blogs, this argument is not only legally and ethically problematic, but is based on the flawed assumption that the FDA has the resources, authority, and capability to ensure product safety. Unfortunately, as the heparin debacle as reminded us, such is not the case. Without accountability of companies who unapologetically put profits over people, innocent Americans will continue to die from unsafe drugs and medical devices.

To read Senator Leahy’s powerful statement regarding the bill and the dangers of preemption, click here.

We thank Senators Leahy and Kennedy for their efforts to protect the American public from unsafe drugs and medical devices.

Labels: Baxter, Baxter Heparin, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, Kennedy, Leahy

In a letter dated July 7, 2008, the FDA warned that Baxter’s promotion for its bleeding treatment FEIBA VH misleads doctors about the drug’s safety and effectiveness. (Chicago Tribune/Bloomberg News 7/31/08: “Baxter Warned on Hemophilia Drug Promotion.”)

The FDA advised that the "clinical thank you e-mail" submitted for review by Baxter violates FDA policies and is misleading with respect to both the efficacy and the safety of the drug. Specifically, the FDA held that the promotion overstated the efficacy of the drug and minimizes the fact that serious thrombotic events can occur with the drug. In its letter, the FDA states:

"This Email makes false or misleading safety and efficacy claims for FEIBA VH. Therefore, this material misbrands FEIBA VH in violation of the Federal Food, Drug and Cosmetic Act (the Act) 21 U.S.C. §§ 352(a) and 321(n), and FDA implementing regulations. Cf. 21 CFR 202.1 (e)(6)(i) and (iv). These violations are concerning from a public health perspective because by promoting misleading safety and efficacy claims, you are potentially encouraging the unsafe use of FEIBA VH."

A complete copy of this letter is available by clicking here.

After the heparin debacle, one would hope that Baxter would not be so quick to overstate the safety of its drugs. Apparently, as the old idiom warns, a leopard can never change its spots.

Labels: Baxter, Baxter Heparin, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer

Today the Chicago Tribune reported that the FDA has only been able so far to "conclusively link" three fatalities to contaminated heparin manufactured by Baxter. (07/30/08 Chicago Tribune: Heparin Taint Tied to Deaths.)

According to the article, in an interview Tuesday with the Tribune, the FDA said it completed its review of 93 death reports related to heparin that the agency received from January 1 to March 31, 2008. (07/30/08 Chicago Tribune: Heparin Taint Tied to Deaths.) Of the 10 reports of death from severe shock known as anaphylaxis or hypotension, three of those could be traced to lot numbers of Baxter products that tested positive for oversulfated chondroitin sulfate (“OSCS”). Heparin lot numbers were not known for the other seven deaths from anaphylaxis or hypotension, so the FDA could not determine whether those 7 patients received heparin contaminated with the substance.

Of the remaining 83 reports, 13 were described as "potential complications of heparin use" such as bleeding; and 25 cases were due to causes unrelated to heparin use such as pneumonia, sepsis and kidney failure. (07/30/08 Chicago Tribune: Heparin Taint Tied to Deaths.) In the remaining 45 deaths, FDA spokeswoman Janet Woodcock stated, "clinical information in the adverse-event reports is insufficient to specify the cause of death with clinical certainty,” and that the FDA was missing information from providers or others who filled out the reports to make an adequate determination. She also added, "While some of these [reports] appear definitely related [to contaminated heparin] many are still in the gray zone…We have looked over all of these death reports and a number of them were probably not related to the contaminated heparin."

While it is good that the FDA has finally conclusively linked some of the deaths, many questions are still unanswered. The top five questions that immediately jump out to me are as follows:

1) If additional information is needed 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, we have filed multiple adverse-event reports of clients, but 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.

2) Is the FDA relying on death certificates to determine cause of death? If so, this analysis is suspect, as many individuals died before the public recall and before the medical community learned of the contaminated heparin. As such, a medical provider would not have known or appreciated that their patient could have died from an anaphylactic reaction from contaminated heparin.

3) Is the FDA investigating or supporting scientific studies to determine whether the contaminate, OSCS, and its resulting symptoms can cause or contribute 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.” (See FDA Questions and Answers, updated 7/3/08.) For example, the FDA admittedly does not know whether there are any long term health effects of the contaminant. (See FDA Questions and Answers, updated 7/3/08.) With the New England Journal of Medicine article (that had severely restricted testing parameters) being the only scientific study published to date regarding the effects of OSCS, it may be too quick to report that the only deaths caused by that contaminate are those from anaphylaxis or hypotension.

4) Why has the FDA failed to analyze any of the reports that were filed after March 31, 2008? Or if they have analyzed them, why have they failed to report on them?

5) Why did it take an interview with the Chicago Tribune to ferret out this important information?

Baxter, SPL and the FDA have each admittedly failed the American public with respect to Heparin. As such, it is in their best interests to minimize the national disaster that they allowed to occur. It is no wonder, therefore, that they are quick to try to limit the number of deaths. Speculation is worthless. What we need is science. We implore the scientific community to not accept the FDA’s and drug companies’ unfounded conjectures at face value, but to test and study this contaminate further. Only then will we reach the truth… something that the victims of this disaster and their loved ones deserve.

Labels: Baxter, Baxter Heparin, China, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, nightline, OSCS, oversulfated chondroitin sulfate, Scientific Protein Labs, SPL

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

In a statement released July 10, 2008, Texas Hospital, Christus Spohn, indicated that the recent heparin overdose of 17 children in its Neonatal Intensive Care Unit, was a result of an error that occurred during the mixing process in its hospital pharmacy. (See 07/10/08 Christus Spohn Statement.) While the hospital claims this mistake in mixing was unrelated to product labeling or packaging, (which has recently resulted in similar deaths), it has not released details as to how the “mixing error,” occurred.

Likewise, in true defense fashion, the Texas Hospital is quick to speculate publicly that the heparin overdose of twins Keith and Kaylyn Garcia, (which was 100 times stronger than recommended), did not directly result in their deaths, before the conclusion of any autopsies. Relatives of the twins had planned a baby shower for their mother today, instead their funerals will be held. (7/11/08 ABC news, “Hospital Error Blamed for More Infant Overdoes.”)

If hospitals spent as much time figuring out ways to eliminate and reduce errors, as setting up defenses to protect themselves from anticipated future litigation, we would all be safer.

Labels: Baxter, Christus Spohn, Dennis Quaid, heparin attorney, Heparin Class Action, heparin lawsuit, heparin mixing error, kaylyn garcia, keith garcia, nightline, Scientific Protein Labs

This week Ohio Senator Sherrod Brown sent a letter to the FDA challenging them to evaluate the level of outsourcing by U.S. Pharmaceutical companies, and the impact of that outsourcing on Drug Safety. He also asked Pfizer, who admitted outsourcing 17% of their API ("Active Pharmaceutical Ingredient"), to make public how much money they save by doing so. Sherrod Brown Press release and letters.

Now the FDA has announced that it will spend taxpayer money to set up inspection offices in China and India. (Three offices in China this year, followed by offices in India. Story here.) It seems to me that the drug companies that profit from overseas operations and the lax or total absence of controls and inspections should pay for these offices and the cost of inspecting the foreign operations.

Senator Brown is absolutely right to dig into this issue that is so critical to the health and safety of our citizens. As he stated to Janet Woodcock, head of the FDA:

You also asserted that FDA must have the tools to hold drug companies accountable when they outsource. What, in your opinion, is the best means of holding these drug companies accountable? All parties throughout the drug supply chain should be held accountable for the quality and integrity of the products they produce.

I seriously doubt that the current FDA will hold drug companies accountable. But they must do so. And those injured by the failure of the drug companies to perform their duties must be able to obtain full and fair compensation from the drug companies that have failed to provide products that are safe and effective.

Thank you Senator Brown. Please keep challenging the FDA, Pfizer, and the rest of the phamaceutical industry to do their duty. And please give those persons and families who are injured and killed the ability to seek full compensation. It is ridiculous to protect these companies from liability on the basis that the FDA is doing its job.

As we have seen in the Heparin Disaster, and as I pointed out in my blog yesterday, the Chinese operations, subcontractors and joint ventures of these drug companies are flying under the radar of the FDA. Even when the FDA tries to inspect these companies they cannot do so.

Labels: FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawyer, nightline, Pfizer, Sherrod Brown

The US FDA inspected, or rather attempted to inspect, three heparin manufacturing facilities between February 20th and February 29, 2008. The first facility was that of Changzhous SPL Company, Ltd., ("CZ-SPL") a wholly owned subsidiary of SPL. All of the CZ-SPL product was shipped to Baxter.

This inspection lasted 6 days. This was the first time the FDA had ever inspected the facility, in violation of FDA policy.

The inspection found that the process validation for the purification of Heparin Crude was inadequate . It further found a number of other deficiences, including:

• process changes included removal of Heparin Crude quality attributes based on ease of procurement without adequate raw material evaluation.
• No impurity profile had been established.
• A discontinued workshop's crude heparin was included in lots sold to SPL.
• Equipment was not cleaned.

The report states that, beginning in June of 2007, CZ-SPL started testing incoming lots by Polymerase Chain Reaction (PCR) for species verification. In other words, because SPL was worried about counterfeit sheep product being substituted for pig product, it started doing a basic PCR analysis. As a result of the inspection, the FDA issued a Form 483 report.

The second inspection began February 27, 2008. This inspection was of a facility located right next door to CZ-SPL. The neighboring factory is known as Changzhou Techpool Pharmaceutical Co. Ltd. ("CT"). CT is 45% owned by CZ-SPL. All of the product made by CT is sold to CZ - SPL. Importantly, the plant is not registered with the Chinese FDA because it does not make product for consumption in China. Nor is it registered with or inspected by the US FDA. The inspection lasted only 2 days. On both days the company refused to give the FDA copies of basic documents, including raw material crude specification, test methods, cards, certificates of analysis, blend records, and inventory records. The FDA did take photographs, which we are seeking to obtain.

The third inspection was even less successful. This inspection began the afternoon of February 28th and ended the next day when the FDA inspection team was refused reentry into the facility. This facility was located in Hangzhou, China. The name of the firm was Hangzhou Ruihua Biochemical Products Co. Ltd. This firm was a manufacturer and tester of crude heparin that was sold to CZ-SPL for further processing. A photograph of Dr. Wang, the general manager of CZ-SPL and an officer of SPL hung in the entryway of the facility.

The firm refused to provide copies of any records and no samples were collected. The firm is not regulated or inspected by the Chinese FDA or the US FDA. The owner of the firm, Mr. Ruihua, admitted that the firm had been unable to meet the needs of CZ-SPL because there was not enough heparin available. He indicated that CZ-SPL was his sole customer.

Ruiha collects raw heparin from the countryside and nearby provinces. The workshops are all on a list provided by CZ-SPL. However Mr. Ruiha refused to provide any documents, refused to permit the FDA to inspect the laboratory, refused to provide a list of the workshops from which they get the raw heparin, and would not even state the Provinces in which the workshops were located.

On April 21, 2008 the FDA issued a warning letter, which held that the deficiencies and deviations from current good manufacturing processes were so severe that CZ-SPL was barred from shipping product into the United States.

Labels: Baxter, Changzhou, China, Chinese, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, MDL, MDL; Multi-District Litigation, nightline, OSCS, Scientific Protein, Scientific Protein Labs, SPL

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

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

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

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

The contaminant activates chemicals in the body called enzymes. These enzymes cause the body to make inflammatory mediators (chemicals that are released by immune cells). Inflammatory mediators can lead to some of the symptoms such as low blood pressure, abdominal symptoms and shortness of breath. This mechanism can explain many of the serious adverse events that occurred immediately after patients were given the contaminated heparin.

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

Labels: Baxter, Changzhou, Chinese, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, MDL, nightline, NMR, OSCS, over sulfated chondroitin sulfate, oversulfated chondroitin sulfate, Scientific Protein Labs, SPL

On February 20, 2008, the United States Supreme Court severely curbed the rights of injured victims in the case of Riegel v. Medtronic, which held that the Federal Food, Drug and Cosmetic Act (FDCA) preempts state-law claims seeking damages for injuries caused by medical devices with premarket approval from the FDA. (The problems with preemption have been discussed previously on this blog including, “The Preemption Problem” and “Should FDA Drug and Medical Device Regulation Bar State Liability Claims?”)

However, as reported in the 6/10/08 FDA news Device Daily Bulletin, prominent lawmakers are now seeking to introduce a bill in the next few weeks that would render this harsh U.S. Supreme Court decision moot. (FDAnews Device Daily Bulletin, Vol 5 No. 113, “Device Preemption Ruling Threatened by Draft Bill.”) This important bill would add a subsection to the FDCA stating, “Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.” The draft bill is sponsored by Congressmen Pallone and Waxman and is available at: www.fdanews.com/ext/files/FinalBill.pdf.

As this legislation is critical to ensuring the accountability of medical drug and device manufacturers for the safety of their products, we support this new bill.

Labels: Baxter, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, MDL, MDL; Multi-District Litigation, nightline, Pallone, preemption, Scientific Protein, Scientific Protein Labs, SPL, Waxman

Zoll, Kranz & Borgess, LLC has just posted a detailed timeline relevant to the Heparin recall and subsequent litigation. This timeline created solely by Zoll, Kranz & Borgess, also features web-links to almost a hundred articles, videos, and other documents, including public documents from Baxter, SPL and the FDA. Please visit this timeline by clicking here.

Labels: Baxter, Changzhou, China, Chinese, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, Heparin Timeline, MDL, MDL; Multi-District Litigation, nightline, OSCS, Scientific Protein, SPL

Labels: Baxter, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, MDL, MDL; Multi-District Litigation, nightline, OSCS, over sulfated chondroitin sulfate

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

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

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

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

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

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

It didn't even own an NMR machine.

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

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

Labels: Baxter, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, MDL, MDL; Multi-District Litigation, nightline, NMR, OSCS, over sulfated chondroitin sulfate, oversulfated chondroitin sulfate, Scientific Protein Labs, SPL

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

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

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

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

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

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

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

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

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

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

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

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

Labels: Baxter, David Kessler, Dennis Quaid, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, House Committee on Oversight and Government Reform, MDL, MDL; Multi-District Litigation, OSCS, over sulfated chondroitin sulfate, preemption