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 efficiency 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, "By promoting misleading safety and efficacy claims, you are potentially encouraging the unsafe use of FEIBA VH.” A 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

Last night, our client, Leroy Hubley, and his family, were featured on ABC’s television news program, “Nightline,” which discussed the heparin disaster. (07/30/08 Nightline, “Pharmaceutical Companies Must Take Responsibility.”)

The Hubley family, like hundreds of others, lost loved ones as a result of the contaminated heparin sold by Baxter, and supplied by SPL. The Hubley family not only lost their mother, Bonnie Hubley, but their 47 year-old son, Randy Hubley.

Previously on April 29, 2008, the Hubley family, along with Johanna Staples, (another client of Zoll, Kranz & Borgess who lost her husband, Dennis Staples), were invited to tell their tragic stories to the U.S. House Commerce Committee on Energy and Commerce at a hearing entitled, “The Heparin Disaster: Chinese Counterfeits and American Failures.” Video of this hearing is available by clicking on the links below.

Panel I (Witnesses: David Nelson, Senior Investigator for the Committee on Energy and Commerce, Colleen Hubley, Leroy Hubley, and Johanna Marie Staples)

Panel II (Witnesses: Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, Deborah M. Autor, Director of FDA’s Office of Compliance, and Regina T. Brown, Consumer Safter Officer of the FDA’s Division of Field Investigations)

Panels III and IV (Witnesses: Robert Parkinson, CEO and President of Baxter International, Inc., David Strunce, CEO of Scientific Protein Laboratories, Yan Wang, Ph.D., Vice President of Business Development and Research at Scientific Protein Laboratories, and Clive Meanwell, CEO of The Medicines Co.)

In addition, the written statements submitted to Congress by Leroy Hubley, Colleen Hubley Johanna Staples, and other witnesses, are available by clicking on their name below:

• Leroy Hubley
• Colleen Hubley
• Johanna Staples
• David Nelson, Senior Investigator for the Committee on Energy and Commerce
• Janet Woodcock, Director of the FDA’s Center for Drug Evaluation
• Robert Parkinson, CEO and President of Baxter International, Inc.
• David Strunce, CEO of Scientific Protein Laboratories
• Clive Meanwell, CEO of The Medicines Co.

We are proud and honored to represent these brave individuals, who have selflessly agreed to share their private losses and suffering with the public so that the extent and severity of this tragedy may be exposed and hopefully, prevented in the future.

Labels: Baxter, Baxter Heparin, FDA, heparin attorney, heparin lawsuit, heparin lawyer, Hubley, Johanna Staples, Leroy Hubley, nightline, OSCS, over sulfated chondroitin sulfate, Randy Hubley, SPL

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

The FDA recently increased the number of reported deaths in which one or more allergic / hypotensive symptoms occurred in correlation to the receipt of heparin to 149 deaths.

Here is the table from the FDA Report:

Number of Deaths of Patients Receiving Heparin Reported to FDA, January 1, 2007 through May 31, 2008
Month the Medical Event(s) Occurred	Number of Reported Deaths*	Reported Deaths with One or More Allergic/Hypotensive Symptom(s)
Jan-07	6	3
Feb-07	2	1
Mar-07	5	2
Apr-07	7	4
May-07	3	1
Jun-07	5	2
Jul-07	6	3
Aug-07	4	4
Sep-07	3	2
Oct-07	10	5
Nov-07	12	11
Dec-07	34	23
Jan-08	50	32
Feb-08	49	29
Mar-08	14	10
Apr-08	7	4
May-08	5	3
Unknown date	24	10
Total	246	149
*The reports in this table concern heparin produced by any manufacturer.

A review of this table shows a significant spike in events for the months of November 2007 through March of 2008. There is no doubt but that this spike is the result of deaths caused by the contaminant oversulfated chondroitin sulfate (OSCS), which was intentionally added to the raw heparin in China.

While there have been a few deaths related to products sold by other manufacturers, the overwhelming majority of the deaths arose from the administration of heparin manufactured and sold by Baxter.

There is also no question but that this table significantly underestimates the actual number of people who died from the contaminated heparin. The FDA adverse events reports only capture a relatively small percentage of the actual number of adverse events.

According to the FDA: "A small percentage of adverse reactions are reported to Centers for Deisease Control and Prevetnion and FDA by health care professionals and industry."

Therefore the actual number of deaths attibutable to the contaminated heparin is much larger.

Labels: Baxter, China, Chinese, dialysis, FDA, Heparin, heparin attorney, heparin lawsuit, heparin lawyer, nightline, oversulfated chondroitin sulfate

According to Chinese news, the Chinese Ministry of Health announced Friday that despite its “joint investigation” with U.S. drug authorities, it could still not conclude that the multiple U.S. deaths were a result of contaminated heparin sold by Baxter, who bought the raw ingredient supplied by SPL from its facility in China, SPL Changzhou. (07/18/08 China View News: “Cause of deaths still in doubt after Sino-U.S. Investigation on Blood Thinner.”)

As you may recall, China’s drug agency reported the same inability to link the reported deaths in May of this year. (See our May 7, 2008 Blog: China Points the Finger at Baxter and the FDA.”) At that time, the inability of China and the U.S. FDA to cooperate was evident. Chinese officials claimed that Baxter and the FDA failed to provide them with medical records, medical histories, and information on Baxter's manufacturing practices. The Chinese also complained that they had not been given samples of the contaminated product. The FDA complained that it was not provided records from Changzhou Techpool Pharmaceutical Co. (“CZTP”), a company who supplied SPL Changzhou with raw heparin and may have been a source for the contaminant.

U.S. researchers confirmed the link between the adverse events, including death, and the contaminant, OSCS, since at least April 23, 2008, when the results of the first study were reported in an article published online by the New England Journal of Medicine entitled, “Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact System.” As reported on the FDA website, “The contaminant activates chemicals in the body called enzymes. These enzymes cause the body to make inflammatory mediators (chemicals that are released by immune cells). Inflammatory mediators can lead to some of the symptoms such as low blood pressure, abdominal symptoms and shortness of breath.” (FDA: Questions and Answers re Heparin.)

It seems, therefore, that the two agencies are still failing to cooperate and exchange pertinent information. Maybe someone should give the Chinese Ministry of Health a copy of the New England Journal of Medicine article.

Labels: Baxter, Baxter Heparin, Changzhou, China, Chinese, FDA, Heparin, heparin lawsuit, heparin lawyer, MDL, nightline, OSCS, over sulfated chondroitin sulfate, oversulfated chondroitin sulfate, SPL

Labels: Baxter, China, Chinese, Eschenbach, FDA, Heparin, heparin attorney, heparin lawsuit, heparin lawyer, House Committee on Oversight and Government Reform, Lutter, MDL, nightline, preemption, Scientific Protein, Waxman

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

Labels: Baxter, CDRH, China, Chinese, FDA, Heparin, heparin attorney, heparin lawsuit, heparin lawyer, MDL, nightline, OSCS, over sulfated chondroitin sulfate, Scientific Protein Labs

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

• Heparin lock flush solutions in vials and solutions in pre-filled syringes;
• Devices used during cardiopulmonary bypass procedures, including certain oxygenators, filters, reservoirs, and cannulae;
• Catheters including certain vascular access catheters, drainage, retransfusion and thermodilution catheters, and oximetry probes;
• Certain vascular stents and grafts;
• Certain assisted reproduction media devices; and
• Certain In-Vitro Diagnostic media and related devices

A list of other medical devices and diagnostic products that may contain or be coated with heparin can be found by clicking here. This list also includes the manufacturer or distributor.

Labels: American Health Packaging, B. Braun, Baxter, Covidien, FDA, Heparin, heparin attorney, heparin lawsuit, heparin lawyer, heparin medical device, Medtronic, nightline, over sulfated chondroitin sulfate, Scientific Protein Labs