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

Last weekend, two Delaware patients died and a third suffered medical complications after taking Baxter heparin, sparking concern of a repeat of last year’s contamination that killed hundreds of Americans. (See 05/11/09, Wall Street Journal, “Two Delaware Deaths Prompt Review of Baxter’s Heparin.”)

Although there is not specific evidence tying heparin to the illnesses, a spokesman for the Medical Center where the reactions occurred stated, "We don't know what's going on, but heparin is the only commonality that we were able to see ourselves. (Id.)

Baxter claims that unlike last year’s deadly contamination, the bulk material in the recent cases did not come from China and did not involve the counterfeit additive, over-sulfated chondroitin sulfate, (“OSCS”). However, testing is still ongoing.

Labels: Baxter, Baxter Heparin, China, Chinese heparin, FDA, Heparin, heparin attorney, heparin disaster, heparin lawsuit, heparin lawyer, OSCS, over sulfated chondroitin sulfate

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

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

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

As addressed periodically on this blog, powerful drug companies such as Baxter, have advocated for complete immunity from the majority of suits involving unsafe medical drugs and devices under a legal concept called “preemption.” Specifically, they have argued that regardless of misconduct or failures on their part, Americans injured by defective drugs should be stripped of their constitutional right to a trial by jury for most, if not all, legal claims, where the drugs are regulated or approved by the FDA.

It looked like for a time, the drug companies were winning in this battle against victims harmed by their defective drugs. This was particularly true a little over a year ago in February 2008, when the United States Supreme Court severely curbed the rights of injured victims in the case of Riegel v. Medtronic, which held that the Federal Food, Drug and Cosmetic Act (FDCA) preempts state-law claims seeking damages for injuries caused by medical devices with premarket approval from the FDA. (The harsh effects of this decision are now being sought to be reversed in a bill sponsored by Congressmen Pallone and Waxman.)

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

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

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

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

A copy of the decision is available by clicking here.

Labels: Baxter, Baxter Heparin, China, Heparin, heparin attorney, heparin lawsuit, Levine, OSCS, Pallone, preemption, Waxman, Wyeth

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

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

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

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

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

Labels: Baxter, Baxter Heparin, China, FDA, Heparin, heparin attorney, heparin lawsuit, heparin lawyer, OSCS, Sherrod Brown

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

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

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

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

Yesterday, the FDA seized 11 lots of Heparin products, valued at approximately $112,000, which were found to be contaminated with over-sulfated chondroitin sulfate (OSCS) from Celsus Laboratories in Cincinnati, Ohio. All 11 lots were manufactured with material imported from China, although the FDA reported that the contaminated crude heparin entered the United States prior to the import ban in April 2008. The discovery was found as part of the cooperative efforts by manufactures and the FDA to perform additional testing on all heparin materials to ensure no OCSC contamination. In fact, Celsus informed CNN that these lots had been quarantined by Celsus since March 8, 2008.

The FDA previously reported recalls of heparin products from Celsus Laboratories because of finding that batches of crude heparin Celsus received from their supplier contained OCSC. Celsus was also reprimanded by the FDA earlier this year for insufficient efforts by Celsus to notify its customers about the contaminated heparin products.

Celsus is a private business that has been manufacturing heparin related products, among others, since 1987. It not only provides its products here in the U.S., but also exports to many other countries, such as Australia, Canada, the European Union, and Japan.

Correction to reflect updated information:

USA Today originally reported that the contaminated heparin was imported from Changzhou SPL, the Chinese arm of U.S. based Scientific Protein Labs. USA Today cited FDA Spokeswoman Karen Riley for that information. They have now corrected their story to eliminate SPL as the source of the contaminated heparin after I brought this claim to the attention of the SPL attorney. Celsus had never been listed before as a customer of SPL or CZSPL. It is not clear whether the FDA spokesperson was misunderstood by USA Today, or if the FDA spokesperson was simply wrong as to the source of the contaminated product. Certainly the FDA should clarify this and should announce, publicly, the source of the OSCS contaminated heparin utilized by Celsus.

The FDA says it inspected Celsus Laboratories in April and found that two of its heparin products were contaminated.

The company had sent a letter to its customers telling them its heparin was contaminated, but FDA wanted the company to physically recall the product because of the danger it presented to patients.

FDA sent a follow-up letter to the company again asking for a recall on May 8.

What the federal marshals did Thursday was to seize the contaminated heparin that remained at the company's facilities, Riley says.

Comment: There is nothing in this latest story to establish that importations of contaminated heparin have occurred since April of 2008. But the story does show a conscious disregard by Celsus for the health and safety of the consumer. The FDA should have more power so that they can enforce the recall of these products.

In my opinion the FDA should also focus on inspection of existing health care facilities in this country to insure that all the bad stuff is off the shelf. I am personally more concerned about seizure of existing product in the hands of health care providers than raids to recover product that has already been quarantined.

And I want to know if Celsus used any of the contaminated Heparin in any of the products it shipped since April.

It is going to take much more than this raid to convince Americans that the FDA is doing its job; however the fact that Celsus chose to ignore the FDA request for a recall shows that Celsus has failed to act responsibly and has instead shown callous disregard for the consumer.

UPDATE COMMENT: Celsus should immediately disclose the source of the contaminant. Was Celsus experimenting with the use of OSCS? Did it know the products it sold contained OSCS? Celsus, up to now, has had a very good reputation. Its web site, www.heparin.com states:

Celsus is pursuing the development of a proprietary complex carbohydrate comprising a rare disaccharide sequence that may be prepared by chemical synthesis, genetically modified organism or site selected 6-O-sulfation of dermatan sulfate for medical needs unmet by heparin or its low molecular weight derivatives.

Celsus owes the world an explanation.

Labels: Baxter Heparin, Celsus, FDA, OSCS, over sulfated chondroitin sulfate

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 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

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.

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Last week, the U.S. Department of Health and Human Services (HHS) announced a new program in conjunction with the U.S. Food and Drug Administration (“FDA”) to enhance the safety of medical drugs and food exported to the United States. (07/09/08 HHS Press Release.)

Specifically, the program is a pilot project with the European Union and Australian authorities “to jointly plan, allocate for and conduct inspections of drug-manufacturing facilities.” (07/09/08 HHS Press Release.) The program will initially focus on makers of active pharmaceutical ingredients, but will expand to other types of manufacturing facilities if successful.

Additional information about this import safety initiative, as well as other import safety news, reports and blogs are available at the HHS’ import safety website: http://www.importsafety.gov/.

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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.

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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.

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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.

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