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

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

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

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

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

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/.

Labels: Baxter, Health and Human Services; HHS; FDA; European Union;, Heparin, heparin lawsuit, heparin lawyer, heparin medical device, import safety, nightline, OSCS, over sulfated chondroitin sulfate, SPL

Labels: Abel, Baxter, Best, Charles, Connaught, Heparin, heparin attorney, heparin lawsuit, heparin lawyer, Heparin Timeline, Howell, Johns Hopkins, McLean, MDL, Murray, nightline, over sulfated chondroitin sulfate, Scientific Protein Labs, Scott

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

• 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

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

Labels: Baxter, China, Dennis Quaid, FDA, Heparin, heparin attorney, heparin lawsuit, heparin lawyer, House Committee on Oversight and Government Reform, MDL, MDL; Multi-District Litigation, nightline, OSCS, over sulfated chondroitin sulfate, preemption, Scientific Protein Labs

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

Yesterday I had the honor to present oral argument before the United States Judicial Panel on Multidistrict Litigation. This is a very distinguished panel of Federal Judges from around the country who meet once a month to decide if particular groups of cases should be consolidated before a single judge for purposes of discovery, and, if so, to decide which judge should hear the cases.

The Court sat yesterday in Asheville, North Carolina to decide several dozen matters. One of them was MDL 1953, the Heparin Disaster cases. The first attorney to argue asked the cases be transferred to San Francisco, even though there as yet are no cases pending there, because San Fran is closest to China, where some of the discovery needs to be done.

I argued second for Toledo. My reasons included the following:

Toledo has the best resources and is most convenient, and we were the first to file, had the most cases, and it would be best not to have the cases heard in Baxter's back yard of Illinios.

I pointed out that Chief Judge Jim Carr has the time, experience, dedication and resources to resolve these cases in a fair and expeditious manner, pointed out that our Toledo courthouse has state of the art equipment in the clerk's office and courtroom, run by tech savvy skilled personnel.

I indicated that Baxter's claim that all the witnesses were in either New Jersey or Illinois was really incorrect. The main issue in this case isn't what Baxter or SPL did, but what they didn't do. Why they failed to perform critical customary testing of incoming raw material for purity, and why they relied on Chinese subcontractors to perform this critical purity testing without documentation. NMR analysis is a basic fundamental test that is done for purity. It should have been used for Heparin.

Finally I concluded that Toledo was centrally located and convenient to the entire country. I pointed out that the federal courthouse in Toledo was only 45 minutes from Detroit Metro, which has a state of the art Northwest hub with connections throughout the world, and that it is much easier to drive from Detroit Metro to the Toledo courthouse than to go from OHare to downtown Chicago. I ended by mentioning that Northwest has just announced a new nonstop flight from Detroit to Shanghai, China.

After my argument other attorneys argued for Puerto Rico, Illinois and New Jersey. I am cautiously optimistic that the cases may be referred here. I expect a decision within thirty days.

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

To date there are twenty-four (24) heparin cases filed in Federal District Courts across the country. This number includes our seven (7) cases which are filed in the United States District Court for the Northern District of Ohio, Western Division. We expect to file additional cases shortly. Other Federal District Courts include:

· U.S. Dist. Ct., Southern District of Florida (1 case)
· U.S. Dist. Ct., Middle District of Florida (1 case)
· U.S. Dist. Ct., District of New Jersey (2 cases)
· U.S. Dist. Ct., Eastern District of Texas (2 cases)
· U.S. Dist. Ct., Northern District of Illinois (4 cases)
· U.S. Dist. Ct., Western District of Pennsylvania (1 case)
· U.S. Dist. Ct., Eastern District of Louisiana (1 case)
· U.S. Dist. Ct., District of Puerto Rico (3 cases)
· U.S. Dist. Ct., Eastern District of Tennessee (1 case)
· U.S. Dist. Ct., Eastern District of Pennsylvania (1 case)

There may be several other cases filed in state courts.

At the present time, the federal cases are being considered for multi-district litigation. Multidistrict litigation (“MDL”) is a procedure utilized in the federal court system to transfer to one federal judge all pending civil cases of a similar type, such as the heparin cases, filed throughout the United States. A panel of seven federal judges that are appointed by the Chief Justice of the United States Supreme Court decide on whether the cases should be transferred.

The judge who gets all the federal cases assigned to him is known as the "transferee judge." The judges from throughout the United States who send cases to the MDL judge are know as the "transferor judges" or "transferor courts."

At a hearing scheduled on May 29, 2008 in Asheville, North Carolina, we will be arguing that all of the federal cases should be transferred here to Toledo on the basis that our federal court has the time, resources and experience to handle the MDL and Toledo is conveniently and centrally located. Other attorneys are seeking a transfer to courts in Illinois, New Jersey, Pennsylvania, Florida and Puerto Rico. We hope to have a decision in the next few months.


-Submitted by Pamela A. Borgess

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

Labels: Baxter, China, FDA, Heparin, heparin attorney, heparin lawsuit, heparin lawyer, House Committee on Oversight and Government Reform, MDL, MDL; Multi-District Litigation, OSCS, over sulfated chondroitin sulfate, SPL, Stupak

On Monday, during an interview with The Associated Press, U.S. Health and Human Services Secretary, Mike Leavitt, represented that the heparin in the United States is now safe in light of tighter testing and controls. (5/12/08 Chicago Tribune Article: “U.S. Health Secretary: Chinese Heparin Now Safe.”) He discussed the additional guidelines regarding quality and safety that exporters must now meet. I hope he is right. I hope that after months of Americans dying from contaminated heparin, import alerts at the borders and proper testing, heparin and all drugs coming into the United States are now safe. (Although based on the evidence presented to the U.S. House Commerce Committee on Energy and Commerce at the April 29, 2008 hearing entitled, “The Heparin Disaster: Chinese Counterfeits and American Failures,” I doubt this is the case.) But what about what is on our shelves already?
Unfortunately, just a week ago, the FDA stepped up its heparin alert to hundreds of hospitals, medical societies and pharmaceutical organizations after learning that some medical facilities still had contaminated heparin among their supplies. (5/9/08 Wall Street Journal, “FDA Issues Update Heparin Alerts to Medical Facilities.”) The notice to the facilities read, "Please help FDA spread the word about recalls of injectable heparin products and heparin flush solutions that may be contaminated with oversulfated chondroitin sulfate (OSCS). Affected heparin products have been found in medical care facilities in one state since the recall announcement…Although product recall instructions were widely distributed, they may not have been fully acted upon at all sites where heparin is used.”
Indeed, many manufacturers and distributors of medical products containing or coated with heparin have only recently begun to identify and recall products containing the contaminant, as requested by the FDA last month. For example, on Monday, Atrium Medical Corporation recalled selected lots of HYDRAGLIDE™ Brand Heparin-Coated Thoracic Drainage Catheters that were manufactured with heparin that was contaminated with OSCS. Likewise, on May 7, 2008, Medtronic, Inc. recalled selected products with a “Carmeda BioActive surface” that were manufactured with heparin found to have been contaminated with OSCS. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs.
This delayed response is unfortunately consistent with the experience of our clients, some of whom we believe received recalled heparin after the date of recall, or who never received notice of the recall from their pharmacy or medical facility. Authorities must continue to focus not only on what is being imported, but what is already within our borders. A blanket promise of safety to the unsuspecting American public should only be made when it is certain that it is a promise that can be kept.

-Submitted by Pamela A. Borgess

Labels: Atrium, Baxter, Changzhou, China, Chinese, FDA, Heparin, heparin attorney, heparin lawsuit, heparin lawyer, Leavitt, MDL, MDL; Multi-District Litigation, Medtronic, OSCS, over sulfated chondroitin sulfate, oversulfated chondroitin sulfate

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

Most of the Heparin cases have been either filed in or removed to federal court. The federal court system has jurisdiction over the cases because of diversity of citizenship between the Plaintiffs and Defendants.

A motion has been filed to consolidate all of the federal cases into a single case for purposes of discovery and related proceedings. This motion will be heard on May 29, 2008 before a special panel of federal judges who will sit in Asheville, North Carolina.

The Judicial Panel on Multi-District Litigation ("MDL") has two issues to decide. First, they must decide if the cases should all be consolidated. It is highly probably that they will agree that the cases should be consolidated. In fact no one has opposed the motion to consolidate so far.

The second issue for the Panel to decide is to which District the cases should be sent. So far there have been a number of options presented to the panel. Baxter and SPL have argued that the cases should be decided in the home districts of Baxter, namely, New Jersey or Illinois. We have argued that the cases should be sent to the Northern District of Ohio. At the hearing I will present the argument for Ohio while other attorneys will request the panel to send the cases to Pennsylvania, Florida or Puerto Rico.

I expect that the panel will act quickly on this matter. I do believe there is a fair chance that the cases will be sent to our district.

Once the cases are assigned to a particular judge the parties will begin the discovery process. This involves obtaining copies of all relevant documents and taking the depositions of the Baxter and SPL employees and officers, as well as experts in the relevant fields of specialty.

Other MDL's have resulted in settlements. For example, we have recently worked on the Vioxx and Sulzer Hip MDLs which resulted in negotiation of a universal settlement. At this stage, though, the primary goal is to lock in the liability of SPL and Baxter for this tragedy. Once the evidence has established their irrevocable responsibility we can start to focus on the other issues.

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

One of the key issues in the Heparin Disaster litigation is whether Baxter and SPL should have taken reasonable steps to insure the safety and purity of the raw materials used in the finished heparin product.

We now know that a test called NMR Spectroscopy can easily distinguish over sufated chondroitin sulfate ("OSCS") contaminated heparin from the real thing. So what is NMR Spectroscopy?

According to Wikipedia:

Nuclear magnetic resonance spectroscopy, most commonly known as NMR, is the name given to a technique which exploits the magnetic properties of certain nuclei. This phenomenon and its origins are detailed in a separate section on nuclear magnetic resonance. The most important applications for the organic chemist are proton NMR and carbon-13 NMR spectroscopy. In principle, NMR is applicable to any nucleus possessing spin.

Many types of information can be obtained from an NMR spectrum. Much like using infrared spectroscopy to identify functional groups, analysis of a 1D NMR spectrum provides information on the number and type of chemical entities in a molecule.

The impact of NMR spectroscopy on the natural sciences has been substantial. It can, among other things, be used to study mixtures of analytes, to understand dynamic effects such as change in temperature and reaction mechanisms, and is an invaluable tool in understanding protein and nucleic acid structure and function. It can be applied to a wide variety of samples, both in the solution and the solid state.

Over the past 50 years NMR has become the preeminent technique for analysis of organic compounds. Here is a very good explanation (with pictures!) as to how NMR works from an undergraduate level course in Organic Chemistry at Michigan State University:

NMR Spectroscopy

While the science and theory maybe complex to a layman, NMR has been around a long time and is a very common analysis method taught at the undergraduate level. We intend to find out from Baxter and SPL why they failed to use this common test method in the analysis of raw materials from unknown sources before inclusion in such an important and sensitive product as heparin.

We continue to investigate cases from patients or their families around the country who have been killed or injured by this counterfeit product.

Labels: Baxter, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, MDL, MDL; Multi-District Litigation, NMR, nuclear magnetic resonance spectroscopy, OSCS, over sulfated chondroitin sulfate

Baxter held its annual meeting yesterday in Chicago. According to press reports:

Although the hourlong meeting focused on Baxter's record sales last year and rising share price, about 15 minutes was devoted to the heparin imbroglio. One investor wondered whether Baxter has taken steps to "close the loopholes" in its supply chain to make sure such a situation did not happen again.

Parkinson acknowledged "challenges associated with managing the supply chain," but that Baxter and other companies were making changes for the better.

Parkinson said Baxter and other companies get heparin's raw ingredient from China because "that's where the pig population is," adding that the Chinese supply of hogs is five times larger than in the U.S.

Well it wasn't the Chinese pigs that added oversulphated chondroitin sulphate (OSCS) to their intestines. It was someone looking to substitue a counterfeit product that was 100 times cheaper than Chinese raw heparan made from pig intestines. Someplace between the workshop that received the raw intestines and the bottling of the finished heparin, someone substituted counterfeit OSCS.

We have obtained a translated copy of a Chinese patent for the manufacture of OSCS. The Chinese patent was filed December 20, 2005 by Shandong University in Shandong China. This patent claims that OSCS can be cheaply manufactured using the claimed technique and the resulting OSCS product "has anticoagulant activity of 10 IU/mg," "anti-inflammatory and pain killing activity," and "inhibits tumor growth and metastasis."

It doesn't take a great leap of imagination to figure out that this or a similar product might be used as a substitute for heparin, particularly when disease in China had caused a sharp increase in the price of the raw product.

I commend the responsible Baxter shareholders who are challenging their company to act responsibly and "close the loopholes" that let this counterfeit product into the Baxter products.

All manufacturers of food and drug products owe a non-delegable duty to the consumers to insure the safety of their products, even if this means they have to use only those raw materials that can be securely monitored.

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

The director of China's "FDA" told a press conference that Baxter had failed to cooperate with Chinese experts sent to the U.S. to investigate the Heparin Disaster. The director, Jin Shauhong, also claimed that there was no "confirmed" link between the Over Sulfated Chondroitin Sulfate ("OSCS") and the deaths of patients in the United States.

Chinese representatives 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. Baxter now says it will give the Chinese samples of the product to test.

The FDA tried to inspect the Changzhou Techpool Pharmaceutical Co. ("CZTP") in Changzhou, China on February 27, 28 and 29, 2008. This company supplied SPL Changzhou with raw heparin and may have been a source for the contaminant.

During those inspections the FDA was accompanied by a representative of the U.S. Embassy from Beijing. This facility was NOT regulated by the Chinese because it did not sell any product within China. Instead its products were all made for export; therefore neither the Chinese nor the FDA inspected this plant.

Changzhou SPL, a defendant in the cases we have filed, owns 45% of CZTP. During the FDA inspection CZTP refused to provide the FDA with records for review.

Now the Chinese are complaining that U.S. companies are not cooperating with them in their investigation. What a surprise.

This illustrates a number of critical shortcomings in our drug system. First, as admitted by the FDA last week, the FDA is woefully underfunded and unable to inspect foreign manufacturers. Second, the manufacturers themselves cannot be relied upon to self-regulate their suppliers. Third, China and the United States have been unable to cooperate with each other to insure that good manufacturing practices are followed throughout the chain.

The only regulation that is truly reliable is that obtained by our common law. Companies that fail to insure the safety of ingredients in their products must be held strictly accountable for all injuries and deaths they cause. They must be held strictly accountable.

SPL used to be called Oscar Mayer. It used the small intestines of American grown hogs to make the raw heparin. There was no adulteration by counterfeit heparin because Oscar Mayer was an American company with a reputation to protect and a business to run. It would be unthinkable.

Yet somewhere along the way, through free trade agreements, the drive for ever higher shareholder return, corporate profits, deregulation, and business - friendly agencies we have lost our way. As we go through the documents and take the depositions of these corporate officers we are going to learn a lot more. And it isn't going to be a pretty picture.

By the way, if the Chinese are really worried about the relationship between the counterfeit heparin and the injuries and deaths, I suggest they read the recent article in the New England Journal of Medicine. We have a link to it on our web site. Maybe we should translate it into Mandarin.

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

• Oral swelling


• Abdominal pain


• Burning sensation


• Chest pain


• Diarrhea


• Dizziness


• Drug ineffectiveness


• Painful, difficult, or disturbed digestion


• Dyspnea [unpleasant or uncomfortable breathing]


• Erythema [redness of the skin]


• Flushing


• Headache


• Hyperhidrosis [excessive sweating]


• Hypoesthesia [reduced sense of touch or sensation]


• Increased lacrimation [production, secretion, and shedding of tears]


• Loss of consciousness


• Malaise [general discomfort or uneasiness]


• Nausea


• Pallor


• Palpitations


• Paresthesia [tingling, pricking, or numbness of a person's skin]


• Pharyngeal edema [swelling in throat]


• Restlessness


• Vomiting/retching


• Shortness of breath


• Stomach discomfort


• Tachycardia [rapid beating of the heart]


• Thirst


• Trismus [Inability to open the mouth fully]


• Unresponsiveness to stimuli


• Severe hypotension [abnormally low blood pressure]

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