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Baxter Heparin Contamination.

What is Heparin

Heparin is a well known anticoagulant used subcutaneously and intravenously in patients undergoing kidney dialysis, whether at a dialysis center or hospital, or in the privacy of their own home. The drug is also used in patients undergoing certain types of cardiac surgery and other medical procedures, in lock flush” solutions which are administered to keep catheters unblocked and free flowing, and heparin can be used as a coating device for certain medical devices and diagnostic products. Contaminated heparin may have been ingested by way of any of these methods.

Recall Overview

On January 17 2008, Baxter International recalled 9 lots of its 1000/unit mL multi-dose Heparin vials. The Heparin recall was initiated voluntarily as a precautionary measure after Baxter received dozens of reports of serious adverse reactions in patients who had been administered Baxter Heparin. Baxter also announced that they would suspended future Heparin production until the cause of the adverse reactions could be determined.

Image of Heparin bottlesThe following month, the Food & Drug Administration (FDA) issued a Public Health Advisory to physicians, dialysis center staff, and other health care providers with recommendations and warnings about the use of Baxter Heparin products. Reports from the FDA indicated that in 2008, it had already received over 400 reports of serious side effects and adverse reactions related to Baxter Heparin. Some of the serious adverse events included allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension requiring treatment. The FDA warning also noted that four patients had died after being administered the drug although the relationship between the deaths and the heparin use was not certain.

Readers should note that in the advisory, the FDA reported that, although most adverse events (symptoms) developed within minutes after a patient received heparin, “the possibility for a delayed response has not been excluded.” Readers should also be aware that Baxter’s initial recall in January 2008 involved only nine (9) specific lot numbers. However, its subsequent recall on February 28, 2008 involved the recall of all remaining lots and doses of its heparin sodium injection multi-dose, single-dose vials as well as its HEP-LOCK heparin flush products. The FDA’s February 11th Advisory confirmed that “Adverse events are not limited to only the recalled heparin lots.”

If you, or someone you love, have been injured using Baxter Heparin and would like the attorneys at Nolan Law Group to review your case, please contact us.

Symptoms Experienced After Receiving Contaminated Heparin?

Serious adverse events have been reported as allergic or hypersensitivity-type reactions with the following symptoms:

  • stomach pain
  • difficulty breathing
  • nausea
  • vomiting
  • excessive sweating
  • rapid fall in blood pressure
  • organ failure
  • shock
  • heart problems
  • chest pain
  • increased heart rate
  • throat swelling
  • headache
  • rash
  • dizziness
  • those that may resemble the symptoms of Heparin-Induced Thrombocytopenia (HIT), such as a low platelet count, bruising, loss of circulation to the hands and feet, gangrene, bleeding, and blood clots
  • additional symptoms, including potential long-term effects that have not been identified.

If you, or someone you love, experienced any of these symptoms after undergoing kidney dialysis, cardiac surgery or other medical procedures (either at home or in a dialysis center or hospital) and would like the attorneys at Nolan Law Group to review your case, please contact us.

Recall Timeline

January 16, 2008: FDA initiates investigation of U.S. Baxter’s manufacturing facility as a result of reports of severe adverse reactions in patients.

January 17, 2008: Baxter International Inc. voluntarily recalls specific lots of heparin. The initial recall was issued to Baxter’s customers, wholesalers and distributors.

January 22, 2008: Recall was issued to dialysis centers.

January 23, 2008: Recall was issued to renal home patients.

February 5, 2008: Baxter and the FDA announce that their initial investigations revealed the presence of an unknown contaminant in the active ingredient used in Baxter heparin.

February 11, 2008: Baxter, in conjunction with the FDA, send Important Safety Information” letter to healthcare professionals and renal home patients.

February 11, 2008: The FDA issues an advisory alert announcing a link between Baxter’s multiple-dose vials of heparin and severe reactions.

February 14, 2008: FDA investigations reveal information about inadequate testing and supply-chain issues associated with the Baxter Heparin. Further investigations reveal that a Chinese factory which supplied the active ingredient for Baxter Heparin may be link and had never been inspected by the FDA.

February 28, 2008: Baxter expands its urgent heparin recall to include all lots of single and multidose vials.

February 28, 2008: Baxter recalls HEP-LOCK heparin flush products.

February 29, 2008: FDA announces that Baxter would be recalling all of its remaining heparin products.

March 19 2008: The FDA announces that it has identified a contaminant found in the Baxter heparin as Oversulfated Chondroitin Sulfate (OSCS), a derivative of a popular supplement used to relieve arthritis, and a chemical that does not occur naturally during heparin production.

April 21, 2008: The FDA issues a warning letter to General Manager of the Changzhou SPL Facility detailing the findings of it’s investigation.

April 29, 2008: The House and Energy Committee hold live hearings to examine the events leading up to the distribution of a contaminated batch of heparin.

April 29, 2008: Robert Parkinson, CEO of Baxter International, Inc. testifies before Subcommittee on Oversight and Investigations and admits responsibility for heparin disaster, irrespective of wrongdoing in China.

May 16, 2008: The (FDA) announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products.

If you, or someone you love, have been injured using Baxter Heparin and would like the attorneys at Nolan Law Group to review your case, please contact us.

Investigation Findings

Since the initial recall, the Food and Drug Administration (FDA) has conducted a formal investigation in which they identified an unknown contaminant found in the Baxter Heparin. In early April of 2008, researchers confirmed the FDA’S suspicion that the contaminant found in the Heparin is Oversulfated Chondroitin Sulfate (OSCS), a derivative of a popular supplement used to relieve arthritis, and a chemical that does not occur naturally during Heparin production.

The contaminant was found in samples of heparin that the FDA tested from Wisconsin-based Scientific Protein’s Changzhou SPL plant in China, which supplied Baxter with the active ingredient in heparin. The FDA investigation revealed that the Chinese factory had never been inspected by the FDA and that there had been a mix-up in the FDA’s database causing the FDA to overlook the required inspection. Baxter claimed it had inspected the facility during the previous six months and was planning another inspection. Additionally, the investigation revealed serious supply-chain issues associated with the production and distribution of Baxter Heparin.

According to the FDA’s inspection and in a warning letter written to Dr. Yan Wang, Ph.D. (General Manager of the Changzhou SPL Facility) the Changzhou SPL Facility was unable to provide FDA with any assurance “that processing steps used to manufacture heparin sodium, USP are capable of effectively removing impurities.” FDA also found that the facility failed “to have adequate systems for evaluating the suppliers of crude heparin materials, or the crude materials themselves, to ensure that these materials are acceptable for use.” Moreover, the methods employed to test Heparin Sodium United States Pharmacopoeia (USP) had not been verified to ensure suitability under actual conditions of use, and the equipment used to manufacture the product was “unsuitable” for its intended use.

The FDA gave Changzhou SPL 30 days to respond to the charges in the letter and stated that until they are able confirm that Changzhou has corrected violations at the factory, and certify that it now meets current Good Manufacturing Practice standards, all products made there will be denied entry to the U.S.

SPL responded by saying that it regretted FDA’s decision and that it did not believe the warning letter reflected Changzhou SPL’s actual state of compliance with good manufacturing practices.

China’s Ministry of Commerce is now requiring local Heparin makers to increase testing of raw materials, improve post-sale tracking and ensure that their raw material comes from registered suppliers. This requirement follows U.S. Congressional inquiries into the FDA’s overseas inspection process.

If you, or someone you love, have been injured using Baxter Heparin and would like the attorneys at Nolan Law Group to review your case, please contact us.

Congressional Inquiries

The House Oversight and Investigations Subcommittee held a hearing on April 15th of this year regarding the distribution of contaminated Heparin. A follow-up hearing took place on April 22nd at which time the committee asked FDA Commissioner Andrew von Eschenbach how the agency will address concerns regarding its efforts to inspect foreign drug facilities.

On April 29, 2008, yet another hearing was held, at which Mr. Robert L. Parkinson, Jr., CEO of Baxter International, gave testimony wherein he depicts Baxter’s heparin manufacturing process, including its affiliation with the Scientific Protein Laboratories’ API manufacturing facility in Changzhou, China, describes Baxter’s February 2008 heparin recalls, and explains Baxter’s investigation of the contamination and its attempts to correct the problems that may have contributed to the contamination.

Mr. David Strunce, CEO of Scientific Protein Laboratories also gave testimony. Mr. Strunce testified as to the background of his company, its heparin production, and the recent contamination of heparin from the SPL plant in China.

The Committee has posted these and other prepared testimony on its website including that of Mr. David Nelson, Senior Investigator for the Committee, who posited: “An obvious question that must be asked in relation to FDA’s inspection findings is why Baxter obtained drug product from a facility that FDA found to be unsuitable? More specifically, what due diligence did Baxter perform to determine that it could safely manufacture heparin API for the U.S. market before using this facility?”

If you, or someone you love, have been injured using Baxter Heparin and would like the attorneys at Nolan Law Group to review your case, please contact us.

Nolan Law Group Litigation Status

April 1, 2008: Lawsuit is filed by Nolan Law Group in the Circuit Court of Cook County against Deerfield, Illinois-based Baxter International Inc. on behalf of Davenport, Iowa resident, Mark Scott who suffered the tragic loss of his wife, Melissa Scott.

April 4, 2008: Motion is filed of behalf of David D’ Amico to transfer and consolidate cases to the Southern District of Florida (Multidistrict Litigation “MDL”).

May 2, 2008: Nolan Law Group files lawsuit in Federal Court against Chicago-area pharmaceutical giant, Baxter International Inc. on behalf of Louisville, Kentucky resident, Artemus Banks.

May 2, 2008: Lawsuit is filed by Nolan Law Group in the Circuit Court of Cook County against Deerfield, Illinois-based Baxter International Inc. on behalf of Coeburn, Virginia resident, Angela Lawson-Greear.

May 09, 2008: Nolan Law Group files a motion in the District Court of Northern Illinois requiring Baxter International Inc. to preserve evidence.

May 15, 2008: On behalf of Atememus Banks, Nolan Law Group files response and memorandum in support of consolidation and transfer to the Northern District of Illinois.

May 27, 2008: District Court of Northern Illinois issues order to preserve all test results and data generated from tests and testing protocols possessed and controlled by Baxter International and a minimum of 10 vials from each finished lot of recalled Baxter heparin.

May 21, 2008: Nolan Law Group files a motion in the District Court of Northern Illinois requiring Scientific Protein Laboratories, LLC to preserve evidence.

May 29, 2008: Nolan Law Group presents oral arguments before the United States Judicial Panel on Multidistrict Litigation. Nolan Law Group maintains that the consolidation of the case is appropriate and that the Northern District of Illinois is the most suitable forum for the pre-trial litigation.

June 05, 2008: District Court of Northern Illinois issues order to preserve all test results and data generated from tests and testing protocols from recall-related testing of heparin sodium active pharmaceutical ingredient (“API”) possessed or controlled by Scientific Protein Laboratories as well as remaining samples from lot no. 1060-06-0038.

June 6, 2008: United States Judicial Panel rules that all lawsuits nationwide dealing with a contaminated blood thinner called heparin will be transferred to U.S. Northern District Court in Toledo before Judge James G. Carr.

July 7, 2008: The Judicial Panel on Multidistrict Litigation appoints Donald J. Nolan of Nolan Law Group to the Plaintiff’s Steering Committee as State Court Liaison.

July 14 2008: United States Northern District of Ohio issues order to preserve written or recorded communications, documents, electronically stored information and other tangible objects as well as all test results and raw data generated from tests and testing protocols possessed and controlled by Baxter International Inc., Scientific Protein Laboratories “SPL” and Changzhou SPL Co Ltd. The order also limits “Ongoing Destructive Testing” and constrains the destruction of Chinese-sourced crude heparin.

September 24, 2008: Nolan Law Group sends a Freedom of Information Act (FOIA) request to the Food and Drug Administration (FDA), requesting that the FDA provide documents relating to contaminated Baxter heparin, specifically any document that relates to Baxter heparin known to be received by patients.

September 29, 2008: Attorneys for Nolan Law Group attend an initial status hearing before the Honorable Judge Jennifer Duncan Brice in Chicago, Illinois, to discuss heparin related cases filed in the Circuit Court of Cook County, Illinois. The next status is scheduled for November 20, 2008.

September 29, 2008: Donald J. Nolan is appointed by the Circuit Court of Cook County, Illinois as Plaintiffs’ Lead Counsel, to coordinate the activities of plaintiffs filing suit in Cook County during pretrial proceedings.

If you, or someone you love, have been injured using Baxter Heparin and would like the attorneys at Nolan Law Group to review your case, please contact us.

Recent Filings

Baby O. was born March 9, 2007 with choroid plexus carcinoma (brain tumor). He underwent surgery to remove the entire tumor and began chemotherapy in April. To administer his treatment, doctors inserted a broviac catheter that was flushed with heparin twice daily to prevent the catheter from clogging. Until September 2007, Baby O. was responding positively to chemotherapy and was showing signs of improvement. Late that month, however, he suddenly began suffering from respiratory distress, went into renal failure and ultimately passed away on November 19, 2007. Baby O.’s physicians were baffled by the sudden unexplained deterioration in his condition.

On August 26, 2008, Nolan Law Group filed a wrongful death case in the Circuit Court of Cook County, Illinois, located in Chicago, against Baxter International, Inc. and Baxter Healthcare Corporation.

In January of this year, Little Girl B was diagnosed with a subdural empyema (pus on the brain sometimes caused by sinusitis). Little Girl B underwent surgery with no complications that successfully removed the pus. After the procedure, physicians inserted a Peripherally Inserted Central Catheter (PICC line) for antibiotic medication to prevent post-surgery infection. The PICC line was flushed with heparin to keep the antibiotics free-flowing. Doctors expected Little Girl B to fully recover, but soon after they began administering heparin flushes, Little Girl B. developed a high fever and was re-hospitalized. Blood tests came back negative for infection despite Little Girl B.’s increasing symptoms which included a rash, very low blood pressures, nausea,
vomiting and seizures. Little Girl B. passed away on February 9, 2008.

Nolan Law Group filed suit in the Circuit Court of Cook County, Illinois against Baxter International, Inc. and Baxter Healthcare Corporation on October 7, 2008.

Recent Heparin News/Articles/Links

Despite previous beliefs that Heparin contaminated with over sulfated chondroitin sulfate was in circulation in the United States beginning in the Fall of 2007, new information confirms that several manufacturers received contaminated heparin API (active pharmaceutical ingredient) from Scientific Protein Laboratories, L.L.C. as early as December 2006.

This means that contaminated finished heparin could have been ingested by patients in the U.S. earlier than Fall of 2007. Companies who received contaminated Heparin API before Fall of 2007 include B. Braun, Covidien, Becton Dickinson, Beckman, Emisphere, and Medefil.

Heparin Taint Tied To Deaths
Chicago Tribune, July 30, 2008, by Bruce Jaspen

In this article, the FDA reports that it conclusively linked three deaths to contaminated heparin. However, the FDA’s review encompassed 93 reports of death related to heparin, which were received only during the period of time from January 1 -March 31 of 2008. Many other deaths that may be related to contamined heparin occurred outside of this window.

Also, the three conclusively linked deaths came from a group of 10 where reports indicated the patients suffered anaphylaxis or hypotension. The lot numbers for the remaining 7 in the group were not known, and so were not conclusively linked. This doesn’t necessarily mean they were not caused by contaminated heparin.

Furthermore, the remaining 83 of 93 reports of death were not irrefutably ruled out and are considered “still in the gray zone.” A number of the reports, submitted to the FDA by medical providers or other individuals, lacked sufficient inforamtion to specify the cause of death with “clinical certainty” which reports were the sole source of the FDA’s determinations.

Hospitals Kept Tainted Drug on Shelves, Statewide Probe Targets Pharmacists, Care Facilities, Heparin Recall,
Los Angeles Daily Journal, August 20, 2008, By Evan George

Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact System
New England Journal of Medicine (NEJM), April 23, 2008, by Takashi Kei Kishimoto, Ph.D., et al.

This article, authored by numerous people including Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research, reported that there is a biological link between the contaminant recently found in Baxter International, Inc.’s supply of Heparin, and adverse symptoms that recipients of Baxter Heparin have experienced. These symptoms are listed above in the section of this website titled: “Symptoms Experienced After Receiving Contaminated Heparin.”

On September 18, 2008, however, in response to the NEJM article, various authors pointed out that the contaminant may also cause symptoms that are “indistinguishable from Heparin-Induced Thrombocytopenia”, more commonly referred to as “HIT.” HIT is a relatively common allergic-type reaction to heparin, discovered in the 1970’s, that occurs in some patients who receive non-contaminated Heparin. Patients can be tested for HIT after showing certain symptoms including a low platelet count, bruising, loss of circulation to the hands and feet, gangrene, bleeding, and blod clots.

Readers should be aware that the symptoms of HIT may also indicate that an individual received contaminated heparin.

Legal Rights

If you or someone you love have been injured from the use of Baxter recalled Heparin, you have the right to file a legal claim. Our attoneys can help you determine if you have a case and how to file a claim. All claims are handled on a contingency fee basis, meaning you do not have to pay attorney fees unless you are awarded compensation.

If you would like the attorneys at Nolan Law Group to review your case, please contact us.