Illinois Pharmaceutical Manufacturer Named In Yet Another Heparin Lawsuit After Virginia Resident Dies
CHICAGO, Illinois (May 14, 2008) – The blood thinner Heparin continues to make headlines as more people are found to have suffered serious injuries and/or death after using the contaminated drug – a group of which appears to include several Virginia residents.
On Friday May 2, 2008, a lawsuit was filed against Deerfield, Illinois-based Baxter International Inc. on behalf of Coeburn, Virginia resident, Angela Lawson-Greear who suffered the tragic loss of her father, Thomas Troy Lawson, on February 13, 2008. This is the third lawsuit of its kind filed by Nolan Law Group and follows a recent finding by the Food and Drug Administration (FDA) identifying an unknown contaminant found in Baxter Heparin. Due to the enormity and severity of the contamination, the firm expects to file several similar cases in the near future.
The complaint was filed in the Circuit Court of Cook County by Nolan Law Group and alleges that Thomas Lawson’s untimely death was caused by his exposure to contaminated Heparin. The complaint cites multiple counts of Products Liability, Negligence, Breach of Warranties and Willful and Wanton Misconduct on the part of Baxter International and Baxter Healthcare Corporation.
The lawsuit filed by Mrs. Lawson and Nolan Law Group asserts that Baxter International and its wholly-owned subsidiary, Baxter Healthcare Corporation, was responsible for the manufacture, sale and distribution of a product containing toxic chemicals. It also claims that the product was manufactured with a contaminated API and that Baxter failed to recall the defective drug in a timely fashion.
Baxter’s Heparin has been implicated in more than 400 life-threatening incidents and may be responsible for as many as 81 deaths. In February 2008, Baxter initiated a voluntary recall of nine lots of Heparin Sodium Injection Multi-Dose Vials. According to Baxter International, they recalled the lots due to a spike in adverse reports associated with the use of Baxter Heparin Sodium Injections. After receiving additional reports of similar adverse reactions from other lots of their Heparin Sodium Injection Products, Baxter recalled their remaining multi-dose and single-dose vials, as well as HEP-LOCK Heparin Flush Products.
Prior to February 13, 2008, Thomas Lawson was receiving home dialysis for a medical condition and was prescribed Baxter Heparin as part of his Heparin Sodium Injection Therapy. Mr. Lawson used the product as prescribed but began experiencing numerous physical symptoms, such as wheezing, shortness of breath, coughing, dizziness, increased perspiration and sudden weakness. Mr. Lawson ultimately died as a result of his contaminated Heparin use.
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 which does not occur naturally during Heparin production.
Raw Heparin is derived from pig intestines and is often processed by small, unregistered “mom-and-pop” workshops in China. The key to establishing causation in this case, despite all of the issues with unsanitary conditions, etc., will be Baxter’s failure to perform a chemical test on the Heparin which would have been sensitive enough to identify the difference between Heparin and OSCS. The abhorrent conditions in China from where Heparin was being imported (and the fact that the FDA was not doing significant inspections) required the need for more sensitive testing.
According to FDA’s inspection, 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.
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.
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.
Angela Lawson has been appointed special administrator of her father’s estate and as such is seeking personal and pecuniary damages from Baxter International Inc. for the loss of her father in a sum in excess of the minimal jurisdictional limits of the Cook County Circuit Court.
Nolan Law Group is a Chicago-based personal injury law firm concentrating in aviation accidents, construction accidents, brain injury litigation, medical malpractice, premises liability, product liability, and trucking accidents.