May 14, 2008 — /PRNewswire/ — CHICAGO, IL — Last month a lawsuit was filed against Deerfield, IL-based Baxter International Inc. on behalf of Davenport, IA resident, Mark Scott who suffered the tragic loss of his wife, Melissa Scott, on Nov. 30, 2007. The complaint was filed on April 1, 2008 in the Circuit Court of Cook County by Nolan Law Group and alleges that Melissa Scott’s untimely death was caused by her exposure to heparin sodium injection therapy. The complaint cites two counts of product liability and negligence on the part of Baxter International.
The lawsuit filed by Nolan Law Group and Mark Scott asserts that Baxter International was responsible for the manufacture, sale, and distribution of a product containing toxic chemicals. It also claims that the product was manufactured with insufficient amounts of the active pharmaceutical ingredient (API) and that Baxter International failed to provide adequate warnings or instructions to assist users in identifying adverse reactions.
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.
It was around this same time that the Food & Drug Administration (FDA) issued its initial Public Health Advisory warning doctors and other health practitioners not to use Baxter heparin products. The report stated that serious injuries and deaths have been associated with the use of heparin. The adverse effects have included allergic or hypersensitivity-type reactions with symptoms such as low blood pressure, shortness of breath, nausea, vomiting, diarrhea, and abdominal pain and death.
Since the original complaint was filed, 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 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. Additionally, the FDA investigation revealed more information about inadequate testing and supply-chain issues associated with the Baxter heparin.
Raw heparin is often processed by small, unregistered “mom-and-pop” workshops in China. However, the key to establishing causation in the Scott 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 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.
Scott has been appointed special administrator of his wife’s estate and, as such, is seeking personal and pecuniary damages from Baxter International Inc. for the loss of his wife in a sum in excess of the minimal jurisdictional limits of the Cook County Circuit Court.
Source: Nolan Law Group