Baxter Cited in Tainted Heparin Class Action

Madison, ILA class-action lawsuit filed this week not only seeks compensation for scores of patients harmed by tainted heparin, the claim sheds new light on the whole sordid story. For the first time, a manufacturer has been accused of altering the profile of the drug, in an attempt to reduce costs. The allegation is that Baxter—the pharmaceutical giant—altered an ingredient in heparin that flowed through heparin syringes to patients, resulting in pain and suffering, and sometimes death, to those affected.

When the tainted heparin story broke last year, the focus appeared to be on China as a source for the raw heparin, and the conditions inherent with the raw heparin industry that exists over there. And for a long while, the focus and accusations centered on crude, unregulated heparin sweatshops, operated in many cases by entire families that slaved away in horrid conditions, cooking up the swine intestines necessary to produce the raw ingredient.

It has also long been alleged that a heparin mimic, subsequently identified as over-sulfated chondroitin sulfate (OSCS), found its way into the adulterated heparin through Changzhou SPL, a Baxter-approved production facility owned by an American firm based in Wisconsin but located in China.

Up to this point it has been assumed that any perceived greed in the decrease of costs and the potential for increased profits through such use of a rogue ingredient, had its unexplained roots in China, and had little to do with Baxter.

Until now. The proposed class action lawsuit filed January 5th changes all that.

For the first time, Baxter has been accused of adulterating the tainted heparin in an apparent attempt to lower costs.

According to the lawsuit, Baxter has historically manufactured heparin from enzymes found in the intestines of pigs. The swine is slaughtered, and the intestines are cooked in an effort to extract the enzymes that serve as the basis for raw heparin. Once the cooked intestines are dry, a granular substance emerges. This is the crude heparin that forms the basis for the final product.

"The crude Heparin is then processed to remove impurities and results in the production of an API such as Heparin Sodium or Heparin Lithium," the suit states. "This processing may include, but is not limited to, fractional precipitation, purification and chemical treatment."

The suit goes on to reveal that upwards of 3500 pig intestines are required to produce 2.2 pounds of raw heparin. While the suit did not quantify heparin mass relative to value, it was alleged that it costs Baxter $900 to produce heparin the old-fashioned way.

But then, it is alleged, Baxter found a way to make that same amount of heparin for just $9. And the heparin mimic OSCS, according to the lawsuit, was the key.

Rather than simply acknowledging that OSCS had somehow found its way into its supply of heparin in some mysterious fashion, the lawsuit accuses Baxter of purposely using OSCS to dilute, or to substitute for the more costly, natural ingredient in heparin.

The lawsuit accuses Baxter of using a more dangerous ingredient to "reap greater profits as a result of utilizing cheap component parts."

The lawsuit notes that OSCS is not found in nature, and is not approved in the United States.

"Un-approved APIs significantly increases the likelihood that exposed patients will experience adverse side effects and reactions that can result from the un-approved doses," the suit states. "In other words, an unapproved API enhances the risk and danger."

As of April 8, there have been 103 reported deaths in patients who received tainted heparin since January 1st of 2007, the suit states. Of those deaths, 91 were reported after January 1st of last year.

"On or about July 30th, 2008 the (US Food and Drug Administration) conclusively linked the deaths of patients infused with heparin to specific lots made by Baxter," the suit states. "The specific lots of Baxter product tested positive for OSCS."

The lawsuit includes information, and accusations that have been made in the past, with respect to allegedly shoddy and lax conditions at a production facility in China. Inspectors reported a breakdown in critical processing steps identified for heparin sodium USP process, a lack of an impurity profile established for heparin sodium, and a lack of evaluation for degradents. Manufacturing instructions were found to be incomplete, and there had been no verification performed for the reported USP test methods.

Heparin crude lots received in August 2006 are said to have included material from an unacceptable workshop vendor, according to the suit. Raw material inventory records were incomplete, the control of material flow in the processing area was found to be inadequate, and a collection of outer foil bags containing heparin sodium were unlabeled. There was also no report or data to verify that the leachable for certain bags used for heparin sodium had been evaluated, according to the complaint.

Joyce Ann Osteen of Illinois filed the complaint in St. Clair County Circuit Court January 5th 2009, and will serve as the lead plaintiff in the proposed class action. A tainted heparin patient herself, she is seeking damages for her pain and suffering and is pursuing the four-count lawsuit in order to seek compensation and damages, attorney's fees and pre-judgment interest in an amount less than $74,999 per plaintiff or class member, the suit states.

Other lawsuits have been filed in relation to the tainted heparin issue, and much has been written with regard to the presence, and the ultimate identity of the heparin contaminant that has been making everybody sick. However, up until now China has always been painted as the lone bandit.

For the first time, someone is pointing a finger directly at Baxter…