A group of people whose spouses have died from Heparin use have filed a class action suit against the maker of the blood thinning drug, claiming the company is substituting safer ingredients - cooked, dried pig intestines - with more dangerous ones.
Linda Chapman of South Carolina is among a group of 28 suing Baxter over its anticoagulant drug Heparin in St. Clair County Circuit Court.
She and the group claim the company began substituting a more dangerous ingredient to "reap greater profits as a result of utilizing cheap component parts."
She and other plaintiffs will be represented by John J. Driscoll of St. Louis, by Christopher Cueto of Belleville and by Robert L. Salim of Nachitoches, La.
Baxter began making the drug from enzymes found in pork intestines, according to the complaint filed Feb. 23.
It takes about 3,500 pigs' intestines to produce 2.2 pounds of raw Heparin, the suit states.
Once intestines are gathered from slaughtered pigs, intestines are cooked.
After the intestines are dry, a granular substance called crude Heparin emerges, according to the complaint.
"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."
On March 5, Baxter found a much cheaper way to produce the drug, the suit claims.
The company discovered a molecule similar to Heparin in Heparin Sodium, according to the complaint.
"On or about March 19, 2008, and prior thereto, the heparin-like molecule contaminant in Heparin products was identified as over-sulfated chondroitin sulfate (hereinafter "OSCS")," the suit states.
OSCS mimics Heparin's activities, and Baxter began to use it to dilute or to substitute for the active pharmaceutical ingredient in Heparin, according to the complaint.
OSCS costs only $9 to produce compared to the $900 it takes to produce heparin, the suit states.
However, OSCS is not found in nature and is not approved in the United States, Chapman and the group allege.
"Un-approved API's 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."
When there was an abnormal increase in the number of reports of adverse patient reactions associated with the use of Heparin, Baxter issued press releases regarding a voluntary recall of nine lots of Heparin Sodium Injection multiple dose vials on Jan. 17, according to the complaint.
Then, on Feb. 28, Baxter expanded the recall to include all lots and sizes of its multi-dose vials of Heparin Sodium injection, single-dose vials and Heparin lock flush products, the suit states.
The FDA made an announcement on March 19 that the mysterious contaminant in Heparin was an inexpensive, unapproved ingredient altered to mimic the real ingredient, Chapman and the group claim.
As of April 8, there have been 103 reported deaths in patients who received Heparin since Jan. 1, 2007, the suit states. Of those deaths, 91 were reported after Jan. 1, 2008, the suit states.
"On or about July 30, 2008, the FDA 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."
For the most part, Heparin is manufactured in China and in Wisconsin, according to the complaint.
But China has not met the requirements for importation and sale in the United States, which includes an inspection and approval by the United States Food and Drug Administration, the suit states.
When inspectors went to visit China's facility, they reported there had been no critical processing steps identified for Heparin Sodium USP process, there had been no impurity profile established for Heparin Sodium and no evaluation for degradants, the manufacturing instructions were incomplete and there had been no test method verification performed for the reported USP test methods, Chapman and the group claim.
In addition, inspectors found Heparin crude lots received in August 2006 included material from an unacceptable workshop vendor, that raw material inventory records were incomplete, that control of material flow in the processing area was inadequate, that certain outer foil bags containing Heparin Sodium were no labeled and that there was no report or data to show the leachable for certain bags used to Heparin Sodium had been evaluated, according to the complaint.
Chapman, whose deceased husband was given Heparin and died of its use, claims Baxter's conduct showed "reckless indifference to the interest of others."
"The Recalled Heparin was adulterated, misbranded, defective, unreasonably dangerous and unfit for its intended uses," the suit states. "Baxter placed tens of thousands of patients, including the Plaintiffs, at unnecessarily risk of serious injury and/or death."
Baxter wrongfully allowed the Heparin to be placed on the market, Chapman and the group allege.
It also breached its express warranties that Heparin had no dangerous side effects and that its ingredients were manufactured in a plant in accordance with FDA regulations, according to the complaint.
Baxter represented to the plaintiffs and their doctors that Heparin was safe and of merchantable quality when the drug was not fit for its intended use, the suit states.
"The Defendants knew or should have known that it was foreseeable that users of their Heparin, such as Plaintiffs' Decedents, would suffer injury or death as a result of Defendants' failure to exercise ordinary care as described in the foregoing," the suit states.
In the six-count suit, Chapman and the group of plaintiffs are seeking a judgment in excess of $300,000, plus costs and other relief deemed proper.
St. Clair County Circuit Court case number: 09-L-0094.