Lawsuit: Heparin caused dialysis patient’s death

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Lawsuit: Heparin caused dialysis patient’s death

By BOB WHITE

bwhite@thenewsenterprise.com

CHICAGO – Attorneys seeking compensation and answers surrounding potentially deadly lots of the anticoagulant Heparin say a contaminated batch of the drug made its way to Elizabethtown last year and was administered to a hemodialysis patient who died the next day.

Franke Leon Isom, 59, of Webster, died Dec. 14, 2007, a day after he received the drug at Elizabethtown’s Woodland Dialysis Clinic.

When he experienced adverse symptoms, Isom was taken to Breckinridge Memorial Hospital where he later was pronounced dead by Dr. Peter Rives, according to staff and records at Alexander Funeral Home in Irvington.

A warning from Heparin’s distributor about possible adverse effects from the drug was issued a month later.

Attorneys with Chicago’s Nolan Law Group say the Heparin administered to Isom was among 55,000 gallons of blood-thinner contaminated with over-sulfated chondroitin sulfate (OSCS) during its manufacturing process in China, where most of the world’s Heparin originates.

The claim, filed on behalf of Isom’s estate Thursday in Cook County, Ill., is among more than 50 similar civil tort claims against the Wisconsin-based Heparin manufacturer, Scientific Protein Laboratories, and one of its major distributors, Baxter International Inc.

Isom’s suit — the most recently filed – claims Baxter and Scientific Protein Laboratories are responsible for allowing Heparin to reach hospitals and medical facilities, such as Woodland Dialysis Center, where it could be administered to patients.

Heparin is used as a blood-thinner in many medical procedures, with large doses given to patients undergoing heart surgery, moderate doses administered during hemodialysis and smaller doses used in minor medical procedures.

After Isom’s death and a highly publicized civil claim filed in January by actor Dennis Quaid, regarding an alleged overdose of Heparin given to Quaid’s infant twins, Baxter recalled nine lots, or about 10 percent of its annual production.

On Monday, the Associated Press reported a $750,000 settlement between the Quaids and a hospital that administered an overdose.

A February recall by Baxter ordered more of the drug to be pulled from hospital and medical facilities’ shelves.

In March, the U.S. Food and Drug Administration announced a link to contaminated Heparin and a Chinese manufacturer. Scientific Protein Laboratories owns a majority stake in that manufacturer, according to Tom Ellis, detective and spokesman for Chicago-based Nolan Law offices.

According to the FDA, there were 246 deaths blamed on contaminated Heparin between January 2007 and May 31, 2008. Of those reported deaths, 149  included patients experiencing allergic symptoms associated with OSCS – such as hypotension and swelling.

Ellis said contaminated Heparin reached all parts of the United States. While recalls were issued by Baxter, Ellis said lots from those tied to contaminated batches were found on the shelves of 92 California hospitals after March.

“This is probably just the tip of the iceberg for Elizabethtown,” Ellis said. “Per the February recall, some 55,000 gallons of Heparin may have been contaminated.”

No answer to Isom’s claim against Baxter and SPL had been filed as of Tuesday. Leslie Smith, the Chicago attorney representing Baxter and SPL on both federal and state cases, did not return calls as of Tuesday evening.

Michelle Murphy, spokes woman for Hardin Memorial Hospital, said HMH reacted quickly after the January and February  recalls – immediately removing all lots of suspected contaminated Heparin from the shelves.

“We have very stringent policies and procedures and we comply promptly with any mandatory recalls,” Murphy said.

State Medical Examiner Barbara Weakley-Jones said chondrointin sulfate occurs naturally in the body, but confirmed OSCS does not. OSCS is, however, found in medications designed to aid joint function, she said.

Weakley-Jones said she has not heard of any other deaths stemming from contaminated Heparin. Neither had coroners from Hardin and Breckinridge counties.

“But how would I know?” said Breckinridge County Coroner Tim Bandy. “These people are usually already sick and under a physician’s care.”

Bandy, as did Hardin County Coroner Dr. Bill Lee, said under situations such as Isom’s, where ongoing care was overseen by a physician, coroners don’t normally sign death certificates.

“Those are usually considered death by natural causes,” Lee said. “We only get involved when someone dies for unknown or unnatural reasons.”

Ellis said he’s seen “death by natural causes” and even “air embolism” noted as the cause of death in contaminated Heparin-related death cases.

Rives, who could not be reached for comment, no longer practices in Kentucky, according to multiple officials at medical facilities in Daviess, Meade and Breckinridge counties.

The chief administrator and regional director of Woodland Dialysis Center would not comment on Isom’s death, acknowledge if any patients had been exposed to contaminated Heparin, or discuss the lots of Heparin recalled. The two officials, instead, deferred to a spokesperson in California, for comment.

A statement released Tuesday night by California-based DaVita — parent company of Woodland Dialysis Center — failed to address any issue relating to contaminated Heparin or answer the two questions asked of it by The News Enterprise.

“At DaVita, quality patient care is our utmost concern. However, our existing corporate policies and the active nature of this litigation involving parties outside of DaVita, preclude us from making any further comment,” DaVita’s statement reads.

SPL issued a statement in March saying there was no intentional contamination of the Heparin. SPL spokesman Wayne Pines told the New York Times on March 6 there had been no evidence of tampering or counterfeiting uncovered.

Ellis said all “bad lots” of contaminated Heparin should by now have been removed from medical facilities’ shelves.

Along with the deaths, hundreds of patients claim to have survived after having adverse allergic reactions to OSCS, according to the FDA.

“No one can fix what’s already happened,” Ellis said. “And it’s a personal decision for anyone exposed to know if they could be subjected to some kind of long-term effect.”

Ellis said there has not yet been any answer to the question of long-term negative effects of Heparin contaminated with OSCS.

Bob White can be reached at (270) 505-1750.

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