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On May 8, 2009, Beebe Medical Center officials announced that at least five patients had bad reactions from the use of pre-mixed bags of heparin from Baxter Healthcare Corp. Heparin is a blood thinner and used prevent clots, has been suspended, officials said.

One patient was transferred by air ambulance to Christiana Care Health System and two patients were flown to the University of Maryland Hospital. Additional patients are being closely monitored at Beebe.

Officials said they have informed the manufacturer, the FDA and the Delaware Health Care Operations Center. Wally Hudson, vice president of Beebe’s corporate affairs, said the three patients suffered internal bleeding, but tests on two other patients with similar symptoms ruled out internal bleeding.

“The patients affected experienced internal bleeding,” he said. “We started to see it overnight, and because of the nature of the bleeding, we (needed to transport the patients to other facilities).”

Hudson said hospital officials have received no updates from other medical centers regarding patient conditions. Contents of the bags have been sent off for testing.

“I’m not saying these were tainted bags of medicine,” he said. “What I am saying is we’ve had some unusual patient outcomes and (the heparin seems to be) the common denominator.”

Hudson said an investigation will be conducted as to what caused the patients’ reactions.

Rehoboth Beach resident Walter Brittingham said in most cases Beebe gives “excellent service.”

“Have I or my family encountered problems as a patient or patients at Beebe, yes,” he said. “But all in all, I think they offer good care.”

A spokeswoman for Baxter said the company has not received similar reports from any other institutions and was working with Beebe to establish what happened. The spokeswoman also said that premixed bags such as those involved in the incident were not part of last year’s heparin product recall, which was made after increased reports of adverse reactions.

On May 6, 2009, The Wall Street Journal discusses how Rep. Joe Barton, R.-Texas, is pressing the FDA for additional information regarding contaminated heparin from China amid concerns that the agency doesn’t know what caused U.S. patients to get sick or die while taking the blood thinner last year.

Barton, the ranking member on the House Energy and Commerce Committee, wants the FDA to turn over any databases that show heparin was contaminated, according to a letter sent to Acting FDA Commissioner Joshua Sharfstein.

In early 2008, the FDA began investigating heparin, essential for procedures such as cardiac surgery, after receiving hundreds of reports of allergic reactions and dozens of deaths in patients who had taken the blood thinner.

The FDA has said the raw heparin came from factories in China and was purposefully contaminated, for economic reasons, with a man-made chemical called over-sulfated chondroitin sulfate, or OSCS. Chinese drug officials have disagreed with the FDA, saying OSCS may not be responsible.

The FDA’s handling of the issue has drawn scrutiny, especially from Barton. He has asked the investigative arm of Congress, the Government Accountability Office, to investigate the FDA’s response to the heparin affair. The GAO said it recently began its investigation but couldn’t provide a time frame for when it would be finished.

Barton wants to know if the FDA tracked the origins of the contamination and whether the agency has sought assistance from the Chinese government. He also wants to know what actions, if any, the Chinese government has taken related to the contamination.

A Republican staffer for the Energy and Commerce Committee said Barton is trying to determine whether anyone in China has been held responsible for contaminating heparin that ultimately sickened and killed U.S. citizens.

“We don’t seem to be any further along a year later from understanding” this issue, said the staffer, who asked not to be named. “What are they doing about it? Is this an acceptable practice in China?”

The heparin issue doesn’t seem to be going away. Last month, the FDA publicized documents showing two Chinese-based companies shipped contaminated heparin to the U.S. between 2007 and 2008 and one lied to federal health regulators about their role in the matter. It was the first public disclosure of the firms involvement in the heparin matter.

On May 1, 2009, the agency held a public hearing to better understand how to prevent people from contaminating products for economic reasons.

Barton wants the FDA to respond to his letter within two weeks.

On December 15, 2008, Dennis Quaid and his wife Kimberly reached a settlement with Cedars-Sinai Medical Center for $750,000 over a medication error last year that nearly killed the couple’s twin infants.

Nurses at the hospital mistakenly gave twins Thomas Boone and Zoe Grace 1,000 times the recommended dose of the blood thinner heparin, leaving them vulnerable to uncontrolled bleeding and leaving them, for a time, in critical condition.

Cedars-Sinai Medical Center was not sued, though the hospital was described in a court filing as a “potential defendant.”

Hospital officials have cited at least three safety lapses that led to the overdoses.

The couple has a pending lawsuit against Baxter Healthcare Corp., alleging that the labeling and design of heparin led to the massive overdose. The suit alleges that the company knew other infants had died as a result of errors involving the drug but failed to recall the high-concentration vials.