The Heparin Disaster

Wednesday, December 17, 2008

WORLDFOCUS NEWS STORY ON CONTAMINATED HEPARIN

Today, Worldfocus editorial consultant Peter Eisner, the former deputy foreign editor of The Washington Post, reported on the deadly contamination of U.S. drugs produced overseas, including heparin.

This news program tells the story of a young couple, Alex and Ann Oryschak, whose infant son, Julien, may have been one of the hundreds of victims who died in late 2007 and early 2008 from tainted heparin that was produced overseas. Producing drugs overseas not only allows powerful drug companies, like Baxter (who sold much of the contaminated heparin), to fly under the FDA radar and avoid government regulation and oversight, but it is cheaper. However, when safety is sacrificed in order to increase corporate profits, there is still a price to be paid. It is Julien Oryschak, Bonnie Hubley, Randy Hubley, Dennis Staples, and the hundreds of others who have lost their lives, who have borne that cost.

We thank reporters like Knut Royce, Peter Eisner, legislators like Representative Bart Stupak, and others, who, like our firm, fight to publicly expose the dirty secrets of the drug industry and effectuate real change.

To view this latest news report by Worldfocus, click here. Also be sure to read Knut Royce's detailed story posted here.

Labels: Baxter, Baxter Heparin, China, Eisner, FDA, Heparin, heparin attorney, heparin lawsuit, heparin lawyer, Hubley, Oryschak, Oversight and Government Reform, Staples, Stupak, Worldfocus

posted by Pamela A. Borgess # 4:53 PM 0 Comments

Sunday, November 23, 2008

Questions Raised Over FDA's Investigation of Heparin Deaths

In a letter to the Government Accountability Office (GAO) dated November 19, 2008, Rep. Joe Barton questioned the adequacy of the FDA's ongoing investigation and evaluation of the recent heparin deaths, casting doubt on whether the FDA in fact has used all available postmarket surveillance tools when determining the likelihood that contaminated heparin caused patient fatalities. Specifically the letter states, “Based on the available information …there is a serious and potentially troubling question about whether FDA availed itself [of] all of its tools to conduct comprehensive surveillance of heparin deaths.” The letter also questions "whether [the] FDA has confounding or conflicting information about Heparin death cases that has not been made public." A copy of this letter is available by clicking here.

As first described in our July 30, 2008 blog, we also have questions concerning the conclusions reached by the FDA as reported to the Chicago Tribune and Nightline. For example, is the FDA investigating or supporting scientific studies to determine whether the contaminate, OSCS, and its resulting symptoms can cause, contribute to, or leave an individual susceptible to other complications leading to death, such as heart failure? (To date, the FDA admits that it has limited knowledge “since the contaminant was only recently discovered” and that all effects are not yet known. (See FDA Questions and Answers, updated 7/3/08.)) Without such studies, the FDA's conclusions may be premature.

Likewise, if the FDA requires additional information to determine whether additional deaths are related, why isn’t this information being gathered or at least requested from the providers or others who filled out the reports to make an adequate determination? For example, as we stated in our July blog, while we have filed multiple adverse-event reports of clients, to date WE HAVE NEVER BEEN CONTACTED BY THE FDA REGARDING THESE REPORTS, NEVER BEEN ADVISED OF THE STATUS OF THEIR INVESTIGATION, OR TOLD THAT ADDITIONAL INFORMATION IS NEEDED.

We have been contacted, however, by many caring lawmakers, journalists, and scientists who have not forgotten the victims of the heparin disaster. We commend and support their ongoing efforts to obtain answers and accountability from the FDA, Baxter and SPL.

Labels: Baxter, Baxter Heparin, China, Chinese, contamination, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, Hubley, nightline, OSCS, SPL

posted by Pamela A. Borgess # 8:57 PM 0 Comments

Friday, November 14, 2008

Hubleys and Staples Featured in Time Magazine

This week our clients, the Hubley Family and Johanna Staples, were featured in Time Magazine regarding the heparin disaster. To read this article, click here. We continue to be proud and honored to represent these brave individuals, who have selflessly agreed to share their private losses and suffering with the public so that the extent and severity of this tragedy may be exposed and hopefully, prevented in the future.

Labels: Baxter, Baxter Heparin, China, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, Hubley, Johanna Staples, Leroy Hubley, OSCS, Time

posted by Pamela A. Borgess # 4:38 PM 0 Comments

Thursday, July 31, 2008

HUBLEY FAMILY FEATURED ON NIGHTLINE

Last night, our client, Leroy Hubley, and his family, were featured on ABC’s television news program, “Nightline,” which discussed the heparin disaster. (07/30/08 Nightline, “Pharmaceutical Companies Must Take Responsibility.”)

The Hubley family, like hundreds of others, lost loved ones as a result of the contaminated heparin sold by Baxter, and supplied by SPL. The Hubley family not only lost their mother, Bonnie Hubley, but their 47 year-old son, Randy Hubley.

Previously on April 29, 2008, the Hubley family, along with Johanna Staples, (another client of Zoll, Kranz & Borgess who lost her husband, Dennis Staples), were invited to tell their tragic stories to the U.S. House Commerce Committee on Energy and Commerce at a hearing entitled, “The Heparin Disaster: Chinese Counterfeits and American Failures.” Video of this hearing is available by clicking on the links below.

Panel I (Witnesses: David Nelson, Senior Investigator for the Committee on Energy and Commerce, Colleen Hubley, Leroy Hubley, and Johanna Marie Staples)

Panel II (Witnesses: Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, Deborah M. Autor, Director of FDA’s Office of Compliance, and Regina T. Brown, Consumer Safter Officer of the FDA’s Division of Field Investigations)

Panels III and IV (Witnesses: Robert Parkinson, CEO and President of Baxter International, Inc., David Strunce, CEO of Scientific Protein Laboratories, Yan Wang, Ph.D., Vice President of Business Development and Research at Scientific Protein Laboratories, and Clive Meanwell, CEO of The Medicines Co.)

In addition, the written statements submitted to Congress by Leroy Hubley, Colleen Hubley Johanna Staples, and other witnesses, are available by clicking on their name below:

• Leroy Hubley
• Colleen Hubley
• Johanna Staples
• David Nelson, Senior Investigator for the Committee on Energy and Commerce
• Janet Woodcock, Director of the FDA’s Center for Drug Evaluation
• Robert Parkinson, CEO and President of Baxter International, Inc.
• David Strunce, CEO of Scientific Protein Laboratories
• Clive Meanwell, CEO of The Medicines Co.

We are proud and honored to represent these brave individuals, who have selflessly agreed to share their private losses and suffering with the public so that the extent and severity of this tragedy may be exposed and hopefully, prevented in the future.

Labels: Baxter, Baxter Heparin, FDA, heparin attorney, heparin lawsuit, heparin lawyer, Hubley, Johanna Staples, Leroy Hubley, nightline, OSCS, over sulfated chondroitin sulfate, Randy Hubley, SPL

posted by Pamela A. Borgess # 9:28 AM 0 Comments

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