PolyHeme Lawsuit
The February 22, 2006, Wall St. Journal carried a front-page article about reported health risks of PolyHeme, a blood substitute made by Northfield Laboratories, Inc.
The article says that Northfield "quietly shut down" a trial in which 10 of 81 patients who received PolyHeme suffered heart attacks within 7 days, compared with none of 71 recipients of real blood. According to the article, the company did not publicly disclose the results. The company states that it "did not allocate resources to publication."
Now the Food and Drug Administration is allowing the company to test the drug on potentially hundreds of trauma patients, many of whom will be unconscious and unable to give or deny informed consent. In order to avoid receiving the product, a person must be wearing a blue wristband when they are brought into the ER (or have someone with the knowledge and authority to refuse the treatment on their behalf).
Scientists have long sought a substitute for real blood. Real blood needs refrigeration, carries a risk of infections and must be refrigerated. In addition, it must be typed and matched to the patient's blood to avoid the risk of fatal clotting. The ideal artificial blood would have none of these properties, and could be administered in ambulances or on the battlefield.
Unfortunately, artificial bloods tend to irritate the blood vessels and consequently cause heart attacks.
Some day a safe artificial blood will be developed, but
many believe that PolyHeme is not that product.p>
...The complaint...alleges that the Company failed to disclose that a significant portion of patients taking PolyHeme
in a clinical study suffered heart attacks and two patients died, within seven days of taking PolyHeme -- as compared
to zero heart attacks from patients receiving real blood in the same study.
A class action lawsuit has already been filed on behalf of Northfield shareholders....
William Hoffman, chief of cardiac surgery / critical care at Mass. General Hospital, said, "In my opinion, it
would be irresponsible and unprecedented to grant an approval for PolyHeme based on these data."
Northfield Labs considers the test results to be "preliminary" and plans to continue its attempt to get
approval for the product.
A class action lawsuit was filed in the United States District Court on behalf of all securities purchasers of Northfield
Laboratories Inc., the makers of Polyheme.
A class action has been commenced in the United States District Court on behalf of all persons who purchased or
otherwise acquired the publicly traded securities of Northfield Laboratories, Inc.
An investor sued Northfield Laboratories, Inc., today in federal court, accusing the Company of securities law violations.
The firm has filed a class action lawsuit in the United States District Court against Northfield Laboratories Inc.
On April 10, 2006, Northfield Labs filed this release which discusses
PolyHeme, litigation and company
financial status.
April 12, 2006, The law firm of Milberg Weiss Bershad & Schulman LLP announced that a class action lawsuit was filed
yesterday on behalf of purchasers of the securities of Northfield Laboratories, Inc.
April 13, 2006, (CBS4) DENVER Denver is one of 32 cities across the country using a blood substitute as part of a field
study. That experimental blood product, known as PolyHeme, has been coming under fire from lawyers and medical critics.
Denver Health and its ambulances are taking part in the nationwide study that gives some trauma patients PolyHeme.
NEW YORK, May 1, 2006 (PRIMEZONE) -- Pomerantz Haudek Block Grossman & Gross LLP ("Pomerantz")
(www.pomerantzlaw.com) reminds investors of Northfield Laboratories Inc. ("Northfield" or the "Company") (Nasdaq:NFLD)
that May 16, 2006 is the deadline to ask the Court to appoint you as lead plaintiff for the class. Pomerantz filed a class
action lawsuit in the United States District Court Northern District of Illinois, Eastern Division against Northfield, on
behalf of purchasers of the common stock of the Company during the period from February 20, 2004 to
February 21, 2006.
May 12, 2006 | The complaint alleges that in press releases, SEC Filings and on the company's website,
Defendants represented
that PolyHeme is a human hemoglobin-based temporary oxygen-carrying red blood cell substitute, which
simultaneously restores lost blood volume and hemoglobin levels and is designed for rapid, massive infusion.
PolyHeme requires no cross-matching and is compatible with all blood types. Beginning in 1998, Northfield started
a Phase III elective surgery trial with PolyHeme known as the Acute Normovolemic Hemodilution clinical trial
(the "ANH clinical trial"). The study was designed to assess whether the use of PolyHeme would allow an increase
in the volume of autologous blood collected during ANH and therefore avoid transfusion of donated blood.
Unbeknownst to investors, however, Defendants failed to disclose the full study results of the ANH clinical trial,
which revealed that ten of eighty-one patients who received PolyHeme experienced myocardial infarction, two of
whom died.
June 30, 2006 | Beginning June 30, drug manufacturers will be required by the Food and
Drug Administration to provide more concise and better organized
patient information package insert sheets. Any drug approved within the last five years will have new
requirements implemented gradually over the next seven years.
New evidence related to the drugs will be updated and available online free of cost to healthcare
professionals and consumers at http://dailymed.nlm.nih.gov.
Dr. Dominick Trombetta, assistant professor of pharmacy practice at Wilkes University in Wilkes-Barre, Pa.,
believes this is a positive step in improving medication use, but has concerns about the current label changes
that will make it more difficult to sue drug manufacturers over product liability. "FDA's response to drug
manufacturer's concerns over increased liability was to include wording that would exempt them from state
product liability," a decision that Trombetta anticipates will be challenged in court.
Though Dr. Trombetta believes the FDA's new rules are a positive step in improving medication use if fully
utilized, he calls the limitations on product liability "extremely disturbing."
CBS4boston | July 13, 2006: ...Northfield Laboratories Inc., is wrapping up clinical trials begun in 2004 of another product, called
Polyheme, amid ongoing ethical concerns. Polyheme is being given to trauma patients without their
consent as they're being whisked to -- and later, at -- more than 20 hospitals around the country.
Motley Fool | July 10, 2006: ...At this point in the PolyHeme trial, I'm left scratching my head as to why 20/20 ran
the story. In the next few weeks, Northfield will have completely enrolled its final patients in the phase 3 trial.
NEW YORK, July 28, 2006 (PRIMEZONE) -- The Rosen Law Firm announces that the U.S. District Court has set a
deadline of August 16, 2006 for investors to file applications to serve as lead plaintiff in the consolidated class
action against Northfield Laboratories, Inc...
Wall St. Journal | December 20, 2006: An article in the Wall Street Journal of Dec. 20 reports that preliminary
findings are that Polyheme caused more deaths than did standard treatment. In a study of trauma patients, 46
died after receiving Polyheme compared with only 35 who died after receiving standard treatment of saline
solution and donor blood.
Wall St. Journal | February 13, 2007: For the FDA to approve Northfield's blood substitute, the agency would have to look past
a series of trial results in which blood substitutes were linked to higher deaths than standard therapies. This includes results
of a major study that has not been reported until now.