San Antonio Personal Injury Lawyer - Heparin

Jury Awards 10 million in Heparin Case

Beth Janicek — Sat, 04 Jul 2009 13:50:37 GMT

In Houston, Texas, a jury recently awarded 10 million in a medical malpractice case against Methodist Hospital and the doctors who treated John German. He sustained an amputation of his left leg above the knee, all the toes on his right foot and all of his fingers following heart surgery. The lawsuit claimed the hospital nurses failed to properly monitor him after he had been administered Heparin. He had a reaction commonly referred to as HIT, heparin-induced thrombocytopenia. The hospital claimed the nurses had not done anything wrong and had helped save Mr. German’s life. Apparently, the jury did not agree.

The jury award will help provide for the extensive medical care Mr German will have in the future.

As he stated,” It’s like closing a painful chapter in my life, even though I have to live every day like this.”

The hospital intends to appeal the case. Hopefully, the verdict will stand on appeal. I have blogged in the past about the devastating damages which result from HIT and the importance of the medical community to be vigilant in monitoring patients following heart procedures. This Texas jury has sent that message to the medical community.

Originally posted at InjuryBoard by Beth Janicek

Two Die at Delaware Hospital After Taking Heparin

Beth Janicek — Fri, 15 May 2009 11:57:02 GMT

Medical care providers at a Delaware Hospital and U.S. health officials are investigating the deaths of two patients that may have been related to a brand of heparin blood thinner Baxter Internal Inc. The U.S. Food and Drug Administration said that the situation “appears to be an isolated incident.”

Although there is no specific evidence tying heparin to the illnesses, use of Baxter’s heparin has been suspended at Beebe Medical Center where adverse reactions were reported in five patients. Erin Gardiner, Baxter spokeswoman said that they “have not received any similar reports of adverse events from any other hospital regarding this widely-used product.

Last year after roughly 80 deaths were linked to contaminated heparin, Baxter recalled the medicine from several companies. Heparin is used largely before kidney dialysis and before major surgeries such as heart operations. The heparin used in these patients at Beebe Medical Center came in pre-mixed bags and was not the same product sold in vials that was part of the global recall last year. The heparin came from a North American derived bulk material supplied by Pfizer and not from the heparin Baxter claimed was altered in the China-based supply. Pfizer, based in New York, has not received any other reports of adverse reactions from heparin.

The two patients in Delaware, a 71-year old man and a 64-year old woman, did not have severe hypertension, or low blood pressure like the earlier cases. The symptoms involved intracranial bleeding. Wallace Hudson, Beebe Medical Center spokesman said, “We are not pointing fingers at Baxter. We don’t know what’s going on, but heparin is the only commonality that we were able to see ourselves.”

The hospital informed Baxter on Friday that the patients had become ill, and the company immediately contacted the Food and Drug Administration. The FDA sent medical teams to Delaware, and an FDA agent drove samples of the heparin bags directly to an agency laboratory in Queens, NY. The FDA spokeswoman, Karen Riley said, “Results of product testing to date by FDA and Baxter have not revealed any problems.”

Heparin has caused a flurry of litigation involving contaminated heparin and the allergic reaction, heparin induced thrombocytopenia, HIT. The injuries have been devastating. Our office is currently handling heparin related cases and would be happy to answer any questions.

Originally posted at InjuryBoard by Beth Janicek

Rep. Barton Questions FDA Investigation of Heparin

Beth Janicek — Tue, 06 Jan 2009 12:06:40 GMT

The controversy surrounding the drug Heparin has been unfolding over the past year with reports of drug recalls and deaths and injuries as a result of contaminated Heparin. It appears, however, that some of the reports the public has been receiving contains conflicting information.

The Food and Drug Administration (FDA) began their investigation this year after news of patients having allergic reactions to Heparin. In May, the FDA contributed three deaths to the drug. In December, three officials from the FDA reported in the New England Journal of Medicine that there have been no deaths resulting from Heparin. This is puzzling because in October the FDA sent a letter to Representative Joe Barton of Texas stating that of 16 deaths involving heparin they investigated, the FDA found heparin to be the “possible” cause of death in three cases and the “probable” cause of death in one case.

As a result of this conflicting information, Rep. Barton sent a request to the Government Accountability Office (GAO) asking them to review the FDA’s handling of the heparin issue. In his letter Rep. Barton also points out that the FDA linked one of their “probable” heparin related deaths to drugs made by the American Pharmaceutical Partners APP company, but the APP drugs were never implicated in the heparin recall and the companies own investigation found no links from the heparin they manufactured to the deaths reported. For more details, a copy of Rep. Barton’s letter to the FDA can be found here.

In the end we have medical journals, pharmaceutical companies, and the FDA giving conflicting information about Heparin and the risks it poses to patients. The public deserves clear answers and thorough investigations when it comes to potentially deadly drugs. Maybe Rep. Barton’s letter will initiate some discovery into the truth on Heparin.

Originally posted at InjuryBoard by Beth Janicek

Tainted Heparin Seized by Federal Marshals

Beth Janicek — Fri, 07 Nov 2008 15:20:35 GMT

I have blogged in the past on contaminated heparin and found this recent article very interesting as a follow up to the contaminated heparin issue.

The Food and Drug Administration (FDA) sent federal marshals into a Cincinnati based manufacturer, Celsus Laboratories, to seize 11 lots of heparin, a blood-thinning drug. The FDA had asked the manufacturer twice to recall the contaminated heparin but received no cooperation.

Large amounts of Chinese raw heparin imported into the United States were contaminated with oversulfated chondroitin sulfate. The tainted blood thinner which is given during heart surgery and kidney dialysis was blamed for nearly 250 deaths and hundreds of allergic reactions.

Heparin sodium is given to patients as a blood thinner and heparin lithium is used to coat medical devices. Two pounds of heparin sodium and 31 pounds of heparin lithium were seized. The heparin that was seized was worth $112,000.00 which represented a portion of the 11 lots which had already been shipped to other manufacturers.

FDA said in a release that it has also advised manufacturers who might have bought heparin from the company to contact the agency to make sure they don't have any of the contaminated heparin. "The product does not meet acceptable quality standards," the agency said.

If you or a loved one has been injured by contaminated heparin or had an allergic reaction to heparin, contact my office as we are currently litigating several cases regarding heparin.

Originally posted at InjuryBoard by Beth Janicek

HEPARIN, CONTAMINATED HEPARIN and HEPARIN-INDUCED THROMBOCYTOPENIA

Beth Janicek — Thu, 26 Jun 2008 08:23:00 GMT

I have been discussing in my recent blogs Heparin, Heparin contaminated products and HIT. The FDA has come up with the following helpful Q & A to help educate the public. The following are some important questions posted by the FDA:

1. What is the contaminant?

Oversulfated chondroitin sulfate (OSCS), a substance that mimics the biological activity of heparin, was identified as the contaminant.

2. Where is the contaminant found?

The contaminant was found in samples of heparin crude materials, heparin active pharmaceutical ingredients (API), and finished heparin drug products.

3. Is oversulfated chondroitin sulfate unsafe by itself or in combination with heparin?

The adverse events were reported in patients who received heparin contaminated with oversulfated chondroitin sulfate. The lab studies suggest that when oversulfated chondroitin sulfate is given alone or in combination to animals, similar adverse events occur (N Engl J Med 358;23 June 5, 2008 p2457) .

4. Have all heparin products used in the U.S. been tested for the contaminant?

The active pharmaceutical ingredient (API) used for products in the U.S. market has been tested for the contaminant. FDA has been working with manufacturers to analyze the heparin API used to manufacture the existing finished products. This testing will assure that no contaminated finished heparin products are available to the U.S. market.

5. How did the contaminant get into the product?

At this point, FDA does not know how the contaminant got into the heparin active pharmaceutical ingredient (API). The agency is continuing to aggressively investigate the situation.

6. Why does the contaminant cause serious adverse events?

The contaminant activates chemicals in the body called enzymes. These enzymes cause the body to make inflammatory mediators (chemicals that are released by immune cells). Inflammatory mediators can lead to some of the symptoms such as low blood pressure, abdominal symptoms and shortness of breath. This mechanism can explain many of the serious adverse events that occurred immediately after patients were given the contaminated heparin.

7. Has all contaminated heparin been removed from the U.S. market?

Since March 10, FDA has been screening and reviewing all imported heparin products. This gives FDA the opportunity to sample and test products that pose a significant risk to U.S. consumers. FDA can ultimately refuse and request the destruction of products that appear to be contaminated based on the testing. In addition, FDA has been working with manufacturers to retrospectively analyze heparin sodium API. These measures have resulted in a number of recalls to remove contaminated heparin products from the U.S. market.

8. I received the Baxter product in the past. Am I still at risk for a serious reaction?

The serious reactions have generally occurred rapidly; usually within minutes of when heparin was given. However, some patients undergoing cardiac procedures have developed very low blood pressures as late as an hour following the start of the heparin bolus. Other reports have noted adverse events of one kind or another that occurred even later than that. In this case, it is more likely that the adverse events that occurred right away were related to the heparin. So it is unlikely that an adverse event of this type will happen a long time after the heparin was given.

9. Are there any long-term health effects from exposure to the contaminant?

We do not know whether there could be long term health effects of the contaminant, since the contaminant was only recently discovered. The FDA is in the process of having this question investigated.

There is a distinct difference between contaminated heparin products and heparin inducted thrombocytopenia. There are two types of HIT, non-immune HIT and immune-mediated (HIT type II). Non-immune HIT occurs more frequently and is distinguishable by a mild decrease in platelet count but is not harmful to the patient. Immune-mediated HIT (HIT type II) causes a very low platelet count, is less common and patients who develop this are at risk for major clotting problems which can result in deep vein thrombosis (DVT), pulmonary embolism, heart attack or stroke. HIT usually occurs from five to 14 days after the start of heparin. For more information on HIT type II the following website is very informative: http://ndt.oxfordjournals.org/cgi/content/full/21/6/1721 .

Originally posted at InjuryBoard by Beth Janicek

HEPARIN SODIUM INJECTION MANUFACTURED BY BAXTER

Beth Janicek — Tue, 24 Jun 2008 16:57:52 GMT

I have recently made several posts regarding Heparin Induced Thrombocytopenia (HIT and/or HITT). As I am handling several cases related to HIT and/or HITT, in my research I have found several informative articles related to Heparin and it’s uses in medical treatment. In the next several days I would like share with you this information through my posts.

What is Heparin and what is it used for?

Heparin is a class of medication called anticoagulants, commonly referred to as blood thinners. Heparin makes an anti-clotting protein in your body work better, thus decreasing the clotting ability of the blood. Heparin is made from pig intestines and is available as a solution to be injected by IV or deeply under the skin; and as a dilute solution to be injected into IV catheters. The medication is used to prevent and treat blood clots in the veins, arteries and lungs. Certain types of surgery, including coronary artery bypass graft surgery, and in kidney patients before they undergo dialysis, commonly use Heparin prior to surgery.

Medical devices and some diagnostic testing products are manufactured using heparin. FDA is aware that some of these products have been affected by the recent contamination. Questions and Answers on Herparin, Medical Devices and In-vitro Diagnostic Assays.

In my blog in the upcoming days I will further discuss additional information from the Federal Drug Administrations (FDA) on Heparin and contaminated heparin.

Originally posted at InjuryBoard by Beth Janicek