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Baxter Heparin Recall and Injuries.

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Information on Adverse Event Reports and Heparin 6/19/08

Department of Health & Human Services Warning Letter 4/21/08

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The Heparin recall and injury lawyers at our firm are currently evaluating potential lawsuits on behalf of people injured by Baxter Heparin.   As of March 2008, Baxter Heparin had been linked to hundreds of serious and sometimes life-threatening reactions, including at least four deaths.  Our Baxter Heparin injury lawyers are offering free consultations to victims of the tainted drug and their families.  The Baxter Heparin injury lawyers at our firm will work hard to make sure people injured by this defective drug receive the compensation they deserve.

Call 800-LAW-INFO For Free Consultation with a Experienced Heparin Recall / Side Effects Lawyer

Heparin is a blood thinner, and the vital drug is used in surgery, dialysis, and to prevent blood clots in the bedridden.  Other drugs thin blood, but they do not work as quickly as Heparin, and their effects are not as easily reversed.  Baxter International manufactures about half of the multi-dose Heparin vials used in the US.

Baxter Heparin Recall

In January 2008, Baxter International recalled 9 lots of its 1000/unit mL multi-dose Heparin vials.  The Baxter Heparin recall was initiated after the company received 100 reports of serious allergy-type reactions in patients who had been administered Baxter Heparin.  Following the recall, Baxter said that it was suspending the manufacture of Heparin until the reason behind the reactions could be determined.

In mid-February 2008, the Food & Drug Administration (FDA) issued a Public Health Advisory warning doctors and other health practitioners not to use Baxter Heparin products.  According to the FDA, since the beginning of 2008, it has received 350 reports  of side effects linked to Baxter Heparin. The FDA also said that four patients had died after being administered the drug. The FDA said nearly all the reported reactions to Baxter Heparin had been in dialysis patients who received high doses of Heparin over a short time. The FDA cautioned that doctors who continued to use Baxter Heparin should use the lowest doses possible and administer it slowly. 

 
Finally, on February 29, the FDA announced that Baxter would be recalling all of its remaining Heparin products.  By this time, Baxter Heparin had been implicated in more than 400 life-threatening reactions and could have been responsible for as many as 21 deaths.  Baxter claimed that it had waited to issue the full-scale Heparin recall because the company wanted to avoid causing a Heparin shortage.  The Baxter Heparin injury lawyers at our firm contend that the company and the FDA erred in allowing this tainted drug to remain in circulation for so long, and we intend to hold Baxter accountable for its negligence. 

Heparin's Side Effects

Heparin's side effects involved a variety of symptoms including abdominal pain, decreased blood pressure, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnea, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, loss of consciousness, malaise, nausea, pallor, palpitations, paresthesia, pharyngeal edema, restlessness, vomiting/retching, stomach discomfort, tachycardia, thirst, trismus, and unresponsiveness to stimuli.  Our Heparin injury lawyers have determined that the drug involved in these reactions was defective, and that Baxter's failure to adequately regulate its suppliers contributed to the Heparin's defects.

Baxter Heparin Supplier Never Inspected by FDA

On February 14, 2008, it was revealed that a Chinese factory that supplied the active ingredient for Baxter Heparin had never been inspected by the FDA.  That ingredient is made by the Chinese facility, as well as a US plant, both owned by Wisconsin-based Scientific Protein Laboratories LLC.   At the time, the FDA said it did not know why the Chinese manufacturer had not been subject to an inspection.  Eventually, the FDA determined that the name of the Chinese plant had been mixed-up in the agency's database with another Chinese company, causing the FDA to overlook the required inspection.

 
At the same time, Baxter claimed it had inspected the facility during the previous six months and planned another inspection in the near future. Following the revelations about the lack of FDA inspections, Baxter International CEO Robert Parkinson said that the company did not know much about its Chinese supplier.  Parkinson tried to shift blame for the Heparin debacle to Scientific Protein Laboratories.  Our Baxter Heparin injury lawyers believe the response of Baxter's CEO is indicative of the negligent attitude the company took towards this drug, and we believe both Baxter International and Scientific Protein Laboratories are liable for injuries caused by the tainted Heparin.

 
When the FDA finally did conduct an inspection of  Baxter's Chinese Heparin supplier, it found serious deficiencies at the facility which the FDA detailed in a letter to the Chinese company.  The FDA cited the manufacturer for a number of violations, including:

·         Incomplete manufacturing instructions

·         Lack of critical processing steps or annual test results

·         Lack of an impurity profile for Heparin

·         Incomplete manufacturing instructions for Heparin Sodium USP

·         Investigations into failed lots were approved as complete, but no cause was listed

·         Inadequate control of material flow in the processing area

Baxter Heparin Found to be Contaminated

On March 5, 2008, both Baxter and the FDA announced that their respective investigations had found a contaminant in the active ingredient used in Baxter Heparin.  The FDA said its investigators found a contaminant in some batches of the active ingredient used in recalled Baxter Heparin. FDA Deputy Commissioner Janet Woodcock told reporters that the agency had not yet determined if the contaminant was responsible for the Heparin reactions. 

 
Independently, Baxter also said its investigators had found chemical differences in the active pharmaceutical ingredient used in lots of Heparin associated with the adverse reactions.  The company said its findings "suggest that the root cause may be associated with the crude Heparin, sourced from China, or from the subsequent processing of that product before it reaches Baxter".  Our Baxter Heparin injury lawyers believe that Baxter International's failure to insure that its Chinese supplier had been appropriately inspected by the FDA played a large role in the deplorable conditions that existed at that facility and allowed this contamination to occur.  This lack of inspection was also one of the main factors contributing to the Baxter Heparin reactions that seriously injured so many patients.

 
Other Baxter Heparin Problems

Our Baxter Heparin lawyers are also offering free consultations to victims of other Heparin injuries, including accidental overdoses.  In February 2007, the FDA and Baxter International issued a two-page safety alert warning of the fatal dangers of mistaking high 10,000 unit and low 10 unit dose vials of Heparin. The memo advised hospitals to double-check their inventory to ensure dispensing errors did not occur. The 2007 alert was issued after three infants died in Indiana when they were mistakenly given adult doses. In December 2007, actor Dennis Quaid and his wife named Baxter in a lawsuit after their newborn twins were mistakenly given potentially fatal overdoses of Heparin. In addition to the Quaid twins, at least six newborns and two other patients are known to have received an overdose of Heparin since 2001.

Other Heparin Side Effects

Our heparin injury lawyers are also offering free case evaluations to people injured by other heparin side effects.  Heparin can have serious side effects, so it is important that people being treated with heparin be carefully monitored.  Heparin should not be used to treat people with low numbers of blood cells called platelets in their blood, or who have previously developed a reduced platelet count due to treatment with heparin. Patients who are actively bleeding,  or those who are more prone to bleeding than normal, (for example, due to the blood clotting disorder hemophilia) should also not be given heparin. Patients with severe high blood pressure, peptic ulcer or bacterial infections of the heart valves or lining around the heart must also not be given heparin.  Heparin also cannot be used in patients who have had recent injury or surgery to the brain, spinal cord or eyes, or are due to have lumbar puncture or epidural anesthesia, or who have severe liver disease.

People being treated with heparin need to have regular blood tests, usually on a daily basis, to check the length of time it takes their blood to clot. This is so that the dose can be adjusted to ensure that the lowest effective dose is used at all times, thus reducing the risk of bleeding.  Heparin can sometimes cause the number of platelets in the blood to fall - a condition known as thrombocytopenia. If this happens, the heparin will need to be stopped and alternative treatment used. Heparin can also cause elevated levels of potassium in the blood.  This is called hyperkalaemia. Some people may be at a greater risk of this, for example those with diabetes or kidney problems, or people taking other medicines that can cause potassium to be retained in the body.

If you or a loved one suffered a serious injury after being administered Baxter Heparin, you have valuable legal rights.  Please fill out our online form or call us at 1-800 LAW INFO (1-800-529-4636) to discuss your case with an experienced Baxter Heparin injury lawyer / Attorney.