Davis & Crump | The Heperin Recall and Injury Lawyers at the Law Office of Davis & Crump

HEPARIN

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

What is Heparin?

Heparin is a blood thinner 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 United States.

Baxter Heparin Recalls

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.

The Heparin reactions 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. It has been 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.

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 lawyers at the law office of Mark Davis 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.

Baxter Heparin Supplier Never Inspected by FDA

On February 14, 2008, it was revealed that a Chinese factory that supplied the active ingredient for 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. The lawyers at the law firm of Davis & Crump 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
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 Woodstock 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”. We 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 Heparin Problems

Our 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.

Contact Us
Davis & Crump is now handling claims for individuals who have suffered a severe allergic reaction after administration of Heparin. Davis & Crump is experienced in pharmaceutical product liability cases and settlements. If you or a loved one has suffered a severe allergic reaction while taking Heparin, contact us at 1-800-277-0300 or send us an email at info@daviscrump.com.