Heparin Recall and Litigation
Learn More About Heparin Claims
Heparin is a blood thinner and an anticoagulant which prevents the formation of blood clots. While Heparin does not break down existing blood clots, it does stop new ones from developing.
Heparin is given by intravenous or subcutaneous injection rather than by mouth, as it degrades when digested in the stomach.
Because of its short half-life of only one hour, Heparin must be administered frequently, or as a continuous infusion.
While Heparin is routinely used in emergency rooms and dialysis centers, overdoses can prove fatal. If you or a loved one were harmed by the use of Heparin, call a Heparin attorney, pharmaceutical lawyer, medical malpractice attorney, or drug defects lawyer. In September, 2006, three premature infants at an Indianapolis hospital died after mistakenly being given overdoses of Heparin. In a similar mix-up in Los Angeles, in November, 2007, an adult dosage of Heparin — which was one thousand times the prescribed dose for a newborn – was administered to actor Dennis Quaid’s 12-day-old twins, putting their lives at severe risk. Once again, if Heparin has caused damage to you or a loved one, contact one of our specialized Heparin Attorneys.
Heparin is made from pig intestine and has been marketed in the U.S. for over 70 years. It was first discovered in 1916, after being isolated in the liver cells of dogs, but did not enter clinical trials until 1935. Today, it is one of the oldest drugs in widespread use in this country.
The Heparin recall crisis began in late 2007, when four Missouri children came down with severe allergic reactions after receiving Heparin as a part of their dialysis treatment. Soon afterwards the Food and Drug Administration (FDA) had received hundreds more drug reaction reports involving Heparin. If you have experienced adverse reactions after the use of Heparin, call a pharmaceutical lawyer, medical malpractice attorney, or Heparin lawyer. Most of these were linked to dialysis centers but others involved patients undergoing heart surgery or a blood cell treatment called photopheresis.
Adverse Heparin reactions include a variety of symptoms, such as: stomach pain, shortness of breath, nausea, throat swelling, low blood pressure, chest pain, accelerated heart rate, dizziness; headaches, restlessness, vomiting, diarrhea, fainting, tachycardia, burning sensations, redness or paleness of skin, abnormal sensation of the skin, mouth, or lips, flushing, thirst and difficulty opening the mouth, increased sweating, decreased skin sensitivity; watery eyes, bleeding tendencies and low blood pressure. Some of these reactions may be severe or life threatening.
On January 29, 2008, Baxter Healthcare – which makes about half of the U.S. Heparin supply and is one of the leading Heparin manufacturers worldwide — and the FDA announced a voluntary recall of nine lots of their Heparin multi-dose vials as a precaution.
As the adverse reaction and death reports continued to pour in, Baxter realized that the recalled batches were not the problem, and instead focused its attention on the dosage. On February 28, 2008 Baxter announced that it would no longer sell any multi-dose vials of Heparin and promptly recalled all remaining lots of its Heparin sodium injection multi-dose, single-dose vials and hep-lock Heparin flush products.
By March, 2008, the FDA announced that the real Heparin problem was due to contaminated raw stock imported from China.
On March 7, 2008, German medical officials also announced a recall of Heparin made in that country after 80 patients suffered adverse events, including shortness of breath, low blood pressure and rapid heartbeats. A pharmaceutical attorney or drug defects attorney can help seek financial retribution for your medical bills. The Heparin, which was manufactured by RotexMedica GmbHm, was believed to be linked to contaminated ingredients from China. This announcement was followed only days later by three Japanese pharmaceutical companies who also recalled Heparin products made with raw ingredients from China.
On April 2, 2008, Covidien — another U.S. Heparin manufacturer — announced that it too was recalling lots of pre-filled Heparin syringes because of contamination. Covidien used the same Wisconsin supplier, Scientific Protein Laboratories (SPL), for its active ingredient as did Baxter Healthcare. Ironically, SPL said that it relied on its Chinese vendor — which the FDA said had quality control issues and cleanliness problems – to supply the Heparin ingredient which it then resold to both Baxter and Covidien.
Not affected by the Heparin FDA recall is a premixed IV solution that does not come from China, including Baxter’s Heparin pre-mix IV solutions in bags, Heparin sodium in 5% dextrose injection and Heparin sodium in 0.9% sodium chloride injection.
Prior to its Heparin recall, Baxter sold about 100,000 vials of Heparin a day. The drug also generated about $30 million in sales for the company in 2007.
U.S. product supplies of Heparin from Baxter and other vendors are said to be sufficient to meet the current medical demand
Who Can Sue
If you or a loved one has fallen ill because of Heparin treatments following: 1/ kidney dialysis, 2/ heart surgery or 3/ a blood cell treatment called photopheresis contact a Heparin attorney who can evaluate your case and advise you if you are eligible for a financial settlement.
If you used Heparin as a blood thinner, or received Heparin during surgery and fell ill as a result, you may be eligible to become part of a class action lawsuit against Baxter or one of the other Heparin pharmaceutical manufacturers.
A qualified Heparin injury attorney who is skilled in drug effects law can quickly review the facts of your case and advise you on whether it would be more advantageous for you to join with others in an existing Heparin class action or file your own lawsuit.
Because drug reaction to Heparin can lead to severe and even fatal consequences, you should contact your doctor immediately if you have any of the listed symptoms – as well as any symptom that is out of the ordinary. Do not stop taking Heparin without first consulting a physician.
Despite its recall, there are approximately 450,000 people in U.S. currently on dialysis — and Heparin is used by almost all of them. Heparin also continues to be widely used in most cardiac surgeries.
In July 2008, eight months after Dennis Quaid’s 12-day old twins were mistakenly given an adult-sized dose of Heparin in California, another set of twins born at a Texas hospital died after an accidental overdose of the drug. Unlike the Quaid case, which was related to faulty packaging, the Texas overdose was due to a mixing error in the hospital pharmacy. A Heparin attorney will be of use in this instance.
When too large a dose of Heparin is given — and the normal blood clotting response is prevented — the results can be frightening, if not fatal.