Synopsis of Prescription Drug Litigation
Beginning around November 2007, the FDA started receiving a large number of reports involving adverse events associated with allergic-type reactions to heparin. Subsequent investigations have uncovered that a large portion of the heparin sold in the United States around this time was contaminated with a fake ingredient. In early 2008, a nationwide Baxter Heparin Recall was issued involving nearly half of the supply of injectible heparin sold in the U.S. Other forms of the blood thinner made from the same raw ingredients have also been recalled. To date, there have been over 80 reported deaths and hundreds of severe allergic reactions in the U.S. linked to the use of contaminated Heparin produced by Baxter Healthcare that was supplied by a Chinese facility called Scientific Protein Labs, LLC.
Heparin®: Manufactured by Baxter Healthcare and approved by the FDA in 1972, Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity, in water for injection. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram.
Why is this medication prescribed?: Heparin is used to prevent blood clots from forming in people who have certain medical conditions or who are undergoing certain medical procedures that increase the chance that clots will form. Heparin is also used to stop the growth of clots that have already formed in the blood vessels, but it cannot be used to decrease the size of clots that have already formed. Heparin is also used in small amounts to prevent blood clots from forming in catheters (small plastic tubes through which medication can be administered or blood drawn) that are left in veins over a period of time. Heparin is in a class of medications called anticoagulants ('blood thinners'). It works by decreasing the clotting ability of the blood.
FDA indications: Heparin Sodium Injection is indicated for:
- Anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension;
- Low-dose regimen for prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdomino-thoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease.
- Prophylaxis and treatment of pulmonary embolism;
- Atrial fibrillation with embolization;
- Diagnosis and treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation);
- Prevention of clotting in arterial and cardiac surgery;
- Prophylaxis and treatment of peripheral arterial embolism.
- Heparin may also be employed as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures and in blood samples for laboratory purposes.
- Heparin Sodium and 0.9% Sodium Chloride Injection at a concentration of 2 units/mL is indicated as an aid in the maintenance of catheter patency.
What special precautions should I follow when using heparin?
- tell your doctor and pharmacist if you are allergic to heparin, any other medications, beef products, pork products, or any of the ingredients in heparin injection. Ask your doctor or pharmacist for a list of the ingredients.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: other anticoagulants such as warfarin (Coumadin); antihistamines (in many cough and cold products); antithrombin III (Thrombate III); aspirin or aspirin-containing products and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); dextran; digoxin (Digitek, Lanoxin); dipyridamole (Persantine, in Aggrenox); hydroxychloroquine (Plaquenil); indomethacin (Indocin); phenylbutazone (Azolid) (not available in the US); quinine; and tetracycline antibiotics such as demeclocycline (Declomycin), doxycycline (Monodox, Vibramycin), minocycline (Dynacin, Minocin) and tetracycline (Bristacycline, Sumycin). Your doctor may need to change the doses of your medications or monitor you carefully for side effects
- tell your doctor if you have a low level of platelets (type of blood cells needed for normal clotting) in your blood and if you have heavy bleeding that cannot be stopped anywhere in your body. Your doctor may tell you not to use heparin.
- tell your doctor if you are currently experiencing your menstrual period; if you have a fever or an infection; and if you have recently had a spinal tap (removal of a small amount of the fluid that bathes the spinal cord to test for infection or other problems), spinal anesthesia (administration of pain medication in the area around the spine), surgery, especially involving the brain, spinal cord or eye, or a heart attack. Also tell your doctor if you have or have ever had a bleeding disorder such as hemophilia (condition in which the blood does not clot normally), antithrombin III deficiency (condition that causes blood clots to form), blood clots in the legs, lungs, or anywhere in the body, unusual bruising or purple spots under the skin, cancer, ulcers in the stomach or intestine, a tube that drains the stomach or intestine, high blood pressure, or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using heparin, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are using heparin.
- tell your doctor if you smoke or use tobacco products and if you stop smoking at any time during your treatment with heparin. Smoking may decrease the effectiveness of this medication.
Lawsuits: As many as 300 product-liability lawsuits may be filed in the Illinois state court against drug maker Baxter International Inc., by people injured by or families who lost loved ones to contaminated batches of the blood thinner heparin. Per a judge's order last year, attorneys are working to convert an aggregate lawsuit to individual claims against the Deerfield, Illinois-based drug company.
The nightmare began in late 2007, as reports of serious allergic reactions and deaths following use of Baxter's heparin began mounting. By March 2008, the Food and Drug Administration (FDA) issued a major recall of heparin. At the time, Baxter supplied about 50 percent of heparin to the U.S. As Baxter began pulling its heparin, investigations into the source of the contaminant focused on Baxter International's China plant. The culprit was identified as over sulfated chondroitin sulfate, or OSCS, a man-made chemical that mimics heparin.
While Baxter was at fault for distributing the tainted heparin, critical eyes fell on the FDA for not properly inspecting foreign drug manufacturing plants. The agency admitted it was simply too understaffed to properly inspect most of the foreign food and drug manufacturing plants. The FDA soon after received funding to open overseas field offices, the first three of which were opened in China.
When to call the Venardi Law Firm: To find out if you have a case, prospective plaintiffs should set up an initial consultation with an experienced heparin lawyer. During this meeting, affected individuals can:
- Learn more about the process of building and winning heparin lawsuits
- Get estimates regarding possible heparin lawsuits, based on past cases similar to your own.
- Decide whether you want to file an individual lawsuit or join a class action case, based on your specific needs and unique situations.
The Venardi Firm does consultations for free and works on contingency to encourage injured patients to stand up for their legal rights and seek out the compensation they need and deserve. Patients injured after taking the heparin drug, as well as families of deceased heparin patients, will be entitled to compensation for their injuries by pursuing a heparin lawsuit with the Venardi Law Firm.
