We give the FDA an "F"

What’s the world coming to?

143 million pounds of beef are recalled because of bad and inhumane practices at a Calif, meat packing company investigated and brought to light by the national Humane Society. In no time, the U.S. Centers for Disease Control and Prevention had reports of more than 350 similar cases from 12 states, most of them adults. Four people died. Why did this happen? It happened from contaminated heparin, an anticoagulant drug or blood thinner used in surgery and dialysis to prevent blood from clotting. Its primary ingredient was never inspected by the FDA or the Chinese equivalent to the FDA. What’s wrong with the FDA? This crucial agency is under-funded and under staffed. The very agency that is supposed to protect our health and well-being – isn’t.

China has more than 700 plants approved to ship drugs here. Between 2002 and 2007, the FDA inspected only 88 plants. In what doesn’t make much sense, the inspection budget comes from user fees paid by drug companies. More inspections are in countries that have regulatory systems like Switzerland and Germany than China. Why has Congress and successive presidential administrations repeatedly underfund the FDA, the USDA, and the Consumer Product Safety Commission, which has been forced to recall record numbers of unsafe toys over the past year? We all know self-policing doesn’t work.

Family Files Heparin Lawsuits

A family with hereditary kidney conditions required kidney transplants and kidney dialysis (hemodialysis) to keep them alive. What they didn’t count on is that the lifesaving blood thinner heparin may have killed their loved ones. The family believes that the recently recalled heparin manufactured by Baxter Health care was administered just prior to the death of two family members. The drug has not been identified as the cause of the deaths. However, recalled heparin and the facilities that manufactured it are being investigated by the FDA and the Centers for Disease Control and Prevention.

Currently, there are no answers, and that is not acceptable. Heparin is most often administered intravenously to decrease the clotting of blood. Patients undergoing medical procedures such as cardiac surgery and kidney dialysis are often given the drug to help with the procedure. Reports of adverse reactions to heparin began surfacing in November. In January, the CDC and FDA were notified, and on Jan. 17, Baxter voluntarily recalled portions of the product. The day before the recall, the FDA initiated an inspection of Baxter's manufacturing plant in Cherry Hill, N.J. Now lawsuits are being filed in New Jersey and elsewhere across the nation. Cherry Hill, NJ is certain to be a hot-bed for this litigation, since the manufacturer is located there.If you were injured, you might consider the question, "Do you need a personal injury law firm in Cherry Hill NJ?"

On Jan. 25, Baxter issued a news release informing the public of the voluntary recall, saying that it was a precautionary measure due to an increase in the number of reports of adverse patient reactions that may be associated with the product and that the company was conducting a thorough investigation to identify the cause of the increase in allergic-type reactions. Reported allergic reactions to heparin have ranged from stomach pain and vomiting to fainting and unresponsiveness. The FDA noted that four people have died after receiving heparin, although the relationship to the drug is unclear. Suspected, though not confirmed, as the source of the contaminated product is a plant in China that the FDA admitted recently was never inspected by U.S. officials. This week, the FDA and CDC sent a team to the facility for an inspection.

An active pharmaceutical ingredient in heparin is an enzyme found in pig intestines. According to FDA policies, drug manufacturers and any plants supplying them with components are inspected before an application to produce a drug is approved. Because the plant in China had a name similar to one that had recently been inspected, FDA regulators inadvertently approved the application without an inspection. Heparin is a generic drug that has been in widespread clinical use since the 1930s and that Baxter Health care is one of several manufacturers that produce it. Baxter produces about half of the more than one million multiple-dose vials of heparin sold each month in the United States. Heparin is injected into the blood stream during dialysis and used in the tubes leading into the body; heparin thins the blood and prevents blood clots. The Ohio family is plagued with polycystic kidney disease, a genetic disease that passed from the mother to her three children.

The mother died Dec. 19 at age 65. The official cause of death was septicemia. Three weeks later, the son, age 47 died on Jan. 15. The cause of death was electrolyte imbalance. Family members said that each was experiencing reactions prior to their deaths consistent with the warnings released by the FDA but because the warnings were not yet public, no one could figure out what was going wrong. They said they believed they finally understood when told by employees of the dialysis center where the two were being treated that recalled heparin was pulled from the shelves in January. Although not yet substantiated, the attorney for the family said he is looking into seven death claims in the Toledo area certainly an extraordinary number of deaths in a small time in a small town. Someone must be held accountable said the family.

About the Author: Anapol Schwartz Law Firm is Located in Philadelphia, PA and has offices in Cherry Hill, NJ, and elsewhere in the state of Pennsylvania. They can be reached at 1710 Spruce Street, Philadelphia, PA 19103 or Toll Free at 866-735-2792.