On September 24, 2008, the Joint Commission, an independent, not-for-profit organization that accredits and certifies more than 15,000 health care organizations and programs in the United States, issued a heparin safety alert. (See JOINT COMMISSION WEBSITE: 9/24/08 Sentinel Event Alert, “Preventing errors relating to commonly used anticoagulants.”)

According to this report, “anticoagulants have been identified as one of the top five drug types associated with patient safety incidents in the United States.” (Id.) From January 1997 through December 2007, the Joint Commission reported that there 446 medication-related sentinel events (9.3 percent of all events) reported in their event database, with 7.2 percent (32) of these involving anticoagulants; of those, two-thirds (21) involve heparin. (Id. See also the illustrative chart on the Joint Commission Website.) Further, according to the United States Pharmacopeia MEDMARX database, there were a total of 59,316 medication errors related to anticoagulants reported to their database from 2001 to 2006 (these data do not include errors involving heparin lock flush). (Id.) According to the report, “nearly 60 percent of these errors reached the patient and nearly 3 percent resulted in harm or death.” (Id.) Further, “performance error (e.g., administration) is the most common cause of adverse events relating to anticoagulant medications.” (Id.)

The Joint Commission explained in its report that “heparin and warfarin in particular have narrow therapeutic ranges and a high potential for complications, so there is a greater risk of patient harm.” (Id.) It also listed the following factors which also contribute to medication errors involving anticoagulants:

• Lack of standardization for the naming, labeling and packaging of anticoagulants creates confusion. For example, heparin flush syringes have been confused with LMW heparin syringes. In addition, other, lesser-known anticoagulant drug names exist (e.g., enoxaparin, dalteparin, tinzaparin) and are used less commonly, which can result in duplicate medication orders and erroneous dosing.
• Keeping current with different dosing regimens for various patient populations, newer assay methods, the expanding lists of drug interactions, and the potential reversal strategies can be a challenge for providers—especially those who infrequently prescribe or administer anticoagulants.
• The specific and individualized instructions and monitoring information (for example, dose adjustments, lab values, changing patient condition) that accompany the prescribing and administration of anticoagulants may fail to get documented or communicated during transfers and hand-offs.
• Neonates and other pediatric patients are problematic to treat, specifically because the medications are formulated and packaged primarily for adults.

(Id.) The Joint Commission offers suggestions on how to reduce these dangers.

What is missing from the report is the danger of contamination and the lack of updated and appropriate testing for imported drugs, which unfortunately, may have claimed as many lives in a just few months, as dosage errors have claimed in the past ten years.

Labels: Baxter, Baxter Heparin, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, imported drugs, Joint Commission, OSCS, safety alert, Scientific Protein, USP

On Monday, Chinese health officials raised the total number of infants sickened by Sanlu brand milk powder to more than 1,200. (09/15/08 USA TODAY, “Tainted Milk Sickens More than 1,200 Babies in China.”)

The formula was spiked with the industrial chemical, melamine, a contaminate that causes kidney stones (which are otherwise rare in infants). (Id. See also 9/12/08 FDA PRESS RELEASE, “FDA Issues Health Information Advisory on Infant Formula.”) Like the Heparin scandal, the contamination was intentional and a result of corporate greed. Specifically, Chinese investigators say melamine was added to make the milk seem higher in protein and thus, fool quality tests after water was added to fraudulently increase the milk's volume. (Id.)

Unlike the Heparin tragedy, however, it appears that Americans might have missed this latest batch of contaminated products manufactured in China. The FDA has indicated “that there is no known threat of contamination” as “no Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States.” (9/12/08 FDA PRESS RELEASE, “FDA Issues Health Information Advisory on Infant Formula.”) Yet, the FDA has not completed its current investigation as to whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community. (Id.)

Regardless, this latest contamination is another example of why drugs and other products manufactured in poorly regulated foreign countries cannot be blindly accepted as pure. It should continue to serve as a warning to large U.S. companies who buy these cheaper products and pass them on to the unsuspecting American public…A warning, which unfortunately, was ignored by the big drug company, Baxter, in the heparin disaster that killed numerous Americans.

Labels: Baxter, Baxter Heparin, China, Chinese, contamination, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, import safety, OSCS, oversulfated chondroitin sulfate, SPL

Recently, the New England Journal of Medicine (NEJM) voiced strong opposition to preemption of cases involving defective medical devices and drugs, which would strip Americans injured by defective medical devices or drugs of their constitutional right to a trial by jury for most, if not all, legal claims, where the drugs or medical devices are regulated or approved by the FDA.

In an Amicus Brief filed in a case pending before the United States Supreme Court, Wyeth v. Levine, the NEJM editors wrote that the “FDA alone simply lacks the ability to serve as the sole guarantor of drug safety'’ and that without the discoveries made by plaintiff’s lawyers as a result of defective drug lawsuits, “the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct.'’

A copy of this compelling brief is available by clicking here. In addition, the recent NEJM article, “Why Doctors Should Worry about Preemption,” is available on the NEJM’s website, by clicking here.

Labels: Baxter, Baxter Heparin, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, OSCS, preemption, SPL