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Rhonda Baker Debevec
Rhonda Baker Debevec
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Baxter Heparin Recall Demonstrates Limitations On FDA's Ability To Adequately Protect Patient Safety

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On February 28, 2008, the U.S. Food and Drug Administration issued its most recent Public Health Advisory concerning a popular blood thinner, Heparin, manufactured by Baxter Healthcare Corporation. An unusually high number of severe allergic reactions have been associated with this product when it is administered in high doses over short periods of time – commonly referred to as a bolus. The FDA continues to investigate but has not yet determined the cause. In the meantime, Baxter has temporarily suspended manufacturing its multiple-dose vials of heparin sodium.

Heparin sodium is a blood thinner (anticoagulant) frequently given through an IV. The medication is used to treat patients undergoing kidney dialysis and some heart surgeries. It is also used to treat or prevent some serious medical conditions like blood clots in the lower legs (deep vein thrombosis) and/or lungs (pulmonary embolus). Within the hospital-setting, heparin therapy often is started by giving a large dose (5000-50,000 units) at one time. This method is often referred to as a bolus dose and differs from an infusion of the drug over a long period of time. There have been a significant number of serious reactions with bolus administration. These serious adverse events have included mouth swelling, nausea, vomiting, sweating, shortness of breath and severe drops in blood pressure (hypotension) within minutes of the drug’s administration. The majority of reported events occurred at hemodialysis center. Although most of these adverse events were not fatal, four fatalities have been reported; the relationship between these deaths and the heparin use is uncertain at this time.

Heparin is widely used throughout the United States. It is estimated that over 1 million of the “multiple-dose” vials of heparin are sold each month. Approximately half of this supply is manufactured by Baxter. Because the FDA is concerned about the potential health hazard a shortage of heparin may pose, the FDA believes the drug currently in distribution may be used with the following cautions:

When bolus use is required, try to use a heparin product from another manufacturer or another blood thinner;

When Baxter heparin is the only heparin available and use of heparin is considered medically necessary:

i) Administer infusions without using a bolus dose whenever possible;
ii) Use the lowest dose necessary at the slowest infusion rate acceptable to obtain the desired effect;
iii) Closely monitor the patient for adverse events, particularly hypotension (low blood pressure) and signs and symptoms of hypersensitivity, and ensure that resuscitation equipment is available;
iv) Consider the potential risks and benefits of corticosteroids or antihistamines.

Questions are raised for this attorney whether the FDA’s recent investigation of Baxter’s manufacturing plant in Jiangsu, China may have some relationship to the problems recently encountered. During the FDA’s five-day inspection in February 2008, the FDA investigator noted several deficiencies within the plant including incomplete manufacturing instructions and failure to identify the root cause of failed inspections before re-processing the failed lots.

While the FDA appears to be investigating the heparin matter vigorously, we all must acknowledge the limitations of the FDA’s resources. These limitations, however, were recently ignored by the United States Supreme Court in the Riegel v. Medtronic, Inc. decision. Within this decision, the Supreme Court wiped out injured individuals’ rights to sue negligent manufacturers for poorly designed medical devices when the manufacturer followed the FDA’s pre-market approval process. This decision places too much responsibility on an already over-burdened government agency and simultaneously takes away the injured victim’s right to be compensated by the responsible party. Under this decision, seriously injured victims of dangerous medical devices will increasingly need to rely on government-sponsored programs to provide for their ongoing support and complex health needs while the responsible manufacturers will often enjoy immunity from suit and enormous profits from their defective devices.