Attorneys understand the importance of the role of the U.S. Food and Drug Administration (FDA).  But, do you have access to someone who is able educate you regarding pertinent safety information?  Do you have the time to relate released safety information by the FDA to its potential impact on that case you are working?  This is exactly where a legal nurse consultant, can augment your practice and support your case.

This two-part series will briefly overview the FDA’s MedWatch program and its importance in medical legal issues.  Part 2 will provide an overview of FDA recently released drug safety warnings for the third quarter of 2017.

The FDA’s MedWatch program addresses safety in two ways.  First, the program is responsible for coordination of the Adverse Event Reporting System (AERS), the Vaccine Adverse Event Reporting System (VAERS) and the Manufacturer and User Facility Device Experience Database (MAUDE).  These reports cover the failure of a gamut of human medical products including:

• Prescriptions, over-the-counter drugs, and drugs/products used in the hospital or outpatient setting;
• Biologics such as blood components;
• Medical devices;
• Special nutritional products;
• Cosmetics; and
• Food/beverages (including reporting of serious allergic reactions).

Health care professionals and consumers are encouraged to report issues such as drug side effects, errors of medication administration or product use, problems with product quality, and device failure.

The second way that the MedWatch program supports patient safety is in how it utilizes the data it collects.  When safety issues are identified, the FDA utilizes the gathered information to determine if further action is necessary.  If action is necessary, after the response, the FDA provides education for health care professionals about the action taken and how it affects or may affect the delivery of patient care.

During the month of January, in less than a week’s time, the FDA released statements regarding a variety of issues. A sampling of those includes, but is not limited to the following:

• Anaphylaxis (a severe life-threatening allergic reaction) and other serious hypersensitivity reactions are identified with the administration of a drug used for nausea following chemotherapy;
• Feeding tube placement systems are noted associated with development of pneumothorax (a build up of pressure around the lung which compromises lung function) and are linked to the deaths of patients;
• Safety label changes were required for prescription cough and cold medicines containing codeine or hydrocodone which limit the prescription use to adults only, because the risk to pediatric patients outweighs the benefit of the use. In addition, the FDA required the issue of safety information regarding the risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing be added to the label of these same drugs; and finally,
• There was a recall of a certain lot of an aortic valve delivery system, because of a defect which resulted in the potential for embolization (vessels blocked by clots) resulting in serious injury and potential death.

Given that there is copious safety information released daily, having a legal nurse available to advise you can play an important role in your success.  The information might be used by either plaintiff or defense attorneys to bolster a strong case, anticipate opposing counsel arguments, or determine whether a case has merit.

In Part 2, the MedWatch boxed warning will be reviewed.  There will also be a brief discussion about recently released FDA drug safety warnings and updates from the third quarter of 2017.

Terri Chabaud, RN, CLNC
Terri Chabaud & Associates

References

U.S. Food & Drug Administration (2017). MedWatch: The FDA safety information and adverse event reporting program.     Retrieved from https://www.fda.gov/Safety/MedWatch/default.htm