Rx & The Law

"We Did Everything Right"

by Donald McGuire, R.Ph., J.D.
Professional Claims Attorney
Pharmacists Mutual Insurance Company

The following scenario has been played out hundreds of times during the past few years.  Bob Palmer had had his prescriptions filled for many years at Brown’s Pharmacy.  He had always been happy with the service he received from Anne and Charles, the pharmacists at Brown’s Pharmacy.  Bob had taken Rezulin® for two years prior to its withdrawal.  He later read the large ad in the daily newspaper telling people that they may be entitled to compensation if they had taken Rezulin®.  Was he entitled to compensation?  Bob decided to call the number in the paper the next day.  Charles and Anne were soon served with a lawsuit naming the pharmacy as a defendant.  Their reaction was:  “What’s going on here?  We did everything right and we still got sued!”

Welcome to the world of products liability.  Following on the heels of asbestos and tobacco litigation, the tactics learned in those cases are now being applied to drugs.  The first cases were phen/fen and Redux®.   The success there spawned the continuation of these types of suits as successive drugs were withdrawn from the market.  Following close behind was Duract®, Rezulin®, and Propulsid®.  Then there was phenylpropanolamine, Stadol® nasal spray, and just recently, Baycol®.  The difference in these instances is that, in addition to the manufacturer, the pharmacy and the pharmacists are also targets.  Along with the products liability claims, the typical
lawsuit also alleges that the pharmacist failed to perform an adequate DUR and/or failed to warn the patient about the hazards of the drug.  These professional activities are then tied to the products liability case. 

The theory behind products liability law is that consumers are entitled to compensation when defective or dangerous products injure them.  Products liability law includes everyone in the chain of distribution:  the retailer, the wholesaler, and the manufacturer.  Many states’ laws allow the retailer to pass the claim up the chain to the manufacturer, provided the manufacturer is known and is capable of paying the claim.  The manufacturers are facing a difficult decision.  Continuing the sale of a drug after reports of adverse events sets them up for products liability claims, while withdrawal of the product is seen as an indication that the product is unsafe.  Should prescription drugs be treated the same as asbestos, lawnmowers, or stepladders? 

Prescription drugs are unique because, by their very nature, they cannot be completely safe.  They have side effects, both known and unknown.  But withholding them from the market because they are not completely safe will prevent other patients from receiving the benefits they can provide.  This is a risk/benefit decision made by the FDA based on the immense amount of data and information submitted to the FDA prior to the product ever appearing on the pharmacies’ shelves.  The purpose of the pre-market review is to make sure the product is safe and effective, and also as an efficiency measure.  It would be extremely cumbersome and expensive to have pharmacies all across the country carrying out their own studies.  The pharmacist should be able to rely on this review as an indication that the product is at least minimally safe to dispense. 

This trend is not likely to end anytime soon.  What can pharmacists do to protect themselves?  It’s not always easy to predict which product is going to be the next to be removed from the market, so pharmacists can only protect themselves from the allegations regarding their professional duties.  A pharmacist must do their job.

1. Know the product and its labeling.  This includes the proper dose, the duration of therapy, and contraindications.  If the prescription calls for an unlabeled use, be aware of the rationale for and the propriety of that off-label use.  This does not mean that prescriptions cannot be filled for unlabeled uses, they can.  It means only that the pharmacist should be aware. 
2. Perform an effective drug utilization review on every new prescription.  Pay attention to the help that computer warnings can give, but do not rely entirely on the computer system. 
3. Heed all new information provided by the manufacturers in a “Dear Doctor” or “Dear Health Professional” letter.  Keep this information available for use in DUR and counseling because there may be a time lag before it is included in the software.  Keep copies of the letters with a date stamp to indicate when they were received in the pharmacy. 
4. Provide effective counseling to patients.  This may mean more thorough counseling of all patients than is required by state law.  Provide both verbal and written information.  This counseling should also include new information as provided by the manufacturer. 
5. Pharmacists should document their dispensing activities, especially any interventions.  The pharmacy and pharmacist should be able to show that all of the dispensing functions were performed, by whom they were performed, and how they were performed.

While these steps won’t insure that a pharmacist or  pharmacy is never going to be included in a products liability suit, this type of documentation can help the pharmacy to negate claims of professional negligence.  It will help to insure that the true products liability claim can be passed up the chain of distribution.  It may also greatly assist in obtaining an outright dismissal of the pharmacy or pharmacist from the suit.  Performing your professional duties effectively is your best protection. 

This article discusses general principles of law and risk management. It is not intended as legal advice. Pharmacists should consult their own attorneys and insurance companies for specific advice. Pharmacists should be familiar with the policies and procedures of their employers and insurance companies, and act accordingly.