Hot topics in the legal arena: Current Pharmaceutical Litigation

© 2009 The Medical-Legal News

By Rolando Morales, RPh

Many thousands of medications have received Federal Drug Administration (FDA) approval over the years and are determined to be safe and effective. Among these are Avandia, Heparin, Digitek and Duragesic, all of which have been repeatedly linked to safety issues. Consultants and attorneys are likely to see cases involving these medications.
Avandia (rosiglitazone), which is intended to lower blood sugar, has been associated with increased risk of myocardial infarction and with death from cardiovascular causes having otherwise minor significance.
A study reported in the May 21, 2007 issue of the New England Journal of Medicine, utilizing 42 clinical trials and 28,000 patients, reported a 64% increased risk of heart-related death and a 43% increased risk of heart attack in patients taking Avandia.
Heparin is among the 10 most common medications involved in adverse drug reactions (ADR) that require consumers to seek treatment in hospital emergency departments. Heparin is available in many strengths and dosages. Among the strengths available are 10 units/ml, 100 units/ml, 1,000 units/ml, 5,000 units/0.5ml and 10,000 units/ml (the last two are the same concentration). Although convenient, the availability of all these strengths increases the likelihood of administering the wrong concentration. Of late, the issues making headlines have primarily involved contaminated heparin. The contamination involved several lots with Serratia marcescens, a bacterium. The bacterium has been linked with urinary tract infections, pneumonia and septicemia.
Digitek (digoxin), a generic version of the heart medication Lanoxin, has been involved in an FDA recall due to its being manufactured and distributed as a double-size tablet containing twice the listed active ingredient. During manufacturing two tablets were pressed together, much like a double-stuffed Oreo. Signs of digoxin toxicity include nausea and vomiting, diarrhea, confusion, dizziness, loss of appetite, low blood pressure, irregular pulse, reduced heart rate and visual disturbances. Nurses and pharmacists are in a unique position to spot such variations in medication appearance — and to educate consumers as well.
Duragesic (Fentanyl) patches also have been involved in the news headlines lately. The patch is available in multiple strengths which release a powerful opiate pain killer at a sustained rate over a three-day period. The patches are intended for patients suffering moderate to severe pain who have been pre-conditioned to opiate pain killers. Several lots had been determined to be faulty and lacking the sustained release over the 72-hour period. When this opiate pain killer is released too quickly the risk of severe overdose is tremendous. Over-dosage may lead to respiratory depression and death.
To keep abreast of FDA recalls, LNCs and attorneys may subscribe to the FDA newsletter at www.fda.gov/medwatch/elist.htm. Another useful site is www.globalrph.com, which features dosage calculators, drug tables, renal dosing and more.
The challenges involved in such product liability cases are 1) defining the duties of the drug manufacturer to the public, 2) determining what, if any, breaches of duty or deviations from the standard of care occurred, 3) discovering what actions were taken to reveal or conceal risks and 4) proving causation of the alleged damages.
Defining the consumers’ responsibilities may include whether or not the consumer accepted counseling from the pharmacist, where many drug errors can be detected. Nurse consultants are in a unique position to use their expertise to develop these cases for the attorney. •

Rolando Morales, RPh, is a pharmacist consultant with DisceRNment, LLC. He and his wife, a legal nurse consultant, are based in Ellijay, Ga.; (706) 636 5276, www.DisceRNment.Biz.