Rebecca L. Haffajee and Michelle M. Mello
N Engl J Med 2017; 377:2301-2305
December 14, 2017
Here is an excerpt:
Opioid products, they alleged, were defectively designed because companies failed to include safety mechanisms, such as an antagonist agent or tamper-resistant formulation. Manufacturers also purportedly failed to adequately warn about addiction risks on drug packaging and in promotional activities. Some claims alleged that opioid manufacturers deliberately withheld information about their products’ dangers, misrepresenting them as safer than alternatives.
These suits faced formidable barriers that persist today. As with other prescription drugs, persuading a jury that an opioid is defectively designed if the Food and Drug Administration approved it is challenging. Furthermore, in most states, a drug manufacturer’s duty to warn about risks is limited to issuing an adequate warning to prescribers, who are responsible for communicating with patients. Finally, juries may resist laying legal responsibility at the manufacturer’s feet when the prescriber’s decisions and the patient’s behavior contributed to the harm. Some individuals do not take opioids as prescribed or purchase them illegally. Companies may argue that such conduct precludes holding manufacturers liable, or at least should reduce damages awards.
One procedural strategy adopted in opioid litigation that can help overcome defenses based on users’ conduct is the class action suit, brought by a large group of similarly situated individuals. In such suits, the causal relationship between the companies’ business practices and the harm is assessed at the group level, with the focus on statistical associations between product use and injury. The use of class actions was instrumental in overcoming tobacco companies’ defenses based on smokers’ conduct. But early attempts to bring class actions against opioid manufacturers encountered procedural barriers. Because of different factual circumstances surrounding individuals’ opioid use and clinical conditions, judges often deemed proposed class members to lack sufficiently common claims.
The article is here.