There have recently been a growing number of product liability lawsuits filed against drug manufacturers for culpability in the injury and death of persons who were given transdermal fentanyl patches.
It is alleged in these cases that the drug, when administered in this manner, has the potential to deliver an injurious or even fatal dose – something patients are never warned about prior to placing the patch on their skin.
In one such case out of Michigan, Miller v. Mylan Inc., the patch had to be defined under the state’s product liability law as it pertains to drug manufacturers. The Sixth Circuit Court of Appeals recently wrestled with the issue of whether the patch should be considered a drug, a device or a combination product. The distinction will determine whether the case will be allowed to move forward.
Fentanyl (also known as Duragesic) is a powerful opioid pain reliever that is prescribed to individuals who suffer moderate to severe chronic pain. It’s generally not recommended for mild or short-term pain or following a surgical or dental procedure.
The problem is that these patches have been known to cause serious or life-threatening breathing problems, particularly during the first three days of use.
In the Miller case, the family of a woman who died after receiving a fatal amount of fentanyl from the patch are suing the manufacturer, Mylan. They allege:
- Negligent misrepresentation;
- Strict product liability;
- Violation of the state’s consumer protection act.
What’s important to note here is that under Michigan law, makers of “drugs” are shielded from lawsuits so long as the drug received a safety approval stamp from the U.S. Food and Drug Administration, the drug labeling was in compliance with FDA standards and the drug was no longer in the control of the manufacturer or seller at the time of the incident.
The district court determined that the patch is a drug, and as such, the complaint should be dismissed.
It was this conclusion that was analyzed by the Sixth Circuit Court of Appeals. The big question here was whether the patch is a drug, a medical device or some combination of both.
The plaintiff here argued that the patch is not a drug, even if its active ingredient, fentanyl, is a drug.
The district court had reasoned that it could not separate the active and inactive components of the product, and therefore it should be considered an FDA-approved drug. The court compared the patch to a time-release pill capsule.
However, the appellate court didn’t think the issue was this straightforward, saying, “We are not entirely convinced that it applies to a product, like the patch, that appears to have a mechanical (rather than chemical) effect on the human body.”
In 1990, Congress amended federal law to include “combination products.” This classification was important because it had a bearing on how these products would be regulated. While a drug would be regulated by the FDA and a device by the Consumer Product Safety Commission, regulation of combination products is left to the discretion of the Secretary of Health and Human Services.
The defendant here argued that it didn’t matter whether the drug was labeled a combination product because the FDA had regulated it as a drug. But the court rejected this argument.
However, the court was also not prepared to rule on how the fentanyl patch should be classified, particularly as the federal law doesn’t explicitly define combination product.
As such, the case was remanded back to the district court for determination of how the product should be classified. For product liability plaintiffs in Alabama, the case will be closely watched because the court’s determination of this classification could have an impact on how local judges view the regulatory obligations of fentanyl patch manufacturers.
Call Allred & Allred P.C. at 334.396.9200 to speak with a personal injury attorney today.
Miller v. Mylan Inc., Jan. 21, 2014, Sixth Circuit Court of Appeals
More Blog Entries:
Montgomery Premises Liability Claims With Multiple Defendants, Jan. 15, 2014, Montgomery Product Liability Lawyer Blog