More than 131 million Americans use prescription drugs. Studies have shown that there were 2.74 million serious adverse drug reactions in 2014 and around 128,000 people have died from drugs prescribed to them. So, what happens when drug manufacturers fail to warn consumers of dangerous and deadly side effects? Consumers are able to sue the drug manufacturer, but they must come prepared because the drug manufacturer will already have the argument that the consumer’s suit is preempted. A lot of times this argument will force the case to be dismissed, leaving consumers hanging out to dry.
What is Preemption and What does it Mean for Pharmaceutical Cases?
Preemption occurs when state and federal law conflict. Under the United States Constitution’s Supremacy Clause, when these conflicts happen, the federal law will trump the state law. That means that in pharmaceutical cases, drug manufacturers can argue that they cannot comply with their obligations under state law to make additional disclosures about a drug’s side effects and also comply with federal law that requires FDA approval of any label modification. This argument is called impossibility preemption. If the drug manufacturer’s argument is proven to be correct, then the plaintiff’s lawsuit is dismissed.
Over time, the Supreme Court created an exception to impossibility preemption. If the drug manufacturer has “newly acquired information” that allows it to unilaterally change the drug label, and there is no clear evidence that the FDA would disapprove a modification, there is no impossibility preemption.
What is “Newly Acquired Information?”
The FDA defines “newly acquired information” as including “data, analyses, or other information not previously submitted to the FDA, which may include (but is not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data if the studies, events, or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to the FDA.” A clinically significant adverse reaction has a significant impact on therapeutic decision-making, such as a risk that it is potentially fatal or otherwise serious.
The FDA’s hyper-technical definition provides little practical guidance for what “newly acquired information” is. So, in laymen’s terms, it can be broken down to mean that “newly acquired information” is information that the FDA does not already have access to about a drug’s side effect that is either potentially fatal, serious even if infrequent, or can be prevented or reduced through the appropriate use of the drug. The FDA might not have access to the information because the manufacturer has not provided the information or previous drug studies have not generated side effect information.
For example, a drug manufacturer that produced a chemotherapy drug for women with breast cancer did not update its label to warn about the risk of permanent hair loss. The FDA received over 40 complaints that this chemotherapy caused permanent hair loss. Additionally, a doctor presented a study at a breast cancer conference about how chemotherapy caused permanent hair loss. After this claim was brought before a court, the court decided that these complaints and the study were “newly acquired information.” As a result, the consumers’ lawsuits were not barred by preemption.
10,000 Foot Overview: Setting the Background for when Newly Acquired Information is Relevant
What has to happen in order for us to ask about newly acquired information and preemption? First, drug manufacturers must have an FDA-approved label for a prescription drug. If a consumer takes the drug and suffers a side effect that the label does not warn of, then the consumer is able to sue the drug manufacturer for failure to warn consumers of the side effect. In the lawsuit, the consumer can argue that the drug manufacturer should have and could have updated the label under the “Changes Being Effected” regulations while the drug manufacturer may argue that the consumer’s claim is preempted because the drug manufacturer could not update the label.
The “Changes Being Effected” regulation allows drug manufacturers to change a drug label without FDA approval “if the changes add or strengthen a contraindication, warning, precaution, or adverse reaction” or “add or strengthen” an instruction about dosing and administration that is intended to increase the safe usage of the drug product in order to reflect newly acquired information.”
What is Not “Newly Acquired Information?”
Newly acquired information must establish that the different or increased risks are actual and real. Below are some examples of information that courts determined were not newly acquired information.
- Hypothetical information.
- A statement from a single scientist.
- An exception to this is when the statement becomes part of a peer-reviewed article or some other form of corroboration.
- Expert testimony at trial, unsupported by any published research.
- An expert report generated in preparation for litigation that is not supported by published research.
- Studies reaching inconclusive results.
- A study finding a connection between exposure to the drug and side effects in mice did not provide sufficient evidence of a causal connection between the drug and the side effect because the study has not been replicated on humans and only demonstrates an adverse reaction in mice.
To recap, drug manufacturers will almost always argue that a consumer’s lawsuit is preempted and must be dismissed. All those who sue need not abandon hope though because the drug manufacturer must provide proof that the suit is preempted. Drug manufacturers with newly acquired information about a drug’s side effects must update their label to warn consumers of the risk and cannot simply hide behind preemption to dodge this responsibility.
Written by:
Katie Quillen
Law Clerk
WATTS GUERRA LLP
Four Dominion Drive, Bldg. Three, Suite 100
San Antonio, Texas 78257
Phone: (210) 447-0500
Frank Guerra
Board Certified – Personal Injury Law
Texas Board of Legal Specialization
WATTS GUERRA LLP
Four Dominion Drive, Bldg. Three, Suite 100
San Antonio, Texas 78257
Phone: (210) 447-0500
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