> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# State Opioid Suits Raise Preemption Issues
- URL: https://www.fdaweb.com/state-opioid-suits-raise-preemption-issues/
- Published: 2018-03-27T12:00:00.000Z
- Updated: 2026-09-14T23:55:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141081

Attorneys **Erika Maley** and **Jacquelyn Fradette** (Sidley Austin) say that courts and litigants should be very aware of the potential preemption and jurisdiction issues raised by state suits against opioid manufacturers alleging inadequate warnings. Writing in a Washington Legal Foundation [*Legal Backgrounder*](http://www.wlf.org/upload/legalstudies/legalbackgrounder/032318LB%5FMaley.pdf?ref=fdaweb.com), the two say that state tort suits’ claims that manufacturers gave inadequate warnings on the use of opioid analgesics to treat chronic pain “present a serious risk of conflicting with FDA’s expert judgment in this area.”

The backgrounder reviews the legal background on preemption of failure-to-warn claims and says the failure-to-warn claims for extended-release/long-acting (ER/LA) opioids raise serious preemption issues. “While the lawsuits claim manufacturers should have given additional warnings or ceased marketing opioids for chronic pain,” the attorneys write, “FDA has thoroughly considered this issue and determined that ER/LA opioids should be approved to treat chronic pain.” They say the same preemption standard applies whether the claims assert that the additional warnings should have been given in the labeling itself, or in the marketing of the drug. To hold otherwise, they write, would lead to a scenario where manufacturers would be subjected to liability or even directly required to include additional warnings that FDA has specifically considered and rejected. Any such holding, they add, would plainly conflict with FDA’s considered judgment that the scientific evidence does not support the additional warnings, and that ER/LA opioids can “effectively manage pain,” including chronic pain.

The backgrounder also reviews issues of primary jurisdiction that help prevent state tort law interference with FDA authority to regulate and promulgate uniform standards for drugs.