Oral Phenylephrine — Cue the Lawsuits

On September 12, an FDA Advisory Committee unanimously recommended that oral phenylephrine, the active ingredient in numerous popular over-the-counter (OTC) nasal decongestant products, was not effective at its intended purpose: reducing nasal congestion. While the Advisory Committee vote is not binding on the FDA, the agency’s own analysis presented prior to the panel’s meeting concluded that oral phenylephrine formulations are safe but ineffective at standard or even higher doses. Thus, the Advisory Committee vote appears to pave the way for an FDA decision withdrawing the monograph pursuant to which phenylephrine is legally sold.

As night follows the day, the consumer class action lawsuits are being readied and filed. The first was filed last week against companies currently marketing OTC products containing the ingredient. There will be a race to the courthouse, followed by a potential multi-district litigation process.  

This follows a familiar pattern. Agency action triggers a wave of consumer class action filings based on putative theories of false advertising: "You said it worked, but now I know it didn't. I want my money back."  

But how should these be defended? Here are some ideas:

1. The race to the courthouse itself may be a problem for plaintiffs. Many class representatives identified are probably inappropriate. Did they actually buy the product? Do they have other disqualifying attributes? Were they happy when they bought the product? (data submitted to the Advisory Committee shows that 68% of consumers actually repurchased oral decongestants containing the ingredient). The speed of filing implies that plaintiff attorneys did not carefully vet their named representatives.

2. The products are often sold OTC and are more easily obtainable than competing decongestant products such as pseudoephedrine, which the FDA has put behind the counter, thereby decreasing their availability. For decades, the phenylephrine products were sold pursuant to FDA monograph: essentially, the FDA's blanket blessing that sales were appropriate based on extensive data already made available to agency reviewers. This regulatory history suggests a preemption defense.

3. The totality of evidence supports a finding of efficacy, at least for non-allergic sinus congestion. Moreover, there is no evidence of a lack of safety. While few products work equally well for everyone, nobody was demonstrably worse off for purchasing, and CHPA's survey shows that many reported satisfaction, and even happiness, with their purchase. These are merits defenses, of course.

4. The FDA process is itself not complete. The Advisory Committee vote is the initial step, but the FDA itself has not formally ruled, and even if it does, there may be further litigation regarding the legality of the FDA decision that could take years. The positioning suggests a primary jurisdiction defense —essentially asking the court to dismiss without prejudice or stay the action, pending the outcome of a highly determinative agency process.

5. The ingredient is often sold in various combination drug formulations. The synergistic effect of other ingredients could complicate plaintiffs' causation arguments.

6. Can a class be certified on these issues at all? Substantial evidence shows that phenylephrine works to reverse dilation of nasal blood vessels that cause temporary symptoms of allergic nasal congestion. Whether this occurs in every person depends on unique circumstances such as the severity of their symptoms, cause of their symptoms, consumption patterns, and unique physiology. What other drugs did the class members take concurrently? While the cause of action of false advertising suggests a pleading can be made without inquiry into the actual impact of the product on the body of class members, this situation may be different. Individual issues could well predominate. 

Initial questions to consider will also include how to work with co-defendants and ingredient suppliers, if at all.

The only certainty seems to be the likelihood of widespread litigation.