Lawsuits Over Ineffective Nasal Decongestant Phenylephrine Consolidated for MDL Proceedings

Nasal decongestant lawsuits began to be filed throughout the federal court system this year, after an FDA advisory committee determined the ingredient phenylephrine is not effective when taken orally.

A panel of federal judges has determined that all lawsuits filed over the ineffectiveness of the nasal decongestant phenylephrine, which was used in popular cold and flu products such as Sudafed and Tylenol, should be consolidated for coordinated pretrial proceedings in the Eastern District of New York.

There are dozens of nasal decongestant lawsuits currently filed or pending in federal courts nationwide, each raising similar allegations that pharmaceutical manufacturers sold millions of consumers an ineffective nasal decongestant for decades.

The litigation emerged after an advisory committee to the U.S. Food and Drug Administration (FDA) determined in September that phenylephrine is an ineffective decongestant when taken orally. The committee examined the fourteen original clinic trials that granted the FDA’s prior approval of PE, as well as multiple analyses and studies showing the ingredient was ineffective when taken orally.

The FDA must now decide whether it should be allowed to remain on the market, or whether phenylephrine decongestants will be recalled. While the agency is not required to follow the recommendations made by the advisory committee, it usually does.

In the meantime, class action lawsuits over economic loss have begun to be filed against a number of drug manufacturers, including Bayer, Johnson & Johnson, GlaxoSmithKline, Pfizer and others, as well as major retailers such as CVS and Amazon.

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Late last month, the U.S. Judicial Panel on Multidistrict Litigation (JPML) heard oral arguments over whether the cases should be consolidated before one federal judge for coordinated pretrial proceedings, after a petition for centralization was filed by one of the plaintiffs.

In complex pharmaceutical litigation, where large numbers of claims are brought by users of the same medication or medical product, each experiencing the same or similar injuries or economic losses, it is common for the U.S. JPML to centralize the litigation to reduce duplicative discovery into common issues that will arise in all claims, avoid conflicting pretrial rulings and to serve the convenience of certain witnesses and parties who will be required to testify in each of the lawsuits.

Nasal Decongestant Lawsuits Consolidated in New York

In a transfer order (PDF) issued on December 6, the judges indicated there are currently 11 actions pending in seven districts, with an additional 73 related actions that were not included in the original petition. As a result of common issues in the claims, the panel determined that the cases should be consolidated in the U.S. District Court for the Eastern District of New York, under Judge Brian M. Cogan.

Plaintiffs and defendants had agreed that consolidation would benefit the litigation, and both sides had suggested Eastern New York as an appropriate venue.

However, five of the lawsuits involve allegations that some Johnson & Johnson products were deceptively advertised under the “Maximum Strength” label. The panel ruled that these cases were only slightly connected to the rest of the litigation, and removed them from the nasal decongestant MDL, or multidistrict litigation, after the plaintiffs in those cases agreed to remove claims involving phenylephrine’s ineffectiveness.

As part of the coordinated management of the nasal decongestant MDL, it is expected that Judge Cogan will establish a “bellwether” program, where a small group of representative cases are prepared for early trial dates, to help the parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout various cases in the litigation.

If no nasal decongestant settlement agreement or other resolution is reached during the MDL pretrial proceedings, each individual claim may later be remanded back to the U.S. District Court where it was originally filed for trial.


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