Thank you for sharing!

Your article was successfully shared with the contacts you provided.
A once-common additive to over-the-counter cold remedies and other non-prescription drugs may be the focal point of the latest wave of large-scale tort litigation. But the impact in New York courts is still uncertain. The additive, phenylpropanolamine, or PPA, has been used in cold remedies because it eases nasal congestion, and used in non-prescription weight-loss aids. It was voluntarily removed from over-the-counter products last year by drug manufacturers, and replaced by alternatives such as pseudoephedrine. The removal took place because PPA was linked to strokes by a Yale University study. Claims for the persons affected by the additive are being studied, and some lawsuits are beginning to be filed. New York has not yet seen a large number of complaints, and there is no telling how many cases there ultimately may be, according to a leading trial lawyer who has handled PPA cases. However, forecasting the volume of PPA litigation in New York is like forecasting the weather months in advance. “There will be litigation here,” said Paul D. Rheingold of Rheingold, Valet, Rheingold & Shkolnick in Manhattan. “There might be enough to go to Justice Freedman,” he said, referring to Manhattan Supreme Court Justice Helen E. Freedman, the court’s expert in complex litigation. But he added he has “no idea” how many cases will be litigated in New York courts. With major defendants such as Bristol-Myers Squibb headquartered in the state, it is certain that New York will be a locus of discovery. Other law firms, including Early & Strauss in New York, have formed consortiums to address the expected PPA litigation. They are using the Internet to exchange information and organize their efforts on behalf of plaintiffs. The additive was implicated in hemorrhagic strokes in the Yale study, which was published in the New England Journal of Medicine late last year. The federal Food and Drug Administration in the fall of 2000 asked manufacturers to remove PPA from their products, citing what it termed a “very low risk” of stroke. The FDA also noted the seriousness of the risk, and the inability to identify which populations may be more at risk for PPA-related stroke. PPA was used in dozens of products up to last year, and was in wide use for about 50 years. The FDA’s Center for Drug Evaluation and Research estimates that 10,000 persons ages 18 to 49 suffer hemorrhagic strokes each year, and anywhere from 200 to 500 of those may be associated with PPA. Shortly after drug makers changed their products in response to the FDA’s request, they said they would be ready to face any potential litigation. A spokesperson for Chattem Inc., the maker of the Dexatrim diet pill, said last fall that the company would not be surprised by a lawsuit and was “prepared to handled it.” NEW YORK COURTS It is not yet clear how the litigation will affect New York courts, since there are class actions before federal courts in Louisiana and Washington, and state courts in California. Those class actions that may become the vehicle for resolving many claims, but may not be adequate to redress the damages suffered by persons who underwent strokes or other serious side effects. Rheingold, who has already settled claims on behalf of four plaintiffs and taught courses on the emerging litigation, said that individual plaintiffs may be well-advised to opt out of a nationwide class action. He said that advice is consistent with his firm’s general philosophy in favor of individual litigation. A class action could be used, as it was in diet drug litigation, as a vehicle for settling claims, Rheingold said. But defendants with more serious claims may choose to opt out of the class. Meanwhile, it is not difficult to find information about PPA claims. Discussions of PPA risk, injury and redress may be found on literally dozens of consumer-oriented Internet sites, as well as some law firm Web sites. Lawyers and consumer advocates have used the Internet and advertising media to alert persons to the possibility of PPA liability. Since the FDA’s action in the fall, class action complaints have been filed in several jurisdictions alleging that the drug manufacturers knew for more than 20 years that PPA could cause strokes — and that it had other deleterious side effects — but continued to sell the products. Plaintiffs in the suits also said that the medications were advertised falsely and lacked warnings about known health risks. The Bureau of National Affairs reported that the relief sought includes the refund of billions of dollars used to purchase the medications, and the establishment of medical monitoring for consumers. Rheingold said that actual litigation of PPA claims has been “sporadic” to date, with his firm settling four cases. Rheingold wrote in a January 2001 article in Mealey’s Emerging Drugs and Devices legal newsletter that litigation involving unpatented over-the-counter products, such as PPA, is vastly different from litigation over prescription drugs. Most fundamentally, while a patented drug has only one manufacturer, there are “probably 50 or more companies which had PPA in its products,” Rheingold said. Also, the testing of such common additives is usually less stringent and less carefully recorded than that for prescription medication, he said. “It follows that one cannot expect to see the concentration of plaintiffs’ ‘firepower’ against a single company,” he wrote. Also, parallel discovery will be needed with regard to the dozens of companies that are likely to become defendants in PPA litigation. That will require large deployments of lawyers and a great deal of discovery practice, he concluded. The multiplicity of defendants and the need for particularized discovery with regard to each of them may discourage courts from granting class certification, which requires common issues to predominate over individual issues, he wrote. Rheingold said that the basis of liability for manufacturers is the failure to warn consumers of the possibility of strokes and other side effects, although he notes that a popular over-the-counter diet pill, Dexatrim, did include such a warning after the mid-1990s. He also said there could be punitive damage exposure if it can be proved that manufacturers were aware of stroke risks but stalled in removing the additive from products.

This content has been archived. It is available through our partners, LexisNexis® and Bloomberg Law.

To view this content, please continue to their sites.

Not a Lexis Advance® Subscriber?
Subscribe Now

Not a Bloomberg Law Subscriber?
Subscribe Now

Why am I seeing this?

LexisNexis® and Bloomberg Law are third party online distributors of the broad collection of current and archived versions of ALM's legal news publications. LexisNexis® and Bloomberg Law customers are able to access and use ALM's content, including content from the National Law Journal, The American Lawyer, Legaltech News, The New York Law Journal, and Corporate Counsel, as well as other sources of legal information.

For questions call 1-877-256-2472 or contact us at [email protected]

Reprints & Licensing
Mentioned in a Law.com story?

License our industry-leading legal content to extend your thought leadership and build your brand.


ALM Legal Publication Newsletters

Sign Up Today and Never Miss Another Story.

As part of your digital membership, you can sign up for an unlimited number of a wide range of complimentary newsletters. Visit your My Account page to make your selections. Get the timely legal news and critical analysis you cannot afford to miss. Tailored just for you. In your inbox. Every day.

Copyright © 2021 ALM Media Properties, LLC. All Rights Reserved.