After nine months and thousands of hours of research, MTN has finally unraveled the conspiracy (and identified most, if not all, of the conspirators) that led to the entry into interstate commerce of approximately 1000 counterfeit Ranitidine products, a crime, in violation of 21 U.S. Code § 331 (k).

MTN has reviewed all of the various NIH and FDA databases necessary to identify all Ranitidine NDC codes deactivated under Code I (this will all be explained).

What is the difference between the Recall of a Drug Product and an NDC Deactivation under Code I?

A recall of an approved drug product generally occurs when something new is discovered relevant to the risks associated with the approved product. A recall does not indicate that the product was unlawfully marketed in the first instance.

Conversely, the deactivation of an NDC code, for any reason other than Code “E” (expired), is prima facia evidence that the particular drug package or finished drug product was, at all times in commerce, in violation of one or more regulations that carry the force of law (civil) as well as other violations that can be subject to criminal prosecution. If you understand the laws and regulations, which you will after attending the Whiteboard Wednesday series on December 16th, you will be able to identify a counterfeit drug product as well as a product entered into the stream of commerce in violation of 21 U.S. Code § 331 (k), simply by reviewing the SPL dataset for that product, even if you are currently unfamiliar with the term “SPL date set”.

FYI: MTN has already identified all Ranitidine products entered into the stream of commerce in violation of 21 U.S. Code § 331 (k); however, we would like to teach you how to identify these violative products as the Zantac/Ranitidine litigation is not the only current litigation where these matters are relevant.

We did not end our review with the products the FDA has discovered and taken action via NDC code deactivation, we reviewed every label for every Ranitidine NDC code, ever marketed in the United States (including those in various NIH and FDA archives), in order to identify all products involved in what we now simply refer to as “the scheme”.

To the best of our knowledge, there have been no prior mass product liability litigations in which the FDA has deactivated a plurality of the products (by NDC code) long prior to the onset of the product liability litigation.

Among the benefits attendees will gain include:

  1. The ability to counter any Defendant that avers that they had stopped marketing a product before a given date, when a Plaintiff claims to have consumed that product. The “end marketing” date for any given drug product is part of an official record, for which the drug maker is responsible to maintain and update, the accuracy thereof being subject to oath under the penalty of perjury. The Defendant’s averments as to any alleged “end marketing date” are irrelevant, the official record governs. Defendants will be forced to pick their perjury: Did they perjure themselves in an official Federal Record, or are they now perjuring themselves before the MDL court?
  2. The ability to add allegations and claims to your complaints that are likely to make certain Defendants more amenable to settlement, sooner rather than later. Ranbaxy had to shell out approximately $525 billion in 2013, after the DOJ charged the drug maker with violations of 21 U.S. Code § 331 (k) (among other things). The breadth and scope of the 331 (k) charges brought against Ranbaxy pale in comparison to what MTN has discovered occurred among a large group of the Zantac generic conspirators. We have the proof!

This series of Whiteboard Wednesdays will only be open to MTN members or individual attorneys sponsored and vouched for by MTN members.

If you are not an MTN member, contact annemarie@masstortnexus.com or call 954-530-9892 to discover how to become a member of the largest network of mass tort attorneys in the country.

Upon completion of your Registration for Whiteboard Wednesday, you will receive a copy of our white paper that should be read prior to attending the first in this series of “Zantac Whiteboard Wednesdays”. We need to hit the ground running, and it is likely that you will need to act on behalf of your Zantac generic clients sooner rather than later, based on the knowledge and evidence provided.

Register now for the first in the series of Zantac Whiteboard Wednesdays, held on Wednesday, December 16th. The presentation runs from 2:00pm EST – 4:00pm EST with Q&A to follow.


Share this Post: