Zantac / Ranitidine Litigation Common Misconceptions By John Ray

The topic below will be discussed in depth in the Mass Tort Nexus (MTN) Whiteboard Wednesday (January 20, 2021), if you have not registered for the session, you can do so here:

Common Misconception: Sales of prescription versions of Zantac/Ranitidine were insignificant after the OTC versions were approved.

Fact: Sales of prescription versions of Zantac/Ranitidine remained strong even after the OTC versions were approved. Between 18 million and 20 million prescriptions were written for Zantac/Ranitidine, each year, over the last decade. Zantac/Ranitidine made the list of “Top 50 Most Prescribed Drugs” every single year over the last decade.

Why is this important?

  1. There will be a potentially far greater number of potential Zantac/Ranitidine “prescription use” plaintiffs.
  2. Due to the significant number of arguably counterfeit Zantac/Ranitidine finished drugs, placed into the stream of commerce by “repacking entities,” combined with the fact that the FDA has discovered these products and deactivated the NDC codes for many of these products, it is highly unlikely that your firm has a complete list of Zantac/Ranitidine NDC codes.

Why does this matter?

1. When the FDA deactivates an NDC code, it is removed from the public database of active NDC codes. MTN has uncovered and compiled these deactivated NDC codes.
2. Firms accepting Zantac/Ranitidine clients may believe they have a full list of all Zantac/Ranitidine NDC codes; however, it is improbable that any firm is working from a complete list of codes (it took MTN over 9 months to locate all Zantac/Ranitidine NDC codes, including those that have been deactivated by the FDA, or removed from the public view for other reasons).

Why is having a complete list of NDC codes critical?

  1. Your firm has a prospective client that claims to have taken prescription Zantac/Ranitidine, you sign the client and order their pharmacy records.
  2. Your record review department or company reviews the pharmacy and/or insurance records, looking for Zantac/Ranitidine NDC codes; the proof that your client did, in fact, consume a prescription Zantac/Ranitidine product.
  3. If you are not working from a complete list of Zantac/Ranitidine NDC codes (which is likely), then your record review may conclude that your client who claims to have taken prescription Zantac/Ranitidine, did not, because the NDC code for the product they consumed is not on the “incomplete” list of NDC codes in your possession.

Additionally, once you have access to a comprehensive list of NDC codes, you are likely to discover that many of your clients consumed one of the repackaged (arguably counterfeit) versions of prescription Zantac/Ranitidine.

In addition to the reasons previously stated, identifying all of your clients who took repackaged (arguably counterfeit) versions of Zantac/Ranitidine, is also crucial for the following reasons:

  1. Overcoming PLIVA v Mensing (in addition to the other facts that make Mensing inapt).
  2. A majority of the repacking entities are located in California, were the JCCP has already established an MDL-like consolidation for these cases.
  3. Given the ever-growing appearance, that the Zantac/Ranitidine MDL has landed in the hands of a defense-friendly Judge, the ability to establish jurisdiction and file cases in various State Court Consolidation, is now of paramount importance.

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