Zantac Setting the Record Straight

THERE IS NO ACCEPTABLE LEVEL OF NDMA

MTN has reviewed numerous complaints filed against the makers of Zantac/Ranitidine products. Many complaints have referenced the FDA having determined the “safe level” of NDMA. These statements make it appear that the FDA has determined that it is “ok” for a drug to contain a certain level of NDMA.

It is important that plaintiffs attorneys do not give the various Courts the impression that the FDA has established a level of NDMA that can be found in a drug and that drug not be considered adulterated and misbranded. If plaintiff counsel opens this door, the defendants are surely to walk through it, or at least attempt to do so.

Pursuant to 21 U.S. Code § 351. (Adulterated drugs and devices) a drug is considered adulterated if it contains any substance not listed on its “ingredients” label, as approved by the FDA. Drugs are commonly recalled due to the presence of significant amounts of harmless substances or particles simply because those harmless substances and/or particles render the lot or batch in which they were found, adulterated.

A drug is mislabeled pursuant to 21 U.S. Code § 352.(Misbranded drugs and devices) if (a)(1) If its labeling is false or misleading in any particular.

Pursuant to Title 21-§331. (Prohibited acts) the introduction of any drug into interstate commerce, as well as receiving any such drug (relevant to those entities in the distribution chain, including retailers) that is adulterated, misbranded or both, a criminal offense.

A drug could be misbranded but not adulterated however, all adulterated drugs are also misbranded.

No “statement or finding” by the FDA can change any aspect of a law enacted by Congress. The Safe Levels of NDMA mentioned by the FDA, prior to the FDA’s request that all makers of Zantac/Ranitidine (OTC and RX) remove all of these products from the market, were intended to prevent consumers who had taken these drugs from panicking. The “save levels of NDMA” the FDA was referring to were those established by the EPA and other agencies relevant to drinking water. The FDA changed course on April 1, of 2020 relevant to their focus on keeping consumers calm and converted to the position inter alia: Stop taking these drugs, the contaminant found in these drugs is a probable carcinogen.

As of April 1, 2020, the FDA, after an investigation that lasted over 7 months, the FDA, in addition to “requesting” (the limit of the FDAs unilateral power) that all makers of Zantac/Ranitidine products remove (recall) their products from the market. The April 1, 2020 Statement.

NDMA is not approved by the FDA as an active or inactive ingredient (excipient) for use in any drug product. The FDA would not approve a drug that listed NDMA has an ingredient.

No product for which the FDA has determined contains NDMA can be held to have been approved by the FDA. The FDA does not approve adulterated and misbranded drugs.

The April 1, 2020 Statement by the FDA also expressed the following finding by the FDA.

“New FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions,

MTN Note: This is a reference to storage temperatures or temperatures at which NDMA conversion begins relevant to Zantac/Ranitidine. Prior to the FDAs determination made public in the April 1, 2020 statement, all prior FDA statements had indicated that the FDA believed Zantac/Ranitidine was subject to converting to NDMA at temperatures significantly higher than normal “room temperatures”.

It is worth nothing that the FDA investigation relevant to certain batches and lots of blood pressure drugs found to contain N-Nitroso Compounds, that has been ongoing far longer than the Zantac/Ranitidine products investigation and the FDA has not requested a total recall of these products nor has the FDA found that NDMA begins to form at room temperature, relevant to the blood pressure drugs.

The EPA determined that NDMA was an “extremely hazardous substance” as early as the 1980s. “Extremely hazardous substance” is technical EPA speak for poison. Based on the findings of the FDA, it does not appear that defendants simply sold Plaintiffs a defective and harmful product, they “poisoned” plaintiffs.

NDMA IS A POISION! We are not being hyperbolic, NDMA has been successfully used as a murder weapon in at least 4 documented cases, three of which resulted in murder convictions and the forth resulting in the perpetrators on death prior to trial, as he poisoned himself with NDMA while trying (successfully) to murder his wife.

DESIGN IS A BROAD TERM UNDER THE LAW

The packing as well as the temperature at which a product is manufactured and held (stored) by the manufacturer are all included as part of the design of the drug. If other entities in the supply chain, such as shippers, distributors and retailers need to maintain a drug at below normal temperatures (refrigeration) then it is the legal duty of the manufacturer to instruct these other members of the supply chain as to the necessity to “hold” the drug at temperatures that assures that the drug will remain in the same condition (including contain the same ingredients and only those ingredients) that were present when it left the hands of the drug makers.

If the consumer needs to maintain a drug at a certain temperature so as to prevent the drug from “deteriorating” or any portion of the drug from converting to a substance not listed on the label (ingredients) it is the duty of the manufacturer to provide the appropriate instructions on the label. Many drugs carry a “refrigeration instruction” but not Zantac/Ranitidine.

Why is the fact that the FDA has found that NDMA begins to develop in Zantac/Ranitidine at room temperature so important?

  1. The products were presumably (discovery will tell) manufactured at refrigerated temperatures. It is quite possible that many of the outsource overseas manufacturing facilities that made Zantac/Ranitidine are not even air conditioned.
  2. Once any given Zantac/Ranitidine rolled of the line, it was not held pre nor post packing by the manufacturer (packing and warehousing) at refrigerated temperatures.Presumption/Conclusion: NDMA began to form before the product left the original manufacturers hands.
  3. The shippers (including overseas container shippers) were not instructed to, nor did they maintain the product at refrigerated temperatures.
  4. The various land base shippers (trucking companies) that handled the product, were not instructed to, nor did they maintain the product at refrigerated temperatures.
  5. The retailers were not were not instructed to, nor did they maintain the product at refrigerated temperatures.
  6. The retailers were not were not instructed to, nor did they maintain the product at refrigerated temperatures.

Final Presumption/Conclusion: Every Zantac/Ranitidine tablet that ever rolled off any drug makers line, from the first tablet ever made, began converting in part, to NDMA and continued to do so, throughout the supply chain and in the consumers hands. More simply stated, all Zantac/Ranitidine per the FDAs statements are presumed by the agency, to be and to always, and at all times, been contaminated with NDMA.

Takeaway’s

  1. The acceptable level of NDMA that can be found in a drug and that drug is not adulterated and misbranded is zero, nada, zip, none.
  2. The FDA has established that every Zantac/Ranitidine tablet ever made (unless refrigerated though out its entire lifecycle) is and or was prior to consumption, contaminated with NDMA and thus misbranded and adulterated.
  3. The products consumed by Plaintiffs were not approved by the FDA in that the FDA does not approve misbranded and adulterated drugs. In fact, misbranded and adulterated drugs are specifically not approved by the FDA and Federal as well as every States law makes the introduction of such products into the stream of commerce an offense (generally criminal). Federal Law (Our State Survey on this matter is not completed however, Federal Law will suffice) as well as State laws, make the receiving and further distributions (by those in the supply chain) an offense equal to that of the original manufacturer.
  4. Generic Drug makers, whether OTC or RX, for these reasons as well as others, can not claim protection under Pliva v. Mensing in that any restriction under the law relevant to a generic drug makers ability to unilaterally make changes to their warning label, is irrelevant to drugs that were not approved by the FDA in the first instance. The FDA does not approve adulterated and misbranded drugs nor does the FDA approve nor place restrictions relevant to the labels of these products. The law restricts these products from being sold, hard stop.

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