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Court of Appeal:
Makers of Generic Drug Must Copy Brand-Name Labeling
Opinion Affirms Dismissal of Action Against Retailers, Manufacturers of Antacid That Contained Same Ingredient
As Zantac—but Controversy Appears Moot Because That Ingredient Is No Longer Used
By a MetNews Staff Writer
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Depicted above is a package containing Zantac. A Court of Appeal opinion issued yesterday does not mention the apparent mootness of the issue raised on appeal in light of the reformulation of the product. |
A judge properly dismissed an action against makers and retailers of generic versions of the antacid Zantac aimed at forcing them to provide Proposition 65 warnings, Div. One of the First District Court of Appeal held yesterday, because any deviation from the labeling that’s on the brand-name product would run afoul of a federal “sameness” requirement.
Presiding Justice James M. Humes authored the opinion. It affirms a judgment of dismissal by Alameda Superior Court Judge Winifred Y. Smith of an action by the Center for Environmental Health (“CEH”) against Target Corporation, 7-Eleven, Inc., and others.
Litigation against the brand-name manufacturers, Sanofi-Aventis U.S. LLC and Chattem Inc., continues.
Unless and until the brand-name makers are forced to affix Proposition 65 warnings to their packaging, Humes said, the makers of the generic antacids can’t be in light of a provision of the federal Food, Drug, and Cosmetic Act (“FDCA”) requiring copycat labeling of generic over-the-counter (“OTC”) versions.
However, prospects of such compulsion appear improbable given that Zantac no longer contains ranitidine, the active ingredient that’s been found sometimes to transform into N-nitroso dimethylamine, a carcinogen. Humes did not mention the recent reformulation of Zantac nor the matter of whether the issue on appeal is moot.
Hume’s Opinion
He wrote:
“Due to the unusual interplay between an express preemption provision governing OTC drugs and Proposition 65, the viability of CEH’s suit against the generic-drug defendants turns on whether federal law governs warning in a manner that preempts state law governing warning. We conclude that it does. Although we do not hold that all methods of publicly communicating a warning about a drug necessarily qualify as “labeling,” CEH fails to identify any method by which the generic-drug defendants could provide a warning about their consumer products that would satisfy both Proposition 65 and the federal duty of sameness. As a result, until brand-name manufacturers give a Proposition 65 warning on their products’ labeling, the generic-drug defendants cannot be required to do so.”
Humes added:
“CEH fails to demonstrate that the generic-drug defendants could give Proposition 65 warnings by any method that would not constitute ‘labeling’ under the FDCA. Accordingly, it would be impossible for the generic-drug defendants to give such warnings without violating the federal duty of sameness, and CEH’s claim is preempted.”
The case is Center for Environmental Health v. Perrigo Company, A163682
Federal Ruling
U.S. District Court Judge Robin L. Rosenberg of the Southern District of Florida, presiding over multidistrict litigation in In re Zantac (Ranitidine) Products Liability Litigation, on July 8, 2021, dismissed actions against makers of generic versions, saying:
“A generic drug manufacturer’s duty under federal law is a duty of sameness, meaning that the manufacturer must ensure that its generic drug is the same as the brand-name equivalent drug in key respects….Thus, a generic drug’s chemical composition and labeling must be the same as the brand-name equivalent drug.”
She held:
“The Generic Manufacturer Defendants could not warn consumers of the alleged risks that ranitidine posed when the labeling on brand-name ranitidine products did not contain such warnings.:
FDA Warning
On April 1, 2020, the federal Food and Drug Administration (“FDA”) announced it was “requesting” that all prescription and OTC ranitidine drugs be recalled while its investigation proceeded. It said:
“The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.”
The active ingredient in Zantac is now famotidine which has not been linked to cancer. It’s the same ingredient that’s in Pepcid, approved by the FDA in 1998.
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