In July, the federal MDL court dismissed all pending claims against generic and store-brand manufacturers of ranitidine.
For people who took generic forms of ranitidine and have been diagnosed with cancer, or who lost loved ones to cancer after their family member took generic ranitidine, this is obviously bad news. But, it’s important to understand who the ruling does and doesn’t impact, and what comes next.
Why Were the Claims Relating to Generic Ranitidine Dismissed?
The Food & Drug Administration (FDA) provides a process for quick approval for generic forms of a drug that has already been approved. This process, called the “abbreviated new drug application” (ADNA) requires that the drug be “identical in key respects” to the already-approved drug. Those key respects include both the formulation of the drug and the labeling associated with it.
That means that a generic manufacturer whose drug has been approved through the ADNA process can’t make significant changes on their own. Relying on prior U.S. Supreme Court decisions, the MDL court ruled that the generic defendants couldn’t have done what plaintiffs are asserting they should have done without violating federal law.
For example, both brand-name and generic plaintiffs are claiming the companies should have included certain warnings on their packaging. But, the MDL court ruled that the generic defendants were barred by federal law from substantially altering the warning labels. So, they can’t be held responsible for not adding warnings. Similarly, the plaintiffs claim that the drug’s design was flawed–but, generic manufacturer’s relying on ADNA approval can’t change the formulation of the drug.
Where Do Generic Ranitidine Cancer Victims Stand Now?
At this point, the generic drug manufacturers and other generic defendants have been dismissed from the federal MDL. The plaintiffs’ claims relating to the generic drug defendants were dismissed without leave to amend. That means the court did not give them the chance to make changes to their complaints that might allow them to move forward. They were also dismissed with prejudice, which means that the plaintiffs can’t re-file their cases.
Some plaintiffs had also asserted “innovator liability” claims. These claims are based on the theory that brand name manufacturers may be liable for damages suffered by people who took generic versions of the drug. In an earlier unrelated case, the California Supreme Court ruled that the brand name manufacturer’s duty to warn of risks associated with the drug could extend to people who took the generic version of the drug. So far, the MDL court has largely rejected these claims.
We’ll continue to post updates as litigation and any related appeals move forward.
Does the Dismissal Affect Brand-Name Zantac Plaintiffs?
No. The generic drug defendants were dismissed from the MDL because the court concluded that federal law prevented those defendants from altering the formulation of the drug or the warnings associated with the packaging and communications to medical professionals. That limitation is based on the requirement that manufacturers who receive approval through the ADNA process based on prior approval of a virtually identical drug cannot unilaterally make changes.
The brand name drug was approved through the regular NDA process, and is not subject to the same limitations. The Zantac MDL is moving forward against the brand-name defendants.
What if I Took Both Brand-Name and Generic Zantac?
People who took both generic forms of ranitidine and brand-name Zantac and were later diagnosed with cancer may have been harmed directly by the brand-name product. That means people who took a mix of generic and brand-name ranitidine may have claims against the brand manufacturers and distributors.
If you took brand-name Zantac, whether or not you also took generic forms of ranitidine, it’s in your best interest to talk with a ranitidine litigation lawyer. Your time to file a claim is limited, so the sooner you speak with an attorney, the better.
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