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In Phase II, the liver attaches a moleculeoften glutathioneto the toxin to make it water-soluble so it can be flushed out of the body
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Lead plaintiffs' attorney Jonathan Orent told USA TODAY that the warning letter "gives me tremendous comfort both that we're right, but also that the government is actually now doing something about these problems." He compared the reporting failures to "the opioid days," noting that expert witnesses reviewing the case had "not seen anything quite that bad." Novo Nordisk responded that the letter "does not make any conclusions about the quality or safety of our medicines" and that the company plans to "address the requests in the warning letter expeditiously and holistically." What This Means for GLP-1 Litigation Strengthening Failure-to-Warn Claims The warning letter provides plaintiffs' attorneys with a critical piece of evidence: documentation that Novo Nordisk had institutional procedures that systematically prevented adverse events from reaching the FDA
Throughout this period, the favorable safety profile remained consistent with no delayed-onset adverse effects or concerning laboratory changes emerging over time
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