Criminals protect their own.
Criminals protect their own.
What could possibly go wrong?
“Even if we assume, as the District Court did, that Merck made misrepresentations (i.e., false claims), based on our de novo review of these considerations, no reasonable jury could conclude that the representations were material to the CDC’s purchasing decisions,” the ruling stated.
I hope that juries start becoming unreasonable...
In other words, the judges said that even if the evidence shows the government knew about Merck’s misrepresentations and data falsification related to its mumps vaccine because the U.S. Food and Drug Administration (FDA) was aware of the behavior and the CDC continued to purchase the vaccine with that knowledge, the company was not in violation of the False Claims Act.
Also, it appears that they changed manufacturing process with FDA knowledge and tacit approval with no new clinical trial...
In the late 1990s, a regulatory labeling review revealed that the mumps component of Merck’s measles, mumps and rubella vaccine, MMRII, did not maintain the stated potency — and therefore effectiveness — over its shelf life, in violation of FDA regulations.
Rather than recalling the vaccine or attempting to develop a different formula, the company spent years trying to develop new and more sensitive ways to test the existing vaccine that would show high efficacy results, so it would still be in compliance with regulatory requirements and allow Merck to maintain its exclusive license.
Merck did this even though its existing data showed the vaccine was significantly less effective than claimed, according to the former head of the FDA Dr. David Kessler, who wrote an expert report for the plaintiffs.
To achieve its potency claims, Merck and the FDA agreed the company would temporarily “overfill” the vaccine with extra virus, while it addressed the potency issue.
Just put more bugs in the jugs, bro.
What could possibly go wrong?
>“Even if we assume, as the District Court did, that Merck made misrepresentations (i.e., false claims), based on our de novo review of these considerations, **no reasonable jury could conclude that the representations were material to the CDC’s purchasing decisions**,” the ruling stated.
I hope that juries start becoming unreasonable...
>In other words, the judges said that even if the evidence shows the government knew about Merck’s misrepresentations and data falsification related to its mumps vaccine because the U.S. Food and Drug Administration (FDA) was aware of the behavior and the CDC continued to purchase the vaccine with that knowledge, the company was not in violation of the False Claims Act.
Also, it appears that they changed manufacturing process with FDA knowledge and tacit approval with no new clinical trial...
>In the late 1990s, a regulatory labeling review revealed that the mumps component of Merck’s measles, mumps and rubella vaccine, MMRII, did not maintain the stated potency — and therefore effectiveness — over its shelf life, in violation of FDA regulations.
>Rather than recalling the vaccine or attempting to develop a different formula, the company spent years trying to develop new and more sensitive ways to test the existing vaccine that would show high efficacy results, so it would still be in compliance with regulatory requirements and allow Merck to maintain its exclusive license.
>Merck did this even though its existing data showed the vaccine was significantly less effective than claimed, according to the former head of the FDA Dr. David Kessler, who wrote an expert report for the plaintiffs.
>To achieve its potency claims, Merck and the FDA agreed the company would temporarily “overfill” the vaccine with extra virus, while it addressed the potency issue.
Just put more bugs in the jugs, bro.
(post is archived)