We have been reporting on third party payer/payor (“TPP”) litigation for a long time. This category covers a range of causes of action and allegations but boils down to boils down to insurance companies or other entities trying to recover amounts they paid for patients to receive medical products because the manufacturers or sellers allegedly did something wrong (e.g., promoted off-label, failed to warn). These cases often follow other litigation against the manufacturers, such as product liability or False Claims Act cases, and involve huge stakes. We have derided some of the statistical mumbo jumbo and arguments used to try to connect the defendant’s conduct to plaintiffs’ decisions to spend what they spent on the products. It seems that just about every successful and/or costly prescription drug ends up the subject of at least some TPP cases. This is true independent of whether the drug represented a major advance or continues to fill an important medical need.
We know that the use of a series of drugs based on thalidomide to treat the cancer multiple myeloma has improved survival rates in a meaningful way. Taking an old compound with well-known teratogenicity issues and re-purposing it (or its enantiomers or metabolites) to treat a virulent cancer has also been a triumph of drug development. Because of teratogenicity risks, the risk minimization measures for these cancer drugs have included limits on how they are distributed and dispensed and heightened surveillance...
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