A Generic Drug Failure to Warn Claim? –Michelle Hart Yeary

April 14th, 2019|Categories: HB Tort Notes|Tags: , , , , , |

  "Rather than focusing on what plaintiff’s off-label marketing claim really was – a claim that defendant’s label should have contained different information or warnings about off-label uses – an impliedly preempted claim, the court got distracted trying to fit the case in under Bausch and started talking about parallel violation claims. "The court found that because plaintiff was alleging a violation of federal regulations, his claims “run parallel to [defendant’s] state law duties,” and thus were not preempted. The problem with this is that Mensing is not an express preemption case.  It was an implied preemption case, and the district court had no business applying 'parallel claim' analysis to implied preemption, where a 'parallel claim' exception does not exist.  It makes no difference whether plaintiff’s off-label promotion claim is 'parallel' to federal regulations, defendant could not have offered any different warning so any [...]

How on Earth can a plaintiff plead and prove that a purported failure to report adverse events to the FDA caused him or her any injury?

May 31st, 2018|Categories: HB Tort Notes|Tags: , , |

Maybe a learned plaintiff attorney would like to weigh in, but for a defense commentary on the preemption — or not — of claims relating to injuries alleged to be the result of pre-market approved medical devices, see what Steven Boranian had to say in his recent post in the Drug & Device Law blog. Read more

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