Wish you were here: Physicians fess up to fondness for face-to-face over fishbowl sales calls

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Hi, I’m Geraldine Young, and this is Norton
Rose Fulbright’s The Pharma 5.

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In a blow to rigorous MDL case management,

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the 3rd Circuit recently raised from the
dead a lawsuit that alleged that LivaNova’s

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3T Heater-Cooler System
caused a man to develop

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a bacterial infection at the site of
his open heart surgery incision.

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The district court had dismissed the
claims with prejudice because

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the plaintiff failed to submit medical
records showing he tested positive for

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the bacteria — a requirement under
the MDL Case Management Order.

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In reversing, the 3rd Circuit held

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the MDL court abused its discretion
because it failed to evaluate

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the plaintiff's alternate theories of injury.

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Turns out Zoom may make the heart grow
fonder, at least in the sales rep arena.

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In response to COVID-19 social restrictions,

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pharma sales reps had to quickly pivot from
in-person meetings to digital only

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interactions with doctors.

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But a surprise ZoomRx consultants’ poll reveals
that doctors now admit that for pharma

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promotion they actually prefer face-to-face
sales rep visits to Zoom sessions.

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The intersection of federal,

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state and tribal law continues to be
a quandary for pharma litigation.

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Now, an upcoming ruling will test

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the enforceability of arbitration
with Indian tribal pharmacies.

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The Chickasaw Nation filed suit in

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the Eastern District of Oklahoma against
Aetna Health, CVS Caremark,

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drug companies and other retailers,
alleging the defendants violated

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the 1976 Indian Health Care Improvement
Act by refusing to reimburse

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the tribe’s pharmacies for pharma claims
made by the Nation’s members.

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CVS countered by filing a lawsuit against
the Nation in Arizona that argues

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the provider agreement signed by

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the tribal pharmacies requires any dispute
be settled by arbitration in Scottsdale.

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The Supremacy Clause of the US Constitution
has reigned supreme in a pair of rulings

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on federal preemption. In the first,
AstraZeneca and Bristol-Myers Squibb,

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won dismissal of a product
liability suit filed by

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a Texas plaintiff in Delaware state
court, alleging design defect

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and failure to warn after he developed a
life threatening infection from using

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the defendant’s diabetes medication.
The Superior Court of Delaware held

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the claims were preempted by the FDCA
and related FDA regulations because

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the FDA approved warnings were adequate,
and federal law prohibits

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the defendants from changing
the design of the drug in

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a meaningful way without prior FDA approval.

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In preemption part two, a California state
court judge has tossed hundreds of

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plaintiffs failure to warn of pancreatic
cancer claims arising from

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the use of incretin-based diabetes drugs.

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The drugmakers moved for summary
judgment on the grounds that

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the claims were preempted under the US
Supreme Court rule in <i>Wyeth v. Levine</i>

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because they had no duty to include a
warning beyond the label approved by

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the FDA, and because the plaintiffs failed
to show the FDA would have approved

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an additional warning if it had
been given more information.

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The district court agreed: a CBE label change
would have been rejected by the FDA

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because the agency had published an article
dismissing a link between incretin drugs

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and cancer.

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Thanks for watching. See you next time on
Norton Rose Fulbright’s The Pharma 5.