The Pharma 5: What to know now in Pharma and Med Device litigation

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I’m Madison Gaona and this is Norton
Rose Fulbright’s The Pharma 5.

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Philips is breathing a little uneasily
this month as the company's CPAP

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and BiPAP machine recall has spurred
a class action lawsuit.

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The machines contain PE-PUR foam,

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which allegedly can degrade under certain
conditions and cause cancer

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and respiratory inflammation.

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Baird Respiratory and other retailers
have filed the action in

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the Eastern District of Pennsylvania
alleging negligence,

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fraud and breach of warranty,

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claiming that Philips had
been aware of the foam

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and unreasonably continued
to profit from its sales.

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Discount or Miscount? Walgreens Prescriptions
Savings Club Program offers

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a wide variety of prescription
drugs at discounted prices.

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Several TPPs, however, have brought
suit in Illinois Federal Court,

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alleging that Walgreens fraudulently
requested reimbursement benefits from TPPs

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without the appropriate discount,

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resulting in hundreds of millions
of dollars in overages.

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The TPPs argued that the scheme undermines

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the purpose of any health insurance company’s
prescription drug benefit program;

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that is TPPs don’t pay
more than cash customers.

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Now, a failure to warn trifecta.

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In the securities arena, Judge Lewis J.

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Liman of the Southern District
of New York has dismissed

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an investor action filed against
Intercept Pharmaceuticals.

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The investors allege that the company
failed to warn of fatalities

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and other adverse events from use of Ocaliva,
a drug designed to treat liver disease,

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while the co-founder sold his
stock at inflated price.

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The shareholders, however, have failed
to adequately plead causation.

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Only two adverse events had occurred,

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both of which plaintiffs failed
to causally link to Ocaliva.

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An atypical preemption response
on atypical fractures.

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New Jersey federal Judge Freda Wolfson has
ruled that Albrecht preempts plaintiff’s

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state law failure to warn claims involving
the osteoporosis drug Fosamax.

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Merck had proposed to the FDA various
atypical fracture label changes in the ADR

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and warning and precautions sections.

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The FDA added the ADR language, but
rejected the proposed W&P additions.

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There was not, quote, reasonable evidence
of a causal association, end quote,

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as required by the regs. The
court ruled it was clear

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the FDA would have rejected any
proposed warning at the time.

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And finally, one hand, giveth.
The Ninth Circuit,

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has shockingly interpreted California drug
and device failure to warn causation law

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as deficient and requested instruction
on the issue from

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the State Supreme Court. In Hymes
versus Somatics LLC,

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the plaintiff allegedly suffered
permanent cognitive damage from

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an ECT therapy machine manufactured
by Somatics.

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The federal trial court granted a defense
summary judgment on causation grounds.

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There was no evidence that a stronger
warning would have changed

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the doctor’s decision to prescribe the ECT.

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The Ninth Circuit, however, has found that
while it is clear under California failure

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to warn causation law that a plaintiff
must show, one, that

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the warning provided was inadequate, and two,

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that the inadequacy of the warning
caused the plaintiff’s injury,

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California law has not resolved
the question of how

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the stronger warning must have altered the
content of the prescribing physician.

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So in a move that could upend pharma and
medical device litigation in California,

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the Ninth Circuit has certified for
the California Supreme Court

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the following question: Is the plaintiff
required to show that

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a stronger risk warning than
given would have altered

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the physician’s decision to prescribe?
Obviously we’re pulling for a yes,

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which we all thought was already the law.

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