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Results: 1-10 of 687

Game of Thrones, the FDA under attack, an in-house view of Amarin
  • Reed Smith LLP
  • USA
  • August 31 2015

Today's guest post is a first for this blog in two ways, first, our guest poster is anonymous. Second, our guest post is from an in-house source. The


Ask but don’t tell: Kentucky allows defendant to seek ex parte interviews of Plaintiff’s treating physicians
  • Reed Smith LLP
  • USA
  • August 31 2015

We walked into the Drug and Device Law Rock Climber's room last night to find her packing for her return to college while the ignored TV blared in


Lack of proximate cause for failure to warn nets a directed verdict
  • Reed Smith LLP
  • USA
  • August 28 2015

A week ago, in a post-script to a post on Daubertdecisions, we reported that the trial court in Hexum v. Eli Lilly & Co., No. 2:13-cv-02701-SVM-MAN


Batting down generic plaintiffs’ Amarin Hail Mary pass
  • Reed Smith LLP
  • USA
  • August 27 2015

We received a couple of odd anonymous comments to our "breaking news" post about the Amarin First Amendment victory for truthful off-label promotion


SDNY dismisses manufacturing and fraud claims in fertility drug case, but conflates and confuses the rest
  • Reed Smith LLP
  • USA
  • August 26 2015

By all rights, it should be Sullivan writing about the Sullivan case. But John is taking a well-deserved vacation. We do not know if Sullivan's


Preemption (and other things) defanging Depakote claims
  • Reed Smith LLP
  • USA
  • August 24 2015

It wasn't a complete win, but the summary judgment outcome in Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio


Central District of California discontinues much of Plaintiffs' experts' testimony in Cymbalta discontinuation symptoms case
  • Reed Smith LLP
  • USA
  • August 22 2015

"I'm not a doctor, but I play one on TV" - shorthand for "I am pretending to know what I'm talking about, but I really don't." We have blogged


PMA medical device preemption decision better late than never
  • Reed Smith LLP
  • USA
  • August 20 2015

We recently learned of Thomas v. Alcon Laboratories, ___ F. Supp.3d ___, 2013 WL 10888983 (N.D. Ga. Jan. 29, 2013), dismissing a contact lens product


Identification of overpayments: a win for DOJ cautions 'prosecutorial discretion' in enforcement of an 'unforgiving rule'
  • Reed Smith LLP
  • USA
  • August 18 2015

On August 3, 2015, the Southern District of New York issued the first judicial opinion interpreting the Affordable Care Act's "60-Day Overpayment


Impossibility preemption for innovator drug manufacturers: where are we now?
  • Reed Smith LLP
  • USA
  • August 14 2015

As this blog has been explaining for a while, the rationale in Mensing that “the question for ‘impossibility’ is whether the private party could