Publication: Drug and Device Law

First reported Sep 16 2014 - Updated Sep 16 2014 - 1 reports

Who is the Prescriber?

You’ve no doubt heard that hard cases make bad law.  But sometimes hard cases make no law.  That is, the judge decides not to decide, because deciding seems too difficult.  We would have thought that ‘deciding stuff’ would have been way up there in the ... [Published Drug and Device Law - Sep 16 2014]
First reported Sep 15 2014 - Updated Sep 16 2014 - 1 reports

Important FOIA Decision

We don’t normally follow Freedom of Information Act (“FOIA”) decisions, but Public Citizen v. U.S. Dep’t of Health and Human Services, ___ F. Supp.2d ___, 2014 WL 4388062 (D.D.C. Sept. 5, 2014), falls more or less in our sweet spot.  Back in 2009, Public ... [Published Drug and Device Law - Sep 15 2014]
First reported Sep 12 2014 - Updated Sep 12 2014 - 1 reports

A Foregone Conclusion On A Runaway Verdict

            From our ivory tower in the kingdom of blogdom, we track cases and litigations from afar, peeking in on them from decisions rendered at specific points in time.  Sometimes, from a single decision, we venture on what will happen next, like ... [Published Drug and Device Law - Sep 12 2014]
First reported Sep 12 2014 - Updated Sep 12 2014 - 1 reports

Third Circuit Rejects Consumer Fraud/Unjust Enrichment Class Action

br />!--[if gte mso 10]> /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-qformat:yes; mso-style-parent:""; ... [Published Drug and Device Law - Sep 12 2014]
First reported Sep 11 2014 - Updated Sep 11 2014 - 1 reports

Telling It Like It Is

The Eleventh Circuit’s recent decision in In re Engle Cases, ___ F.3d ___, 2014 WL 4435893 (11th Cir. Sept 10, 2014), although involving cigarettes rather than prescription medical products, rips the scab off shoddy practices that plague many mass torts ... [Published Drug and Device Law - Sep 11 2014]
First reported Sep 10 2014 - Updated Sep 10 2014 - 1 reports

Later is not Better than Never

 We do not devote a lot of space to statute of limitations cases.  That is not because they are unimportant.  To the contrary, statutes of limitations serve fundamental principles of fairness and predictability.  Parties should not have to worry about ... [Published Drug and Device Law - Sep 10 2014]
First reported Sep 09 2014 - Updated Sep 09 2014 - 1 reports

Recent Development Highlighting The Off-Label Paradox

We’ve blogged a number of times about the illogical, and often downright counterproductive, nature of the FDA’s position that regulated manufacturers are generally banned from providing the medical community (or the public) with truthful information ... [Published Drug and Device Law - Sep 09 2014]
First reported Sep 08 2014 - Updated Sep 08 2014 - 1 reports

Yet Another Infusion of the InFuse Litigation

br />!--[if gte mso 9]><![endif]-->This post is from the non-Reed Smith side of the blog only.Even on a slow week, we can count on one litigation to infuse our inbox with blogging opportunities.  The decision comes from a federal court in ... [Published Drug and Device Law - Sep 08 2014]
First reported Sep 05 2014 - Updated Sep 05 2014 - 1 reports

Expert Couldn’t Carry The Plaintiff’s Water

Is a product defective because it did not perform as hoped?  How about if it failed or even if it broke?  Of course not, and this is doubly true for implanted medical devices because all treatment with medical devices carries risk, including the risk ... [Published Drug and Device Law - Sep 05 2014]
First reported Sep 04 2014 - Updated Sep 05 2014 - 1 reports

Removal of Discretion = Preemption

One of the big TwIqbalissues in PMA medical device preemption cases is whether plaintiffs can plead “parallel” claims based on allegations that defendants violated vague FDA regulations (typically involving Current Good Manufacturing Practices, or “CGMPs”) ... [Published Drug and Device Law - Sep 04 2014]
First reported Sep 03 2014 - Updated Sep 03 2014 - 1 reports

Don't Shoot the Piano Player

 It’s an old time Western movie cliché:  after a shoot-out commences in a saloon, the piano-player meekly holds up his hands and pleads, “Don’t shoot me, I’m only the piano player.”  He had no role in the fight.  The phrase got subverted in Francois Truffaut’s ... [Published Drug and Device Law - Sep 03 2014]
First reported Sep 02 2014 - Updated Sep 02 2014 - 1 reports

Remand Granted . . . Claim Against Non-Diverse Sales Rep Allowed

br />!--[if gte mso 10]> /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-qformat:yes; mso-style-parent:""; ... [Published Drug and Device Law - Sep 02 2014]

Quotes

...As to such "losses," the defendant asserted "that it sought to remedy the problem by directing patients to return the product to their respective pharmacies for replacement or reimbursement" but the court never had to go there. Id. at *1...
...in the Qui Tam Action, Eisai allegedly committed the causing of false or fraudulent claims to be submitted in connection with certain acts such as "failure to adopt adequate workplace or employment policies and procedures" and "negligent evaluation of employees."
After "tactfully re-characteriz[ing] their failure to warn claims through the procession of this MDL" plaintiff (and plaintiffs) finally had to put up evidence to maintain a warnings claim under New York law, which is fairly standard in terms of learned...
...D Cal. 2008) (off-label promotion violates the FDCA but the FDCA provides for no private right of action; nor can plaintiffs use "state unfair competitioncompetition laws as a vehicle to bring a private cause of action that is based on violations of the FDCA." ). Id. at *5-6

More Content

All (180) | News (0) | Reports (0) | Blogs (180) | Audio/Video (0) | Fact Sheets (0) | Press Releases (0)
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Who is the Prescriber? [Published Drug and Device Law - Sep 16 2014]
Important FOIA Decision [Published Drug and Device Law - Sep 15 2014]
A Foregone Conclusion On A Runaway Verdict [Published Drug and Device Law - Sep 12 2014]
Third Circuit Rejects Consumer Fraud/Unjust Enr... [Published Drug and Device Law - Sep 12 2014]
Telling It Like It Is [Published Drug and Device Law - Sep 11 2014]
Later is not Better than Never [Published Drug and Device Law - Sep 10 2014]
Recent Development Highlighting The Off-Label P... [Published Drug and Device Law - Sep 09 2014]
Yet Another Infusion of the InFuse Litigation [Published Drug and Device Law - Sep 08 2014]
Expert Couldn’t Carry The Plaintiff’s Water [Published Drug and Device Law - Sep 05 2014]
Removal of Discretion = Preemption [Published Drug and Device Law - Sep 04 2014]
Don't Shoot the Piano Player [Published Drug and Device Law - Sep 03 2014]
Remand Granted . . . Claim Against Non-Diverse ... [Published Drug and Device Law - Sep 02 2014]
Help With California’s Learned Intermediary Doc... [Published Drug and Device Law - Aug 29 2014]
Guest Post - Not Quite a One-Two-Three Punch [Published Drug and Device Law - Aug 28 2014]
ECF: Ignoring It Means Entire Case Fails [Published Drug and Device Law - Aug 27 2014]
The Sound of Silence . . . Not Good for Complaints [Published Drug and Device Law - Aug 26 2014]
Another Way of Getting Rid of Unjust Enrichment... [Published Drug and Device Law - Aug 25 2014]
Dreaming The Impossible Dream [Published Drug and Device Law - Aug 22 2014]
Hindsight is 20/20, And Yet Still So Blind [Published Drug and Device Law - Aug 21 2014]
A Cause for Celebration [Published Drug and Device Law - Aug 20 2014]
Plaintiffs’ Causation Case in The Zoloft MDL: I... [Published Drug and Device Law - Aug 19 2014]
POM Doesn’t Seem to Have Changed Much [Published Drug and Device Law - Aug 18 2014]
Interesting Cases Sent By Users (Part II) Off-L... [Published Drug and Device Law - Aug 18 2014]
Breaking News: Weeks II – Lipstick (and Not All... [Published Drug and Device Law - Aug 15 2014]
Allowing An End Run on Proximate Cause for Fail... [Published Drug and Device Law - Aug 15 2014]
Interesting Cases Sent By Users (Part 1) Person... [Published Drug and Device Law - Aug 14 2014]
EDNY Tosses Non-manufacturing Claims from Hip R... [Published Drug and Device Law - Aug 13 2014]
Hey Jude! Reprise – Still a Sad Song for Plaint... [Published Drug and Device Law - Aug 12 2014]
Court Holds that Claim Against a Doctor Who Ser... [Published Drug and Device Law - Aug 11 2014]
Hotel California: You Can Check Out Anytime You... [Published Drug and Device Law - Aug 08 2014]
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sort by: Date | Relevance
Who is the Prescriber? [Published Drug and Device Law - Sep 16 2014]
You’ve no doubt heard that hard cases make bad law.  But sometimes hard cases make no law.  That is, the judge decides not to decide, because deciding seems too difficult.  We would have thought that ‘deciding stuff’ would have been way up there in the ...
Important FOIA Decision [Published Drug and Device Law - Sep 15 2014]
We don’t normally follow Freedom of Information Act (“FOIA”) decisions, but Public Citizen v. U.S. Dep’t of Health and Human Services, ___ F. Supp.2d ___, 2014 WL 4388062 (D.D.C. Sept. 5, 2014), falls more or less in our sweet spot.  Back in 2009, Public ...
A Foregone Conclusion On A Runaway Verdict [Published Drug and Device Law - Sep 12 2014]
            From our ivory tower in the kingdom of blogdom, we track cases and litigations from afar, peeking in on them from decisions rendered at specific points in time.  Sometimes, from a single decision, we venture on what will happen next, like ...
Third Circuit Rejects Consumer Fraud/Unjust Enr... [Published Drug and Device Law - Sep 12 2014]
br />!--[if gte mso 10]> /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-qformat:yes; mso-style-parent:""; ...
Telling It Like It Is [Published Drug and Device Law - Sep 11 2014]
The Eleventh Circuit’s recent decision in In re Engle Cases, ___ F.3d ___, 2014 WL 4435893 (11th Cir. Sept 10, 2014), although involving cigarettes rather than prescription medical products, rips the scab off shoddy practices that plague many mass torts ...
1 2 3 4 5 6 7 8 9 10 ...
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