@DDLaw

James Beck, Stephen McConnell, Eric Alexander, Steven Boranian, & Rachel Weil of Reed Smith, Michelle Hart Yeary of Dechert, & Andy Tauber of Winston & Strawn

 United States
druganddevicelawblog.com/
Joined November 2008
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Drug and Device Law: No Medical Device Exemptions to Texas Statute of Repose druganddevicelawblog.com/202…

No Medical Device Exemptions to Texas Statute of Repose

It’s a short week, so we are going to do a short post about a short decision on a product that lasted a long time.  An inferior vena cava (“IVC”)

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Drug & Device Law: Post-Out Sticky Notes druganddevicelawblog.com/202…
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Drug and Device Law: The Fiction Of Non-Preempted Pre-Market Design Defect Claims For Prescription Drugs druganddevicelawblog.com/202…

The Fiction Of Non-Preempted Pre-Market Design Defect Claims For Prescription Drugs

As we emerge from our fourth month-long trial in a little over two years, we are sure that we have missed some recent legal developments.  As good as this

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Drug and Device Law: Reporter’s Privilege Protects JAMA Peer-Review Documents from Discovery druganddevicelawblog.com/202…

Reporter’s Privilege Protects JAMA Peer-Review Documents from Discovery

The legal doctrine we discuss today, the reporter’s privilege, lies outside our traditional bailiwick but is worth a quick visit. Recognized in most

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Drug and Device Law: S.D. Alabama Tosses SJS Case Against Defendant that did not Make or Sell the Product druganddevicelawblog.com/202…

S.D. Alabama Tosses SJS Case Against Defendant that did not Make or Sell the Product

In 1972, Neil Young wrote his great song, “Alabama,” the lyrics of which included the following: “Alabama, you’ve got the rest of the union, to help you

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Drug and Device Law: Another Opioid Addict Overdose Case Dismissed, Several Times Over druganddevicelawblog.com/202…

Another Opioid Addict Overdose Case Dismissed, Several Times Over

We don’t have much patience for litigation attempting to seek damages for drug addicts who injured or killed themselves through their illegal use of

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Drug and Device Law: Here Is Another Thing Wrong With Prop 65 druganddevicelawblog.com/202…

Here Is Another Thing Wrong With Prop 65

California’s Proposition 65 has become a poster child for ineffective and counterproductive over-warning.  You know what we are talking about.  Prop 65 is

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Drug and Device Law: An Abuse of Discretion So Vast…. Our Long-Delayed Critique of the Valsartan MDL Class Action Certifications druganddevicelawblog.com/202…

An Abuse of Discretion So Vast....  Our Long-Delayed Critique of the Valsartan MDL Class Action...

In 1919, J. Edgar Hoover described Communism as a “conspiracy so vast” that it was impossible for the populace to comprehend it.  The Palmer Raids

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Drug and Device Law: FDA and Off-Label Communication – Getting Closer to Truth druganddevicelawblog.com/202…

FDA and Off-Label Communication - Getting Closer to Truth

In addition to its recent revamp of its “§510(k)” substantial equivalence clearance process for medical devices, (see our post here), the FDA has also

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Drug and Device Law: State of the Art Defense Precludes Design Defect Claim vs. 1986 Retinal Repair Implant druganddevicelawblog.com/202…

State of the Art Defense Precludes Design Defect Claim vs. 1986 Retinal Repair Implant

The opening line of Daley v. Mira, Inc., 2023 U.S. Dist. LEXIS 193926 (D. Mass. Oct. 30, 2023), is eye-catching: “Nancy Daley has sued two defendants,

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Drug and Device Law: Learned Intermediary Testimony Sinks Causation in California druganddevicelawblog.com/202…

Learned Intermediary Testimony Sinks Causation in California

Today’s case is about a very unfortunate set of circumstances.  A woman who suffered from bipolar disorder and who was not trying to get pregnant did

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Drug and Device Law: Tort-Related Implications of Recent FDA Device Draft Guidances druganddevicelawblog.com/202…

Tort-Related Implications of Recent FDA Device Draft Guidances

The FDA has taken recent steps that may, or may not, affect product liability litigation.  We’re discussing the “may” aspect.  For purely

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Drug and Device Law: Shameless Plug: Reed Smith’s Virtual Life Sciences Litigation CLE Day (Nov. 16) druganddevicelawblog.com/202…

Shameless Plug: Reed Smith’s Virtual Life Sciences Litigation CLE Day (Nov. 16)

If any of our loyal readers are looking for some CLE before the end of the year, Reed Smith is offering a virtual (live webcast) Life Sciences Litigation

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Drug and Device Law: RICO Madness: Medical Marijuana, Inc. v. Horn druganddevicelawblog.com/202…

RICO Madness: Medical Marijuana, Inc. v. Horn

No surprise, we are not fans of civil RICO.  We don’t like how it is misused by lawyers on the other side to convert run-of-the-mill pharmaceutical

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Drug and Device Law: Drug Manufacturer’s Claims Against Compounding Pharmacy Held Impliedly Preempted by S.D. Tex. Notwithstanding Fifth Circuit’s Spano Decision druganddevicelawblog.com/202…

Drug Manufacturer’s Claims Against Compounding Pharmacy Held Impliedly Preempted by S.D. Tex....

This post is solely from the non-Reed Smith side of the Blog. A court within the Fifth Circuit has held that the FDCA impliedly preempts

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Drug and Device Law: Cold Remedy/Vitamin C Convenience Pack is Not Deceptive druganddevicelawblog.com/202…

Cold Remedy/Vitamin C Convenience Pack is Not Deceptive

Lately, there seems to be an overdose of OTC (Over the Counter) drug cases. Everywhere we look, we see more and more lawsuits centered on OTC’s, both in

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Drug and Device Law: Plaintiff’s Expert’s “Gut” Feeling Not Enough to Withstand Rule 702 or Summary Judgment druganddevicelawblog.com/202…

Plaintiff's Expert's "Gut" Feeling Not Enough to Withstand Rule 702 or Summary Judgment

Listen to your gut.  Follow your instincts.  Trust your intuition.  Great advice in many situations.  Like deciding whether to buy

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Drug and Device Law: GranuFlo/NaturaLyte MDL Substantive Rulings – Better Late Than Never druganddevicelawblog.com/202…

GranuFlo/NaturaLyte MDL Substantive Rulings - Better Late Than Never

The Granuflo/Naturalyte MDL (“G/N”) was created a decade ago, in 2013.  In re Fresenius Granuflo/Naturalyte Dialysate Products Liability Litigation,

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Drug and Device Law: In Pari Delicto Once More In Kansas druganddevicelawblog.com/202…

In Pari Delicto Once More In Kansas

We write today with an update on a case applying the defense of illegality (or “in pari delicto”) to cut off product liability claims under Kansas law. 

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Drug and Device Law: Beating FDCA-Based Negligence Per Se Claims on Non-Preemption Grounds druganddevicelawblog.com/202…

Beating FDCA-Based Negligence Per Se Claims on Non-Preemption Grounds

Recently, within the course of a couple of weeks, two different courts reached the same conclusion – that a plaintiff’s negligence per se claims, largely

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