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Susanna Moldoveanu

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We wrote a few days ago about a favorable ruling on a state human tissue shield statute in Heitman v. Aziyo Biologics, Inc. (N.D. Fla.).  That case gave us another good procedural ruling to share, rejecting a trick we see all too often:  an attempt to join a non-diverse defendant post-removal.Continue Reading N.D. Fla. Rejects Post-Removal Attempt to Amend to Defeat Diversity

Today we discuss an excellent express preemption decision from the District of Arizona, Skinner v. Small Bone Innovations Inc., 2024 WL 3639296 (D. Ariz. Aug. 2, 2024).

This decision involved the Scandinavian Total Ankle Replacement device (“STAR”).  The STAR® Ankle is a Class III medical device subject to the Medical Device Amendments’ express preemption provision, 21 U.S.C. § 360k(a).  This was Plaintiff’s second bite at the apple:  The Court had already granted Defendants’ motion to dismiss but with leave to amend to attempt to state a parallel claim.  See Skinner v. Small Bone Innovations Inc., No. CV-23-01051-PHX-MTL, 2023 WL 6318014, at *6 (D. Ariz. Sept. 28, 2023).  After striking out in round one, Plaintiff fared no better in round two.Continue Reading Slam-Dunk Express Preemption Decision from the District of Arizona

Last week, FDA released for comment a draft guidance titled Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers.  FDA guidances are nonbinding recommendations without force of law, and this is only a draft.  Nonetheless, it addresses a frequent and important problem in our industry.Continue Reading FDA Releases Draft Guidance on Responding to Internet Hogwash

Posted in FDA

This post is from the non-Reed Smith, non-Dechert, and non-Holland & Knight side of the blog. 

We have covered the ranitidine litigation before. As we explained in prior posts (including here and here), plaintiffs allege that ranitidine, the active ingredient in Zantac, breaks down into N-Nitrosodimethylamine (“NDMA”), particularly at higher temperatures.  NDMA is a known carcinogen and a ubiquitous substance present in the environment and in all manner of foods including bacon, beer, and cheese.  Readers will remember that in a sweeping, 341-page opinion, the MDL court cut the head off the federal Zantac litigation by excluding plaintiffs’ experts.  But other parts of the snake keep slithering. Continue Reading Delaware Zantac Court Fails to Keep the Gate

This post is from the non-Reed Smith, non-Dechert , and non-Holland & Knight side of the blog. Everyone else is involved.

The Good, the Bad, and the Ugly is a classic Clint Eastwood spaghetti Western where even the Good may not be all good.  In California state court, a demurrer sustained is a defense win, right?  Although there are some bright spots, In re Ranitidine Cases is one of the ugliest defense wins we have seen in a while, providing leave to amend and a roadmap for further expansion of the Gilead duty-to-innovate.Continue Reading Post-Gilead Heartburn in the California Ranitidine Litigation

We posted last year about plaintiffs who were dismissed from the Taxotere MDL for failure to serve defendants. To put it simply, the Federal Rules still apply in an MDL. 153 plaintiffs didn’t comply with the Rules, and their cases were dismissed. Not knowing when to walk away, as Kenny Rogers instructs, a number of these plaintiffs filed for reconsideration. The MDL Court rightly shut them down.Continue Reading No Second Chance at Service for Taxotere Plaintiffs

The orders denying untimely, post-remand attempts to amend complaints in the Taxotere litigation are piling up, and it doesn’t get old.  We recently reported on one such denial in the Northern District of California.  In recent weeks, district courts in New York, North Carolina, and Tennessee (among others) have joined in.  Today we report on three of those decisions.Continue Reading More Taxotere Remand Courts Deny Untimely Amendments

This post is from the non-Reed Smith side of the blog.

Today we discuss two discovery orders from a case in the Northern District of California, Lin v. Solta Medical, Inc.  In this case, Plaintiff, a California resident, alleged that she was burned by a skin treatment she received in Taiwan with the Thermage CPT device manufactured by Defendant.  Plaintiff sought expansive discovery from Defendant while at the same time trying to restrict discovery plainly relevant to her own claims for her damages.  The court didn’t buy it.Continue Reading Solid Discovery Orders in the Northern District of California

They say that in California everybody’s a star.  Or maybe, in today’s terms, everybody’s an influencer, has social media, a blog, or—in this case—an autobiography.  Today we discuss a discovery dispute in a California federal court that is somewhat unique, but that raises issues we see every day in drug and device cases. Continue Reading Lifestyle Discovery Fair Game Where Plaintiff Puts Quality of Life at Issue

For readers noticing the new byline, let me introduce myself.  I am Susanna Moldoveanu, and I practice with Butler Snow LLP’s Pharmaceutical, Medical Device and Healthcare group.  I am excited to join the Drug & Device Law Blogging Team.  The best group of legal wonks there is.

Today we discuss the Western District of Washington’s recent summary judgment order in Dearinger v. Eli Lilly & Co., 2023 WL 8717570 (W.D. Wash. Dec. 18, 2023).  A prior opinion in this case earned the top spot on the Blog’s Ten Best Prescription Drug/Medical Device Decisions of 2022.  This opinion is short and sweet, but a good one too.Continue Reading W.D. Wash. Nixes Failure to Warn Claim Under Learned Intermediary Doctrine

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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