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Learned Intermediary Doctrine Bar’s Plaintiff’s Discovery of Direct-to-Consumer Advertising in Ambien Case in District of Nevada

We are back in the trenches today after spending a wonderful day in New York with our lifelong best friend, in yet another of the blissfully endless celebrations of the milestone birthday we marked in December. We saw “The...more

Opinions of Plaintiff’s Designated Experts – Including Herself — Excluded in Bravelle Economic Loss Case

This morning, our commuter train was packed with overjoyed Villanova students headed for the NCAA Championship Victory Parade. It was the second time in a few months that our fair city has been lifted by a huge sports...more

No Proof of Specific Causation Equals Summary Judgment for Defendants in Northern District of Alabama Risperdal Case

We write this as key elements of the Drug and Device Law Passover Feast languish in the oven. On March 31, 2018, the Drug and Device Law Bubbie will force four generations of our family – the devout and the not and everyone...more

Mostly Favorable MIL Rulings in IVC Filters Litigation

Here in Philadelphia, less than a week before the first day of Spring, it is sunny and calm, albeit a bit chilly. Not so last week, when we were hit with the second Nor’easter in less than a week. As much as sixteen inches...more

3/15/2018  /  510(k) RTA , FDA , Medical Devices

Bad “Innovator Liability” Decision from the Central District of Illinois in Generic Fluoroquinolone Case

We recently read a news story about a man who was imprisoned for 39 years for a crime he did not commit. The crime was grisly and resulted in the violent deaths of a 24-year-old woman and a small child, leaving a community...more

California Superior Court Refuses to Allow Discovery in Aid of “Litigation Tourism” in Consolidated Xarelto Litigation

...In In re Xarelto Cases, 2018 WL 809633 (Cal. Super. Feb, 6, 2018), the plaintiffs sued several manufacturers and a distributor, claiming various injuries and alleging the usual litany of causes of action. Appearing...more

Eleventh Circuit Affirms Summary Judgment for Defendants in Embrel Case

This year’s Academy Award nominations came out last week. That means that we have spent the past few days setting a schedule for seeing all of the Best Picture nominees (well, most – we don’t do war movies and tend to opt out...more

California Court of Appeal Limits Duty of Clinical Study Sponsor to Intervene in Treaters’ Care of Study Participants

Last week, we took a short Western Caribbean cruise to celebrate a jarringly-advanced birthday. While the weather wasn’t an asset (it was 43 degrees when we departed Fort Lauderdale, and hovered in the 60s for most of the...more

Note to Experts: Do Not Cruelly Disparage Your Client’s Decedent, Curse Out Your Judge, and Flout the Court’s Orders, or You May...

Those of us who practice in the mass tort space spend vast portions of our professional lives dealing with our opponents’ experts. In our minds, we seek only to enforce the dictates of the Federal Rules and of the United...more

No Voluntary Dismissal for Plaintiffs, and a Summary Judgment Win for Defendants, in Central District of California Risperdal Case

In the mass torts world in which we find ourselves, glimmers of jurisprudential light can seem few and far between. Two things we love are good warnings causation decisions and sneaky plaintiffs getting caught at their own...more

Second Circuit Affirms Exclusion of Plaintiffs’ Experts – and Summary Judgment for Defendant – in Mirena MDL

As we write this, our fair city remains in a blissful haze following our Eagles’ 33-10 rout of the 49’ers to go 7-1 in the NFC East, so it might be appropriate to call today’s opinion a “touchdown.” On the other hand, the...more

Emphatic Win for Pre-Service Removal in Eliquis MDL

Recently, in downsizing our elderly father to a smaller residence and cleaning out his house, we came upon a cassette recording of our too-many-decades-ago Bat Mitzvah. We dug an old boom box out of the basement, listened to...more

Relevant Social Media Posts are Fair Game for Discovery in the IVC Filter MDL

A couple of weeks ago, we reported that, under pressure from the Drug and Device Law Rock Climber, we were headed to New York to see the Broadway production of Orwell’s 1984. Publicity surrounding this spectacle focused on...more

Northern District of New York (Quickly!) Holds that the MDA Expressly Preempts Essure Suit

A couple of weeks ago, our co-blogger, Mr. McConnell, published a post on the benefits of brevity. That post sprang from an argument before the JPML, but we can riff on it today as we examine a short and lovely decision from...more

Good Risperdal Times, Part Three: Summary Judgment for Janssen in Philadelphia

We write this in the first minutes of the eclipse, about 75 minutes from whatever “totality” will be visible here in southeastern Pennsylvania. We have our certified safety glasses at the ready, we have instructed the midday...more

Compensatory Damages Allowed to Stand in Depakote Trial, Despite Adequate Warnings and Lack of Warnings Causation

We are beginning to feel like the Drug and Device Law theatre critic. Or perhaps we should say “theatre cheerleader,” as we rarely wax critical (at least about the stuff we include in our blog posts). Last week, we saw the...more

Causation Testimony Excluded as “Unhelpful” and “Unreliable” in Heart-Lung Machine Death Case

One of the wonders of parenthood is its ability to deliver interludes so sublime in their exquisite simplicity that they provoke smiles long after they end. Such was an evening last week when we journeyed to New York to...more

Eighth Circuit Affirms Exclusion of Expert in Hip Implant Case

We just got tickets to see “Wicked” again (we think this will be the fourth or fifth time). Since we first saw it (on Broadway in 2003, featuring Idina Menzel’s Tony-winning performance), we have loved this quirky and...more

Eastern District of Wisconsin Grants Summary Judgment on Hip Component Manufacturer’s Negligence Claims But Denies Summary...

Last week, like most weeks during the past year, we spent a lot of our time on airplanes. One of those trips fell on a day with “lots of weather.” All of our flights were delayed, although we were luckier than many. When we...more

Summary Judgment for Concentric Medical on Design Defect and Warnings Claims Related to Fracture of Merci Retriever Device

When last we wrote, we were about to embark on a journey to Budapest and Vienna to visit the Drug and Device Law Rock Climber. We mentioned that we were thrilled to hold tickets to see the Lipizzaner stallions perform at the...more

Southern District of Illinois Excludes Plaintiff’s Experts in OTC NSAID Kidney Injury Case

Next week, we are traveling to Budapest, with a side trip to Vienna. We are visiting the Drug and Device Law Rock Climber, who is spending this semester abroad studying computer science (in Budapest) and climbing rocks (in...more

Another One Bites the Dust: Plaintiff’s Causation Expert Excluded in Hernia Mesh Litigation

We spent Sunday evening in the familiar confines of a top-notch local professional theatre. The production was a short (80-minute), two-character play. It was entirely dialogue-driven, so everything the audience learned came...more

Plaintiffs’ Causation Expert Renounces His Own Conclusions – and Withdraws – in Mirena IIH Litigation

We have blogged before about the Mirena IUD litigation. Cases alleging injuries from device migration and uterine perforation were centralized in an MDL in the Southern District of New York but summary judgment was granted...more

Hip Implant MDL Denies Summary Judgment on Claims of Plaintiffs Who Failed to Preserve Explanted Devices

Regular readers of this blog know that we have a pretty jaded view of many MDLs. Obviously consolidation makes sense, at least on paper, in terms of efficiency and the best use of scarce court resources. But, in practice,...more

Southern District of Indiana Excludes Plaintiffs’ Experts in Hernia Mesh Case

We loved La La Land. We were enchanted by the colors and the music and the dancing. We were transported by the dreams-come-true and saddened by the could-have-beens. We disappeared into the characters’ world for two hours...more

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