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New Favorable Risperdal Decisions

by Reed Smith on

Risperdal, an antipsychotic drug prescribed to treat serious mental conditions – schizophrenia, manic depression, and autism – allegedly causes some male users to develop abnormal breast tissue growth. Particularly when...more

Causation Testimony Excluded in Heart-Lung Bypass Machine Death Case – Again

by Reed Smith on

Not even three weeks ago, back on July 28, we discussed the court’s rigorous application of Daubert in excluding expert medical causation opinions in Smith v. Terumo Cardiovascular Sys. Corp., a federal case in the district...more

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

by Reed Smith on

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

The Luck of The Draw: A Strong Preemption Ruling from an Anticoagulant MDL

by Reed Smith on

We have offered our view that cases seeking to impose liability based on well-known risks found with an entire class of prescription medications tend to be weak. We think design defect claims usually are clearly preempted in...more

Comment K and Non-Implanted Medical Devices

by Reed Smith on

About two years ago, in our post “How Does a Bad Idea Get Implanted,” we discussed what at the time seemed a California peculiar argument that the “unavoidably unsafe” product doctrine epitomized by Restatement (Second) of...more

How Not To Create an “Exception” to the Learned Intermediary Rule

by Reed Smith on

We’ve heard more about the constitutional “emoluments clause,” Art 1 §9, clause 8, this year than during the entire rest of our legal careers. But while it’s illegal for anybody working for the U.S. government to accept...more

The Rule of Law is the Best Medicine, Part 2

by Reed Smith on

Last week, we summarized PhRMA’s comments on the FDA’s proposed amendments to regulations regarding “intended uses.” PhRMA showed how the FDA’s insistence that it could read manufacturer’s minds about intended uses made no...more

Pro Te: Solutio - Vol. 10 No. 2 – Spring 2017

by Butler Snow LLP on

It’s Spring! In this issue of Pro Te, we do a little a “spring cleaning” to brush the dust off some familiar topics that we consider in day-to-day pharmaceutical litigation. In The Forgotten Element? Warnings Proximate...more

Post-BMS Personal Jurisdiction Cheat Sheet

by Reed Smith on

In the wake of the defense wins during the last Supreme Court term in Bristol-Myers Squibb Co. v. Superior Court, 137 S.Ct. 1773 (2017) (“BMS”), and BNSF Ry. Co. v. Tyrell, 137 S. Ct. 1549 (2017), we’re retiring the personal...more

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

by Reed Smith on

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

PhRMA Comment on the FDA’s Proposed Off-label Rule: The Rule of Law is the Best Medicine

by Reed Smith on

The FDA cannot get out of its own way on the issue of off-label communications. Its power to punish off-label promotion comes from an odd regulatory two-step, whereby off-label promotions are said to prove an indicated use...more

Artificial Intelligence and Learned Intermediaries

by Reed Smith on

In the July 7, 2017, “Artificial Intelligence” issue of Science, we were intrigued by a short piece in the “Insights” section on “Artificial Intelligence in Research” that discussed the future use of autonomous robots in...more

Don’t give medical device makers more time before disclosing product woes

Pro-business and anti-consumer lawmakers in Congress are racing to slacken rules for medical device makers to report problems with their products. This move may imperil more patients, many of whom already have been harmed...more

A Sometimes Overlooked Fact About Express Warranty

by Reed Smith on

The warranty is “express.” Before you say, “Well, duh,” this sometimes actually does matter. Here’s how. Most complaints in product liability actions involving prescription medical products that include express warranty...more

Eighth Circuit Affirms Exclusion of Expert in Hip Implant Case

by Reed Smith on

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

FDA’s Denial of Citizen’s Petition “Clear” Enough for Preemption of Failure-to-Warn Claims

The Tenth Circuit recently upheld a Utah district court’s finding that a branded drug manufacturer could not be held liable for failing to warn consumers about alleged birth defect risks when the FDA had previously rejected a...more

Reversal of $48 Million Product Liability Verdict Required Due to Inconsistent Jury Findings on Failure to Warn Claims and...

In Trejo v. Johnson & Johnson, et al. (No. B238339, filed 6/30/2017), the California Second Appellate District held, among other things, that the jury’s finding that defendant was liable for negligent failure to warn was...more

Boxed Warnings and Adequacy as a Matter of Law

by Reed Smith on

One of the (many) things that made last year’s decision in Barron v. Abbott Laboratories, Inc., ___ S.W.3d ___, 2016 WL 6596091 (Mo. App. Nov. 8, 2016), so hideous that it weighed in at #3 of our worst decisions of the year...more

Personal Jurisdiction Update In Supreme Court’s Bristol-Myers Squibb Co. v. Superior Court

by Weintraub Tobin on

Several weeks ago, the U.S. Supreme Court issued its opinion in Bristol-Myers Squibb Co. v. Superior Court of Cal., No. 16-466, 581 U.S. —, 2017 WL 2621322 (June 19, 2017) (“Bristol-Myers Squibb”). The more than 600...more

California Is At It Again On Personal Jurisdiction

by Reed Smith on

Maybe we should not be surprised when courts within California reach to find personal jurisdiction over out-of-state corporations even when non-Californians sue. That is what BMS v. Superior Court was all about. Right? ...more

A Double Whammy for California Design Defect Claims

by Reed Smith on

Finally, some good news out of California – at least when personal jurisdiction isn’t the issue. Design and warning defects were the questions presented in Trejo v. Johnson & Johnson, ___ Cal. Rptr.3d ___, 2017 WL 2825803...more

New Mexico Wrongful Conduct Rule Shuts Down Opioid Case Against Pharmacist

by Reed Smith on

New Mexico is called the Land of Enchantment, but when it comes to law it is the Land of You Can’t Make this Up. You might think it weird that New Mexico’s state constitution (Article VII, section 1) specifies that idiots...more

Eleventh Circuit Gets It Wrong on Preemption

by Reed Smith on

We have a point of view. Our readers understand that we represent folks on the right side of the v., and our posts tend to read cases and legal trends with a pro-defense bent, although you can rest assured that we put a lot...more

Law Review Article on Off-label is On Target

by Reed Smith on

More than once we’ve said that we read law review articles so you don’t have to. We separate the wheat from the chaff. The wheat is scarce. That is because law review articles usually drown the little bits of objective...more

Electronic Drug Product Listing Errors Can Result in FDA Warning Letter

by Morgan Lewis on

FDA Warning Letters focus on inaccurate drug product listings. Over the last year, the US Food and Drug Administration (FDA or Agency) has increased its enforcement efforts concerning drug product listing requirements,...more

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