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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

D.C. Circuit Finds that Theft of Health Insurance Subscriber ID Numbers Is a Cognizable Injury in Identity Theft Litigation

by Moore & Van Allen PLLC on

Recently, the D.C. Circuit Court of Appeals ruled in Attias v. CareFirst, Inc., No. 16-7108, that customers had standing to sue a health insurer for a 2014 data breach in which the customers’ information was stolen. ...more

The DC Circuit Opens the Door to Data Breach Plaintiffs Alleging Substantial Risk of Future ID Theft

by Fenwick & West LLP on

The U.S. Court of Appeals for the D.C. Circuit has held that allegations of a heightened risk of future identity theft resulting from a data breach established a concrete injury at the pleading stage....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

Minnesota Patent Litigation Wrap-Up – July 2017

by Fish & Richardson on

This post continues our monthly summary of patent litigation in the District of Minnesota, including short summaries of substantive orders issued in pending cases. In July 2017, there were three notable decisions for...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

Are DC Federal Courts the Next Hotbed for Data Breach Class Actions?

by Carlton Fields on

We have previously reported on the evolving circuit split over standing in data breach class actions. On August 1st, a three judge panel for the District of Columbia Circuit became the latest to weigh in on the issue. In...more

Federal Appeals Court Says Healthcare Insurer Must Face Data Breach Lawsuit

A federal appeals court earlier this week dealt a blow to healthcare insurer CareFirst, Inc., concluding that a group of customers have the right to pursue a class action data breach lawsuit based on a 2014 cyberattack....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

Impact of Eli Lilly v. Teva Parenteral Medicines Inc. on Divided Infringement

The Federal Circuit in Eli Lilly v. Teva Parenteral Medicines Inc., 845 F.3d 1357 (Fed. Cir. 2017), recently addressed the issue of “divided infringement” in the context of pharmaceutical patents for the first time since its...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

Article: July 2017: White Collar Litigation Update

Three Tips for Preparing an FCA Case for Trial, One Year After Universal Health. The stakes in False Claims Act cases have never been higher. Potential statutory penalties per claim doubled last year, and ten cases settled in...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

Health Update - July 2017

Contracting With Technology Vendors: Obligations and Compliance Strategies - Editor’s Note: In a recent webinar, Manatt Health examined how to protect privacy when communicating in the digital age. The session revealed how...more

Rx IP Update - July 2017

by Smart & Biggar on

Supreme Court of Canada strikes down "promise doctrine", upholds AstraZeneca’s NEXIUM patent as useful - As previously reported, on June 30, 2017, the Supreme Court of Canada granted AstraZeneca’s appeal in the NEXIUM...more

Protecting Communications From PR Privilege Issues

by Pepper Hamilton LLP on

Two recent cases in state appellate court show the risks of sharing privileged communications with public relations consultants. But they also provide practical guidance on how to protect the confidentiality of...more

German Federal Court: Permission granted - HIV/AIDS drug distribution continued

by Hogan Lovells on

The X. Civil Senate of the German Federal Court of Justice has granted a motion by three companies of the Merck Sharp & Dohme group (Merck) for a preliminary permission for the continued distribution of Isentress®, a drug...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

Court Dismisses Infringement Theory Premised on Speculated Future Formulation Changes

by McDermott Will & Emery on

The US District Court for the District of New Jersey granted generic manufacturer’s motion for judgment on the pleadings under Fed. R. Civ. P. 12(c) on the basis of non-infringement. Par Pharmaceutical, Inc. v. Luitpold...more

The Effects of the Actavis Decision on Reverse Payment Settlement Agreements in ANDA cases -- Four Years After

In 2013, the U.S. Supreme Court rendered its decision in FTC v. Actavis, finding that although so-called reverse payment settlement agreements were not per se antitrust violations in cases brought against generic drug makers...more

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