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Health Science, Computers & Technology Civil Procedure

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

FDA Weighs in on Off-Label Use and Preemption

by Reed Smith on

Back in 2013, Ramirez v. Medtronic Inc., 961 F. Supp.2d 977 (D. Ariz. 2013), made it to #9 on our worst cases of the year list – which is pretty good (actually, pretty bad) for a trial court decision. Purporting to apply...more

Medical Monitoring Class Certification Fails

by Reed Smith on

Normally, when we think of decisions relating to medical monitoring, the issue is whether a state will recognize medical monitoring for uninjured people as a separate claim or relief that can be sought under an existing...more

FDA Marketing Exclusivity Periods Limited To Same Active Moiety

by Foley & Lardner LLP on

In Otsuka Pharm. Co., Ltd. v. Price, No. 16-5229 (D.C. Cir. Aug. 29, 2017), the U.S. Court of Appeals for the District of Columbia Circuit affirmed the district court decision upholding FDA’s “same moiety” test for defining...more

Will I Get Sued After a Data Breach? D.C. Circuit Broadens Scope of Data That Gives Rise to Identity Theft in CareFirst

by Orrick - Trust Anchor on

In the latest sign that data breach class actions are here to stay—and, indeed, growing—the D.C. Circuit resuscitated claims against health insurer CareFirst BlueCross and Blue Shield, following a 2015 breach that compromised...more

Healthcare Law Update: September 2017

by Holland & Knight LLP on

OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

August 2017: Product Liability Litigation Update

Hot Topic: Plaintiffs’ Efforts to Evade the Burden of Supporting Products Liability Claims with Expert Testimony. The core allegations in many product liability cases are that the manufacturer failed to adequately warn of its...more

Federal Right To Try Legislation – Is It Any Better?

by Reed Smith on

We’ve generally been skeptical of state “Right To Try” statutes, for several reasons. First, to the extent that they try to circumvent the FDCA, they’re likely to be preempted. Second, drugmakers aren’t likely to distribute...more

Nixing Discovery on Foreign Regulatory Submissions

by Reed Smith on

The cases we typically write about focus on events after medical products have made their way through the applicable regulatory process and been marketed in the United States. The marketed product is used, people claim to...more

Specialty Pharmacy's Antitrust Claim against Humana Fails

by Baker Ober Health Law on

On August 9, District Judge Susan Wigenton (D. NJ) issued a ruling in Prime Aid Pharmacy v. Humana, Civ. No. 16-2104, granting Humana's motion to dismiss the plaintiff's Second Amended Complaint, finding that the plaintiff...more

Dental Device Class Action Bites The Dust

by Reed Smith on

This is our second post in three weeks on class actions, owing to the filing of two really interesting class action opinions within a couple of weeks of each other. We posted two weeks ago on the Eleventh Circuit’s rejection...more

Guest Post – Before the Flood: Fifth Circuit Oral Argument on Writ of Mandamus From Pinnacle Hip Implant MDL

by Reed Smith on

Today’s guest post is by Reed Smith Houston office associate Curtis Waldo. Given the Noachic weather down there recently, one might ask “where’s Waldo?” The answer is safe and sound, if not quite high and dry. Curt is...more

Rx IP Update - August 2017

by Smart & Biggar on

Gilead prevails in SOVALDI appeal - The Federal Court of Appeal recently affirmed a trial decision relating to two competing patents over Gilead’s SOVALDI (sofosbuvir). In the trial decision, as previously reported, the...more

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

by Reed Smith on

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

Innovator Liability Fails Again

by Reed Smith on

As we discussed at the time, the MDL-wide innovator liability appeals in In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. 2014), resulted in rulings under more than 20 states’ laws...more

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

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