This message is directed primarily to our overseas readers, and those who represent non-United States drug and medical device companies.  Under FDA registration regulations, non-United States manufacturers (and other regulated companies) that import their regulated products into this country are required to appoint a domestic “agent” for regulatory purposes:

(i) Registration of foreign establishments

(1)

A year and a half ago we celebrated a rare prescription drug preemption win in the Philadelphia County Court of Common Pleas.  Then the decision was appealed, and we held our breath.  Preemption is never an easy sell in state courts, and Pennsylvania appellate courts are not exactly defendant friendly in prescription medical product liability

We have always had a soft spot for zebras.   They are the equine world’s version of some of our favorite acquaintances — the ones who always dress a little outlandishly and always stand out from the crowd. (Fun facts:   1. Although most zebras have black stripes on a white background, a white-on-black specimen shows up

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

We truly dislike decisions that find that claims of failure to report adverse events to the FDA are non-preempted, parallel violation failure to warn claims. Failure to report claims are not parallel.  Federal law does not require warnings to plaintiff or her doctors. 

Today’s guest post is by Reed Smith associate Regina Nelson.  In it she tackles an issue that inevitably arises whenever ediscovery for defendants is successful, that is, what must be done to have the fruits of that discovery be admitted at trial, otherwise known as authentication.  She discusses a recent Pennsylvania appellate case that

We were reading the appallingly bad personal jurisdiction (and other things, but those aren’t what we’re interested in today) decision in Hammons v. Ethicon, Inc., ___ A.3d ___, 2018 WL 3030754 (Pa. Super. June 19, 2018).  While many of the jurisdictional issues in Hammons are factually limited to the particular defendant and the particular

You’ll have to excuse us a bit today.  This post is about product liability – specifically Pennsylvania product liability.  However, it is not really focused on prescription medical products.  But what can we say?  We were provoked.

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“The dark side of the Force is a pathway to many abilities some consider to be unnatural.”