July 2014

Photo of John Sullivan
Today the World Cup takes another day off before it starts its semifinals to determine who will play for the Trophy on Sunday.  I know this only because other people have told me.  Left to my own predilections, I’d know none of it.  But other people’s interest and intense enthusiasm for these games has swept

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Photo of Steven Boranian

We are sometime not sure what to make of pharmacy monographs.  You know what we mean.  Those sheets that pharmacists print out and give us with our prescriptions.  They are not drug labeling, and they are not medication guides.  They are summaries intended for patient perusal, with information taken from the labeling, but digested in a fashion intended for the lay reader.  Notably, the FDA has not asserted any prerogative to review and approve pharmacy monographs, leaving publishers essentially self-regulated under an FDA action plan.

From time to time, we are surprised when a plaintiff produces a pharmacy monograph in discovery, one that he or she received from the pharmacy and has saved.  (We have not seen the data, but we expect that people who save pharmacy monographs are the same people who have their utility bills from the mid 1990s and who know where the instructions and warranties are for all their household appliances.)  But even when this happens, we are unsure how the monographs help us.  The parties we represent – drug manufacturers – do not publish these things, and they generally don’t have any duty to warn patients anyway.
In a way, pharmacy monographs are more useful to the other side because they give plaintiffs someone else to sue – the monograph publishers.  We have commented on this before (here and here) and noted that lawsuits against publishers have met with virtually no success, and for good reason.  Publishers do not make prescription drugs; they do not sell or dispense prescription drugs; and they have no relationship or contact with the plaintiffs.  That is to say, they owe plaintiffs no duty of care, which is and should be enough to stop litigation.

Continue Reading Pharmacy Monographs and an Illusory Duty of Care

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On the Drug and Device Law Son’s 13th birthday, back in 2008, we reflected on the contrast between his experience as a Philly sports fan versus that of a 13 year old in Boston.  Our son had no idea what a sports championship looked like.  Philly had not hoisted a banner since Moses Malone led the Sixers to the “Fo Five Fo” payoff run in 1983.  But a 13 year old New Englander probably had come to assume championships as a birthright.  The Celtics had a parade that Spring, the Patriots had won three Super Bowls (one against the Eagles), and even the Sawcks, who had dashed the hopes of the region for four score and six years, had managed to break the curse of the Babe and win the World Series in 2004 and 2007.  (In the 1915 World Series, the Red Sox demolished … Philadelphia.)  The Bruins had not won a championship in that 13 year period, but they would soon.

The Boston-Philly rivalry is an old one, and more one-sided than makes sense.  Even a Penn professor, Digby Baltzell, acknowledged that Boston seemed to overachieve while Philly persistently underachieved.  He thought that the historical Puritanism of Boston pointed the way toward public proofs of accomplishment and virtue, while the Quaker roots of Philly prompted people to tend to their own gardens and steer clear of the public sphere. The theory explained why Bostonians were braggarts and Philadelphians tended toward self-disparagement.  The Puritans hanged the Quakers, and both were happy.  Of course, it is hard to imagine how these old religious differences could say much about current mores.  We know some Quakers here, but not that many. In our four years in the Boston-area, we never encountered a Puritan.  Still, there are some odd points supporting Baltzell. Boston leaders are usually home-grown, but Philly has often chased away local high-achievers (Harvard’s main library came from a Philly-area fortune) and has frequently brought in outsiders to run things.  The most consequential Philly mayor in recent times hails from NYC.  We’re not sure how this fact fits in with Baltzell’s theory, but Ben Franklin fled Beantown and ended up doing fairly well in Philly.

We have no problem liking both cities a lot.  Both have great history, great schools, great museums, and great bars.  For many key criteria, Philly comes out ahead. Philly’s citizens get abused for their supposed hostility (throwing snowballs at Santa Claus, blah-blah-blah), but have you ever tried sharing a street with Boston drivers?  Philly is much better for bike riders.  Philly’s weather is okay; Boston’s is horrible.Continue Reading Massachusetts Federal Court Applies Comment K; Rejects Pennsylvania Lance Folly

Photo of Michelle Yeary

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

We’re going to be right up front with you today.  It’s a work day.  It’s the World Cup.  The US is playing Belgium in the Round of 16 at 4:00 EDT.  We don’t want to miss it.  And soccer — unlike sports like football and baseball — has no time-outs, no 7th inning stretch.  There aren’t even any commercials.  You look away for a minute to answer an e-mail, you could miss the only goal of the game.  So, we’ll get right to the point.

Medtronic scored another InFuse victory in Dunbar v. Medtronic, No. 2:14-cv-01529-RGK-AJW, slip op. (C.D. Cal. Jun. 25, 2014).  The allegations in this complaint, like all of the others we’ve previously discussed, focus almost exclusively on off-label use of the Class III, PMA spinal fusion device.  Seeing Class III and PMA in the description of the medical device should almost certainly guarantee a defense win on preemption as most courts have acknowledged that there is only a “narrow gap” between Riegel preemption and Buckman preemption in which plaintiffs can state a claim.  And that is why the InFuse plaintiffs have tried, with only limited success, to get courts to recognize a preemption exception when a PMA device is used off-label.Continue Reading Latest InFuse Win – Good on Negligence Per Se

Drug & Device Resources

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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