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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

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There’s been a lot of movement amongst the bloggers on this site over the last two years.  And now there’s more.  Sullivan – that’s me – has moved to Cozen O’Connor.  I’ll miss my old firm, Dechert.  But I’m excited about my move to Cozen, and I look forward to continuing to give you my thoughts on drug and device law, and sometimes pop culture, from within Cozen’s walls.  And, for me, those walls will be in two Cozen offices, one in downtown Manhattan  (where I practiced for years when I started my career) and the other in Cherry Hill, New Jersey.  Now, Cherry Hill is a great town.  I was in that office Friday when I began drafting this post.  But today I’m in Manhattan. That’s different.  If for no other reason than the views.  It’s hard to beat the Freedom Tower as it’s being completed or ships sailing their way down the Hudson River into New York Harbor.

Frankly, if you’re in an office in just about any town other than New York City, “you lose that battle, you lose that battle nine times out of ten.”  But that’s not the real advantage of spending much of my time in Cozen’s New York office.  The most important benefit is that I now have the ultimate “bona fides” to counter what has been a distinctly Philadelphia voice on this blog.  The New York-Philadelphia rivalry has now hit the legal blogosphere.  If all else fails, I can just say, “fuhgeddaboudit.”Anyway, here’s my first Cozen post.

So where were we?  Oh yes, the learned intermediary doctrine.  On Friday, we reported on Calisi v. Abbott Labs., 2013 U.S. Dis. LEXIS 139257 (D. Mass. Sept. 27, 2013), a decision in which the court excluded plaintiff’s warnings expert thereby ending plaintiff’s failure to warn claim.  Underlying that decision was the court’s refusal to adopt plaintiff’s argument that Abbott had “assumed a duty” to warn the plaintiff directly rather than warn her doctor because Abbott had earlier communicated directly with plaintiff via a patient video and direct-to-consumer (DTC) advertising.Continue Reading Moving on to a New Law Firm; Still Discussing the Learned Intermediary Doctrine

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We sometimes take an impish delight in the comments we get from readers who are surprised that we tout defense wins, question the logic of decisions that allow plaintiffs to get past summary judgment with questionable evidence, or—gasp—use sarcasm in how we discuss cases.  The approach of this blog is not a mystery—the contributors spend most of their working days defending drug and device manufacturers from lawsuits that we often think are bogus, over reaching, and/or an affront to the regulatory scheme that governs the products at issue.  We describe cases or discuss recurring issues with the hopes that lawyers who do what we do or those in-house who hire them will be able to repeat successful strategies and avoid pitfalls in their own cases.  We also get the opportunity to blather on about things we think are important, legal or otherwise.

Sometimes, we run across a case that does not require much of our renowned wit.  We can just set out what happened and crow.

In Calisi v. Abbott Labs., No. 11-10671-DJC, 2013 U.S. Dist. LEXIS 139257 (D. Mass. Sept. 27, 2013), the court struck questionable expert testimony on the adequacy of a prescription rheumatoid arthritis drug’s warnings for lymphoma.  Without admissible expert testimony—and, as a Calisi instead of Khaleesi, she was unable to rely on bloodriders, dragons, or Unsullied for her cause—plaintiff had no way to carry her burden and lost.  Along the way, the court made a number of sensible decisions on issues that recur in prescription drug cases.
Continue Reading Getting 702ed on The Impact of Warnings to Prescribing Physicians

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We appreciate being on Joe Hollingsworth’s mailing list – we really do.  Much of the Aredia/Zometa stuff he sends us is manifestly blogworthy.  That, and all things being equal, we’d rather discuss a defense win than a defense loss.  Joe doesn’t send us his bad ones (although certain plaintiff lawyers do pass

Photo of Bexis

Not too long ago we advised that it’s a good idea to check whether your plaintiffs were actually alive when they filed their suits.  We’d like to amend that to add that it’s also a good idea to check whether your plaintiffs were financially alive as well.
By that, we mean plaintiffs should be checked

Photo of Bexis

The FDA law blog has a very interesting post today about Massachusetts’ enactment of a law governing prescription drug and medical device marketing. Not only is the Commonwealth regulating promotional activities, but its also decided to do its part to combat the obesity epidemic – by prohibiting the “free lunch.” Can’t have fat doctors, we