2012

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Not exactly a catchy title.  And probably not enough to compete with all the other distractions of this time of year – wandering through a snow-covered field to chop down a Christmas tree, hand-dipping your own candles to give as gifts, delicately decorating gingerbread men baked from scratch.  No wait – we really meant setting up the artificial snowing Christmas tree (nothing says happy holidays like millions of tiny pieces of Styrofoam floating through your home), waiting to see if Amazon is going to get you the complete second season of Shameless on DVD before the 25th, and popping a Mrs. Smith’s frozen apple pie in the oven.  Whether your holidays are like the former, the latter or somewhere in between, you probably have something more pressing to attend to than reading this blog.  So, we thought we’d give you something to think about for the future – a proposed change to Federal Rule of Civil Procedure 37 regarding when sanctions can be imposed for failure to preserve evidence.  See Excerpt from Report of Civil Rules Advisory Committee here.
Honestly, we just happened upon this ourselves and haven’t had much time to fully digest all the implications.  As with any rule change, the real ramifications won’t be known until the courts start to apply it.  But since the proposed change looks to be slated for discussion early in the new year by the Civil Rules Advisory Committee, we thought we’d take a look.Continue Reading Proposed Changes to Federal Rules on Preservation of Evidence

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It probably won’t surprise you to know that Bexis keeps a scorecard of the number of posts we’ve done over the years.  Bexis likes scorecards. This post will be a big one.  It’s the 2000th in Drug and Device Law Blog history.  It’s taken a lot of law – and a lot of other silly

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It occurs to us that there’s a missing link in the chain which makes United States v. Caronia, ___ F.3d ___, 2012 WL 5992141 (2d Cir. Dec. 3, 2012), important to what we do most of the time – that’s defend product liability litigation.  The blog’s never posted before about how one gets from state action to private litigation.  So this post is about how the First Amendment protects speakers from tort claims based on their exercise of the right to free speech.
It all started back in the 1960s with the civil rights movement.  Down in Alabama, George Wallace, Bull Connor, and other powers that once were enlisted the state’s tort system in their massive resistance to racial equality.  In 1960 a jury returned a half million dollar libel judgment against the New York Times and others on the basis of a political advertisement that did not even mention the plaintiff by name.  The Supreme Court held that the First Amendment right to free speech was a defense to the tort of defamation:

Although this is a civil lawsuit between private parties, the Alabama courts have applied a state rule of law which petitioners claim to impose invalid restrictions on their constitutional rights of speech and press.  It matters not that that law has been applied in a civil action and that it is common law only. . . .  The test is not the form in which state power has been applied but, whatever the form, whether such power has in fact been exercised.

New York Times Co. v. Sullivan, 376 U.S. 254, 265 (1964).  “What a State may not constitutionally bring about by means of a criminal statute is likewise beyond the reach of its civil law. . . .  The fear of damage awards. . .may be markedly more inhibiting than the fear of prosecution under a criminal statute.”  Id. at 277.  The First Amendment’s protection is not necessarily limited to truthful statements because “[e]rroneous statement is inevitable in free debate, and. . .must be protected if the freedoms of expression are to have the ‘breathing space’ that they need. . .to survive.”  Id. at 271-72.  From the Sullivan case, the First Amendment evolved into a defense against any form of tort action that sought to penalize protected speech.Continue Reading How the First Amendment Affects Tort Law

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We aren’t the only folks on the web with opinions and commentary concerning the recent decision in United States v. Caronia, ___ F.3d ___, 2012 WL 5992141 (2d Cir. Dec. 3, 2012), which (if you haven’t been following our prior posts) declared in essence that the truthful promotion of off-label use is protected speech under the First Amendment.  We’ve read a bunch of it − however, we must admit that after about the thirtieth law firm client alert stating “here’s what the court did; be careful; call us for real analysis, our eyes glazed over.  So here’s our collection of Caronia commentary that, for one reason or another, we found most interesting.
Other Bloggers
We’ll start with the always informative FDA Law Blog, which took a “deep dive”into Caronia yesterday.  It’s discussion has:  (1) a detailed rundown of how the FDA converts truthful speech about off-label use into a criminal offense (even if the FDA denies doing so); a schedule for future appellate steps in Caronia; a thoughtful analysis of how Caronia could influence prosecutions of different flavors of off-label promotion (including some distinctions between drugs and devices); and references a recent warning letter about the “evidence of intended use” approach that may become more prevalent after Caronia.
A lot of other bloggers who cover one or another aspect of the pharmaceutical beat have chimed in with Caronia commentary.  We found nicely detailed analysis and general commentary on the case at Policy and Medicine.
Point of Law has an interesting take on governmental coercion, or alternatively, why it took a drug representative to litigate this issue to a successful conclusion where multi-billion dollar corporations feared to tread.
The ACLU generally agrees with the First Amendment protecting truthful off-label promotion, and has a very accessible discussion of Caronia.  Their post raises a couple of interesting questions:  the First Amendment’s application to an experimental off-label use, and whether different rules should apply to advertisements (including DTC), as opposed in person discussions with doctors.  Maybe the ACLU will file an amicus brief if/when Caronia is further appealed.Continue Reading Caronia Web Roundup

Photo of Stephen McConnell
Good news/Bad news jokes are a staple of the Great American
Joke Machine. Not surprisingly, a lot of the jokes involve doctors. For
example:
 
Doctor: I have good news and bad
news for you. The good news is that these test results say you have 24 hours to
live. The bad news ….
Patient:

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Photo of Michelle Yeary

The case of Murthy v. Abbott Laboratories, first came to our attention last year when it took the #8 spot on our list of the top ten worst drug and devices decisions for 2011.  That decision, 2011 U.S. Dist. LEXIS 129102 (S.D. Tex. Nov. 7, 2011), without citing any law – and contrary to a lot of law it didn’t cite – announced what amounted to a blanket exception to the learned intermediary rule for all investigational drug cases and carved out a second exception for DTC advertised drugs.  You can see our full discussion of this “ugly” decision here.  Fortunately, this year’s Texas Supreme Court decision in Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012) fully embracing the learned intermediary doctrine and rejecting a DTC exception (see our post on Centocor here) undercuts much of the 2011 Murthy decision making it more like a nightmare – we’ve woken up and it found out it wasn’t real (or at least easily discounted).
A few months before the Centocor decision, the Murthy court was at it again in Murthy v. Abbott Labs., 847 F. Supp. 2d 958 (S.D. Tex. 2012).  Here they incorrectly predicted that the Texas Supreme Court would recognize a DTC learned intermediary exception and based on that again refused to dismiss plaintiff’s claims based on the learned intermediary doctrine.  Id. at 967-973.  Since Texas has gone the way of every other state except New Jersey and rejected the DTC exception, that portion of the March 2012 Murthy decision is likewise just part of history.
The remainder of that decision, however, gave us some better news.  The court dismissed all of plaintiff’s claims except breach of contract based on Texas’s immunity statute.  The statute provides that in a pharmaceutical products liability action “there is a rebuttable presumption that the defendant . . . [is] not liable with respect to the allegations involving failure to provide adequate warnings . . . if  the warnings or information that accompanied the product . . . were those approved by the [FDA].”  § 82.007 of the Texas Civil Practices and Remedies Code.   Since the presumption is rebuttable, the statute also provides certain exceptions to the rule and for a failure to warn claim to survive, plaintiff must adequately plead at least one of those exceptions.  In March, the Murthy court found that plaintiff had not sufficiently pleaded any of the exceptions and dismissed her failure to warn, breach of warranty, strict liability and negligence claims accordingly.  Id. at 973-77.Continue Reading Murthy Update – The Case That Wouldn’t Go Away

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Almost all of us dabble in social media.  We did when we posted this.  You are while reading it.  And we know that druganddevicelaw.blogspot.com isn’t all you do with social media.  Talking law is spine-tingling excitement, particularly drug and device law.  But we’d bet that you use social media for other stuff.  Lots of it.…

Posted in FDA
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In our first-on-the-web quickie analysis of United States v. Caronia, ___ F.3d ___, 2012 WL 5992141 (2d Cir. Dec. 3, 2012), we didn’t have time to do much more than unwrap the Second Circuit’s early Christmas present.  Now that we’ve had a little more opportunity to consider some (but not nearly all) of the implications of Caronia, we offer the following.
First and foremost, whatever anybody else might say, truthful off-label promotion is not all of a sudden “legal in the Second Circuit.”  Caronia was one individual’s successful appeal of a criminal conviction for conspiracy to introduce misbranded drugs in interstate commerce.  It was not a declaratory judgment action.  Neither the FDA nor the Department of Justice has been enjoined from doing anything.  The brave Mr. Caronia’s conviction has simply been vacated and remanded, rather than the action dismissed.  Theoretically, if it could prove falsity, the Agency could even (ignoring such things as the statute of limitations or double jeopardy) prosecute the poor guy again.  What Caronia actually held (as opposed to the court’s reasoning) was this:

[T]he government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.

2012 WL 5992141, at *15.  It did this by construing the FDCA (and with it, the FDA’s regulations) “narrowly” to avoid having to declare them unconstitutional.  That narrowing interpretation required that truth be a defense to a misbranding claim in the context of off-label promotion.

[E]ven if speech can be used as evidence of a drug’s intended use, we decline to adopt the government’s construction of the FDCA’s misbranding provisions to prohibit manufacturer promotion alone as it would unconstitutionally restrict free speech.  We construe the misbranding provisions of the FDCA as not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs.

Id. (emphasis added).  Although it’s by no means 100% sure, it looks like Caronia’s narrowing interpretation (the court invoked a legal doctrine of construing a statute narrowly to avoid constitutional challenge, id. at *10) carves out a truth exception to the statute itself.  So we’re probably incorrect to speak of a constitutionally mandated truth “defense.”  That would imply that the burden of proving truth is on the defendant.  By construing the statute as exempting “truthful off-label promotion,” it appears that falsity is now an element of off-label-related misbranding, with the burden of proof correspondingly falling on the government.Continue Reading Caronia, Off-Label Promotion, And The First Amendment

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The big developments – the Caronia opinion, and the Supreme Court’s grant of certiorari in Bartlett – along with other distractions, such as our ABA Blawg 100 award, have left us with a pile of unblogged stuff that we think is of interest to our readers.
Today we’re taking a crack at that pile.  We apologize in advance if these discussions aren’t as detailed (and thus aren’t as useful) as our usual posts.
California Leans Daubert
California has long gone its merry, idiosyncratic way in the Daubert/Frye wars.  The California Supreme Court has fashioned something called “Kelly/Leahy”
after the names of the two most important opinions.  However, in Sargon Enterprises, Inc. v. University of Southern California, ___ P.3d ___, 2012 WL 5897314 (Cal. Nov. 26, 2012), the court spoke about California expert admissibility with a distinct Daubert accent.  Sargon (great name – it evokes space aliens, unknown elements, or even ancient Sumer) is a drug/medical device case only in the loosest sense.  It’s about an alleged “breach of a contract
for the [defendant] to clinically test a new implant the [plaintiff] had patented.”  Id. at *1.  The expert testimony at issue involved lost profits.  Id. at *2.  The testimony was vague and tautological, involving the expert’s supposition that the defendant, because it was “innovative,” would have joined the “big six” dental implant manufacturers.  But he measured “innovation” according to “the proof is in the pudding” – successful companies were “innovative,” less successful ones less so.  Why was the plaintiff company “innovative” even though it was small?  That opinion was a bunch of gobbledygook and jargon amounting to “because I think so.”  See Id. at *3-5.  The trial court threw the expert out.  The Court of Appeals reversed and found the testimony admissible, then the
California Supreme Court granted review.
This blog doesn’t care all that much about the ins and outs of calculating lost profits, but we do care about the standards for expert admissibility.  Sargon is
noteworthy for the court’s repeated reliance on the federal precedent that we have (usually) come to know and love, starting with “[u]nder California law,
trial courts have a substantial ‘gatekeeping’ responsibility.”  Sargon, 2012 WL 5897314, at *14 (footnote citing Joiner and Kuhmo Tire omitted).  That leads to “[e]xclusion of expert opinions that rest on guess, surmise or conjecture is an inherent corollary to the foundational predicate for admission of the expert testimony.”  Id.Continue Reading Stuff

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