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This post comes from only the Cozen O’Connor side of the blog.

The plaintiffs in the Whitener v. Pliva case danced through the Mensing raindrops for quite some time, using off-label promotion allegations to avoid preemption.  But, no matter however inventively they articulated their claim, it was still a claim that the manufacturer didn’t warn about risks of the drug, in this instance, off-label risks.  And a claim that the manufacturer should have warned about those risks triggers Mensing implied conflict preemption.  Yet the Whitener plaintiffs had a history of surviving Mensing preemption, even if just barely.

Their off-label allegations survived the defense’s first motion to dismiss because the court handed them the opportunity to fix their pleadings.  Whitener, v. PLIVA, Inc., 2011 WL 6056546 (E.D. La. Dec. 6, 2011).  The next time around, the court found their off-label allegations to be sufficient to survive a motion to dismiss.  The court was concerned about the defense’s argument, particularly with “permitting a generic defendant to violate federal law by actively and aggressively promising a drug for a purpose not contemplated by the label approved by the FDA while also hiding behind an inability to provide warnings connected to that off-label use because it cannot change the approved label.”  Whitener v. PLIVA, Inc., 2012 WL 3948797, at *4 (E.D. La. Sept. 10, 2012).  While the court may have been concerned with the defense’s argument, Bexis became uber-concerned with the court’s ruling, particularly its conflation of the express-preemption concept of a “parallel violation” and the implied-preemption basis for Mensing.  Finally, everything – well, everything but that particular piece of reasoning – got fixed at summary judgment, when the court granted judgment against the off-label claim for lack of proximate causation.  The alleged off-label promotion hadn’t influenced the doctor.  Whitener v. Pliva, Inc., 2014 U.S. Dist. LEXIS 41121(E.D. La. March 27, 2014).  We were at least satisfied with the outcome, if not all of the reasoning.  While avoiding the Mensing raindrops, plaintiffs couldn’t avoid the reality of the prescribing doctor independently exercising his own medical judgment.

Plaintiffs tried their luck with the Fifth Circuit and just recently lost there too.  On Thursday, the Fifth Circuit affirmed summary judgment against plaintiff.  It did so in all respects, which is to say that it was still a little unsatisfying. The court did not invoke Mensing preemption.  But that may have been a little too much to expect given that the court had such an easy basis on which to affirm – the prescribing doctor’s testimony and proximate causation. So we won’t lament a good decision for not being great.…

Continue Reading The Next Best Thing to Mensing Preemption: Winning for Lack of Connection between Marketing and the Prescriber

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Last week the FDA issued a draft guidance on the use of social media in connection with the sale and distribution of drugs and biologics.  It’s called “Guidance for Industry: Fulfilling Regulatory Requirements for Postmarketing Submission of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.  We’ve been remiss in not mentioning it. …

Posted in FDA
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It is common to characterize an opponent’s discovery request as a “fishing expedition.”  Of course, all discovery seeks something it may not find—much like our own experience with actual fishing for, you know, fish.  However, Federal Rule of Civil Procedure 26 (like various state court equivalents) requires that “the discovery appears reasonably calculated to lead to the discovery of admissible evidence,” focusing on the level of expectation that the discovery will turn up something relevant to the issues in the case.

Throwing a line in a dirty pond in Nebraska may be reasonably calculated to find you some fish, but not salmon.  In prescription drug product liability cases, it is the prescribing physician whose actions and testimony help define what marketing evidence is admissible.  (OK, so we got tired of talking about fish.)  When the prescriber has already testified what she did and did not rely on in making her decision to prescribe to the plaintiff, there is a good indication of what discovery on marketing practices will or will not be reasonably calculated to lead to the discovery of admissible evidence.  Like a big sign that says “there are fish here” or “there are no fish here.”  (We gave the fish thing another shot.)

Peetz v. Genentech, Inc., No. 8:10-CV-297, 2013 U.S. Dist. LEXIS 126803 (D. Neb. Sept. 5, 2013), is a case where the court ignored such a sign in the context of a motion for protective order on 30(b)(6) depositions on general marketing practices.  The plaintiff used defendants’ immunosuppressant drug for something called thrombotic thrombocytopenic purpura (TTP), an off-label autoimmune disorder—the drug was approved only for lymphoma—and claimed to have developed a paralyzing viral infection.  He claimed that defendants had not adequately warned in their marketing materials, and, presumably, label, that the immunosuppressant drug “carried a risk of severe immunosuppression.”  Id. at *6.
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Continue Reading Marketing Omission Fishing Expedition

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This discussion of an opinion in the Pelvic Mesh litigation once again comes only from the Dechert side of the blog. The MDL court in the pelvic mesh litigation issued rulings on motions in limine last week.  In re: Bard, Inc. Pelvic Repair Sys. Prods. Liab. Litig., MDL No. 2187, 2:11-cv-00195, 2:11-cv-00012, 2:10-cv-01224, 2:11-cv-00114, 2013 U.S. Dist. LEXIS 90210 (S.D.W.V. June 27, 2013).  In previous pretrial rulings, the defense made out well, winning summary judgment on a number of plaintiffs’ claims, including a failure to warn claim in one case (see here and here), and winning a number of key Daubert motions (here).  Things didn’t go as well with the in limine motions.  It was more of a mixed bag.  Here are a few of the issues addressed by the court.

FDA 510(k) Clearance 

This was plaintiffs’ motion.  They wanted to exclude evidence related to the FDA’s clearance of the Avaulta products through its 510(k) process.  Id. at *4-6.  Seems pretty relevant, doesn’t it?  It’s the process established by the industry’s primary regulator as to what the industry must do and how it must do it in order to be able to bring its product to market.  Yet the court granted plaintiffs’ motion.
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Continue Reading Pelvic Mesh Litigation: In Limine Rulings

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If you are a regular reader of this blog, and we hope you are, you know that we have been paying close attention to when the FDA will issue its guidance on internet and social media promotion of drugs and devices.  You can find our latest update here.  As we’ve said before, we, and more importantly our clients, want and need word from the FDA as to what it will consider proper and what it will not.  We know the rules for print and broadcast promotion, but those media continue to lose readers/viewers to the internet, and in particular to social media.  And, in that marketplace – there remain too many unanswered questions for our clients to have any comfort in using the internet as a means of communicating information about their products.

The single biggest question for which we don’t have an answer is what actually constitutes promotion.  Is it providing a link to a scientific article?  Is it “liking” a Facebook post?  Or “re-tweeting” someone else’s comments?  We just don’t know.  So, while we sit and wait for the FDA to decide the answer, we thought we’d bring you a recent decision from a food labeling case that grappled with the internet issue.  The rules about food labeling are different from those for drugs and devices, but in the absence of formal FDA guidance, it behooves us to be aware of what courts are saying about our cousins in the food industry.

We doubt you’ll be surprised to learn that the issue arose in the context of a putative class action brought in California alleging violations of California’s Unfair Competition Law’s (“UCL”), False Advertising Law (“FAL”), and Consumers Legal Remedies Act (“CLRA”); as well as unjust enrichment and breach of warranty.  Wilson v. Frito-Lay North America, Inc., 2013 U.S. Dist. LEXIS 47126, at *4-5 (N.D. Cal. Apr. 1, 2013).  Perhaps you’ll be slightly more surprised, as we were, that anyone was claiming they were misled about the nutritional content and value of such products as “Lay’s Classic Potato Chips, Lay’s Honey Barbeque Potato Chips, Lay’s Kettle Cooked Mesquite BBQ Potato Chips, Cheetos Puffs, and Fritos Original Corn Chips.”  Id. at *2.  Can anyone claim — with a straight face – that they both purchased these products and that “they care about the nutritional content of food and seek to maintain a healthy diet”?  This is the food of juvenile ignorance, youthful metabolism, and the occasional late night, perhaps alcohol-influenced, binge.  It’s called junk food for a reason!  But, back to the case.

There is a lot going on this decision, including a finding that several of plaintiffs’ claims are not preempted because the requirements they seek to impose mirror those imposed by the FDA – in drug and device parlance, they are allowable parallel violation claims.  Not a result we’d champion and since we blogged about a similar result last week in Brazil v. Dole Food Company, 2013 WL 1209955 (C.D. Cal. Mar. 25, 2013), we won’t re-hash the issue here.  See Wilson, 2013 U.S. Dist. LEXIS 47126 at *19-29.  There is also an interesting discussion of the deference to be afforded to an agency’s informal, non-binding interpretation of its own regulations.  In this case, the court found that because the regulation in question (on MSG labeling) was subject to different possible interpretations, it would give deference to the FDA’s statement on its website which “appears to be its own interpretation of an ambiguous regulatory scheme.”  Id. at *26-29.  Again, not a ground breaking ruling, but noteworthy.…

Continue Reading Website Not Considered Labeling in Food Case

Any time a sales rep’s conduct and statements are the centerpiece of a trial, our natural inclination as defense lawyers is to cringe. We know we will be fighting tooth and nail to explain to the judge and jury why the evidence should be excluded or ignored. Because let’s face it – the plaintiffs’ lawyer’s…

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A new lawsuit was filed in our favorite Judicial Hellhole, Madison County, Illinois, alleging that a pharmaceutical company failed to warn that African-Americans face an elevated risk of certain dermatological side-effects from Tegretol. At this point it’s merely a complaint. Anyone with a word processor and a check can file one, especially in Madison County.…

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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…

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The Pharmaceutical Research and Manufacturers of America (“PhRMA”) released a new set of voluntary guidelines for the conduct of pharmaceutical marketing (called “Code on Interactions with Health Care Professionals”) on July 11.
That’s almost two weeks ago – an eternity in the blogosphere.
What can we say? We’re busy. We’re also lazy. So being both,…

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