Thursday, January 31, 2013

Silver Linings Casebook: Getting Happy with a Bad Discovery Ruling


You have to hand it to the Academy of Motion Pictures. By expanding the number of Best Picture nominees, it ended up selling lots more tickets. Like many people we know, we try to see all the Best Picture nominees so as to earn the right to grouse about the Academy’s inevitable injustices (e.g., Oliver! over 2001?! Gandhi over ET?!! Art Carney over Jack Nicholson, Al Pacino, and Dustin Hoffman?!!!). In past years, that meant seeing five films. This year, we need to see nine. So that's almost twice as many movie tickets, popcorns, nachos, snowcaps, and slushees.  Last weekend we saw Silver Linings Playbook.  It is weird that it took us so long, considering the Philly-centric nature of the story. Brad Cooper plays a bipolar patient who has trouble coping with life, especially the disintegration of his marriage. He keeps telling himself that he needs to find the silver linings in tough situations. His father seems to have a serious case of OCD, especially when it comes to rooting for and betting on the Philadelphia Eagles. (If one wants to make the point that the enterprise of life is rescuing the good bits from a failure pile, it’s hard to come up with a better metaphor than cheering for a Philadelphia sports team.) A psychiatrist tells the Cooper character that he needs a “strategy” (presumably that is the “Playbook” of the title) to pluck out the glories from the dismal parade of life's indignities. Nevertheless, it’s not clear what sort of strategy would work – beyond, maybe, just being open to the possibility of happiness.

 

A week ago, we were watching one of our favorite sitcoms, Modern Family. For the first twenty or so minutes, it seemed like a whole lot of nothing. The episode was disappointing.  It was flat.  But it turned out that it was setting us up for a concluding couple of minutes that are as brilliant as anything we’ve seen in a while. Levitan et al served up a parody of the conclusion of The Godfather. See it for yourself here. More than a few of our lawyer buddies have a running gag about how the most valuable lessons for life and litigation are contained in The Godfather. What we learned from the Modern Family reenactment of The Godfather is that human cleverness is endless, a long set-up can prepare the way for a sublime punch line, that even in our dotage we can laugh ourselves to tears, and that Ty Burrell (again) can make us giddy with stonefaced genius.  It sounds overblown and frivolous, but a tv show managed to amplify our delight in being alive.  

 

For some reason, that excellent television show and excellent movie put us in mind of a New Yorker article we read many years ago about a corporate coach named Marshall Goldsmith.  Companies invited Goldsmith to help executives who were smart, driven, and completely successful, save for the fact that they were utterly obnoxious.  Goldsmith applied his modified Zen Buddhism to organizational dynamics and emerged with three rules:  (1) Life is Good; (2) Be Happy Now; and (3) Let it Go.  He was convinced that those three rules are the key to happiness.  Stop complaining and, instead,  appreciate how gorgeous existence is.  Do not play the game of 'I'll be happy when' [e.g., when I get that promotion, when I make enough money, when I get that certain someone to love me back].  And if something wrong is done to you, or, perhaps more importantly, if you have done something you regret, learn from it, and then stop obsessing over it.  To this day, we think more about that New Yorker article than any other we've read over the past (gulp) 35 years.

 

Armed with this wisdom and joy and openness, let's dance in the rain of dodgy legal analysis.  The case is from the Pradaxa MDL, In re Pradaxa, 2013 U.S. Dist. LEXIS 7979 (S.D. Illinois January 18, 2013).  The plaintiffs brought a product liability claim against Boehringer Ingelheim Pharmaceuticals, Inc. ("BIPI") relating to Pradaxa.  As we all know, discovery in mass tort cases is a grim slog. There are way too many custodial files, way too many databases, and way too many things to do with this stuff, including reviews for responsiveness, privilege, and confidentiality.  Even then, we haven't scratched the surface of tasks associated with this mountain of documents and terabytes.  (De-duplication, anyone?)  Responding to this discovery costs a company more money than most civil litigation defendants must pay after being found liable -- yet when we talk about mass tort defendants responding to discovery, we are talking about defendants who have not yet been found liable for anything.  The American discovery regime is, not to put too fine a point on it, insane.

 

Now consider how much more insane it gets when the plaintiff asks for documents relating to drugs that are not at issue in the litigation.  The Pradaxa MDL plaintiffs asked for documents relating to any lawsuit alleging that BIPI engaged in off-label promotion of any medicine or that BIPI paid kickbacks to induce doctors to prescribe any BIPI medicine.  The plaintiffs also asked BIPI to identify witnesses relating to such lawsuits, and employees who participated in the alleged wrongful activities.  When the plaintiffs inquired about earlier lawsuits, they were focusing on a qui tam suit alleging off-label marketing of four products, none of them Pradaxa.  As part of the settlement of that qui tam action, BIPI entered into a Corporate Integrity Agreement ("CIA").  That CIA governed BIPI's conduct as it relates to all of BIPI's drugs, including Pradaxa. 

 

BIPI objected to the non-Pradaxa discovery requests on grounds of relevance and burden.  That is not surprising in the least.  Nor are the grounds asserted by BIPI surprising:  (a) Pradaxa is the only drug at issue in the Pradaxa MDL; (b) the sought-for discovery mostly antedates the conduct at issue in the Pradaxa litigation; and (c) obtaining the non-Pradaxa information would "impose a great expense and an undue burden."  2013 U.S. Dist. LEXIS 7979 at *9.  The plaintiffs, you will be shocked to learn, disagreed.  They argued that the non-Pradaxa materials might lead to other acts evidence admissible under Fed. R. Evid. 404(b), that impeachment ammo might surface, and that evidence of improper conduct would be relevant on the issue of punitive damages. 

 

We are displeased to report that Chief Judge Herndon bought more arguments from the plaintiffs than the defendant.  The court begins by observing how "federal discovery rules are liberal in order to assist in the preparation for trial and settlement of litigated disputes."  Id. at * 11-12.  Sometimes the beginning gives you a clear idea of the end.  Think of Reservoir Dogs.  Or Citizen Kane.  Sometimes you just know you're not headed for a happy ending.  In this case, the unhappy ending is the virtual disappearance of any notion of proportionality in discovery.  Okay, so the rules of discovery are liberal.  Boy,  are they ever liberal.  But they are not limitless ... are they?  The court cites Fed. R. 26(b)(1).  Remember that. 

 

The court reads the Pradaxa MDL complaint to assert "allegations related to the manner in which Pradaxa was marketed."  Id. at * 13.  Then here's the kicker:  "It is entirely possible that the marketing policies and strategies at issue in the qui tam action extended to BIPI's marketing of Pradaxa."  Id. at * 15.  Later, in addressing the issue of undue burden, the court ... well, the court does not really seem to care about that issue very much.  First, the court "finds that this evidence is extremely probative."  Id. at *19.  Really?  That information the relevance of which is "entirely possible"?  Anyway, that is not a burden point.  What the court does say about burden is that the "identity of witnesses and documentation sought is not that extensive in relative terms."  Id.  Sorry, but that conclusion (and it really is nothing more than a conclusion; there isn’t even a smidgen of factual support) seems profoundly wrong.  The information relating to the earlier lawsuit may be, as the court says, "obtainable," but we'd make a wager bigger than any wager the DeNiro character makes in Silver Linings Playbook that production of those materials will be massive and expensive.  What are the "relative terms" that the court alludes to? Relative to an ordinary case?  Relative to the rest of the massive production in the case?  Relative to all the paper and data in the world?  Relative to our nation’s GDP?

 

Remember when we mentioned how the court mentioned Rule 26(b)(1)?  What about 26(b)(2) (Limitations on Frequency and Extent) or 26(g)(1)(B)(iii) (signing a request for discovery is a certification that the discovery sought is "neither unreasonable nor unduly burdensome or expensive, considering the needs of the case, prior discovery in the case, the amount in controversy, and the importance of the issues at stake in the action")?  We do not see how the non-Pradaxa discovery requests satisfy a rigorous application of the benefit vs. burden balancing test.  Yes, as any former federal prosecutor will tell you, Rule 404(b) is a rule of inclusion not exclusion.  But "other acts" evidence is usually fairly unnecessary, tangential stuff and it is still hemmed in by Rule 403 (undue prejudice).  Accordingly, if production of the 404(b) material involves significant time, effort, and expense (and please do not ignore the expense issue just because the defendant is a large corporation, because that is not part of the balancing test nor should it be), then we think the sideshow of other acts evidence should be shut down.

 

There is a scene in Silver Linings Playbook where Cooper, disgusted with the unhappy ending in A Farewell to Arms, heaves the book through the bedroom window.  Hemingway's book streaks through the night and plops on the middle of an Upper Darby street.  It lays there, no doubt stunned at the insult.  Poor thing.  It’s not such a bad book.  We were tempted to treat the Pradaxa opinion with similar belligerence.  But it is only six pages long, so it would merely bounce off our office window.  Then we thought about Silver Linings.  And we thought about laughter.  And we thought about Marshall Goldsmith and his three rules.  Is there a way to fend off our unhappy feelings about the batty discovery ruling in Pradaxa?

 

There are a couple of things.  We've been on panels with Chief Judge Herndon and we like and respect him.  He has a good sense of humor.  We are not saying that the Pradaxa opinion is a joke (wishful thinking, that), but we should pay attention to the nice parts of the opinion, especially understanding how difficult and enervating it is to resolve discovery disputes.  There are some things in the opinion you might even want to cite in the face of overreaching plaintiffs.  In seeking a protective order, BIPI attached a sealed document. Ever the opportunists, the plaintiffs requested that the document be unsealed.  The court denied the plaintiffs' motion without breaking a sweat.  Id. at * 12.  The court also narrowed the non-Pradaxa discovery by timeframe -- it had to be 1990 or later.  Not great, but it's something.  The court also did not get to the plaintiffs' punitive damages justification for the discovery, so we dodged a bad law bullet there.

 

Life is still good.  In our experience, when plaintiffs get broad-ranging, additional discovery of things that should not matter, the things discovered seldom help their case much.  Meanwhile, plaintiff-specific discovery inevitably reveals that a huge chunk of the MDL inventory is pure, unmitigated junk.  Can we be happy now?  Of course we can (though we are still grieving over that last episode of Downton Abbey).  A bad discovery ruling does not diminish the delight we experience from a job that surrounds us with smart, engaging people, or from the Drug and Device Law Son bringing home an A on his latest French test, or from a praline dessert we cannot stop thinking about.  Can we let the Pradaxa ruling go?  Sure.  It is annoying and wrong, but it is, “in relative terms,” a minor skirmish.  There is more day to dawn.   We look forward to reporting on the silver lining.     

 

                   

Wednesday, January 30, 2013

Negligence Per Se Trivia

Bexis is updating chapter 4 of his book, which includes a thorough discussion of negligence per se.  Negligence per se in the context of the Food, Drug & Cosmetic Act ("FDCA") has taken on increased salience, particularly in preemption cases where courts leave an "out" for parallel claims.  Because there must be a pre-existing state-law tort claim for an FDCA violation claim to be "parallel" to (since the FDCA expressly bars private rights of action), state-law precedent that independently bars FDCA-based negligence per se claims can shut the "parallel claim" door in preemption cases.

There are, of course, the big five:  (1) no negligence per se when it would violate the "intent" of the legislature to preclude private causes of action; (2) no negligence per se for non-statutory violations; (3) no negligence per se that establishes novel duties; (4) no negligence per se where the enactment is too vague to provide a meaningful replacement to the "reasonable man" standard; and (5) no negligence per se for mere failure to have a required permit/license (which we've covered at length before), but did you know:

In Kentucky, negligence per se has been codified, and claims based on federal (but not state) statutes or regulations (like the FDCA) are prohibited.  St. Luke Hospital, Inc. v. Straub, 354 S.W.3d 529, 534 & n.14 (Ky. 2011); T & M Jewelry, Inc. v. Hicks, 189 S.W.3d 526, 530 (Ky. 2006).

In Louisiana, Kansas and Ohio, comprehensive tort reform statutes have abrogated negligence per se in product liabilty cases.  Mattos v. Eli Lilly & Co., 2012 WL 1893551, at *3 (D. Kan. May 23, 2012); Tolliver v. Bristol-Myers Squibb Co., 2012 WL 3074538, at *2 (N.D. Ohio July 30, 2012); Boroff v. ALZA Corp., 685 F. Supp.2d 704, 711 (N.D. Ohio 2010) (applying Ohio law); King v. Bayer Pharmaceuticals Corp., 2009 WL 2135223, at *3-4 (W.D. La. July 13, 2009); In re Air Bag Products Liability Litigation, 7 F. Supp.2d 792, 800 (E.D. La. 1998)

. In Montana, you can't have negligence per se at all without an express statutory private right of action. 
Doyle v. Clark, 254 P.3d 570, 577 (Mont. 2011).

In South Carolina, you can't have negligence per se at all without at least an implied statutory private right of action.  Salley v. Heartland-Charleston, LLC, 2011 WL 2728051, at *3 (D.S.C. July 12, 2011) (applying Court v. Ash factors).

  That's six states (two by their supreme courts) where, if we can't kill purported parallel FDCA-based claims on the front end with implied preemption under Buckman, we can try killing them on the back end as simply not stating a cause of action under existing state law (and if we're in federal court, we can add the Erie point about not reaching for novel, expansive state-law liability) - all by relying on state-specific peculiarities of negligence per se law.  Most of these states (except Ohio) aren't particularly large, but these quirks are things we'd definitely want to know if we happened to have a case originating there.

State-law specific quirks - that's one reason why folks like us, who practice in "big firms," need to have local counsel.  So we'd like to hear from our "local counsel" readers - anybody out there know of any other state-specific negligence per se peculiarities that can defeat purported "parallel" FDCA-based claims?

As always, we'll give name and firm credit to our readers.

Tuesday, January 29, 2013

Good Confidentiality Ruling Out of Oregon

            In the drug and device arena, we are well versed in confidentiality agreements.  In fact, we can’t recall a drug or device products case that hasn’t involved some form of confidentiality order.  And that’s not surprising.  Plaintiffs sue our clients making serious allegations about their products, their marketing and labeling, their manufacture and design, dealings with the FDA, communications with doctors, and on and on.   Those allegations – if sufficiently pleaded – are followed by scores of interrogatories and document requests seeking all manner of confidential, proprietary, and trade secret information.  Typically, in a products case the process goes something like this:  confidentiality agreement negotiated and entered by the court, documents produced and marked confidential in accordance with the terms of said order, then plaintiffs want to disclose those confidential documents to the press, and a fight ensues.  We’ve all been there.  We’ve all won some and lost some. 
            Our clients are also subject to government investigations regarding their products.  Again, because the investigations necessarily involve trade secret and proprietary information, confidentiality agreements are par for the course.  After entry of which, manufacturers produce confidential documents to state and federal government officials.  In this context, confidentiality can become a contested issue when third parties – namely the press and private plaintiffs’ counsel – request those documents from the government via a Freedom of Information Act, or state-equivalent, request.  That’s precisely the scenario that prompted the case of Pfizer Inc. v. Oregon Department of Justice, 254 Ore. App. 144 (2012).  And the issue that caught our attention.  When dealing with the government, our clients need to consider both the terms of the confidentiality order and the applicable state public record acts.  Government officials are governed by the latter, the provisions of which could conceivably undercut the terms of the confidentiality agreement.  This seemed to be what the trial court found in the Pfizer case – fortunately, the appellate court saw things differently.    
            We won’t cover all the details of the investigation, but they are in the opinion if you are interested.  In the course of the investigation, documents were turned over to the Oregon Department of Justice (DOJ) pursuant to a confidentiality order that prohibited DOJ from disclosing documents or materials that the manufacturer designated confidential based on a good faith belief that they contained “proprietary or trade secret information.”  Id. at 148.   The order also incorporated the Oregon Public Records Law (OPRL) which governs disclosure requests addressed to Oregon state officials, including the DOJ.  The OPRL, however, exempts trade secrets, among other things, from disclosure.  Id. at 146, 149.  So, when a private plaintiff’s attorney and two reporters requested all documents produced during the investigation, Pfizer filed suit to protect the confidential information.  Id. at 150-151.
            We’ll skip over the detailed discussion of the trial’s court reasoning – since it was largely discounted – and get straight to the appellate analysis.  First, the court summed up the terms of the confidentiality agreement.  DOJ is prohibited from disclosing documents marked confidential “to anyone in the absence of a subpoena or court order.”  Id. at 159.  However, the DOJ’s obligation is “further subject to the OPRL.”  Here’s that rub we were talking about.  Read together, the confidentiality agreement and the OPRL provide that “if the exhibits are not exempt from disclosure under the OPRL, DOJ is obligated to disclose them; however, if any exhibits are exempt under the OPRL, DOJ is obligated not to disclose them.”  Id.  Sort of sounds like OPRL trumps confidentiality agreement.  And, if that’s the case we and our clients better make sure we know how things like “trade secret” and “proprietary information” are defined by state public records acts and how they’ve been interpreted by the courts. 
            Given that conclusion, most of the opinion goes on to deal with the OPRL disclosure exemptions for “trade secrets,” “confidential submissions,” and “attorney work product.”  But not before the court addressed DOJ’s attempt to “re-write” the confidentiality agreement so that it would actually narrow the exemptions available under the OPRL.  DOJ argued that it was its “understanding” that under the confidentiality agreement, Pfizer would only designate as confidential, documents and information that were trade secrets.  Not so said the court: 
However, contrary to DOJ's understanding, the agreements provide that confidential documents are those that contained "proprietary or trade secret information." (Emphasis added.) That is, the agreements provide for protection of "proprietary" information beyond "trade secrets." Thus, DOJ's contention that the agreements obligate it to apply only the OPRL exemptions related to trade secrets is unavailing.

Id.  We certainly like that the court adhered to the true letter of the confidentiality order, especially since it embraced the broader scope intended by the parties – which in this case also meant the availability of more statutory exemptions.  So, another word to the wise – make sure your confidentiality agreement spells out what type of documents you want kept confidential.  Making the agreement precise helps defendants by eliminating the ambiguities plaintiffs can cling to.
            As it turns out, the difference between trade secret and proprietary information didn’t really amount to anything in this case.  The court’s analysis really came down to whether the requested documents were trade secrets under the OPRL.  And, for the most part the answer was yes.  In Oregon, “[t]o constitute a trade secret . . . information (including compilations) must both (1) gain value because it is not generally known and (2) be the subject of reasonable efforts to maintain that secrecy." Id. at 161 (citation omitted).  Further, the party asserting the trade secret must demonstrate “that disclosure will work a clearly defined and serious injury.”  Id. at 162.  How did Pfizer satisfy its obligation?  With the declaration of its director detailing the economic value of the information, the efforts to maintain confidentiality and the benefit the information would be to Pfizer’s competitors.  Id.  DOJ proffered no evidence to controvert the declaration.  Id. at 152.  And the court found the declaration was “legally sufficient to establish the availability of the trade secrets exemption.”  Id. at 163 (quotation marks omitted). 
            Unable to get around the declaration, DOJ tried two arguments that we’ve seen many times in products cases.  First, it argued that the information “is old and of no value to a competitor.”  Id. at 165.  Yep, plaintiffs like that one a lot.  By the time a mass tort or even a single drug or device case gets through document discovery, usually the product at issue has been on the market for years and the documents are in fact old.  But, without more, age alone is insufficient to defeat trade secret status.  Because “DOJ failed to offer any factual submission in support of those bare assertions,” that argument was rejected.
            DOJ’s second argument had slightly more merit – it’s no longer a trade secret if it has been made publicly available.  It was the scope of their argument that was seriously flawed.  DOJ argued that certain information, such as the complaint, the stipulated judgment, the federal plea agreement and press releases pertaining to these events, were publicly available.  Id. at 164.   DOJ went onto to contend that the documents at issue “contain examples of the conduct described in those publicly available documents. [ ] Therefore, the information in the exhibits has essentially been made public and is generally available.”  Id.  Fortunately, the court was unwilling to make the enormous leap required to agree with DOJ:
The success of [DOJ’s] syllogism depends on the correctness of DOJ's predicate premise that the exhibits are nothing more than examples of conduct described in the publicly available documents to which it refers. . . .  [W]e conclude that that premise is incorrect as to the great majority of the exhibits.
. . .
Even as redacted, those exhibits reveal more than generic examples of conduct. In other words, the specific, underlying details in those exhibits have not been revealed by the publicly available sources on which DOJ relies--and it is that underlying detail that Pfizer contends is a trade secret. Accordingly, . . . we reject DOJ's contention that the "information had already been made public or that similar information was readily available."

Id. at 164-65.
            We said the argument had some merit – and it did as to a handful of documents.  As to documents, the content of which was reproduced – sometimes verbatim – in the federal information or quoted in the New York Times, the court had to agree, they were no longer protected by the trade secret exemption (or any of the other OPRL exemptions for that matter).  Id.  So, in summary DOJ was permitted to provide to third parties only those documents which had been previously publicly disclosed.  Hard to find fault with this conclusion.
           

Friday, January 25, 2013

Bartlett – DOJ Says Remove-From-The-Market Claims Preempted


It’s written somewhat strangely – weak at the beginning, strong at the end – but the Department of Justice’s amicus curiae brief , filed yesterday in Mutual Pharmaceutical Co. v. Bartlett, No. 12-142 (U.S. pending), eventually gets to the right place.  That is, even the generally anti-preemption political leadership of this FDA and DoJ took the only institutionally logical position that they could take and told the Supreme Court that, yes, state tort claims asserting that an FDA-approved product should have been removed from the market altogether were impliedly preempted.

Because we like good news (and still can use some after Stengel and Weeks), we flip right to the back of the DoJ’s Bartlett brief.  The last substantive paragraph states:

Federal law would preempt a pure defective-drug-design claim that required a jury to second-guess FDA’s safety determination, without any further need to find the existence of new and scientifically significant evidence that rendered the product misbranded under federal law.


Let’s look at this.  First of all, what’s this “pure” design defect business?  As we said above, the DoJ brief starts out weakly, trying to turn Bartlett into something it wasn’t in order to avoid what it was.  Instead of what really went on at trial (the trial court allowing plaintiffs’ counsel to ask the jury to flip a bird at the FDA), the DoJ first portrayed the verdict as based primarily on an “unreasonably dangerous even with warnings” theory under Restatement (Second) of Torts §402A, comment k (1965).  DoJ br. at 14-18.  The primary purpose of that argument was to reduce Bartlett to a “nothing to see here” misapplication of Mensing.

But it wasn’t, and the Court wouldn’t have taken such a case.  Rather, the trial court construed New Hampshire law as allowing a design defect claim based on pure risk utility factors without any need for an alternative design, and the First Circuit converted that theory on appeal to the “remove-from-the-market” claim that the Supreme Court actually granted certiorari to review.  So eventually, DoJ had to come to grips with what is actually at issue: that the trial court told the jury it could − and plaintiff’s counsel told the jury it should − find that the FDA should not have approved a drug that it did approve:

[The District Court] instructed the jury that it . . . was free to give FDA’s approval “as much or as little weight as you think it deserves. . . .”  [Plaintiff’s counsel] “argued that sulindac was a “needless and useless drug. . . .”  Counsel asserted that FDA merely “rubber stamped” the ANDA . . ., and that “no evidence (showed) that FDA has ever done a focused analysis on (s)ulindac” to justify its “be(ing) on the market.”  FDA, counsel asserted, lacks “expertise in risk⁄benefit assessment” and “impos(es) a significant risk to . . . the safety of the public” because it is unable to perform its “mission to monitor drug safety for any class of drugs.”

DoJ br. at 10-11 (quoting trial record).  Given this view of the law and the evidence, it’s hardly surprising that the Bartlett jury, applying only state law, told the FDA to pound sand and decided that an FDA-approved drug simply shouldn’t be sold at all.  That’s the “pure” theory that DoJ addresses in the most interesting part of its brief.

As the first block quote above indicates, the FDA supports preemption – and does so without any use of “generic” as an adjective.  That's important.  The FDA states that remove-from-the-market claims are preempted as to all drugs (and presumably all other products it regulates):

Brand-name and generic drugs should be treated the same for purposes of design-defect claims. . . .  [T]he active ingredient in a generic drug must be the same as that in the brand-name drug.  The generic manufacturer may not alter that ingredient without prior FDA approval.  But the same is true of the manufacturer of a brand-name drug. for both, any change that created a new active ingredient would require prior FDA approval. . . .  [P]reemption in the generic-drug context, just as in the brand-name-drug context, should not be defeated on the rationale that the manufacturer could always comply with state law by declining to provide the very drug whose availability Congress sought to provide.

DoJ br. at 30-31 (citations and footnote omitted) (emphasis added).  We’ve received the same bone-headed response from an appellate court in a branded case, see Wimbush v. Wyeth, 619 F.3d 632, 645 (6th Cir. 2010) (our #1 worst caseof 2010), so we know that allowing state juries to order federally approved drugs off the market is just as preemptive a conflict (and just as absurd a theory) in branded as in generic cases.

We note that while the DoJ to some extent addresses a straw man – the form of design defect described in Restatement (Third) of Torts, Products Liability §6(c) (1998), which it concedes has not been accepted to “any significant degree” (DoJ br. at 20) – this reasoning is also relevant to the even more extreme so-called “categorical liability” design defect claims that the Third Statement rejected, which are precisely what the plaintiff was permitted to pursue in Bartlett.  Since none of these now mostly discredited meat-axe design-related theories includes an caveat approaching the “new and scientifically significant evidence that rendered the product misbranded under federal law” qualifier added by DoJ, the government’s position is effectively that all remove-from-the-market theories asserted in tort cases against FDA-approved products are preempted.

That’s as it should be.

We particularly recommend DoJ’s discussion of why failure to withdraw claims inherently conflict and interfere with the FDA’s parallel post-marketing processes – because plaintiffs (including in Bartlett) have made contrafactual statements about the FDA’s post-marketing authority, leading some courts into error as to “pharmacovigilence”:

Congress has further charged FDA with monitoring post-marketing drug safety.  A manufacturer must maintain extensive clinical records and make numerous reports to FDA. . . .  Those duties apply to manufacturers of generic drugs as well as the brand-name drug. . . .

The Act provides that FDA shall withdraw approval of a drug if, inter alia, it finds that the drug is not safe for the uses identified at the time of the drug’s approval or is not effective as claimed for those uses.  Approval may be withdrawn only following procedures that afford the manufacturer due process and the opportunity for a hearing.  Since 2007, FDA may also require (not merely request) labeling changes.

FDA’s ongoing risk-benefit analysis will sometimes take into account the availability of more effective or less risky alternatives . . . .  FDA did not request withdrawal of sulindac. . . .

In the face of this elaborate regulatory regime instituted to safeguard the national market and protect consumers throughout the United States, and the extensive commitment of public and private resources to those ends, it would be inconsistent with the FDCA to conclude that a manufacturer must abandon a market it has been approved by FDA to enter in order to avoid violating a duty recognized by a jury under state tort law that deems its product unsafe.

By requiring a jury independently to balance the health risks and benefits of FDA-approved uses of a drug and to determine if the drug is “unreasonably dangerous” for those uses, a state with a pure design-defect product-liability law would force the jury to second-guess FDA’s safety determination, which balances the drug’s therapeutic risks and benefits for its labeled uses.  Such ad-hoc reconsiderations on a state-by-state and lawsuit-by-lawsuit basis would undermine FDA’s drug-safety determinations, which are made based on sound scientific judgments by an expert federal agency with appropriate access to pertinent safety data, and the assurance that FDA’s approval provides for all participants in the market.

DoJ br. at 26-28 (various stuff omitted).

DoJ also distinguished the heck out of Wyeth v. Levine, 555 U.S. 555 (2009), which is probably the worst prescription drug decision of all time (at least as to preemption):

  • Levine didn’t adopt any “general no-preemption rule.”  Rather, Levine (like any other case) depends on “context.”  DoJ br. at 31.
  • Levine involved “newly acquired information undermining its drug’s safety” that the defendant had “failed to strengthen its labeling as specifically contemplated by FDA’s CBE regulation.  Id.
  • Levine found no obstacle preemption in “FDA’s labeling approvals, and the mere possibility that FDA would disapprove a manufacturer’s subsequent enhanced warning.”  Id. at 32.
  • Levine “does not categorically extend to all claims,” and in particular does not extend to design claims, because “because a manufacturer cannot unilaterally alter the design (unlike the labeling) of a drug.”  Id.
  • Unlike the FDA’s position in Levine, FDA drug approval as a “an expert judgment that the drug’s therapeutic benefits outweigh its risks” is a “longstanding interpretation” of the FDCA.  Id. at 32-33.
  • Levine involved “traditional” warning-based litigation, whereas design-based claims have been “rare” and “unusual.”  Id. at 33.
  • The claims at issue in Bartlett fit within Levine’s “recogni[tion] that some state-law claims might well frustrate the achievement of congressional objectives.”  Id. (quoting Levine, 555 U.S. at 581).

So the good news is that, after some hemming and hawing, the DOJ did the right thing in Bartlett.

The bad news is the hemming and hawing.  Whether a state-law jury should be allowed to say “no” to the marketing of a product after the FDA has said “yes” is hardly “difficult and close.”  DoJ br. at 12.  This type of absolute and utter conflict between state and federal law is a no-brainer, since 1913, when the Court decided in McDermott v. Wisconsin, 228 U.S. 115 (1913), that a state couldn’t ban FDA-approved dairy products.

Moreover, it was egregious and unnecessary for DoJ to advocate exceptions for Levine branded labeling claims or Riegel parallel claims, br. at 23-24, since as the brief admits, “neither of the foregoing theories is available here.”  Id. at 24.  Even worse is DoJ’s backhanded endorsement of a “state-law duty not to market the drug in the same circumstances,” parallel to federal “misbranding” law as not preempted.  Id.  Not only was (1) no such claim raised in Bartlett, and (2) “parallel” claims analysis isn’t an implied preemption concept, but generally there is no state-law cause of action for failure to recall, as we discussed here and here, among other places.  We hope the Supreme Court won’t have time for such irrelevant nuances when it decides Bartlett, but anything that gives comfort to bizarre new tort theories we can’t stomach.

Thursday, January 24, 2013

Plavix Plaintiffs’ Counts Continue To Drop

This post is really the work of co-blogger Eric Alexander, but technical problems meant that Bexis had to post it.

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On this week of Martin Luther King Day and the Presidential Inauguration, we start this post with some regrets. We regret that we lack the eloquence to offer a sufficiently meaningful link between the cases we discuss and the inspiration that Dr. King has provided to so many, even after his brutally untimely death.  We regret that any homage we pay to our nation and its democracy might come across as fluff.  In our day job, we are happy to take on tough cases, depositions, motions, whatever.  Here, the wiser choice seems to be to decline the challenge of trying to establish a link.  We might offer the familiar quote that “Injustice anywhere is a threat to justice everywhere.  We are caught in an inescapable network of mutuality, tied in a single garment of destiny.  Whatever affects one directly, affects all indirectly” and argue that justice to manufacturers of drugs and devices in the courts of our nation is included.  Nah.  We like when courts get the law right and hold plaintiffs to their proof. We decry when courts tilt the table for whatever reason. We will not, however, cheapen the real struggles in the country or the importance of our democratic ideals usually winning out by making comparisons to the cases we are discussing. At least not this week. We make no promises for the next post.  We might just hum “Abraham, Martin and John” or “Renegades of Funk” as we type.    

            We do not regret the decisions in Begley v. Bristol-Myers Squibb Co., No. 06-6051 (FLW), 2103 US. Dist. LEXIS 4849 (D.N.J. Jan. 11, 2013), and LaBarre v. Bristol-Myers Squibb Co., No. 06-6050 (FLW) (D.N.J. Jan. 11, 2013), each granting summary judgments on all claims in cases alleging bleeding from Plavix based principally on lack of evidence that the warning was inadequate as to bleeding.  If this sounds familiar, it should.  Two weeks ago, we posted on the Solomon decision from the same judge. So, why are we posting on more of the same?  Well, Solomon applied Texas law, while Begley applied Illinois law and LaBarre applied Florida law.  Also, the decisions brushed aside some different arguments from the various plaintiffs, even though they were represented by the same firm and relying on the same expert—we will get to them later.  Why are we justifying ourselves?  Read or read not.  There is no why.  (A little pre-CGI Yoda.)

            As would be expected, each decision is well thought out and systematic.  We particularly appreciate the restraint shown in each for a federal court to resist making new state law.  We also appreciate the efficiency in each of denying a “negligence claim [that] is nothing more than a restatement of her defective design, defective manufacturing, and failure-to-warn claims” and in denying Rule 56(d) requests for more discovery on subjects that are “neither relevant nor probative Plaintiff’s claims.”  Particularly on the former point, we have seen some courts take a claim for “negligence” in a drug case as encompassing any conduct that can be criticized; the more sensible view is that negligence claims are still really claims based on warnings, design, or manufacturing, but requiring additional proof beyond strict liability.  For instance, that the Defendant was negligent in failing to provide inadequate warnings.  We also enjoyed the clear rejection that arguments as to the efficacy of the product have anything to do with whether the warnings were adequate, at least under Illinois and Florida law.  There may be claims in some states based on overstating the efficacy of a drug, but failure to warn claims in Illinois and Florida are about “the product’s known dangerous propensities” and “any danger or harm that may result from ingesting the drug,” respectively.  Begley, *17; LaBarre, *22.  We also liked the simple recognition that the adoption of Comment k in Illinois and Florida meant that the design defect claims fell with the lack of proof of inadequate warnings and that a manufacturing defect claim fails when there is no allegation that the plaintiff’s drug “deviated from the construction or specifications of Plavix.”  Begley, **27-28; LaBarre, **32-34.

            This brings us to the meat of the decisions, which was whether there was evidence to raise a genuine issue of material fact as to the adequacy of the Plavix warnings for the risk of bleeding.  After recognizing that Illinois and Florida require expert testimony where there are allegations that the extensive warnings provided were not good enough, the court turned to what plaintiffs had to offer.  It is not clear why the plaintiff in Begley had more criticisms of the Plavix label than the plaintiff in LaBarre did or why the plaintiff in LaBarre also pointed to at least one company document to support her argument.  Our friends at the Miller firm, who represented these plaintiffs, surely know from many summary judgment decisions on warnings in diet drug cases in the Philadelphia Court of Common Pleas, if from nowhere else, that it is important to generate evidence of a failure to warn and an impact of that failure to warn on the prescriber’s decision to prescribe.  (Rumor has it that we once handed over a stipulation of dismissal to one of their lawyers in the middle of a deposition based on the expectation that they understood the consequence of not getting magic words. We cannot confirm or deny that rumor.)  Regardless, the real problem with plaintiff’s warnings case was that they relied on a single expert, our old friend, Lemuel Moye, M.D., Ph.D., to establish the inadequacy of warnings and he never articulated what different warnings as to a risk of bleeding should have said.  We are not sure if this came up, but Dr. Moye was on the Cardiovascular and Renal Drugs Advisory Committee when it recommended approval of Plavix in 1997 and he was the only one who voted against it.  Back then, he had concerns about proof of efficacy—not safety—so it is not surprising that his opinions as an expert in litigation over Plavix continued to focus on efficacy.  Since the court had already determined that risk of the injury that plaintiff suffered, not whether the drug works for its indication, is the focus, it was pretty easy to see that Dr. Moye’s opinions on the treatment of efficacy in the Plavix label went nowhere.  He did have some opinions about the risk of bleeding of the product, but never offered “how Plavix’s warning label should have reflected the duration of therapy and the impact of a long term therapy on the risk of increased bleeding.”  LaBarre, *28. 

            This begs the question why plaintiffs would get through expert discovery and summary judgment briefing without an expert who would say that the warning of the risk at issue should have been revised in a particular way to make it adequate.  At what point was it apparent that they could not find an expert who would actually say what is typically required to get by summary judgment?  We would expect that this shortcoming will cripple quite a few of these plaintiffs, at least if they only have Dr. Moye to carry the water.  While the court notes that it is proceeding with summary judgment motions one by one in these “related cases”—footnote 2 in each decision—there certainly will be a point where summary judgment on some or all these cases can be decided in one fell swoop.   In Begley, the court did not reach the issue of proof of proximate cause for a failure of warn, but, in LaBarre, it reached the issue as an additional ground for summary judgment.  A pretty easy conclusion where, as would be expected given the lack of warnings evidence, the prescribers “both represented that they would have not changed their prescription for Mr. LaBarre even understanding the additional risk or questions of efficacy Plaintiff has raised in this litigation.”  LaBarre, *32.  Of course, courts do like to limit the chance of successful appeal by offering alternative grounds, but every plaintiff is going to fail proximate cause for failure to warn when there is no failure to warn.  It seems like a lot of work for the court to keep writing detailed decisions when the common failings of plaintiffs’ proof should submarine a bunch of their cases. 

            If the court had really wanted to be efficient, though, these plaintiffs would not have been allowed to re-plead from New Jersey law to their home state law after “two separate decisions rendered by the New Jersey Supreme Court in 2007.”  Begley, *1 n.1; LaBarre, *1 n.1.  Presumably the cases were two of the ones discussed here  http://druganddevicelaw.blogspot.com/2008/06/ebb-and-flow-of-law-new-jersey-edition.html  and not miscites to the later powerful DeBoard and Bailey decisions that made New Jersey law less plaintiff-friendly.  Plaintiffs obviously picked New Jersey law when they filed back in 2006 because they thought it would give them a better shot than their home state law.  They had active complaints asserting New Jersey claims for three years before reversing field.  Without belaboring the standards for allowing plaintiffs to amend their complaints well after filing or many times, it does seem that the amendments here forestalled the inevitable summary judgment and just forced the court to issue separate decisions where a single ruling that no plaintiff could satisfy the requirements of the New Jersey Product Liability Act that they had pled was once possible.  We will take separate decisions when the end result is the same and just.

Positive PMA Preemption Pronouncements

            We are so used to favorable PMA preemption rulings, that previously we may have just added these next two cases to our regular tallies and moved on.  In light of Stengel, however, we decided to accentuate the positive.  While we can’t eliminate the negative (well at least not immediately), we can certainly latch on to the affirmative. . . . OK, either you know where we are going with this or you don’t -- if you don’t here’s a link to catch you up.    While you watch that, we’ll move on to the cases.
            First came Sons v. Medtronic Inc., __ F. Supp.2d __, 2013 WL 164007 (W.D. La. Jan. 14, 2013); then a day later – Desai v. Sorin CRM USA, Inc., 2013 U.S. Dist. LEXIS 5795 (D.N.J. Jan. 15, 2013).  Both decisions dismiss plaintiffs’ claims in their entirety based on express preemption.  And we were sure happy to read the good news.  In short, both cases involved Class III medical devices that went through the pre-market approval process.  In both cases defendants filed motions to dismiss and plaintiffs attempted to save their claims with amended complaints.  Neither plaintiffs’ arguments or amendments were enough to survive the combination of TwIqbal  and Riegel. 
            Another similarity between the cases is that both New Jersey and Louisiana have products liability statutes.  The New Jersey Products Liability Act (“NJPLA”) and the Louisiana Products Liability Act (“LPLA”) provide the exclusive theories of liability for injuries resulting from products in those states.  Thus, plaintiffs in these cases were constrained in the claims they could bring.  Likewise, the courts here weren’t free to accept new theories of liability created by plaintiffs in an attempt to state a non-preempted parallel violation claim.  For instance, in Sons, the court had this to say about Louisiana law:
Even if plaintiff could rely on the theories of negligence and strict liability to prove his case, it is well-established that the LPLA establishes the exclusive theories of liability for manufacturers for damages caused by their products and state law claims are therefore barred under Louisiana law.  Louisiana does not recognize any claim for violations of FDA regulations. The only remedies available to plaintiffs in this case are provided in the LPLA.

Sons, at *6 (citations and quotation marks omitted).  The Desai court similarly recognized that any claims under the NJPLA would be preempted:
Plaintiffs would only be able to prevail on the New Jersey PLA claims if they proved that the lead wire, as designed, manufactured, and distributed, was defective and unreasonably dangerous. It follows that liability would necessitate a finding that the lead wire - designed, manufactured, and labeled in a way that the FDA deemed safe and effective - was both defective and unreasonably dangerous. Such a determination would necessarily constitute a requirement different from, or in addition to, the standard required by federal authorities.

Desai at *13. 
            The New Jersey court, however, went on to examine plaintiff’s proposed amended complaint which purported to include “claims of an alleged deviation from the federal requirements for Class III lead wires.”  Id. at *15.  But, that’s essentially all the amended complaint said and under TwIqbal – that’s simply not enough.  First, we should note that plaintiffs appear to be trying to assert a manufacturing defect claim and this is the one parallel violation claim that we have acknowledged may be possible -- a violation of an FDA manufacturing regulation that resulted in the production of a device that did not meet the manufacturer’s standards could state a “parallel” violation claim for manufacturing defect if that nonconforming aspect of the device was also responsible for the plaintiff’s injuries.   That said, such an allegation still has to meet federal pleading standards to overcome a motion to dismiss. Plaintiff’s proposed amended complaint did not:  “These allegations fail to assert the facts necessary, or indeed, any facts at all, to establish a claim that would parallel a violation of federal law, or even meet the federal pleading standard.”  Id. at *16.  The amended complaint also failed on causation:  “Plaintiffs also consistently fail to allege any ‘cognizable link’ between [Defendant’s] alleged federal violations and Mr. Desai’s injury.”  Id. at *17.
            Plaintiff’s response to the court finding his complaint lacking was in essence a request that the “unspecified” violations be considered a placeholder, that plaintiff be allowed to conduct discovery, and “fill in the blanks” later.  Really, we couldn’t make this stuff up.  Not surprisingly, the court had this to say about plaintiff’s suggestion to completely toss out the Federal Rules and TwIqbal:
But a plaintiff must successfully plead a claim before obtaining discovery, and not the other way around. Such a premature request for discovery is inapposite to Rules 8 and 11(b) of the Federal Rules of Civil Procedure.
. . .
Although courts have acknowledged that plaintiffs might have limited access to crucial information, this Court's research suggests that no courts have let cases enter discovery based on the type of generalized allegations that are present here.

Id. at *18-19, 21 (emphasis added) (decision has many useful citations should you be faced with this argument in one of your cases).  We consider this a nice little bonus on top of the preemption win.
            The Louisiana decision likewise gave us another favorable ruling on top of preemption.  In Sons, plaintiff tried to make a claim for failure to train or educate the surgeons and hospital staff.   Sons, 2013 WL 164007 at *6.  The court cites to a Fifth Circuit case finding such failure to train claims preempted.  But, even if not preempted, the court found such claims can’t survive:
It is well established that a medical device manufacturer is not responsible for the practice of medicine. . . . [i]t is both impractical and unrealistic to expect . . .  manufacturers to police individual operating rooms to determine which doctors adequately supervise their surgical teams. 

Id. (citations and quotation marks omitted). 
            Finally, of note in both cases, the courts took judicial notice of PMA information on the FDA website.  Desai, 2013 U.S. Dist. LEXIS 5795 at *10 (“This Court takes judicial notice of the FDA’s website, and holds that it establishes premarket approval of the Biotronik lead.”); Sons, 2013 WL  164007 at *4 (“The Court takes judicial notice of the FDA Websites stating that the Medtronic Devices are Class III PMA medical devices”). 
            So, while these decisions don’t erase Stengel, they provide some counter-balance and some reassuring positivity.

Fennell Followup

Earlier this month we featured a guest post on a potentially game-changing forum non conviens decision by the Illinois Supreme Court, Fennell v. Illinois Central Railroad, ___ N.E.2d ___, 2012 WL 6725822 (Ill. Dec. 28, 2012).  While Fennell was an asbestos case, our reading of the case suggested that it would be equally applicable to out-of-state plaintiffs in drug/device cases - meaning that they would be out of court (at least in Illinois).

Things seems to be playing out that way.  In the wake of Fennell, non-Illinois plaintiffs in two pharma-related forum non appeals pending in Illinois' Fifth Appellate District (which includes Madison/St. Clair) have outright given up and agreed to dismiss their cases - even though they won in St. Clair, and the defendants were the appellants.  That's really rare.  Here are copies of the relevant orders (which, of course, are non-precedential because of the plaintiffs' surrender):

Baker v. Johnson & Johnson, No. 5-12-0019, slip op. (Ill. App. Jan. 14, 2013) (involving Levaquin); Wilson v. McNeil-PPC, No. 5-12-0316, slip op. (Ill. App. Jan. 14, 2013) (involving Tylenol).

Obviously, pharmaceutical litigation tourists in Illinois see Fennell's handwriting on the wall.  We should, too.

Thanks to Brendan Kenny from Blackwell Burke (who wrote the original Fennell post) and Stephen Strauss at Bryan Cave - both of whom sent these orders our way.

Tuesday, January 22, 2013

Off-Label Use and the False Claims Act – Another Win for Common Sense


Here's another "guest" post (at this point, only in the sense that we have to load it) from our semi-regular contributor, Melissa Wojtylak of Reed Smith.  She gets all the credit for her work.
 
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The Fourth Circuit is the latest court to reject a claim that prescribing a drug for off label use gives rise to False Claims Act liability.  As regular readers of the blog know, the False Claims Act imposes liability for knowingly presenting a false or fraudulent claim for payment to the government.  See 31 U.S.C. § 3729 (a)(1)(A).  And as regular readers also know, in recent years, enterprising relators (who can often also be described as “disgruntled former employees of the defendant”) have attempted to cash in under the FCA by bringing qui tam actions against pharmaceutical companies, claiming that the company purposely marketed its drugs for off-label uses.  While various explanations and theories are advanced by these relators, the underlying premise of these actions is essentially the flawed proposition that the mere existence of off label use of a drug is, in and of itself, a bad thing.  Which, or course, it isn’t.   As we’ve discussed on the blog in the past, several courts have seen the flaw in this logic and sent relators packing. 
 
In U.S. ex rel. Nathan v. Takeda Pharmaceuticals North America, Inc., 2013 U.S. App. LEXIS 765 (4th Cir. Jan. 11, 2013), the Fourth Circuit affirmed a district court’s dismissal of the relator-plaintiff’s third amended complaint on the grounds that it did not plausibly allege that any false claims had ever been presented to the government for payment, let alone that any conduct on the defendant’s part  – in particular,  an alleged scheme of promoting drugs for off-label uses − had caused those phantom claims to be presented.   While the products liability lawyer in us in drawn to the latter part of that statement and really wanted to see the Fourth Circuit address it, the court didn’t, as it held that the relator couldn’t even get out of the gate on the first part – that is, the need to show that false claims for payment were in fact made to government programs such as Medicaid. 

The court began its analysis by noting that the relator’s complaint was governed by Rule 9(b), which sets out the minimum standard for pleading an actionable (i.e., false) representation under the FCA.   This relator, faced with a pesky absence of specifics about things such as the dates on which reimbursement claims were submitted to the government and who submitted them, argued that Rule 9(b)’s standard could be met if the complaint pled acts sufficient to show a scheme by the defendant to promote the drug for off label use.  Id. at *11-14.  Once that was done, relator argued, the court could plausibly find that false claims must have been presented as a result of this scheme.   Id.   Well, no, the court responded.   Just because the existence of such a scheme could have led to presentation of false claims, it need not necessarily have done so, and therefore the relator was still required to plead some facts that showed that false claims actually were presented.   Id. at *14.  The court rejected cases cited by the relator in which other courts had relaxed the standard, while at the same time acknowledging that without such relaxation, some relators would face a tough road.   In essence, the court held that the rules are the rules, for better or for worse, and the relator’s complaint would have to be judged by them.

Things quickly fell apart for the relator at that point.   The Fourth Circuit examined four types of allegations from the third amended complaint that supposedly satisfied relator’s pleading burden, rejecting every single one.   First, the relator alleged that the company’s sales reps had marketed to doctors who didn’t even treat the condition that the drug at issue was labeled to treat.   Id. at *16.  Somewhat disappointingly, the court didn’t call this statement out for the nonsense that it is, and instead just noted that the third amended complaint didn’t allege that any of these doctors had actually written prescriptions for the drug.  Id.  at *17.  (Yeah, we know that’s the appropriate legal analysis, but still, a little smackdown on the flawed logic would have been nice).  Given the failure to allege that prescriptions were even written, the relator could hardly have plausibly alleged that reimbursement claims for the costs of these prescriptions were presented to the government for payment, and on this point, the allegations fell short of the standard.  Id.  

Moving on, the court next rejected a variation on the theme.   Relator alleged that 98 prescriptions written by 16 primary care physicians had resulted in false claims because 1) those physicians had gotten samples of the drug in a 60 mg dosage, which was only approved for treatment of one condition, and 2) primary care physicians typically do not treat this condition.  Id. at *18-19.  Ergo, these primary care physicians must have been writing the prescriptions for off-label uses.   There’s that underlying theme that we mentioned earlier – that if it’s an off-label use, it must be bad/wrong/fraudulent.

But here it gets even more incredible:   while the relator pled that 98 prescriptions for the drug were filled after being written by PCP’s who got the 60 mg samples, he didn’t even plead the dosages of the prescriptions that these physicians wrote.   Instead, relator argued that physicians tend to prescribe drugs in the same dosage as the samples that they give to patients, so these 98 prescriptions must have been for the 60 mg dosage.   The relator tried to buttress this sheer speculation by quoting a statistic that 93% of all prescriptions written for this particular drug were for the 60 mg dosage. 

Here the court delivered a gentle form of the smackdown we were hoping to see earlier.  It pointed out that 1) if it was true that PCP’s don’t normally treat the condition for which the 60 mg dose was approved, then it would be more logical to assume that these doctors were not prescribing this dosage; 2) the third amended complaint didn’t directly allege that the prescriptions were written for off-label use (to which we say, “so what if it had?”), and 3) the mere fact that PCP’s don’t normally treat the condition for which the 60 mg dose was approved doesn’t necessarily mean that they weren’t treating the condition in the patients for whom the 98 prescriptions were written.   Id. at 20-21. 

The relator next tried to argue that because 9,000 prescriptions had been submitted to government agencies for reimbursement in just two of the defendant’s sales districts during certain time periods, this must support the averment that false claims were presented.   The court made short work of this one, noting the stark lack of detail with regard to who wrote these prescriptions, the illnesses that they were intended to treat, and – importantly – whether these physicians had been on the receiving end of the defendant’s (alleged) sample distribution practices.   Id. at 21-22. 

Finally, the court rejected the affidavits of three different doctors submitted with the latest version of the complaint, in which the doctors said they had prescribed the 60 mg dose of the drug to Medicare patients because they didn’t know the drug was available in a lower dose, thanks to the company’s bang-up marketing efforts for the 60 mg dose.  (Note to these physicians:  you should check out this fabulous new invention called the “internet” – or even an older one called the “PDR.”  You’d be amazed what you could learn about the drugs you prescribe.)  The court similarly shot down this claim, noting that the physicians and the relator had failed to provide critical details such as dates of prescriptions, or to allege that the Medicare patients actually filled these prescriptions, thus resulting in claims to Medicare for reimbursement.  Id. at 22. 

After looking at these four groups of allegations identified by relator, the court boiled down the relators’ alleged factual bases for his claims as follows:

Relator essentially has alleged that some claims must have been presented to the government for payment because prescriptions of this kind are frequently and routinely obtained by persons who participate in health care programs sponsored by the federal government, or because federally insured patients receive off-label prescriptions.

Id. at *24.  The court noted, however, that allegations of this type don’t survive a motion to dismiss because they are “inherently speculative in nature.” Id.   The court also reminded the relator that the purported scheme, as alleged, was not “an integrated scheme in which presentment of a claim for payment was a necessary result.”  Id.  

Good stuff, but what happens next is our favorite part.  The Fourth Circuit affirmed the district court’s denial of the relator’s motion for leave to amend his complaint yet again, finding no abuse of discretion where the relator had been given two years and four chances to get a properly-pled complaint on file.  (Because of this, we were tempted to title this post “Four Strikes and You’re (Finally) Out”).  The Fourth Circuit noted that allowing yet another amendment – the fifth complaint, as it pointed out - “would undermine the substantial interest of finality in litigation and unduly subject [defendant] to the continued time and expense occasioned by Relator’s pleading failures. “  Id. at *25-26.  We couldn’t have said it better ourselves.