Friday, May 20, 2016

SPECIAL ANNOUNCEMENT – WE’RE MOVING THE BLOG THIS WEEKEND


As you’ve probably gathered from our posts this week, the Drug and Device Law blog is going on a brief hiatus as we move to an upgraded platform.  We have well over 3000 posts, and it takes our technical people time to move them all and check all the various links.  That requires us to go dark on this coming Monday and Tuesday, but we look forward to bringing you our usual updates and analysis on drug and device product liability cases at our new site starting on Wednesday.

At that point, you’ll be able to visit us at DrugAndDeviceLawBlog.com (please note this URL will not be live until May 24).  Don’t worry about old bookmarks.  If you try to come to this site in the future, you’ll be automatically redirected to our new home.  That means that, if you’ve bookmarked any particular post or guide, those links will also redirect you to that exact same post or guide on the new site.  All the redirecting should be seamless.

If you receive the Drug and Device Law posts via e-mail – and more than 1000 email addresses do – you will have to fill out a short (3 item) new e-mail subscription form here.  We’re sorry for the inconvenience, but we can’t legally redirect our subscriber’s email addresses unilaterally, and we figure if anyone can appreciate the law, it’s our readers.  After you complete the form, you’ll receive an e-mail at the address you provide.  Just click on the link to confirm your subscription, and you’re (and we’re) in business.

Have a great weekend, everyone, and keep those defense wins coming.  We’ll see you Wednesday.

Guest Post - The Connecticut Supreme Court Modifies The State’s Consumer Expectation Test By Adopting The Modified Test



Today’s guest post is by Adam M. Masin, a partner at Shipman & Goodwin LLP.  It’s about the most significant general Connecticut product liability decision in almost 20 years.  It’s not a drug/device case, though.  Instead it involves tobacco.  But make no mistake about it, this case could affect our sandbox – particular design defect cases involving medical devices.


 


As always our guest posters deserve all the credit, and any blame, for the contents of their posts.


 


Finally – be sure to read the repeated IMPORTANT ANNOUNCEMENT at the end of this post.  DDLaw blog is getting ready to move, and that means you’ll have to resubscribe to continue getting our posts.  But don’t worry, it’s easy.


 


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            The Connecticut Supreme Court this month clarified how Connecticut distinguishes between the use of the “ordinary consumer expectation test” and the “modified consumer expectation test” in strict product liability design defect cases.  Izzarelli v. R.J. Reynolds Tobacco Co., ___ A.3d ___, 321 Conn. 172 (2016).  Not to confuse things from the start, but Court’s key holding was that the “modified consumer expectation test” is now the “primary strict liability test.”  In other words, the prior ordinary test in Connecticut is no longer the ordinary test, and the primary test is the modified test.  Just so we are clear.  Wordplay aside, this is an unfortunate through probably unsurprising development in a state that still has a ways to go to firm up its product liability law (more on that below).


            Some background helps to clarify how a “modified” test supplanted an “ordinary” test.  As the Court noted, Connecticut was one of the first states to adopt § 402 of the Restatement (Second) of Torts.  (Connecticut was also the first state to adopt a speed limit restriction for cars − a blazing 12 MPH).  [Editor’s note, both make about the same amount of sense these days.]  Connecticut interpreted § 402 to require a plaintiff alleging a strict liability claim to prove, amongst other things, “the product was in a defective condition unreasonably dangerous to the consumer or user.”  Giglio v. Connecticut Light & Power Co., 180 Conn. 230, 234 (1980).  Connecticut interpreted that element to mean, based on comment (i) to § 402, that “the article sold must be dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics.”  That became known as the “ordinary consumer expectation test.”


            In 1997, the Connecticut Supreme Court in Potter v. Chicago Pneumatic Tool Co., 241 Conn. 199 (1997), finally noticed that the “ordinary consumer expectation test” did not adequately address “the problem of complex products for which a consumer might not have informed safety expectations.”  It of course doesn’t make a whole lot of sense to apply a consumer expectations test to a product about which a consumer would not have reasonable expectations. 


            So the Potter Court’s solution was to create a “modified consumer expectation test” whereby the jury would be asked to “weigh the product's risks and utility and then inquire, in light of those factors, whether a ‘reasonable consumer would consider the product design unreasonably dangerous.’”  The Potter court decided that the “ordinary consumer expectation test” would “when the everyday experience of the particular product's users permits the inference that the product did not meet minimum safety expectations.”  That required proof of an incident “so bizarre or unusual” that expert testimony would not be required to conclude that the product failed to meet the consumer’s expectations.  One might imagine what qualified as “so bizarre or unusual.”  For the most part, one had to imagine because so few Connecticut state courts were faced with deciding that issue in the subsequent years. 


            As the Izzarelli Court noted, Connecticut state courts had limited opportunities to determine what test would be appropriate under what circumstances because actions under Connecticut’s product liability act were typically brought in federal court.  Those decisions − including a recent federal court case involving combination hormone replacement therapy, Moss v. Wyeth, Inc., 872 F. Supp.2d 162, 166 (D. Conn. 2012) − were all over the map.  The Moss decision, for example, predicted that that both tests applied somehow before launching into a discussion of the learned intermediary doctrine.  In fact, the reason Izzarelli finally addressed this issue was because it answered a certified question from the Second Circuit, but the Connecticut Supreme Court actually had to expand on  Second Circuit’s question in order to clear up the confusion.


            Fortunately for good lawyering, the Izzarelli Court now makes it clear that the modified consumer expectation test is the primary or “default” test in Connecticut in a strict product liability action based on defective design.  The “ordinary consumer expectation test” is reserved for “res ipsa type cases” when the product failed to meet “the ordinary consumer’s minimum safety expectations.” (the Court’s italics, not ours).  The Court did not define “minimum” and it later referred to “legitimate, commonly accepted minimum safety expectations,” without much indication of what those words meant either.  But the Court’s italics and the result of the case indicate that the safety bar is set really, really low for purposes of clearing the ordinary consumer expectation test − so low that the Court held that a cigarette that exposes a user to the risk of cancer cannot be said to fail to meet minimum safety expectations.


            Don’t be tempted to view that as a defense-friendly result.  It isn’t.  It actually means, as the Court stressed at length, that Connecticut will allow strict liability design defect claims to proceed under a “risk-utility” analysis even when the consumer knows about the danger.  As the Court put it, a “product might meet the consumer’s minimum safety expectations because the product’s dangers are known or obvious but nonetheless be defective because it could have been designed to be less dangerous without unreasonably compromising cost or utility.”  The Court also held that expert testimony on product design is not needed to prove the product’s defect.  So at least we in Connecticut don’t need to argue about “bizarre and unusual” incidents anymore to handle these cases.  The bizarre and unusual in our cases will still likely come up, only now only in the context of plaintiffs’ expert opinions.  Despite the fact that Connecticut does not require experts in this context, as a practical matter we don’t expect too many situations in our area of the law when a plaintiff’s lawyer won’t trot out a bunch of experts.


            Izzarelli goes a long way to clarify what needs to be shown in a strict product liability case in Connecticut, so its at least helpful in that regard.  It’s worth noting, however, that Izzarelli does not clarify many of the pharmaceutical product-specific issues discussed in Moss, so the Connecticut Supreme Court has ample room to develop that law.  In addition, as the Izzarelli Court noted, the Connecticut Supreme Court is in the middle of writing a decision that will likely clarify how these principles apply to a product liability claim for negligence and will also clarify Connecticut’s law on punitive damages.  Stay tuned.


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IMPORTANT ANNOUNCEMENT – When we created the Drug and Device Law Blog back in 2008 we frankly didn’t know if anything would come of it.  So we used the Google Blogger software program because the price was right (it was free).  Unfortunately, we got what we paid for.  For about six months we’ve had problems with emails to our loyal subscribers, and Google hasn’t been able to fix it.  So next week we’re moving to an upgraded – and supported − platform.  What does that mean for you, our loyal readers?


           All our new posts (and all our old ones) will be located at a new URL, but don’t worry:  If you type in (or use a bookmark) for this site in the future, you’ll be redirected to the new Drug and Device Law blog site.


           We’re sorry for the inconvenience, but privacy laws won’t let us resubscribe you automatically.  But we’re making it as easy as we can for you.  All you need to do is fill out a new, really short (three things) e-mail sign-up form to continue to receive our blog posts by e-mail.  You can fill out the form right now, right here, and you’ll continue to get all of our posts after we’ve moved to the new site. As you did the first time you subscribed to DDLaw by email, you’ll get a confirmation e-mail to the address you provide, and once you click to confirm your subscription, we’re in business.


           The change over also means we have to go silent for a couple days so the techies can do their thing.  We won’t be able to post on May 23 or May 24 as the blog is moved, but you’ll still be able to visit our site and read any and all of our previous posts.  We’ll be back with our usual updates and analysis on drug and device product liability cases on May 25, so don’t put it off − sign up today.

Thursday, May 19, 2016

Trimming Some Fat From Statin Litigation With Daubert and Preemption


            One of the greatest spectacles on earth is the annual migration of wildebeest, zebras, and antelope in a loop around the Serengeti.  The Blog will have its own migration shortly, which we hope will be a one-time event without dangerous river crossings or, well, loads of crap for either us or our readers.  Next week, the Drug and Device Law Blog will be moving to an upgraded platform via LexBlog.  All the old posts will be available and going to the old site should redirect you to the new site.  That’s the easy part.  The comparatively difficult part should take you about 30 seconds, less time than it usually takes to google one of McConnell’s obscure movie references.  Click HERE to fill out the new e-mail sign-up form.  (Personal information will not be used for holiday cards from Bexis or any other nefarious purpose.)  After you complete the form, you will receive a confirmation e-mail and you will have to click to confirm your subscription.  Then you will get posts by email once we have completed the not-so-great migration.  As an added bonus (?) from the migration, we will not be posting on May 23 or May 24.  If your DDL addiction is too strong for that much of a break, then feel free to peruse old posts.  Checklists and surveys might do the trick.  If you need a stronger fix, then try searching for obscure or inflammatory words used in past posts.  Hours of fun.

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            In the mythical days of product liability yore, a big drug litigation was spurred by a notable event—like a study describing a new risk appearing in a major journal, a significant labeling change because of new or greater risk, or the withdrawal of the drug—and was built on identifiable and otherwise uncommon injuries in patients who took the drug.  Because there was a notable event and there were identifiable injuries, the manufacturer could generally expect when lawsuits about those injuries would need to be filed and that it could figure out if a plaintiff was suing over an injury that fit the larger liability issues.  In the purportedly distinct modern era of drug litigation, the only notable events sometimes are the start of plaintiff lawyer conferences and advertising on the drug and the injuries claimed may not be particularly identifiable or otherwise uncommon.  The cases brought probably include non-product liability claims for economic harm and product liability claims loosely tied to the risk of the injury actually sustained by the individual plaintiffs.  Even if there is no good science backing up the plaintiffs’ claims, it can take quite a bit of time and effort for the manufacturer to get the rulings needed to show the claims and evidence offered in support of them to be bogus.

            This seems to be what is going on in litigation involving the drug Lipitor, which has been one of the most widely prescribed drugs over the last twenty years (although generic entry had an effect a few years ago).  Along the way, the manufacturer has faced litigation over liver injuries and rhabdomyolysis (like the other statins), antitrust claims, and some other issues.  Meanwhile, the drug continued to be recommended as first line therapy for an expanding range of indications related to improving lipids and reducing cardiovascular risk.  From what we can tell, without anything terribly dramatic, the drug was also one of several in the class associated with a possible small increase in the risk of developing Type 2 diabetes.  If you have been paying attention over the last few decades, then you probably know that the rates of Type 2 diabetes have climbed dramatically, basically hand-in-hand with increases in the rates of obesity, hypertension, unhealthy eating, inactivity, and some other bad habits that call to mind the scooter-bound humans of the future in “WALL-E.”  You might also know that the risks of heart attacks and strokes go up when you add a bad lipid profile to the mix and go down when the lipid profile improves.  That is why doctors and patients care about LDL, HDL, and triglycerides in trying to prevent first or second heart attacks, for instance, just as they try to monitor and control obesity, hypertension, diabetes, sleep apnea, etc.  In this context, it makes sense that doctors might continue to prescribe Lipitor or any of the other statins pretty much as they did before the labels warned of a possible increase in blood sugar levels and the rate of diabetes.  That might make you think plaintiffs suing over a risk of diabetes might have hard time establishing either medical causation or proximate cause for failure to warn of diabetes.  But the plaintiff lawyers filed enough cases that an MDL was established, so they must have mustered some good theories and evidence to support their claims, right?

            Starting about six months ago, we reported on a series of Daubert decisions from the MDL (here, here and here) that generally excluded plaintiffs’ experts on general and specific causation for plaintiffs’ injuries.  We recently also saw that the Second Circuit affirmed the dismissal of a separate False Claims Act case about the purported off-label use and promotion of Lipitor based on a nonsensical interpretation of the drug’s label, which happened to have been one of our first posts.  We now get two more orders from Lipitor MDL, which we read as being more of the delayed inevitable response to a questionable litigation.  The second in time, In re: Lipitor (Atorvastatin Calcium) Mkt’g Sales Practs. & Prods. Lib. Litig., MDL no. 2:14-mn-02502-RMG, -- F. Supp. 3d --, 2016 WL 2851445 (D.S.C. May 11, 2016), is similar to the prior Daubert decisions, particularly the one on the other expert in the same two cases.  In this decision, Dr. Handshoe, whose pulmonology background seems ill-suited to weigh in on whether a lipid drug causes diabetes, could not offer a reliable causation opinion for either plaintiff.  The court started by saying that the relative risk of 1.25 that Dr. Handshoe thinks applies to Lipitor and diabetes means that “20% of the people who take Lipitor and develop diabetes did so only because they took Lipitor.”   We can quibble with this discussion of attributable risk exposed calculations—it presupposes general causation, for one—but it does show the uphill battle of connecting diabetes to the drug for a specific plaintiff.  The case-specific facts for the first plaintiff made it even harder, as she had a strong family history of Type 2 diabetes, was overweight and had “pre-diabetes” when she started Lipitor and was obese when she was diagnosed as diabetic six years later.  (This case, as one might expect with a litigation like this, was brought more than ten years after her diagnosis and without regard to the massive improvement in her lipid while on the drug whose manufacturer she sued.)  She also had hypertension and hyperlipidemia (duh), which he considered risk factors for diabetes, and was a smoker, which he did not think was a risk factor even through some studies and governmental publications say otherwise.  He also could not interpret relative risk data and relied heavily on the timing of plaintiff’s progression from pre-diabetes to diabetes occurring while she was on the drug.  Without belaboring it too much, this shoddy case-specific causation opinion failed just about every criterion for reliability.  The analysis for the second plaintiff was not quite as egregious, but was also excluded.  While this plaintiff had a weaker family history of diabetes and no recorded history of abnormal blood sugar readings when she started a lower dose of Lipitor (taken irregularly), she had risk factors from her weight (overweight and continuing to gain weight), age, ethnic background, hyperlipidemia, and hypertension, which Dr. Handshoe could not rule out or reliably place into context.  If you consider that these plaintiffs took a dose  of Lipitor as to which one of the plaintiffs’ epidemiologists could not offer a general causation opinion, then the inability of an expert to offer a reliable case-specific causation opinion for plaintiffs with multiple risk factors other than the drug should not be surprising.

            The second decision, In re: Lipitor (Atorvastatin Calcium) Mkt’g Sales Practs. & Prods. Lib. Litig., -- F. Supp.3d  --, MDL No. 2:14-mn-02502-RMG, 2016 WL 2840215 (D.S.C. May 6, 2016), is somewhat more interesting and more controversial to us for a few reasons.  First, it spells out that the plaintiffs—it applies to all of them—have asserted warnings and design claims predicated on the lack of efficacy in preventing coronary heart disease in women who have not had a coronary event.  We think those claims are highly suspect even if true—although there might be other claims associated with false affirmative representations about efficacy for a subgroup.  Second, it evaluated the impact of Bartlett and Mensing on preemption of these “lack of efficacy claims” for a branded prescription drug.  Third, it used both Daubert and preemption in excluding most of the challenged expert testimony supporting these claims.  Although the results here are pretty good, we think the court could have gone a little farther.

            A little more background is needed to understand these issues.  Among the various approved indications for Lipitor was one for “primary prevention of cardiovascular disease” for men and women based on the ASCOT study, as to which the label remarked “due to the small number of events, the results for women were inconclusive.”  Following the Levine game plan, the plaintiffs claimed that a CBE could have been used to change the label to essentially re-frame the approved primary prevention indication as being for men only.  Noting that “any claim that a drug label should be changed based on information previously submitted to the FDA is preempted because the CBE regulation cannot be used to make a label change based on such information,” the court held that plaintiffs could not use a for-litigation reevaluation of the ASCOT study as basis for their claims.  The plaintiffs also could not use new risk information as a basis for requiring a labeling change as to efficacy through a CBE, given that the CBE regulations themselves require a link between the new data and the aspect of the label to be changed.  The court also recognized that claims other types of labeling provided to healthcare professionals should have been changed are just as preempted as claims that the label itself should have been changed.  And it recognized that plaintiffs cannot get around any of this preemption by claiming that the manufacturer could have just stopped selling the drug for primary prevention in women.  All of that is good and part of the progression of branded drug preemption that we have urged for some time.

            Where we think the court could have gone farther is on some issues that would have required more analysis.  The court elected not to analyze if the law of any of 52 jurisdictions actually imposed duties on the manufacturer to take the steps plaintiffs claimed related to lack of efficacy and left open that the defendant could re-raise the arguments that specific requirements for liability based on advertising to the general public were preempted.  It also did not dig deeply behind plaintiffs’ allegations that a study called CASHMERE could have been used as the basis for a CBE to change the approved primary prevention indication.  While the “Defendant argues that ‘the results of CASHMERE have no bearing on the primary prevention indications’ [and] such arguments concern the sufficiency of evidence to survive summary judgment, not preemption,” there is the issue of whether CASHMERE was ever evaluated by FDA and what FDA thought about it.  A temporary labeling change that would have been reversed by FDA because it still thought its approval of the primary prevention indication for both sexes was still correct has little impact on the claims of most plaintiffs.  Thus, the conclusion that “[t]o the extent that Plaintiffs claim that a state law duty required Defendant to include different statements on Lipitor’s label regarding Lipitor’s efficacy for prevention in women, based on CASHMERE or other newly acquired information, the claims are not preempted” seems incomplete.  We also think—without having tried to re-do the regulatory arguments—that there is a fairly direct conflict between the requirement for advertisements directed to the general public must truthfully summarize the efficacy of the drug and a contention that the advertisements should have said primary prevention indication was wrong in not excluding women.  With a little more digging, it should be fairly obvious that all the “lack of efficacy claims” involve second guessing the FDA’s repeated decisions about efficacy, which should lead to broad preemption if any such claims actually exist under state law.

            The Daubert portion of the ruling also seemed somewhat inconsistent, although the defendant got almost all of what it wanted on the five experts challenged.  First, it did not look like any of the experts opined that CASHMERE—as opposed to just reinterpreting ASCOT—should have led to a revision of the drug’s indication, which undercuts the preemption ruling above.  Second, while one expert was allowed to offer his own for-litigation re-analysis of ASCOT (which was also a peer-review publication) because “I think I was the only one to ever check the proportional hazards assumption” underlying the statistical test used in the original analysis to determine whether the results could properly be applied to men and women.  We are not sure how this is relevant to any non-preempted claim in the case or the basis of the expert’s belief that nobody else checked the assumptions.  We would wager that FDA only approved the primary prevention indication based on the ASCOT study after getting its data and checking it thoroughly, which would raise the issue of how plaintiffs’ claims are predicated on FDA making informed but incorrect decisions.  When another expert opined that “the ASCOT data did not establish efficacy of Lipitor in women for primary prevention, and the label was misleading on this point,” his opinions were excluded as irrelevant based on the preemption decision.  They were also confusing and misleading under Fed. R. Evid. 402 and 403 given that “such allegations cannot be the basis of Plaintiffs’ claims.”  It seems like that same analysis could have been applied to the first expert’s opinions.  Likewise, these rules provided the basis for precluding a third expert from offering his opinion that “I don’t think FDA should have approved Lipitor for primary prevention in women.”  The court was consistent, however, in excluding opinions from multiple experts—phrased in slightly different ways—that there was no evidence that Lipitor (or other drugs of its class) was effective in women for primary prevention.  In doing so, the experts had no reasoned basis for disregarding multiple large published studies and meta-analyses that found efficacy in women.  As such, we will not dwell on how the different experts failed in trying to offer their lack of efficacy opinions.

            We see this all as related to the problem we identified up front:  a drug litigation that is not driven by science suggesting a significant risk of an identifiable and otherwise uncommon injury will struggle to fit into the existing legal framework.  Proving that overweight hypertensive patients developed diabetes because of a drug that might increase the risk by 25%--far less than the patient’s weight or blood pressure does—is difficult.  It is also hard to prove that a warning about such a risk would have changed any physician’s decision to prescribe a lipid medication to try to avoid heart attacks and strokes.  That is why the plaintiffs make up “lack of efficacy claims” that should not be cognizable in most states, walk right into conflict preemption, and set up experts to offer unsustainable opinions.  We suspect that it will take several more decisions from this court before the plaintiffs pack it in, though.

Wednesday, May 18, 2016

Mass Appeal of Off Label Use



Hardly a week goes by without our blogging about accusations of off label promotion.  This week is no exception.  On Monday, we discussed a nice New York opinion rejecting a plaintiff argument that off label promotion saved a case from preemption.  And hardly a week goes by without plaintiff lawyers attempting to inject off label issues into our cases, as though mere mention of the possibility conjured up liability, punitive damages, and settlement-grids.  As we have discussed many times before, the demonization of off label use is wrongheaded and counterproductive, given how off label use can be the only thing standing between patients and pain.  Today’s case, Tangney v. Burwell, Secy of HHS, 2016 U.S. Dist. LEXIS 61724 (D. Mass. May 10, 2016), reminds us of that fact yet again.  

The plaintiff in Tangney suffered from severe nausea and abdominal pain emanating from gastrointestinal issues, not cancer - facts that, as you will see, possibly become pertinent.  It was undisputed that off label use of Dronabinol alleviated these symptoms.  The issue was whether Medicare Part D covered the cost of the medicine.  Such coverage is available if the drug’s use is approved by the FDA (not the case here) or is “supported by one or more citations included or approved for inclusion in any of the [listed] compendia.”  42 U.S.C. Section 1396r-8(k)(6).  The particular compendium at issue in Tangney was Drugdex, which cited the successful use of Dronabinol to treat nausea resulting ... in a case involving cancer.

Medicare rejected coverage because the plaintiff’s nausea was unconnected to cancer.  Then a hearing officer reversed that decision and concluded there was coverage, because (1) the title of the Drugdex citation was not limited to cancer, even if the underlying case study was, and (2) the plaintiff’s real-world history showed that without coverage of the off-label use of the medicine, the plaintiff would “either have to remain in the hospital indefinitely or possibly die.”  The Appeals Council then reversed the hearing officer”s decision and concluded there was no coverage, because the underlying case study involved a cancer patient, and there was insufficient evidence to show that efficacy would extend to non-cancer patients.  The Appeals Council decision is considered a decision by the Secretary of the U.S. Department of Health and Human Services, Sylvia Burwell, and that is why she is listed as the defendant in the case that subsequently went before a federal judge.

The first decision for that federal judge was whether or how much to defer to the HHS Appeals Council.   On this blog, we talk about product liability, not administrative law, so we will not linger on the niceties of Chevron or Skidmore deference to agency decisions.  Leave it at this:  the court held that the denial of Medicare Part D coverage of this particular off label use was not the sort of precedential, legislative ruling by an agency that required full-blown (and usually dispositive) Chevron deference.  Rather, a lower level of deference, called Skidmore deference, came into play.  Skidmore deference focuses on consistency and persuasiveness.   Even with this lower level deference, the government usually wins.  

But it did not win this time.  The court held that the hearing officer got it right, and that it made more sense to frame the degree of generality in terms of effective treatment of nausea as opposed to effective treatment of nausea associated with cancer.  Palliative care is palliative care.  Our favorite part of the D. Mass. opinion is a footnote where the court observes how “Kafkaesque” it was to force the plaintiff to prove that the underlying case study supporting the Drugdex citation to off label use should apply to her, when she herself offered the most compelling case study, “with her having taken Dronabinol to near miraculous effect for three years before switching to Part D and being denied coverage.”  The plaintiff herself presented a strong instance of challenge, rechallenge, etc.  She suffered from severe nausea, the off label drug alleviated the pain, and then the pain returned when she had to go off the drug after coverage was denied.   


Try telling this plaintiff, or millions of other patients in this country, that there is something nefarious with off label use of medicines.   Try telling doctors.  Or try telling judges who pay more attention to reality than rhetoric.  

Tuesday, May 17, 2016

Guest Post − Implied Certification: An Eradicated Pest or Here to Stay?


Today’s guest post is courtesy of Reed Smith’s Lindsey Harteis.  She’s been following the big-deal UHS v. Escobar False Claims Act that the Supreme Court could decide any day now (or could wait until the end of June), which involves the existence and (perhaps) extent of the so-called “implied certification” theory of FCA liability.

As always our guest posters deserve all the credit, and any blame, for the contents of their posts.

Finally – be sure to read the IMPORTANT ANNOUNCEMENT at the end of this post.  DDLaw blog is getting ready to move, and that means you’ll have to resubscribe to continue getting our posts.  But don’t worry, it’s easy.

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            We spent this past weekend chasing our ten-week old Samoyed puppy around the backyard, where he ventured “down in the weeds” more than a few times.  This caused the OCD in us to go over him multiple times with a fine-toothed comb:  We reasoned that he was bound to pick up some ticks.  Lucky for us, he didn’t.  But it got us thinking that when courts go down in the weeds like our dog did, they are bound to pick up a few nasty buggers themselves.  In the oral argument for the appeal in United Health Services v. Escobar, 780 F. 3d 504 (1st Cir. 2015), the Court definitely took a run through the weeds.  (We blogged briefly on the case here).  We’re taking our fine tooth comb through the oral argument to look for ticks, and we fear we’re bound to find in this ruling another “corpus juris festooned with various duties.” 

            That’s a quote from a Justice we missed dearly while listening to the oral argument in this case.  Justice Scalia used it in his concurring opinion in Skilling v. United States, 561 U.S. 358 (2010), which limited a fraud statute in the criminal context due to vagueness and via the 5th Amendment Due Process route. 

            Skilling reminds us of United Health Services for a couple of reasons: (1) It dealt with defining the contours of a sort of fraud – honest services fraud – for which the lower courts took an expansive view that wasn’t foreseeable based on the plain language in the statute; (2) Scalia was accusing the Courts of Appeals of invention of law rather than interpretation in their rulings on what constituted honest services fraud; and (3) the case involved a fusion of Restatement and black letter law in an unrelated area (Agency and Trusteeship) but was a criminal case. 

            There are definite parallels.  Again, United Health Services presents an opportunity for the high court to define the contours of an actionable sort of fraud, this time fraud in submitting claims for payment to the government.  Here, the punitive lever is the False Claims Act (“FCA”).  This case also features a situation where Courts of Appeals, beginning with Ab-Tech in 1994 (discussed below) seem to have wielded legislative power instead of judicial restraint.  United Health Services also involved, at least in oral argument, the suggestion by more than one justice that the proper standard might invoke principles from an entirely different area of law – and invoked Hornbook contract law when trying to grasp at a standard for liability.

            Before we take you much deeper in the weeds, here’s how United Health Services came to be before the eight justice court.  Beginning with Ab-Tech Cons., Inc. v. United States, 31 Fed. Cl. 429 (1994), federal courts birthed a new theory that expanded FCA liability.  The theory is called “implied certification."  This theory expanded the scope of FCA liability to allow a claim where a company submitted a claim for payment to the government after making an “implied certification” that it was in compliance with the conditions to participating in a SBA program, namely using third party contractors that are minority owned, to further the interests of the program.  In fact, the company did not use any third party contractors that met the criteria for its participation in the program.  So, the Federal Circuit held, this was a false claim for payment that violated the FCA.

            Over the last twenty years, some federal courts have run amok with this theory, expanding it in every direction.  They have created a significant problem of identifying types of regulatory noncompliance which are relevant enough to trigger a finding of a “false or fraudulent claim,” whether the certification of regulatory compliance should be explicit (or if a mere failure to disclose noncompliance triggers liability), and even what sense the courts use the word “material,” to sort the actionable FCA claims due to a regulatory violation from inactionable ones. 

            On the United Health Services appeal, the First Circuit had no problem stepping into the shoes of not only the Massachusetts Legislature and Congress, but also those of executive agencies by invoking multiple regulations (some of which contradicted one another about the qualifications a provider should have in order to bill for services), and interpreting the regulations based on a statement by a non-promulgating entity in favor of a finding of fraud.  What’s more – the First Circuit seemingly usurped the role of counsel and cited a regulation not cited in the Complaint, in any appellate brief and not even in the state government’s amicus brief – to make the finding of fraud.  To us, this looks like anything but calling balls and strikes.

            Here the regs used as the basis of liability not only lacked an explicit indication that, when read together, they created preconditions of payment, but the court had to layer three separate regulations (not all of which clearly cross-referenced one another)  on top of each other to conclude this “precondition of payment” was violated.  Further, this isn’t something either the Massachusetts Government or Federal Government thought they did.  They both declined to intervene in the suit altogether. 

            The regulatory agencies at issue all reviewed the facts in this case, and two of them entered into agreements with the provider to restore compliance.  Just one individual was issued a $1,000 civil penalty for holding herself out as a therapist without the appropriate license.  It seems to us that if the Government doesn’t think a provider has submitted a false claim due to some “implied certification” by the claimant, then a relator shouldn’t be able to replace the Government or contracting party and offer a different interpretation of how material the alleged regulatory breach was, or even if there was a breach at all.

            Seemingly, the First Circuit believed as long as some court is willing to divine material noncompliance, it doesn’t matter if the Government thinks there was noncompliance or if the Government thinks it was material – or even if the Government is willing to pay the claim at all.  Indeed, the First Circuit says, even if the Government doesn’t lift a finger and intervene in the suit, the relator can play a plaintiff’s lawyer game of after-the-fact “gotcha!” and that’s precisely what Defense counsel argued before the Supreme Court.

            To get a sense of where the Supreme Court is on all this, we listened to the oral argument, which occurred on April 19, 2016.  Justice Breyer described the problem as how to distinguish the regulations for which a breach is fraudulent and contains an implicit promise not to breach versus those in a sea of “millions of regulations” – and for which a breach is less than fraudulent.  Breyer was grabbing at contract principles of materiality – and suggested that perhaps violations and nondisclosure of violations that would be “material” to the government’s decision to pay a claim would be actionable. 

            The chief problem with such reasoning is that is that FCA cases often don’t involve contracts.  But that didn’t stop the justices from trying to invoke contract law.  Chief Justice Roberts approached the idea of phrasing liability in terms of whether the Government might “repudiate” or deny payment of the claim on the basis of the regulatory infraction.  A second problem is how anybody could get in the Government’s head in a case like this where the Government didn’t see fit to intervene.  A third and perhaps more significant problem, as counsel for the provider argued, is that materiality is a separate FCA requirement apart from any contract law understanding of that term.  It makes no sense that contract-variety materiality is an appropriate substitute for the falsity or mens rea elements of a FCA claim.

            Justices Sotomayor and Kagan seemed downright annoyed that the First Circuit ventured into the regulatory weeds in the first place.  To them, this case was as simple as the reason the FCA was enacted.  Back then, the “Lincoln law” was enacted because government contractors provided cardboard boots, dead mules and guns that didn’t shoot for the Civil War.  Kagan likened the provision of services by someone who is not a doctor, when the state was charged for a doctor’s services, to providing a gun that doesn’t shoot and then claiming payment for a gun.

            To us, DOJ’s primer on what constitutes a FCA violation is instructive:  “A person does not violate the False Claims Act by submitting a false claim to the government; to violate the FCA a person must have submitted, or caused the submission of, the false claim (or made a false statement or record) with knowledge of the falsity, knowledge of false information is defined as being (1) actual knowledge, (2) deliberate ignorance of the truth or falsity of the information, or (3) reckless disregard of the truth or falsity of the information.”  If the United States via DOJ doesn’t think a regulatory infraction is a false claim, it seems that should be good enough for the Court.  The fact of a regulatory violation shouldn’t be confused with the submission of false information.

            A regulatory infraction might have happened here.  Maybe, although the Government isn’t convinced.  But that’s a different thing from submitting an explicitly false claim to the Government and a thing that has separate regulatory and other remedies.  As defense counsel argued, the Government holds all the keys in how it can address regulatory infractions, but the FCA is not one of them.  We didn’t do the math, but are willing to bet that the majority of implied certification theory-founded FCA claims are products of relators and their counsel and not the United States Government.

            At least three and maybe even all the justices think fraud occurred on the facts here.  But it remains to be seen if they agree about which of those facts made for the fraud, which of those regulations they might be willing to invoke to make a finding of fraud, and whether they need or can agree to invoke the implied certification theory to get there.  We’re still hoping for a deus ex machina here.  The Court should avoid the regulatory weeds – and the implied certification theory – whatever it decides.  And on our next walk, we too will avoid the weeds.  Stay tuned and we’ll be sure to announce the fate of the theory – and this case – as soon as it drops from the high Court.

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IMPORTANT ANNOUNCEMENT – When we created the Drug and Device Law Blog back in 2008 we frankly didn’t know if anything would come of it.  So we used the Google Blogger software program because the price was right (it was free).  Unfortunately, we got what we paid for.  For about six months we’ve had problems with emails to our loyal subscribers, and Google hasn’t been able to fix it.  So next week we’re moving to an upgraded – and supported − platform.  What does that mean for you, our loyal readers?

           All our new posts (and all our old ones) will be located at a new URL, but don’t worry: If you type in (or use a bookmark) for this site in the future, you’ll be redirected to the new Drug and Device Law blog site.

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           The change over also means we have to go silent for a couple days so the techies can do their thing.  We won’t be able to post on May 23 or May 24 as the blog is moved, but you’ll still be able to visit our site and read any and all of our previous posts.  We’ll be back with our usual updates and analysis on drug and device product liability cases on May 25, so don’t put it off − sign up today.

Monday, May 16, 2016

New York Appellate Division Rejects Parallel Violation Claims Based on Off-Label Promotion

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


Last week, the New York Appellate Division upheld a preemption decision in a medical device case involving alleged off-label promotion.  Pitkow v. Lautin, 2016 WL 2746469 (N.Y. App. Div. May 12, 2016).  While the Appellate Division’s opinion was only three-paragraphs long, it affirmed the trial court’s ruling in every respect, making the trial court’s lengthier opinion that much more important.  We obtained a copy, and here it is. 
The plaintiff’s claims were based on complications that arose after her use of an injectable product, Sculptra, for cosmetic purposes, which was an off-label use.  Plaintiff sued the doctors who injected her and the manufacturers of Sculptra.  Among other things, she alleged that the manufacturers had improperly promoted off-label use of Sculptra. 
After discovery, the manufacturers moved for summary judgment, arguing that all of plaintiff’s claims were preempted.  The trial court agreed and, quite effectively, walked through the manner in which both Riegel and Buckman preempted plaintiff’s claims as well as the deficiencies of plaintiff’s attempts at parallel violation claims. 
First up was Riegel preemption, since Sculptra was approved under the FDA’s PMA process:
Sculptra is a Class III medical device that was undeniably approved through the PMA process.  What is more, all of the plaintiff’s claims against the [manufacturers] regard the safety and effectiveness of the device or require a finding that Sculptra’s design, labeling, and/or manufacturing process should have differed from that approved by the FDA via the PMA process . . . .  Thus, the claims are preempted by the federal law. 
Slip. Op. at 8-9.
The trial court had at least as much to say about plaintiff’s parallel violation claims.  Plaintiff alleged “that the defendants promoted an off-label use of Sculptra that was contrary to the representations of the [manufacturers] made to the FDA during the PMA process.”  Id. at 9.  The court, however, found that plaintiff pointed to no violation of an FDA requirement or state law that paralleled that requirement: “plaintiff has failed to cite a specific federal regulation that was violated, or an obligation existing under state law that was ‘identical’ or ‘generally equivalent’ to a specific obligation imposed by federal law.”  Id.  
The trial court went further in taking out plaintiff’s parallel violations claims.  The court held that Buckman prohibits the broad use of state law to enforce FDA requirements, in particular for fraud on the FDA, and made the important point that the Riegel case itself involved allegations of off-label claim promotion:
What is more, any claims based on alleged off-label promotion and/or misrepresentations to the FDA during the PMA process are barred by Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001).  The Supreme Court there indicated that only the FDA, and not private litigants, may sue based on alleged noncompliance with the Medical Device Amendments, stating (at 347) that the FDA is “amply empower[ed] to police fraud against the Administration, and policing the fraud is not a field the States have traditionally occupied.”  The Court explained that while the doctrine may be read to allow for some state-law claims that are parallel to the requirements under the MDA, “it does not and cannot stand for the proposition that any violation of the FDCA will support a state law claim.” Id. at 353.
The Court rejects plaintiff’s claim here (at ¶42) that Buckman should not be applied because the fraud on the FDA allegedly committed by the Sculptra Defendants was of greater magnitude than usual.  Buckman makes no such distinction.  What is more, the plaintiff in Riegel had alleged that the medical device was used in an off-label and contra-indicated manner, similar to plaintiff’s claims here, but those claims did not escape preemption.
Id. at 9-10.  Given plaintiff’s arguments, the trial court also had to explain, very quickly, why Wyeth v. Levine (prescription drugs, no Medical Device Amendments’ preemption clause) and Medtronic v. Lohr (§510k process, not PMA process) did not apply.  
With that, the trial court, now with a stamp of approval from the Appellate Division, made it much more difficult for New York plaintiffs to state parallel violation claims based on off-label promotion.  New York plaintiffs face a significant challenge in identifying an FDA requirement that would be violated by such off-label promotion and, more important, a parallel New York law that also prohibits it.  

Friday, May 13, 2016

Yet Another Failure-To-Update Claim Bites the Dust


In terms of the legal gyrations plaintiffs try to avoid preemption, we’ve already expressed our opinion that so-called “failure to update” claims take the booby prize.  There are good reasons, discussed in these prior posts, why plaintiffs not faced with preemption never bring claims for failure to update a warning – they’re simply lousy claims.  The latest example of this fact is Woods v. Wyeth, LLC, 2016 WL 1719550 (N.D. Ala. April 29, 2016).

Woods is yet another metoclopramide case – that’s the generic drug that produced PLIVA v. Mensing, 131 S. Ct. 2567 (2011).  Stuck between a rock and a hard place, the plaintiff:

Argue[d] that her claims are not preempted because they are based on the generic defendants’ “failure to update” their labels to be consistent with the brand name labeling.

Woods, 2016 WL 1719550, at *1.  Woods, after examining various non-binding precedents, concluded that plaintiff “has set out a narrow claim that falls outside the scope of federal preemption” – the failure to update claim involving no more than the FDA-approved labeling.  Id. at *8.

OK, so take generic preemption out of the mix entirely – what happens with Woods?

Same ultimate result as if the claim had been preempted; that is to say, judgment on the pleadings for the generic defendants.

For a few months, in 2004-05, plaintiffs alleged that the generic defendants did not include the latest of a number of FDA-approved labeling revisions.  Id. at *3.  This period overlapped briefly with the allegedly injured plaintiff’s 2005-09 use of the drug.  Id. at *4.  So there is a short period where it is temporally possible that a prescribing physician could have acted on the basis of un-updated labels.

Temporality of use is not enough to establish causation, particularly in a case that turns on information, and that’s exactly what happened.  Plaintiff’s own allegations were incompatible with causation, because the doctor in question didn’t even prescribe generic metoclopramide.  Instead, the doctor’s prescription was for the branded drug, and generic substitution came later.  Id. at *9.

In the instant case, [plaintiff’s] doctors prescribed her the brand name drug . . . – not the generic drug metoclopramide – from 2005 to 2009.  The labels for [the branded product] already contained the 2004 warnings at the time that [plaintiff’s] doctors prescribed. . . .  Thus, [plaintiff’s] doctors had already gleaned “substantially the same” knowledge about the effects of using [the drug] from the 2004 updates to the [branded] label that they would have gained from an identical update to the labels of the generic version of the drug.

Id. (emphasis added).  The opinion pointed out that exactly the same result has been reached in other update-related cases.  Id. (citing Fullington v. Pfizer, Inc., 720 F.3d 739, 747 (8th Cir. 2013); Bell v. Pfizer, Inc., 716 F.3d 1087, 1097 (8th Cir. 2013)).  Why are we not surprised?

Allegations of failure to update imply that something else needed updating, and that something was the branded label.  Thus, the adequacy of the branded label, for a doctor who prescribed the branded product, defeat causation.  We’ve seen in other cases how plaintiffs complain about pharmacies and generic substitution.  Whether or not such complaints have merit in other contexts, they certainly kill causation in failure-to-update cases.  Where the prescriber never even prescribed the defendant's product, how could s/he have relied on the defendant's warnings?

[B]ecause [plaintiff’s] physicians prescribed her [the branded drug], not generic metoclopramide, [she] has not shown that her physicians relied on the labeling of generic metoclopramide.

*          *          *          *

[Plaintiff] does not allege that her physicians prescribed [the branded drug] because of any labeling or representations made by the generic defendants.

Woods, 2016 WL 1719550, at *9-10 (emphasis original).  Of course plaintiff did not.  That’s the opposite of what plaintiffs normally allege, particularly in Alabama, where for a few months the courts imposed innovator liability before the legislature put a stop to it.  Indeed, “[plaintiff] has not alleged that her physicians ever saw the package inserts or labeling for the generic drug . . ., much less that they relied on those labels.”  Id. at *10.

Oh, and for the sake of completeness, two plaintiffs’ other claims – failure to add warnings and failure to send reminder “Dear Doctor” letters (“consistent with” FDA-mandated labeling) – were preempted.  Woods, 2016 WL 1719550, at *4-6.  The final claim, fraud, wasn’t pleaded with specificity under Fed. R. Civ. P. 9(b), id. at *10-11, a conclusion that was a fortiori from the just-discussed analysis of how failure-to-warn lacked evidence of causation.

Woods is further confirmation that the other side’s duty-to-update ruse to avoid preemption is hardly worth the candle.  Even if they beat preemption, the claim itself is worthless.  Most doctors never see generic labeling at all, particularly those who prescribe the branded product subject to pharmacy substitution.  As we’ve discussed at great length, failure to read the allegedly inadequate label is fatal to causation in a warning case.

Thursday, May 12, 2016

Guest Post – Highlights of FDA Draft Guidance on 3D Printing


Another guest post today, this one by Reed Smith’s Matt Jacobson on the draft guidance document released earlier this week by the FDA.  With the 3D printing of medical devices at the forefront of the burgeoning additive manufacturing revolution − and inevitably to become the target, eventually, of product liability litigation – anything the FDA does to move the ball forward (or not) is of great interest.

As always, our guest blogger deserves all the credit (and any blame) for what follows.  Take it away Matt.

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The blog is not a stranger to 3D printing, the cooler and slang term for the additive manufacturing process.  See here, here, here, and here.

The U.S. Food and Drug Administration (FDA) is not a stranger to 3D printing either.  It has already approved more than 80 medical devices and one prescription drug that are produced by 3D printing techniques.  It also held a public workshop to obtain information and input about 3D printing issues on October 8 and 9, 2014.   FDA brought together technical 3D printing expertise from various industries and sectors to help the agency develop an evaluation process for future submissions of medical devices resulting from additive manufacturing techniques.  After the workshop, FDA was silent on 3D printing, well that is, until last Tuesday, when it released a draft guidance for Technical Considerations for Additive Manufactured Devices. 

Although the FDA workshop was almost a year-and-a-half ago, it was not for nothing, as the draft guidance is based on the feedback from the workshop.  According to FDA, the draft guidance is a “leap-frog” guidance to share FDA’s “initial thoughts regarding technologies that are likely to be of public health importance early in product development.”  While the draft guidance is not meant to be a comprehensive document to address all regulatory requirements, it highlights the technical considerations and recommendations for design, manufacturing, and testing of medical devices that include at least one fabrication step using additive manufacturing.  

FDA is careful to warn that the guidance does not apply to any devices that use bioprinting − incorporating biological, cellular, or tissue-based products into the additive manufacturing process. 

FDA also provides that point-of-care manufacturing (that is, on-site 3D printing of devices in hospitals and doctor's offices) “may” raise additional technical considerations.  Despite the mounting desire to migrate personalized, 3D device manufacturing from central processing hubs to point-of-care manufacturing in a health care setting, we understand why FDA avoided detailed discussion and guidance regarding point-of-care manufacturing.  Not only does point-of-care manufacturing involve additional technical considerations, but it also raises not insignificant regulatory and legal complications (such as whether each “point of care” is a “manufacturer” under the statute) – all of which remain unresolved.

The guidance is split up into two categories of considerations: 1) design and manufacturing and 2) device testing.   Both sections overlap in substance, and the device testing section in particular provides strong, detailed recommendations for what a device manufacturer should include in a premarket submission for a device that uses additive manufacturing.  This will likely have an effect on how 3D printing device companies design, manufacture, and test their devices, especially those who manufacture patient-matched devices (devices that are “customized” for a specific patient’s anatomy, usually based on medical imaging data), to which the FDA draft guidance pays particular attention.

FDA’s recommendations for design and manufacturing considerations, are not as useful, as many of the sound platitudinous.  These include:

  • That manufacturing and dimensional specifications be carefully considered and documented.
  • For patient-matched devices, understanding the image quality and the role deformation may play.  Also ensuring that the label expiration date account “for time-dependent changes to the patient anatomy before the device is used.”
  • Any software used to make patient-matched modifications to a device’s design should include “internal checks to prevent the user from exceeding the pre-established device specifications documented in the device master record.”
  • All software file conversation steps should be tested in “worst-case scenarios.”
  • Before a device is additively manufactured, considerations should be made for  build volume placements, use of support material, layer thickness, build paths, machine parameters, and environmental considerations.
  • Understanding the chemical properties of the material being used and how the additive manufacturing process may affect those properties.
  • Process validation and consistency of quality are key.  In other words, “knowledge of how the variability of each input parameter and processing step affects the final finished device or component is critical to ensuring party quality.”
     

For device testing considerations, FDA recommends that the following (if applicable for the particular device) be included in a premarket submission for a medical device using 3D printing:

  • Range of dimensions for the device (small, medium, large) and any dimensions that may be altered to match a patient’s anatomy.
  • Performance testing results.  While these are generally the same for any device, whether 3D printed or traditionally manufactured, for 3D printed devices build direction orientation should be considered when testing is performed.
  • Dimensional tolerances and measurements should be specified.
  • All materials involved in the manufacturing of the medical device should be clearly identified.
  • Material polymers may need to be tested to ensure that they will not unintentionally form chemical properties through the additive manufacturing process, which may pose a risk to patient health.
  • Interlayer bonding materials should be characterized.
  • Any cleaning and sterilization process for a final product should be validated and should consider the complex geometry of the final product.   Only additive manufactured devices that were cleaned of manufacturing materials should be provided to the end user.
  • The biocompatibility of the final device should be evaluated.
  • Additional labeling considerations for patient-matched devices is recommended to include the patient identifier, identifying use, file design iteration, and that the patient be surveyed for potential anatomical changes (between the time of imaging and surgery).
     

As stated in the guidance, FDA is aware that 3D printing “is a rapidly growing technology,” which has numerous advantages for medical devices, but at the same time “pose[s] challenges in determining optimal characterization and assessment methods for the final finished device, as well as optimal process validation and acceptance methods for these devices.”  The FDA’s guidance is long overdue, but the agency has evidently thought about the unique considerations involved in 3D printing of medical devices.
Interested parties should note that FDA is accepting comments on the draft guidance now and hopefully the final guidance will come soon (at least quicker than the draft guidance). To ensure FDA considers your comments before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance within 90 days [Docket No. FDA-2016-D-1210].   Who knows maybe by the time the final guidance comes out, we may be 3D printing a version for our book shelf, or even of our book shelf.