However a drug/device product liability is styled, it will almost always be focused on a claim of failure to warn.  Why do plaintiffs insist on inserting a cause of action for manufacturing liability when there is not a whiff of evidence that anything went wrong on the production line?  Seldom do we see the pharma equivalent of a mouse in the Coke bottle or, thinking of a more recent case, a bat in the salad.  Similarly, a design defect claim is often a make-weight claim.  How should the design have been improved?  Not selling the product at all is hardly a design improvement.  An entirely different product is not a safer alternative under the law of any enlightened state.  Changing the molecule or the device design cannot be done without FDA approval, so preemption should apply (even if courts often miss this point).  No, failure to warn is where the action is.  In the wake of Wyeth v. Levine, it seemed that preemption would be a tough row to hoe in such cases, but keep hoeing that row because the preemption defense might still be available – as a motion to dismiss, summary judgment motion, directed verdict, or argument to the jury.

 

The recent case of Amos v. Biogen Idec, Inc. et al., 2017 WL 1316968 (W.D.N.Y. April 10, 2017), makes every one of these points for us.  The court granted summary judgment to the defendants in that case, holding that all of the claims were fundamentally about failure to warn, the warning was adequate as a matter of law, and the FDA’s earlier rejection of proposed warnings meant that the plaintiff’s claims were preempted.  The facts of Amos present the sort of situation defendants encounter all too often, but which make for a hard sell to a jury: something very sad happened to an innocent patient, but it was nobody’s fault.  The patient had Multiple Sclerosis too severe to respond well to the usual treatments.  Her doctor recommended Tysabri.  That medicine came with a black box warning that it might increase the risk of Progressive Multifocal Leukoencephalopathy (“PML”), a viral infection of the brain that is as incurable as MS is.  The patient eventually contracted PML and died.  Her estate filed a lawsuit that included claims for negligence, negligent misrepresentation, strict liability, and breach of implied warranty. 

 

From the recital of facts in the Amos case, it appears that the manufacturer of Tysabri was quite diligent and proactive.  It also appears that the defense attorneys did an excellent job of mining the administrative record.  The manufacturer continued to perform clinical trials after initial approval, and promptly alerted the FDA of whatever risks it observed.  Among other things, the company asked the FDA to add information in the label about screening for certain virus antibodies that might increase the risk of PML.  The FDA rejected this proposal a couple of times, finding insufficient evidence at those times to support the label change.  The FDA ultimately relented and approved a label change in 2012 – after the plaintiff’s decedent died.

 

In considering the defense motion for summary judgment, the court concluded that all of the plaintiff’s claims turned on the sufficiency of the warnings.  New York law applied, and there was ample precedent under New York law that adequate warnings precluded claims for negligence, strict liability, breach of warranties, or fraud.  What’s more, the learned intermediary applied to claims regarding prescription drug warnings, and the record was replete with evidence that the prescribing doctor was well aware of the increased risk of  PMI.  It certainly helped the defense that the defendant, in collaboration with the FDA, had created a program called Tysabri Outreach: Unified Commitment to Health (“TOUCH”), which required that, prior to prescribing Tysabri, a physician had to acknowledge in writing that he/she understood the risks of PML and obtained a written acknowledgment from the patient that the patient understands the PML risk. The existence of the TOUCH program was one of several facts that made Amos a hard case for the plaintiff to win.

 

Even so, we all know that no matter how comprehensive and informative a warning label is, a good plaintiff lawyer can flyspeck it and find, or make up, some gaps.  The plaintiff lawyers in the Amos case are well known to us, and are very, very good.  They argued that the Tysabri warnings were inadequate because they failed to include information regarding the correlation between the virus antibodies and PML, and failed to inform doctors of the risks associated with duration of treatment and prior treatment with an immunosuppressant.  To our eyes, the plaintiff lawyers made the best arguments they could.  In too many courts, such an argument would furnish enough of a crutch for a plaintiff-leaning (or lazy-leaning) judge to mutter ‘factual dispute’ and deny the motion in a post-card ruling.  But not this court.  The judge analyzed New York law and held that even without the details regarding specific risk factors, “when read as a whole, the warnings unmistakably conveyed the seriousness of PML and its association with Tysabri treatment.”  That “read as a whole” point is important.  Do not let a court tell you that it is the jury’s duty to read the warnings as a whole.  It is the court’s job to assess whether the warning is adequate as a matter of law, and plaintiff post hoc fly-specking should not be enough to plant a case in front of twelve citizens good and true (and half-asleep and inflamed with sympathy and anti-corporate hatred).    

 

Even aside from the conclusion that the Tysabri warnings were adequate as a matter of law, the court offered an alternative basis for dismissing the case:  the claims were preempted as a matter of law.  Wyeth v. Levine ruled against preemption on the (at least partially specious) ground that drug companies can unilaterally ramp up warnings through the Changes Being Effected (“CBE”) process.  But the Amos court accurately observed that CBE is not available in all situations, and definitely is not available to add or change a black box warning, which is what was at issue in this Tysabri case.  Moreover, “the evidence of record leads inescapably to the conclusion that the FDA would not have approved a change to Tysabri’s label prior to 2012.”  With respect to Tysabri, there were two “smoking gun” rejections from the FDA. 

 

Also notable in Amos:  a second defendant in the case, a distributor of Tysabri, received summary judgment on preemption grounds.  The distributor did not own the drug’s New Drug Application, and thus had no power under the FDA scheme to alter warnings in any way.  The distributor’s inability to act independently to change warnings meant that, under the Mensing and Bartlett decisions, all claims against it were preempted.

 

There have been other cases around the country where courts arrived at similar rulings that Tysabri warnings were adequate as a matter of law and that failure to warn claims were preempted.  Perhaps plaintiff lawyers will do their best to distinguish these cases on their facts.  We will, doubtless, hear that “smoking gun” has become the standard for the Wyeth v. Levine “clear evidence” standard. We heard something nearly as silly from our home appellate court recently.  But reading the Amos case in the same way that the Amos court read the Tysabri label – as a whole – there is an awful lot of comfort in that case for drug and device defendants.

   

 

Imagine a conspiracy so vast that it includes not only your usual plaintiff-side fantasy of the FDA conspiring with a drug company, but also high FDA officials, President Obama, Robert Mercer (noted Trump supporter and reputed Breitbart financier), a number of other investors, and just for good measure President and Hillary Clinton.

Larry Klaman could, and thus brought the lawsuit that recently resulted in Aston v. Johnson & Johnson, ___ F. Supp.3d ___, 2017 WL 1214399 (D.D.C. March 31, 2017).

Nobody else did, though.

In particular, and fortunately for everyone on the defense side, the judge in Aston could not.  Reading the Aston opinion, it is evident that the court is beyond skeptical of the vast, or even half-vast, conspiracy claims.  In a nutshell, five plaintiffs who claimed a great many personal injuries (the opinion lists 74 separate alleged injuries, 2017 WL 1214399, at *1) from their use of the drug Levaquin, brought suit alleging that the drug’s manufacturer and the FDA were in cahoots to cover up the drug’s risks, in order to increase the value of the manufacturer’s stock, to the advantage of various investors.  As for the political officials, according to the opinion:

Amazingly, former presidents Barack Obama and Bill Clinton also make cameo appearances in plaintiffs’ alleged scheme, together with former Secretary of State Hillary Clinton, and the Clinton Foundation; these actors are alleged to have solicited, or received, “gratuities” from defendants in exchange for securing [another alleged conspirator’s] appointment as FDA Commissioner.

Id. at *2.  We admit, this is an extreme oversimplification – the opinion took two Westlaw pages just to sort through the Aston plaintiffs’ labyrinthine conspiracy allegations.

Plaintiffs’ legal theories were almost as numerous as their injury allegations – twenty-two counts, including RICO, state-law (Arizona (?)) RICO, strict product liability, negligence, fraud, express and implied warranty, unjust enrichment, Lanham Act, and a bunch of state consumer fraud claims (D.C., New York, Maryland, Pennsylvania, Illinois, Arizona, and California). Id. at *3.

Aston threw everything out on the many defendants’ motions to dismiss. The half-vast conspiracy, and all its subsidiary theories of liability went down in a hail of defense-friendly rulings, and that’s why – aside from its humor value – the Aston opinion is well worth reading.  We’ll list the rulings so our readers will have an idea of what this goodie basket contains.

RICO – The deficiency in the RICO counts was rather basic. RICO does not allow recovery for personal injuries.  “The overwhelming weight of authority discussing the RICO standing issue holds that the ‘business or property’ language of Section 1964(c) does not encompass personal injuries.” Aston, 2017 WL 1214399, at *4 (citation and quotation marks omitted).  For a compilation of that authority, see Bexis’ Book, §2.15, footnote 3.  Further, “as plaintiffs’ counsel is well aware, courts in this District and elsewhere have consistently rejected the argument that pecuniary losses derivative of personal injuries are injuries to ‘business or property’ cognizable under RICO.”  Aston, 2017 WL 1214399, at *4 (citing, inter alia, Klayman v. Obama, 125 F. Supp.3d 67, 88 (D.D.C. 2015)).  Aston also distinguishes “tobacco litigation [RICO] precedents” because those cases arose from a federal prosecution that was not limited by the “business or property” requirements of RICO’s private cause of action.  2017 WL 1214399, at *5.

Nor did the Aston plaintiffs satisfy RICO’s causation requirements – for another very basic reason.  Even the most recent of the five plaintiffs’ injuries arose before the conspirators allegedly acted:

Barring some sort of temporal paradox, there is no way that suppression of an FDA report in 2013 could have caused plaintiffs to be injured in 2012 or earlier.  Because plaintiffs’ allegations, taken as true, are insufficient to establish proximate causation, their federal RICO counts must be dismissed.

Id. (citing H.G. Wells, The Time Machine, 22–23 (1895)) (other citation omitted).  On this basis alone, we’re rooting for the defendants to obtain recovery of their counsel fees, since the underlying premise of the entire litigation was physically impossible.

Arizona RICO – Same basis:  “[P]laintiffs have failed to plead facts that make possible − let alone plausible − the conclusion that the alleged cover up by defendants was the proximate cause of plaintiffs’ injuries.”  Id. at *6.  Unfortunately, the relatively terse dismissal of does not answer the burning question − Why Arizona?

Lanham Act – Another fundamental basis for dismissal.  “[T]o come within the zone of interests in a suit for false advertising under [the Lanham Act], a plaintiff must allege an injury to a commercial interest in reputation or sales.”  Id. (quoting Lexmark International, Inc. v. Static Control Components, Inc., 134 S. Ct. 1377, 1390 (2014) (emphasis original in Aston).

Now comes the most useful stuff – dismissal of the common-law claims.  For the record, Aston applies the law of the District of Columbia rather than the law of the plaintiffs’ (Maryland, Pennsylvania, Arizona, Illinois, California) or defendants’ (New Jersey) domiciles.  Aston, 2017 WL 1214399, at *6.

Product Liability (both strict liability and negligence) – Manufacturing defect is TwIqballed.  For all its factual prolixity, the Aston complaint was utterly devoid of any allegations that the drug wasn’t made precisely as intended.  Id. at *7 (“for all these recitals of the term ‘manufacture’ and its derivatives, plaintiffs plead no facts that would appear to relate to manufacturing defects”) (citation and quotation marks omitted).

Warning related claims were also dismissed, in a usefully rigorous application of TwIqbal.  Dismissal in Aston occurred because plaintiffs failed to plead:  (1) “the contents of the warning label” when the drug was taken (2) “how the contents of the label were inadequate,” (3) “the timing of each plaintiffs use of” the drug, including “when each individual plaintiff was prescribed,” (4) “the onset of [plaintiffs’] injuries,” (5) “how the alleged distinctions in the warnings would have had a causal effect,” (6) “what injuries each individual plaintiff experienced,” (7) “why [plaintiffs] think [the drug] was the cause of the[ir] injuries,” and (8) “why [plaintiffs] think inadequate warnings contributed to their injuries.”  Id. (various quotations omitted).  That’s a spicy TwIqbal – without even having to get into the learned intermediary rule.

As to warnings, we also note that the court held that all warnings publicly available on the FDA’s website are subject to judicial notice.  Id. at *2 n.1.

Design defect claims were preempted under Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013), and Aston rejected the well-worn plaintiff argument that, for some reason, implied preemption is different in generic, as opposed to branded (as in Aston) drugs:

Plaintiffs are mistaken.  [Bartlett] expressly found that “[o]nce a drug − whether generic or brand-name − is approved, the manufacturer is prohibited from making any major changes to [its formulation]” by federal law.  133 S. Ct. at 2471.  Thus, even though [Bartlett] arose from a state-law design-defect claim against a manufacturer of a generic drug, its holding applies to both types of drugs, and plaintiffs’ design-defect claim must be dismissed.

Aston, 2017 WL 1214399, at *8. Preemption is “fully consistent with the well-established tort law principle, ‘especially common in the field of drugs,’ that an unavoidably unsafe product is ‘not defective, nor is it unreasonably dangerous’ where it is ‘properly prepared, and accompanied by proper directions and warning.’”  Id. at *8 n.7 (quoting Restatement (Second) of Torts §402A, comment k (1965)).

Fraud/Misrepresentation – Perhaps predictably, plaintiffs’ fraud-based claims failed under Fed. R. Civ. P. 9(b).  Id.  Allegations broadly “span[ning] the more than twenty-year period” alleged could not possibly allow defendants to file a response.  Id.  Plaintiffs “do not even specify which corporate entity they believe was responsible.”  Id.  Nor did any of the five plaintiffs allege their own circumstances with the required specificity.  Id.  “In sum, plaintiffs fall woefully short of pleading any specific allegations that would support a claim of fraud or misrepresentation.”  Id.

Warranty – Again, perhaps predictably, plaintiffs’ express warranty claims failed for not “plead[ing] any express promises.”  Id. at *9.  Here, Aston made another good TwIqbal ruling:

[T]o state a claim for breach of express warranty in cases involving prescription drugs, Plaintiffs must allege facts demonstrating that Defendants’ affirmations formed the basis of the bargain, i.e., facts regarding how the warranties were made to Plaintiff’s physician, and that Plaintiff’s specific physician relied on them.

Id. (citations and quotation marks omitted).  Implied warranty claims “cannot be independently maintained in a case involving prescription drugs.”  Id.

Unjust Enrichment – As against the investor defendants, merely “earn[ing] profits” from allegedly more valuable stock was “far too remote and speculative to support an unjust enrichment claim.”  Id. at *9.  As against the drug manufacturer defendants, the plaintiffs did not allege “that they conferred a benefit” on those defendants.  Id. at *10 (emphasis original).

[Plaintiffs] do[] not allege that [they] paid any money for [the drug], rather than relying on an insurer, as most patients do.  This omission is significant because there is no authority demonstrating that benefits received from third-parties can be the proper subject of an unjust enrichment claim.

Id. “Because plaintiffs have not pleaded any facts showing that they paid for [the drug], I must dismiss their unjust enrichment claim.”  Id.

Obamacare to the rescue.

Readers should remember this point; we don’t remember ever seeing an individual (as opposed to TPP) unjust enrichment claim that contains the allegations – personal, as opposed to third party payer – required by Aston and the precedent it follows.

Consumer Fraud Claims

Seven states’ laws were implicated − D.C., New York, Maryland, Pennsylvania, Illinois, Arizona, and California. “Each count fails to state a claim.” Id.

Six of the states (all but Arizona) did not recognize consumer fraud claims involving prescription drugs.  Some states’ statutes did not allow personal injury damages (Pennsylvania, California, D.C.).  Others did not consider prescription drugs to be “consumer” goods (Maryland, New York).  Still other statutes simply had been held inapplicable to prescription drugs (California, Pennsylvania, Illinois).  Id.  Beyond that, all of the consumer fraud claims were dismissed as inadequately pleaded under Rule 9(b), which Aston applied to all consumer fraud claims.  Id. at *11.  In prescription drug cases, Rule 9(b) required specific pleading of prescriber reliance:

[T]he circumstances of those prescription decisions, and plaintiffs’ reliance on them, are particularly important − yet plaintiffs allege no information about them. The absence of detail about Plaintiffs experiences leads to the conclusion that Plaintiffs have not pleaded these claims with the requisite particularity.

Id. (citations and quotation marks omitted).

Finally, none of the plaintiffs resided in D.C. or New York.  Thus, claims under those two states’ consumer fraud statutes were also “dismissed because neither statute applies extraterritorially.”  Id. at *10 n.9.  We’ve always been interested in extraterritoriality.

So that’s Aston for you – an example of really poor facts (for the plaintiffs) making some quite excellent law for our side of the “v.”  Our only quibble with Aston is grammatical – in a couple of places, “principle” is used where “principal” is meant.  Id. at *2 (“principle role”); *6 (“principle place of business”).  But apart from a law clerk needing to repeat fifth grade English, the legal rulings in Aston are truly vast, and not half-vast at all.  In Ashton all too many defendants were made to spend all too much money to hire all too many of us lawyers.  With Aston now dismissed in its entirety, we certainly hope that all the defendants so inconvenienced seek to recover their fees as a sanction against such frivolous litigation.

Earlier this week, we discussed how the presentation of the federal question of express preemption from the face of a complaint can lead to removal.  Part of why the defendant drug or device manufacturer may prefer federal court over state court is that the belief that the chances of winning on preemption are better in federal court.  On the other hand, we have described many instances where federal courts mess up their preemption analysis by presuming that state law imposes the duty that plaintiff claims does not conflict with FDA obligations or by extending state law in new directions to provide a basis for a parallel claim, Erie restraint notwithstanding.  It may be that state court judges are less likely to impose duties not recognized explicitly in higher court decisions.

Tibbe v. Ranbaxy, Inc., No. C-16o472, 2017 Ohio App. LEXIS 1139 (Ohio App. Mar. 29, 2017), is a case that stayed in state court despite the explicit claims that the defendants—the generic drug manufacturer and the non-diverse pharmacy defendant—violated the FDCA in various ways.  On its basic facts and history, the case had the hallmarks of a case pursued in disregard of controlling law.  A typical warnings claim that information in the generic drug label about the risk that allegedly befell plaintiff was insufficient should not fly post-Mensing.  A claim predicated on defrauding the FDA should not fly post-Buckman.  Claims against the pharmacy that it should be liable for nothing more than filling a prescription with the generic form of the particular antibiotic (presumably as required by plaintiff’s insurance) should not fly under Ohio law.  It should not have been enough to defeat a motion to dismiss for plaintiff to claim that discovery might help them determine if the generic drug’s label was different than the reference drug’s label.  After the Sixth Circuit’s decision in Fulgenzi v. Pliva, 711 F.3d 578 (6th Cir. 2013), discussed here, this is something that can and should be determined before suing.  Even though Fulgenzi held that there is exception to Mensing’s preemption of warnings claims for generic drugs where there has been a failure to update, the plaintiff there lost because the prescriber did not review the label.  So, you would think some pre-suit investigation into the labels of the reference drug and the generic drug and the prescriber’s practices should be done in determining if there is a good faith basis to plead a non-preempted claim.  Maybe that is just our silly defense-sided way of thinking.

Regardless, in Tibbe, the plaintiff got her discovery and the preemption issues were presented again on motion for summary judgment.  Despite plaintiff’s earlier protestations, the labels were actually the same during the relevant time periods, including the language as to the risk of the condition that plaintiff claimed to have developed from the medication, so Mensing applied and Fulgenzi did not.  2017 Ohio App. LEXIS 1139, *10.  The intermediate appellate court reviewed the grant of summary judgment de novo.  Even though the Sixth Circuit had carved out an exception for non-preempted generic drug warnings claims in Fulgenzi, later the same year it recognized in Strayhorn v. Wyeth Pharms., Inc., 737 F.3d 378, 391 (6th Cir. 2013), discussed here, that Mensing had broad application to “claims that the generic manufacturers failed to provide additional warnings beyond that which was required by federal law of the brand-name manufacturer,” no matter how the claims were couched. Id. at *18.  Faced with this law and the factual record on sameness, plaintiff came up with an argument that we do not recall seeing before.  She claimed that there was a “duty to warn consumers of the generic version of the drug that they cannot bring a state-law failure-to-warn claim when their prescriptions are filled with Ranbaxy’s generic minocycline and the labeling is that of the RLD.” Id. at *19.  In other words, the plaintiff claimed the manufacturer had to give legal advice—not just legal advice, but legal advice about Mensing that was contrary to the position plaintiff advocated.

This is where being in state court maybe helped the defendants.  The court did not have to engage in much of an analysis to see whether there was already a duty to do what the plaintiff wanted and did not even consider making up a new duty.  The duty to warn under the Ohio Product Liability Act related to “the risks associated with the product.” Id. at *20.  “There is no corresponding duty to warn a consumer of her legal rights or the prospective outcome of litigation should she decide to sue a drug manufacturer at a future point in time.  Thus, a claim based on that theory would not be available under Ohio law.” Id. at **20-21.  Any warnings claim based on actual Ohio law conflicted with federal law and was preempted.

Today we give you something rare from the Philadelphia Court of Common Pleas — a defense win on preemption. The Philadelphia CCP has been the source of some rather vexing decisions over the years and has certainly taken its share of criticism. Criticism that we think has been rather overstated. Don’t get us wrong, we’ve vehemently voiced our disapproval of several Philadelphia CCP decisions over the years. But there are plenty of times when Philadelphia judges get it right. That happened two weeks ago in Caltagirone v. Cephalon, Inc., 2017 WL 1135576 (Pa. CCP Mar. 23, 2017).

Plaintiff was prescribed an opioid medication to treat his migraines. The drug was approved for use to treat pain related to cancer, so the prescription was off-label. We use that term a lot, but it is worth stopping to remind ourselves what that really means. The FDA-approved labeling for the drug says its intended use is for treating pain in cancer patients. In other words, that was the patient population in which the drug was studied and the data presented to and examined by the FDA and therefore, the indication for which it was approved. Once a drug or device is on the market, however, doctors, who are not governed by the FDA, are free to use those products for any reason they find is medically necessary. Indeed, much of what we know today about drugs and devices comes from physicians using them in the field in ways that they were not originally intended (aspirin as a blood thinner being among the most well-known example). When you break it down like that, it is not surprising that doctors treating patients with migraines who have not been receptive to standard treatments would look to alternative pain medications, such as an opioid with proven success in alleviating pain in cancer patients. In this context, the drug is still being used to treat pain, just a different type of pain.

Back to Caltagirone. The opioid prescribed to plaintiff, in addition to being labeled for use with cancer patients, was also known to be highly addictive. Id. at *1 & 5. The drug was prescribed to plaintiff for 7 years during which time he was in and out of drug treatment programs due to opioid and other drug addictions. Plaintiff ultimately died from his drug addiction. Id. at *1.

Plaintiff’s claims were for negligence, fraud, misrepresentation, and violation of the UTPCPL. The basis for each claim was an allegation that defendants illegally promoted the drug for off-label uses, which was forbidden by the FDA. Id. at *2. The first thing the court does is negate plaintiff’s premise by holding that “generally off-label sales, promotions and prescriptions are proper.” Id. at *3. Further, at the motion to dismiss stage, the court had to accept as true the material facts pleaded by plaintiff. But a critical material fact was missing from plaintiff’s complaint – any allegation that any off-label promotion was false. A false or misleading statement or omission is a requirement for each of plaintiff’s claims under state law. However, plaintiff only alleges that defendants marketed the drug off-label, not that that off-label promotion was false in any way. Because there is no state-law duty to avoid off-label promotion, plaintiff’s claims “could not exist in the absence of federal laws and regulations.” Id. In other words, plaintiff is suing “because the conduct of promoting the drug for migraine headaches violates the FDCA,” not because defendant has breached any state-law duty. Therefore, plaintiff’s action is a private attempt to enforce the FDCA; the type of action that is barred by Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).

While the court dismissed the case with prejudice as preempted, because defendants also asserted that it was barred by the learned intermediary doctrine, the court addressed that issue as well.

Plaintiff argued that the doctrine should not apply because plaintiff’s doctor was not learned because he was given “misinformation” by defendants. Id. at *4. The court saw that for the disingenuous argument that it was. Not only did the prescribing doctor have access to the risk and precaution information provided by defendants and his own medical training and judgment – in this case, the doctor had “actual knowledge” that his patient had become addicted and continued to prescribe the drug for many years. Id. at *5. The physician is the customer under the learned intermediary rule. Id. And it is the physician’s “duty to read and consider the materials from [other medical sources] and writings from the Defendant manufacturers.” Id. The fact that the prescriber may also have read or seen off-label promotion, didn’t change the fact that it was his duty to use all his training and experience, combined with his personal knowledge of the patient, which here included knowledge of addiction (the harm complained of), to treat the plaintiff. The court usefully also noted that the treater has a duty to know what other medications the patient is taking. Id. Keep in mind this strong statement of the learned intermediary’s duty the next time you are arguing this issue in Philadelphia.

This post is from the non-Reed Smith side of the blog, only.

Last week the Third Circuit overturned the dismissal of thousands of cases in In re: Fosamax Products Liability Litigation, — F.3d –, 2017 WL 1075047 (3rd Cir. Mar. 22, 2017), finding that the trial court had improperly granted summary judgement on preemption grounds by misapplying the Supreme Court’s “clear evidence” standard announced in Wyeth v. Levine. It should come as no surprise that we firmly believe the trial court got it right and have lauded its decision in the past. So, it should be equally unsurprising that the Third Circuit’s abysmal “clear evidence” preemption decision is a front-runner for our list of the ten worst cases for 2017.

Regrettably, since Wyeth v. Levine, successful applications of preemption against warning claims asserted in litigation involving branded drugs have been few and far between. That is due in large measure to the both dauntingly high and utterly ill-defined preemption standard set by the Court in Levine, which requires an intensive fact-based analysis and a powerful regulatory case. So when the standard has been met, it is usually with facts that can hardly be described as equivocal. The district court in In re Fosamax, found as much and therefore a somewhat detailed recitation of the regulatory history is warranted.

Fosamax was approved by the FDA in 1995 for the treatment of osteoporosis in postmenopausal women. In re Fosamax, 2017 WL 1075047 at *4. Over the next 15 years, scientific studies were published concerning a possible link between long-term Fosamax use and atypical femur fractures (“AFF”). Merck kept the FDA aware of these studies and in June 2008, FDA asked Merck and other manufacturers to submit whatever data they had on the issue. Id. at *4-5. In September 2008, Merck submitted a “Prior Approval Supplement” (“PAS”) – the same thing as the “Changes Being Effected” (“CBE”) process discussed in Levine, only involving prior FDA review − seeking FDA approval to add information about AFF to both the Warnings & Precautions and Adverse Reactions sections of the Fosamax label. Because it is important to the arguments and the court’s conclusion, we quote some specific language from the requested change and the FDA’s response. Merck’s proposed language included:

Low-energy fractures of the subtrochanteric and proximal femoral shaft have been reported in a small number of bisphosphonate-treated patients. Some were stress fractures (also known as insufficiency fractures) occurring in the absence of trauma. . . . Patients with suspected stress fractures should be evaluated, including evaluation for known causes and risk factors . . . and receive appropriate orthopedic care. Interruption of bisphosphonate therapy in patients with stress fractures should be considered, pending evaluation of the patient, based on individual benefit/risk assessment.

Id. at *5. In April 2009, the FDA responded that Merck could add the information to the Adverse Reactions section of the label, but as to the Warnings/Precautions section, “more time [was] need[ed] for FDA to formulate a formal opinion on the issue of a precaution around these data.” Id. at *5. In its formal response the FDA wrote:

Identification of “stress fractures” may not be clearly related to the atypical subtrochanteric fractures that have been reported in the literature. Discussion of the risk factors for stress fractures is not warranted and is not adequately supported by the available literature and post-marketing adverse event reporting.

Id. at *6.

Almost a year later, the FDA issued a public statement that the data to date “had not shown a clear connection” between Fosamax and a risk of AFF. The FDA commissioned a task force, which after another six months (September 2010) reported a “relationship” between AFF and the class of bisphosphonate drugs, but not anything “proven to be causal.” Id. The FDA responded to the task force’s report with a statement also indicating that causation “is not clear,” and that the Agency was “considering label revisions.” Id. After another month, the FDA announced revised labeling for AFF for this class of drug. Causation was described as “not clear.” Id. at *7. The FDA’s proposed label change stated “[c]ausality has not been established.” Id. In response, Merck proposed adding additional language advising doctors to rule out stress fractures. The FDA ultimately rejected the addition of the term “stress fractures,” finding that the term “represents a minor fracture and this would contradict the seriousness of the atypical femur fractures associated with bisphosphonate use.” Id. The FDA’s approved language, including lack of causality, was added to the Fosamax label in January 2011. Id.

Against this regulatory background, the district court found that the claims of all MDL plaintiffs with injury dates before September 14, 2010 – when the FDA last reaffirmed its position that it did not have enough evidence of a causal association to allow a warning change – were preempted. Id. at *8. The district court ruled that the regulatory history “provided clear evidence that the FDA would have rejected a stronger Precautions warnings because the FDA did reject a stronger Precautions warning.” Id. at *9.

The Third Circuit clearly saw things differently. On appeal, it considered two questions: What is clear evidence? And who should determine whether clear evidence exists? Id.

As to the first question, and perhaps most significantly, this is the first case formally to make the leap from Levine’s amorphous “clear evidence” requirement for implied preemption of warning claims involving branded drugs, to a “clear and convincing” evidence standard for proof of preemption, which required a “highly probable” result. Our problems with Levine are many, and among them has always been this ill-defined standard. Coupled with the Court’s describing impossibility preemption as a “demanding defense,” district courts knew that the standard was high, but just how high was left completely open-ended and has resulted in a lineage of case law that is highly fact-specific with no clearly established definitions or guidelines.

Despite 8 years of court rulings all over the country using the facts of Levine as a benchmark against which to assess the facts of a given case (if stronger facts than Levine then preemption might be possible, if less than Levine, no preemption), the Third Circuit retroactively undertook to read the Supreme Court’s mind, deciding that what Levine really meant when it used the term “clear evidence” was to announce a standard of proof. Id. at *11. The court parsed the ruling in Levine – that absent clear evidence that the FDA would not have approved the label change, it cannot be ruled that it is impossible for a manufacturer to comply with both federal and state law – into three parts. First, it established the legal rule — a manufacturer is “absolved of state-law liability” where it is impossible to comply with both federal and state law simultaneously (impossibility preemption). Second, it established the factual showing needed to satisfy the legal rule – the FDA would not have approved the label change. Third, it established the standard of proof specifying “how convincing the factual showing must be” – by clear evidence. Id. So, according to the Third Circuit:

The term “clear evidence” therefore does not refer directly to the type of facts that a manufacturer must show, or to the circumstances in which preemption will be appropriate. Rather, it specifies how difficult it will be for the manufacturer to convince the factfinder that the FDA would have rejected a proposed label change. The manufacturer must prove that the FDA would have rejected a warning not simply by a preponderance of the evidence, as in most civil cases, but by “clear evidence.”

Id.

The principal problem with this aspect of Fosamax is that it flies in the face of other, binding United States Supreme Court precedent. Because the Third Circuit reached its conclusion without even mentioning the Supreme Court precedent that explicitly rejects any “special burden” in implied preemption cases, one wonders if the Third Circuit went off on its own adventure, beyond the scope of the parties’ briefing. The controlling case is Geier v. American Honda Motor Co., 529 U.S. 861, 872-873 (2000), which held that imposition of any “special burden” on the implied preemption defense both lacks “basis . . . in this Court’s precedents” and creates “practical difficulty by further complicating well-established pre-emption principles.” Geier not only rejected imposition of purported “special burdens” in the implied preemption context, but did so on a stronger set of facts for creating such a burden, where Congress had expressly spoken to preemption with both statutory preemption and savings clauses. In the FDCA, by contrast, Congress was merely silent.

Fosamax thus did just what Geier held was not the law. The Third Circuit determined that when the Court said “clear evidence” it really meant “clear and convincing evidence” as a heightened standard of proof requiring a defendant asserting a preemption defense to prove that it is “highly probable” or “reasonably certain” that the FDA would have rejected a label change. Id. at *12.

The court then moved on to the question of whether deciding what the FDA would have done was a question of law or fact. Disregarding uniform precedent since Levine that has treated the issue as a question of law, the Third Circuit determined it was a question of fact. The court found that none of those other cases explicitly addressed the issue and so could not be the basis for concluding that the “clear evidence” test is a legal question. Id. at *13. But if it sounds like a duck, and walks like a duck . . . . In so ruling, Fosamax violated 3d Cir. I.O.P. 9.1 on a truly epic scale. IOP 9.1 provides:

It is the tradition of this court that the holding of a panel in a precedential opinion is binding on subsequent panels. Thus no subsequent panel overrules the holding in a precedential opinion of a previous panel.

Fosamax conceded that its finding that preemption was a matter of fact for jury consideration was contrary to a number of prior Third Circuit statements, which the panel dismissed as “off-hand.” 2017 WL 1075047 at *12. That is not a legitimate characterization. Relegated to an “e.g.” citation in footnote 106 was the standard of review that controlled in In re Federal-Mogul Global Inc., 684 F.3d 355, 364 n.16 (3d Cir. 2012): “The scope of preemption presents a pure question of law, which we review de novo”; as well as the prior FDCA preemption case, Horn v. Thoratec Corp., 376 F.3d 163, 166 (3d Cir. 2004), which likewise held that preemption was a matter for “plenary review” because “it is a question of law.” But Fosamax ignored a lot more precedent than that, including the en banc decision in Orson, Inc. v. Miramax Film Corp., 189 F.3d 377 (3d Cir. 1999), which held specifically that, because it was not bound by “prior decisions, the court was “free to consider the preemption issue as a matter of law.” Id. at 380. Preemption being a matter of law was plainly the holding of the court in Taj Mahal Travel, Inc. v. Delta Airlines, Inc.:

[Plaintiff] argues that [defendant] waived the preemption defense by not raising it until it moved to dismiss [a different] claim, which occurred [later]. . . . However, the preemption defense is a pure issue of law . . . and could be dispositive. Since the parties have briefed and argued preemption on appeal, we will consider it.

164 F.3d 186, 190 (3d Cir. 1998). See also: South Jersey Sanitation Co. v. Applied Underwriters Captive Risk Assurance Co., 840 F.3d 138, 143 (3d Cir. 2016) (“preemption determinations are questions of law”); Roth v. Norfalco LLC, 651 F.3d 367, 374 (3d Cir. 2011) (“preemption … determinations [a]re based on questions of law”); Elassaad v. Independence Air, Inc., 613 F.3d 119, 124 (3d Cir. 2010) (“[w]e also exercise de novo review of a preemption determination, as it is a question of law”); Deweese v. National Railroad Passenger Corp., 590 F.3d 239, 244 n.8 (3d Cir. 2009) (“a preemption determination . . . is a question of law”; Travitz v. Northeast Dep’t ILGWU Health & Welfare Fund, 13 F.3d 704, 708 (3d Cir. 1994) (“[t]he issue of preemption is essentially legal”); Pennsylvania Medical Society v. Marconis, 942 F.2d 842, 846 (3d Cir. 1991) (“[t]he question of preemption involves an issue of law”); Ayers v. Philadelphia Housing Auth., 908 F.2d 1184, 1188 (3d Cir. 1990) (“we determine that as a matter of law the federal regulations . . . preempt the application of [state law]”) (citations and footnote omitted); Pokorny v. Ford Motor Co., 902 F.2d 1116, 1119 (3d Cir. 1990) (“the question of whether [plaintiff’s] action is pre-empted . . . involves a pure issue of law”). These are not “off-hand” statements or dicta of any sort. Some of them are even West case headnotes. In deciding, after decades of contrary precedent, to convert preemption into a factual issue, Fosamax blatantly disregarded the “tradition” of the Third Circuit and did what panels are forbidden to do by IOP 9.1. We have said many times before that strange things happen in tort preemption cases, but Fosamax goes beyond “strange.” If precedent means anything, this aspect of Fosamax is a lawless decision.

Having decided that preemption doesn’t necessarily have to be a question of law, the court’s next awful conclusion was that juries are to determine what the FDA might have done with a different warning. The court looked at the specific question to be answered under Levine – would the FDA have rejected the label change plaintiffs argue was required – and determined it was the type of fact question that could be decided by a jury. The court’s reasoning was threefold: (1) the question asks about the probability of a future event; (2) the question requires the decision maker to weigh conflicting evidence and draw inferences; and (3) the question requires predicting FDA’s actions which requires assessments of FDA official’s motives and thought processes. All of which the court says are functions left to juries. 2017 WL 1075047 at *15-16. Which leads to the court’s ultimate conclusion that “[a] state-law failure-to-warn claim will only be preempted if a jury concludes it is highly probable that the FDA would not have approved a label change.” Id. at *18. Thus the decision opens the door to dueling FDA experts speculating about how the FDA would have viewed some hypothetical proposed label change, while discovery from actual FDA employees is mostly prohibited. See United States ex rel. Touhy v. Ragen, 340 U.S. 462, 468 (1951); Giza v. HHS, 628 F.2d 748, 751-52 (1st Cir. 1980).

This kind of jury second-guessing creates the kind of practical problems that drove the preemption decision in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001) (also not cited in Fosamax). It “will dramatically increase the burdens facing potential applicants-burdens not contemplated by Congress,” id. at 350, by encouraging plaintiffs to nit-pick FDA decisions – such as those involving bisphosphonates that we discussed above – without regard to the FDA’s actual decision-making process. It will expose “would-be applicants” to unpredictable civil liability,” id. for doing what the FDA directed them to do. Looking at how the plaintiffs in Fosamax discounted the FDA’s “don’t say that” decision, it is likewise plain that allowing such claims to survive preemption will “also cause applicants to fear that their [interactions with] the FDA, although deemed appropriate by the Administration, will later be judged insufficient in state court.” Id. at 351. Allowing jury speculation about what the FDA might have done, had it received a different submission from a regulated company is, as a practical matter, no different than allowing the same jury speculation about what the FDA might have done, had it not been “defrauded” in Buckman.

Since the court in Fosamax was no longer addressing a question of law, its role at the summary judgment stage was “therefore limited to determining whether there are genuine issues of material fact that preclude judgment as a matter of law.” Id. at *13. Remember, the court is imposing a heightened standard of proof, so to affirm summary judgment the court concluded it would have to find “that no reasonable juror could conclude that it is anything less than highly probable that the FDA would have rejected Plaintiff’s proposed atypical-fracture warning had Merck proposed it to the FDA in September 2010.” Id. at *19. Sure sounds like a “special burden” on preemption to us.

What does that mean in the context of Fosamax? Despite the FDA’s rejection of the defendant’s proposal to warn about the particular risk, the court, enforcing the clear and convincing standard against the defendant (preemption being an affirmative defense), holds that plaintiffs can get to the jury on their contention that the FDA’s rejection, after 10 months of review and back-and-forth, was merely a semantic quibble that the defendant could have fixed. See id. at *21 (“a reasonable jury could also conclude that the FDA rejected [defendant’s] proposed warning about femoral fractures in 2009 not because it denied the existence of a causal link between Fosamax and fractures, but because [defendant] repeatedly characterized the fractures at issue as “stress fractures.”). And when you read the court’s view of what Levine requires to get summary judgment, it leaves us very concerned that such a standard will ever be met: “Because the [Levine] test requires the factfinder to speculate about hypothetical scenarios using inferences drawn from historical facts, reasonable jurors could reach a broad range of conclusions.” Id. at *22.

White the Third Circuit claims its adoption of a clear and convincing standard of proof is less than proof beyond a reasonable doubt, id. at *12, the piling of a special burden of proof atop the standard for summary judgment certainly sounds very close to indisputable proof. We used to be concerned that courts would only find “clear evidence” in the context of an outright rejection of a label change. But even that wasn’t enough in Fosamax to allow the court to find that jurors might not differ in their interpretation of that rejection. And it is those differences which bring us back to the fact that this should be a question for the court, not a jury. For a defense like preemption that is equally operative for all plaintiffs, there should be some element of consistency – which will be eradicated if the decision is left to multiple juries to decide. Moreover, deciding federal preemption is an analytical process where legal training adds value and where testing credibility, something usually reserved for a jury, is not as material.

There remain many questions about how this decision and the Fosamax MDL will play out and we’ll be watching it all closely. Definitely more commentary to come.

If you have been following along for a while, then you have surely run across our posts making some combination of the following points:  1) design defect claims rarely make sense for a drug because changing the design in some material way will usually make it a different drug, 2) such design defect claims, if recognized by state law, will usually be preempted because FDA approval of a different drug cannot be assumed, and 3) courts really should analyze conflict preemption by first determining that there is an actual state law duty that has been asserted or supported (depending on the procedural posture).  One such post walked through why it took so long until a circuit court held that a design defect claim with a prescription drug was preempted.   That case, Yates, has been followed a number of times, including on motions to dismiss, but there are still some glitches.

The decision in Young v. Bristol-Myers Squibb Co., No. 4:16-CV-00108-DMB-JMV, 2017 WL 706320 (D. Miss. Feb. 22, 2017), counts as a glitch on the preemption front even though the court dismissed (without prejudice) the design defect claim and eight of the nine other claims asserted.  The plaintiff claimed to have suffered ketoacidosis and renal failure from taking a prescription diabetes medication right around the time FDA issued a Public Health Advisory about the risk of ketoacidosis for the class of medications, SGLT-2 inhibitors, to which it belonged.  Several months later, the drug’s label was revised to include warnings about ketoacidosis and urosepsis, a blood infection stemming from a urinary tract infection.  Plaintiff claimed that the inherent design of the drug, like all SGLT-2 inhibitors, created a risk of ketoacidosis.  When plaintiff sued, she asserted a wide range of claims and defendants moved to dismiss on various grounds.  We will address only some of them.

Part of our point here is that the order can matter.  We do not have the briefs, so all we can go off of here is the opinion.  After the preliminary issue of whether common law claims are subsumed by the Mississippi Product Liability Act—the four here were—the court starts off the meat of the analysis with this:  “The defendants argue that Young’s claim for defective design must fail because Young has failed to plead a feasible design alternative and because federal law preempts the design defect claims.” Id. at *5. So, what gets analyzed first? Preemption. (Remember, federal courts are supposed to try to resolve disputes on nonconstitutional grounds if they can.) In so doing, the court has to hold out as unresolved whether Mississippi law imposes the very duties that might create the conflict leading to preemption. As the court recognized at the end of its, to us, flawed preemption analysis:

If there is no state law duty, the state law cause of action must certainly fail but there can be no conflict so as to justify preemption. Put differently, the absence of a state law duty is fatal to a claim but not under the doctrine of conflict preemption.

Id. at *8.  This logic suggests that the court needs to decide first whether there is a state law duty to do what the plaintiff urges was necessary.  Because the court never determined that there was such a duty, the whole discussion of preemption seems like a bunch of dictum to us.

Continue Reading Another Court Tackles Prescription Drug Design Defect

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

We’ve been following the Pinnacle MDL closely through the last two bellwether trials, starting with the news coming out of the second bellwether trial of particularly curious and prejudicial evidence being presented to the jury. Given that evidence, we expected a plaintiffs’ victory, an expectation that was borne out with a whopping $498 million verdict. It raised an immediate question: “What will the Fifth Circuit do?”

Well, we’re on our way to finding out. The defense recently filed their opening appellate brief. While it features the controversial evidentiary rulings, much more is in play. If you would like to take a look for yourself, here is the brief.  Below are some of the key issues, along with a quick description of the defense’s arguments:

Design Defect Claim against DePuy (Brief at 20-29): Claim that all metal-on-metal hip implants are defective is not viable under Texas law because a wholly different product cannot serve as a safer design; design claim is preempted because the FDA approved metal-on-metal hip implants; and design claim fails under Restatement (Second) of Torts 402A comment k (adopted in Texas), which recognizes that products like implantable devices are unavoidably unsafe and therefore not defective if properly made and warned about.

Continue Reading Briefing Underway in Appeal of Half-Billion-Dollar Verdict in Pinnacle MDL

This post is from the non-Reed Smith side of the blog.

Within days of each other, courts in Ohio and California entered decisions finding all claims brought against Medtronic’s pre-market approved (“PMA”) pain pump device completely preempted – Warstler v. Medtronic Inc., 2017 WL 769810 (N.D. Ohio Feb. 28, 2017) and Martin v. Medtronic Inc., 2017 U.S. Dist. LEXIS 26350 (E.D. Cal. Feb. 24, 2017). While the two courts eventually reached the same destination – the route each took to get there was a little bit different. So, let’s compare the journey.

Manufacturing defect: In both cases plaintiffs appear to attempt to base their claims on alleged violations of Current Good Manufacturing Practices (“CGMPs”) – general, open-ended, non-device specific regulations. There is a current split in authority on whether CGMPs are specific enough to support a parallel violation claim. We think not. Ohio leaned more toward our thinking on this issue. Plaintiff Warstler failed to allege that the defendant deviated from any “specific FDA-prescribed manufacturing requirement.” Warstler, at *6. Without an alleged violation, plaintiff is essentially arguing that the FDA’s manufacturing process is insufficient. That would make Ohio state law different from or in addition to federal law and therefore the claim is preempted. When the court looked at the CGMPs cited by plaintiff, it couldn’t find one that “is not so vague as to be incapable of enforcement.” Id. at *7. In California, on the other hand, the court found that plaintiff’s allegations about CGMP violations were sufficient to state a parallel claim so that plaintiff’s claim survived express preemption. Martin, at *18-19. But, because plaintiff based his claim entirely on alleged violations of federal requirements, the claim was impliedly preempted. Id. at *19. To have a non-preempted parallel claim, plaintiff must be suing for conduct that violated the FDCA but not because the conduct violates the FDCA. The Martin complaint apparently gave only a cursory nod to the state law basis for his claim, alleging only generally that plaintiff did not take reasonable care in manufacturing. Id. at *20.

Continue Reading A Pair of Pain Pump PMA Preemption Cases

The Reed Smith blogging team has just returned from this year’s annual ACI Drug & Medical Device Litigation conference.  In addition to excessive amounts of eating, drinking, and socializing (now called “networking”), we kept our eyes open for new and interesting topics to blog about.  We were not disappointed.  We learned a lot more regarding preemption of claims involving non-prescription, over-the-counter (“OTC”) drugs, particularly those governed by parts of the FDA’s monograph system that we haven’t considered much before.

We knew, of course, that OTC drug preemption is governed by 21 U.S.C. §379r, which contains not only an express preemption clause, but also a savings clause. Under the preemption clause, tort claims demanding warnings or other information that is “different from,” “addition[al] to,” or “otherwise not identical with” federal labeling requirements are preempted.  However – and it’s a great big however – the savings clause exempts “product liability” claims from preemption. Id. §379r(e).  That doesn’t mean that preemption covers nothing of interest to us.  We’ve discussed at some length how many courts have considered non-personal injury claims to be outside the scope of the “product liability” saving language, and therefore precluded by express preemption.  Most recently, we described a 2014 New Jersey case involving mouthwash that refused to apply a presumption against preemption to the express preemption clause, finding the presumption precedent “confused” and inapplicable.  Bowling v. Johnson & Johnson, 65 F. Supp. 3d 371, 374 & n.17 (S.D.N.Y. 2014).

But what about implied preemption by reason of conflict – specifically the impossibility preemption rationale adopted in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2468, (2013)?  What we heard at the ACI conference sounded good enough to us that we thought we’d investigate it pass along what we found.

Continue Reading Implied Preemption and Monograph Drugs

This post is from the non-Reed Smith side of the blog.

If you’re even remotely interested in the topic of preemption in Pre-Market Approved (PMA) medical devices that were used in an off-label manner, simply search this blog for our Infuse cases. There are dozens and almost all are complete victories for the defense. What occasionally survives are fraud or misrepresentation claims, although they have a tough time meeting the heightened pleading standard of Rule 9(b), or failure to warn claims where a court recognizes failure to submit adverse events to the FDA as parallel to a state law duty to warn physicians. As you’ll easily see from our prior writings, we don’t understand that parallelism at all.

The most recent Infuse victory strikes a blow at each and every attempt by plaintiffs to circumvent, dodge, sidestep, and elude preemption and pleadings standards. And with each by-pass blocked, plaintiffs’ claims had nowhere to go.

As a quick refresher, Infuse is a medical device used to stimulate bone growth in spinal fusion surgeries. It is a multi-component device that received FDA PMA approval for use in single-level, anterior, lumbar surgeries. Aaron v. Medtronic, Inc., — F. Supp.3d –, 2016 WL 5242957, *1-2 (W.D. Ohio Sep. 22, 2016). Aaron is actually a consolidation of the claims of several hundred plaintiffs who alleged they were injured by their surgeon’s use of the Infuse device in an off-label manner. Specifically, they allege the device was either implanted without all of its component parts, implanted posteriorly, implanted at multiple levels, or implanted in their cervical or thoracic spines. Id. at *2. Plaintiffs’ causes of action are fraud/misrepresentation, strict liability failure to warn, strict liability design defect, negligence, and breach of express and implied warranties. Id. Defendants moved to dismiss all claims on several grounds, including most predominantly preemption.

Before getting to the substantive analysis, the court had to consider what pleadings standard to apply. Wait. Isn’t it TwIqbal? What’s the issue? The answer is the Seventh Circuit decision in Bausch v. Stryker. The Aaron plaintiffs alleged that they did not need to plead the specific federal law or regulations that defendant allegedly violated because medical device products liability cases should have a “more permissive” review standard. Id. at *3. Plaintiffs got that idea from Bausch which held that particularity in pleading the specific FDA regulations violated was not necessary due to much of the “critical information” being kept confidential. Id. at *3-4. Many courts disagree with Bausch, including the Sixth Circuit which held in a non-medical device case that a “natural imbalance of information” does not warrant lowering Rule 8’s pleading standards. Id. at *4. The discovery process cannot be used to find sufficient factual support for plaintiffs’ pleadings after the fact. So, Aaron applies TwIqbal, not some watered down version (although the court does state that some of plaintiffs’ claims might not have withstood application of that lesser standard).

Continue Reading Another Slam Dunk Infuse Win – Preemption and More