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With a little luck on our part, by the time you read this we will be vacationing in a sunnier clime.  Our beachfront cottage is an Oddjob’s hat-toss away from where Ian Fleming wrote the James Bond novels.  Mind you, we are not pretending to be serving On Her Majesty’s Secret Service.  If anything, with the secluded location of our holiday, the absurd luxury, and our ever-expanding girth, we are more appropriately cast as a Bond villain.  That suits us just fine.  More than one plaintiff lawyer has called us Dr. No. And more than once, we have reached under our desk, probing for a trap-door button that would plunge an opponent into the piranha pool.

The judge in today’s case, Livingston v. Hoffman-LaRoche Inc., No. 17C-7650-MEA (N.D. Ill. March 7, 2018), pushed the button, holding that there was no personal jurisdiction.  Livingston was yet another Accutane case, with allegations of bowel injury.  We have written frequently on the aggregated forms of this litigation in both the federal and New Jersey court systems.  The Livingston case is different.  To be sure, the Livingston opinion last week was largely an obvious application of the SCOTUS Bauman and BMS cases, but there was a scary threat lurking just off-stage.  More on that later.  Moreover, anything good on jurisdiction from Illinois is noteworthy.


The history of the Livingston case is more complicated than the plot of The World is Not Enough.  The case was originally filed in Cook County, Illinois – a fabulous pro-plaintiff jurisdiction.  The case was then removed.  Then it was remanded — nine years ago.  The case sat in state court with little happening.  The generics got out on Pliva v. Mensing in the meantime, but by then the branded defendant could no longer remove the case because of the one-year bar.  Then the plaintiff lawyers did the defense a great favor (not the last) by taking their one dismissal in Illinois, which allowed them to refile within a year.  The plaintiff eventually did refile in Cook County, and the branded defendant removed.  That’s the case in our sights today.  The case was initially assigned to a different judge, but then it got reassigned to the same federal judge who remanded a long time ago.  The defendant would have been entitled to view that as a bad sign.  But it wasn’t.

So much for foreshadowing.  Here are the facts, at least the ones that matter for this decision.  The plaintiff took Accutane to treat his acne in Wisconsin in 1999 and in Ohio in 2004.  In 2005, the plaintiff had a surgical procedure to remove his colon.  The gravamen of the plaintiff’s lawsuit is that Accutane made this surgery necessary.  More specifically, the plaintiff claimed that the product was defectively designed and was accompanied by inadequate warnings.  But we are getting ahead of ourselves.  The plaintiff moved to Illinois in 2007. There, he was prescribed a generic version of the drug that allegedly caused him the earlier harm, and the plaintiff asserted that his Illinois doctor committed malpractice.  It is because the plaintiff lived in Illinois that he filed his lawsuit there, even though the manufacturer of branded Accutane was not “at home” in Illinois and the branded prescription and the alleged injury occurred outside of Illinois.

It is thus no surprise that the branded defendant moved to dismiss for lack of personal jurisdiction.  The plaintiff filed no opposition.  The Livingston court references a reply brief filed by the defendant.  Presumably, that reply brief was one of those short, triumphal papers pointing out that the plaintiff’s silence amounts to a concession, so a ruling for the defendant should be compulsory and easy.  And, in fact, the dismissal for want of personal jurisdiction was compulsory and easy.  We’ve seen a report on this case in one of the major online legal publications, and for some reason that report focused on general jurisdiction.  That aspect of the decision is certainly the least interesting part.  The manufacturer of Accutane was not incorporated in Illinois and did not locate its headquarters there.  To our mind,  Bauman makes that a no-brainer.
No, for us there are two angles to the decision that are much more interesting.  First, the Livingston court followed what seems to be the emerging consensus rule for federal courts faced with simultaneous issues of subject matter jurisdiction (is there diversity?  is there fraudulent joinder?) and personal jurisdiction (can this particular defendant be sued by this particular plaintiff here?).  Plaintiffs would prefer the district court to handle the subject matter jurisdiction issue first, conclude that the defendant had not met the difficult test for fraudulent joinder, and then remand the case to state court without ever getting to personal jurisdiction.  Defendants would prefer the federal court to look at personal jurisdiction, find it does not exist, and then dismiss the case without ever getting to subject matter jurisdiction.  It turns out the defendants are right and the plaintiffs are wrong (you’re not exactly surprised to hear us say this, are you?) for a simple reason — literally a simple reason: the personal jurisdiction issue is simple, and the fraudulent joinder issue is not.  That is what the Livingston court concluded, alluding to the “enormous judicial confusion” engendered by the fraudulent joinder doctrine, while viewing the personal jurisdiction issue as being “straightforward” and not presenting “a complex issue of law.”  As addressed above, the general jurisdiction prong of personal jurisdiction truly was simple here: no incorporation or headquarters means no general jurisdiction.
The specific jurisdiction prong was almost as simple, though we are mindful that some plaintiff lawyers and some courts now seem determined to make it much less simple.  (We recently read of a court from one of the very worst jurisdictions deciding to tackle the subject matter jurisdiction issue first, because the plaintiffs had successfully muddied the personal jurisdiction waters.  We don’t recall the judge’s name.  Perhaps Blofeld?)  As SCOTUS set forth in Walden v. Fiore, to support the exercise of specific personal jurisdiction, “the defendant’s suit-related conduct must create a substantial connection with the forum state.”  Here, the plaintiff’s Accutane prescription and treatment occurred outside of Illinois.  Predictably, the plaintiff alleged that the branded defendant “marketed, distributed, and sold” Accutane all over the United States, including Cook County.  The answer to that is: So what?  That conduct played no role in the plaintiff’s injury.  What about the fact that the plaintiff does currently reside in Illinois?  Again, Walden supplies the refutation: “[T]he plaintiff cannot be the only link between the defendant and the forum.  Rather, it is the defendant’s conduct that must form the necessary connection with the forum state that is the basis for its jurisdiction over him.”  Go back and read the facts of the Walden case, and you will understand how the plaintiff’s residence, absent some connection to the defendant’s conduct, cannot unilaterally establish specific personal jurisdiction.  End of story.  Push the button. Cue the piranhas.

But there is one additional, potentially interesting aspect of this opinion.  The physician who prescribed the generic version of the drug was, in fact, a citizen of Illinois.  Again, the court regarded this as a big fat So-what:  “The claim against the local doctor did not mention the manufacturer of Accutane, involved the generic product only, “comprises different time periods, and entails different injuries.”  Swell.  But we must admit that as we read the final portion of the Livingston opinion, we were haunted by a spectre.  It is very, very nice that the bottom line of Livingston is that the prescription of a generic drug in Illinois did not create personal jurisdiction over the brand defendant. For a moment, though, a terrible dread wormed its way into our brain-pan.  We alluded above to the fact that Illinois is the home of some awful personal jurisdiction opinions.  Illinois has also been crazy-bad on the issue of innovator liability.  One might have feared that an Illinois court might contrive to find a way to merge innovator liability with the “arise out of”/”related to” prong of specific jurisdiction and thereby keep the case in Illinois. If a branded company can be on the hook for injury allegedly caused by a generic, why not require the branded company come to the forum where the generic was consumed.  An utterly crazy syllogism is at work there.  But Illinois is the one jurisdiction batty enough (well, along with California) to throw out all of tort and jurisdictional law on grounds of foreseeability and misplaced judicial compassion.  Such an outrageous opinion would have made the judicial sky fall. Mercifully, that did not happen in the Livingston case.  Indeed, now defendants have a precedent to argue that it never should.

We offer a tip of the cyber-cap to the winning lawyers, a defense all-star team including longtime friend-of-the-blog Michael Imbroscio (Covington), as well as Colleen Hennessey (Peabody), and Sherri Arrigo (Donohue Brown).

Last year’s list of the Ten Worst DDL cases was remarkable because all ten decisions came from appellate courts.  Yikes.  And it is not as if the bad appellate decisions were spread around.  Two came from our home circuit, the Third.  Two came from the reliably problematic Ninth Circuit.  But the ‘winner’ was the Eleventh Circuit, with three terrible opinions.  For defense practitioners, Eleventh Circuit precedents can create something of an obstacle course. 


It turns out that good federal district judges in SEC country also can be frustrated with what their appellate brethren hath wrought.  Last week we were sent an interesting example of this: Rowe v. Mentor Worldwide, LLC, No. 8:17-cv-2438-T-30CPT (M.D. Fla. March 2, 2018).  In that case, the plaintiff sued for negligence, strict liability, and breach of warranty arising out of injuries allegedly caused by a silicone gel breast implant. The breast implants are class 3 devices requiring premarket approval from the FDA.  The plaintiff’s implants had ruptured.  The plaintiff asserted that the defendant failed to conduct proper studies and failed to warn about known risks.  The defendant filed a motion to dismiss.  The district court wrote a thorough and well-reasoned opinion, concluding that all of the claims save one must be dismissed.  All of the claims would have been dismissed had it not been for a pesky Eleventh Circuit case that is unsound and inconsistent with other Eleventh Circuit cases.  The district judge acknowledged being stuck, but was none too happy about it.  The Rowe court’s opinion is laid out logically, and we will do our best to track it.




The court addresses “a growing plague on the justice system, which has wreaked havoc in this case and numerous others: poorly drafted pleadings.” Slip op. at 4. We get an Iqbal name-check.  The Rowe court recognizes the liberalities of notice pleading, but also recognizes that “[t]here is a point, though, where a pleading becomes deficient not because it lacks sufficient allegations to provide notice of claims, but because it buries those allegations among pages of irrelevant and impertinent material.”  Id. at 5  The complaint in this case was 60 pages, with 151 pages of exhibits.  The negligence claim includes “six separate negligence theories that are confusingly interwoven among each other.”  Id. at 5.  In short, the plaintiff “threw every allegation into the Complaint to see what would stick.”  Id. at 6.  But instead of throwing out the complaint wholesale, the court examined the particular causes of action to see which ones, in fact, would stick.


Preemption Overview


For its preemption analysis, the Rowe court largely relied on the recent Eleventh Circuit decision in Godelia.  That ends up having its ups and downs.  But the general preemption analysis is straightforward enough.  The threshold questions is whether the claims are valid under Florida state law, which governs the case.  If not, those claims are gone.  If so, the next questions is whether those claims are preempted by federal law.


Negligence failure to warn 


The plaintiff does not allege that the defendant failed to give the warning required by FDA. Therefore, the plaintiff must be seeking to impose a warning requirement that is different from or in addition to federal law.  Such a claim is expressly preempted by statute. Slip op. at 9.


Failure to report adverse events 


As any even semi-faithful reader of this blog knows, we think this claim is hogwash.  It should fail both on simple causation grounds as well as preemption.  We wrote about this issue earlier this week.  Some of you might know that the Ninth Circuit is a devilishly bad place for defendants on this issue.  But the Rowe court is not in the Ninth Circuit.  Instead, it is Eleventh Circuit law that supplies the framework, and this is one area where the Eleventh Circuit is pretty good, as it sees failure to report claims under Florida law as essentially alleging a claim of fraud on the FDA, which is preempted by Buckman. Slip op. at 10.


Failure to comply with federal laws 


The claims under this category pertain to alleged breaches of federal requirements and regulations. One example mentioned in the complaint is failure to do required studies.  But Florida law imposes no such requirement. So this claim flunks the preliminary test.  Even if the claim somehow survived that test, it would be impliedly preempted.  Id. at 11.


Negligent misrepresentation  


The plaintiff offered only the most general allegations of failures to disclose the risks of the implants. The court deemed these allegations to fall far short of Fed. R. Civ. P. 9(b), which requires specificity of fraud allegations.  The plaintiff “never identifies what the misrepresentations were, when they were made, how they were made, where they were made, or who made them.”  Id. at 12. In any event, the misrepresentations seemed to involve what was and was not told to the FDA.  Accordingly, those claims are impliedly preempted under BuckmanId. at 13.


Negligence per se 


Violation of a federal statute does not establish negligence per se if there is no federal private cause of action.  No such federal private cause of action exists here.  The complaint does not state a parallel claim, and is therefore impliedly preempted. Id. at 14.


Manufacturing defect 


Everything had been gliding along so smoothly up to this point.  Now we hit a rough patch.  The plaintiff alleged deviations from requirements in the device’s PMA, departures from good manufacturing practices, and vague failures to exercise care in the manufacturing process.  The defendant argued that the plaintiff never pointed to any device-specific requirements. It supported its argument by citing WolickiGables (11th Cir. 2011).  The Rowe court agreed that the Wolicki-Gables standard would require dismissal of the complaint.  But recent Eleventh Circuit decisions in Mink and Godelia cut the other way.  “The holdings in Mink and Godelia are directly at odds with Wolicki-Gables and appear to announce a new standard the Eleventh Circuit is directing courts to apply.”  Slip op. at 16-17.  (We listed Mink as the eighth worst DDL case of 2017.  Here is the post where we explained why we think Mink stinks.)  The Rowe court felt stuck.  Under recent rulings, the plaintiff could conceivably state a claim under parallel requirement.  At the same time, the court recognized that the “negligence count is nearly eviscerated by the Court’s ruling on the other theories.”  Id. at 17.  This, just to ensure there really is some there there, the court directed the plaintiff to replead the one surviving claim in an amended complaint. 


(This kerfuffle over what to do about competing circuit precedents reminds us of our time clerking on the Ninth Circuit, which is so huge and spread out that, believe it or not, inconsistent holdings proliferate.  What to do?  Assume there was  no en banc decision, which is what it should take to alter circuit precedent.  Does a panel need to follow the earlier or later decisions.  Your instincts might prompt you to conclude that it is always the most recent precedent that controls.  But if the recent decision’s reversal of precedent was improper, maybe even illegitimate, because it did not go the en banc route, should it really command respect?  We wrote a bit on this issue last year, as part of our extended Fosamax mourning period, and argued that the earlier precedent should control and the later deviation deserves no respect.)



Strict liability – failure to warn 


The analysis here is the same as for negligent failure to warn, and so is the result: preempted. Slip op. at 18.


Strict liability – manufacturing defect 


Remarkably, the result here is different from the negligent manufacturing defect claim.  For some unknown reason, the plaintiff did not ladle any specific federal requirements into this claim. Instead, the plaintiff simply relied on good manufacturing practices.  Not good enough.  Such allegations do not pass muster under either old or new Eleventh Circuit precedent.  Id. at 18.


Breach of implied warranty 


Plaintiffs constantly toss in warranty claims as an apparent afterthought.  Or maybe it is a no-thought.  The Rowe case is controlled by Florida law, and Florida law requires privity.  That is all perfectly obvious.  Equally obvious is that breast implants are not available for purchase directly by consumers.  The plaintiff pretty much conceded absence of privity and absence of a legal basis for proceeding with this claim, by not responding to the argument.  The court dismissed the warranty claim. 


Final scorecard


All that is left is the negligent manufacturing defect claim.  That should be a hard one for the plaintiff to win.


It occurs to us that good district judges such as Rowe’s are not the only folks who must grit their teeth and do battle with the Eleventh Circuit’s doctrinal wanderings.  Defense DDL practitioners are in the same boat.  We can relate, inasmuch as the Third Circuit (think of Fosamax) has done us few favors lately.  So we commiserate with excellent defense lawyers such as the ones who fought for and won as complete a victory as reasonably possible in the Rowe case.  Congratulations to Dustin Rawlin, Monee Hanna, and Allison Burke of Tucker Ellis, and David Walz of Carlton Fields.



Last weekend we returned to Utah, one of the most beautiful states in the USA.  Over the years we had taken in the polite delights of Salt Lake City, the powderpuff snow of Park City, and the cinematic enthusiasms of the Sundance Festival.  This time was different.  It was an occasion to explore Zion National Park, where wind, water, and time have carved splendor out of the rocks.  The apricot-colored natural amphitheaters put on quite a show in February.  Mule deer didn’t mind us at all as they chomped on rough, stubborn grass, mere feet away from us and a frozen waterfall. We drove through a mile-long tunnel with occasional natural ‘windows’ allowing light in from the canyons.  Every sublime inch of the place, every cactus skirted by snow, every stone arch, every smiling hiker, every helpful ranger, supplied further proof that the National Park system truly is America’s best idea.  If Yellowstone, Yosemite, and Grand Canyon do not already clinch the argument, Zion silences the debate with one long shadow cast from the Court of the Patriarch peaks or one gurgling note from the demure but insistent Virgin River.

It was good to get back to Utah.

Today’s post also gets back to Utah.  Three weeks ago we reported on a federal court decision in Burlingame v. Wright Medical Group, Inc., (D. Utah), a product liability personal injury case involving a hip implant.  The defendant filed a motion for summary judgment.  The solitary vexing issue was whether comment k to section 402A of the Restatement (Second) of Torts applies to medical devices so as to shield them strict liability design defect.  Utah law governed, and it is absolutely clear that Utah law applied comment k across the board to prescription drugs. But what about medical devices?  Our take on that question is to wonder why devices and drugs should be any different.  The need for a prescription should be enough to establish the “unavoidably unsafe” element of comment k, so the issue should be clear.

That’s apparently what the defendant in Burlingame thought, too, as it argued that the federal court had all the case law it needed to apply comment k and dismiss the strict liability claim.  The plaintiff  also was content with existing law, but in a different way, as the plaintiff argued that the federal court could conclude that medical devices fell outside of comment k.  Neither party asked the court to certify the question to the Utah Supreme Court, but that is what happened. It not only happened sua sponte, it happened over both sides’ objections.  That is what we reported on three weeks ago.

But it is not the end of the story.   The federal court then invited the parties to try to agree on what issues should go to the Utah Supreme Court.  Well, inasmuch as neither party wanted to add the Utah Supreme Court to the festivities, should anyone really be surprised that the parties could not agree? The federal court certainly seemed surprised, and more than a little disappointed.   In a new opinion, Burlingame v. Wright Medical Group, Inc., 2018 U.S. Dist. LEXIS 25637 (D. Utah Feb. 15, 2018), the federal court blasts the parties for submitting one-sided, self-serving position papers.  Isn’t that a little like Captain Renault in Casablanca declaring how shocked he is that gambling has been going on at Rick’s Cafe?  Anyway, the federal judge grabbed a pen and crafted the following questions for the Utah Supreme Court to enjoy and resolve:

1.  Under Utah law, does the unavoidably unsafe exception to strict liability in design defect recognized in Comment K to section 402(A) of the Restatement (Second) of Torts apply to implanted medical devices?

2.  If the answer to Question 1 is in the affirmative, does the exception apply to all implanted devices, or does the exception apply only to some devices on a case-by-case basis?

3.  If the exception applies on a case-by-case basis, what is the proper analysis to determine whether the exception applies?

4.  If the answer to Question 1 is in the affirmative, does the exception require a showing that such devices were cleared for market approval through the FDA’s premarket approval process as opposed to the 510(k) clearance process?

Dear reader, we hope you do not think it presumptuous if we draft answers on behalf of the Utah Supreme Court:

1.  Yes, comment k applies to medical devices.  The number of courts that have distinguished between drugs and devices with respect to application of comment k is truly miniscule.  And the reasoning is … unimpressive. Why would Utah want to join such a dreadful, dull minority? But the correct adjective is “prescription,” not “implanted.”  Sure, any implanted device will require a prescription, but there are plenty of other medical devices that fit the unavoidably unsafe bill without being implants.  Ever heard of medical lasers?  Why some plaintiffs or courts fixate on implantation is beyond us.  The permanence of the thing shouldn’t matter.  Prescription drugs don’t stay in the system permanently.  If the court wants to stay parallel (not our favorite word in the DDL universe, but stay with us a moment) with drug comment k case law, the issue is whether or not a doctor’s prescription is required.

2.  The comment k exception should apply to all prescription medical devices.  Across the board.  Case-by-case noodling makes no sense, is a burden on the court, provides no guidance to parties and, all-in-all, is the way of nincompoops.

3.  See, by adopting across-the-board, we’ve already aided judicial economy by freeing you from answering this silly question.

4.  The only thing dumber than drawing a line between implant and no-implant would be to draw a line between preapproval and 510(k).  By the way, the court’s question mucks up the distinction between approval and clearance. More to the point, how does regulatory pathway determine the unavoidably unsafe categorization?  There is no logical connection whatsoever. Either pathway concludes in a determination of safety. You do know about the substantial similarity test, right?  The plaintiffs asked for this horrible question, didn’t they?  (To be fair, this is not the first time a court mixed up the 510(k) vs. PMA issue with comment k.  Last year, we grieved over an 11th Circuit decision that engaged in the selfsame heresy.)

Some of these certification questions strike us as being unsafe, but there is nothing remotely unavoidable about them.

When a drug or device case goes to trial, who is the most important witness?  Let’s straightaway eliminate the plaintiff as a possible answer to that question.  Based on what we’ve heard from jurors (both real and mock), when plaintiffs prevail it is often despite themselves.  So then who?  A credible company witness can turn things around and defuse jury anger over company conduct.  Or that witness can make things much worse by squirming or fencing.  Or the plaintiff lawyers could overplay their hand by overplaying videotaped testimony, thereby boring the jurors into catatonia. What about experts?  Most jurors will tell you they discounted the experts from both sides, viewing paid-for testimony with measured skepticism. 


For our money, the most important witness is often the plaintiff’s prescribing or treating physician.  People trust doctors.  It is easy to see a particular plaintiff’s doctors as practicing medicine, not litigation.  They talk about what they actually did to treat a patient.  It seems that they truthfully recount reality, not merely mouth a script authorized by the lawyers.  Perhaps it is a vast oversimplification, but when we assess cases as being favorable or unfavorable, as being a good or bad case for bellwether trial selection, or when we assess settlement valuation, whether the plaintiff’s doctors offer a thumbs up or thumbs down on the product ranks near the top of the criteria.


Sometimes figuring out what the plaintiff treaters will say amounts to a game of chicken.  We can read the medical records.  That part is easy.  We can depose the doctors on the obvious medical questions about what happened.  But it becomes a bit terrifying when it comes to asking doctors the bottom line questions of whether the product in question actually caused the injury, or whether the doctors would still use the product knowing what they know now.  It’s nice to get helpful testimony, but one is always wary about eliciting testimony that kills one’s case.  If things go kablooey, it is time for the dunce cap and time for a difficult conversation with the client.  So you nibble a bit with your questions here and there, and pounce only if things look really promising.


And then what?  Is the doctor’s opinion – for that is where we are now – admissible?  Can we label it as an expert opinion?  Do we need to disclose the doctor as an expert?  If so, what does the disclosure need to say?  This process can also amount to a game of chicken.  How much or how little of a preview is required?  Playing this game wrong can have severe consequences.


That was certainly the case in Webb v. Zimmer, Inc., 2018 WL 836366 (E.D.N.Y. Feb. 12, 2018).  It is a knee replacement product liability case.  What do we learn from the Webb case?  To begin with, it doesn’t pay to be less than forthcoming with opposing counsel about your expert witnesses.  The plaintiff side did not inform the defense that a treater would also testify as an expert on a key issue, and then tried to bring the witness in as an expert at the last minute, after a summary judgment motion was filed.  That is a classic backfilling operation. The Webb court provides a solid discussion of what treaters can and can’t testify to when no expert report is provided.  Ultimately, the plaintiff was allowed to get away with belated testimony about the doctor’s own response to different warnings, but only at the price of having to pay for having a second deposition of the doctor.  Other non-treatment opinions were excluded. The Webb case offers a decent list of do’s and don’ts.


Let’s flesh out the particulars. 



The physician/maybe-expert was Dr. Unis, who performed a right total knee replacement on the plaintiff using the defendant’s knee flex system.  At the time, Dr. Unis was using this product for all of his primary knee replacements, regardless of the specifics of his patients’ conditions.  That was because Dr. Unis felt “comfortable with the nuances of the system which [he believes] contributes to the success of putting in an implant.”  Ten days after the initial knee surgery on the plaintiff, Dr. Unis remarked that the plaintiff “really looked great.”  But that greatness did not last.  Dr. Unis later performed three revision surgeries on the plaintiff’s knee.  The plaintiff was displeased and filed a lawsuit alleging the usual array of product liability claims.  After discovery and the usual pretrial skirmishes, the plaintiff abandoned her design defect theory and confined her claims to those based on a failure to warn theory.  What was the relevant warning?  It actually seems pretty complete.  It informed the surgeon that soft tissues should be balanced and components positioning confirmed to minimize edge loading.  Under “Patient Counseling Information,” the insert stated that because prosthetic joints are not as strong, some might need to be replaced at some point.



The defendants filed a motion for summary judgment.  In her opposition papers, the plaintiff included an affidavit from Dr. Unis that, among other things, addressed the failure to warn theory, including what Dr. Unis would have done if the warning had been improved. The defendants then sought to exclude the Unis affidavit on the grounds that the plaintiff did not disclose Dr. Unis as an expert witness on the failure to warn elements, and because the plaintiff did not provide the required disclosures under Rule 26(a).


Now let’s turn to a bit of history.  Prior to 2010, when Rule 26(a)(2)(C) was added, as a general rule, parties did not need formally to designate treating physicians as experts or serve expert reports summarizing their opinions in order to bring those treaters in to testify.  Rather, the treating physician was considered a special species of fact witness and could offer medical opinions only if such opinions were formed during the course and scope of treatment of the plaintiff.  Information or opinion that was acquired by the treating physician from an outside source was out of bounds.  Things changed significantly after the adoption of Rule 26(a)(2)(C) in 2010, though not many lawyers seem to know it.  Under the new rule, a treating physician may offer factual testimony as well as opinion testimony regarding his patient’s diagnosis, treatment, prognosis, or causation as long as the proper disclosure is served on the other side.  Rule 26(a)(2)(C) requires a statement regarding “(i) the subject matter on which the witness is expected to present evidence under 702, 703, or 705; and (ii) a summary of the facts and opinions to which the witness is expected to testify.” Fed. R. Civ. P. 26(a)(2)(C). This requirement is much more extensive than formerly had been required for treaters, though still less extensive than expert reports and disclosures required under Rule 26(a)(2)(B) for retained experts.  Without the required disclosure under either Rule 26(a)(2)(B) or Rule 26(a)(2)(C), a treating physician may testify only as a fact witness regarding patient treatment.


In the Webb case, the plaintiff tendered an expert disclosure for Dr. Unis as an expert witness, but provided no summary of his expert opinions, as required by Rule 26(a)(2)(C). Instead, that disclosure revealed that Dr. Unis’s testimony would be confined to his care and treatment of the plaintiff, as well as “causation” and “any other questions that relate to the issue of plaintiff’s damages.”  Not a word was whispered about the effect of the warnings.  Following the initial disclosures, the plaintiff withdrew her initial expert reports for revision, based on her revised theory of the case. Remember, that revised theory centered on failure to warn.  The defense counsel asked about the scope of Dr. Unis’s expert opinions, and made clear that the defense assumed that Dr. Unis would not offer opinions related to the adequacy of the product warnings or that a failure-to-warn caused the injuries.  The plaintiff’s counsel responded that “I am not sure we disagree,” and that Dr. Unis’s opinions would “not be as an expert but as a fact witness to what he observed and concluded about the product and the plaintiff’s physical condition based on his personal experiences in this case.”  Again, there was no hint about warnings. 


The Webb court held that this expert disclosure provided no indication that Dr. Unis intended to testify as to the plaintiff’s failure to warn theory, or that he would utilize outside information to form his expert opinions.  That conclusion seems utterly inescapable. By contrast, the Unis affidavit submitted by the plaintiff in opposition to the summary judgment motion contained Dr. Unis’s “thoughts regarding the adequacy of Zimmer’s warnings or what he would have done differently had he known about any alleged improper warning or contraindication.”  Significantly, the Webb court concluded that “these statements constitute an expert opinion. These paragraphs do not contain treatment explanations or opinions as to the Plaintiff’s diagnoses; these are statements of hypothetical thoughts or actions that involve outside information.”  Wow.  We have always thought that it was pure speculation for a physician to offer post hoc testimony about what he or she would have done had the warnings said what the plaintiff’s lawyer – with 20/20 litigation and medical hindsight – now says the warning should have said.  But Webb now gives defense lawyers an additional ground to repel such testimony:  it is expert testimony that implicates the disclosure requirements of Rule 26(a)(2)(C).  Check your file.  We bet that the plaintiff lawyer did not supply the requisite disclosure.


Unfortunately, the Webb court did not flat-out preclude the belated “expert” testimony about warning causation.  The court held that the plaintiff’s failure to comply with Rule 26(a)(2)(C) did not automatically preclude the affidavit under Rule 37(c). A district court has wide discretion to impose sanctions, including severe sanctions, under Rule 37.  The typical sanctions analysis militated in favor of some sort of sanctions in the Webb case for the plaintiff’s expert shell-game, because the plaintiff offered “no persuasive explanation for not appropriately disclosing Dr. Unis’s expert testimony, which is beyond what is properly given by a treating physician.”  Moreover, the defendants would be prejudiced if the court were to allow portions of the Unis Affidavit to be admitted  — without allowing the defendants to conduct additional discovery.  Thus, the court decided to reopen discovery only to allow the defendants to re-depose Dr. Unis on the failure to warn theory and his affidavit.  The Webb court further ordered plaintiff’s counsel pay the defendants’ reasonable attorney’s fees associated with the renewed deposition of Dr. Unis, as well as reasonable attorney’s fees that the defendants’ incurred in bringing the motion to strike.  Literally, the plaintiff lawyers paid the price for failing to disclose the true scope of the treating doctor’s opinion.  Time will tell whether that price was high enough. 




Our first stint in a law firm was on the transactional side.  Yes, it sounds crazy even to us, but we spent our first 18 months in the profession pulling all-nighters on triple-tier financings of leveraged buyouts, doing clueless due diligence in far-flung back-offices, drafting trust indentures, ‘slugging’ at the printers, and collecting acrylic cubes as gaudy monuments to all those 23 billable hour days.  There was one problem: we labored in pure, unadulterated idiocy.  We would negotiate incessantly over boilerplate whilst the truly important issues crept by us without our paying the slightest attention to them.  Eventually, we were visited by Feedback, that process law students think they want from their future employers but maybe really shouldn’t.  There is something to that ignorance-is-bliss business.  But we were not completely ignorant; we suspected that we were doing a rotten job.  It turns out that we were not alone in that assessment.  Our supervisor gently sat us down and reported that we were becoming widely known as the Deal Doofus.   Every hour we devoted to a matter required two or three hours from a senior associate to remedy.  Our transactional sojourn simply was not working out for anyone.  But we didn’t need to box up our personal belongings, hand in our key-card, and head for the exit just yet.  There was an alternative: get thee to the Litigation Department.  And so we did. 

It is possible we learned nothing from our brief duncitude in the Corporate Department save a little bit of humility.  Then again, we might have learned this: if you acquire a corporation via merger or stock sale, you also acquire that corporation’s tort liabilities.  By contrast, if you acquire the corporation’s assets, you probably don’t acquire the tort liabilities.  As a product liability litigator, we have come to know this as the issue of successor liability.  That issue enjoys its own mention in this blog’s index, which you can find to the lower-right side of this post.  Perhaps we do not bloviate over that topic nearly so much as preemption, but it can be important.  It can be a get-out-of-jail card, a way of extricating a client from a case before the hyper-expensive merits-discovery machine gets rolling.

Shortly before the end of 2017, we wrote a post entitled “EDNY Rejects Successor Liability in Hip Implant Case.”  That case involved product liability claims against a hip implant manufactured by Portland, an Australian company, that had sold its assets before the plaintiffs filed their action.  One of the parties sued by the plaintiffs was Portland, but that went nowhere because it was apparently judgment proof.  The plaintiffs also sued the company that acquired the assets, including the hip implant business.  Applying both New York law (because it governed) and Pennsylvania law (because it was fun),  the court held that there was no successor liability because the acquirer had not expressly assumed liability, there was no continuity of ownership or management, it was not a mere continuation of the business, and the acquisition was not a fraudulent effort to evade liability.  The court also looked at whether the product line exception – available under Pennsylvania but not New York law – might save the case for the plaintiffs.  The answer was “No” because the acquisition did not cause the former company’s insolvency, and the acquirer did not purchase the predecessor’s good will.  Part of the rationale of the product line exception is that a company should not profit from the predecessor’s good will whilst also dodging responsibility.  But that did not happen the in the EDNY case.

It also did not happen in the case we discuss today, Gentle v. Portland Orthopaedics Ltd., 2018 WL 771333 (E.D. Wash. Feb. 7, 2018).  That case applied Washington state law and also concluded that successor liability, whether viewed through traditional principles or the dreaded product line exception, did not apply to the product liability claims.  The claims were similar to the EDNY case. The defendants were similar.  The analyses were similar.  So were the results.  Perhaps we have an area of drug and device liability law that is pretty well resolved.   

In Gentle, the plaintiffs argued that the defendants were liable as manufacturers/sellers under the doctrines of successor liability, acting in concert, agency, and vicarious liability.  The actual manufacturer (Portland, just as in the EDNY case we blogged about last December) went bankrupt.  The moving defendants acquired substantially all the assets associated with the hip implant product line.  Standard successor liability would not work here, because we have none of the following:  (1) the purchaser expressly or impliedly agrees to assume the obligations of the predecessor; (2) the transaction amounts to a consolidation or merger; (3) the purchasing corporation is merely a continuation of the predecessor; or (4) the transaction is fraudulent and intended to escape liability.  But the Washington Supreme Court adopted the product line liability rule, so we’re not done yet. 

The theory behind the product line liability rule is that the “benefit of being able to take over a going concern manufacturing a specific product line is necessarily burdened with potential product liability linked to the product line.” To prove product line liability under Washington law, a plaintiff must show that the product line transferee: has acquired virtually all of the transferor’s assets; holds itself out as a continuation of the transferor by producing the same product line under a similar name; and benefits from the transferor’s goodwill.  Washington law also limits the product line liability rule to cases where the predecessor corporation must be unavailable as a source for the plaintiff’s remedy and the successor corporation must have contributed to the predecessor’s unavailability.  The plaintiff argued that that last requirement of causation was not truly part of the test, but lost, and that’s too bad for the plaintiff because the court concluded that the successor companies “did not cause the destruction of Plaintiffs’ remedy against Portland Ortho.”  Further, the plaintiffs did not demonstrate that the defendants had acquired substantially all of Portland’s assets.  For instance, they did not acquire assets related to the manufacture and distribution of the hip implant product line outside the United States, nor did they acquire accounts receivable, cash, contracts, or goodwill.  Just as in the EDNY case, the failure to acquire goodwill was a key point in the court’s reasoning:  “Under Washington law, product line liability contemplates the benefits derived from the goodwill of the corporation, not a single product line.”  Indeed, the plaintiffs conceded that the original manufacturer had no goodwill at the time of the asset purchase.  Thus, the Gentle court had no problem granting summary judgment to the plaintiff.

So if any of you litigators have to play transactional lawyer sometime in the future, or if you are merely rendering advice to colleagues working on an acquisition, do not be shy about advising them to choose an asset purchase over a stock purchase if possible, to find some assets to exclude from the deal, and no-way-no-how buy the goodwill.  Maybe the result is that you’ll have one less litigation to handle down the road, or maybe such litigation will be way easier to win.  Either way, your client will likely be happier.



Strict liability is not the same as absolute liability.  We learned that truth in law school, but too many plaintiff lawyers and judges seem to have unlearned it along the way.  The key separator between strict liability and absolute liability is comment k to section 402A of the Restatement (Second) of Torts (1965), which observes that “[t]here are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use.”  Think of dynamite, for example.  More pertinent to our practice area, comment k included prescription drugs and vaccines among its examples.  But it did not mention medical devices.  That is probably because comment k antedated anything approximating the degree of regulation of medical devices we enjoy today.  In any event, we are left with this question: does comment k apply to medical devices?  If so, which ones?

This is not the first time that we have faced this issue.  Back in 2011, we authored a magnum opus called “Comment k, Some of the Way.”  To this day, it is one of our most widely read posts.  The question keeps cropping up, as product liability plaintiffs keep trying to minimize the scope of comment k.  One simple way of bifurcating judicial treatment of comment k is “across-the-board” versus “case-by-case,” but that misses some nuances.  In 2015, in a post charmingly entitled “How Does a Bad Idea Get Implanted?” we blasted the commonplace California plaintiff argument that comment k applied to medical devices only if they were implantable.  As we demonstrated, that argument lacked sense and support, and the real issue should be whether the medical device required a doctor’s prescription. Tongue depressors come with neither prescriptions nor comment k protection, but, say, medical lasers should come with both.  In 2017, we revisited the issue to look beyond California, finding cases in other jurisdictions applying comment k to medical devices. It is an important issue, and it keeps surfacing.  Here is another post where we scrutinized the contours of comment k. So, is it unusual for courts to apply comment k to medical devices?  Not at all.  Take a look at our favorite reference book, Beck/Vale, Drug and Medical Device Product Liability Deskbook, section 2.02[2] and footnote 14.  There are literally hundreds of cases that have applied comment k to medical devices, in the same way they apply it to prescription drugs. 

Recently, the scope of comment k surfaced in Burningham v. Wright Med. Grp., Inc., 2018 U.S. Dist. LEXIS 10726 (D. Utah Jan. 23, 2018).  In that case, the plaintiff alleged injuries from an implanted hip device.  The design defect claims were premised on a theory of strict liability.  The defendants argued that the hip implant was an “unavoidably unsafe” product and was, therefore, categorically barred from design defect claims. Utah law controlled and the Utah Supreme Court has adopted the comment k “unavoidably unsafe products” exception to strict products liability.  But while the Utah Supreme Court has explicitly applied comment k to prescription drugs (categorically, not case-by-case), it has thus far been silent on whether comment k reached medical devices.  The defendant in Burningham argued that the doctrine regarding unreasonably unsafe products should apply equally to the medical device at issue.   

The Burningham case has traveled a circuitous path through the judicial system.  It was filed in California state court, then became part of a coordinated proceeding, then was released from that proceeding, then was moved by consent to the federal court in Utah.  Meanwhile, there is a federal MDL in Georgia dealing with design defect claims against these same hip implants.  Not so long ago, we authored a screed against a decision in that litigation involving what we saw as a complete misreading of Utah law on … wait for it .. comment k.  The Georgia federal court did not apply comment k to the medical devices and, just for good measure, completely mangled Utah law on design defect.  We were disappointed. Then the Eleventh Circuit affirmed the horrible result and wretched reasoning.  We were disappointed again.

So we have some history with this topic.

You will not be surprised to hear that we agree with the defense argument that Utah law should and would include hip implant medical devices as “unavoidably unsafe” products warranting comment k protection. The Burningham court stated that the defendant pointed “to decisions from courts in Oklahoma, Washington, California, and Pennsylvania, which do apply the doctrine to implanted medical devices.”  Yikes – there’s that unnecessary/wrong restriction to implanted devices, but since the devices in Burningham definitely were implanted one can see why the defendant in that case would take the most conservative approach.  If the federal court was going to try to predict which way the Utah Supreme Court would go, the broader reading of comment k, which would include medical devices, would probably prevail. But because the “question of whether the categorical exception applies to implanted medical devices is a question of first impression for Utah courts,” the federal court sua sponte (on its own) decided to issue an order certifying the issue to the Utah Supreme Court.  Our bet is that the defense will persuade the Utah court to extend comment k to medical devices.  Just don’t dig in too hard on the question of implantation.  Leave us room later to argue that comment k should apply to all prescription medical devices, please-and-thank-you.

Meanwhile the federal court was in a perfectly fine position to dismiss the misrepresentation and breach of warranty claims for lack of reliance.  The complaint supplied conclusory allegations of generalized reliance, but never listed any factual allegations that the plaintiff or his doctors “actually read or saw Defendant’s misrepresentations” and the complaint contained “no allegation that the Defendants’ express warranties were ever communicated to Plaintiffs or Mr. Burningham‘s physicians.”  The complaint could not “withstand the Twombly/Iqbal analysis.”  So much for those claims, and now it is up to the Utah Supreme Court to read comment k correctly and pave the way for dismissal of the strict liability claims. 


Having worked in the federal government, we are familiar with how important Department of Justice Guidance Policy memoranda can be.  They set priorities, outline criteria for acceptable guilty pleas and sentencing factors, and can make a huge difference in terms of who gets indicted or sued for what, when, and under which circumstances.  These DOJ guidances are seldom secret.  They can make quite a splash and set in motion a series of CLE conferences, complete with client glad-handing, Statements of the Obvious, and rubber chicken lunches. 


Now that we work on drug and device law, we are familiar with how important Food and Drug Administration Guidances can be.  They can address all sorts of things, such as off-label communications, social media, 510(k) submissions, cybersecurity, and 3D printing, just to name a few.  They, too, inevitably prompt a series of CLE circuses.  We have also become familiar with the propensity for plaintiff lawyers to hire FDA ‘experts’ who skillfully turn to the jury at just the right moment, break out in a wise and world-weary grin, and spin a tale of how the corporate malefactor broke the law.  It is, frankly, a mystery to us why some judges permit these travelling pseudoexperts to instruct the jury on the law,  and it is even worse when the experts’ legal opinions are not close to being legally sound.  For example, think of cases where an expert pretend-ruefully lays out a company’s purported violation of some FDA guidance (a violation, by the way, that the FDA itself has not decried), that is not even an actual violation of law.  What we have in such cases is a faux negligence per se theory – call it negligence per say so.


We’re now more than a month past Christmas, but the federal government seems to be handing out swell presents to the drug and device defense bar.  We wrote earlier this week about the Pharmaceutical Information Exchange Act, which is pending in the House of Representatives and which would introduce a rare note of sanity into the controversy over off-label communications.  A couple of weeks ago we praised the FDA’s decision to postpone implementation of its execrable “intended use” rule.  Today, we have the good fortune to report on the DOJ’s January 25, 2018 announcement that “Guidance documents cannot create binding requirements that do not already exist by statute or regulation.”  This remarkably refreshing policy flows from the Attorney General’s November 16, 2017 Guidance Policy, which stated that government guidances, which are not subject to the notice-and-comment rulemaking process, cannot bind the public.  The Attorney General in November 2017 was talking about DOJ guidances, but last week’s announcement makes clear that the same principles “should guide Department litigators in determining the legal relevance of other agencies’ guidance documents in affirmative civil enforcement.”  Thus, going forward, DOJ “litigators may not use noncompliance with guidance documents as a basis for proving violations of applicable law” in civil enforcement cases.  To the extent that guidances offer a useful paraphrase from existing statutes or regulations, they might be relevant.  To the extent that a defendant read a specific guidance, that fact could conceivably establish knowledge of a legal mandate that can be traced to a statute or regulation.  But the government cannot “treat a party’s noncompliance with an agency guidance document as presumptively or conclusively establishing that the party violated the applicable statute or regulation.”


At first blush, this new guidance will have immediate and profound effects on actions brought by the government against health care companies under the False Claims Act.  Too many of those actions are premised on no actual false statement and no actual violation of a statute or regulation.  Instead, these FCA cases have been permitted to go forward and exercise their in terrorem effect based on some vague violation of vague FDA guidances.  Even if not vague, an FDA guidance has no real legal effect.  The DOJ’s recognition of what guidances are and, more importantly, what they are not, should have the effect of cabining FCA actions in some reasonable and predictable fashion.  (If you think we are leaping to an unwarranted conclusion about what looks to us like the government’s concern about overreaching FCA cases, consider the fact that on January 10, 2018 – shortly before the policy guidance that inspired this post – the government published another policy memorandum, and that memorandum set out the factors that government attorneys should take into account in deciding whether the government should dismiss unmeritorious qui tam lawsuits.  QED.)  Since January 25, some defendants in qui tam cases have already filed motions based on the new DOJ policy.  If you represent a qui tam defendant, and if the complaint cites an alleged violation of an FDA policy, you might want to file a motion.  


What about civil cases brought by private plaintiffs?  The DOJ closed its January 25 announcement of the new policy by stating that “it is not intended to, does not, and may not be relied upon to, create any rights, substantive or procedural, enforceable at law by any party in any matter civil or criminal.”  That is all fine and good and is a typical  of careful draftsmanship.  But why wouldn’t the DOJ announcement strengthen an argument that we have already made (here, for example) that FDA guidances are only what they say they are – guidances – and are not laws or regulations?  Such guidances  have no legal effect on defendants, certainly do not establish negligence per se, and should not be in the bag of tricks of some plaintiff FDA expert who seeks to invade the province of both jury and judge.  Maybe a court will not consider the DOJ’s guidance to be binding, but wouldn’t it be fine if the court at least took the guidance as a worthy source of … guidance?    




There are plenty of f-words in this post, but fear not, for they are all fully capable of traveling in polite company. Most are even family-friendly. The most tasty f-word here is the “F” in FDA: food. While we focus on drug and device cases in this blog, we frequently find that food cases furnish fine fodder for some of the legal issues we fiddle with, such as in this 2008 post on food as a four letter word.  Food cases can also suggest flanking maneuvers to prop up our favorite f-word defense, federal preemption. For example, feast your eyes on the recent case of Organic Consumers Ass’n v. Hain Celestial Grp., Inc., 2018 U.S. Dist. LEXIS 1053 (D.D.C. Jan. 3, 2018). The plaintiff alleged that the defendant’s infant formulas were falsely labeled as “organic” because they contained products that flunked the federal Organic Food Production Act of 1990 (“OFPA”). The defendant filed a motion to dismiss the complaint on the ground that private enforcement of organic labelling is preempted by the OFPA.

The court fastidiously began with the standing issue, and held that the Organic Consumers Association had standing to sue. Then the court forfeited some more goodwill with us by presuming that “Congress does not cavalierly preempt state causes of action.” Such reference to a presumption against preemption is foolish and makes us feel forlorn. (As we have blogged before, the presumption against preemption has fallen by the wayside when it comes to express preemption.)  At this early point in the decision, we are fidgeting and fuming. But then the court mentioned another, much more formidable principle: that “the purpose of Congress is the ultimate touchstone.” That further point should foreclose the need to indulge in any feckless presumption against preemption, because, in enacting the OFPA, Congress made forcefully clear its purpose to establish national standards for marketing organic products, to assure consumers of consistency, and to facilitate interstate commerce of organic products. These purposes were folded into a USDA final rule that created the National Organic Program, with regulations requiring that a product can be sold as “organic” only if it contains at least 95% organically produced products, with the remaining five percent consisting of synthetic ingredients included on a “National” list. The OFPA also provides for a “certifying agent” to certify a manufacturer’s fidelity to an approved organic plan.

The products in question in the Organic Consumers case were certified, but the plaintiff argued that such certification is not synonymous with OFPA compliance. The plaintiff argued that its lawsuit would not foil the federal scheme but, in fact, was faithful to it. That position seems to be, in a literal sense, fantastic. The plaintiff’s position certainly failed to convince the judge.

This is not the first case to face the issue of preemption under the OFPA. Far from it. In the only appellate case on point, In re Aurora Dairy Corp. Organic Milk Mktg. & Sales Practices Litig., 621 F.3d 781 (8th Cir. 2010), the Eight Circuit held that any attempt to hold the defendant liable under state law for products mislabeled as organic would directly conflict with the OFPA and the role of the certifying agent. The Eighth Circuit rejected the defendant’s express and field preemption arguments, but concluded that the plaintiff’s lawsuit present an obstacle to the federal scheme. Permitting private suits to challenge the federal certification of a product as “organic” would result in different interpretations and different enforcement, inevitably plunging manufacturers and consumers into a fog of confusion. Based on the fundamental need for uniformity, the plaintiff’s claims were fatally preempted.

We are unabashedly fond of the Aurora case, and we are hardly alone. F. Supp. 3d is filled with cases that followed Aurora’s reasoning. (We will not make the mistake of praising the Aurora court for its “fulsome” reasoning. “Fulsome” is not a dressed-up stand-in for other, perfectly adequate words such as “complete,” “thorough,” or, perish the thought, the simple, direct “full.” Most uses in our presence of the word “fulsome” are wrong.  We become flush and fight hard to contain our fury. You see, we adhere to the primary dictionary definition of “fulsome” as “excessively flattering.” Yes, we have become fossilized. We follow Fowler’s Modern English Usage – the oldest, crankiest edition. Get off our lawn.)

But, of course, there is one pesky fluke out there: Segedie v. Hain Celestial Grp., Inc., 2015 U.S. Dist. LEXIS 60739 (S.D.N.Y. May 7, 2015). Not to put too fine a point on it, but the Segedie is not a favorable decision to those of us who are fans of preemption. The reasoning in Segedie is sheer folly, but one cannot be sure that some other courts won’t flock to its flawed logic just because of SDNY’s fame. The Segedie court found fault with Aurora‘s preemption analysis, and concluded that private enforcement of what is and is not “organic” would boost consumer confidence, and that the risk of divergent interpretations did not present a “sharp” obstacle to uniformity. That logic is hard to fathom. We were not aware that the degree of “sharp”-ness – whatever that is – is a factor in preemption analysis.  Segedie is a flop.

The Organic Producers court sided with Aurora and declined to adopt the faux reasoning of Segedie. Permitting a plaintiff to sue on the basis that a product labeled and federally certified as organic is not, in fact, organic runs afoul of all three purposes of the OFPA:

1. Local fact-finders can be fickle and there is no reason to expect uniformity from their outcomes. Forget about ever having a national standard. What is “organic” in Florida might not be on F Street in D.C.
2. Consumers would be flummoxed by the different rules governing what is and is not organic.
3. Rather than foster interstate commerce, the differing outcomes would provide the worst possible feedback to food manufacturers – they would not be able to sell their products in certain parts of the country where some jurors decided that the “organic” should be forbidden for such products.

Naturally, the plaintiff fought against the flow of this reasoning. The plaintiff made a foray into the usual anti-preemption fallback position that states can impose more restrictive standards. But the plaintiff forgot that the federal system included an enforcement system that never mentioned private enforcement but, rather, forged a system of inspections, compliance reviews, suspensions or revocation of certifications, and other civil and criminal penalties. Permitting private enforcement would be unnecessary and would flirt with disaster.

We are not merely fond of the Organic Producers because it is a fair statement of food preemption. Nope. We think that Organic Producers represents a return to first principles of preemption law, which are just as applicable to personal injury drug and device litigation as to food labeling. Flipping issues of drug or device product defect and adequate warning to various jurors scattered around the country, including jurors flailing about in that fever-dream litigation festival known as an MDL, wrecks uniformity, fans the flames of confusion, and is a fist to the gut of interstate commerce. Rather than flatter jurors, we ought to acknowledge that their foibles and the varying, frenzied, irrational outcomes they permit plaintiff lawyers to foist on the public are a rotten way to fix health and safety problems.

The pro-preemption holding in Organic Producers flat-out makes sense. It should flourish. It should be the way forward.

Perhaps you have heard that elections have consequences. That is true not only for high-profile issues that hog the headlines on CNN and Fox News, but it is also true for drug and device litigation regulation. Such drug and device regulation can be just as important, if not considerably more important, than whatever current political claptrap is getting all the bandwidth.  Drug and device availability and innovation actually affects people’s lives regularly and profoundly. Despite the typical claims of plaintiff lawyers at trial, the FDA is not a paper tiger.  The FDA’s actions and attitudes have a huge impact on the industry.  Those attitudes and actions can oscillate with election results. For example, in 2016, the FDA issued 15 warning letters to drug and device manufacturers regarding alleged false or misleading advertising. 2017 saw only three such warning letters and one untitled letter.  Change is in the air.  We did not see any coverage this weekend of the FDA’s January 12, 2018 statement “on FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‘intended use’ of medical products.”  Take a look at the FDA’s announcement here:  If you are a completist, here is the full proposal of delay from the Federal Register:  Whatever else you might think about the Trump vs. Obama administrations, this rethink is an example of the new FDA leadership doing the right thing.

The background is a bit byzantine.  In the waning days of the Obama administration, on January 9, 2017, the FDA issued a Final Rule on “Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses.’” That “clarification” was both a trick and a double-cross.  The tobacco features were a distraction from the FDA’s desperate attempt to save its constitutionally-suspect enterprise of clamping down on communications about off-label use of drugs or devices.  As we have described several times before, the FDA’s power to punish off-label promotion rests on a regulatory two-step, whereby off-label promotions are said to prove an indicated use not included in the label and, thus, not accompanied by adequate directions for use – making the product misbranded. Got that? The regulations supporting this tortured logic have been around since the 1950s, but a recent series of court decisions invoking the First Amendment called into question the FDA’s interpretation of “intended use” and its efforts to shut down truthful medical-science communications about potential benefits from off-label use.  In a 2015 proposed rule, the FDA proposed striking the language from the regulations permitting the FDA to consider a manufacturer’s mere knowledge of actual use as evidence of intended use. Good news, right? We thought so.  But not so fast. The FDA’s January 9, 2017 proposal reversed course, retained knowledge of off-label use as evidence of intended use, clarified that any relevant source of evidence, whether circumstantial or direct could demonstrate intended use, and ultimately invoked the dreaded “totality of the evidence” standard.  A constitutionally frail regulatory regime looked like it was about to become even worse – even more vague, over broad, and chilling.

We bemoaned this ugly turn of events, as did many other legal commentators.  Not to take undue credit, but we suspect that the eruption of the legal blogosphere on this issue had a beneficial result.  The incoming Trump administration placed a brief hold on new regulations, and then delayed the “intended use” regulation to March 19, 2018 so that comments could be received and considered.  Did comments pour in?  Yes they did.  Fifteen comments came in.  Two addressed the tobacco issues.  (That portion of the regulation will go forward.)  Thirteen criticized the new broadening of the types of evidence that could be considered in determining intended use.  One of those comments was written by PhRMA.  We summarized that excellent, persuasive comment here.  Read as a whole (or, if you prefer, the totality of the circumstances), the comments made a strong case that the proposed final rule violated the First Amendment, was so vague as to implicate due process, interfered with the practice of medicine, departed from existing statutes, cases, regulations, and past practices, and would have negative health implications.  You all spoke up, and the FDA listened. The bottom line is that the FDA is now proposing to “delay until further notice” the portions of the final rule amending the FDA’s existing regulations describing the types of evidence that may be considered in determining a medical product’s intended uses.  The FDA will receive comments on this proposal through February 5, 2018.  If you haven’t spoken up on this very important issue, speak up now.  How many times in your life and career can you take a position that actually makes a difference, and that both saves lives and free speech?

We sometimes spend time on this blog grousing.  Not this time.  Well done, FDA. Well done, all of you who contributed to the debate.

Today we are talking about a case that is not exactly in the heartland of what we generally examine.  It is not a product liability or mass tort case.  But it is reasonably close.  It is kind of an off label promotion/False Claims Act case.  Okay, let’s admit what it really is: a wrongful discharge/employment case.   The plaintiff alleged that she was constructively discharged because she blew the whistle on what she perceived to be unlawful off label promotion.  The notion of causation is front and center.  The causation issue is always near and dear to our defense hearts.

And yet.  And yet.  Not so long ago we watched a mock jury reach agreement that whether or not the product caused the plaintiff’s injury, the mock jurors were hell-bent on awarding damages.  The jury decided that there were things about the company’s conduct that could be improved, and their verdict would set such improvements in motion.   Swell.  The mock jurors were essentially mocking the jury instructions.  Causation-schmausation.  We shudder at the realization that real, not mock, jurors also do this.  Every. Damned. Day.

Today’s case is also literally near to us, because it was authored by the Third Circuit, which is just down the street from several of us DDL blogsters.  It is also apparently a decision of first impression on the appellate level — that a “but for” (and not a lesser “motivating factor”) causation standard is necessary for FCA retaliatory discharge claims.  So sit back and take in this DDL-adjacent blogpost, wherein we lay out a significant ruling on a significant issue by a significant court.

The case is DiFiore v. CSL Behring, LLC, 2018 U.S. App. LEXIS 92 (3d Cir. Jan. 3, 2018), and is primarily focused on the federal False Claims Act (FCA) anti-retaliation provision protecting employee-whistleblowers who engage in activity protected by the FCA.The district court granted summary judgment in favor of the employer on the wrongful discharge claim because the plaintiff had failed to show constructive discharge as a matter of law. Then the FCA retaliation claim proceeded to trial. The judge instructed the jury that the FCA retaliation provision required that protected activity be the “but-for” cause of adverse actions against the employee. In the jury instruction, the judge listed some, but not all, of the alleged adverse actions.  The jury found in favor of the employer.  On appeal, the employee raised three arguments:  (1) the court improperly granted summary judgment on the state law wrongful discharge claim; (2) the but-for causation standard for retaliation was too exacting; and (3) the court erred by not listing all the alleged adverse actions in its jury instruction.  That middle issue is the reason you are reading about the DiFiore case on the DDL.  Otherwise, you’d have to run to an Employment Discrimination Law (EDL) blogpost to find out about it.

The Third Circuit rejected these arguments and affirmed the decisions below.  We will get to the Third Circuit’s analysis momentarily, but let’s first supply a bit more background.  The plaintiff in DiFiore had risen to Director of Marketing. That’s a pretty high position for a whistle-blower.  The plaintiff took issue with what she saw as off-label marketing strategies, such as reference to off label sales in forecasts.  The plaintiff expressed her concerns to her supervisors, and she claimed in her lawsuit that the company initiated a third-party compliance audit in part because of her complaints.  So far so good.  But the plaintiff contended that, as a consequence of her protected conduct, she suffered several adverse employment actions, including warning letters about her interactions with other employees and failure to pay off her company credit card charges, an uncharacteristically poor performance review, deteriorating relationships with supervisors, diminution of duties, removal from a committee, and a Performance Improvement Plan (PIP) that she interpreted to be a death knell.  The PIP required improvement the designated areas within 45 days or she could be subject to discipline up to and including termination.  According to the plaintiff, most employees hit with a PIP were eventually terminated.  After receiving the PIP, the plaintiff reached out to a supervisor and an HR employee and requested a meeting to discuss an amicable separation.  The meeting was canceled for unspecified reasons.  Then the plaintiff resigned.  Then the plaintiff sued.

1.  Wrongful discharge

The plaintiff in DiFiore was not actually fired, so she needed to allege constructive discharge.  Under Pennsylvania law, constructive discharge occurs when working conditions “are so intolerable that a reasonable employee is forced to resign.”  The court concluded that while the plaintiff might have been subjected to difficult or unpleasant working conditions, those conditions fell well short of being unbearable. You might (certainly a plaintiff lawyer would) suggest that the difference between unpleasant and unbearable could be a jury question.  But the court emphasized that the plaintiff “did not sufficiently explore alternative solutions or means of improving her situation. She made no attempt to comply with the PIP.”  She chose to resign rather than reschedule the canceled meeting.  None of that was disputed. Based on those facts, the court held that no reasonable jury could find constructive discharge.

2. But-for Causation for Retaliation

This is the issue that most interests us.  We more than occasionally noodle over False Claims Act cases, off label promotion, and a little thing called causation.  Under the FCA’s anti-retaliation provision, an employee is entitled to relief if she was “discharged, demoted, suspended, threatened, harassed, or in any other manner discriminated against in the terms and conditions of employment because of lawful acts” conducted in furtherance of an FCA action. 31 U.S.C. § 3730(h)(1).  The district court (we are in an Inn of Court with this Judge, and he is lightning smart and relentlessly fair, by the way) ruled that the plaintiff was required to show that her protected activity was the “but-for” cause of an adverse action.  Thus, that standard found a home in the jury instructions.  The plaintiff in DiFiore argued that a lower standard applies and she should have been required to prove only that her protected activity was a “motivating factor” in the adverse actions taken by the employer.  That “motivating factor” resides as dicta in an earlier Third Circuit decision, but in the meantime SCOTUS came out with a pair of decisions interpreting identical “because of” language in similar statutes (ADEA and Title VII) to require that illegal motive (age-ism or retaliation) be the “but-for” cause of the employer’s adverse action. Even if the earlier Third Circuit “motivating factor” language was not mere dicta, the intervening SCOTUS precedents controlled (there was no need for an en banc call), so the district court got it right.  The jury was properly instructed, and the defense verdict was affirmed.  Lesson for DDL practitioners: even if you do not do much employment work, remember that statutory “because of” language translates into a but-for standard.

3. Listing of adverse employer actions

The plaintiff contended that the district court’s inclusion of only four of the alleged adverse employer actions in the jury instructions—the two warning letters, the mid-year performance review, and the PIP—may have confused the jurors and led them to believe that they were not permitted to consider evidence of other incidents beyond those four events. But the Third Circuit took in the totality of the circumstances below, including that the district court correctly instructed the jury that its determination should take into account the totality of the circumstances. The district court instructed the jury that the four events occurred “among other things.” The district court’s list was, on its face, illustrative, not exhaustive.  It is hard to say that the district court got it wrong, and it is impossible to say that the omission of certain examples was prejudicial.  The district court’s failure to follow the plaintiff’s list exactly could not be a basis for reversal.