Friday, August 29, 2014

Help With California’s Learned Intermediary Doctrine . . . From West Virginia


While we are often critical of federal courts that reach out to make new state law, today we commend a far-away judge for bringing California’s learned intermediary doctrine law back to its basics.  The case is Sanchez v. Boston Scientific Corp., No. 2:12-cv-05762, 2014 U.S. Dist. LEXIS 114122 (S.D. W. Va. Aug. 18, 2014), which is one of many cases in the various pelvic mesh MDLs currently ongoing in West Virginia.  In Sanchez, the defendant surgical mesh manufacturer moved for summary judgment with mixed results, but we like the district court’s no-nonsense approach to the learned intermediary doctrine.  The district court also ruled on design defect, punitive damages, and preemption, which we will get to at the end.  For now, the focus is on our favorite topic, the LID. 
The best part is the court’s rejection of the plaintiffs’ argument that the learned intermediary doctrine “does not apply when a plaintiff alleges that a manufacturer failed to adequately warn a plaintiff’s doctor of a device’s risks.”  Id. at *5.  This, of course, is a silly argument, but it is based on careless language in a number of cases applying multiple states’ laws, including California.  Some courts have said that the learned intermediary “does not apply” when the plaintiff alleges inadequate warnings, but they really mean that the defendant can be liable under the learned intermediary doctrine for an inadequate warning if all the elements of a failure-to-warn claims are established. 
The district court in Sanchez was not fooled:

The learned intermediary rule is part and parcel of a failure-to-warn analysis in California.  Under the learned intermediary rule, manufacturers of prescription drugs and medical devices satisfy their duty to warn if they provide adequate warnings to the prescribing physicians, rather than the patients.  A pharmaceutical manufacturer is not required to warn anybody other than prescribing physicians about the dangerous propensities of their prescription drugs and medical devices.  Period. 

            In order to satisfy the element of causation under the learned intermediary doctrine, a plaintiff must demonstrate that the prescribing physicians would have acted differently had he or she received adequate warnings.

Id. at *7 (Emphasis added, citations omitted).  The learned intermediary doctrine therefore regulates cases where the warnings allegedly were inadequate.  That is to say, it not only “applies,” it is the governing principle, which makes it a total non sequitur to say that it would not apply where plaintiffs alleged inadequate warnings. 
For those for whom this point is not self-evident, the district court explained it this way:

To the extent that . . . cases suggest that the learned intermediary doctrine has no effect where plaintiffs allege that warnings are inadequate, I respectfully believe that these cases are incorrect. . . .  California holds that in the case of prescription drugs and medical devices, “the duty to warn runs to the physician, not to the patient.”

            It does not withstand scrutiny to say that the learned intermediary doctrine suddenly becomes inapplicable when a plaintiff alleges that warnings are inadequate.  If the learned intermediary doctrine became inapplicable when a plaintiff alleged that warnings were inadequate, the doctrine would never operate in California.  Plaintiffs could simply plead around the doctrine by alleging inadequate warnings—which they must necessarily do to state a claim for failure to warn. . . .

            Even where a plaintiff proves that warnings were inadequate, the learned intermediary doctrine still applies.  A plaintiff must prove that inadequate warnings altered the prescribing physician’s decision to prescribe.  Anything to the contrary would violate the California Supreme Court’s clear holding that “the duty to warn runs to the physician, not to the patient.”

Id. at **10-11 (citations omitted).  If you skipped over the long block quote, go back and read it because you’re going to want to use it the next time a plaintiff tries to argue that the learned intermediary doctrine “does not apply.”  It may be from a judge more than 2,000 miles from California, but this issue is not unique to the Golden State, and the judge’s analysis is darn persuasive.
The result was pretty good, too.  Because the treating physician did not rely on the defendant’s warnings in connection with one device, the district court granted summary judgment for lack of warnings causation in connection with that device.  Id. at **15-16.  With regard to a second device, the physician said that she reviewed the device’s instructions for use, but could not remember when.  It seems to us the defendant had a good motion, since it was plaintiff’s burden to prove that the physician reviewed the instructions before using the device to treat the plaintiff.  But the uncertainty as to timing resulted in an order denying summary judgment as to that device, leaving us to observe only that half a win is better than none.  Id. at *15. 
The remainder of the court’s order provides mixed results as well, and we will keep it brief: 
Design Defect:  The defendant moved for summary judgment on design defect under California law.  Strict liability is easy because California law does not recognize strict liability for an allegedly defective design in prescription drugs and medical devices.  Summary judgment granted.  Id. at **16-17.  The result is different for negligent design.  Plaintiffs have been pursuing design defect under negligence theories in drug and medical device cases in California for quite some time, and while we vigorously resist, we sometimes lose that battle.  So did the defendant in Sanchez.  Id. at *17. 
Punitive Damages:  The court’s order on punitive damages turned mainly on the choice of law.  The plaintiff was from California, and the defendant is based in Massachusetts.  Because the parties agreed that Massachusetts law prohibited an award of punitive damages, it is not difficult to guess which side urged which state’s law.  The district court applied California’s choice of law rules to find that California law would apply, and thus denied the defendant’s motion for summary judgment.  We have argued both side of this, depending on the applicable states’ laws and our clients’ interests.  This time, the state where the plaintiffs resided won out, which is not an uncommon result.  Id. at **19-29. 
Preemption:  When we’re not writing on the learned intermediary doctrine, we can be found musing on the various forms of federal preemption.  The defendant in Sanchez raised two kinds—express preemption under the Medical Device Amendments and implied conflict preemption.  The court’s order on preemption could fill another blog post—and maybe it will someday.  For today, we will observe only that the surgical mesh at issue was not a premarket approved device.  The FDA cleared it for marketing under the 510(k) process, which makes preemption—especially express preemption—a really tough row to hoe.  The defendant in Sanchez found it to be no easier and lost this part of its motion.  There is history here, with the court observing that “I have repeatedly addressed preemption issues throughout this multidistrict litigation, and I have consistently found that federal preemption does not apply.”  Id. at *33.  
With this mixed bag, we think the takeaway is on the learned intermediary doctrine, where the district court provided clear and useful analysis, if not all the results that the defendant wanted. 

Thursday, August 28, 2014

Guest Post - Not Quite a One-Two-Three Punch

What follows is another of our occasional guest posts, this time by fellow Reed Smith attorney Danielle Devens.  As always with our guest posts, the author gets all the credit, and any blame, for the contents of his/her work.

******************

            This week, a panel of the Missouri Court of Appeals issued an opinion allowing a plaintiff to maintain a small subset of warning-related claims against a generic drug manufacturer.  It also dismissed the claims against the brand name manufacturers, albeit reluctantly, pointing out the “inherent unfairness” of the supposedly “unjust result.”  Finally, same opinion reversed the trial court decision dismissing plaintiff’s claims against a publisher of information disseminated by pharmacies, but only on statute of limitations grounds.  The case is Franzman v. Wyeth Inc., No. ED100312, slip op. (Mo. App. Aug. 26, 2014) [ed note:  Now at 2014 WL 4210207, as of this morning].

            The plaintiff allegedly took generic version of the drug Reglan from March 2002 through October 2005, at which point she allegedly developed tardive dyskinesia, a known risk of this drug.  She brought claims against the brand-name manufacturers, generic manufacturers, and a publisher.  In a prime example of litigation tourism, plaintiff is a Kentucky resident pursuing claims under Kentucky law who filed her suit in the notoriously plaintiff-friendly St. Louis, Missouri.  [Slip Op. at 2]

            But even St. Louis was not that friendly to this plaintiff.  The trial court knocked out plaintiff with a one-two-three combination, dismissing all claims against:  (1) the generic manufacturers based on Mensing preemption; (2) the brand name defendants based on lack of legal causation because they did not make the product the plaintiff took; and (3) the publisher based on the Kentucky one-year statute of limitations.  Plaintiff appealed each ruling. 

            As to the publisher, it is worth noting that the only issues litigated pertained to the statute of limitations.  The trial court’s determination that plaintiff’s claims were barred by the statute of limitations was reversed as the court held that when plaintiff acquired knowledge of her legal injury is a question of fact to be decided by the jury.  The underlying question of whether any claims lie against publishers was not raised.  [Slip Op. at 24-27]  This blog has highlighted this simple truth several times before − publishers do not make or sell drugs.  Even though publishers do not owe plaintiffs any duty of care, unfortunately, these claims sometimes survive.

            As to the generic manufacturer, plaintiff offered the predictable argument that preemption is not applicable where state law duties do not conflict with federal law.  The appellate court largely agreed, making its attitude clear in the section of its opinion titled, “Mensing does not provide blanket immunity to the Generic Defendants.”  [Slip Op. at 15 - 18]  Even though the court agreed that all of plaintiff’s claims sounded in failure to warn regardless of how they were framed, it did a distinct analysis under Mensing to determine whether requirements of federal law preempt the manufacturer’s state law duties for each claim plaintiff asserted.  [Id.]  In 2004, the brand name labeling was updated to include bold language stating, “Therapy should not exceed 12 weeks in duration.”  Plaintiff claimed that the defendants took too long to copy this change in their labels.  The court held that this claim involved only state law duties and was not preempted.  “While the Generic Defendants were limited with respect to the warnings they could provide by their ‘federal duty of sameness’ . . . federal law did not prohibit the Generic Defendants from updating their label to conform to the 2004 Reglan label revision.”  [Slip Op. at 17]

            So, the issue is whether a generic manufacturer is responsible for making its product labeling the same as that of the brand manufacturer, right?  And “sameness” is a federal law requirement, right?  And private causes of action attempting to enforce federal law are prohibited by the FDCA, right?  The court somehow escapes this conclusion that this was a private attempt to enforce the FDCA by reliance upon “parallel claim” analysis drawn from express preemption cases involving medical devices, even though the statutory language allowing that exception did not apply to generic drugs.  [Slip Op. at 19].  The blog has discussed this concept here.

            When given an opportunity, the court took the pro-plaintiff route.  Citing Fulgenzi, which is discussed here, the court held that plaintiff’s claim that the generic defendants breached their state law duty by failing to update their warning labels to match the 2004 brand-name Reglan revision stems from the independent duty under Kentucky law to warn of foreseeable risks.  [Slip Op. at 19]  But that’s all.  The court also determined that claims that the generic labeling should have had stronger warnings than the brand labels are clearly preempted by federal law, and thus the plaintiff is “limited to arguing that the Generic Defendants’ label was inadequate to the extent that it did not include the language contained in the updated 2004 brand-name Reglan label.”  [Slip Op. at 19-20]

            So in the span of a few paragraphs, the court first acknowledges that plaintiff’s entire argument depends on whether the labels were the same, not on the adequacy of the warnings themselves, while conveniently ignoring that “sameness” is a duty which comes only from federal law, which is why there is preemption in the first place.  These points would seem to support a different conclusion, that state law has nothing to do with whether generic and brand labels are required to be the same, and allowing plaintiffs to file state law claims related to “sameness” circumvents the FDCA proscription on using state law claims to enforce federal law.

            While the court dismissed all claims against brand-name manufacturers, it nonetheless editorialized about the one-two punch packed into this kind of case.  Bound to apply Kentucky law, the court held that plaintiff’s claims were all subsumed by the Kentucky Product Liability Act (“KPLA”).  The KPLA requires the plaintiff to prove that the brand defendants’ product was the legal cause of her injury.  [Slip Op. at 21]  As plaintiff conceded that she ingested only generic Reglan, summary judgment was affirmed.  [Slip Op. at 20] The court went out of its way, however, to bemoan the supposed unfairness of the one-two punch, describing generic consumers as “cut adrift in a sea of hopelessness.”  [Slip Op. at 23]  Lost was the fact that, by taking generic drugs, plaintiff saved quite a bit of money, which is the point of both federal Hatch-Waxman and state substitution statutes concerning these drugs.  Given the court’s comments, it was just as well that this panel was applying settled Kentucky law.  Sometimes litigation tourism has a downside for plaintiffs.

            Missouri is historically a tough jurisdiction for defendants in drug/device litigation.  The defendants here did about as well as could be expected, with the court's rhetoric indicating its inclination to cut plaintiffs every break it could. 

            Thanks to Quentin Urquhart http://www.irwinllc.com/attorney-detail.asp?ProfileID=44 at Irwin Fritchie http://www.irwinllc.com/ for sending us the case.

Wednesday, August 27, 2014

ECF: Ignoring It Means Entire Case Fails


Luddite.  Technophobe.  Fogey.  Fossil.  Geezer.  We’ve been called all of those.  We plead guilty.  We prefer matches to lighters, manual transmission to automatic, fountain pens to uniballs, and wind-up watches to quartz.  We refuse to (that is, cannot) redline documents.  When it comes to computers, we are an easily confused fogey.  We leave the court’s electronic case filing system, charmingly known as ECF, to our secretary.  But at least we have someone attend to ECF.  Not doing so, it turns out, can be fatal.


The case of Freeman v. Wyeth, 2014 U.S. App. LEXIS 15504 (8th Cir. August 13, 2014) is a cautionary tale.  Woe unto those lawyers who resist or ignore the ECF system.  The plaintiff sued Wyeth in New York state court, alleging that she developed breast cancer after using hormone therapy medication.  We don’t know whether New York has any sort of electronic court filing system.  But it doesn’t matter, because Wyeth removed the case to the federal court in the Southern District of New York.  Then the case was transferred to the MDL in the Eastern District of Arkansas.


The clerk for the Eastern District of Arkansas filed a memorandum regarding the MDL’s use of the ECF system.  The court made it clear that “All counsel are directed to register, here and now.”  The plaintiff lawyer in Freeman did not pay attention to this order, and that ended up being a Big Problem.  Between May 13, 2009, and November 16, 2012, nothing was posted to Freeman’s individual docket.  Then, on November 16, 2012, the district court issued an order designating Freeman’s case for discovery.  Via the ECF, the court instructed Freeman to provide updated medical authorizations to Wyeth within three weeks and warned her that “[f]ailure to do so may result in dismissal for failure to prosecute.” 


Time goes by.  Picture pages falling from a calendar, scattered in the wind.  Picture a lonely, ignored ECF system, staying home with no company, eating a sadness bowl of ice cream, occasionally glancing at a silent phone.  Picture a plaintiff who did nothing to comply with the court order, unaware that her case was about to get thrown away like a broken spork. 


On January 8, 2013, Wyeth moved to dismiss Freeman’s case because she had not provided the medical authorizations per the district court’s instructions.  The district court granted the motion on January 28, 2013.  Now the camera pans up over the courthouse.  It looks like an eerily calm fortress. We hear the door clanging shut.  An ice cream truck (clearly, there is some sort of theme, coda, trope, motif at work here) rolls by, playing a tinny version of Eric Clapton's “Forever Man.”  Somewhere, a big dog barks.


Nearly nine months later, Freeman’s attorney filed a Rule 60(b)(1) motion to set aside the dismissal.  What’s the hurry?  He represented that he had “monitored the case, including the time period following its transfer to the Eastern District.”  That monitoring somehow did not result in his registering for the ECF system until October 22, 2013, which also happens to be the day he filed his motion to vacate the dismissal order.  The district court was unmoved.  That is, the court denied the motion to set aside the judgment. 


The action shifts to the Eighth Circuit Court of Appeals.  It reviews a denial of a Rule 60(b) for abuse of discretion.  Things are looking bleak for our monitoring-but-non-ECF-ing plaintiff attorney.  Under Rule 60(b)(1), a court can set aside a judgment entered because of a party’s “excusable neglect.”  Do we have that here?  Neither the district nor appellate court thought so.  It is true that a default judgment is hard cheese (sticking with our dairy product imagery).  But it is also true that “[a]dministering cases in multidistrict litigation is different from administering cases on a routine docket.”  Id. at *6.  To encourage efficiency, “MDL courts must be given greater discretion to organize, coordinate and adjudicate its proceedings, including the dismissal of cases for failure to comply with its orders.”   Id


And it is not as if the dismissal was a complete surprise.  The district court’s order designating discovery in Freeman’s case, dated November 16, 2012, warned that failure to provide Wyeth with updated medical authorizations “may result in dismissal for failure to prosecute.”  Except, that would be a surprise if one declined to sign up for the ECF.  D'oh!  Now we know what ECF really stands for:  Excuses Cannot Fool the court.  



The Eighth Circuit was not entirely unsympathetic.  It acknowledged a preference for “merits dispositions over default judgments.”  Id. at *7.  Still, “that interest must be weighed against the unique problems an MDL judge faces, especially when the MDL litigation involves hundreds of attorneys representing thousands of clients.  The MDL judge must be given “greater discretion” to create and enforce deadlines in order to administrate the litigation effectively.”  Id. at *8.  There was no “exceptional circumstance” supporting the Rule 60(b)(1) motion, the district court did not abuse its discretion, and the Freeman case was consigned to the dustbin of history.  Blowing off the ECF system ended up being an extremely costly folly.  


Now picture a corner office in a sand-colored Philly high-rise. The walls have pictures of canyons and mountains.  The desk overflows with slip opinions and books – some authored by the very occupant of the office!  He must be an extremely clever fellow.  And so he is.  The office gives off an aura of scholarly rigor.  The Freeman opinion is held up to the light, and then put down on the desk.  We now see Bexis.  He’s smiling.  The Eight Circuit flushing of the case pleases him.  Suddenly he gets up.  The computer screen stares up at him, expectantly.  But it can wait.  (Though not too long.)  Bexis is headed down to the Wawa for ice cream. An Espresso Chocolate Fudge would be nice.   

Tuesday, August 26, 2014

The Sound of Silence . . . Not Good for Complaints



            Appreciation of silence has probably never been as important as in this age of near constant noise and distraction – says someone who starts streaming Pandora radio the minute she hits her office in the morning.  But with ringing phones, pinging texts, Twitter updates, Facebook pokes, and weather alerts the adage “silence is golden” takes on heightened meaning.  Just a small reprieve from audio-stimulation can change your outlook, offer a fresh perspective, or simply calm you down. 

            And then there is the value in being silent oneself.  In the words of Will Rogers: “Never miss a good chance to shut up.”  Good advice for lawyers.  There is the value of silence in those around us.  “You have a grand gift for silence, Watson. It makes you quite invaluable as a companion.”  Sir Arthur Conan Doyle.  It’s always good to have a sounding board.  Finally, as Leonard da Vinci is credited as saying: “Nothing strengthens authority so much as silence.”  Well. . . that one might not be that helpful for plaintiffs.

            If there is one time you simply cannot be silent is in your complaint – at least in federal court.  That’s more or less what the court said in Kennedy v. Pfizer, Inc., 2104 U.S. Dist. LEXIS 113874 (W.D. La. Aug. 15, 2014).  The suit was brought under the Louisiana Products Liability Act (“LPLA”) on behalf of a minor child whose mother died after being treated for seizures.  Id. at *2-4.  Plaintiff alleges the decedent was treated with multiple drugs, including Keppra manufactured by one of the defendants and that Keppra was unreasonably dangerous as defined in the LPLA.  The court examined each cause of action and found the allegations in each completely lacking. 

            The first cause of action under the LPLA is for a product that is unreasonably dangerous in its construction or composition – more commonly known as a manufacturing defect claim.  As to Keppra, the complaint said only that it was “unreasonably dangerous in [its] construction and composition.”  Id. at *8.  Sound familiar?  Applying TwIqbal, the court found this was a “clear example of mere labels and conclusions and a formulaic recitation of the elements of a cause of action.”  Id.  at *9.  Silent on any facts to support this conclusory allegation, the claim was dismissed.

            Next – design defect.  Under the LPLA, plaintiff has to prove two elements on a design defect claim – an alternative design capable of preventing the alleged injury and that the likelihood and gravity of injury from the product outweighed the burden of adopting the alternative design.  Id.  Once again, as to Keppra, the complaint was silent except for an allegation that it “was unreasonably dangerous in [its] . . . design.”  Id.  Failure to plead an alternative design was fatal to this cause of action on its own and also doomed plaintiff’s ability to make any allegation about the balancing test element of the claim.  Id. at *10-11. 

            Plaintiff’s best pleaded claim was failure to warn.  Here the complaint alleged that the label did not adequately warn about the “likelihood to cause consumers to develop Steven Johnson Syndrome.”  Id. at *12.  While the allegation was at least specific to the condition decedent allegedly developed, there were no allegations concerning the effect of an alternative warning on the decedent or her prescriber (i.e. with a different warning physician wouldn’t have prescribed).  Silence on causation leads to dismissal.

            Finally, plaintiff attempted to plead a breach of express warranty claim.  This time the court found the complaint was silent as to whether “the defendant had advertised its product; [whether] the defendant had detailed its product to doctors; [whether] the defendant had made any other form of communication regarding the product; or [whether] the plaintiff was induced to take the product because of any alleged express warranty.”  Id. at *14-15.  That’s a lot of silence.  The loudest of which was plaintiff’s “failure to allege that [the drug’s] express warranty induced the use of the product” – an essential element of a breach of express warranty claim.  Id. at *15.

            Overall this was just a bad complaint and a good use of TwIqbal.  In light of which, we might need to amend the wisdom of Confucius:  “Silence is a true friend who never betrays” except under federal pleadings standards.  Doesn’t have the same ring to it, but you get our point.

Monday, August 25, 2014

Another Way of Getting Rid of Unjust Enrichment Claims

We’ve seen an increase in allegations of "unjust enrichment," particularly in strike suits seeking recovery of purely economic loss. A number of states don’t even recognize this theory as a separate cause of action (according to Bexis’ book, these include California, New Jersey, Pennsylvania, and Tennessee), and others preclude it when there is an "adequate remedy at law" (Florida, Louisiana, Massachusetts, Minnesota). But last week we ran across a case dismissing an unjust enrichment claim on a ground we hadn’t considered – privity.

In Smith v. Glenmark Generics, Inc., 2014 WL 4087968 (Mich. App. Aug. 19, 2014), the court dismissed a garbage class action for unjust enrichment based on alleged loss of value of birth control pills that had been mislabeled. As to such "losses," the defendant asserted "that it sought to remedy the problem by directing patients to return the product to their respective pharmacies for replacement or reimbursement," but the court never had to go there. Id. at *1. Instead, it affirmed dismissal on the basis of lack of "direct" enrichment, which in the case of products sold through supply chains, appears indistinguishable from privity:
[O]ur courts only employ the doctrine of unjust enrichment in cases where the defendant directly receives a benefit from the plaintiff.   Notably, caselaw does not specifically state that the benefit must be received directly from the plaintiff, but these decisions make it clear that it must. This is particularly true where emphasis is placed on the fact that the defendant must receive a benefit from the plaintiff, and where the facts show that a benefit received indirectly is not enough to establish a claim for unjust enrichment.
Smith, 2014 WL 4087968, at *1 (citations omitted). This "direct benefit" requirement killed off all unjust enrichment claims under Michigan law because:
[D]efendant did not receive a direct benefit from plaintiff. Defendant did not sell the contraceptives directly to plaintiff, and plaintiff admitted that she did not purchase the contraceptives from defendant, but rather from a pharmacy.

Id. (emphasis added).


We confess that we haven’t looked very deeply at this cause of action, which is usually something of a throw-away, so we don’t know whether the direct benefit/privity defense discussed in Smith is widespread or peculiar to Michigan. Since we’re always on the lookout for "new" (or at least so old as to be new to us) defenses to any and all of the causes of action we encounter, we thought this one was worth passing along.

Friday, August 22, 2014

Dreaming The Impossible Dream

A short history of recent implied preemption “impossibility” decisions:  (1) In Wyeth v. Levine, 555 U.S. 555 (2009), impossibility preemption did not apply to innovator prescription drugs because simultaneous compliance with FDA and state tort law labeling obligations was possible due to the “changes being effected” (“CBE”) exception allowing updated warnings without prior FDA approval.  Id. at 568-69.  (2) In PLIVA v. Mensing, 131 S.Ct. 2567 (2011), the same “impossibility” principle, expressed pithily as a “hold[ing] that when a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes,” was applied affirmatively to preempt warning claims concerning generic drugs because a verbatim labeling requirement precluded unilateral CBE warning changes.  Id. 2580-81.  (3) In Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013), the Court extended impossibility preemption to (at least) generic design defect claims, recognizing that design changes affecting safety and effectiveness also required prior FDA approval, while recognizing that the same restrictions on “major changes” applied to the designs of all “drug[s] − whether generic or brand-name.”  Id. at 2471.

What the implied preemption combination of Levine, Mensing, and Bartlett tells us about preemption due to impossibility is that state tort law can’t create a duty for a defendant to do something immediately that, under supreme federal law, requires the prior approval of a federal agency.  That proposition is in no way limited to generic drugs, since implied preemption isn’t dependent on the language of any particular statute.  We’ve pointed this out in a number of contexts, including “stop selling” claims , “major changes” in drug labeling, innovator drugs, warnings about off-label use.  That’s not counting our posts on individual cases.

We’re now two years post-Mensing and a year post-Bartlett, so we thought we’d take stock and see to what extent defendants have had any success in applying the impossibility preemption principles those decisions recognized outside of the limited context of generic drugs.  It turns out there has been some progress.  Favorable decisions have been rendered in three general areas:

Warning claims against entities other than the NDA holder:  Only the holder of the new drug application (“NDA”) has the right to change that drug’s labeling, whether by CBE or otherwise.  Preemption has been recognized in warning claims asserted against defendants that could not institute a unilateral label change because they did not own the NDA.

One situation where preemption has prevailed is against defendants that sold their NDA to someone else before the drug that the plaintiff bought was made.  The claims in In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, ___ F.3d ___, 2014 WL 2959271 (6th Cir. June 27, 2014), were about as strong as any plaintiff could hope to have.  In Darvocet, although the former NDA holder sold out, it also became a contract manufacturer, and thus was still producing the drug.  That didn’t matter, since the former innovator could no longer change its warnings:

[Plaintiff] ingested a product manufactured by [the former NDA-holder] . . ., after [it] had divested its NDAs.  Therefore, her claims against [the former NDA holder] are preempted, failing for the same reasons that the Plaintiffs’ other claims against the Generic Manufacturers do. After the divestiture, [the former NDA holder] had no more power to change the label.

Id. at *19. 

Similarly in In re Fosamax Litigation, 2012 WL 181411 (D.N.J. Jan. 17, 2012), plaintiffs’ claims against alleged distributors of both generic and innovator versions of the drug were dismissed because no distributor had the power to change drug labeling unilaterally.  Whether innovator or generic, “a distributor of Fosamax . . . has no power to change Fosamax labeling.  That power lies with the applicant who filed the New Drug Application (NDA) seeking approval to market Fosamax.  Id. at *3 (citing FDA regulations).

As a result of the scheme set forth by the FDCA, [a distributor] has no authority to initiate a labeling change of Fosamax.  That authority lies with the FDA and/or with [the NDA holder]. . . .  [A] contractual relationship between [a distributor] and [the NDA holder] cannot change the fact that [it] is not the NDA holder.  Consequently, [the distributor] has no power to unilaterally change Fosamax labeling.  Because [the distributor] could not “independently do under federal law what state law requires of it,” the state law claims brought against it are preempted.

Id. at *4 (quoting Mensing).  See also In re Yasmin & Yaz Drospirenone Marketing, Sales Practices & Products Liability Litigation, MDL No. 2100, 2014 WL 1632149, at *7 (S.D. Ill. April 24, 2014) (distributor of generic drugs had no power to change labeling unilaterally); Stevens v. Community Health Care, Inc., 2011 WL 6379298, at *1 (Mass. Super. Oct. 5, 2011) (same).

Black Box Warnings:  FDA regulations explicitly require that all boxed warnings have prior FDA approval.  21 C.F.R. § 201.80(e); 21 C.F.R. § 201.57(c)(1).  While this could be considered a “major” change, because of this additional regulatory support we consider those cases separately.  Claims that the defendant “should have included an aggressive black-box warning” were held preempted by Mensing in Fulgenzi v. PLIVA, Inc., 711 F.3d 578, 584 (6th Cir. 2013), but that is a generic drug case.  In Ray v. Allergan, Inc., 2012 WL 2120018 (E.D. Va. June 1, 2012), after deciding that, as a general proposition, Mensing did not undercut Levine as to innovator drugs, the court recognized that a black box warning was an exception:

[T]he federal regulations do control what must be in a black box warning and so any theory based on a black box warning as a requirement of state law would be preempted.

Id. at *7.

In Guenther v. Novartis Pharmaceutical Corp., 2013 WL 4648449 (M.D. Fla. Aug. 29, 2013), another non-generic case, like Ray, the court found Mensing/Bartlett generally “inapposite” to innovator warnings, but on the black box issue specifically, the plaintiffs failed to “dispute [defendant’s] contention that the FDA regulations preclude a manufacturer from adding a black box warning without preapproval.  Accordingly, the Plaintiffs will not be permitted to argue at trial that [defendant] should have done so.  Id. at *5.  In In re Avandia Marketing, Sales Practices & Products Liability Litigation, 817 F. Supp.2d 535, 553 n.97 (E.D. Pa. 2011), the court noted its “agree[ment]” with the defense position that “unlike other revisions to augment warnings, a boxed warning can be added only with prior FDA approval.”

Major Label Changes:  Not all changes to innovator drug labeling can be done through CBE.  Quite a few changes – some directly impacting safety, some not – are considered “major” and require prior FDA approval.  Several types of changes not falling within the scope of the CBE requirement have been held preempted in innovator cases:

Most notably, in Thompson v. Allergan USA, Inc., ___ F. Supp.2d ___, 2014 WL 308794 (E.D. Mo. Jan. 28, 2014), the plaintiff’s consumer-fraud based “overfilling” allegations were held preempted because the FDA approved the strength of the drug that the defendant was allowed to sell, and the defendant could not change it without going back to the FDA.  If FDA pre-approval was required, a state-law claim based on that product attribute was preempted:

[I]f Defendants were unable, under federal law, to independently lower the volume in each vial of [their drug] to be in compliance with the state duties alleged by Plaintiff, Plaintiff’s state claims would be preempted.  FDA regulations provide that once a drug, whether generic or brand-name, is approved, the manufacturer is prohibited from making any major changes to the “qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application.”

The Court concludes that reducing the amount of medicine in each . . . vial is a major change requiring prior FDA approval.  As noted above, FDA Guidelines from 2001 state that a “decrease in the fill volume” of a drug product “involves a change to the specifications and must be submitted in a prior approval supplement” for FDA approval. . . .  [T]he Court agrees that a decrease in the fill volume of a drug product . . . involves a change to the specifications under the plain meaning of the statute.

Id. at *6 (citations and quotation marks omitted).  Thus, since FDA pre-approval of strength changes for all drugs was necessary, any attack on the permissible dosage of an innovator drug was “therefore preempted under the Supremacy Clause.”  Id.

Having proven its entitlement to preemption under Mensing/Bartlett, the defendant was not obligated to go further and provide additional regulatory evidence under the Levine “clear evidence” test:

Moreover, since neither Mensing or Bartlett required any further “clear evidence” beyond establishing the existence of an FDA pre-approval obligation, there was no need to speculate whether the FDA would have approved such a change.  The requirement of pre-approval sufficed:

The Court does not find persuasive Plaintiff’s argument that . . . [their] claims are not preempted unless Defendants show by clear and convincing evidence that the FDA would have rejected such a change . . . .  Applying this standard “would render conflict pre-emption largely meaningless because . . . [w]e can often imagine that a third party or the Federal Government might do something that makes it lawful for a private party to accomplish under federal law what state law requires of it.”

Id. (citing and quoting Mensing).  See Guenther, 2013 WL 4648449, at *5 (distinguishing between actual change of strength (preempted) and changes of warnings relating to permissible dosage (not preempted). 

Claims that the defendant should have changed the format of its label can also be preempted to the extent that such changes may not occur unilaterally.  In Hill v Novartis Pharmaceuticals Corp., 944 F. Supp.2d 943 (E.D. Cal. 2013), the court “agree[d]” to “bar [plaintiff] from arguing that the FDA-approved label . . . should have placed the warning . . . in a different section of the label, or should have utilized a different font size or bolded text.”  Although the CBE procedure could be used to modify the “contents” of a label, it did not extend to formatting:

FDA regulations for prescription drug labeling extend not only to content but to formatting.  While the case law is clear that manufacturers may modify the contents of a brand-name drug label without FDA approval by adding to or strengthening the warnings, [plaintiff] has provided no authority − and the Court's research reveals no authority − to suggest manufacturers may do the same with the label's formatting.  Accordingly, [defendant’s] motion is hereby granted to the extent it seeks to preclude [plaintiff] from arguing that the [innovator drug’s] labeling should have been formatted differently.

Id. at 957 (citations omitted).

As we’ve discussed in our major changes post, comparative claims (called “superiority” claims) require FDA pre-approval.  FDA regulation specify that a certain level of scientific evidence (essentially statistically significant results from two controlled studies) must exist before a manufacturer may compare the safety (or effectiveness) of its drug to any other.  21 C.F.R. §§201.57(c)(2)(iii), 201.80(c)(3)(v).  Thus, Guenther also indicated (but did not actually hold) that preemption would apply to claims that the defendant should have warned about the relative “safety” of its drug compared to alleged alternative medications in the absence of the requisite studies

[H]aving “indications” that one drug is safer than another is a far cry from having “adequate and well-controlled studies” reaching that conclusion, which the Plaintiffs appear to admit is the applicable standard.  At this juncture, the Court does not know enough about the comparison(s) to be made or the evidence backing them to reach a final conclusion. But it appears that the Plaintiffs' evidence would not satisfy the standard established by [FDA regulations].

2013 WL 4648449, at *6 (regulatory citations omitted).

Stop Selling Arguments:  We haven’t seen any post-Bartlett preemption cases concerning arguments that an FDA-approved drug should simply not have been sold.  Plaintiffs seem to be steering away. The state of Massachusetts, however, recently tried essentially the same thing by legislation and got shot down.  As we discussed here, Zogenix, Inc. v. Patrick, 2014 WL 1454696, at *2 (D. Mass. Apr. 15, 2014), held that – regardless of Levine’s limitations on preemption − a state could not bar the sale of an FDA-approved innovator drug:

[D]efendants [the Commonwealth of Massachusetts] present no evidence or persuasive argument that [Levine’s]  reasoning should control in this different context.  Furthermore, Levine assumed the availability of the drug at issue and analyzed whether stronger state labeling requirements obstructed the FDA's objectives.  Here, the obstruction is clearer because the drug Massachusetts wants [the plaintiff manufacturer] to adopt . . . has not been approved by the FDA.  To satisfy the Commonwealth, [plaintiff] would be required to return to the FDA and seek approval of a drug different from the one the FDA has already deemed safe.  For the reasons described above, Zogenix is likely to prevail on the merits.

Id. at *2.

So by our count, we have seven cases that, in one way or another, apply the Mensing/Bartlett impossibility preemption rationale to some sort of innovator-drug-related claim.  The prevailing argument is always (except for stop selling) some version of the plaintiff demanding something that cannot be done by the defendant without FDA preapproval.

This is still an area where the courts need some “getting used to,” and we hope that defendants will concentrate on claims (such as drastic design changes) where the need for FDA pre-approval is indisputable.  Given that implied preemption is not limited by the language of any particular statutory scheme, plaintiffs should not prevail simply by screaming that “this isn’t a generic drug case.”

Thursday, August 21, 2014

Hindsight is 20/20, And Yet Still So Blind

Would you have bet on the Red Sox to win the 1986 World Series?  Would you have booked passage on the Titanic?  Would you have bought a ticket to see the movie Ishtar?  If someone asked us these questions today, we all would answer in the negative because we already know the outcomes.  The 1986 Red Sox won 95 games that year and were riding the arms of their two young stars, Bruce Hurst and Roger Clemens.  They may have been a good bet at the time, but Bostonians can still see that ground ball wiggling its way between the legs of a certain first baseman.  The Titanic was a modern marvel and highly sought after ticket, but that voyage ended in tragedy (a real tragedy, not a faux tragedy like losing a baseball game).  We actually did buy a ticket to the movie Ishtar when it debuted in 1987 (forgive us, we were young).  It was a big-budget vehicle for two A-list movie stars, Dustin Hoffman and Warren Beatty, but the film was an epic flop. 

We know now how these events in history turned out, yet millions of people placed that bet, booked that passage, or bought that ticket—and they all had good reasons to do so.  Hindsight is 20/20, and if those people said today that they would not have acted that way “if they had known,” they would be met with a smirk and a raised eyebrow.  If you add in a profit motive—such as when a plaintiff stands to recover damages in a lawsuit—a convenient change in position would be more than just irrational, it would be a farce.  When you further add a dire downside—such as leaving cancer untreated (you can see now where we are going with this)—a post hoc claim of different behavior becomes an obvious counterfactual construct aimed at recovering dollars and entitled to no consideration. 

That is why the district court was correct and the Sixth Circuit is wrong in Payne v. Novartis Pharmaceuticals Corp., No. 13-6266, 2014 WL 4056889 (6th Cir. Aug. 18, 2014).  The case is an Aredia and Zometa case in which the plaintiff alleged that the drug manufacturer’s failure to warn regarding the risk of osteonecrosis of the jaw (“ONJ”) resulted in onset of ONJ several years after she first used one of the drugs.  Id. at *2.  The prescribing physician testified that he was not aware of the risk of ONJ when he first prescribed one of the drugs for breast cancer in 1999, but by the time the plaintiff shows jaw-related symptoms in 2005, he was aware of the risk and suspended treatment.  Id.  The plaintiff was later diagnosed with ONJ.  Id.

The district court granted summary judgment on the plaintiff’s failure to warn claims because the plaintiff produced no substantial evidence that a warning regarding ONJ in 1999 would have changed the physician’s decision to prescribe the drug.  Id. at *3.  This of course is a textbook application of the learned intermediary doctrine, under which the manufacturer’s duty to warn runs only to the prescribing physician and under which proximate causation is judged by the impact that a stronger warning would have had on the prescriber’s treatment decisions.

In Payne, there was no evidence that a warning regarding ONJ would have changed anything for this plaintiff, at least no evidence that would justify sending the case to a jury.  The prescribing physician testified that he now warns patients about the risk of ONJ and recommends that they see a dentist before taking bisphosphonates.  Id. at *5.  Fair enough, but there was no evidence that a dental exam would have shown anything noteworthy for this plaintiff, let alone anything that might have prevented the plaintiff’s injury, either in 1999 when the plaintiff started one drug or in 2001 when she switched to the other.

In other words, nothing would have changed in the prescribing physician’s decision making process, which is why the district court was correct to grant summary judgment on the warnings. 

So why did the Sixth Circuit reverse?  It reversed because the doctor said he now instructs patients re ONJ and because the plaintiff filed an affidavit stating that she would not have taken the products if she had been warned.  Id. at *3.  The Sixth Circuit found this to be a “straightforward” argument, under which the plaintiffs had raised a jury issue on whether the lack of a warning on ONJ in 1999 or 2001 caused her injury.

We have two problems with the Sixth Circuit’s analysis.  First, we do not agree with the Sixth Circuit’s gloss on learned intermediary doctrine under the applicable Tennessee law.  According the Sixth Circuit, the learned intermediary rule is a liability-shifting doctrine that can place a duty to warn on the prescribing physician.  As the court explained, “At base, the doctrine can shift liability from drug companies to doctors:  If the drug company adequately warned and instructed the doctor but the doctor did not adequately warn the patient, the patient’s quarrel is with the doctor rather than the drug company.”  Id. at *4. 

This statement misapprehends the law, which probably explains why the Sixth Circuit cited no real support.  (The Sixth Circuit cited only a concurring opinion and a law review article.)  The learned intermediary doctrine imposes no duty on prescribing physicians, nor does it provide patients any basis upon which to “shift liability to” or “quarrel” with doctors.  A healthcare provider’s potential liability to a patient is governed by state law on medical malpractice, which generally requires proof of a breach of a standard of care.  That standard may encompass a duty to provide patients with certain treatment-related information—or it might not.  The learned intermediary doctrine says nothing on that score.  It defines a drug or medical device manufacturer’s duty to warn and the manufacturer’s potential liability, and nothing further. 

Our second problem with the Sixth Circuit’s analysis is more profound.  The district court was absolutely correct in ruling that the plaintiff’s affidavit stating that she would not have used the products if she had been warned of ONJ was not evidence sufficient to defeat summary judgment.  It was very easy for the plaintiff to say that she would not have used the drug after she already knew the outcome, i.e., that she experienced the exact condition about which she claims she should have been warned.  When bearing in mind that this plaintiff was being treated for a potentially fatal disease (breast cancer) and that she now stands to gain financially by saying that she would have refused cancer treatment, her statement is entitled to no weight, even if admissible.  We have commented on plaintiffs' attempts to do an "end run" on warnings causation before, including within the last few days, and we consider such attempts to be idle conjecture based on "evidence" that does not prove anything. 

States define the sufficiency of the evidence differently, but the law typically requires substantial evidence, something more than a mere scintilla or speculation.  The Sixth Circuit glossed past this point too, first by stating that there was no authority “that supports the proposition that this testimony is insufficient to forestall summary judgment.”  Id. at *6.  The problem with this conclusion is that there is no authority supporting the Sixth Circuit’s position either.  The Sixth Circuit therefore again inappropriately blended medical malpractice and product liability and analogized to cases involving informed consent, observing that “we can find no indication that the Tennessee Supreme Court would adopt a different standard.”  Id. at *6.  This is problematic too, because a patient’s consent—or lack thereof—is not an element of a product defect claim, even one based on allegedly inadequate warnings.  The Sixth Circuit again could find no legal support for this extension of Tennessee law, citing another law review article, this time with the telltale “cf.” signal, code for “here's something that is not totally off the wall.” 

We have thought long and hard about whether a plaintiff’s retrospective change of heart can ever be substantial evidence sufficient to reach a jury.  If there is a scenario under which this can be true, we can’t think of it.  We understand that juries hear this sort of evidence somewhat regularly, and maybe there is corroborating evidence from time to time.  But that was not the case in Payne, which came to wrong result.  Now if only we can get a refund for our ticket to Ishtar.  Does anyone know a lawyer?