If we were to recap briefly our reactions to the Levine decision and ten years of decisions attempting to apply it, then we might say something like this. The Court’s creation of a clear evidence standard for conflict preemption in the context of warnings claims for branded drugs was both novel and misguided. The Court gave more credence to the CBE mechanism as a way to change the label, at least temporarily, without FDA approval than FDA ever had. Over time, courts took baby steps to recognizing that some warnings claims—even the fundamental claims underlying a litigation—should not proceed where the label plaintiffs wanted would not have passed muster with FDA at the time. Facts like FDA’s rejection of the same proposed label, FDA’s statements about the lack of an association with the risk at issue, the lack of new evidence to justify submitting a CBE, and FDA’s pronouncements that a CBE could not be used for a certain type of labeling change allowed courts to find that the high standard had been met. The endorsement of complimentary conflict preemption principles in some Supreme Court cases and rejection of the presumption against preemption in others helped emboldened courts to find warnings claims preempted. This trend might have peaked in a series of Fosamax decisions out of the District of New Jersey, which we touted not too subtly. Then the Third Circuit reversed, essentially holding that summary judgment cannot be granted for defendants under a Levine analysis because juries have to decide whether the clear evidence bar was met. We sharpened our proverbial pens to decry the reasoning of that decision, its impact on litigation, and its invitation for juries to second-guess FDA.

We have, of course, tracked the appeal of Fosamax to the Supreme Court, including the amicus brief of the Solicitor General and the oral argument. The Solicitor’s brief advocated that judges should decide preemption under Levine when interpreting the scope of an agency decision is required for the decision. Drawing on the Administrative Procedures Act, the brief argued that “[n]o sound reason exists for treating the meaning and effect of an FDA administrative determination differently” than other federal agency decisions, which are questions of law. Drawing on Supreme Court authority in the patent context, the brief reasoned that “[t]o the extent extrinsic evidence may sometimes be relevant in litigation between private parties to determine the meaning and effect of FDA’s agency action, the court’s evaluation of such subsidiary facts does not alter the ultimate legal character of the inquiry or the court’s exclusive authority to resolve it.” Cases are not exactly on hold while the Supreme Court mulls over what to do with the Fosamax appeal, so we were intrigued by the question certified on appeal in Rinder v. Merck Sharpe & Dohme Corp., — N.E. 3d –, 2019 IL App. (1st) 171969 (Ill. App. Jan. 23, 2019):

Under [Levine] federal law preempts state-law failure to warn claims related to the use of a prescription drug if there is “clear evidence” that the FDA would not permit the manufacturer to include the plaintiff’s requested warning in the drug’s labeling. Is the question whether the defendant has presented the necessary “clear evidence” one for resolution by the court or jury?

We will skip over the underlying facts of the case, but we can say there are multiple FDA decisions to be interpreted, it was pretty to clear to us that FDA would have rejected the label plaintiff wanted when they wanted it, and the plaintiff’s arguments seemed to hinge on after-the-fact evidence of causation. But here is where we come back to Fosamax. Although most published decisions involved the court deciding whether there was the clear evidence in the record required by Levine, the court identified Fosamax as the only relevant federal circuit decision and proceeded to follow it in rejected each of defendant’s arguments for why the court should decide the issue and find it was impossible to the defendant to have the label that plaintiff wanted. In essence, the Rinder court ruled that “the issue presented by the [Levine] inquiry is simply a particular application of the task juries regularly perform in tort cases, determining what the evidence shows probably would have happened if the allegedly wrongful conduct had not occurred.” Therefore, substantive Illinois law would require a jury to consider the defense of conflict preemption and summary judgment would be impossible in cases where plaintiff could come up with some arguments against defendant’s urged interpretation of the FDA’s decisions. Until Fosamax is reversed or at least rejected by other circuit courts, this is the sort of facile decision we will keep seeing.

 

Today is Ash Wednesday and begins the 40 days (not counting Sundays) of Lent. Lent comes from the Anglo Saxon word for Spring. For Christians, the 40 day period represents the time Jesus sojourned in the wilderness, resisting the temptation of Satan, and preparing his final ministry. Lent is a time for repentance, fasting, and preparing for the coming of Easter. Many Christians, even minimally-observant ones, follow the tradition of giving up something for Lent. In that spirit, we offer our list of what we will forego between now and April 21.

1. When the other side finishes deposing our company witness, no more will we smugly say “our questions are reserved for trial,” and pack up our things. It is smarter to do some sort of redirect exam. Yes, we hate to show the other side our hand, but what if our hand – the witness – disappears? Or he/she becomes hostile or evasive? We have geared up for trial too many times wishing we had a decent deposition direct exam of our witness because, for whatever reason, it had become impossible or inconvenient or imprudent to bring that witness to trial. Occasionally, we felt a bit steamed about prior counsel’s decisions not to do a redirect at the deposition. But see point 3 below.

2. From now on, or at least for the next six weeks, we will keep our smart phone and iPad more than six feet from the bed. Consulting the buzzing, too-well-lit device in the middle of the night ruins sleep and peace of mind. Whatever it is, it’ll keep.

3. However much we might disagree with former counsel’s decisions, we will not complain about them. We might try to alter or remedy them, but there is no sense in mere grousing. When a client invites you to parachute into a trial, it is an honor and a delight. You get all the good bits of doing a trial, but very little of the drudgery. Better just to take what was given to you, say thank you, and put on the best show at trial you can. By the way, it is possible that those decisions you now bemoan might have been perfectly justified under the circumstances at the time. We promise to shut up and do the work.

4. Adios, sports talk radio. We can probably slog through the early mud season sans this air-wave festival of carping by loud-mouth know-nothings. Who deserves blame for the Sixers’ latest loss after building a double-digit lead? Who will the Patriots face in the next Super Bowl? Who should bat after Bryce Harper? Who cares? The opinions shared by sports-talk blowhards would not pass the Daubert test in even the most lenient jurisdictions. Plus, the radio hosts recycle the same trio of topics every hour, so even a medium length car-ride of this nonsense will leave you bitter and lobotomized. Did we mention that we live in Philadelphia?

5. We will take a time-out on trying to discern or characterize the motives of our adversaries. It is fine to challenge the other side’s arguments, but imputing motives to one’s opponent is pointless, lacks foundation, and annoys the judge. Is there a more overused word in legal briefing than “disingenuous”? When lawyers deploy that word, they are essentially saying that the other side cannot sincerely believe what they are saying. But the court will not decide the issue based upon who is more sincere. If the argument is weak, show why it is weak. So much of law and life is brought to ruin by misunderstandings about the other side’s motives. There is a reason why philosophers have puzzled over the problem of other people’s minds. Even if Descartes proved that he exists and that God exists, he could not prove that other people’s minds are like ours. Other people could be robots. Or simpletons. Or predatory plaintiff lawyers. Or oafish writers. It doesn’t matter. It is not actionable. Moreover, since we actually do believe (on faith) that other people’s minds aren’t so different from our own, we see no reason to turn bad assumptions into nasty words and thereby hurt others’ feelings.

6. We will stop griping to our kids about how they never return our calls, emails, or texts. Obviously, they were raised badly and it is too late to do anything about it. (And yet, when money or free vacations are on offer, the Drug and Device Daughter and Son suddenly become robustly responsive.) Make no mistake, though; on April 22, our litany of recriminations on this subject shall recommence.

7. It will be hard, but we will halt, at least temporarily, our stereotyping of jurisdictions. Every once in a while, good opinions do emerge from California and Missouri. And, conversely, sometimes the Good Place turns out to be a Very Bad Place. Of course, Madison County is always a Very Bad Place … oops, there we go again.

8. We will give Amazon, EBay, and Costco a rest for a while. Our house is full of unnecessary purchases. We have enough batteries to power a 767. That three pound jar of salsa will go bad before it is even a quarter consumed. Sure, it’s nice to be greeted by one of those smiley boxes on the porch at the end of the day, but how many tactical flashlights do we need? (At least we’ve got the batteries.) EBay might be the worst. Someday, those not-responding heirs will have to throw out the Flintstones lunchbox, Gillette safety razor from the year we were born, and Oddjob action figure. Serves them right; they should have answered our texts

9. For at least the next 40 days, we will leave off certain arguments we keep trotting out and losing. Perhaps we need to make a record, but we are starting to worry about injury to our credibility. Will we tell you what those arguments are? No, we will not. Do you think we are crazy?

10. Bacon. No, wait a minute, speaking of crazy, that would be crazy torture. Desserts? But what about crème brulee? We really, really love crème brulee. Hmmm. This last one’s a toughie. Okay, got it: for Lent this year, we are giving up brussels sprouts. (Unless they are adorned with bacon.)

 

Today, Reed Smith is hosting a client roundtable in London, “Identifying and Mitigating Risk in a Changing Global Economy,” for life sciences clients.  In light of that, we thought it would be a good idea to have a blogpost that’s relevant to what’s hot in the UK.  Well, there’s nothing hotter on that side of the Pond right now than the increasingly shambollixed up approach to Brexit.  One thing we were wondering about, over here, is whether a crash out Brexit would at least get rid of, in the UK anyway, a couple of extremely unfavorable decisions from the European Court of Justice that we’d blogged about earlier.  We didn’t know, so we asked Simon Greer, a Reed Smith lawyer in our London office if he knew the answer.  He did, and below is his response.  As always our guest posters deserve all of the credit (and any blame) for their posts.

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The timing and implications of Brexit in the UK are currently one of life’s great unknowns. The latest position is that Theresa May’s latest proposed Brexit deal will be voted on by MPs in Parliament by 12 March 2019. However, the Prime Minister has also indicated that if her latest deal is rejected, MPs will be offered two separate votes shortly thereafter:

  1. Whether or not MPs would support a ‘no-deal’ Brexit, meaning that the UK would only leave without a deal on 29 March 2019 if there was consent from the House of Commons for a ‘no-deal’ Brexit; and
  2. If the prospect of a ‘no-deal’ Brexit on 29 March 2019 is rejected by MPs, they will then be given a vote by 14 March 2019 as to whether the UK should request an extension to the 2 year Article 50 process, thereby delaying the UK’s withdrawal to a date beyond 29 March 2019 (the length of such a delay is, as yet, unknown).

In the pharmaceutical industry, the impact of a potential ‘no-deal’ Brexit on 29 March 2019 on the precedential value of the decisions of the Court of Justice of the European Union (“CJEU”), will be of significant interest. This is because the CJEU’s recent decisions in the pharmaceutical sector have had a significant impact on the law in the UK, adverse to pharmaceutical companies, two examples of which we have discussed in previous blog posts:

Causation or No Causation, That Is the Question.

Bad News from Europe for Makers of Life-Saving Medical Devices

So, would a ‘no-deal’ Brexit effectively re-set the clock and eliminate the consequences of CJEU’s decisions in the UK made prior to Brexit?  The answer, unfortunately, is: no, so a ‘no deal’ Brexit would not even have this silver lining.

Whilst Theresa May on 17 January 2017 stated that: “we will take back control of our laws and bring an end to the jurisdiction of the European Court of Justice in Britain. Leaving the European Union will mean that our laws will be made in Westminster, Edinburgh, Cardiff and Belfast.  And those laws will be interpreted by judges not in Luxembourg but in courts across this country.  Because we will not have truly left the European Union if we are not in control of our own laws”, that rhetoric was hollow.  Her comments were in fact forward looking only, rather than applying to adverse CJEU decisions made prior to Brexit.

This is clear from the provisions of the EU (Withdrawal) Act 2018 (“the Act”).

In terms of CJEU decisions made after Brexit, the courts of the UK will no longer be bound by them but they will still be permitted to have regard to [Ed. Note – that’s British English for ‘follow’] them, if they are relevant to an issue that is before them. Sections 6(1) and (2) of the EU (Withdrawal) Act 2018 provide:

6 Interpretation of retained EU law

(1) A court or tribunal—

(a) is not bound by any principles laid down, or any decisions made, on or after exit day by the European Court, and

(b) cannot refer any matter to the European Court on or after exit day.

(2) Subject to this and subsections (3) to (6), a court or tribunal may have regard to anything done on or after exit day by the European Court, another EU entity or the EU so far as it is relevant to any matter before the court or tribunal.

As for CJEU decisions made before Brexit, these will form part of what is described as ‘retained’ EU law under the Act. The treatment of retained EU law after Brexit in the UK is explained in sections 6(3) to (6) of the Act (set out below). In short, whilst the Supreme Court in the UK and Scotland’s High Court of Justiciary (the supreme criminal court in Scotland) are not bound by any decisions of the CJEU made prior to Brexit, all other courts in the UK will be bound by CJEU decisions made prior to Brexit:

(3) Any question as to the validity, meaning or effect of any retained EU law is to be decided, so far as that law is unmodified on or after exit day and so far as they are relevant to it—

(a) in accordance with any retained case law and any retained general principles of EU law, and

(b) having regard (among other things) to the limits, immediately before exit day, of EU competences.

(4) But—

(a) the Supreme Court is not bound by any retained EU case law,

(b) the High Court of Justiciary is not bound by any retained EU case law when—

(i) sitting as a court of appeal otherwise than in relation to a compatibility issue (within the meaning given by section 288ZA(2) of the Criminal Procedure (Scotland) Act 1995) or a devolution issue (within the meaning given by paragraph 1 of Schedule 6 to the Scotland Act 1998), or

(ii) sitting on a reference under section 123(1) of the Criminal Procedure (Scotland) Act 1995, and

(c) no court or tribunal is bound by any retained domestic case law that it would not otherwise be bound by.

(5) In deciding whether to depart from any retained EU case law, the Supreme Court or the High Court of Justiciary must apply the same test as it would apply in deciding whether to depart from its own case law.

(6) Subsection (3) does not prevent the validity, meaning or effect of any retained EU law which has been modified on or after exit day from being decided as provided for in that subsection if doing so is consistent with the intention of the modifications.

In summary, pharmaceutical companies need to be mindful of the fact that existing CJEU decisions made prior to Brexit, even if it is a ‘no-deal’ Brexit, will be binding on courts in the UK, unless those decisions come before the Supreme Court and are overruled by a new, post-Brexit decision of the Supreme Court, which would then take primacy in the UK over the prior CJEU decision.

Our recent post on “wrinkle removal” – that is, removal before service – case got us thinking.  The opinion discussed in that post, Dechow v. Gilead Sciences, Inc., ___ F. Supp.3d ___, 2019 WL 5176243 (C.D. Cal. Feb. 8, 2019), was out of California, in the Ninth Circuit.  That didn’t keep Dechow from citing the Third Circuit case we blogged about last August, Encompass Insurance Co. v. Stone Mansion Restaurant, Inc., 902 F.3d 147 (3d Cir. 2018).  As we discussed last year, Encompass Insurance was the first appellate decision to address removal before service, and it was a resounding victory for the defense position that such removal is expressly allowed by statute and is a perfectly rational (and hardly absurd) response to the repeated gamesmanship that forum-shopping plaintiffs have resorted to, literally for decades.

So, how has removal before service fared since Encompass Insurance has been in the books?  Previously, we thought the defense “plain language” approach was the majority position, but the split was anything but overwhelming.  We’re pleased to report that the Third Circuit’s reasoning appears to have tipped the balance towards “overwhelming.”  First of all, we can run through new decisions by district courts (in Pennsylvania, New Jersey, Delaware, and the Virgin Islands) that are precedentially bound to follow Encompass Insurance.  These are: Anderson v. Merck & Co., 2019 WL 161512, at *1-2 (D.N.J. Jan. 10, 2019) (denying remand in 104 cases) (mentioned in this post), and Mendoza v. Ferro, 2019 WL 316727, at *2 (E.D. Pa. Jan. 24, 2019) (second removal, within 30 days of Encompass Insurance decision).  We can also, of course, subtract any adverse decisions (there were more than a handful) previously issued from district courts in the Third Circuit.

Outside the Third Circuit, courts have mostly found Encompass Insurance persuasive.  A second case from the Central District of California held:

[W]hen a natural reading of the statute leads to a rational, common-sense result, an alteration of meaning is not only unnecessary, but also extrajudicial.  As the Third Circuit explained, a plain meaning interpretation of the language “properly joined and served” in the Forum Defendant Rule “envisions a broader right of removal only in the narrow circumstances where a defendant is aware of an action prior to service of process with sufficient time to initiate removal.”  Stone Mansion, 902 F.3d at 153. . . .  While it is clear that courts in this district have found that permitting pre-service removal absurd, others have not, concluding that the plain language of Section 1441(b)(2) states that it only applies when the local defendants have been “properly joined and served.” Finally, and arguably most importantly − a Plaintiff in this very district, in a similar removal action unsuccessfully invoked [the absurd results argument] to support remand. [Citing Dechow]

Zirkin v. Shandy Media, Inc., 2019 WL 626138, at *3 (C.D. Cal. Feb. 14, 2019) (other citations and quotation marks omitted).  We are particularly gratified to see these two cases out of the Central District of California.  Our last research post on removal before service tallied up all the favorable decisions between 2011 and mid-2018 (it was written about a week before Encompass Insurance was decided).  It found twelve cases out of California, but only two from the Central District.  Encompass Insurance seems to have convinced the judges in that previously rather refractory district to be less refractory.

Another California decision, Monfort v. Adomani, Inc., 2019 WL 131842 (N.D. Cal. Jan. 8, 2019), expressly “agree[d] with the Third Circuit” and permitted removal before service.  Id. at *4.

[T]he more precise question is whether pre-service removal frustrates the purpose behind §1441(b)(2)’s “joined and served” language.  As the Third Circuit explained, the “joined and served” language reflects Congress’s intent to prevent a plaintiff from fraudulently joining a resident party in order to avoid removal to federal court.  Encompass, 902 F.3d at 153.  Interpreting “joined and served” to permit pre-service removal by an in-state defendant does not impair the provision’s anti-fraudulent joinder purpose, which focuses on what a plaintiff may or may not do to defeat diversity jurisdiction.  Id. (noting that a plain language interpretation of joined and served “protects the statute’s goal without rendering any of the language unnecessary”).  Moreover, . . . Congress amended the removal statute after decisions permitting pre-service removal, but did not alter the “joined and served” language.

Id. (non-Encompass Insurance citations omitted).  Encompass Insurance also proved persuasive in Texas Brine Co., LLC v. American Arbitration Ass’n, 2018 WL 4927640 (E.D. La. Oct. 11, 2018), which cited it for the propositions that “defendants may remove despite unserved resident defendants,” and that “[n]o exception for gamesmanship exists.”  Id. at *2.

Still, while there’s been a shift since Encompass Insurance, there remain courts that find gamesmanship by plaintiffs somehow less bothersome than gamesmanship by defendants, and still refuse to recognize removal before service as permitted by the express terms of the removal statute.  Such a case is Delaughder v. Colonial Pipeline Co., ___ F. Supp.3d ___, 2018 WL 6716047 (N.D. Ga. Dec. 21, 2018), which refused to follow Encompass Insurance on a record that revealed both sides engaging in procedural machinations – with plaintiffs determined to keep a personal injury suit in a plaintiff-friendly court, and a diverse defendant just as determined to be in federal court instead.

Here’s what happened in Delaughder.  Two out-of-state litigation tourists sued the target defendant (a Delaware corporation) in Atlanta over an Alabama accident, also joining a Georgia “forum defendant” that would have prevented removal.  Id. at *1-2 & nn 1-2.  The Delaware defendant successfully snap removed.  In response, plaintiffs moved for voluntary dismissed, fully intending to win the race to the courthouse on their second try.  Id.  The defendant was just ready.  On the same day the voluntary dismissal was effective, the defendant changed its Georgia registered agent.  Id.  Plaintiff refiled the next day and – loaded for bear – served the defendant’s former agent less than half an hour after refiling.  Id.  But service was ineffective because of the change in agents, and the defendant snap removed again.  Id.

Although non-residents suing in Georgia over an accident in Alabama seems, to us, a most blatant example of forum-shopping gamesmanship, the court in Delaughder focused solely on the defendant’s actions.  Although recognizing that “the Third Circuit has definitively come down on one side of the issue,” 2018 WL 6716047, at *3, that court nonetheless went with the “absurd result” argument and remanded.  “While [defendant] found a possible avenue to take away Plaintiffs’ power to decide the forum for this litigation, the Court cannot overlook the clear gamesmanship present in this case.”  Id. at *6.

In the words of another Georgia court, “[o]ne person’s ‘gamesmanship’ is strategy to another.”  Francis v. Great West Casualty Co., 2018 WL 999679, at *2 (M.D. Ga. Feb. 21, 2018).  As for Delaughder itself, there are other words Bexis picked up while living in the Peach State:

Forget, hell.

Here’s something we know about Georgia precedent:

Georgia’s registration statute, Ga. Code §14-2-1501, provides no indication that registration affects jurisdiction one way or another; nor are there relevant state cases. However, in Orafol Americas, Inc. v. DBi Services, LLC, 2017 WL 3473217 (N.D. Ga. July 20, 2017), the court held:

Plaintiff notes that [defendant] is registered to do business in Georgia, and has a registered agent in the State.  Additionally, [defendant] has actually engaged in business in Georgia. . . .  But these contacts are woefully insufficient to render [defendant] “at home” in Georgia.  Every company that does any business in Georgia must register with the State and maintain a registered agent.  Just because a company does some small amount of business in Georgia does not mean that due process will allow that company to be sued in Georgia for acts that occurred outside the State.

Id. at *3.

Out of the frying pan, into the fire.  Nothing in the Delaughder opinion gives us any reason to believe that there is any basis for personal jurisdiction in Georgia over the non-forum defendant.  And not only that, once those plaintiffs lose on jurisdiction, they’ll get no tolling of the statute of limitations in Alabama for their frolic and detour in the Georgia courts, since Alabama is one of “[s]ix states [with] no mechanism for preserving claims following a dismissal without prejudice.”

Game on.

Today’s guest post, by Luther Munford of Butler Snow, engages in one of our currently favorite activities, that being informed speculation on what might be the consequences of a favorable Supreme Court resolution of its currently pending preemption appeal in Merck Sharp & Dohme Corp. v. Albrecht.  We hope he’s right.  As always, our guest posters deserve 100% of the credit (and any blame) for their thoughts published here.  We only provide the forum.

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In Merck Sharp & Dohme Corp. v. Albrecht, the Solicitor General as amicus curiae argues that judges, not juries, are best suited to evaluate the scope of an FDA determination. Brief of the United States as Amicus Curiae Supporting Petitioner, Merck Sharp & Dohme Corp. v. Albrecht, (No. 17-290), 2018 WL 4562163 (filed Sept. 20, 2018).  Judges, he says, “are trained and experienced in construing legal documents and are far better equipped to understand agency decisions in light of the governing statutory and regulatory context.”  Id. at *15.

To support his argument, he cites the Administrative Procedure Act’s statement that a reviewing court shall “determine the meaning or applicability of the terms of an agency action,” 5 U.S.C. § 706, and precedent that has looked to judges to interpret the meaning of prior adjudications.  See id. at 18-20.

While that case has nothing to do with either medical devices in general or 510(k) clearance in particular, Supreme Court agreement with the Solicitor General on this point could radically alter the way courts view the admissibility of 510(k) clearance, at least where Class II devices are concerned.  To gain 510(k) clearance, unless the FDA decides that more is required, the manufacturer need only establish that a new device is as safe and effective as an existing lawfully marketed device.  No other evidence of safety and effectiveness is required in the absence of FDA action.

At present, courts have treated the meaning of 510(k) clearance as a subject for warring expert testimony as to its meaning, as discussed here on the blog (discussing In re Cook Medical, Inc. IVC Filters Mktg., Sales Practices and Prod. Liab. Litig., 2018 WL 6617375 (S.D. Ind. Dec. 18, 2018)).  In other cases evidence of clearance has been excluded, with one explanation being the mistaken theory that the evidence was of such slight probative value that the battle was best avoided.  In re C.R. Bard, Inc. MDL No. 2187, 810 F.3d 913, 922 (4th Cir. 2016). [Ed. note: Other cases, collected and discussed here, admit evidence of FDA device clearance.]

But if the United States Supreme Court decides that preemption issues are treated as purely legal, the courts will be forced to examine the statutory context that controls Class II clearance using 510(k).  That context shows that such a clearance is almost always an FDA “determination” that the device, with whatever special controls that the FDA ultimately imposes, does not present a potential unreasonable risk of illness or injury.  Nothing could be more relevant to a product liability claim.

To begin at the beginning, in 1976 Congress directed the FDA to engage in a sort of regulatory “triage.”  Triage sorts patients according to the seriousness of their injuries and gives them different levels of care.  The FDA’s statutory scheme sorts devices according to the seriousness of the risks they present and requires different levels of premarket review.

More precisely, Congress directed the FDA to engage medical panels to classify medical devices according to their need for regulation.  Congress specified the qualifications the panel members were to have. 21 USC § 360c(b).  The FDA methodically proceeded over the ensuing decades to classify device types into classes I, II or III according to the risk they present.  It convened the panels, held hearings, published panel recommendations, entertained comments from the public, and fixed the classifications.

Devices that present little risk, such as tongue depressors, were put in Class I and do not need FDA review before they are sold to the public.

Moderate risk devices, such as surgical suture, were put in Class II and, if not exempt, must be “cleared” by the FDA before they are marketed.  To gain Class II clearance, the manufacturer must show in a §510(k) submission that they are as safe and effective as an existing Class II legally marketed device that presents a moderate risk.

Finally, devices that may “present a potential unreasonable risk of illness or injury” or are for sustaining life, such as a pacemaker, were put in Class III and generally must be “approved” by the FDA based on extensive independent evidence of their safety and effectiveness.  21 U.S.C. § 360c(a)(1)(C).

On its face, this is a reasonable way to regulate medical devices.  In fact, Congress stated in the statute that it believed this system of classification and review provided “reasonable assurance” of safety and effectiveness for each class of medical device.  21 U.S.C. § 360c(a)(1)(A), (B), (C).

It is encouraging, but not necessary, to observe that the FDA’s sorting of devices seems to have worked.  Even though they receive less FDA scrutiny, “cleared” devices of moderate risk are less likely to result in a serious recall than “approved” devices that may present an unreasonable risk.  One study showed that while 510(k) cleared devices constitute 98% of all devices, they account for only 71% of serious recalls.  And the 2% of devices that are PMA-approved made up 19% of serious recalls.  Jeffrey Shapiro, Substantial Equivalence Premarket Review: The Right Approach for Medical Devices, 69 Food & Drug L.J. 365, 389-390 (2014).

But that is not all. According to the statute, placement in Class II is itself a determination of safety.  If a device is a Class II device, then, with special controls, it usually does not present “an unreasonable risk of illness or injury” that would require it to be in Class III.  21 U.S.C. §360c(a)(1)(C).  The FDA has made that determination based on the initial work of a medical panel and information in the §510(k) which confirmed that the specific device fell within the panel’s classification of the device type.  Otero v. Zeltiq Aesthetics, Inc., 2018 WL 3012942 *3 (C.D. Cal. June 11, 2018).  This can be confirmed when the decision classifying the device type expresses the opinion that there is no unreasonable risk, or uses words to that effect.

In other words, clearance of a moderate risk device using 510(k) is normally a sign of relative safety, even though the FDA review of more risky Class III devices is more rigorous.  That is what the statute says, and experience seems to bear that out.

If the Supreme Court should agree that the interpretation of an FDA decision is a matter of law for the court, then in any case involving a Class II device, the defendant should be entitled to an instruction on the meaning of that decision.

If the FDA decision classifying the device type rests on a finding of no unreasonable risk then, as a matter of law, the defendant should be entitled to an instruction that “The United States Food and Drug Administration has cleared this device for marketing as a Class II device.  That clearance is a determination that there is reasonable assurance of its safety and effectiveness and that, with whatever special controls may have been imposed, the device does not present a potential unreasonable risk of illness or injury.”

Such an instruction would, of course, be radically different from the treatment courts have recently given §510(k) clearance.  Those courts have not only mistakenly allowed juries to decide the meaning of §510(k) clearance, but they have done so in part because of fundamental legal error in the way they have examined §510(k) clearance.

The fundamental error of those courts has been to overlook the distinction between the normal use of §510(k) to clear devices of a type placed in Class II, and the increasingly rare transitional use of §510(k) to clear devices in Class III based on a pre-1976 predicate.

The use of pre-1976 predicates originated in an interim provision Congress adopted in 1976, when the statutory scheme was new. Congress put all implantable devices in Class III as presenting an unreasonable risk pending medical panel review to reclassify them.  Then, anticipating that it would take medical panels a long time to do their work – and has taken more than 40 years – it allowed these devices to be “cleared” using §510(k) if they could be shown to be equivalent to a device on the market in 1976.  This process, unlike the normal use of §510(k), did not involve any medical panel review and did not require equivalence to a classified device.

This increasingly rare scenario was what the Supreme Court addressed in Medtronic v. Lohr, 518 U.S. 470, 477 n.3 (1996), which, quite incorrectly, has been taken as being representative of all FDA clearance decisions.  But it is not. In fact, now that the medical panel reviews of devices with a potential high risk appear to have been almost completed, the scenario is not representative of practically anything that the FDA is still doing today.  See FDA, FDA Has Taken Steps to Strengthen The 510(k) Program 7 (November 2018).

Where a device has been placed in Class II in what is now the ordinary fashion − based on equivalence in safety and effectiveness to a predicate device placed by a medical panel in Class II because its risks are reasonable − that decision, as a matter of simple statutory interpretation, is a determination of safety.  Even if juries are free to disagree with it, they should not be allowed to ignore it. What the Supreme Court tells us in Merck Sharp & Dohme Corp. may have effects far beyond the resolution of the case at hand.

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

 

Michigan’s product liability statute says that a drug is neither defective nor unreasonably dangerous, and the manufacturer and seller cannot be liable in a product liability suit, if the FDA approved it and the drug and its labeling were in compliance with that FDA approval:

In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved for safety and efficacy by the United States food and drug administration, and the drug and its labeling were in compliance with the United States food and drug administration’s approval at the time the drug left the control of the manufacturer or seller.

MCL 600.2946(5). There are two exceptions (which, as discussed below, present their own problems): withholding or misrepresenting information that would have resulted in FDA non-approval, and bribing the FDA:

This subsection does not apply if the defendant at any time before the event that allegedly caused the injury does any of the following:

(a) Intentionally withholds from or misrepresents to the United States food and drug administration information concerning the drug that is required to be submitted under the [FDCA] and the drug would not have been approved, or the United States food and drug administration would have withdrawn approval for the drug if the information were accurately submitted.

(b) Makes an illegal payment to an official or employee of the United States food and drug administration for the purpose of securing or maintaining approval of the drug.

MCL 600.2946(5) (a) & (b).

In the consolidated litigation concerning Lipitor, Michigan recently faced an effort by plaintiffs to expand these exceptions. There, plaintiffs alleged that the Pfizer failed to conduct post-marketing surveillance that would have changed Lipitor’s labeling regarding diabetes, arguing that this too triggered an exception to immunity under the statute. Trees v. Pfizer, Inc., 2018 Mich. App. LEXIS 3757, at *11 (Mich. Ct. App. 2018). After plaintiffs lost at summary judgment, the issued was teed up for the Court of Appeals of Michigan. The result was a per curiam affirmance.

In short, the Court of Appeals didn’t bite. It confirmed that statutory immunity attaches if the FDA approved the drug and the drug and its labeling complied with that approval:

MCL 600.2946(5) specifically provides that . . . the manufacturer or seller is not liable, if two conditions are met: (1) the drug was approved for safety and efficacy by the FDA and, (2) the drug and its labeling were in compliance with the FDA’s approval at the time the drug left the control of the manufacturer or seller.

Id.

Adopting the Sixth Circuit’s decision in Marsh v Genentech, Inc., 693 F3d 546 (6th Cir. 2012), the Court of Appeals held that immunity under Michigan’s product liability statute is based on “substantive compliance with FDA approval,” something that Pfizer did by marketing Lipitor under the FDA approved label. Plaintiffs’ allegations, on the other hand, suggested only “procedural non-compliance” with general FDA regulations on post-marketing safety information that apply to all manufacturers. That was insufficient to set aside the immunity granted by the statute, id. at *10-11, something that the Michigan Supreme Court has described as “an absolute defense to a products liability claim.” Taylor v. Smith-Kline Beecham Corp., 658 N.W.2d 127, 130-31 (Mich. 2003).

The statute meant what it said: “unless the fraud exception in subsection a or the bribery exception contained in subsection b applies (plaintiffs make no such claim here), a manufacturer or seller of a drug that has been approved by the FDA has an absolute defense to a product liability claim if the drug and its labeling were in compliance with the FDA’s approval at the time the drug left the control of the manufacturer or seller.” Id. at *12-13.

There is meaningful subtext to this decision. By arguing non-compliance with general FDA regulations on post-marketing surveillance, plaintiffs were trying to set aside the manufacturer’s statutory immunity while side-stepping implied Buckman preemption that would have almost certainly preempted a claim that the manufacturer withheld required information from the FDA. The Marsh court, relied on by the Court of appeals, took this issue head-on, as we discussed over six years ago here. So now, as it turns out, in Michigan, no matter how a plaintiff massages its allegations concerning post-marketing surveillance, the result will be the same. The manufacturer has immunity.

 

It’s hard to escape the suspicion that blue states are more pro-plaintiff and red states are more pro-defense, though that is not a hard and fast rule. There are parts of Alabama and Texas where it is hard for an out of state corporate defendant to get a fair shake. Delaware and West Virginia also do not fit neatly into the blue/plaintiff-red/defense model.

Still, when we read a case where a Massachusetts court tries to predict New York tort law, our fears toggle between whether the pro-plaintiff errors will be multiplied linearly or exponentially. Daley v. Mira, Inc., 2019 WL 499775 (D.Mass. Feb. 8, 2019), is pretty bad. Check that; it is really bad.

The plaintiff in Daley alleged that a surgical implant used in an eye operation in 1986 went bad in 2015 (that’s right – 29 years later) resulting in follow-up operations and near total vision loss in one eye. She sued the manufacturer and seller of the implant. She also sued a company that designed and patented the implant. The designer then licensed the product to the aforementioned manufacturer-seller, more than 29 years ago. This much is clear: the patent-holder had no dealings with the plaintiff. So how could it be a proper defendant?

To answer that question it is necessary to look at the plaintiff’s theories of recovery. After some initial skirmishing, it was determined that New York Law governed the tort claims. So goodbye to the claim under Chapter 93A of the Massachusetts General Law. Goodbye, also to the warranty claim, because of the statute of limitations. What was left against the patent-holder? Three other claims remained: negligent pre-market testing, strict product liability, and post-sale failure to warn. The patent-holder moved to dismiss these claims, contending that it would not be held liable under any of these theories under New York Law. That argument was premised largely on the defendant’s status as never having interacted with the plaintiff. You know – standard product liability stuff.

But hold up a moment. The claim of inadequate pre-market testing, based on an alleged failure to make sure the product could not fail after 29 years, is a bit of a reach. There is certainly no indication that the FDA required any of the testing for “long-term effects.” And whatever product testing is necessary is required by the FDA of the company that submitted the device. The court did not ask these questions, or many questions at all in waving this pre-market testing theory along. This ‘what, me worry’ approach may now be responsible for creating a very broad cause of action available to lots of future plaintiffs against lots of fairly remote defendants.

Whether any of these theories should apply to a non-manufacturer/seller is an issue of theoretical majesty. But the Massachusetts court seems to think it is fairly simple. Either the non-manufacturer/seller can be held liable for its own remote role, because New York Law recognizes “that a defendant can owe a duty of care to a third party – even without a contractual or other direct relationship between the defendant and the third party – and, thus, may be liable to the third party for injuries resulting from a breach of that duty,” or it can be dragged into court based on an allegation of concerted action. If that were so, we would see patent holders dragged into product liability litigation all the time – but we don’t.

The result in the Daley case is bad, and it follows ineluctably from the court’s deficient methodology. Here we have a Massachusetts federal court purporting to predict New York law. The opinion is quite short. That brevity is something we ordinarily welcome. But not one of the New York cases cited by the Massachusetts court is at all on point (they do not involve any kind of product, and one ultimately rejected the claimed duty). Absent is the usually rigorous duty analysis undertaken by New York courts. So what we have is something we have griped about many times before – a federal court expanding state law tort doctrine, and here it is doing damage to the law of a different state. (We are not completely discounting the possibility that what is really going on is that a Patriots or Red Sox fan is trying to wreak havoc on New Yorkers. Those two Super Bowl losses to the Giants must still sting. And, recent success notwithstanding, 100 years of losing to the Yankees really smarts.)

Even aside from lacking anything approximating a rigorous legal analysis, the Daley court seems oblivious to the real world implications of the decision. The extension of liability to the patent-holder is particularly dangerous in terms of the chilling effect it would have on the licensing of patents. Must a patent holder undertake extensive testing – including clinical trials – before it can license a patent? How can a patent holder, or anyone for that matter, test whether a medical device might fail after 29 years?

Massachusetts and New York have always had a funny relationship. That is true in all sorts of areas, including historical and cultural. It is possible that Thoreau did not quite get Whitman’s poetry, or got only parts of it (certainly not the sexy bits). Such a misreading might have been unfortunate. But at least it didn’t actually hurt anybody. (Well, maybe it hurt Whitman’s feelings. Come to think of it, we could see a Massachusetts court making that actionable, too.)

You’ll find plenty of decisions from the amiodarone litigation discussed on the blog.  Not surprisingly, because it is a generic drug, they almost exclusively focus on Mensing preemption – or we should say on plaintiffs’ attempts to bypass Mensing.  But there are cases involving exposure to the branded product as well.  And earlier this month, the brand name manufacturer got about the best ruling it could hope to get – defendant’s warnings were adequate as a matter of law.  Generic defendant also got dismissed after plaintiff tried to argue around Mensing by claiming the generic manufacturer was also a distributor.

Plaintiff in Marroquin v. Pfizer, Inc., 2019 WL 636845, *1 (E.D. Cal. Feb. 14, 2019), brought claims for strict liability, negligence, breach of warranty, and various fraud/misrepresentation claims.  Plaintiff’s wife suffered from fatal pulmonary disease caused by the administration of amiodarone.  Id. at *2.  While the complaint does not state why plaintiff’s wife was prescribed the drug, the decision walks through the Indications and Usage and Warnings section of the drug’s label, of which it took judicial notice.  The labeling states that the drug is to be used only to treat two very serious heart conditions and only when other treatments have failed “because of the life-threatening side effects and the substantial difficulties associated with its use.”  Id. at *5.  The label further states that the drug has “several potentially fatal toxicities, the most important of which is pulmonary toxicity,” which is fatal about 10% of the time.  Id.  The court noted that label discussed pulmonary toxicity at least 15 times.  Id. at *2.

While plaintiff argued that the adequacy of a warning is “generally” a jury question, generally doesn’t mean alwaysId. at *6.  In this case, the warnings were clear, conspicuous, and warned of the exact risk plaintiff’s wife suffered – they were adequate.  Id.  Moreover, plaintiff’s complaint contained no allegations that explain why the warning provided was inadequate.  Certainly a difficult task given the breadth and depth of the warning provided, but an essential element that can’t be overlooked.  Nor could the court overlook plaintiff’s lack of allegations that the alleged inadequate warning was a substantial factor in plaintiff’s wife’s death.  Id. at *5.  Plaintiff also tried to argue that the risks as set forth in the label would not have been understood by the “ordinary consumer.”  But that’s not the standard.  The manufacturer’s duty to warn runs to the physician, not the patient.  Id.  Whether the warning was sufficient to inform plaintiff’s wife’s physician is the appropriate question.  One the court answered in the affirmative.

Finally, on failure to warn, plaintiff tried to argue that the physician may not have read the label defendant relied on.  But failure to read does not equal failure to warn.  “The Court is unaware of any authority that holds a warning is inadequate simply because a person or physician failed to read the warning.”  Id. at *6.  Aside from the implication that physicians aren’t people, we agree with this statement completely.

On his breach of warranty claim, the court again had to remind plaintiff that the learned intermediary doctrine applied.  A core element of breach of warranty of fitness for a particular purpose is the buyer’s reliance on the skill or judgment of the seller.

[I]n a context of prescription drugs, a patient’s expectations regarding the effects of a prescription drug are those related to him by his physician, to whom the manufacturer directs the warnings regarding the drug’s properties.  For breach of warranty claims, ordinarily it is the prescribing doctor who in reality stands in the shoes of the ordinary consumer.  [B]reach of express or implied warranty claims … may not be maintained against a manufacturer of prescription drugs who has properly prepared the product and marketed it with warnings of known or knowable dangers.

Id. at *7 (citations omitted).  In this case, plaintiff did not allege what information his wife’s physician considered when deciding to prescribe the drug.  What the evidence does show is that risk of pulmonary toxicity was adequately warned about.  Id.  And, the only inference that the court could draw was that plaintiff’s wife was relying on the skill and judgment of her physician, not defendant.  Id. at *8.

That left only plaintiff’s fraud and misrepresentation claims which were all based on representations that the drug was “safe, fit, and effective for human use.”  Id. at *9.  Plaintiff conceded that he failed to plead his intentional misrepresentation claim with sufficient particularity to satisfy Rule 9(b).  Id.  Which the court informed him applied equally to negligent misrepresentation and concealment.  The defendants were lumped together and the complaint lacked any allegations of who, where, when, and how the alleged misrepresentations were made.  Id.  As to the “what” was misrepresented – safety and effectiveness – the court expressed “serious concerns over the plausibility of this allegation,” given the FDA approval of the drug as a drug of last resort for two serious heart conditions and the fact that it has been used to treat these conditions for over 30 years.  Id.  And, plaintiff’s lack of reliance on defendant, as opposed to her physician, is another obstacle to the fraud/misrepresentation claims.  Id. at *10.

The generic defendant had all of the brand warning and reliance arguments but of course also had a Mensing preemption argument.  Because plaintiff had no allegation that the generic defendant’s label differed from the brand label, plaintiff instead tried to argue that Mensing preemption does not extend to distributors which the generic defendant also was.  However, the cases plaintiff relied on to draw the distinction between distributors and manufacturers were in the context of motions to remand based on fraudulent joinder.  In those cases, where all doubts are to be resolved in favor of remand and no binding authority had extended Mensing to distributors, the courts were required to find proper joinder and remand the cases to state court.  Id. at *11.  “However, context is key.”  Id.  Outside the removal/remand situation, courts have applied Mensing to distributors.  “[A] mere distributor sits in the same shoes as a generic manufacturer, neither has the ability to alter or change an approved FDA warning label.”  Id. at *12.  The Supreme Court’s concern about misleading or confusion caused by competing, different labels applies equally, and perhaps even more so, to distributors.  Id.  Mensing requires dismissal of all of plaintiff’s claims against the generic manufacturer that are based on some duty to convey information about the drug – failure to warn, breach of warranty, fraud/misrepresentation.  It would not apply to a manufacturing defect claim if plaintiff was bringing one.  Id.

Despite the court’s “serious concerns” with the plausibility of plaintiff’s claims, it did grant leave to amend based on the allegations being so conclusory that it could not definitively decide that amendment would be futile.  But the court certainly has made it clear that plaintiff has substantial work to do if the amendment is going to overcome the vast shortcomings of plaintiff’s case.

Last week, in Timbs v. Indiana, ___ S. Ct. ___, 2019 WL 691578 (U.S. Feb. 20, 2019), the Court unanimously held that the Excessive Fines Clause of the U.S. Constitution’s Eighth Amendment applies to the states:

Under the Eighth Amendment, “[e]xcessive bail shall not be required, nor excessive fines imposed, nor cruel and unusual punishments inflicted.” Taken together, these Clauses place “parallel limitations” on “the power of those entrusted with the criminal-law function of government.” Directly at issue here is the phrase “nor excessive fines imposed,” which limits the government’s power to extract payments, whether in cash or in kind, as punishment for some offense. The Fourteenth Amendment, we hold, incorporates this protection.

Id. at *3 (citations and quotation marks omitted).

The historical and logical case for concluding that the Fourteenth Amendment incorporates the Excessive Fines Clause is overwhelming. Protection against excessive punitive economic sanctions secured by the Clause is, to repeat, both fundamental to our scheme of ordered liberty” and “deeply rooted in this Nation’s history and tradition.

Id. at *5 (citation and quotation marks omitted).

So why should readers of the DDLaw Blog care?  After all prescription medical product liability litigation is a far cry from Timbs, which involved whether a state can, through civil forfeiture, seize property worth four times what the maximum criminal fine could be.

We think, as the Court stated, “it makes sense to scrutinize governmental action more closely when the State stands to benefit.”  Id. at *4 (citation and quotation marks omitted).  We’ve complained several times before about states farming out claims against our clients to contingent fee lawyers who also “stand to benefit” if they can convince courts and juries to agree to expansive readings of consumer protection and other statutes and impose the same fine 10,000 times over for a single instance of purportedly “illegal” off-label promotion (to take one example). Interpreting such statutes to impose huge multiples of the maximum possible fine for the same conduct by treating every recipient of a message as a separate statutory violation seems to us to be the epitome of an “excessive fine” that bears strict scrutiny because “fines are a source of revenue, while other forms of punishment cost a State money.”  Id. at *4 (citation and quotation marks omitted).

Indeed, we specifically mentioned a discussion of the Excessive Fines Clause in In re Zyprexa Products Liability Litigation, 671 F. Supp.2d 397, 462-63 (E.D.N.Y. 2009), as a possible defense to an Attorney General action.  Another such case, State v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 777 S.E.2d 176 (S.C. 2015), made our “bottom ten” list in 2015.  In that case, the state recovered a verdict of $327 million (later somewhat reduced), representing thousands of letters, sample packs, and detailing visits, counted separately, because the FDA ordered a “correction” of a Dear Healthcare Provider letter.  Id. at 203 (“[t]he State argued, and the trial court agreed, that the distribution of each sample box containing the deceptive labeling, each DDL, and each follow-up sales call to the DDL . . . constituted a separate SCUTPA violation”).  The South Carolina Supreme Court rejected an excessive fines argument, but the argument at that point was supported only by cases over 50 years old.  Id. at 205.  Perhaps having a new, unanimous, definitive Supreme Court incorporation of the clause will convince lower courts to treat this part of the constitution with more respect.

After all, if a civil seizure around four times the maximum criminal fine plausible implicates the Excessive Fines Clause, then the kind of artificially inflated, contingent-fee-driven litigation that our clients have had to put up with certainly should.

At minimum, something to watch, and perhaps plead as a defense.

 

Regular readers of this blog may recall that, each year at this time, we report on our cherished annual trip to the Westminster Kennel Club dog show. This year, the trip was modified at the outset by a work conflict (an argument in Kentucky that we knew we would keep us from attending any part of the first day of the two-day event). We hoped to make it to Madison Square Garden for the Tuesday evening group judging and Best in Show, but that plan was affected (read, “doomed”) Tuesday afternoon by a weather-related flight cancellation. Disappointed, we arranged for our ticket to be re-printed and held at Will Call for a friend who was delighted by the unexpected treat. But then we re-grouped. We figured out that we could make it to the Garden for the last hour, if everything went just right, by taking a still-on-time flight to Philadelphia and a train to New York. We got on the flight as they were closing the boarding door, and ended up standing at the door to the Garden at 9:35 pm. BUT WE NO LONGER HAD A TICKET. And the box office was closed, and Security was unimpressed by our near-tears offer to “pay anything” if we could just get into the building for the last hour. So we hovered outside for a while looking pathetic, and eventually hung our head and headed toward our hotel. Whereupon we encountered a scalper with a ticket for sale. And you can figure out the (very, very happy) ending.

So sometimes it pays to grasp at an unlikely straw when all logical avenues have been exhausted. Not so in today’s case. In Mitchell v. Wyeth Pharms., Inc., 2018 U.S. Dist. LEXIS 220946 (W.D. Tex. Dec. 17, 2018), the plaintiff alleged that her decedent died from complications of taking the generic drug amiodarone for non-life-threatening atrial fibrillation. But amiodarone is a generic drug, and all ordinary product liability claims against generic drugs are preempted. Thus, plaintiff was forced to be creative. Under federal law, pharmacies must provide Medication Guides to patients filling amiodarone prescriptions. The plaintiff’s original complaint, naming both the innovator drug manufacturer and the manufacturer of the generic version, included a claim that the generic manufacturer failed to supply the pharmacy with a Medication Guide that could be provided to the plaintiff. It also included warnings claims and the usual litany of product liability claims. All of the product liability claims were dismissed on the defendants’ predictable preemption motion. The plaintiff filed an amended complaint against the generic manufacturer, asserting only a single substantive claim for failure to provide the required Medication Guide. The defendant moved for summary judgment again, arguing that the uncontroverted testimony established that the pharmacy had been provided with an adequate quantity of FDA-approved Medication Guides along with its amiodarone supply. In response, the plaintiff argued that, beyond sending the Medication Guides to the pharmacy, the manufacturer was required play nanny to pharmacies − to take reasonable steps to ensure that each and every pharmacy actually distributed the Medication Guides to patients − and that the manufacturer had not taken such steps.

The court disagreed, quoting federal regulations that required only that the manufacturer provide enough Medication Guides to the pharmacy (or provide the pharmacy with the ability to print additional copies). The court held, “The text, contrary to Plaintiff’s contention, does not place a duty upon [the manufacturer] to take steps to ensure that the Medication Guides are distributed to patients beyond providing them in “sufficient numbers” to the pharmacy. Mitchell, 2018 U.S. Dist. LEXIS 220946 at *9-10. Nor did FDA regulations require the manufacturer to monitor pharmacies practices to ensure that they were providing Medication Guides when required. In the absence of any evidence that the manufacturer had failed to supply the pharmacy with the required Medication Guides, the court granted summary judgment for the manufacturer. Id.

This is not the first time plaintiffs have tried to force the pharmaceutical industry to superintend the professional practice of pharmacy, and we doubt it will be the last. Bottom line: regardless of the difficulty of imposing liability for injuries allegedly caused by a generic drug, a plaintiff can’t plead around the generic preemption/innovator liability framework by asserting a duty that doesn’t exist. At least under a judge, like the Mitchell judge, who is committed to applying the law correctly. What more can a defendant ask?