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

 

We’ve been posting for a few months about the procedural and evidentiary controversies that have arisen in the Pinnacle Hip Implant MDL bellwether process. The second bellwether trial involved significant evidentiary and procedural rulings that raised eyebrows across the defense bar (discussed here and here). After that trial unsurprisingly produced a ½ billion dollar jury verdict, the defense asked the MDL Court to stay further bellwether trials so that the Fifth Circuit could review those rulings. No luck. Instead, the MDL Court ordered that the next bellwether trial should happen—and quickly (discussed here). After all that, and with the third bellwether trial approaching fast, the defense must feel like the coyote lying flat on the ground staring up at the bottom of a plummeting anvil coming at him a second time.

Undaunted, however, the defense has now filed a motion to continue the third bellwether trial, a motion that raises serious concerns about the time allotted to “work-up” the plaintiffs’ cases that will be involved in the trial. The defense argues that the allotted time is simply too short, not providing enough time for the complex medical issues underlying each plaintiff’s case to be developed and understood so that a trial can produce the type of verdicts that can advance the MDL process. To illustrate this, the defense compared the discovery and pre-trial periods that led up to the second bellwether trial (Aoki) to those leading up to this trial:

  • In Aoki, there were 11 months between case selection and trial (2/27/2015-1/11/2016); here, by contrast, there are just 3 ½ months between case selection and trial (6/10/2016-9/26/2016).
  • In Aoki, there were more than seven months between case selection and the due dates for defendants’ expert reports (2/27/2015-10/9/2015); here, by contrast, there are just 2 ½ months between case selection and the due date for defendants’ expert reports (6/10/2016-8/26/2016).
  • The Aoki schedule afforded defendants eight weeks to respond to plaintiffs’ expert reports (8/14/2015-10/9/2015); here, by contrast, defendants are being given just two weeks to analyze and respond to plaintiffs’ expert reports.

(Defense Br. at 9.)

This truncated schedule, the defense argues, is inadequate to gather medical records, prepare defense expert reports, or effectively brief and decide dispositive legal issues. For example, the defense still doesn’t have important medical records for three of the bellwether cases. The defense also just recently received about 2,400 pages of medical records in a fourth bellwether case. Yet the defense must serve expert reports in a few days, and trial starts in less than four weeks. The defense must also serve all of its expert reports before it has had the opportunity to depose seven of the eight treating surgeons whose depositions it has requested. You don’t need to be a veteran of medical device mass tort trials to know how important medical records, treating physician testimony and expert opinions are at trial. Jury verdicts often turn on just this type of evidence. Moreover, the court scheduled Daubert and other potentially dispositive motions to be filed on the same day it begins picking a jury. Without addressing whether that schedule already signals that the court intends to go forward with the trial, it certainly doesn’t seem to give the court enough time to give these motions the type of pre-trial consideration that they require. We have seen many a bellwether trial stopped—and rightfully so—by a Daubert motion that highlighted a lack of scientific merit in the plaintiff’s case.

Plaintiffs have responded by arguing that the defense already has enough medical records, that its experts should be able to draft and serve case-specific expert reports very quickly, and that the Court has issued Daubert decisions in the past—which plaintiffs no doubt liked—and so the Court can easily decide the new motions quickly. In other words, full speed ahead.

Given how things have gone so far in this MDL, we don’t expect the court to grant the defense’s request for a continuance. But, with each such decision, the list of evidentiary, procedural and now case-management issues for the Fifth Circuit to consider grows. This all may result in a very interesting Fifth Circuit opinion addressing the things to do, and not to do, when managing a mass tort.  And so, of course, we will continue to follow . . . .

You wouldn’t be the first to notice that some of our posts say more about television programs – and certainly with more gusto – than about the law.  We could make the case that pop culture and the law are related, and that familiarity with the former can make one a better advocate when engaged in the latter.  We could even cite an article on the value of pop culture that was written by an in-house lawyer who might be the smartest person we know.  But let’s not perpetrate a fraud.  Truth be told, it’s flat-out easier to tackle tv than preemption.  Would you rather binge watch Orange is the New Black or the latest judicial jibberings on the parallel violation exception?  Especially in these lingering dog days of Summer, not much in the law seems dramatic or even mildly entertaining.  To be sure, not so long ago the Summer was also a wasteland for television.  The good stuff concluded in the Spring.  Summer was strictly for repeats.  Under the old model, after fine offerings such as Game of Thrones and The Americans wrapped up before Memorial Day, there would be nothing worth watching until the Fall season, when a couple of decent shows might temporarily distract you from the decline of the West (by which we mean the American League West, the AFC West, and the overall culture of the Enlightenment).  But things have changed when it comes to programming.  Television comes through whilst the law remains in its mid-year torpor.  Of a sudden, Summer tv offers a bounty for couch potatoes seeking an escape from the inferno.  So hang up that seersucker suit, pour out a Pimms, and feast your eyes on these tv treasures:   

 

Stranger Things (Netflix) – We love the 80s.  That was when we entered law school and, more importantly, exited law school.  A decade that starts with the eruption of Mt. St. Helens and ends with the collapse of the Berlin Wall, and that introduced Seinfeld and The Simpsons in-between, is special.  Stranger Things is a love letter to the 80s.  It is a Spielbergian, Stephen King-ian mash up of horror, sci-fi, government conspiracy, and teen-agers coming of age. Stranger Things also supplies a great role for Winona Ryder, who first grabbed our eyes in Heathers (1988). You know how at the end of a Netflix episode a clock starts counting down in the corner, and you have to decide either to exit or let the next episode start?  With Stranger Things, we always let the next episode take over the screen, and let all the next episodes take over our day.  Could.  Not.  Stop.  Watching.     

 

Mr. Robot (USA) – Maybe this bold show is undergoing something of a sophomore slump, but the episode that mimics 90s sitcoms (e.g., Full House, Family Matters) may have been the best hour of tv since Cersei burned down the town and the Khalisi set sail with a dragon escort.  If you watch this show, you might actually have something substantive to say to the techno-geeks who patrol your office.  And they might have something to say to you besides, “Have you tried rebooting?”  

 

The Night Of (HBO) – One always has high expectations for any show in the 9 pm Sunday night slot on HBO, and The Night Of does not disappoint. It is based on a British show called Criminal Justice.  One of the writers for the American version is Richard Price, who has penned some fine novels (Lush Life) and some of the best episodes of The Wire.  The first couple chapters of The Night Of were blisteringly suspenseful, reminding us how modern technology spies on us, but how there are still tragedies that manage to evade the cameras and our understanding.  Then the show settled into a Law & Order-type procedural, complete with the requisite interview of someone at their workplace.  (Comedian John Mulaney does a bit about a guy calmly loading crates onto a truck while answering questions about a grisly murder.  “Tony Ramirez?  Yeah, I remember him.  Worked on Tuesdays, I think.”  Keeps lifting crates.  A detective puts a picture under the witness’s nose.  The witness hardly pauses as he flings a crate into the trailer.  “No, I don’t recognize him”  Picks up another crate.)   The workplace interview in The Night Of involved a hearse driver, so the creepiness level was turned up to 11.  The most recent entry of The Night Of featured a cross-examination of a defense expert by the prosecutor.   The expert and prosecutor clearly have been locking horns for many years.  By now, they know each other’s moves.  They even seem to enjoy each other’s company.  The wry back-and-forth reminded us of some mini-battles we have had with certain plaintiff experts we have deposed repeatedly.  Of course, in our case there was no murder — except, you know, for the expert’s occasional murder of the truth.

 

Watch these shows and you will thank us.

  

What’s that?  You came to this blog to learn a little something about the law, not television?  Okay, if you insist.  But how about if we split the difference, and discuss a case about television?  To be precise, it is a case about televisions, in the plural.  In Oliver v. Funai Corp., 2015 WL 930541 (D. N.J. Dec. 21, 2015), the plaintiffs claimed that the defendants sold them defective televisions.  The defect consisted in certain allegedly faulty components.  When those components went bad, the televisions would  “stop displaying a picture and sound.”  That does, indeed, seem like a problem.  The plaintiffs alleged that the televisions in question typically failed outside of the stated one-year warranty period and ninety-day warranty period for labor, leaving consumers with little reprieve.  The legal claims included fraudulent concealment and the like.  There were two plaintiffs, one in Massachusetts and one in Arizona.  One of the plaintiffs alleged that he purchased his television in September of 2012, and that the same television failed in January 2014, after only 190 hours of usage.  At this point, and not just because we are a crotchety defense hack, we grew suspicious of that plaintiff.  Four months of tv viewing, totaling only 190 hours?  That’s just a little more than an hour and a half a day.  Who watches so little tv?    Most people would burn through 190 hours just during the NFL playoffs.  Was this person confining their viewing to PBS specials on How Turtles Do Calculus, or the Cleveland Symphony’s production of an opera based on Kafka’s Metamorphosis, “Roach!”  Surely there is an issue in this case of credibility and/or limitation of damages.   

 

What does any of this have to do with drug or device law?  The Oliver case involves one issue we have addressed a lot recently, personal jurisdiction, and one we hardly ever see, which is whether internet postings constitute information that can be attributed to a corporate defendant. 

 

Personal Jurisdiction

  

The defendants in Oliver were (1) Funai Corp., which is incorporated and has its principal place of business in New Jersey, and (2) its parent, Funai Electric, a company incorporated and headquartered in Japan.   Was there personal jurisdiction over the Japanese parent company?  As most of our readers know by now, personal jurisdiction consist of both general jurisdiction and specific jurisdiction.  With general jurisdiction, a company can be sued for anything.  With specific jurisdiction, a company can be sued only for its conduct specifically in and targeted to that particular jurisdiction.  Under the Supreme Court’s decision in Bauman, general jurisdiction extends only to companies that are essentially “at home” in that jurisdiction, and that at-home-ness applies to place of incorporation, principal place of business, and extremely rare exceptions, such as temporary relocation of a company during war time.  The Oliver court easily decided that the plaintiffs could not show general jurisdiction under the paradigmatic examples laid out in Bauman.  In support of their general jurisdiction argument, the plaintiffs chiefly relied upon the fact that Funai Electric allegedly “funnels its televisions through the State of New Jersey.”  But it is well-settled by the Supreme Court that while “[f]low of a manufacturer’s products into a forum … may bolster an affiliation germane to specific jurisdiction… ties serving to bolster the exercise of specific jurisdiction do not warrant a determination that, based on those ties, the forum has general jurisdiction over a defendant.” 

 

So now we are onto specific jurisdiction.  And the plaintiffs still do not have enough contacts to cross the finish line.  The Oliver court concluded that the connection between Funai Electric’s allegedly manufacturing televisions for distribution to its New Jersey subsidiary was not enough to establish jurisdiction in New Jersey for a case where the plaintiffs bought, used (though clearly not enough), and were unhappy with their televisions in other states.  In fact, the plaintiffs’ argument for specific jurisdiction was really another general jurisdiction argument in disguise.  Under their theory, by running televisions through a New Jersey distributor, a company at home in Japan would have opened itself up to litigation in New Jersey by any American consumer.  The court rejected such a nonsensical result.  Indeed, the court was so struck by the nonsensical nature of the plaintiffs’ position that it also rejected a request for jurisdictional discovery.   

 

Fraudulent Concealment

 

With Funai Electric now out of the Oliver case, that left only Funai Corp., which also had a strong argument for dismissal on the pleadings.  Funai Corp contended that the plaintiffs could not meet the elements of a fraudulent concealment claim because the plaintiffs failed to plead that Funai Corp. knew of the defect prior to the plaintiffs’ purchases.  In response, the plaintiffs directed the court to “numerous consumer complaints that ‘date back to 2011 and beyond.” But the complaints appeared on the websites of third-parties such as Amazon and Wal-Mart, and the plaintiffs provided no indication that the defendants viewed or would have viewed those websites.  Moreover, many of the postings, written by unknown bloggers (i.e., “oliveubabe” and “2ofakind0”) [Sure, those are funny names.  But have you seen some of the names our commenters use?  Which reminds us — “Cocaine Princess,” where have you been?], did not specifically reference the defect alleged in the plaintiffs’ complaint; rather, they alleged general problems with the televisions’ functionality or quality.  Accordingly, the court was not persuaded that knowledge of the alleged defect could be imputed to the defendants based upon anonymous internet complaints on third-party websites.  Nor was the court persuaded that knowledge could be imputed to the defendants based upon the representations made in the anonymous internet complaints that the consumers contacted the defendant via phone to voice their concerns.    

 

This ruling in Oliver should be of interest to our clients.  As the court reasoned in Oliver, “[i]mputing knowledge of a defect to a manufacturer based upon an internet posting would mean that virtually every consumer product company would be subject to fraud claims and extensive discovery.”  That is true because everything is on the internet.  And by “everything,” we mean everything that is true, false, something-in-between, and crazy.  If the mere existence of some statement or accusation on the internet could be attributed to a corporate defendant, then it is open season for alleging all sorts of corporate frauds.   That is an unacceptable result.  The internet, as wonderful and useful as it can be, is a vast mess.  Most of what you see on the internet is ridiculous, frivolous, and merits no assumption of veracity. 

 

There is one exception.  If you are on our website and you are reading legal analysis or a tv recommendation, then you can take judicial notice.    

 

 

 

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

Everybody lies, maybe even several times a day. Often we don’t even realize it because the lies are small. They are white lies like “of course that shirt looks good on you.” What about all those times we nod while someone is talking but we really aren’t listening. Aren’t those lies too? Then there are those lies we tell ourselves, sometimes necessary to get through the day with our self-esteem intact.

But what about the biggies? The look someone in the face and make up something that is simply not true just to benefit oneself type of lie. The type of lie that is told when someone cheats or steals. Or, the type of lie that is told when a lawyer doesn’t do his or her homework but makes representations to the court as if they did. Look, nobody is perfect and there are times, especially in mass torts with lots of plaintiffs, where facts get jumbled or twisted a bit. Times when a little more digging before filing a lawsuit would have revealed different product usage or dates of ingestion. And sometimes those minor differences in facts can lead to cases being dismissed that probably shouldn’t have been brought in the first place. But complete fabrications of the core facts on which a case rests, in multiple cases – that’s going to get you sanctioned. And worse than a sanction, you’re going to lose your credibility with the court.

Losing credibility with the court isn’t something any lawyer ever wants to have happen. It also doesn’t take the extreme misrepresentations we are going to tell you about with today’s case. Promising things by certain dates and not delivering. Overstating a position and not being able to back it up. Being unprepared generally and repeatedly. All of this can lead to a court’s disfavor; to a judge doubting a lawyer’s veracity. While today’s case is very unique and the court’s distrust is directed to plaintiffs’ counsel, the most important to keep in mind is you don’t want to be in this position. Every time you address a court, in writing or in person, know your facts, know your law, and be honest.

That brings us to Johnson v. Smithkline Beecham Corp.2016 WL 4426164, slip op. (E.D. Pa. Aug. 10, 2016) in which fifty-two plaintiffs born in the late 1950’s or early 1960’s filed state-court Thalidomide suits in Philadelphia against GlaxoSmithKline and certain of its affiliates (“GSK”), along with Sanofi-Aventis and/or Grunenthal GmbH. The cases were removed to the United States District Court for the Eastern District of Pennsylvania on diversity grounds.

We posted about this case over a year ago when one of the plaintiff’s claims was dismissed on summary judgment. At that time we noted that in October 2015, twenty-eight plaintiffs had moved to dismiss their claims against GSK with prejudice (their claims against the other defendants would continue). Those dismissals are the subject of this month’s Report and Recommendation by the Special Discovery Master. The ultimate conclusion of the Special Master is that the dismissals should be allowed, the heart of the decision is about why the dismissals were questioned in the first place.

The problems with this group of cases goes back to the original complaints, which were verified, upon information and belief, by plaintiffs’ counsel.  Because plaintiffs were seeking to bring what amount to 50-year old claims, their complaints had to address how it was that they were unaware of their thalidomide-related injuries until approximately 2010. Johnson, slip op. at 8. At the motion to dismiss phase, the court had to accept these allegations as true. But discovery quickly showed that not to be the case. That’s when it was learned, for instance, that three plaintiffs, who in their complaint alleged they couldn’t have known about the defendants’ roles in their alleged injuries before 2010, had previously filed legal claims for these injuries and at least one was still collecting settlement checks. Id. at 10. Another plaintiff alleged in his complaint that he “was left with no understanding of what it meant to be a thalidomider.” Id. at 12. But at his deposition, that same plaintiff not only testified that in the 1960s his mother told him thalidomide had caused his injuries, but also that in 1983 he sought disability for his thalidomide-based injuries, in the 1990s plaintiff’s mother gave him the bottle of thalidomide pills she had taken, and in 2000 plaintiff gave an interview in which he stated that his injuries were caused by thalidomide. Id. at 12-13. These “major discrepancies” between the allegations and the facts are what led the court to refer to plaintiffs’ counsel as “unreliable bringers of truth.” Id. at 12. They also led to GSK filing multiple motions for sanctions against plaintiffs’ counsel, at least one of which plaintiffs’ counsel didn’t oppose. Id. at 13.

It was against that background that the court decide to have the Special Master conduct an investigation into the twenty-eight dismissals with prejudice.   The court was concerned that the “deal was suspiciously out of balance.” Id. at 2. Plaintiffs were dismissing their claims against GSK for seemingly “no discernible benefit” while their lawyers on the other hand reaped a significant advantage. In return for the dismissals, GSK agreed to drop the sanctions motions and forego any monetary payment in relation thereto. Id. at 15. While concerning on its own, the dominant consideration for the court in deciding to investigate the dismissals was that it “had lost confidence in the [plaintiffs’] lawyers’ ability and willingness to tell the truth about critical facts when addressing the Court.” Id. at 3. Wow. That’s a punch in the gut no lawyer ever wants to receive.

The court ordered the Special Master to “ensure that [plaintiffs’ counsel] obtained the knowing, voluntary consent of each Plaintiff before agreeing to dismiss his or her case against the GSK Defendants with prejudice.” Id. at 17. The Special Master determined that to fulfill this directive, he had to interview each plaintiff directly. First, plaintiffs’ counsel challenged that the court had the power or jurisdiction to do this at all. Plaintiffs argued that because GSK wasn’t opposing the dismissals, the court had no discretion other than to enter them. Rule 41(a)(2), however, provides that dismissal requires a court order and must be “on terms the court considers proper.” Id. at 26. The court wasn’t questioning the terms of the dismissal or whether they were reasonable, only whether plaintiffs were adequately informed and the dismissals were in fact voluntary. Plaintiffs’ counsel’s second road block to the interviews was to suggest that everything the court needed to know could be conveyed via either declarations signed by each of the plaintiffs or in writing in response to a questionnaire. Id. at 19. But as each of those options still contained the possibility of lawyer involvement and may not be a first-hand account, the court rejected them both. Finally, the interviews were conducted in the presence of both plaintiff and defense counsel.

Throughout the process, the Special Master was acutely aware that he was walking right along the edge of the attorney-client privilege and if you read his very detailed report, you’ll see he took great care to make sure the privilege wasn’t violated. But that didn’t stop plaintiffs’ counsel from making statements at the start of each interview about the privilege. Those statements turned into accusations against the Special Master and the court that they were intentionally seeking to violate the privilege and calling the entire process a “sham” and an attempt to “embarrass plaintiffs and their counsel.” Id. at 30-32. We’re not sure plaintiffs’ counsel were in any position to be accusing the court of wrongdoing. Feels a bit like a schoolyard bully whose bluff has been called and his last resort is “I know you are but what am I.”

Left with healthy skepticism about whether plaintiffs’ counsel “painted a picture of a judiciary so hostile, so malevolent, that the Plaintiffs were incapable of making a reasonably informed decision,” but unwilling to violate the attorney-client privilege, the Special Master concluded that each plaintiff demonstrated a cogent rationale for deciding to dismiss his/her claims against GSK while continuing to pursue claims against the other defendants. It appears most learned that GSK had not been involved with thalidomide at the time their mothers’ ingested it. Id. at 28.

The issue must still be resolved by the court, which we do not believe will be very pleased with the way plaintiffs’ counsel conducted themselves throughout the interview process. So, while it is likely the dismissals will be granted, plaintiff’s counsel themselves seem to be in a hole we aren’t sure they’ll ever be able to climb out of.

Earlier this month the FDA issued a draft guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device.” It’s long, and anyone interested in reviewing the whole thing can download it from the FDA’s website here.  Our interest in this draft guidance, as product liability litigators defending FDA-regulated products, is primarily due to the Agency’s numerous statements about when changes to the design and warnings of 510(k) medical device obligates their manufacturers to resubmit their products for additional FDA clearance prior to marketing.

As we’ve already discussed in much more detail in our September, 2015 “In Case of Good Judge, Break Glass” post, if a product change requires prior FDA review and assent, then that change cannot be mandated by common law tort actions.  The Supreme Court stated in PLIVA v. Mensing, 564 U.S. 604 (2011), “The question for ‘impossibility’ [preemption] is whether the private party could independently do under federal law what state law requires of it.” Id. at 620.  The new FDA draft guidance is all about when product changes to 510(k) devices require prior submission and Agency clearance:

This guidance, when finalized, will aid manufacturers of medical devices subject to premarket notification requirements who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (also referred to together as “existing devices”) during the process of deciding whether the modification exceeds the regulatory threshold of 21 C.F.R. §807.81(a)(3) for submission and clearance of a new 510(k).

Draft Guidance at 3 (“Scope”) (emphasis added).

Initially, we remind everyone that this document is both a “guidance” and a “draft.” It is subject to comment and is not final.  Even when final it has no legally binding effect.  But the guidance does interpret legally binding regulations that, as we discussed in our “Break Glass” post, mandate prior FDA review and clearance of changes to 510(k) devices.  The guidance is useful in that it provides a more comprehensive explication of the regulations, and thus more useful understanding of when a requirement for prior FDA submission of a device change gives rise to implied impossibility preemption under Mensing, Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), and Wyeth v. Levine, 555 U.S. 555 (2009).

Here are the principles that we think are most important to that determination.

First, any change that significantly affects a 510(k) device’s safety or effectiveness – and thus essentially any change that could support a causation argument in product liability – requires the submission of a new 510(k) device notification and prior FDA clearance:

Modifications made with intent to significantly affect safety or effectiveness of a device – If a manufacturer modifies their device with the intent to significantly improve the safety or effectiveness of the device (for example, in response to a known risk, adverse events, etc.), a new 510(k) is likely required.  Changes that are not intended to significantly affect the safety or effectiveness of a device, however, should still be evaluated to determine whether the change could significantly affect device safety or effectiveness.

Draft Guidance at 4 (emphasis original).

Manufacturers are required to submit a new 510(k) when a change (or changes) exceeds the §807.81(a)(3) threshold, “could significantly affect the safety or effectiveness of the device,” or constitutes a “major change or modification in the intended use of the device.”

Id. at 9 (quoting regulations).

[T]he first question is always whether the change is being made with the intent to significantly improve the safety or effectiveness of the device, for example, in response to a known risk, adverse event, etc. (Figure 1 – Main Flowchart). If so, then the change likely “could significantly affect safety or effectiveness” and a new 510(k) likely must be submitted.

Id. at 10.

Second, any change that involves an off-label use – that is, a change affecting the “intended use” of the device – also requires submission of a new 510(k) device notification and prior FDA clearance:

The concept of intended use has particular relevance in determining whether a device can be cleared for marketing through the premarket notification (510(k)) process or must be evaluated in a premarket approval application (PMA) or a de novo request for classification under section 513(f)(2) of the FD&C Act. Manufacturers should recognize that, per section 372513(i) of the FD&C Act, if a particular labeling change results in a different intended use of the device, the device would not be substantially equivalent and a PMA or a de novo submission would be required to market the device.

Draft Guidance at 11 (emphasis added).

Changes in the indications for use section of labeling raise more Agency concern than any other aspect of labeling. In fact, most changes in this part of the labeling that affect the substance, meaning, or scope of the indications for use – referred to here as “substantive changes” – could significantly affect safety or effectiveness and will require the submission of a new 390 510(k).

Id. at 12.

[I]f a design change significantly affects how a device may be used, a new 510(k) is likely required.

Id. at 25.

Third, changes to the composition of the device that affect its safety or effectiveness require requires submission of a new 510(k) device notification and prior FDA clearance:

Manufacturers should consider whether the material change could affect the performance of the device by affecting its strength, hardness, etc. Manufacturers should also consider whether the new material could be affected by any labeled cleaning, disinfection, or sterilization process of the device.  If the answer to this question is yes, manufacturers should . . .  consider whether the change could significantly affect the safety or effectiveness of the device.

Draft Guidance at 31.

Fourth, certain other label changes also require submission of a new 510(k) device notification and prior FDA clearance:

Deletion or modification of a contraindication usually requires the submission of a new 510(k) prior to effecting the change.

Draft Guidance at 16.

If the change significantly affects the device’s risk profile, a new 510(k) is likely required.

Id. at 17 (note, that in many “risk profile” changes, the changes being effected (“CBE”) process would be available, thus precluding preemption under Levine).

Finally, the draft guidance also discusses a wide variety of other device alterations that could trigger an obligation to submit a new 510(k) notification to the FDA, such as changes to sterilization (pp. 21-22), that could conceivably be relevant in specific litigation situations. Any of our defense-side colleagues facing a peculiar claim should review the entire guidance to see if prior FDA action is required by whatever change the plaintiff is demanding.

When we wrote our “Break Glass” post back almost a year ago, there were only a few district court cases applying Mensing/Bartlett preemption outside of generic drugs.  Now there is a lot more helpful precedent (see our post-Levine preemption cheat sheet).  We have several new cases preempting branded drug design defect cases because prior FDA approval of major changes is required. Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015) (affirming a decision cited in our prior post); Brazil v. Janssen Research & Development LLC, ___ F. Supp.3d ___, 2016 WL 3748771 (N.D. Ga. July 11, 2016); Fleming v. Janssen Pharmaceuticals, Inc., ___ F. Supp.3d ___, 2016 WL 3180299 (W.D. Tenn. June 6, 2016); Barcal v. EMD Serono, Inc., 2016 WL 1086028 (N.D. Ala. March 21, 2016); Rheinfrank v. Abbott Laboratories, Inc., 137 F. Supp.3d 1035 (S.D. Ohio 2015); and Rheinfrank v. Abbott Laboratories, Inc., 119 F. Supp.3d 749 (S.D. Ohio 2015) (which had been decided before our earlier post, but we didn’t know about yet).

Mensing/Bartlett preemption has also been extended to OTC drugs. Batoh v. McNeil-PPC, Inc., ___ F. Supp.3d ___, 2016 WL 922779 (D. Conn. March 10, 2016).

Branded drug warning claims involving information not subject to the CBE exception to prior FDA approval of significant changes has also been recognized. In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34 (1st Cir. 2015) (information wasn’t “new”); In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, ___ F. Supp.3d ___, 2016 WL 2840215 (D.S.C. May 6, 2016) (information related to efficacy, not safety).

Mensing/Bartlett preemption has even been applied outside of the FDCA altogether – to bar airplane design claims requiring prior FAA approval – in Sikkelee v. Precision Airmotive Corp., 822 F.3d 680, 703-04 (3d Cir. 2016).

It’s inevitable – barring a change in the composition of the Supreme Court that leads to the overturning of Mensing and Bartlett – that implied impossibility preemption will come to 510(k) medical devices.  Three circuits (1st, 3rd, and 6th) have already applied it outside of generic drugs.  Unlike express preemption (such as Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)), implied preemption isn’t limited to the express terms of particular statutes, and as we discussed in the “Break Glass” post, express and implied preemption operate independently of one another, so Lohr doesn’t restrict the operation of implied preemption.

For us, this is the reason that the FDA’s 510(k) draft guidance is important (although it does other things, too, like debunking the bogus argument that 510(k) clearance doesn’t involve”safety”). Since the key to impossibility preemption, as Mensing held “is whether the private party could independently do under federal law what state law requires of it,” the draft guidance provides a wealth of FDA regulatory explanation of why certain types of changes to the design, labeling, and other features of 510(k) medical devices necessitate prior FDA clearance − and thus cannot be demanded by plaintiffs in common-law product liability litigation.

It’s August and several your valiant bloggers are on vacation, so the skeleton crew manning the fort is even more grateful for reinforcements than usual.  Here is another guest post, this time from Reed Smith‘s Court Chillingworth.  This is about a topic we’ve covered sporadically, the Biomaterials Access Assurance Act.  As always Court is entitled to full credit (and any blame) for everything appearing hereafter.  Except for this:  Edgar Allen Poe wrote on both.  Don’t worry, you’ll understand what it means by the end of Court’s post.

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When is a medical device an implant? When is it not? While far more drab than anything Lewis Carroll would have written, it is still a multi-layered riddle, and one that should be of particular curiosity – and possibly concern – to present-day medical device lawyers. It derives from the Biomaterials Access Assurance Act (“BAAA”), 21 U.S.C. §§ 1601 et seq., a statute that shields from liability in all state and federal courts the manufacturers of biomaterial and component parts that are supplied “for use in the manufacture of an implant.” Id., § 1601(1)(A) (emphasis added); see also id. § 1601(2), 1603(b)(1), 1604(a).  A Connecticut trial judge recently explored the question in Nolen-Hoeksema v. Maquet Cardiopulmonary AG, No. 146049888S, 2016 WL 4203030 (Conn. Super. New Haven Dist. July 11, 2016), and in particular, the question of whether one of the statute’s definitions of an “implant” – a device that is intended be “in contact with bodily fluids or internal human tissue through a surgically produced opening” [21 U.S.C. § 1602(5)(A)(ii) (emphasis added)] – would apply to a medical device that is used during surgery, but is not designed to be in direct contact with the patient.

Ultimately, the court found its answer from an otherwise simplistic source:  the Webster’s Dictionary and its definitions of the word “through.” But its analysis, which involved principles of statutory interpretation and federal preemption, was complex: which one of two Webster’s Dictionary definitions of the word “through” should be applied – one advocated by the defendant, meaning “by way of” in the abstract, or one advocated by the plaintiff, meaning “penetrating.” The court chose the latter, which effectively would require direct contact between the device and the patient for the BAAA to apply to component parts of the device under 21 U.S.C. § 1602(5)(A)(ii).

In Nolen-Hoeksema, the device at issue, an oxygenator, allegedly “fell apart” during the patient’s surgery, leading to the decedent’s death. Nolen-Hoeksema, 2016 WL 4203030, *1. His family sued the oxygenator’s manufacturer, as well as the manufacturer of the adhesive material used to keep the oxygenator assembled. Id. The adhesive manufacturer filed a motion to dismiss on BAAA grounds. As this blog has noted, component part manufacturers have applied the BAAA defense with virtually universal success.  See, e.g., Sadler v. Advanced Bionics, LLC, 2013 WL 1636374 (W.D. Ky. April 16, 2013); Mattern v. Biomet, Inc., 2013 WL 1314695 (D.N.J. March 28, 2013); Whaley v. Morgan Advanced Ceramics, Ltd., 2008 WL 901523 (D. Colo. March 31, 2008); Marshall v. Zimmer, 1999 WL 34996711 (S.D. Cal. Nov. 4, 1999). The court in Nolen-Hoeksema acknowledged these cases, but drew a distinction – none of them involved the question of whether a medical device that is not in direct contact with the patient qualifies as an “implant” under the BAAA.  Nolen-Hoeksema, 2016 WL 4203030, at *4 n.3.

To argue their points, both parties directed the court to the definitions of “through” in the Webster’s Dictionary (Webster’s Third International Dictionary (1993), to be exact).  According to the plaintiff, “through a surgically produced opening” meant literally through, as in physical, functional “penetration of or passage within” the opening, as one of Webster’s definitions described the word. Id. at *3. But the defense countered that Webster’s also defined “through” “in the more general sense of ‘by means of’” [id.], as in, “the author made a poor attempt at levity in his article through strained allusions to Alice in Wonderland.”

Down the rabbit hole went the court to determine which definition would apply. The court’s first step was to decide what principle of statutory interpretation it should apply. Because the BAAA is a federal statute, it found that under Connecticut precedent, it had to apply the rule of construction utilized by the U.S. Second Circuit.  Id. at *2. The Second Circuit “begin[s] with the text of the statute to determine whether the language at issue has a plain and unambiguous meaning. . . . [The court] attempt[s] to ascertain how a reasonable reader would understand the statutory text, considered as a whole.” Id. (quoting Louis Vitton Malletier S.A. v. LY U.S.A., Inc., 676 F.3d 83, 108 (2d Cir. 2012).

Given the BAAA’s explicit recognition that raw material and component suppliers “have ceased supplying certain raw materials and component parts for use in medical devices for a number of reasons, including concerns about the costs of such litigation” [21 U.S.C. § 1601(8)], a reasonable reader may agree with the defense interpretation of what is, after all, a remedial statute. One might argue that the defense’s broader interpretation is not just reasonable, but more appropriate than the alternative interpretation, in light of the BAAA’s goal to offset the discouraging effect litigation has on potential raw material and component suppliers. But while the court preliminarily cited this portion of the statute’s language [Nolen-Hoeksema, 2016 WL 4203030, at *1], it did not consider the language in its eventual analysis. Id. at *3-4. Instead, it looked outside the statute – indeed outside statutory interpretation altogether − to the “presumption against preemption.”  That is, “where the text of a preemption clause,” which the BAAA is, since it bars any state law personal injury claims against medical implant component suppliers, “is ambiguous or open to more than one plausible reading, courts have a duty to accept the read that disfavors pre-emption.”  Id. at *3 (citing New York State Restaurant Ass’n v. Board of Health, 556 F.3d 114, 123 (2d Cir. 2009)). Here, on the one hand, the defendant offered an interpretation of “through” that would “preempt state law in a greater number of cases,” while on the other, “the plaintiff construes it more narrowly.” Nolen-Hoeksema, 2016 WL 4203030, at *3. Given the two potential interpretations of the word “through,” the court sided with the interpretation that would have a lesser preemptive effect – thereby effectively ignoring what Congress intended to achieve through the BAAA.

With all that jabberwocky out of the way, the court finally got to what was probably its first gut reaction, which was to rely on what it understood to be the “ordinary meaning” of the word “implant.” Id. at *4. To this end, the court once again turned to the Webster’s Dictionary, which defined “implant” as “something that is ‘fix[ed] or set securely or deeply,’ ‘[especially] in tissue.’” Id. Since the undisputed evidence (That’s right, evidence. BAAA authorized submission of evidence in connection with a motion to dismiss, even in state court. See 21 U.S.C. §§ 1603(a)(2), (c)(1); see also Nolen-Hoeksema, 2016 WL 4203030, at *2 n.2 (BAAA procedure applies in state court)) showed that the oxygenator “is not inserted into the patient’s body,” it did not fit with the “common understanding” of the word “implant.” Id. Motion denied.

So, when is a medical device an implant under the BAAA? “Either [it] is, or [it] is not,” quoth the court. Id. at *4 n.4. According to the court’s reading of the dictionary, an oxygenator is not, and therefore its components do not qualify for the BAAA defense. Next question: Why is a raven like a writing desk?

If you represented a large corporation or a wealthy individual, wouldn’t you want to know if your prospective jurors were campaigning for Bernie Sanders on Facebook? Or how about criminal prosecutors who might want to know if members of their jury panel had posted strong feelings on police conduct?  If you were adverse to a drug or medical device company, maybe you would want to know if a prospective juror wrote for the Drug and Device Law Blog (although we can guarantee that you will find no more thoughtful and impartial jurors than the seven individuals who make up the collective “we”).

Millions of potential jurors make information like this (and much more) publicly available on the Internet through social media or otherwise, and what trial advocate would not want to uncover it? We got to thinking about this topic a few months ago when we read a unique order that came out of the Northern District of California in Oracle America, Inc. v. Google Inc., ___ F. Supp.3d ___, 2016 WL 1252794 (N.D. Cal. Mar. 25, 2016).  The district judge in Oracle v. Google asked the parties in a high-stakes copyright action to abstain voluntarily from searching the jury panel’s social media.  If the parties would not agree to a complete ban, then the court would impose specific limitations.

We’ll get to the details in a minute. But first, we set out to see if there are any rules that govern searching jurors’ social media (with research assistance from Reed Smith attorney David Chang).  It turns out there are, mainly within the rules of ethics and professional conduct.  The first rules obviously are our duties of competence and diligence.  They are among the first duties listed under the ABA’s Model Rules and probably the rules governing lawyers in most every state. See Model Rules of Professional Conduct, Rules 1.1, 1.3.  If there is publicly available information that would help us identify jurors with potential biases, a competent and diligent trial advocate needs to consider gaining access to it.

There are, however, countervailing considerations. On April 14, 2014, the ABA’s Standing Committee on Ethics and Professional Responsibility published “Formal Opinion 466, Lawyer Reviewing Jurors’ Internet Presence.”  The ABA committee’s opinion came on the heels of an opinion from the Association of the Bar of the City of New York—“Formal Opinion 2012-2, Jury Research and Social Media.”  These are not the only publications on the topic, but they were at the cutting edge, and they cover the major considerations.

The opinions identify essentially three additional issues that you have to keep in mind:

No ex parte communications with jurors. Of course, we cannot engage in ex parte communications with jurors or prospective jurors.  We remember when we were Summer Associates and were told that if we talked to a juror, we would be fired.  Kind of a strange threat to make against a bunch of wide-eyed second-year law students who stood a snowball’s chance in hell of actually being in the presence of a jury.  (Rumor has it that such an incident actually occurred the prior summer, but we never learned any details.)  In any event, ABA Model Rule 3.5 prohibits ex parte contact with jurors, and everyone seems to agree that affirmatively reaching out to a juror on social media—i.e., to “friend,” “connect with,” or “follow” the juror—clearly would violate that rule.  Passive viewing of juror’s Internet presence is probably okay, depending on whether the juror receives notice of the surveillance.  If a juror received notice of your snooping, for example through an automated message that someone has “viewed your profile,” that is okay under the ABA’s Opinion, but it might be an ex parte communication under some state’s rules, including New York’s.  So be careful and tread lightly.

No deception. There are lots of rules that prohibit deception, but we follow the one that a now-retired and much-admired mentor shared with us repeatedly:  “You can’t do that.”  The ABA Opinion curiously does not mention deception, but the NYC Bar Opinion says flat out, “The attorney must not use deception to gain access to a juror’s website or to obtain information.”  So, no, you cannot troll for information on your jurors through a Facebook profile pretending to be a 24-year-old single woman seeking a roommate, or a 54-year-old divorced male who likes waterskiing and long walks on the beach at sunset (unless you happen to be one of those things).  If you search your jurors’ social media, either log in truthfully or don’t log in at all.

Report any juror misconduct. Judges admonish jurors repeatedly that they cannot discuss the case with anyone or engage in their own investigation, and that includes through the Internet and social media.  Still, we hear stories of jurors describing trials on Facebook and even expressing their opinions on the case.  If your social media searches turn up commentary that violates the court’s instructions, you have to reveal it to the court.  You might be thinking, as we did, why on Earth would an attorney not reveal misconduct to the court?  Well, the misconduct might reveal a juror’s bias in your favor.  Maybe she thinks your opening was great or that your experts absolutely killed it on direct.  It doesn’t matter.  If a juror has engaged in misconduct and you learn about it by monitoring social media, you have to tell the judge.

These are the ground rules against which the Northern District of California approached the parties’ intent to search their prospective jurors’ Internet and social media presence in Oracle v. Google.  As of the time of the March 25, 2016 order, one side had not agreed to the court’s request to abstain from searching the jurors’ social media, so the district judge asked them again to agree.  If they would not, the court would inform the jury panel of the “specific extent” to which each side would use Internet searches.  The judge then would give the panel “a few minutes to use their mobile devices to adjust their privacy settings, if they wish.”  2016 WL 1252794, at *3.

There are some things we like about this solution. We like that the court is forward thinking and is looking out for the jurors’ interests in a twenty-first century world.  Not many courts understand privacy settings, or even know what privacy settings are.  This court thoroughly educated itself.  We also like that the district court did not impose an outright ban on social media searches.  A federal court may or may not have the authority to impose such a ban, but assuming that it does, a complete ban would hamstring attorneys (who are bound by duties of competence and diligence) in their efforts to engage in legitimate evaluation of public information.

The order does, however, raise important questions. The court was concerned that allowing social media searches (including telling the jurors what the attorneys were doing) “will likely have a corrosive effect on fidelity to the no-research admonition.” Id. at *2.  In another words, if the attorneys are searching the Internet, then the jurors may feel justified in disregarding the court’s admonition.  There is certainly a risk of that, but it is uncertain to us how significant that risk would be.  It is just as possible that jurors would take the admonition just as seriously whether the lawyers viewed their public profiles or not—particularly if the court instructed them that the difference is based on their role as impartial jurors, which is different from lawyers as advocates

Second, the court cited the danger of attorneys making “improper appeals to particular jurors via jury argument and witness examinations patterned after preferences of jurors found through such Internet searches.” Id. That also is a risk, but it is not unique to the Internet.  The voir dire process, often supplemented by detailed juror questionnaires, also reveals jurors’ preferences and attitudes.  That is the reason for the process, and ever since voir dire was invented, lawyers have known and used such information as they present their cases.

Third, the court wanted to protect the jurors’ privacy. Id. This is always a laudable goal, but we have to ask whether the court valued the jurors’ privacy more than the jurors themselves.  We are continually amazed by what people choose to post on Facebook (see our posts on ediscovery of plaintiff social media), even people with senses of social responsibility sufficient to show up for jury duty.  On this point, the court struck a compromise:  Give the panel members some level of control by allowing them the opportunity to adjust their privacy settings.  If the court followed this path, we would be interested to know how many took the court up on its offer.

The takeaway is not that this order is right or wrong. Either way, attorneys should understand first that rules apply, and they should understand second that issues surrounding juries and the Internet will get only more pervasive as time goes on.

This is our vacation week, so it’s time once again to play the game of “Where in the World is Stevie Mac?”  Last year, we wanted to visit a place with nice sights, great beer, and, most of all, zero chance of terrorism.  We chose Belgium.  Let that sink in for a moment.  This year should be easier.  The animating factors in 2016 — fear of jet-lag, fear of poverty, and, yet again, fear of terrorism – conspired to keep us fear-ly close to home.  Enjoy these hints:

  • Hello misnomer!
  • It never ratified the 18th amendment (prohibition – so, yes, this is our kind of place).
  • There is a specific law against biting off someone’s leg.  (The legislators here have obviously gotten a little too into The Walking Dead.)
  • The first American ever jailed for driving his car too fast earned that distinction by going a rip-roaring 15 mph here in 1904.
  • Cap guns are illegal in this state.
  • You will be fined if you throw pickle juice on a public trolley.  That rule will frustrate the DDL Son to no end.
  • Finally, our all-time favorite basketball player, Marvin Barnes, hailed from these parts.   Barnes (nicknamed “Bad News”) was part of a gang of high schoolers arrested for robbing a bus.  The victim had no trouble identifying Barnes, who had been wearing a letter jacket with his name embroidered on it.  That brush with the law did not stop Bad News (later shortened to “News”) from having a remarkable hoops career.  Barnes began his professional career with the ABA’s St. Louis Spirits.  Once upon a time, his team was scheduled to fly home from Louisville at 8 o’clock.  Because of the East-to-Central time zone change, the flight was scheduled to arrive in St. Louis at 7:56.  Barnes refused to board the flight.  In his immortal words, “I ain’t getting on no time machine.”  Instead, he rented a car and drove home.  Sadly, Barnes died way too young (62) a couple of years ago.  Let’s pour out a little White Ship Lovecraft IPA in his honor this week.

Speaking of time machines, we often feel as if we were in one whilst interviewing law students on campus.  That season will be in full swing just as we return from our sunny sojourn.  Why, it’s simply a continuation of our vacation, isn’t it? High hopes and boat drinks all around.  Watch us squeeze into law school cubbyholes and chat with students well under half our age for positions that pay about five times what we got when we escaped Hyde Park.  We try to avoid asking the usual hack interview questions, if only because we could not ourselves think of answers that are both acceptable and true, so why demand more of others?

“What is your greatest weakness?”  Either cheesecake or judicial balancing tests.  Eating one makes us fatter; reading the other makes us dumber.

“What do your friends and colleagues say about you?”  Nobody knows more about James Bond or less about ESI discovery.

“Where do you see yourself in ten years?”  Probably in the same small law school cubbyhole, interviewing people a third our age for ten times what we first pulled down in our salad days.  And we still will be utterly flummoxed by ESI discovery.

 

Here’s another guest post, this time from Reed Smith‘s Elizabeth Graham Minerd.  This post concerns PMA preemption, and a second opinion largely getting rid of a case that we blogged about before.  As always, Elizabeth deserves all the credit, and any blame, for what follows.  Without further ado:

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In the recent decision of Marion v. Smith & Nephew, Inc., 2016 WL 4098608 (D. Utah July 27, 2016), the Court dismissed all but one of the plaintiffs’ claims relating to a premarket approved medical device from the amended complaint.  This was the Court’s second time finding the plaintiffs’ pleading largely deficient.  This blog previously discussed the Court’s first order dismissing plaintiffs’ original complaint with leave to amend here.  In that order, the Court provided the plaintiffs with a road map to navigating the “Scylla and Charybdis” of pleading a legally viable claim related to a premarket approved device.  But even with a road map, the plaintiffs were only able to navigate one of their nine claims through Scylla and Charybdis and that one claim did not escape unscathed.

In Marion, the plaintiff was implanted with the defendant’s hip resurfacing device—a device that received premarket approval a little over a year prior to the plaintiff’s surgery.  2016 WL 4098608, at *1.  After six years, the device allegedly failed and the plaintiff had it surgically removed. Id. The plaintiffs filed a lawsuit asserting various claims against the defendant for the device’s purported failure. Id.

The Court dismissed the plaintiffs’ original complaint, but granted the plaintiffs leave to amend. Id. In doing so, the Court provided “clear guidance” regarding the three issues that the plaintiffs would need to address in the amended complaint in order to state a parallel claim that would survive both preemption and Twombly/Iqbal [editorial note: regular bloggers call this “TwIqbal“]:

First the court required the [plaintiffs] to identify with specificity the federal law requirements that parallel the state law claims. Second, the court required the [plaintiffs] to identify with specificity the state law duties that existed prior to but allegedly parallel the requirements for the [device] under federal law.  Finally, the [plaintiffs] were required to plead adequate facts to make their parallel state law claims plausible on their face.

Id. at *3.

With this road map in hand, the plaintiffs filed their amended complaint asserting nine claims against the defendant. But again, all but one of the plaintiffs’ claims were left wrecked on the rocks or swallowed by the whirlpool.

Specifically, the plaintiffs’ claims for strict products liability – manufacturing defect ran into both Twombly/ Iqbal and preemption. Id. at *5.  The Court dismissed the manufacturing defect claim because (1) the plaintiffs “offer[ed] only conclusory allegations of alleged regulatory violations without any factual support” and (2) it would be preempted anyway to the extent the plaintiffs allege that the device as approved by the FDA was unreasonably dangerous. Id.  So too plaintiffs’ claims for strict products liability – failure to warn and negligent infliction of emotional distress ran into both Twombly/ Iqbal and preemption and were dismissed.  Id. at *5-*6.

The plaintiffs’ claim for breach of implied warranties crashed into express preemption and was dismissed because the FDA deemed the device fit for the purpose for which it had been approved and the plaintiffs’ implied warranties claim necessarily attacked that determination. Id. at *6.

Meanwhile, the plaintiffs’ claim for breach of express warranty collided with Twombly/Iqbal and was dismissed because the plaintiff failed to plead what express warranty was actually made to her prior to implantation of the device. Id. at *5.  The plaintiffs’ fraud based claims—negligent misrepresentation and fraudulent concealment—were smashed on the rocks of Rule 9 and were dismissed. Id. at *6.  And the plaintiffs voluntarily dismissed their unfair and deceptive trade practices claim. Id.

The plaintiffs were only able to navigate their negligence claim through Scylla and Chaybdis, but even it did not survive unscathed. The Court narrowed the plaintiffs’ negligence claim and rejected it to the extent that it was based on purported violations of regulations that the plaintiffs’ counsel admitted did not apply to the device. Id. at *4.  The Court further narrowed the plaintiffs’ negligence claim and rejected it to the extent it was based on violations of regulations “asserted in conclusory fashion without any factual support to move the allegations from conceivable to plausible.” Id. And the Court narrowed the plaintiffs’ negligence claim even further and rejected it to the extent that it was based on “violations of federal regulations relate to conduct by the defendant during the PMA process prior to the final grant of PMA” because such allegations were no different than the fraud on the FDA theory rejected in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001). Id.

The Court allowed a negligence claim based on alleged violations of the federal requirements relating to adverse event reporting to limp passed the defendant’s motion to dismiss. Id. The Court found that the plaintiffs had raised a plausible inference that the defendant violated federal regulations relating to adverse event reporting based on allegations that there was a delay in the defendant receiving reports of adverse events and the defendant issued a voluntary recall. Id. at 5.  However, the Court recognized that this claim will require plaintiffs to prove that the plaintiff’s injuries would not have occurred or would have been mitigated had the defendant complied with these adverse event reporting regulations. Id.  Since the plaintiff’s implant surgery was only a year after approval, this will likely be an insurmountable causation hurdle.

The Court also allowed, but did not analyze, plaintiffs’ negligence claim to the extent it is based on alleged violations of the federal requirements to train physicians and surgeons regarding the proper use of the device. Id. at *4.  Notably, the Court did not mention any allegation that the device—which was in the plaintiff for six years before its alleged failure—had been implanted improperly by her surgeon.

Overall a solid win for the defense. Having had all but one of their claims wrecked by Scylla and Chaybdis, the plaintiffs now face a likely insurmountable causation hurdle.

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

Looking back at our posts on innovator liability, it’s becoming more and more difficult to title them. According to the DDL blog, innovator liability has been rejected, abolished, denied, refused, disallowed. You get the idea. With the news from earlier this summer that the California Supreme Court is going to consider the issue – which will hopefully spell the demise of Conte – we may be nearing the end of the chapter on innovator liability. In the meantime, we’ll keep bringing you the wins as they stack up.

Today’s case was actually decided right around the time the California Supreme Court decided to take on the issue. Gillette v. Boehringer Ingelheim Pharm., Inc., 2016 WL 4217758 (Mag. D. Minn. Jun. 16, 2016). The decision didn’t come to our attention, however, until the magistrate’s report and recommendation was adopted last week. See 2016 WL 4203422 (D. Minn. Aug. 9, 2016).

The Gillette decision comes out of the Mirapex MDL and involves the application of Indiana law. Indiana products liability claims are governed by the Indiana Products Liability Act (“IPLA”) which provides a single cause of action subsuming all common law strict liability and negligence claims, as well as tort based warranty claims. Gillette, 2016 WL 4217758 at *3-4, *6. So, plaintiff in this case had one cause of action based on her allegations that her use of Mirapex caused her to gamble compulsively.

But was it Mirapex that plaintiff was taking at the time she suffered her injuries? According to her pharmacy records, plaintiff was prescribed Mirapex from 2001 until 2015. Id. at *1-2. It appears that from 2001 until April 2010, plaintiff’s pharmacy filled her prescriptions with brand name Mirapex. In April 2010, when her prescribing physician increased plaintiff’s dosage, her pharmacy began filling her Mirapex prescriptions with its generic equivalent – pramipexole dihydrochloride. Id. at *1. From April 2010 until late 2015, plaintiff received the generic version of the drug manufactured by a succession of four different generic drug manufacturers. Id. at *1-2.

Plaintiff’s complaint and her sworn discovery responses allege that plaintiff did not begin to exhibit signs of compulsive gambling until her prescription was increased in April 2010. Id. at *5. While plaintiff tried to alter her allegations in her sur-reply to the motion for summary judgment to include instances of gambling before 2010, the court rejected them both as self-serving and as insufficient evidence of “compulsive” gambling (they were isolated incidents). Id. So the court concluded that plaintiff’s injuries could only even have been potentially caused by the medication she ingested after April 2010 – the generic version. Id.

Plaintiff, however, only sued the brand-name manufacturer of Mirapex. Meaning plaintiff’s product liability claim could only survive if the court found that a brand manufacturer could be liable for injuries caused to a user of a generic equivalent. Like so many other federal courts to face this issue, the Mirapex MDL court did not have a decision directly on point from the relevant state’s highest court, in this case Indiana. But, it did have other federal court and lower state court interpretations of Indiana law and no reason to quibble with any of them. Id.

The IPLA requires that the defendant must have “sold, leased, or otherwise put into the stream of commerce the product that caused the user or consumer’s physical harm.” Id. Certainly those aren’t the facts here where defendants did none of those things. And the cases to have interpreted the IPLA in similar factual circumstances concluded that brand manufacturers owed no duty of care to users of the generic product. Id. The discussion of innovator liability is neither lengthy nor complicated. It stands on considerable precedent. It’s like a reverse Jenga game. The tower is virtually solid with only a few small holes to fill. Now to see if California plugs one of those gaps.

Anyone who has checked our post-Levine innovator drug & vaccine cheat sheet lately has no doubt noticed our two most recent entries, Gentile v. Biogen Idec, Inc., 2016 WL 4128159 (Mass. Super. July 25, 2016), and Christison v. Biogen Idec Inc., No. 2:11-CV-01140-DN-DBP, slip op. (D. Utah Aug. 5, 2016).  With respect to preemption and innovator drug warnings, these cases provide further support to an emerging, common-sense bright line in the otherwise all-too-murky world of “clear evidence” – that a warning change rejected by the FDA for lack of scientific evidence must be “clear evidence” that this change would have also been rejected at any earlier date.  The logic is inescapable that, if there was insufficient scientific evidence at moment X, there is no more, and usually less, evidence on the same issue at any time before X.

Looking at our cheat sheet, the first case to so hold appears to be In re Fosamax (Alendronate Sodium) Products Liability Litigation, 951 F. Supp.2d 695 (D.N.J. 2013). Fosamax involved the FDA’s partial rejection of a prior approval supplement after the date of the plaintiff’s injury.  Id. at 703 (FDA rejection occurred “approximately one month after” plaintiff’s injury).  The label change failed because “the data that FDA has reviewed have not shown a clear connection” between the drug and the risk at issue.  Id. at 699.

[C]lear evidence exists that the FDA would not have approved a label change to the Precautions section of the [drug] label prior to [plaintiff’s] fracture because Defendant submitted a label change and the FDA rejected it, and the FDA never required Defendant to submit new language or change the label, which demonstrates that the FDA did not think that the label should have been changed at that time.

Id. at 703-04. See In re Fosamax Alendronate Sodium Products Liability Litigation, 2014 WL 1266994, at *11 (D.N.J. March 26, 2014) (applying this ruling “to those Plaintiffs’ whose injuries occurred prior to [the FDA rejection date], without allowing additional discovery”).

Similar decisions – based on FDA insufficient-evidence rejections of label changes that occurred after the plaintiff’s prescription/treatment/injury – have also occurred in two Depakote cases:  In re Depakote, 87 F. Supp.3d 916 (S.D. Ill. 2015), and Rheinfrank v. Abbott Laboratories, Inc., 119 F. Supp.3d 749 (S.D. Ohio), reconsideration denied, 137 F. Supp.3d 1035 (S.D. Ohio 2015).

In light of the fact that the FDA rejected the [particular risk] warning in 2006 because it did not find that the available scientific evidence at that time supported the addition of such a warning, it is highly unlikely that the available scientific evidence, seven years prior to that date in 1999, would have supported the addition of such a warning.

Depakote, 87 F. Supp.3d at 922 (emphasis original).

Preemption is warranted because there is clear evidence the FDA would not have approved a change to the [drug] label adding a [particular risk] warning prior to [plaintiff’s] injury. The Court finds the FDA’s February 2006 decision that [these] warnings “should not be incorporated into [the drug’s] labeling” and the FDA’s 2008 belief that “the data do not provide sufficient evidence to support [] labeling changes at this time” constitute “clear evidence” that when confronted by the issue in 2003, the FDA would have rejected an attempt to add a [the same risk] warning.

Rheinfrank, 119 F. Supp.3d at 766. Cf. In re Incretin-Based Therapies Products Liability Litigation, 142 F. Supp. 3d 1108, 1124-27 (S.D. Cal. 2015) (multiple, recent FDA insufficient evidence conclusions supported “clear evidence” preemption regardless of individual plaintiff prescription or injury dates); In re Byetta Cases, 2015 WL 7184655, at *13-14 (Cal. Super. Nov. 13, 2015) (same).

Several months ago, we discussed another case drawing the same line, Cerveny v. Aventis, Inc., ___ F. Supp.3d ___, 2016 WL 1065826 (D. Utah March 16, 2016).  In Cerveny, two FDA citizen’s petition denials for “fail[ure] to provide reasonable evidence to demonstrate” a causal connection to the alleged risk doomed product liability claims based on a prescription that was made prior to those denials:

[W]here a citizen petition post-dates the alleged injury and addresses the failure-to-warn claim proffered by a plaintiff, a citizen petition denial can be evidence to support a manufacturer’s preemption defense. . . . In this case, the FDA heard and rejected the Plaintiffs’ theory embodied in [the] citizen petitions, which post-dates [plaintiff’s drug] use. . . .  If the FDA concluded in 2009 and 2012 that [the drug] . . . does not pose a risk of [what plaintiff suffered], the Court cannot say the FDA would have approved a contrary warning prior to 1992. . . .  The FDA’s denial of the Plaintiffs’ theories embodied in [the] citizen petitions is clear evidence that the FDA would not have permitted [defendant] to strengthen [the drug’s] label prior to 1992.

Id. at *9-11 (numerous citations omitted)

The Gentile and Christison Tysabri cases follow this line of precedent – and more.  In these cases, the link between the drug in question and the rare, fatal condition that the plaintiffs alleged was undisputed – and quite graphically warned about (more on that after we finish with preemption).  However, the drug was very useful against other, more common, and likewise potentially fatal conditions, and at the time(s) in question, there was essentially nothing predictive of who would suffer the rare risk.  Gentile, 2016 WL 4128159, at *1-3; Christison, slip op. at 6, 9-15.  In both cases, the plaintiffs focused on the potential value of certain antibody tests, but both of them used the drug prior to FDA approval of those tests.  In 2006 FDA determined that “no consensus” existed on whether those tests were “clinically relevant.” Gentile, 2016 WL 4128159, at *2-3; Christison, slip op. at 15.  In 2010, the FDA reached the same conclusion – “that there is currently sufficient information to support the clinical utility of the . . . antibody assay in determining the risk.” Gentile, 2016 WL 4128159, at *3; Christison, slip op. at 47.  Ultimately, after additional study and submissions, the FDA approved an antibody-based test for risk susceptibility in 2012. Gentile, 2016 WL 4128159, at *3; Christison, slip op. at 15-16.

In both Gentile and Christison, the relevant use of the drug occurred prior to one or both of the FDA’s 2006 and 2010 insufficient evidence-based refusals to approve the antibody tests. Gentile, 2016 WL 4128159, at *2-3 (used drug between January, 2007 and September, 2009); Christison, slip op. at 18-20 (used drug between February, 2007 and June, 2009).  Given that, even after the last prescriptions, the FDA had considered and refused to approve the tests at issue due to insufficient scientific support, both cases concluded that “clear evidence” existed to support preemption of warning claims asserting that the tests should have been recommended in the drug’s labeling.

In the present case, the FDA’s decision to reject the proposed modifications regarding risks associated with providing [the drug] to patients with the [] antibody demonstrates that prior to [plaintiff’s decedent’s] diagnosis, defendants could not have strengthened their warnings to comply with state law without violating the FDA’s decision. . . . Here, FDA rejected defendants’ proposed change in the warning not because of the language used, but because the supporting data was not yet sufficiently persuasive.  For this reason, summary judgment is further appropriate, at least in part, because plaintiff’s claims, insofar as they are based on defendants’ allegedly inadequate warnings about the risks of administering [the drug] to patients who are found to have [the] antibodies, are preempted by federal law.

Gentile, 2016 WL 4128159, at *8-9 (citation omitted).

The Companies are correct that if [the data] were insufficient to persuade FDA in 2010 of the predictive value of antibody testing . . ., there clearly would not have been sufficient data more than two years earlier. Accordingly, there is “clear evidence” that the FDA would not have approved a change to the [drug] label prior to [plaintiff’s decedent’s] death, and the causes of action that [plaintiff] raises in this matter − negligence; negligent failure to warn; and negligent misrepresentation − which are based in state law, are preempted by federal requirements mandating FDA approval of changes to a drug’s warning label.

Christison, slip op. at 48 (citations, quotation marks, and footnote omitted).

One of the biggest problems with the Levine “clear evidence” test is that it is so bound up in the facts of any individual case that precedent has been of limited value, and courts have reached inconsistent results on the same facts.  Gentile and Christison demonstrate that, at least on one front, it is now possible to draw a bright line in post-Levine “clear evidence” preemption cases – If the FDA finds insufficient evidence to support a label change on a given date, then logically any warning claim based on prescriptions that occurred before that FDA action will be preempted, because even less scientific evidence than what the FDA found wanting will necessarily exist during an earlier time period.  As we’ve just discussed, this principle can be applied to a variety of branded (and, indeed, OTC) drugs.

But there’s more – considerably more. The warnings and special prescription protocol that surround the use of Tysabri are detailed and extensive (far longer than we would quote here), as befits the magnitude of the risk (an almost always fatal condition) involved.  They are as impressive as the warnings and related special precautions that attend use of Accutane.  Accutane cases have produced quite a few favorable decisions concerning the adequacy of challenged warnings. See, e.g., Felix v. Hoffmann-LaRoche, Inc., 540 So.2d 102, 105 (Fla. 1989); Banner v. Hoffmann-La Roche Inc., 891 A.2d 1229, 1239 (N.J. Super. App. Div. 2006); In re Accutane Products Liability Litigation, 2012 WL 3194954, at *5 (M.D. Fla. July 24, 2012); Gerber v. Hoffmann-La Roche Inc., 392 F. Supp.2d 907, 915-18 (S.D. Tex. 2005).  The same thing occurred here.  The courts in both Gentile and Christison held that the warnings at issue were adequate as a matter of law:

Because [the condition] may lead to death or severe disability, the warnings should have been commensurate with a high level of risk. The black box warning in effect when [the prescriber] first prescribed [the drug] to [the decedent] explicitly warned against the precise risk . . . that [the decedent] ultimately suffered, and fully disclosed the serious consequences of that disease. . . .  [W]hen read as a whole, the warnings unmistakably conveyed the seriousness of [the risk] and its association with [the drug’s] treatment.

Gentile, 2016 WL 4128159, at *6 (applying New York law) 2016 WL 4128159 (citations omitted).

The Companies are correct that the labeling is adequate as a matter of law. . . . the Companies provided an adequate warning because the [the drug’s] warning (1) was designed so it could reasonably be expected to catch the attention of the consumer; (2) was comprehensible and gave a fair indication of the specific risks involved with [the drug]; and (3) was of an intensity justified by the magnitude of the risk.

Christison, slip op. at 40-41.

And more: The plaintiff’s expert testimony was deficient with respect to the adequacy of the warnings.  In Gentile, because the learned intermediary rule applied, the plaintiff needed a physician to testify to the inadequacy of warnings to the medical profession.  2016 WL 4128159, at *7 (plaintiff’s expert “is not a medical doctor, does not have the qualifications necessary to opine on matters of treating patients, and does not assert that he has the experience necessary to interpret warnings from the perspective of a prescribing physician”).  In Christison, the plaintiff failed to offer any warning expert at all.

[Plaintiff] is incorrect.  A lay jury is not able to call on “their own life experiences” to determine the adequacy of a drug label.  Where the injury involves obscure medical factors which are beyond an ordinary lay person’s knowledge, necessitating speculation in making a finding, there must be expert testimony that the defendant’s conduct probably caused the injury. . . .  A lay jury would not be able to determine by calling upon “their own life experiences” and would be speculating in making findings about the adequacy of the [drug’s] warning label, which warned extensively about [the risk].

Slip op. at 36-37 (footnote omitted).  See Id. at 37 (plaintiff must have expert testimony “on what ‘a more adequate label’ would contain”) (footnote omitted).

And in Gentile still more – enough that, in our opinion, Gentile is the best trial court opinion ever to emerge from a Massachusetts trial court in a drug or medical device case.  Specifically:

  • Warning causation:  The plaintiff’s attempted nit-picking of the warnings in Gentile also failed because the prescribing surgeon’s decision “would not have changed” with the additional information. 2016 WL 4128159, at *7.
  • Good Samaritan liability: “[P]laintiff cannot prove defendants voluntarily assumed a duty to warn [the decedent] by providing her with information directly, and not through her doctor.” Id. at *8.
  • Design defect/comment k: “New York does not recognize a design defect theory of liability for prescription medicines” because a drug with adequate warnings is “not defective.” Id.
  • Mensing-style preemption for innovator drugs: All warning claims against the distributor defendant were preempted because it was impossible for the distributor to alter drug warnings because it was not the holder of the FDA new drug application. Id. at *9 (another company “is the holder of the original, approved application for [the drug]. Consequently, [the distributor] could not have sought modifications of the label”).

Innovator drug preemption (2 kinds), warning adequacy as a matter of law, learned intermediary rule-based expert requirements, warning causation, design defect, and assumed duty – that’s a bunch of significant rulings. We’ll certainly be watching out for similar cases coming down the pike in the future, but given the thankfully rare nature of the risk involved, there probably won’t be that many.