When we first looked at the decision for today’s post, we thought about comparing it to fan fiction. If you aren’t familiar with the term it is fiction stories written about characters from an original work of fiction created by fans of the original work as opposed to its creator. Pretty straightforward in concept. But while fan fiction has become more mainstream in recent years (one of the most popular fan fiction websites has almost 600,000 entries under the Harry Potter category alone), it still has a fairly bad reputation as the dark side of geek fandom. And let’s face it, the bulk of the people writing fan fiction aren’t going to be the next J.K. Rowling. And, fan fiction is at its core a product of fandom. So, you have to be fairly well-versed in the original to even think about understanding its offspring. That said, fan fiction having found a home on the internet has led to the development of communities that rally around the original work and discuss and debate everything from literary theory to pop culture.

But upon further reflection, we think the court’s decision in Proffitt v. Bristol Myers Squibb Co., 2018 U.S. Dist. LEXIS 111895 (S.D.W.Va. Jul. 5, 2018), is more like a reimagining of an old classic. There are many lists of books based on other books. Some authors create sequels or prequels to old classics. Possibly delving into storylines that were only marginally touched in the original. Those might be classified as published fan fiction – and some of it quite good. Wicked, for instance, long before it was a hit Broadway musical, was a Wizard of Oz spinoff about the life of the Wicked Witch of the West written by Gregory Maguire. But there are books that are re-tellings of original masterpieces designed to give the reader a more modern or updated take. For example, if you’ve read A Thousand Acres by Jane Smiley and you haven’t read Shakespeare’s King Lear, you should. Shakespeare’s king has to divide his kingdom among his three daughters and only realizes too late which one is the worthiest. Smiley updated the story to a farm in Iowa and overall paints a kinder picture of the sisters but the parallel cannot be denied.   Or, what about Bridget Jones’ Diary and Pride and Prejudice. Bridget and Elizabeth Bennett certainly have plenty in common, but Helen Fielding really stayed close to Jane Austen’s classic when she wrote Mark Darcy who is unquestionably Fitzwilliam Darcy in the 20th century.

So what’s the upshot of all of this, other than perhaps to inspire a summer reading list? Sometimes a story is so good it’s worth telling again, just updated. That’s essentially what the court did in Proffitt. The slip opinion is 12 pages long and almost 5 full pages are block quotes. We don’t mean that to be a negative thing. The court found it needed to say little new because the important stuff was already written.

Plaintiff sued the manufacturer of an antipsychotic drug he took alleging it caused him to develop tardive dyskinesia (limb twitching, facial tics, jaw clenching, etc.). Id. at *1. Plaintiff brought claims for negligent and strict liability failure to warn and breach of implied warranty of merchantability based on a failure to provide a reasonable warning. Id. at *2. Defendant moved to dismiss the complaint on the ground that plaintiff’s claims were insufficiently pleaded. That’s chapter 1 – the background.

In Chapter 2 – the standard of review – the court recounts what has fondly become known on this blog as TwIqbal. Here, the court didn’t need to reinvent the wheel. The Fourth Circuit had already summed it up quite nicely in Nemet Chevrolet, LTD v. Consumeraffairs.com, Inc., 591 F.3d 250 (4th Cir. 2009). The complaint needs enough facts to state a claim that is plausible on its face. Proffitt, at *3-4.

Moving into Chapter 3 – the analysis – the court found two more significant texts on which to rely. Remember, all of plaintiff’s claims are based on alleged failure to warn about tardive dyskinesia. But the drug’s label always contained a warning about that very condition. While plaintiff failed to even allude to the warning in his complaint, the court quoted all 5 paragraphs about tardive dyskinesia. Id. at *6-8. Which led the court to observe that plaintiff’s complaint neither alleges how that warning was inadequate or what an appropriate warning would look like. Id. at *8.

And here is where Proffitt really becomes a re-telling of Reed v. Pfizer, Inc., 839 F. Supp.2d 571, 575-77 (E.D.N.Y 2012). Because Reed had already done all the work. It explains exactly why given facts like Proffitt, a failure to warn claim can’t survive a TwIqbal challenge. The Reeds, like the Proffitts¸ failed to identify how the warning given by the defendant about the very risk at issue was inadequate. In both Reed and the more recent version, Proffitt, plaintiffs failed to allege any facts to suggest that the warnings in both cases were insufficient, erroneous, or contained misrepresentations. See generally Proffitt, at *8-12. Sometimes there is simply no improving on the original:

To cut to the chase, the fact (taken here as true) that [Reed/Proffitt] suffered from certain conditions that were also identified risks of ingesting [the drug] is tragic, but cannot alone make plausible a claim that defendants misrepresented or hid those risks in some way. Plaintiffs have alleged factual content sufficient only to make plausible that [Reed/Proffitt] ingested [the drug] and thereafter suffered serious harm. If such allegations were sufficient to state a failure to warn claim, then anyone experiencing harm after using a product where the harm is a warned-of risk could successfully plead a claim. Perversely, the pleaded fact that a warning was given would be the only pleaded fact supporting the claim that a lawfully adequate warning was not given. To allow such a naked claim to go forward would merely green light for plaintiffs an expedition designed to fish for an in terrorem increment of the settlement value, rather than a reasonably founded hope that the discovery process will reveal relevant evidence.

Id. at *11-12 (quoting Reed, other citations omitted).

Reed had also already done a good job of collecting many supporting cases but the Proffitt court updated the citations as well. Id. at *12-14.

And so the decision concludes by acknowledging the great work of the prior courts to have dealt with the issue and dismissing plaintiff’s claims as inadequately pleaded. Once again TwIqbal triumphs over a factually barren complaint.

Permit us to recount a recent travel misadventure, though whatever eventual connection we draw to today’s case will be specious at best. Last Friday, we traveled from Philadelphia to Hartford, Connecticut for a deposition.  We were fresh off of a long flight home from Europe and were hesitant to take on a couple hundred miles of driving at each end of the day, so we investigated our options.  In the morning, direct flights from PHL to BDL abound.  But after 6 p.m., when our deposition was scheduled to end, there are no direct flights home. Nor are there Amtrak trains leaving Hartford after that hour.  So we threw up our hands and reserved a connecting flight home, reasoning that sleeping, reading, and eating Biscoff cookies would be more relaxing than driving.  This even though, to get from Hartford to Philadelphia, we had a totally illogical connection at Dulles, many miles out of the way.

Our originating flight landed at Dulles early.  And our 9:30 pm connection was showing “on time” on the board.  At 9:15 pm, the following announcement came over the loudspeaker: “We are very sorry, but your first officer is coming in on a flight that is delayed, so we need to delay your 9:30 pm flight until 11:30 pm.”  We were not pleased, but the new schedule would still get us home, crucial because we were leaving at noon on Saturday for an overnight trip.  At 11:20, the gate agent announced, “Your first officer’s flight has landed.  Give us a few minutes and we’ll get you boarded.”  At 11:30, we heard the following, dripping with contrition: “We are SO SORRY, but we are unable to put together a crew for your flight tonight, so we are delaying this flight until NOON TOMORROW.” [Emphasis added.]  Turns out that the long-awaited first officer had now exceeded his maximum hours for the day.

We did not react politely to this. We asked, “You mean to tell us that nothing in your computer could have told you this before we sat here for two hours and lost all other options??”  We did not receive a satisfactory response.  Ultimately, we took a 45-minute cab ride to Union Station (cavernous, pitch-black, and empty) and caught a 3:10 a.m. (!!) Amtrak train to Philadelphia.  When all was said and done, that was all that was left.

“Not much left” also describes (we warned you) today’s case, an excellent PMA and Buckman preemption decision out of the Northern District of Illinois.  In Gravitt v. Mentor Worldwide, 2018 WL 2933609 (N.D. Ill. June 12, 2008), the plaintiff alleged that she was injured by the defendant’s silicone breast implant.  Her complaint asserted claims under Illinois law, alleging design and manufacturing defects, failure to warn, and the defendant’s alleged failure to comply with the FDA’s pre-market approval (“PMA”) process for Class III medical devices, including numerous allegations of deficiencies in the defendant’s design and execution of post-PMA studies ordered by the FDA.

In earlier motion practice, the court dismissed most of the plaintiff’s claims without prejudice.  (We published a guest post on the first dismissals here.)  The plaintiff filed an amended complaint, which the court commented “strongly resemble[d] the original complaint.” Gravitt, 2018 WL 2933609 at *1.  The defendant again moved to dismiss, arguing that the plaintiff’s claims were expressly preempted under the Medical Device Amendments (“MDA”) to the FDCA or impliedly preempted under Buckman.

Express Preemption

The defendant argued that the plaintiff’s claims were expressly preempted to the extent that they were based on alleged methodological defects in the defendant’s post-PMA studies. The Court explained that under SCOTUS’s Lohr decision, as construed by the Seventh Circuit in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), as well as SCOTUS’s Riegel decision, state law tort claims related to Class III medical devices granted PMA are allowed to proceed if they: 1) allege violations of common-law duties that parallel federal requirements; or 2) claim violations of federal law.  Conversely, state law claims that “would impose on [the defendant] a requirement that is in addition to federal requirements” – in other words, claims that the defendant “violated state tort law notwithstanding compliance with the relevant federal requirements” – are preempted. Gravitt, 2018 WL 2933609 at *4 (internal punctuation and citations omitted).

The court held that, while the complaint alleged numerous deficiencies in the defendant’s post-PMA studies and alleged that each deficiency amounted to an “independent failure to comply with the FDA’s post-approval requirements” and thus a ground for withdrawal of PMA, the plaintiffs “simply assume[d], without legal or other support, that those deficiencies amount[ed] to violations of the FDA’s conditions for PMA.” Id. at *6 (citations omitted).   The court concluded that “such an assumption may not ground a viable claim,” id., and held that certain categories of the plaintiff’s allegations were expressly preempted.

Implied Preemption

But the court held that other categories of the plaintiff’s allegations were not expressly preempted. Specifically, the court held that “the complaint plausibly alleged that [the defendant] violated federal law” by failing to satisfy several categories of requirements related to, inter alia, follow-up of study participants, collecting and reporting of data at required intervals and related updates to labeling, warning of newly-discovered risks of the device, and failing to comply with requirements for manufacturing facilities.  Because the plaintiff “plausibly alleged” that these “shortcomings in [the defendant]’s post-PMA testing and manufacturing processes violated federal law,” section 360(a) of the MDA did not preempt those claims. Id. But the court emphasized, “Plaintiffs may proceed with those claims, however, only if they pass through a second legal filter” – the “filter” of implied Buckman preemption of “fraud on the FDA claims.” Id. at *7.

The court explained that, under Buckman, “federal law preempts claims to the extent they seek to deploy state law in the service of policing fraud against federal agencies based on statements that federal  law required the defendant to make to the agency, id. (internal punctuation and citation omitted), but doesn’t preempt traditional tort law claims involving breach of a duty to the plaintiff.  The court held:

Here, several of the claims that survive express preemption – for example, claims that the defendant reported results of the core study for fewer than the required number of years and recruited fewer than the required number of patients for a large post-approval study – are impliedly preempted under Buckman because those shortcomings breached no . . .  [tort duty to the plaintiff].  Rather, as in Buckman, those claims are unconnected to any traditional state tort duty, meaning that the existence of the relevant federal enactments is a critical element of those claims.

Id. (internal punctuation and citation omitted).  The court noted that the plaintiff attempted to tie the defendant’s alleged misconduct to her state tort claims, alleging that, if the defendant had more fully complied with the PMA process, its “disclosures would have led to much wider knowledge of the risks associated with its product.” Id. (internal punctuation and citations omitted).  But, it emphasized, “the Buckman analysis centers on the nature of the asserted claim and the source of the violation, not on the violation’s effects . . . . A claim arising entirely out of a violation of [the defendant’s] compliance with the FDA’s requirements in granting PMA is . . . . preempted under Buckman. Id.

Two categories of claims remained. The court dismissed the plaintiff’s claims alleging that the defendant’s manufacturing facilities failed to comply with applicable law and regulations, holding that the complaint had not adequately alleged a true manufacturing defect claim.  In addition, the plaintiff had failed to respond to the defendant’s arguments against these claims.  The last claim alleged that the defendant learned, but did not disclose, that its device had a higher likelihood of rupture than had been reported.  The court acknowledged that these claims were not fully developed in the complaint, but held that Rule 9(b)’s particularity requirement did not apply to the claims.  Holding that the plaintiff’s pleading “cross[ed] the line from conceivable to plausible,” satisfying Twiqbal, the court allowed the claims to proceed.

But that was all that was left.  The claims that were preempted – expressly and impliedly – were dismissed with prejudice, in an infrequent and laudable turn of events.   We would wax on at greater length, but today’s flight is boarding in a few minutes.  At least that’s what the board says.  We’ll keep you posted.

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

You’re likely all familiar with the phrase, “don’t look a gift horse in the mouth.” Checking out a gift horse’s teeth is like looking for the price tag of the gift to see how much it’s worth. The expression is meant to convey that upon receiving a gift you should accept it gratefully. But what happens when you don’t accept the gift at all. In many instances, politely declining a gift is completely acceptable. When the gift actually comes in the form of help, passing it up may well be to your own detriment. Sure, it looks good to stand on your own two feet. To accomplish something on your own. But sometimes offers of help are extended because they are needed. A parent offers to help a child tie his shoe. A teacher offers to guide a student through a math lesson. A young man offers to cut the grass for an elderly neighbor. Or perhaps a judge offers plaintiff an opportunity to take discovery to save her case. And that plaintiff says: No thanks. I’ll stand “on the allegations contained in [my] original complaint.” That plaintiff shouldn’t be surprised that what wasn’t good enough the first time around, isn’t good enough the second.

The case is Benyak v. Medtronic, Inc., 2018 Ill. App. Unpub. LEXIS 998 (Ill. App. Jun. 14, 2018) and involves an implanted intrathecal pump that plaintiff alleges became inverted in her body causing her pain. Id. at *2. Plaintiff alleged only negligent design and manufacturing defect and negligent education of medical providers. Id. at *2-3. The medical device underwent pre-market approval by the FDA and so defendant moved to dismiss the claims as preempted. That motion was granted but the court granted plaintiff leave to serve written discovery on the manufacturer and then to file an amended complaint. Plaintiff opted to do neither and so the court dismissed her claims with prejudice. Id. at *2. Plaintiff then appealed that dismissal arguing that her original allegations should have survived defendant’s motion to dismiss.

The Illinois Appellate Court authored a nice accounting of PMA preemption, see id. at *5-15, which we won’t completely recount here because if you are even an infrequent reader of this blog, you’re likely well-versed in PMA preemption. And if not, check out this scorecard to start your PMA preemption education. We will point out the court’s proper conclusion that because of the MDA’s express preemption provision, there is no presumption against preemption. Id. at *10. Also that the court landed where most court’s do, finding that there is only “a small window in which a state-law claim may escape express or implied preemption.” Id. at *13. Finally, before turning to the case-specific details, the court notes that “the manner in which allegations are pled guides the analysis of whether a state-law claim involves requirements different from, or in addition to, the federal requirements.” Id. at *15.

Since it was undisputed that the device at issue was a PMA device, there was also no dispute that the FDA had established requirements applicable to it. Id. So the court moved on to the next part of the PMA-preemption analysis – did plaintiff’s state law claims involve requirements related to safety and effectiveness different from or in addition to federal requirements. Because safety was at the heart of plaintiff’s claims, the only real issue was the “different or in addition to” standard. In other words, did plaintiff’s claim parallel the federal requirements established by the FDA for this device.

As for design and manufacturing defect – plaintiff’s complaint was completely silent as to whether the device was designed or manufactured differently or out of compliance with the FDA’s approval and protocols. Id. at *16-17.

Absent such factual allegations, plaintiff, in essence, posits that the [device] should have been designed and manufactured differently than what the FDA approved during the premarket approval process, which necessarily would impose a requirement for the [device] that is different from, or in addition to, the requirements already imposed by the FDA.

Id. at *17.

On appeal, plaintiff argued that “the ability of the [device] to remain upright” was a premarket requirement that defendant failed to meet. However, the complaint “never specifically identified any specific requirement resulting from the premarket approval process.” Id. at *19. And this brings us back to that gift horse:

Understandably, at the time plaintiff filed her complaint, she might not have had enough facts to support her allegations, which is why the circuit court allowed her leave to serve written discovery on defendants and file an amended complaint. Had she taken the opportunity to conduct the discovery, she could have bolstered the allegations of her complaint and perhaps, her state-law claim would not have been expressly preempted by the MDA. But she chose not to conduct the discovery nor file an amended complaint, resulting in her design and manufacturing defect claim, as pled in her complaint, being expressly preempted.

Id. at *19-20. It jumped right up and bit her.

As for plaintiff’s other claim, negligent instruction, it is not a recognized claim under Illinois law. Id. Even if it were, plaintiff didn’t allege that the instructions defendant provided deviated from those approved by the FDA during the PMA process. Id. at *21. So, that’s two grounds to affirm the dismissal. Plaintiff attempted to turn the claim into a learned intermediary claim arguing it was really a failure to warn the doctor claim. But, that’s not what plaintiff alleged in the complaint. The complaint never mentions learned intermediary and the court was unwilling to construe it as such.

Finally, plaintiff asked for the case to be remanded with leave to amend her complaint. Wow. Once you refuse a gift it’s much less likely you’ll get offered it again. The appellate court found that because plaintiff had “intentionally” chose not to take discovery and amend her complaint when that opportunity was afforded to her, “she has waived any right to a remand with leave to amend.” Id. at *22.

We often talk about giving plaintiffs second bites at trying to plead their claims. But if you’re going to toss the apple away without so much as a nibble, don’t be surprised when the gift horse you decided to ignore gobbles it up and spits it out with nothing left for you to chomp on.

 

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

Today is a follow-up post on Bell v. Boehringer Ingelheim Pharms, No. 17-1153, 2018 U.S. Dist. LEXIS 90337 (W.D. PA. May 31, 2018). When we last blogged about this case back in February, the court had tossed out everything except negligence and fraud/misrepresentation claims on well-settled Pennsylvania law that prescription drug cases sound only in negligence. The court then dismissed the remaining claims for failure to satisfy TwIqbal pleading standards. Plaintiffs were afforded an opportunity to amend and re-plead the claims recognized under state law. They did. And once again, they don’t get by TwIqbal.

So, what’s missing this time around? The court starts out by noting that despite being dismissed for factual insufficiency, plaintiff made few factual revisions in the amended complaint. Id. at *4. So few that the court was able to essentially adopt its factual recitation from the first decision. Id. That’s an underwhelming start and things don’t improve for the plaintiff as the court examines each claim in turn.

Starting with plaintiff’s catch-all negligence claim, the court found “[t]he amended complaint contains a boilerplate laundry-list of alleged negligence that is virtually identical to the negligence claim in the original complaint.” Id. at *12. Since plaintiff just re-packaged his conclusory allegations from the original complaint, the amended complaint once again fails to state “any facts about how defendants breached their duty or how defendants’ conduct caused [plaintiff’s] injury.” Id. at *13. At the heart of plaintiff’s negligence claim was his allegation that defendants should have changed their label to warn about the risk of kidney injury following FDA approval. But for that claim to survive, plaintiff would have had to have pleaded what new information became available to warrant a change, what the changed warning should have said, and how any alleged breach was the cause of plaintiff’s injury. Id. at *13-14. Absent all those pieces, plaintiff’s negligence claim was dismissed.

Negligent misrepresentation was even easier to dismiss because it was an exact duplicate of the original complaint. Id. at *14. We’ve all heard the expression that the definition of insanity is doing the same thing over and over and expecting a different result. Well, same allegations equal same result. Dismissal.

Next up was plaintiff’s negligent design claim. This claim was previously dismissed for failure to plead the availability of a safer, alternative design as required by Pennsylvania law. So, plaintiff argued he satisfied that requirement in the amended complaint by pointing to other available products. But different products are just that different products – not alternative ways to design the product at issue. Saying plaintiff could have taken a different product doesn’t do anything to establish how the design of defendant’s product was defective or how it could have been designed differently. Id. at *15. Another dismissal.

Last, plaintiff based his fraud claims on allegations that defendants concealed information about the risks of the drug from the FDA, the public, plaintiff, and plaintiff’s physicians. But fraud claims don’t just have to satisfy TwIqbal, they are held to the more rigorous Rule 9(b) standard. Generality won’t suffice. Id. at *16. And plaintiff’s claim was just that, too general. The amended complaint contained no allegations about what information was concealed. It was missing the “who, what, when, where and how” of defendants’ alleged fraud, i.e., the “first paragraph of any newspaper story.” Id. at *17. So, fraud was dismissed as well.

Despite the complete lack of factual support for any of plaintiff’s claims, he once again asked for a chance to re-plead. The court, somewhat reluctantly, granted the request but made it clear that any final attempt by plaintiff to fix these pleading deficiencies would have to be a significant improvement. Specifically, plaintiff has

to clearly articulate the legal theory he is pursuing and to allege sufficient facts to make each element of the claim plausible. He must also eliminate his overbroad, conclusory “shotgun” allegations so that defendants are given adequate notice of what [plaintiff] claims they did wrong.

Id. at *18-19. Given plaintiff’s track record, this seems like a fairly high hurdle to clear. Stay tuned to see if plaintiff tees it up for strike three.

 

Is fear of injury the same thing as injury?  The question answers itself.  At least it should.  They are not the same, and there are strong jurisprudential reasons for courts to throw out cases alleging mere fear of injury.  We have a No Injury scorecard documenting a pretty clear court consensus that fear of injury should not be enough to get a case to the jury.  Think of diet drug cases where the claim was an increased risk of heart valve injury.  Most courts concluded that such fear did not amount to actionable injury.  Considerations of Article III case or controversy or standing or ripeness usually persuaded courts that fear of physical injury simply did not cut it.  But not always.  So it is good that today’s case, Perez v. B. Braun Medical, Inc., 2018 WL 2316334 (S.D.N.Y. May 9, 2018), gets added to the defense side of the ledger.  In 2010, the plaintiff had been implanted with an IVC filter to treat her pulmonary embolism (PE) and deep vein thrombosis (DVT).  The implant was intended to be permanent.  In subsequent years there were reports of IVC filters causing problems via misalignment and migration.  In 2014, the FDA urged doctors to remove IVC filters within one to two months after the danger of PE subsides.  The plaintiffs alleged that the defendants in this case continued to market their IVC filter for long-term use — according to the court, the complaint alleged that the defendants were “defying the FDA’s general recommendations.”  Meanwhile, no doctor recommended that the plaintiff remove the IVC filter, even though in 2016 a CT scan showed that the tip of the IVC filter possibly had tilted.  That tipping point was apparently not enough to remove the filter, but was enough to file a lawsuit.  The complaint alleged that the IVC filter was defective and increased the risk that the plaintiff would suffer a serious injury. The plaintiff also referenced unspecified economic and psychological damages. The defendants moved to dismiss the complaint for failure to state a claim upon which relief can be granted, arguing that the complaint did not adequately allege that the plaintiff had suffered any cognizable injury.  The court granted the motion to dismiss.  It analyzed the personal injury, warranty, fraud, and New York Business law claims separately, so we will do likewise.

1. Personal Injury Claims

The plaintiff alleged that her physical injuries were the post-implant likely tilting of the IVC filter, psychological trauma of living with a defective product implanted in her body, and the increased risk of future injuries due to the IVC filter.  The problem for the plaintiff was that New York law is reasonably clear that a mere threat of future harm is insufficient to impose liability against a defendant in a tort context.  To be sure, the complaint also alleged that the plaintiff “sustained serious personal injuries,” “serious physical injuries,” and “severe injuries,” that she suffered “loss of enjoyment of life, disability, and other losses,” and that she “incurred substantial medical costs and expenses to treat and care for Plaintiff’s injuries described herein.”  But those are more rote formulas than factual allegations.  The complaint certainly never described the nature of the injuries.  New York law does recognize claims for emotional distress, but such claims must be premised on truly outrageous conduct, and nothing like that resided in the complaint.  Perhaps the best thing that the plaintiff had was an allegation that the defendants marketed permanent filters even after the “FDA warnings that caution generally against long-term implantation of IVC filters.” But because those warnings, whether or not they said what the plaintiff alleged, did not happen until after the plaintiff’s implant, they could not preserve the plaintiff’s claims.

2. Breach of Warranty Claims

The defendants had a strong statute of imitations argument, because the clock on warranty claims usually starts at the time delivery, which was in 2010, more than seven years before the complaint was filed.  New York’s statute of limitations for warranty claims is four years.  The plaintiff trued to dodge the statute of limitations by arguing that the warranty explicitly extended to future performance, and that existed here because the defendants had stated that the IVC filters were safe and effective for permanent implantation.  But the complaint did not explain how the plaintiff’s particular IVC filter had fallen short.  Again, the mere tilting of the IVC filter, even with a risk of future harm, did not equate to a cognizable injury,  New York courts (like most courts on planet Earth) have acknowledged a policy of protecting court dockets from “being clogged with frivolous and unfounded claims.”  Warranty claims often seem like add-ons in product liability cases, and here they were frail add-ons to already frail claims.

3. Fraud Based Claims

Fed. R. Civ. P. 9(b) requires that fraud claims be pleaded with specificity, and the Perez complaint did not come close to meeting this standard.  Again, the plaintiff leaned on the defendants’ representations that the IVC filters were safe and effective for their intended and reasonably foreseeable use.  But the plaintiff never explained why those statements are fraudulent. After all, the the complaint admitted that IVC filters can be used to reduce the risk of PE and DVT, and it nowhere alleges that the plaintiff’s filter performed in a manner different from how the defendants describe.  Whatever the complications and injuries that the defendants failed to warn the plaintiff about, the complaint did not specifically describe them, and could not allege that the plaintiff had sustained any such complications and injuries.  Moreover, the complaint lacked any facts showing that the alleged omissions were made with an intent to deceive.  The plaintiff simply had not made out a case for fraud.

4. New York General Business Law Claim

The complaint’s final count alleged that the defendants engaged in consumer fraud in violation of New York General Business Law Sections 349 and 350<http://www.westlaw.com/Link/Document/FullText?findType=L&pubNum=1000081&cite=NYGBS350&originatingDoc=Ib48241005e2b11e89868e3d0ed3e7ebe&refType=LQ&originationContext=document&vr=3.0&rs=cblt1.0&transitionType=DocumentItem&contextData=(sc.FindAndPrintPortal)>. Section 349 prohibits “[d]eceptive acts or practices in the conduct of any business, trade or commerce or in the furnishing of any service in this state.” Section 350 prohibits “[f]alse advertising.”  As with the plaintiff’s breach of warranty and fraud based claims, the New York Business Law claims failed to show what materially misleading representations the defendants made. That there are side effects associated with IVC filters that are implanted long-term, does not mean that the plaintiff’s IVC filter “had not been effective for implantation into the IVC to prevent PE and DVT for which it was designed or that it is not safer than the alternative.”

What is interesting about the Perez case is how the lack of a real injury did not just undermine the personal injury claims (seems obvious enough), but also undermined the representational claims.  What is doubly interesting about the Perez case is that the no-injury defense worked with respect to an implanted device.  Most of the good cases on our no injury scorecard involved drugs.  Arguably, a plaintiff has a little more to work with when there is a device implanted in the body.  There is a continuing exposure.  Nevertheless, mere fear of injury could not overcome the court’s fear of frivolous claims.

Today’s post is another guest post from friend of the Blog Kevin Hara, of Reed Smith, who channels our resident movie critic in this wide-ranging discussion of pleading and procedural weirdness.  As always with our guest posts, the author deserves 100% of the credit, and any blame, for what follows.

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If ever one wanted to feature a case where the plaintiffs and their attorneys fumbled and stumbled around like Keystone cops, it would be Paulsen v. Abbott Laboratories, 2018 U.S. Dist. LEXIS 50256 (N.D. Ill. March 27, 2018), involving the prescription drug Lupron, used to treat endometriosis.  The case really reminded me of the madcap, masterful ensemble movie, “It’s A Mad, Mad, Mad, Mad World” (hereinafter, “Mad World”) (yes, it’s a bit dated in some ways, but it still merits watching if you haven’t) with a veritable Who’s Who of 1950s-1960s Hollywood comedy royalty, including Edie Adams, Sid Caesar, Milton Berle, Ethel Merman, Jonathan Winters, Terry Thomas, Mickey Rooney, Phil Silvers, and Buddy Hackett.  Not to mention two time Oscar Winner Spencer Tracy and Jimmy Durante, who literally kicks the bucket as his character passes away and starts the mayhem.  Even if one does not consider the film a classic, its cultural relevance is beyond debate, as in addition to the headliners, the supporting cast included Peter Falk, Eddie “Rochester” Anderson, the 3 Stooges, and the great Arnold Stang.  Moreover, it bears mention that the renowned director of Mad World, was Stanley Kramer, more recognized for his social dramas, including Guess Who’s Coming to Dinner, The Defiant Ones, and Judgment at Nuremberg.  With such an accumulation of talent, it comes as no surprise that Mad World received six Academy Award and two Golden Globe nominations, and is categorized by many as an all-time classic in American movie history.  The plot is full of twists and turns, but beautifully elevated, with stellar writing and acting to match: 5 strangers witness an accident, and simultaneously learn about a large sum of money hidden in a park, buried beneath a large “W,” with Durante’s last gasp.  At first, they agreed to equal shares of the $350,000, but soon each plots to recover the loot on his own, and everyone begins a mad dash with assorted partners in crime (spouses, friends, relatives, etc.) to be the first to reach the cash.  In so doing, each of five groups tries to undermine the others, and they all encounter setbacks from being locked in the basement of a hardware store, stranded on a highway with a child’s bicycle, sinking in a river, a drunken airplane pilot, and more.  (For those of you from younger generations who are Googling the names or the movie above, you might be more familiar with a newer iteration of a similar story in the movie Rat Race, starring Whoopi Goldberg, Dean Cain, John Cleese, Cuba Gooding, Jr., Cathy and Kathy Bates, among others.)

If you have not seen the movie, you certainly should, but one iconic scene essentially captures the film, a sequence in which Winters demolishes an entire gas station, mostly by hand, in several hilarious, frenetic minutes. The movie ends with all of the misguided, money hungry adventurers in the hospital with multiple injuries, but none of the treasure.  In a last, desperate (and shameless) grab for the bounty, the hapless male contingent is catapulted, one by one, from the ladder of a fire engine attempting to rescue them, as the terrified crowd below watches and the entire haul slowly floats to the now delighted onlookers.  In short, grasping for money, at the expense of ethics, morality, and intelligent planning gets you nowhere.

Procedural History

Much like the film, Paulsen has misdeeds galore, with seeming chaos at every turn, thanks to its beginning as a multi-plaintiff, misjoined complaint with a California resident, and a Georgia resident (Ms. Paulsen) bringing an action in the Eastern District of New York in April 2010. See Cardenas v. Abbott Labs., 2011 U.S. Dist. LEXIS 116879 (N.D. Ill. March 7, 2011).  Plaintiffs alleged injuries as a result of injections of the drug, and asserted negligence, strict liability, failure to warn, breach of warranty and fraud causes of action against various defendants.  In homage to the movie, it is fitting to provide aliases for the defendants using the names of the actors in the movie – because it is the plaintiff’s shenanigans that are the focus here – not the defendants’ titles and actions. Therefore, in that regard, the defendants are now dubbed Abbott Laboratories (hereinafter “Sid”), Takeda Pharmaceuticals of North America, Inc., (“Ethel”),Takeda Chemical Industries, Inc., (“Milton”) and TAP Pharmaceutical Products, Inc. (“Jonathan”) (collectively, “Defendants”). Id. at *3.  The Defendants filed a motion to dismiss, objecting to venue, so plaintiffs amended their complaint, adding New York and New Jersey plaintiffs.  Didn’t matter.  The case was transferred to the Southern District of New York. Id. Defendants again filed a motion to dismiss, and the Southern District of New York transferred the action to the Northern District of Illinois in 2011, addressing issues of venue and personal jurisdiction, and dismissing defendant “Milton” because it was not served with the complaint. Id. (but more on that later). Id. Finally, the Illinois federal court considered a substantive (Rule 12 (b)(6)) motion to dismiss, and found that plaintiffs provided “nothing but the fact that [they] received Lupron injections ‘on several occasions.’” Id. at *12-13.  For example, the complaint failed to indicate “whether Plaintiffs [were] women, nor [did] it establish whether Lupron was prescribed to Plaintiffs” for on- or for off-label use.  All these omitted facts were, obviously, “particularly within Plaintiffs’ control.” Id. Therefore, the court dismissed the complaint, with leave to amend to allow plaintiffs to put “some minimal amount of flesh” on their bare-bones allegations. Id. at *13-14.

Plaintiffs filed an amended complaint in October 2011, and discovery commenced, but with Paulsen the only remaining plaintiff, in August 2013 her counsel moved to withdraw. See Paulsen, 2018 U.S. Dist. LEXIS 50256, at *8.  The judge granted the motion, allowing plaintiff 30 days to file an appearance.  That didn’t happen either.  The action was dismissed for lack of prosecution in October 2013 after plaintiff failed to appear. Id.

Plaintiff’s Second Action

Undeterred, plaintiff filed a new complaint on May 11, 2015, alleging claims for negligence, strict product liability, failure to warn, breach of warranty, and fraud against “Sid”, “Ethel”, “Milton” and “Jonathan”. Id. at *9.  Plaintiff alleged that she had been injected with Lupron twice for on-label treatments, and had suffered various injuries, all of which occurred in Georgia. Id. at * 3-4.  Defendants moved to dismiss, claiming that the lawsuit was untimely and seeking application of the six-month limitation in Georgia’s savings statute [Ga. Code Ann. § 9-2-61(a)], while plaintiff maintained that Illinois’s one-year period governed the issue, 735 ILCS 5/13-217.6. Id. at *10.  After determining that the only Illinois citizen, Sid, was a real party in interest (a dispositive issue, because if not, Georgia’s statute controlled time-barring the case), the judge denied the motions to dismiss without prejudice. Id. at *10-11.

Dismissal of Milton and Jonathan

Defendants resubmitted their motions to dismiss in April 2017, arguing that Milton and Jonathan were not properly served, an interesting issue that itself could be the subject of its own post. Id. at *17-18.  Suffice it to say that the court ruled that service on Jonathan’s surviving corporation (because Jonathan no longer existed at the time the case was originally filed in 2010) was improper because in essence, “[p]laintiff cannot effectively serve one corporation by serving a completely different corporation.” Id. at *19, 25.

As to Milton, the court did not reach the service issue because plaintiff voluntarily dismissed Milton on July 9, 2011, − but refiled the action, again, on May 11, 2015, well outside the one-year limitation of Illinois’s savings statute. Id. at *26-27.  Thus, the court dismissed the claims against Milton with prejudice. Id. at *27.

Rule 12(b)(6) Motion

At long last, the court turned to the Rule 12(b)(6) motion to dismiss for failure to state any cognizable claims, pursuant to TwIqbal.  By now, it should hardly surprise anyone (even plaintiff herself, one would think) that the claims were almost all poorly pled, and most were dismissed.  For example there was “nothing in the complaint that connect[ed] Ethel to Jonathan and its alleged responsibility for Lupron-related activities beyond their shared parent company.” Id. at *30.  The familiar catchall of “Defendants” failed to state a plausible claim against Ethel and was “therefore insufficient to satisfy Rule 8’s pleading the claims,” resulting in the court’s dismissal of all claims without prejudice. Id.

Merits of Plaintiff’s Causes of Action

Turning to the merits, court next conducted a choice of law analysis, using Illinois’s “most significant relationship test” to determine whether Illinois or Georgia law applied. The court ultimately decided that Georgia law would apply, largely because plaintiff resided in, and suffered her alleged injuries in that state, which had the strongest interest in the litigation. Id. at *35-37.

After determining that plaintiff sufficiently alleged that Sid played a role in manufacturing Lupron beyond its ownership of Jonathan, the court declined to dismiss strict products liability and failure to warn claims against Sid. Id. at *40.  However, it ruled that plaintiff’s allegations that Sid failed to adequately test the product before approval, did not advise “Plaintiffs and their physicians,” and misrepresented “the dangers associated with the use of Lupron,” failed to allege either that Sid owed or breached a duty to plaintiff. Id. at *45.  The allegations could not support plaintiff’s negligence claims against that defendant. Id. Nor could plaintiff state a claim for express warranty through statements that Defendants “expressly represented” that Lupron was “safe and efficacious,” “safe and fit for its intended use,” or “of merchantable quality.” Id. at *46-47.  In dismissing plaintiff’s claim, the court observed that “Plaintiff [did] not identify any specific warranty that Sid made to her … “nor [did] she identify the content of any statement by Abbot.” Id. at *47.  Similarly, plaintiff’s breach of implied warranty claim failed because she could not establish privity – as the complaint stated only that she used Lupron, and was devoid of allegations “that she purchased it.” Id. at * 49.

Further – and utterly unsurprisingly by this point − plaintiff’s fraudulent misrepresentation claim was not pled with the heightened particularity required by Rule 9(b), “[t]he who, what, when, where, and how: the first paragraph of any newspaper story.” Id. at *50 (citation omitted).  Rather, the complaint merely claimed that Defendants generally misrepresented the product’s safety in its labeling, marketing, and advertising over several decades. Id. However, plaintiff failed to articulate “who made these statements (other than Defendants, without specifying which Defendant made which statement), where and when these statements were made (other than to say sometime in the 1990s-2000 in Georgia and elsewhere), or how exactly Lupron’s safety was misrepresented.” Id. at *51.  Finally, her negligent misrepresentation claim was also doomed absent “allegations pointing to [defendant’s] statements on which Plaintiff relied” prior to her Lupron injection. Id.  Therefore, the court concluded that plaintiff’s negligent misrepresentation claim could not proceed “under Rule 8’s pleading standard,” and it too, was dismissed. Id. at *52-53.

In a nutshell, plaintiff ran afoul of every tenet of basic pleading 101 by repeatedly offering only threadbare allegations without specific facts; generalized and conclusory allegations leveled only at “Defendants;” and rote recitations of the elements of a claim without the facts to support it. However, to our chagrin, and much more to that of the Defendants, the court dismissed all of plaintiff’s claims, except for strict product liability and failure to warn, with leave to amend, despite seven years of failed pleadings. Id. at *54.  At least, the court issued plaintiff a none too subtle warning, stating it was “cognizant of the long procedural history,” and conditioning its leave for plaintiff to file an “amended complaint consistent with this opinion, if Plaintiff believes that she can overcome the deficiencies identified above for the dismissed claims.” Id. at *55 (emphasis added).

Given Plaintiff’s history of inartful pleading, repeated procedural errors, and other tactical blunders, one can expect, and hope, that like the buffoons in “Mad World,” when this case finally does end, plaintiff and her attorneys will wind up empty-handed.

It took a while for courts to catch on that implied preemption in drug cases depends on whether the plaintiffs can present “newly acquired evidence” of a relevant risk, but the argument seems to be gaining some traction. The first case to recognize the “newly acquired evidence” argument was the First Circuit’s Marcus v. Forest Pharmaceuticals opinion in 2015, which we covered here.  Since then, we have covered the topic at some length in connection with orders coming out of the Eliquis MDL in New York, which you can revisit here, here, here, and here.  These posts report on a series of orders in which the district judge dismissed multiple cases because federal law impliedly preempted the plaintiffs’ claims.

A district judge has now issued a similar dismissal ruling in a prescription drug case in the Northern District of Alabama, McGee v. Boehringer Ingelheim Pharm., Inc., No. 4:15-cv-2082, 2018 WL 1399237 (N.D. Ala. Mar. 20, 2018).  Here is the gist of it.  We all understand that Wyeth v. Levine opened the anti-preemption door by recognizing that an innovator drug manufacturer could sometimes change its label without the FDA’s pre-approval through the Changed Being Effected (or “CBE”) process.  Because that allowed the manufacturer, under some circumstances, to change its label to accommodate state law without running afoul of federal law, implied preemption did not necessarily apply.  Then came PLIVA v. Mensing, which held that federal law impliedly preempted state-law failure-to-warn claims against generic drug manufactures because generic manufacturers cannot use the CBE process, and therefore cannot change their labels without pre-approval.  Because generic manufacturers cannot change their labeling to comply with state law without violating federal law, state law claims must give way.

In McGee, the district court joined others in recognizing that even an innovator manufacturer cannot use the CBE process unless there is “newly acquired evidence” of a causal association between a risk and the drug.  In that event, the innovators cannot change their drug labeling without the FDA’s pre-approval and implied preemption applies.  Id. at **3-4.  “So, if a plaintiff can allege the existence of newly-acquired information that supports a labeling change under the CBE regulation, and if the manufacturer subsequently fails to show by ‘clear evidence’ that the FDA would not have approved a change to the label, then a failure-to-warn claim will survive the manufacturer’s preemption defense.” Id. at *4.

In other words, before we even get to Wyeth v. Levine’s “clear evidence standard,” the plaintiff has to plead facts establishing that the manufacturer had newly acquired information and that the new information provides reasonable evidence of a causal association between the alleged risk and the drug.

The plaintiff in McGee failed.  He alleged that the product manufacturer failed to warn adequately regarding the risk of diabetic ketoacidosis, or “DKA.” McGee, 2018 WL 1399237, at *1.  But the complaint was ambiguous on what the manufacturer knew about that condition and when the manufacturer knew it. Id. It all came down to timing.  The plaintiff alleged that there were reports of DKA before the FDA approved the defendant’s drug, but reports that pre-date drug approval obviously are not “newly acquired” information.  In addition, any allegation that the manufacturer should have alerted the FDA about the DKA risk before approval is a fraud-on-the-FDA claim preempted under Buckman. Id. at *4.

The plaintiff also alleged that the FDA issued a warning with reference to adverse events after the plaintiff allegedly experienced DKA, but “common sense dictates that any information [the manufacturer] obtained after January 17, 2015, when Mr. McGee suffered DKA, is irrelevant to Mr. McGee’s claims because [the manufacturer] could not have used that information to change its label and prevent Mr. McGee’s injury.” Id.

In theory, the plaintiff could have stated a claim with reference to information newly acquired after approval but before he used the product.  “But Mr. McGee lumps together claims and facts from before, during, and after this brief time period” and “[w]ithout clarification, the court cannot tell when Mr. McGee alleges [the manufacturer] had what information.” Id.  Alas, the court granted leave to amend.  But the district court in the Eliquis cases gave the plaintiffs additional chances to plead too, and they were unable to come up with the facts.

The plaintiff in McGee may have similar difficulty.  We know from Eliquis that dumbing down the complaint and making the allegations more vague will not work, and the district court in McGee has already faulted this plaintiff for his imprecise pleadings in any event.  The court had particular distaste for allegations that were “nothing but a useless set of legal conclusions.” Id. at *5.  The court continued:

Worse, the complaint spews these legal conclusion with few supporting facts that would assist [the defendant] in understanding what the company did wrong. This type of “shotgun” pleading fails to plead a cognizable cause of action.  If Mr. McGee chooses to file an amended complaint, he must eliminate the unnecessary and unhelpful “shotgun” assertions and claims.

Id. (citations omitted). These are pretty strong words, but nothing beyond what any court should expect under Rule 8 and TwIqbal.  The takeaway is that the “newly acquired evidence” argument is well-grounded in the law and supported now by substantial precedent.  Moreover, plaintiffs will not always have the facts to get around it.

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

 

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

 

Pleadings

 

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

 

Preemption Overview

 

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

 

Negligence failure to warn 

 

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

 

Failure to report adverse events 

 

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

 

Failure to comply with federal laws 

 

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

 

Negligent misrepresentation  

 

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

 

Negligence per se 

 

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

 

Manufacturing defect 

 

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

 

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

 

 

Strict liability – failure to warn 

 

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

 

Strict liability – manufacturing defect 

 

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

 

Breach of implied warranty 

 

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

 

Final scorecard

 

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

 

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

 

 

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

We’ve posted on two other occasions about the Shuker v. Smith & Nephew case as the Eastern District of Pennsylvania systematically dismantled the case on the grounds of preemption and pleading deficiencies. You can find those posts here and here. Unfortunately, the recent Third Circuit opinion deciding plaintiff’s appeal isn’t the full affirmance we had been hoping for. But before you get the wrong idea, the Third Circuit got the most important issue right – when you have a multi-component medical device, PMA preemption is to be addressed on a component-by-component basis. After that, however, the appellate decision does some unraveling of the district’s dismissal of the claims that survived preemption and so the case is going back to the Eastern District.

Briefly, the facts are that plaintiff underwent a hip replacement surgery in which his surgeon opted to use a Smith & Nephew device that consisted of several component parts, one of which was the R3 metal liner. Shuker v. Smith & Nephew, PLC, 2018 U.S. App. LEXIS 5160, *11 (3d Cir. Mar. 1, 2018). Unlike the other components of the device, the liner had undergone FDA Pre-Market approval. Id. And, the parties are in agreement that the surgeon’s decision to use the R3 metal liner with this particular device was an off-label use. Id. at *12. Plaintiff suffered complications that required additional revision surgeries.

In its first decision, the district court tossed out almost all claims as preempted and any non-preempted claims for being inadequately pleaded. When plaintiff filed an amended complaint attempting to correct the pleading deficiencies for the non-preempted claims, he again missed the mark and his remaining claims were dismissed with prejudice. The district court also entered a decision finding that it lacked personal jurisdiction over Smith & Nephew, PLC – a foreign parent company. Those three rulings are what the Third Circuit addressed in last week’s decision.

The question of how to apply PMA-preemption to a multi-component device was one of first impression in the Courts of Appeal. Id. at *2. And it is an important question because surgeons engaging in off-label use do mix and match parts with different regulatory backgrounds. The Third Circuit did a precise analysis that landed at the proper conclusion. However, the analysis does start up with a bit of a hiccup. Since we are talking about PMA-preemption, we are dealing with express preemption. Yet, in a footnote the court refused to follow the Supreme Court’s recent abolition of the presumption against preemption in the express preemption context set forth in Puerto Rico v. Franklin Cal. Tax-Free Tr., 136 S.Ct. 1938 (2016), because that decision wasn’t a products liability case and therefore did not directly concern the “historic police powers of the States.” Shuker, at *16n.9. We respectfully disagree with this conclusion for all the reasons we mention in our post discussing Franklin and simply point out that other courts have reached the opposite conclusion. Accord Watson v. Air Methods Corp., 870 F.3d 812, 817 (8th Cir. 2017) (following Franklin and rejecting presumption against preemption in express preemption case); EagleMed LLC v. Cox, 868 F.3d 893, 903, (10th Cir. 2017) (same); Atay v. Cty. of Maui, 842 F.3d 688, 699 (9th Cir. 2016) (same); Conklin v. Medtronic, Inc., ___ P.3d ___, 2017 WL 4682107, at *2 (Ariz. App. Oct. 19, 2017) (under Franklin courts may not invoke a presumption against preemption in PMA preemption cases); Olmstead v. Bayer Corp., 2017 WL 3498696, at *3 n.2 (N.D.N.Y. Aug. 15, 2017) (plaintiff’s assertion of presumption against preemption in PMA preemption case held “frivolous” after Franklin).

Fortunately, that did not derail the Third Circuit from ultimately concluding that plaintiff’s negligence, strict liability, and breach of implied warranty claims were all preempted under Riegel. To do that, the court had to determine to what device it was applying the preemption analysis. Plaintiff argued that you have to look at the device that was implanted as a whole. Whereas defendant, bolstered by an amicus brief filed by the FDA at the court’s request, maintained that the proper focus is on the component of the device with which plaintiff takes issue. Shuker, at *18. Agreeing with the defense position, the court anchored its decision on three findings. First, the FDCA defines “device” to include “components, parts, and accessories.” Id. at *19. Second, the FDCA’s off-label provisions specifically acknowledge that a physician can and will use components separately from the system for which the FDA approved use. Id. at *20. And despite the use to which the component is put, the FDA’s PMA-regulations for the component follow with it. In other words, “premarket approval requirements apply equally to the components, as manufacturers generally may not deviate from the requirements imposed through premarket approval regardless of how [a component] is used.” Id. (citation and quotation marks omitted). Third, the FDA’s position is that the device is not limited to the device as a whole but includes components. Further, the FDA is charged with assuring the safety and effectiveness of components as well as finished devices. Id. at *21-22.

Therefore,

[t]aken together, the statutory definition of “device,” the treatment of off-label uses, and the guidance of the FDA all counsel in favor of scrutinizing hybrid systems at the component-level. . . .. And the Riegel test is properly framed at Step One as “whether the Federal Government has established requirements applicable” to a component of the hybrid system.

Id. at *22-23. Because the part of the device plaintiff attacked was the R3 metal liner which was premarket-approved, any state tort claim that seeks to impose requirements that are different from or in addition to the FDA’s requirements for that component are preempted. That includes plaintiff’s negligence, strict liability, and implied warranty claims.

The appellate court next reviewed the dismissal of plaintiff’s claims that survived preemption – negligence and fraud claims based on alleged off-label promotion in violation of federal law – and found the negligence claim was adequately pleaded but that plaintiff failed again to satisfy Rule 9’s heightened standard for pleading fraud. As to negligence, the court found TwIqbal satisfied as to duty, breach, causation where plaintiff alleged:

  • the R3 metal liner was approved only for use with a different system and therefore under federal law defendant had a duty to refrain from false or misleading advertising;
  • in a press release, defendant misleadingly marketed the R3 metal liner as an option for the system used by plaintiff’s surgeon (one other than the one it was approved for); and
  • plaintiff’s surgeon “either read” or “was aware” of the press release.

Id. at *28-29. Like the district court, the Third Circuit considered and relied upon the press release cited in plaintiff’s complaint. Unlike the district court, the Third Circuit appears to only focus on the portions of the press release upon which plaintiff relied (see prior post for more details) and concludes that’s enough to get plaintiff to the discovery stage. Id. at *29n.18. Although we wonder if the court’s calling plaintiff’s allegations enough to “nudge” the claim over the threshold is a veiled acknowledgement of just how narrowly the complaint squeaked by. See id. at *30.

Meanwhile, plaintiff’s fraud claim needed more than a nudge and it didn’t get even that. The court focused on plaintiff’s failure to plead justifiable reliance on the alleged misrepresentation. The “read” or “was aware” of allegation that sufficed for negligence lacked the requisite details regarding how the press release “induced or influenced” plaintiff’s surgeon for a fraud claim. Id. at *33-34. Plaintiff has to allege the “circumstances of the alleged [influence on Mr. Shuker’s surgeon] with sufficient particularity to place [defendant] on notice of the precise misconduct with which it is charged.” Id. at *34. Despite this having been plaintiff’s second failed attempt at meeting the pleading standard on fraud, the Third Circuit decided to give plaintiff another chance and found the claim should only be dismissed without prejudice.

Finally, there was a separate finding by the district court that it did not have personal jurisdiction over Smith & Nephew, PLC, a foreign parent company. The Third Circuit agreed with the district court that specific personal jurisdiction was not conferred on a stream-of-commerce theory. Id. at *36-37. We’ve talked about this before and more recently in light of BMS v. Superior Court, and like the Third Circuit “we have no cause to revisit” the precedent on the issue (but you should feel free to). But the court did think plaintiff alleged enough in his complaint to allow some limited jurisdictional discovery on possible alter ego based personal jurisdiction. Id. at *38-40. Emphasis on the limited part. See id. at *40n.20 (“District Court should take care to circumscribe the scope of discovery . . . to only the factual questions necessary to determine its jurisdiction;” further referencing proportionality amendment to Rule 26(b)(1)).

So, on the third pass plaintiff got a little life breathed back into this case which is unfortunate, but as the first appellate decision on component preemption – we’ll put it in the win column.

Last week we posted about the need to consider the level of detail and specificity you include in any filing. We happened to stumble across another case that prompted a word to the wise – proofread, proofread, proofread. Today’s case is a defense victory in the battle between state and federal forums, but perhaps more importantly it is a reminder that in the age of “cut and paste,” proofreading is more important than ever.

Grant v. Johnson & Johnson, 2017 U.S. Dist. LEXIS 214078 (S.D.N.Y. Dec. 19, 2017), is not a drug or medical device case. But it involves an attempt by plaintiffs to use local pharmacies to defeat federal diversity jurisdiction and that is something drug and device defense lawyers face on a regular basis. Plaintiff filed a complaint in state court alleging that defendants, including a local New York pharmacy, sold and distributed products containing asbestos which caused plaintiff to develop mesothelioma. Id. at *3. Defendants then removed the case to federal court arguing that the local pharmacy was fraudulently joined. Id. at *3-4. Defendants alleged that plaintiff had not pleaded any facts to support a claim that the pharmacy had ever sold or that plaintiff had ever purchased from it any products containing asbestos. Id. at *4n1.

About a month later, plaintiff filed an amended complaint dismissing the originally named pharmacy and adding five new pharmacy, non-diverse entities as parties. Id. at *4. Plaintiff admitted that the original pharmacy never should have been named. It was an “inadvertent mistake.” In the rush to meet a filing deadline, plaintiff’s counsel copied the allegations from another client’s complaint. Id. at *4-5. Talk about a flub, a botch, a bungle. And it took plaintiff almost a month after removal to fix it. Nobody’s perfect. But naming the wrong defendant – not because of inaccurate, incomplete, or unknown information – but because you didn’t bother to proofread your complaint, is something that should have been caught and remedied immediately.

Once plaintiff “fixed” the complaint, she moved to remand. But sloppiness didn’t win her any points with the court, and more importantly, it revealed plaintiff’s real motive in naming the non-diverse defendants. Which also didn’t help plaintiff’s cause.

First, the procedural posture in this case is slightly different than what we are used to seeing when talking about fraudulent joinder. Because plaintiff admitted that the original pharmacy was improperly joined, its citizenship is discounted for purposes of determining diversity. So, complete diversity existed when the case was removed. Id. at *7n3. The question before the court was whether to allow plaintiff, post-removal, to join the new non-diverse pharmacies. If joinder were permitted, the case would have to be remanded to state court. However, “[w]hen joinder after removal would destroy subject matter jurisdiction, a plaintiff must do more than satisfy the permissive joinder requirements of Fed. R. Civ. P. 20 to succeed on a motion to remand the case.” Id. at *6. That is why, in addition to the permissive joinder rules which would be satisfied in this case, the court considers three additional factors in determining whether to allow a joinder that defeats diversity: (1) whether there was a delay and the reason for it; (2) whether there is any prejudice to the defendant; and (3) plaintiff’s motivation for the amendment. Id. So, why this case doesn’t, strictly speaking, deal with fraudulent joinder, the analysis is quite similar. Id. at *9. The court must examine the “relationship of the non-diverse defendants to the controversy . . . as an independent consideration under the joinder analysis.” Id.

Now for that analysis. The court did not believe there was either a significant delay or prejudice to defendant. Id. at *7. The court recognized the possibility of multiple litigation if joinder was denied based on plaintiff’s stated intention of filing the claims against the new pharmacies in state court. But the court was unpersuaded because “none of these non-diverse Defendants were originally sued . . . even though their existence was known to Plaintiff.” Id. at *8.

But what really drove the court’s decision was the combination of plaintiff’s counsel’s sloppiness and motive for joinder. Needing to make a deadline did not excuse counsel’s inattention:

Plaintiff’s counsel, as he admits, was essentially “copying and pasting” parts of one complaint into that of another—merely lifting a defendant from one complaint and inserting it into another—even though there was no factual or legal basis to do so.

Id. at *9. This is not a trivial thing. Naming the wrong defendant in a complaint may be compared to mistakenly inviting someone to a party. The invitee is now on the hook for a gift, possibly new attire, transportation, a sitter, etc. In other words, it isn’t no harm, no foul. And that’s a modest analogy at best. Once named, a defendant at a minimum has to retain counsel and likely will have to take some affirmative action to get itself extricated from the suit. Certainly more expensive than a bottle of wine and a new tie. Moreover, being named in a lawsuit is a public event that carries with it a certain stigma. To borrow from criminal law – innocent until proven guilty. While that may be true in the courtroom, it’s not necessarily the case in the court of public opinion. One lawsuit may not mean much to a large pharmacy chain, but it can be very unsettling and disruptive to a mom-and-pop shop, or an individually named pharmacist or sales representative, or a small town doctor. So, “oops,” doesn’t cut it.

Adding insult to injury, the amended complaint naming the “correct” pharmacy defendants contained only “boilerplate allegations and is devoid of any specific allegations” about these pharmacies. Id. at *10. Plaintiff lumps all defendants together in almost every allegation with no attempt to “explain what each Defendant’s respective role was.” Id. This also means plaintiff wrongly attributes things like manufacturing and design to the pharmacy defendants. Id. Finally, while plaintiff identifies these new defendants as the locations where she purchased the products over a span of 27 years, the complaint doesn’t allege when these transactions occurred or in what quantity the products were sold. Id.

Taking all of this into consideration, the court concluded:

[W]hile it is certainly plausible that Plaintiffs motive in now seeking to join the Pharmacy Defendants may not be solely to destroy diversity, based on plaintiff’s litigation behavior to this point and the course [s]he has selected to arrive at the current motion, Plaintiff’s motives for joinder are improper and violate the principles of fundamental fairness.

Id. at *11(quotation marks and citation omitted). Joinder was denied so as not to deprive the properly named defendants of their entitlement to litigate in federal court.

We don’t know how the court would have ruled on the remand motion if plaintiff had named the correct defendants the first time around. Given the comments on the boilerplate allegations, we’d like to be optimistic that the result would be the same and the pharmacies would have been found fraudulently joined. We’ll never know because of plaintiff’s carelessness which clearly inured to the benefit of defendants. But we all copy and paste. So, another word of caution – proofread and proofread again.