Photo of Michelle Yeary

We have written a lot about personal jurisdiction. We certainly haven’t lacked for defense favorable decisions since Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017). Its impact has been felt in many contexts – class actions, innovator liability, litigation tourism. And, as we discussed in our post here, “stream of commerce” jurisdiction has also taken a significant hit post-BMS. Today we add another case to the growing precedent that “purposeful availment” rather than the “fortuitous” conduct of third persons is (i) a difficult standard to meet and (ii) is required to establish jurisdiction.

In Morgan v. Trokamed GmbH, 2018 WL 4388457, at *1 (W.D. Wis. Sep. 14, 2018), plaintiff, a citizen of Wisconsin, sued the German manufacturer and the North American distributor of a Class II medical device used in laparoscopic surgery. The manufacturer moved to dismiss for lack of personal jurisdiction and both the plaintiff and the distributor opposed. It was undisputed that the manufacturer had no offices or employees in Wisconsin, no representative of the manufacturer had ever visited Wisconsin, and the manufacturer doesn’t ship products to Wisconsin. Id. at *2. So, for plaintiff to make a prima facie showing of specific jurisdiction, she had to show that the German company had “purposefully availed” itself of conducting business in Wisconsin. The court analyzed each of plaintiff’s allegations of contact.

Exclusive distribution agreement: Plaintiff’s first argument was a straight-forward stream of commerce theory. The manufacturer gave the distributor exclusive rights to sell the manufacturer’s medical devices in the U.S., Canada, and Mexico. Based on that, the manufacturer should have reasonably expected its products to be sold in all 50 states. Id. But, as the court points out, that’s the same argument made by Justice Ginsburg in her dissent in J. McIntyre Mach., Ltd. v. Nicastro, 564 U.S. 873 (2011). But, the plurality (Kennedy, J.) and concurring (Breyer, J.) opinions found nationwide transmission insufficient to confer jurisdiction tethered only to a prediction that a defendant should have known its product would reach a specific state. Id. at *3.

Plaintiff tried to distinguish Nicastro by arguing that the manufacturer here exhibited more control over the distributor, but the court found nothing in the distribution agreement that showed targeting of Wisconsin particularly. The agreement covered the U.S. as a whole and did not direct the distributor to sell the devices in Wisconsin which is “the type of control that matters under a personal jurisdiction analysis.” Id. at *4.

Sales Volume: Plaintiff next tried to distance herself from Nicastro by pointing out that the plurality and the concurrence relied on the small number of sales of the product to New Jersey in deciding personal jurisdiction was lacking. Id. But, plaintiff here could only identify 2 sales of the manufacturer’s medical device in Wisconsin. Id. So, she focused on disposable components (blades and valves) of the device that she claims the distributor “regularly” sent to Wisconsin. This argument failed for several reasons, including that plaintiff neglected to produce any evidence that the components were manufactured by the German defendant. Id. at *5. Plaintiff also doesn’t allege that her injury had anything to do with the component parts, “so those sales would have a more tenuous connection with her claims.” Id. Finally, plaintiff still had no evidence that the manufacturer was aware it had customers in Wisconsin at the relevant time. Plaintiff alleged that the manufacturer became aware of its Wisconsin customers in 2015, but plaintiff “does not explain how knowledge that [the manufacturer] had in 2015 could serve as the basis for an exercise of jurisdiction for a claim arising out of 2014 injury ad a [device] sale made years earlier.” Id.

             Instructions for Use: Relying on Justice Breyer’s concurrence in Nicastro that offering “special state-related . . . advice” might be enough to confer jurisdiction, plaintiff alleged that the manufacturer “established channels of advice” via its warranty and Instructions for Use. Id. at *6. What plaintiff missed, however, is that the instructions “direct the customer to send the device to [the distributor] for repairs,” the instructions have the distributors contact information and logo, and state that the device is a product of the distributor. “No one reading the [instructions] would know that he or she should contact [the manufacturer] for any reason.” Id. at *7.

FDA Approval: Perhaps the most significant part of the opinion is the court’s conclusion that “the process for FDA approval does not provide a basis for exercising jurisdiction in a particular state.” Id. We’ve talked about this in the context of innovator liability, where the innovator may be the NDA holder, but they didn’t sell or distribute the product used by plaintiff. If the brand defendant didn’t sell the product at issue, but rather a different product to different people, and FDA-approval isn’t enough – what’s left on which to base specific jurisdiction?

Plaintiff also tried to use post-approval FDA communications to establish purposeful contacts. In response to a request from the FDA, the manufacturer had its distributor update all the instructions and send them to all customers. During this process, the manufacturer received a list of all of the U.S. customers for its devices. Id. at *8. Not only did this process take place after plaintiff’s alleged injury (after the relevant time period), it still relates only to the manufacturer’s contacts with the U.S. as a whole, not with Wisconsin. Id.

The bottom line: The facts alleged by [plaintiff], may reveal an intent to serve the U.S. market, but they do not show that [the manufacturer] purposefully availed itself of the [Wisconsin] market. Id. at *9 (quoting Nicastro).

We’ve written about a lot of Risperdal summary judgment wins. No medical causation, no warnings causation (learned intermediaries aware of risks), no alternative design, no fraud. So, when we see an opinion that overturns a plaintiff’s verdict on the grounds of (1) impossibility preemption; (2) clear evidence preemption; and (3) no evidence of general causation, we can’t help but wonder how it got to trial in the first place. So we decided to do a little digging. From our review of the case, it appears these issues were all raised at the summary judgment stage but denied. What changed before and after trial? Not the facts that support these arguments. The regulatory history hasn’t changed. The experts’ opinions haven’t changed. Yet, defendant had to go through an amateur-hour trial (we’ll tell you more about that later) and then wait over a year for these post-trial rulings granting judgment as a matter of law. Sure, better a late win then no win at all – but it certainly feels like this could have been avoided.

The case is Byrd v. Janssen Pharm, Inc., No. 1:14-cv-0820, slip op. (N.D.N.Y. Sep. 21, 2018) and, as mentioned above, involved Risperdal, an antipsychotic drug prescribed to treat serious mental conditions – schizophrenia, manic depression, and autism. Plaintiff alleged that his use of Risperdal caused him to develop abnormal breast tissue growth. The two claims that went to trial were negligent design, manufacturing, and warning defect and strict liability design, warning, and misrepresentation. Id. at 3.

The opinion methodically sets out both defendant’s arguments and plaintiff’s responses, but we’re going to jump right to the conclusions. First up was preemption. Standard plaintiff argument: defendant unilaterally should have changed its warning to include gynecomastia and was able to do it via the Changes Being Effected (“CBE”) regulations. Standard impossibility preemption defense: federal law prohibited defendant from changing the FDA-approved labeling and/or there is “clear evidence” that the FDA would have rejected the proposed labeling change. Id. at 12. The court was persuaded as to both impossibility and clear evidence. Defendant presented “clear evidence” that the FDA had rejected its request to add safety and dosing information for pediatric use of Risperdal. Id.

But the court spent most of its analysis on whether a CBE label change even was permissible under federal law. A CBE labeling change can only be made on the basis of new information concerning a serious risk. “[H]ere, the relationship between antipsychotics and [abnormal breast development] was not new information because it had been discussed in basic psychiatry textbooks for decades, and the FDA does not consider gynecomastia a serious adverse event.” Id. at 9. A “serious” adverse event is defined by federal regulations to be an event that either “resulted in inpatient hospitalization or required surgical intervention to prevent inpatient hospitalization.” Id. at 15. And, both plaintiff’s and defendant’s regulatory experts agreed that gynecomastia “would not be a serious adverse event.” Id. at 16-17. Now, plaintiff’s expert was Dr. Plunkett and she was quick to voice her personal disagreement with the FDA on this point – but that’s irrelevant (both to us and to the court). Id. at 17.

The court didn’t stop there. Defendant also argued that plaintiff had failed to satisfy his burden of proof on causation. While defendant made arguments regarding both proximate and medical causation, the court focused its attention on the latter and specifically the lack of general causation evidence. Id. at 26. Starting with Dr. Plunkett who “admitted to not being a causation expert,” but opined on it anyway – the court found her opinion unsupported by the literature. Id. None of the three pieces of literature relied on by Dr. Plunkett included a control group, so at best they were evidence of an association, not a correlation. Dr. Plunkett’s reliance on this literature demonstrated a “disregard for the difference between an association between two things and a causal relationship between those two things.” Id. at 29; see id. at 30 (“a correlation between Risperdal and gynecomastia cannot be drawn without a control group”). The fact that these studies lack a control group was likely not “new” information at trial and again begs the question why this issue is only being properly addressed post-trial.

Plaintiff’s other causation expert likewise had no support for a general causation opinion. His conclusion was that plaintiff’s gynecomastia was “secondary at least in part to prolonged use of Risperdal.” Id. at 31. But, putting aside reliance on the same literature relied on by Plunkett, the only basis plaintiff’s second expert had for his general causation opinion was his differential diagnosis. A differential diagnosis, however, “generally does not prove general causation.” Id. at 33. It assumes general causation has already been proven. Without general causation, defendant was entitled to judgement as a matter of law.

Still, the opinion continues. The remainder of the decision addressed defendant’s alternative request for a new trial based on the inappropriate conduct of plaintiff’s counsel. The court did not need to decide this issue having already found two grounds to overturn the verdict and award judgement in defendant’s favor. Based on the description of plaintiff’s trial antics, however, we can only assume that the court wanted this opportunity to admonish plaintiff’s counsel. Defendant pointed out 23 separate incidences of plaintiff’s attorney’s misconduct in front of the jury. Id. at 34. In concluding that plaintiff’s counsel’s behavior did warrant a new trial, the court relied on:

(1) Plaintiff’s counsel’s self-deprecating tone of voice and posture when referring to his lack of professional skills and/or experience, (2) his helpless tone of voice and posture when referring to the fact that he was bullied as a child, (3) his alternating innocent and defensive tones of voice in response to an admonishment by the Court, (4) the sympathetic facial expressions of the jurors following the aforementioned acts and/or accompanying comments, (5) the credulous expressions of the jurors following Plaintiff’s counsel’s acts of asserting the truth of Plaintiff’s case and/or vouching for his witnesses, and (6) the jurors’ reactions following Plaintiff’s counsel’s acts of offering his personal opinions about the evidence and/or testifying when he could not otherwise introduce evidence.

Id. at 37-38. While this behavior more than justified a new trial – it wasn’t necessary because no childish antics could overcome the fact that plaintiff had failed to prove general causation and that defendant had clear evidence to support impossibility preemption. Both of those things were true a year ago too. But better late than never.

One of our primary goals is to bring you the latest and greatest news in the drug and device litigation world. But sometimes we don’t learn of a case at the time it’s decided. So, then we need to move on to another of our guiding principles – if it’s good for the defense, we talk about it. So, while today we happen to have come upon a case that was decided in 2017, it dovetails with our recent post Taking Out the Laundry With TwIqbal where we talked about plaintiffs’ attempts to bluff their way to a valid parallel violation claim. And that’s exactly what the plaintiff in Rand v. Smith & Nephew, Inc., 2017 WL 8229320 (C.D. Cal. Apr. 5, 2017) tried to do. Plaintiff put together a “laundry list” of allegations that the defendant’s device violated with no hint of what exactly the defendant did that was in violation. In our prior post we commented that “most courts are willing to use TwIqbal to call bull$%@&! on these types of allegations.” Fortunately, Rand can be added to that list.

The device at issue in Rand is a hip resurfacing prosthesis that underwent pre-market approval from the FDA. That’s why we are talking about parallel violation claims. Following a nice Riegel analysis, the court looked at plaintiff’s allegations for each cause of action.

Strict liability: Under California law, this is a claim for a design, manufacturing and warning defect. Because the FDA reviews “device design, manufacturing processes, and device labeling” as part of the PMA, “the MDA preempts state-law claims against these three aspects of PMA-compliant devices.” Id. at *4. So, plaintiff made 2 laundry lists – one of “various federal regulations” and another of defendant’s alleged misconducts. Double the nonsense.

First, plaintiff included regulations that go to the adequacy of defendant’s PMA application. “But FDA’s approval demonstrates the agency’s reasonable assurance of [the device’s] safety and effectiveness based on the application.” Id. So any claim premised on those regulations is preempted. Second, the court moved on to TwIqbal finding some allegations so poorly pleaded that it is “impossible to determine whether they add to federal requirements and hare hence preempted.” Id. Finally, some allegations were completely conclusory.

Plaintiff’s second list wasn’t much better. Not only did it include conclusory allegations – basically just speculation – but plaintiff also included alleged misconduct that was irrelevant. For example, plaintiff alleged wrongdoing regarding device components used in off-label combinations but plaintiff was implanted with such a combination. In other words, plaintiff was tossing pasta at the wall and just hoping something stuck. That’s not good enough under TwIqbal.

The only allegation that made the cut was failure to report adverse events. Id. This is California, so it’s to be expected.

Negligence: This largely mirrors plaintiff’s strict liability claim and suffers the same fate. The only new “misconduct” included in the negligence count was about defendant’s withdrawal of the device for “demographics groups” to which plaintiff didn’t belong. Irrelevant. Id. at *5. And, plaintiff surmised that defendant’s breach proximately caused his injury but provided no support for that allegation. Id. The entire negligence claim was dismissed.

Breach of express warranty: Again, most of plaintiff’s allegations are insufficient:

Without more details, the statements that [defendant’s] devices are of merchantable quality, safe, effective, and fit and proper for its intended use are no more than an affirmation merely of the value of the goods or a statement purporting to be merely the seller’s opinion or commendation of the goods. Such unspecific statements do not create a warranty.

Id. (citation and quotation marks omitted). The court did find that a press release cited by plaintiff created an express warranty but plaintiff failed to allege how the press release violated any PMA requirement. Without that, the claim was dismissed without prejudice.

Breach of implied warranty: This claim was preempted:

Both types of implied warranties involve an assertion that the goods are fit for then intended purpose. Implied warranty of merchantability further imposes labeling requirement and requires that the goods conform to the statements on the label. But these conditions are precisely what a PMA entails. Thus, unless the defendant violates these conditions under the PMA, § 360k(a) expressly preempts this claim.

Id. at *6 (citation omitted). Since plaintiff used the device for the purpose the FDA approved – no breach of implied warranty claim.

Fraudulent concealment: Here again plaintiff attempts to rely on a failure to report adverse events to state his claim. But essential to a fraud claim is that defendant had a duty to disclose the concealed fact to plaintiff. Id. We think this negates failure to report as a basis for strict liability as well and we’ve made our views on that clear many times. Here, plaintiff didn’t allege that federal regulations require defendant to report adverse events to plaintiff – nor can he because that’s not the law. That means that this would be an “additional requirement” which is preempted. Id..

The claim also failed for no allegation of intentional concealment by defendant and for not satisfying Rule 9(b)’s heightened pleading requirement for fraud. Id.

It may not be the latest and greatest, but it adds to the wealth of decisions tossing plaintiffs’ multi-paragraph list of violations which are a lot more bark than bite.

You haven’t heard of Blue Car syndrome?  Remember the last time you went car shopping. You found a particular make and model (a “blue car”) and then, like magic, you see that same “blue car” 10 times in the next week. It’s in the parking lot of your gym. It pulls up next to you in traffic. It’s even parked down the block from your house. The blue cars didn’t just suddenly appear. So what happened? It’s sometimes called the Baader-Meinhof phenomenon or frequency illusion. It occurs when something you’ve just noticed, like a new car, suddenly crops up everywhere. You really are seeing more blue cars, but not because there are more blue cars, but because you are now noticing them more.

That might not strictly speaking be true for us and pre-service removal — we’re pretty sure we’d notice whenever the issue came up – but it certainly feels like out of nowhere pre-service removal became a hot topic last month. No sooner did we update our research on the issue, then the Third Circuit makes a favorable ruling allowing pre-service removal. Just five days after that decision, the Northern District of Illinois does the same thing.

In Cheatham v. Abbott Laboratories Inc., — F. Supp. 3d –, 2018 WL 4095093 (N.D. Ill. Aug. 28, 2018), plaintiff, a citizen of Louisiana sued Abbott, a citizen of Illinois and Delaware, in state court in Illinois. Before the complaint was served on defendant, it removed the case to federal court and plaintiff promptly moved for remand arguing the forum defendant rule. Id. at *1-2. As with any pre-service removal case, the dispute turned on the interpretation of the “properly joined and served” language of 28 U.S.C. §1441(b)(2). If a “properly joined and served” defendant “is a citizen of the State in which [the] action is brought,” removal is not permitted. Id.

Defendant’s argument: Under the plain meaning of the statute, as defendant was not served at the time of removal, the forum defendant rule does not apply. Cheatham, at *3-4.

Plaintiff’s argument: Allowing pre-service removal undermines the purpose of the forum defendant rule to preserve the plaintiff’s choice of forum where there is no prejudice to an out-of-state party. Id. at *2-3.

That’s the debate: purpose v. plain meaning. And that is the split among the courts to have decided the issue. Although, as our recent update points out, plain meaning has been gaining ground in the recent circuit court decisions on the issue. The Cheatham decision does a nice job of setting out both arguments with citations to cases going both ways before ultimately concluding that “the statutory text must control. Courts must give effect to the clear meaning of statutes as written.” Id. at *5 (citations omitted).

Courts that have applied the “purpose” interpretation believe that it is necessary to look beyond the language of the statute to be “faithful to Congressional intent.” Id. at *3. Those courts seem to be particularly concerned by “snap removals” – where a defendant learns of the filing of a lawsuit from monitoring the docket and then immediately removes the case. In the age of online filing, docket monitoring is not new or uncommon. Plaintiff called it both improper and strategic gamesmanship. Id. at *2. But just because something is strategically advantageous to one side doesn’t make it improper. Nor does it make it gamesmanship in the sense that it is a dubious tactic.

When Congress completely re-wrote 28 U.S.C. §1441(b) in 2011 it left the “properly joined and served” language intact. If you want to talk about Congressional intent, the buck stops in 2011. In fact, the Cheatham court, like others applying the plain meaning of the statute, acknowledge that “Congress will rewrite the statute if it feels that removal where an in-forum defendant has not yet been served constitutes an abuse of the judicial system.” Id. at *5. Having left that provision in place, the forum defendant rule does not apply where the forum defendant has not been served at the time of removal.   Defendant learned of the action “before it became a forum defendant that was both properly joined and properly served,” id., and promptly removed it. There was no bending of the rules required. Diligence isn’t gamesmanship.

And, we actually don’t think pre-service removal is not a frequency “illusion” – it’s real and going in defendants’ favor.

On the same day the Seventh Circuit overturned the verdict in Dolin v. GSK, the court handling the coordinated New York state court Plavix Litigation dismissed the claims of all remaining plaintiffs on the grounds of conflict preemption. Oh happy day!

Plavix is a drug prescribed to inhibit the formation of blood clots. As such, ever since it has been on the market, its label has included warnings regarding the risk of bleeding. In re: Plavix Products Liability Litigation, 2018 WL 4005859, at *2 (N.Y. Sup. Aug. 22, 2018). It is that same risk which plaintiffs in the litigation allege was insufficient. Defendants moved for summary judgment arguing plaintiffs’ failure to warn claims were preempted because defendants could not independently have changed the Plavix warning and plaintiffs’ design defect claims were preempted because defendants could not have changed the design (i.e., the chemical composition) of an FDA approved drug. Id. at *3.

Since we led with the result, you know already that defendants’ arguments held the day. So, usually at this point in our posts we comment on plaintiffs’ arguments and why they failed. In this instance, however, plaintiffs didn’t make any substantive arguments. They instead only made a procedural argument about whether the New York plaintiffs’ generally had designated Dr. Randall Tackett and Dr. Lemuel Moyé as generic experts for all cases. It really isn’t worth delving into other than to say that the court wasn’t swayed by plaintiffs’ counsel’s attempt to disassociate themselves from the “the “Dynamic Duo” since they relied on the experts’ reports and defended them at deposition. Id. at *6.  And, since now was the time for plaintiffs “to either prove it or lose it,” id., relying on a “mere procedural technicality” was insufficient to meet a substantive challenge to all of plaintiffs’ remaining claims. Id.

So, we’ll get right to the court’s analysis which starts with the holding that “federal preemption presents a question of law.” Id. at *7. We like checking off that box. The court then dove into whether the plaintiffs’ failure to warn claims were preempted under Wyeth v. Levine. Wyeth said no preemption where a defendant can unilaterally, without the permission of the FDA, change its label via CBE regulations. When is that possible? When the manufacturer has “newly acquired information.” But,

NY Plaintiffs have not produced any evidence that Defendant was in possession of “newly acquired information” after the FDA approved Plavix in 1997 which would have enabled Defendant to make any unilateral changes to the Plavix warning label without further FDA approval.

Id. at *8. The court also observed that plaintiffs did not challenge that defendants fully complied with FDA regulations in obtaining the approval of Plavix. Id. at *7. In other words, there is no allegation that defendants concealed any information from the FDA when it submitted its New Drug Application (“NDA”) or at any time thereafter during the course of the drug approval process. Id. at *6. FDA had all available information in 1997 and nothing new has developed since. And post-approval label changes, if they are based on information known to the FDA prior to approval of the label are preempted. For more on this issue see our posts on In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34 (1st Cir. 2015) and Utts v. Bristol-Myers Squibb Co. here, here, and here.

As to design defect, the court looked at the opinion of plaintiffs’ expert, Dr. Moyé which was essentially that Plavix was defectively designed from its inception and that defendants either had to re-design the drug post-FDA approval or stop selling it. Id. We already know the Supreme Court has rejected these arguments as the answers to conflict preemption.   Mutual Pharm. Co., Inc. v Bartlett, 570 US 472 (2013). Which the court summed up nicely here:

If Defendant did the former to avoid state tort liability, it would be creating a new drug requiring an NDA and FDA approval. Moreover, to have stopped selling Plavix, as this generic expert suggests, to “escape the impossibility of complying with both its federal and state law duties . . . [would be] incompatible with . . . [US Supreme Court] pre-emption jurisprudence.

Id. (citations omitted).

As if preemption wasn’t enough, the court also pointed out that Dr. Moyé’s conclusion that Plavix does more harm than good had to be excluded as it “achieved no consensus in relevant medical and scientific communities.” Id. at *9. His opinion was “grounded on a consensus of one.” Id.

 

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

We haven’t talked about the district court decisions in Dolin v. GlaxoSmithKline LLC, because in our opinion there simply hasn’t been anything good to talk about. Plaintiff sued the manufacturer of the brand drug Paxil arguing that the brand manufacturer should be liable for the death of her husband who took a generic version of the drug manufactured by a different company.  Plaintiff alleged that the brand manufacturer should have amended the warning that accompanied its drug to include the risk of suicidality in adults even though the FDA had expressly rejected such a warning change several times. So, the fact that the defendant’s innovator liability and federal preemption based summary judgment motions were denied left us frankly baffled at how two district courts got it wrong on both counts.

But, now we finally have something good to talk about. The Seventh Circuit just reversed the verdict for the plaintiff in this case overturning the district court’s preemption decision. In Dolin v. GlaxoSmithKline LLC, ___ F.3d ___, 2018 WL 4001208, slip op. (7th Cir. Aug. 22, 2018), the appellate court found overwhelmingly clear evidence that the FDA rejected the very warning proposed by plaintiff, applied Mensing to a brand manufacturer, and also found no evidence of newly acquired information to support a unilateral label change. That’s definitely worth talking about.

Before we get to all those great decisions, we note that the Seventh Circuit opted not to reach the innovator liability question finding that the “evidence of federal preemption is decisive.” Id. at p.25. However, the court did note that the issue had not yet been decided by the Illinois courts, and therefore any ruling would have to be “a prediction of state law under Erie.Id. We point this out as one of problems with the district court decisions was that in the face of an undecided state law question, they over-reached in creating innovator liability where such a claim did not exist.  It was an improper expansion of state law.  Federal Erie predictions are supposed to be conservative, not radical as was the case here.  As discussed in our “Innovator Liability at 100” post, every other court of appeals to consider innovator liability on its merits, has rejected it.  That’s seven courts of appeals (4th, 5th, 6th, 8th, 9th, 10th, & 11th), construing the law of 23 states — including Illinois.  See In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917, 944-45 (6th Cir. 2014).

Turning to the dispositive preemption question, defendant argued that that the FDA would not have allowed it to include the warning sought by plaintiff and therefore plaintiff’s state law tort claim conflicted with federal law and was preempted. Under the standard announced in Wyeth v. Levine, 555 U.S. 555 (2009), a state law claim based on labeling is not preempted “if the manufacturer could have added the warning unilaterally under the [Changes Being Effected (“CBE”)] regulation.” Dolin, at p.15. Under the CBE regulation, a manufacturer can change its label without advance FDA permission if the manufacturer has “newly acquired information.” Id. at p.4. But Levine also held that “there could be preemption if the manufacturer met the stringent standard of proving that there was clear evidence the FDA would have rejected the proposed change in the drug’s label.” Id. at p.16. So, the issue for the court was whether or not defendant could have changed the drug’s label using the CBE regulation.

Before getting to the substance, we’ll start with another question the court decided not to decide – whether preemption under Wyeth v. Levine, 555 U.S. 555 (2009) is a question of fact or law. The court acknowledged the recently created split in the circuits created by the Third Circuit’s decision in In re Fosamax Products Liab. Litig., 852 F.3d 268 (3rd Cir. 2017) (our worst case of the year for 2017), on which, thankfully, the Supreme Court has granted certiorari to review. But even the Third Circuit decision left a window open. One in which Dolin certainly fit. “[W]hen no reasonable jury applying the clear-evidence standard could conclude that the FDA would have approved a label change, then the manufacturer will be entitled to judgement as a matter of law.” Dolin, slip op. at p. 18 (quoting In re Fosamax).

More specifically, the Seventh Circuit held that “no reasonable jury could find that the FDA would have approved an adult-suicidality warning for Paxil under the CBE regulation between 2007 and [decedent’s] suicide in 2010.” Id. Why was it such an open and shut case? About one-third of the opinion is taken up with setting out the extensive regulatory history demonstrating that both GSK and the FDA thoroughly examined the issue and the FDA completely rejected the addition of an adult-suicidality warning.

  • June 1991 – based on supplemental analysis of data related to suicide the FDA determined there was no signal for additional risk of suicide, id. at p.7;
  • September 1991 – an independent committee convened by the FDA “unanimously agreed that there is no credible evidence of a causal link,” id.;
  • January 2004 – FDA concluded based on review of multiple data sets that there was no increased risk of suicide, id. at p.8;
  • 2004 – the FDA requires a black box warning regarding an association between SSRIs (the class of drugs to which Paxil belongs) and suicide in pediatric patients but not adults, id.;
  • April 2006 – GSK unilaterally changed its label under CBE regulations to include the risk of suicide in adults, id. at p.9;
  • November 2006 – the FDA completed a meta-analysis that led it to conclude “the net effect appears to be neutral on” adult suicidality, id. at p.10;
  • 2007 – the FDA orders class-wide labeling to state that “studies did not show an increase in the risk of suicidality with antidepressants . . . in adults beyond the age of 24,” id. at p.11;
  • On at least 4 separate occasions in 2007, GSK asked the FDA whether it could retain the warning it added via CBE in 2006 and the FDA said no. Id. at p.11-13.

The court found this evidence “undisputed,” id. at p. 18, and held “[i]t is hard to imagine clearer evidence that . . .the FDA would not have approved a change.”  Id. at p.19.  It compared this regulatory history to the one the Supreme Court considered in Levine and found the Paxil evidence filled all the “evidentiary gaps” which led to the Levine non-preemption ruling. The risk of suicidality was given “more than passing attention” by the defendant and the FDA. Defendant provided the FDA with re-analyzed data in 2006. Defendant unilaterally changed the label to add a warning of the risk at issue. And, the FDA, more than once, rejected the warning. Id. at p.19-20.

Plaintiff made two arguments in response. First she argued that the FDA only rejected the defendant’s proposed warning because defendant “proposed adding it to the wrong spot on the label.” To which the court responded:

Plaintiff asks us to believe that the FDA – after deciding against an adult-suicidality warning based on its own analysis – rejected [defendant’s] warning only because GSK proposed putting it in the wrong place. That is unreasonable.

Id. at p.21. The court called that “unreasonable.” We’d probably have found a stronger adjective.

Plaintiff’s second argument is more important because it emphasizes what Levine preemption is at its core. Plaintiff argued that the defendant could have asked for a formal meeting with the FDA and therefore defendant lacks clear evidence that the FDA would have rejected the warning after such a meeting. Id. This argument misses the mark because “[s]tate laws requiring a label change are preempted unless the manufacturer could unilaterally add the new warning under the CBE regulation.” Id. In other words, if you need FDA approval there is conflict preemption.

This is where Pliva, Inc. v. Mensing, 564 U.S. 604 (2011), comes in and we of course laud its use in brand drug cases. Mensing held that claims against generic drug manufacturers were preempted because generic manufacturers are not permitted to unilaterally change a drug’s label. Because generic manufacturers cannot independently comply with their state law duties — changing their label would require “special permission or assistance” from the FDA — claims against them are preempted. Equate that to plaintiff’s argument in Dolin:

The preemption analysis asks only whether [defendant] could have added the adult-suicidality warning through the CBE regulation, not whether [defendant] might have been able to persuade the FDA to change its mind in a formal meeting – and certainly not whether [defendant] could have persuaded the FDA after already asking four times to include the warning and being told no four times.

Id. at p.22.

That takes care of the preemption issue up until 2007, when the FDA repeatedly rejected defendant’s CBE warning language. But plaintiff’s husband did not take the drug until 2010. So the remaining question is whether between 2007 and 2010, defendant acquired any “new” information that would have permitted a CBE label change during that period. Newly acquired information is defined as “data, analyses, or other information not previously submitted to the Agency.” 21 C.F.R. § 314.3. Plaintiff argued that in the data defendant submitted to the FDA, it “improperly attributed suicides that occurred in the wash-out phase of the drug tests as occurring on the placebo.” Dolin, slip op. at p.23. But the evidence showed that the FDA was aware that wash-out events were included and that defendant re-submitted the data to the FDA excluding the wash-out phase. Id. at p.24. Plaintiff also pointed to an article published in 2011 but the article was based on a 2006 analysis. So there was no evidence that the analysis was either new or not previously submitted to the FDA. Id. The court, therefore, concluded that plaintiff had offered no evidence that defendant acquired any new information after 2007 that would have supported a CBE label change.

All this was strong preemption evidence indeed.  We note that Dolin was written by Judge Hamilton, who is no friend of preemption generally.  See Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), also authored by Judge Hamilton.

We were always optimistic that the district court’s decisions in Dolin and the verdict would not stand and the Seventh Circuit did not disappoint (well, maybe they could have tossed innovator liability too, but a nod to Erie doesn’t hurt).

 

 

Remember the days when saying things like no cutting, no backsies, no do-overs were the laws you lived by. Or when “calling” something actually gave you priority. When invoked, these rules of the playground were difficult to challenge. And if challenged, the rule-maker always had the option of the comeback position “times infinity.” Now you could try the “times infinity plus one,” but you risked being called out for shenanigans on that. Simpler times? Perhaps. But debates over hierarchy and convention did occur. Take for example, the classic case of Harry v. Lloyd and the question of whether you are permitted to triple stamp and double stamp. While that dispute may have gone unresolved, the judge in In re Bair Hugger Forced Air Warning Devices Prods. Liab. Litig., 2018 U.S. Dist. LEXIS 133061 (D. Minn. Jul. 25, 2018) had no problem relying on the no take backs rule when it came to plaintiffs’ Lexecon waivers.

In case anyone needs a quick reminder, Lexecon refers to the decision in Lexecon v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26 (1998) in which the Supreme Court held that an MDL court could not hold the trial of a transferred case without the consent of the parties. Leading to the birth of the Lexecon waiver.

As we often do when reviewing a new case, we take a look back on the blog to see if we’ve dealt with the topic before. Certainly we’ve shared our thoughts on Lexecon waivers several times. See here, here, and here.  But, we think the issue of retracting a Lexecon waiver is an issue of first impression for us. In fact, the Bair Hugger opinion notes that there is not much precedent on the issue. So, we decided to look at the case law ourselves.

It appears that the first time the question of retracting a Lexecon waiver was addressed was in In re Fosamax Prods. Liab. Litig., 815 F. Supp. 2d 649 (S.D.N.Y. 2011), upholding on reconsideration 2011 WL 1584584 (S.D.N.Y. Apr. 27, 2011). In that MDL, the court ordered the parties to select 25 cases that would be worked up and create the pool from which bellwether trial cases would be selected. One of the conditions of selection was that the parties would execute Lexecon waivers. Id. at 650. After bellwether trials had started, one plaintiff sought to withdraw her waiver on the grounds that her husband was too ill to attend trial in New York (they resided in Alabama) and citing the Americans with Disabilities Act (“ADA”).

In deciding what standard to apply to a request to retract a Lexecon waiver, the court found

The Lexecon waivers at issue here, on which both parties have relied during the discovery and bellwether selection phases of the Fosamax MDL, reflect plaintiffs’ and defendant’s consent to trial before this Court, and are analogous to a stipulation of fact or a stipulation to proceed for trial before the court without a jury.

In re Fosamax, 2011 WL 1584584 at *2. Because one party cannot unilaterally dissolve a stipulation supported by sufficient consideration, the waiver could only be retracted “upon a showing of good cause such as fraud, collusion, mistake or duress” or if the waiver was unconscionable, contrary to public policy, or ambiguous. In re Fosamax, 815 F. Supp. 2d at 653. The court concluded that the waivers were valid stipulations because they were given in exchange for permission to conduct discovery before remand and they were unambiguous. Id. at 654. Plaintiff failed to demonstrate good cause because her case was filed in the Middle District of Tennessee which is where it would be remanded for trial if she was relieved of her Lexecon waiver. Plaintiff’s argument that her husband couldn’t travel for trial didn’t hold up since plaintiffs had since moved to Alabama. Both the transferee and transferor courts were not near her home.

The next court to address the issue was In re Zimmer Durom Hip Cup Prods. Liab. Litig., 2015 WL 5164772 (D.N.J. Sept. 1, 2015). Here, 8 cases were selected as bellwethers and 2 were selected as the initial trial cases. Id. at *1. Counsel for plaintiffs in the first 2 trial cases agreed to waive Lexecon. Shortly after that, a Joint Case Management Order was entered stating that “Plaintiffs and Defendants waive their respective rights under [Lexecon]” and “consent to trial of the cases in the MDL by this Court.” Id. Over 4 months later, Plaintiffs’ Liaison Counsel raised for the first time their position that the language in the order did not cover all plaintiffs in the MDL. Id. at *2. Another 4 months passed before plaintiffs sought to formally retract the waivers.

The court found the language in the joint order was unambiguous and applied to all plaintiffs in the MDL. Id. at *3. Having found a valid waiver, the court had to consider whether it could be rescinded and whether Plaintiffs’ Liaison counsel’s agreement bound all plaintiffs in the MDL. The court examined both the standard utilized in In re Fosamax and the Third Circuit standard for modifying stipulations – the avoidance of manifest injustice. Id. at *4. Plaintiffs argued that the waiver on behalf of all plaintiffs was a mistake. The court found plaintiffs’ failure to take any steps to correct the mistake for months after the order was entered undermined their argument. Moreover, carelessness is not good cause. Id. And, the parties had relied on the waiver in the bellwether selection process. While the waiver could not be retracted and extended beyond the 2 initial trial cases, the court held that it only applied to plaintiffs represented by Plaintiffs’ Liaison Counsel, not every plaintiff in the MDL. Id. at *5 (acknowledging the liaison counsel had authority to enter into stipulations for all MDL plaintiffs, but that “such action would necessitate additional documentation and discussion with” individual plaintiffs’ counsel that did not occur in this instance).

That sets the stage of Bair Hugger and application of the good cause standard to requests to retract Lexecon waivers. Like in the prior cases, the litigation was at the bellwether discovery and trial phase. Eight plaintiffs waived and became the bellwether pool. After the first bellwether trial, which resulted in a defense verdict, the remaining 7 cases moved to retract their Lexecon waivers. In re Bair Hugger, 2018 U.S. Dist. LEXIS 133061 at *9. Resorting to playground rules – shenanigans. The reasons given by plaintiffs were (i) the court’s ruling applying the law of plaintiff’s state of residence rather than Minnesota law which plaintiffs contended made a “material difference in the posture of the case,” (ii) lack of consideration, (iii) no inconvenience to the parties or the court, and (iv) defendants never waived. Id. at *11.

The court quickly dismissed each argument. As to choice of law, plaintiffs provided no grounds for reasonably expecting a contrary ruling and

[r]egardless, it is unlikely that a “material difference in the posture of the case” even amounts to “good cause” for retraction. If it did, any MDL party who disliked a court’s rulings could simply issue a Lexecon retraction and undo months of work performed in reliance on the Lexecon waiver. The prospect of these unilateral retractions would undermine the bellwether trial process.

Id. at *11-12. So much for plaintiffs’ poor loser, I’m taking my toys and going home argument.

As to plaintiffs’ remaining arguments: There was consideration for the waiver. Plaintiffs got to move “to the front of the line to try their cases.” Id. at *12. The parties and the court would be inconvenienced as “changing course now would waste the resources expended in advancing the current list of Bellwethers and would delay the more than 4,500 cases in this MDL by many months.” Id. at *12-13. And, it was unclear whether defendants even needed to waive Lexecon as they reside in Minnesota, but if they did, their agreement to try the cases in Minnesota was a waiver. Id.

So, the Lexecon waivers hold up in Bair Hugger. It is not a robust body of law, but the cases at least seem in agreement on treating Lexecon waivers as pre-trial stipulations bound by the jurisdiction’s applicable law on rescinding or modifying such agreements. Whether that be good cause or manifest injustice, it’s safe to say “I take it back” is as valid an argument as “I’m rubber and your glue. . .”

Today’s post is an update to our post from just a few weeks ago regarding McWilliams v. Novartis AG, No. 2:17-CV-14302 (S.D. Fla.). At that time, the court denied summary judgment on plaintiff’s failure to warn claims, but applying New Jersey law dismissed plaintiff’s claim for punitive damages. Since the case involves an FDA-approved prescription drug, having found that New Jersey law applied to the punitive damages claim, the decision to dismiss seems very straightforward to us because according to the New Jersey Products Liability Act (“NJPLA”):

Punitive damages shall not be awarded if a drug or device or food or food additive which caused the claimant’s harm was subject to premarket approval or licensure by the federal Food and Drug Administration.

N.J. Stat. Ann. § 2A:58C-5. But plaintiff didn’t think that was where the story should end, so she filed a motion for reconsideration. Look before you leap. Be careful what you ask for. You don’t always get what you want. Whatever adage you want to use, the bottom line is still no punitive damages.

Plaintiff’s argument was solely focused on the exception to the NJPLA’s ban on punitive damages for prescription drugs. That exception says that the prohibition on punitive damages does not apply “where the product manufacturer knowingly withheld or misrepresented information required to be submitted under the agency’s regulations, which information was material and relevant to the harm in question.” N.J. Stat. Ann. § 2A:58C-5. In its decision last month, the court held that plaintiff had not argued that the exception applies and so the court did not have to address it. McWilliams v. Novartis AG, 2018 U.S. Dist. LEXIS 113862, *22 n.3 (S.D. Fla. Jul. 9, 2018).

In her motion for reconsideration, plaintiff pointed to a footnote in her opposition to the motion for summary judgment in which she did argue that she had adduced evidence of information withheld from or misrepresented to the FDA that made whether the exception applied a triable issue of fact. McWilliams v. Novartis AG, 2018 WL 3637083, *2 (Jul. 31, 2018). That footnote also stated plaintiff’s belief that “punitive damages under New Jersey law are not preempted.” Id. (citations omitted).

The court agreed that it had not considered plaintiff’s argument regarding the punitive damages exception and so granted plaintiff’s request to consider it. Id. And upon considering it, promptly concluded that it was indeed preempted.

If we’re talking about a misrepresentation to the FDA, we’re talking about fraud-on-the-FDA, so we’re talking about Buckman. It feels like a direct line to us. An express even. No stops, twists, turns, or curves. The exception to the punitive damages ban in the NJPLA is a fraud-on-the-FDA claim and Buckman says those are not allowed.  The federal circuit courts that have considered the issue (in the context of similar provisions of Michigan and Texas law) are split with the Fifth and Sixth Circuits finding the exception preempted and the Second Circuit not. Compare Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004) and Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (5th Cir. 2012) with Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff’d by equally divided court, 552 U.S. 440 (2008). We discuss the split in more detail here, and we’re guessing we don’t need to tell you on which side of the issue we come down.

Fortunately the court in this case was persuaded that the punitive damages exception is “substantially the same” as fraud-on-the-FDA and therefore preempted by Buckman – noting that that was in fact the position of the majority of courts to have considered the issue. McWilliams, 2018 WL 3637083, *3. Another notch on the Garcia/Lofton side of the divide.

Today’s case has a little bit of everything – choice of law, statutory compliance, alternative design, warnings causation. So, the decision is a bit of “grab bag” in addition to being a “mixed bag.”

The case is Hyde v. C.R. Bard, Inc., 2018 WL 3586404 (D. Ariz. Jul. 26, 2018). To begin with, plaintiff voluntarily withdrew several claims – manufacturing defect, breach of express warranty, failure to recall, and breach of implied warranty. Id. at *2. Defendant did not move for summary judgment on negligent design defect, negligence per se, or punitive damages – so those claims remain. That left failure to warn, misrepresentation and fraud, and strict liability design defect. Of those, only strict liability design defect survived. Id.

The court first had to decide which state’s law applied. Plaintiff was living in Wisconsin when she had the IVC filter implanted but did not experience any complications until after moving to Nevada. Plaintiff argued that Nevada law should apply as the location where the injury occurred. The court disagreed. Wisconsin, the forum state, applies a two-step analysis for choice of law questions. First, are one state’s contacts so minimal that applying that state’s law would be “officious intermeddling.” Id. The court found both states to have significant contacts with the case and so moved on to step two. This consists of the analysis of 5 factors. The court found three factors (maintenance of interstate order, simplification of the judicial task, and application of the better rule of law) to be neutral. Id. at *3-4. And the remaining two favored Wisconsin. As to predictability, the IVC filter was sold in Wisconsin, implanted in Wisconsin, and defendant’s interactions with the implanting surgeon took place in Wisconsin. So, defendant could reasonably expect Wisconsin law to apply to any products liability claims arising from the use of the filter. Id. at *4. As to the forum state’s interest, Wisconsin “has a strong interest in having its laws applied to corporations transacting business with the state. Id.

 Wisconsin’s product liability statute provides a presumption that a product is not defective if it complied with relevant standards or specifications approved by a state or federal agency – such as the FDA. Defendant therefore argued that because the IVC filter was cleared by the FDA via the 510(k) process, the presumption applied. The court however, refused to apply the statutory compliance presumption because the 510(k) process is not a safety review and therefore defendant was not entitled to the non-defectiveness presumption. Id. at *6.

Another defense to strict liability claims in Wisconsin is that the harm was caused by a known and inherent risk. Defendants argued, citing to publications, FDA documents, and plaintiff’s surgeon’s testimony, that the very complication suffered by plaintiff was well known in the medical community. Id. at *7. Plaintiff countered that while the general risk may be known, the fact that defendant’s filters had a higher adverse event rate than other filters was not known. The court decided that any challenge as to incident rates is a triable issue of fact for the jury. Id.

Turning to plaintiff’s burden of proof, to maintain a claim for strict liability design or warning defect, plaintiff has to establish that the risk of harm could have been “reduced or avoided” with a “reasonable alternative design or warning.” Id.   In this case, plaintiff’s expert pointed to anchors that were added to other of the defendant’s IVC filters as a specific and available alternative design. Defendant argued that plaintiffs in the litigation claim that those other IVC filters also are defective. Essentially plaintiff relied on an allegedly defective design as the alternative to the allegedly defective design at issue. Id. That feels like it should be a non-starter. But the court said that the alternative design only has to “reduce” the risk of harm. Id. So, if the alternative is slightly less defective that appears to be enough. Again, a bit of a head scratcher.

Moving on to failure to warn, the court found plaintiff’s claim failed for lack of evidence of causation. The court skirted the issue of learned intermediary, on which the Wisconsin Supreme Court has not ruled, finding that plaintiff identified no evidence that either plaintiff or her surgeon would have changed his/her decision regarding implanting the device. Id. at *8-9. In fact, plaintiff’s surgeon testified that he didn’t recall which filter was used or who made the decision to use that filter. He further testified that he trusted the FDA, the device was meeting the expectations of the FDA, and he wouldn’t have deferred implanting the filter where it was medically necessary. Id. at *9. Put all together, there was nothing in the record to establish that a warning about greater risks would have affected either the surgeon’s or the plaintiff’s decision to use the product.

That same rationale carried over to plaintiff’s misrepresentation and fraud claims where reliance is an essential element. Plaintiff never received any independent information from the defendant nor did she point to any information from the defendant on which her surgeon relied. Id. at *10.

So, the case remains although substantially cutback. Just two quick observations from reading between and outside the lines of the opinion as to negligence per se, on which defendant did not move for summary judgment. First, if 510(k) clearance doesn’t involve “safety,” how can negligence per se apply? It would seem that following the court’s logic, the 510(k) process does not rise to the level of a substantive standard of care that can support plaintiff’s negligence per se claim. Second, back in March we reported on another partial summary judgment win in the Bard IVC Filter MDL. In that case, this same court granted summary judgment on negligence per se finding that the claim could not be based on alleged FDCA violations because there is no private right of action to enforce the Act. See prior post here. From an outsider’s perspective, it feels like negligence per se should be out of this case as well.

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

We truly dislike decisions that find that claims of failure to report adverse events to the FDA are non-preempted, parallel violation failure to warn claims. Failure to report claims are not parallel.  Federal law does not require warnings to plaintiff or her doctors.  State law does not require warnings to the FDA. In the absence of a state-law duty to make reports to a government agency, a failure to report claim is an improper private attempt to enforce the FDCA. It is a claim that should not survive either express or implied preemption.

But, some courts do allow it, such as Bull v. St. Jude Medical, Inc., 2018 WL 3397544 (E.D. Pa. Jul. 12, 2018). Now, we think the Bull court is overstating when it says “most courts” to have considered a failure to report claim have found it to be a parallel claim. We refer you to our PMA Preemption scorecard which clearly shows this is an issue on which courts are split. Nor is the reasoning of the opinion anything new. Defendant had a duty under state law to warn physicians and a duty under federal law to comply with adverse event reporting requirements and those two requirements aren’t in conflict with each other. Id. at *8. But just because two roads don’t intersect doesn’t mean they are parallel.

And, because Pennsylvania doesn’t recognize a state law failure to report claim, any such claim exists solely as a result of the FDCA and therefore should also be impliedly preempted. Again, having concluded there are parallel duties, Bull also concludes no implied preemption. The court found that plaintiff alleged a valid state law failure to warn claim that was based on a failure to comply with its federal duty to report adverse events to the FDA. Id. at *9.

We don’t like those conclusions, but it’s also not the first time we’ve seen them. Where we usually take solace is that more often than not a finding that a failure to report claim is not preempted is followed by a finding that it is also not adequately pleaded. We refer you back again to the PMA Preemption scorecard for the many, many decisions reaching that conclusion. The primary reason the claim fails TwIqbal – failure to sufficiently plead causation.

Unfortunately, the court in Bull gave plaintiff a pass on pleading physician-specific warning causation. The complaint “does not even allege that [plaintiff’s] doctors consulted the [FDA adverse event] database, or any other source of . . . adverse event reports, when making their treatment decisions.” Id. But the court found that unnecessary. Instead, all that was required was an allegation that prior to the implantation of the device in plaintiff, defendant failed to disclose adverse events that if disclosed may have led her doctor’s not to use the device. Id.

That shouldn’t be enough. Even Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc), which allowed a failure to report claim, acknowledged that causation is a particularly problematic hurdle for plaintiffs:

Because they predicate their claim on [defendant’s] reporting duty to the FDA, as they must to avoid express preemption, [plaintiffs] face a causation hurdle that would not otherwise exist.  To prevail, they will ultimately have to prove that if [defendant] had properly reported the adverse events to the FDA as required under federal law, that information would have reached [the prescribing] doctors in time to prevent [plaintiffs’] injuries.

Stengel, 704 F.3d at 1234-35 (concurring opinion). Therefore, the causal chain requires both that the FDA would do something differently (such as make the adverse events public), and that that hypothetical action by the FDA would have caused the prescriber, in turn, to change his/her prescribing decision in some way that would have prevented the claimed injuries. Plaintiff’s allegations in Bull, as set forth in the opinion, are much too vague to support a plausible causation claim.

And the analysis shouldn’t have stopped there. The opinion actually sets forth sufficient facts that were pleaded to support reaching just the opposite conclusion on causation.

First, would the FDA would have done something differently? Plaintiff had the device implanted in 2010 and began experiencing problems with it in 2015. Bull at *5. Per the facts alleged, in 2009 the FDA conducted an inspection of defendant’s manufacturing facility. Id. at *2. The report of that inspection included information about Medical Device Reports (MDRs) that were either untimely or not submitted to the FDA. Id. at *3. It also included an analysis of MDRs both at the company and within the FDA’s database. Id. at *2-3. So, what the facts establish is that the FDA became aware of these adverse events a year before plaintiff received the device and at no time prior to plaintiff’s surgery did the FDA require defendant to take any further action to warn physicians beyond the existing labeling and warnings. So there is no causal nexus between the alleged failure to report and plaintiff’s injury.

Moreover, to the extent plaintiff relies on a 2011 FDA Safety Officer Report and a 2012 483 Inspection, those took place after plaintiff was implanted with the device and if they involve allegedly unreported events after 2010 – they can have no bearing on causation. To establish causation plaintiff should be required to prove (and plead) that had the adverse events been properly reported to the FDA, the information would have reached plaintiff’s physician in time to prevent the alleged injuries.

Second, would plaintiff’s doctors have done something differently? Well, because the FDA didn’t take action the answer is there is nothing to trigger plaintiff’s doctors doing anything different either. But, there is also the added fact that in this case after the events were reported and the FDA did require some additional warnings and even after the FDA recalled the device – plaintiff’s doctors did not explant the device. Id. at *5. While we are only privy to what’s reported in the complaint, we think the second link in the causal chain is likely broken as well.

We have a hard time imagining this case getting beyond summary judgment on causation based on what we see as the regulatory history from the opinion. We’ve talked in greater detail about this causation hurdle in failure to report cases here. So, while defendant lost at this stage, we are optimistic about a win in the future.