Photo of Michelle Yeary

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

Last week when we posted about some motion in limine rulings coming out of the IVC Filters MDL, most of our blogging team were enjoying a calm week after being hit by two nasty Nor’easters. We were turning our thoughts to spring. Birds chirping, flowers blooming, sunshine and rainbows. Now a week later as we officially head into spring, bam. Here we go again. The predictions vary and it may only be a few more inches of snow, but March has pretty been all lion and we really hoping to see a little lamb in our future. Mother Nature has decided she’s not quite ready to let go of her grasp on winter. Much like the court in the IVC Filter MDL wasn’t quite ready to let go of the bellwether case Jones v. C.R. Bard, Inc, 2018 U.S. Dist. LEXIS 40020 (D. Ariz. Mar. 12, 2018).

At the heart of the Bard IVC Filters Litigation is an allegation that defendant’s filters have a higher comparative risk rate than other filters and that defendant failed to warn physicians about the higher risk. Id. at *319-20. In the context of this bellwether case set for trial in May, defendant moved for summary judgment on failure to warn, misrepresentation, negligence per se, and punitive damages and won on misrepresentation and negligence per se.

The court was applying Georgia law and therefore the learned intermediary doctrine. Id. at *322-23. Defendant’s first argument was that plaintiff lacked proof of proximate cause on her failure to warn claim because her surgeon testified that he did not read the Eclipse filter label. You all know this argument – even if the defendant had included the very warning plaintiff contends should have been made, it doesn’t matter if the physician wouldn’t have seen it. If the doctor’s testimony is clear, this should shut the door on failure to warn. The court here, however, found a way to prop that door back open by holding that a defendant can breach its duty to warn not only by having a deficient warning but also “by failing to adequately communicate the warning.” Id. at *324. The court looked beyond the label to “dear doctor letters, product pamphlets, and statements by company sales representatives.” Id. at *325. If this is an escape hatch for plaintiffs on failure to warn, then we have more questions for doctors at their depositions.

Defendant’s second argument on failure to warn causation was that the physician was already aware of the very risk which occurred in this case, device fracture – which was also a well-known risk in the medical community. Id. at *326-27. Plaintiff’s countered that the lack warning wasn’t about the general risks of filters but that this particular filter had a higher risk of complication than other filters. On this point, plaintiff’s surgeon testified that higher complication rates is something “he would have wanted to know” before plaintiff’s surgery. That was enough for the court to find a jury question as to prior surgeon knowledge. Id. at *328.

Taking these two rulings together serves to emphasize the critical importance of the physician’s deposition. This court wanted “unequivocal” evidence that the doctor would have made the same prescribing or surgical decision even in the face of different warning information. Id. at *328-29. Only such a response would have cutoff causation with regard to any avenue by which the defendant could have communicated warnings to the surgeon. It’s a risk to ask the ultimate question – would a different warning have mattered – but without it, the risk is a disputed fact issue for the jury.

The court turned next to the adequacy of the warning provided, which it was undisputed did contain a warning regarding fractures. But as noted above, did not contain information about the comparative risk rates for this filter as against other filters. Id. at *330-31. We had the same gut reaction that defendant in this case appears to have had – 1) how can you possibly provide reliable information comparing risks among products and 2) is this even allowed by the FDA. Id. at *334. It’s not for prescription drugs. See 21 C.F.R. §201.57(c)(7)(iii) (“For drug products . . . any claim comparing the drug . . .with other drugs in terms of frequency, severity, or character of adverse reactions must be based on adequate and well-controlled studies.”). But the same logic should apply. Unless the adverse reactions or complications being discussed have been studied side-by-side to account for variables and assorted other unknowns, the comparison is meaningless and potentially more harmful than helpful. It’s one thing to suggest that the label warning of the risk of fractures was insufficient given the state of knowledge defendant had or should have had at the time, but finding that a defendant could be liable for breaching its duty to warn for failing to provide comparative risk rates that are unverified, unapproved, and inherently unreliable puts a defendant in a really precarious position. Don’t include and face tort liability; include a face FDA violations for misbranding and misleading information.

Moving on to the two claims that were dismissed – misrepresentation and negligence per se. The court found that Georgia does not recognize an independent claim for misrepresentation in a products liability case. It is subsumed in failure to warn. Id. at *336-37. Similarly, plaintiffs could not maintain a negligence per se claim based on alleged FDCA violations because there is no private right of action to enforce the Act. The court’s preemption analysis is emphatic and strongly reasoned. Id. at *338-40. Plaintiff’s attempt to sidetrack the court with talk of the difference between PMA and 510(k) devices falls on deaf ears, as it should when talking about Buckman implied preemption. Id. at *340-41. As did plaintiff’s attempt to argue that Georgia allows negligence per se claims based on laws that do not create a private right of action. The difference between those laws and the FDCA is “the plain language of §337(a) and the Buckman decision indicate that, where the FDCA is concerned, such [a] claim fails.” Id. at *341.

Finally, the court also allowed plaintiff to keep her punitive damages claim based on a design claim that was not otherwise part of the motion. The discussion focuses on the state of the evidence regarding what defendant knew and when and what actions it took regarding the design of the device at issue. It is fairly case specific and so we won’t delve into the details here.

Not a banner decision and frankly it raises more questions than it answers about warnings based on comparative risk rates. Hmm, perhaps a deeper dive and a subsequent post is in order. Something for the next snowy day.


Today’s case isn’t about prescription drugs, but rather illegal drugs. More specifically, whether a user of illegal drugs can recover in a civil action against someone who failed to prevent the user from obtaining the drugs. While this is outside our usual field of focus, we have posted about the in pari delicto doctrine before and believe the decision could be analogously useful to drug companies in at least some types of opioid litigation and therefore worthy of notice.

You won’t find that fancy Latin phrase in Hollywood v. Superior Court, 2018 Cal. App. LEXIS 190 (Cal. App. Ct. Mar. 8, 2018), but that is what the case is about. Plaintiff voluntarily checked himself in to a rehabilitation facility and then proceeded to smuggle in heroin and overdose. Id. at *2-3. He then brought a negligence action against the rehab facility alleging it failed to take reasonable steps to make sure residents could not get illegal drugs. Id. at *3-4. So the question is whether plaintiff’s own misconduct bars his right to recovery in tort for his injuries – in pari delicto or “wrongful conduct” rule. The case also discusses whether the claim is barred on statutory grounds.

The court examined defendant’s statutory defense first. The statute at issue is the Drug Dealer Liability Act (DDLA) which is based on the Model Drug Dealers Liability Act which has been adopted in some version in more than 20 states. Id. at *8. The primary goal of the DDLA is to provide a civil remedy for damages to those who are injured as the result of someone else’s use of illegal drugs – parents, employers, insurers. Id. at *9. Such parties are entitled to both economic and non-economic damages and can recover from both the person who actually sold the illegal drugs to the user and anyone “who knowingly participated in the marketing of illegal controlled substances.” Id. at *12. In other words, the DDLA imposes a broad market share liability “in order to deter drug traffickers with potentially high civil damages awards.” Id. at *11.

The DDLA also allows an illegal drug user to bring a more limited claim, if certain conditions regarding cooperation with law enforcement and non-use of illegal drugs are met. The claim can be brought only against the direct supplier/manufacturer/importer of the actual drugs used and only economic damages can be recovered. Id. at *12-13. The DDLA goes on to state: “An individual user of an illegal controlled substance may not bring an action for damages caused by the use of an illegal controlled substance, except as otherwise provided in this section.” Id. at *13. In Hollywood, the rehab facility argued that that sentence precluded plaintiff from bringing his negligence claim against it as it was not the supplier of the drugs that caused his injury. Now all of this should sound like preemption to our DDL blog readers, but because we are talking about co-equal state law (state statute and state common law), the question is framed as whether the enactment of the statute displaced the existing common law. Id. at *8n.7. And yes, California’s general rule is a presumption against displacement. Id. at *15-16.

First, in construing the sentence limiting the claims a drug user can bring, the court noted that the DDLA defines “individual user” as “the individual whose use of a specified illegal controlled substance is the basis for an action under this division.” Id. at *15. Therefore, the DDLA did not need to repeat “under this division” when talking about the claims an individual user could bring because it was already limited by definition to claims under the act. Id. Second, the court found no legislative intent to “supplant common law” as to the circumstances of when a drug user could pursue claims against a third-party. Since the primary goal of the DDLA was to expand the class of potentially liable parties, the court was unwilling to interpret the act to restrict or bar other common law remedies.

Application of that common law to plaintiff’s claim, however, found it was lacking any legal support. In its analysis of the “wrongful conduct” doctrine, the court examined the development of the law in relation to liability for furnishing alcohol. After some back and forth in the courts, the California legislature enacted a statute to limit the liability of those who serve alcohol finding the consumption of alcohol should be the proximate cause of injuries to the intoxicated person or injuries caused be the intoxicated person, with exceptions for serving minors. Id. at *19-21. Similar laws exist protecting hosts who furnish alcohol. Id. at *22. Some plaintiffs have argued that because these laws confer immunity on those who serve/furnish alcohol, “persons less directly responsible for the intoxicated state of another may be liable under nonstatutory theories.” Id. We had to quote it because we couldn’t think of another way to state such a ridiculous concept. Fortunately, California courts have found it just as ridiculous. In this case, the court concluded that the rehab facility took reasonable steps such as a search upon arrival and periodic room checks to prevent residents from using illegal drugs. It was not required to take extraordinary measures. Such a claim is not supported under the law, nor would public policy favor burdening the very facilities who are trying to help addicts with potential liability for “their residents’ foreseeable but unpreventable predilection to obtain and ingest drugs.” Id. at *28.

The Hollywood court could not find a single case “suggesting that liability could be predicated on the mere failure to undertake affirmative efforts to stop the user from ingesting drugs.” Id. at *25. In other words, there is no viable “general failure to thwart drug use” claim.  Id.  The same logic should apply to claims against manufacturers of prescription opioid drugs for failure to monitor distributors and retail sellers.

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.


[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.

We don’t often get to discuss decisions from Maine. In fact, a quick spin through the blog and you’ll see Maine really only comes up in various canvases or surveys of state law. We don’t dislike the state. We love the lobster — that they take very seriously. We can’t say we love the winters there (at least this blogger doesn’t), but the coastline is beautiful in summer. And perhaps our vision of Maine is just ever so slightly skewed by Stephen King having set so many of his horror novels there. While King’s frightening tales are set in fictional towns, avid readers and explorers have suggested that you can visit several real places in Maine that seem to have inspired King’s work. For instance, if you’re looking for Derry, you want to stop in Dexter, Maine (mind the sewers). If you are more of a Cujo or Needful Things fan, Castle Rock is supposedly based on Woodstock, ME. You won’t find a giant dome in Rumford, but you’ll probably notice its otherwise close resemblance to Chester’s Mill (Under the Dome). And finally, there is King’s hometown of Bangor which is rumored to be the inspiration for the town of Haven from The Tommyknockers.

So, we were quite pleased when Dustin Rawlin and Bill Berglund of Tucker Ellis sent us their recent, far from creepy, win from the 23rd state. The case is Novak v. Mentor Worldwide LLC, 2018 WL 893914 (D. Maine Feb. 14, 2018) and the primary issue is statute of limitations. Statute of limitations cases are also not something we spend too much time on here, but this one has a notable ruling specific to prescription medical products liability cases – the discovery rule does not apply.

In 2004, plaintiff underwent surgery during which defendant’s product, a vaginal sling, was implanted to treat stress urinary incontinence. Id. at *1. Around 8 months to 1 year after the surgery, plaintiff started to experience pain during intercourse and by the end of 2006 was experiencing vaginal leaking and bleeding. Id. at *2. Before the end of 2006, plaintiff informed her surgeon of her problems. He ordered tests, the first round of which were inconclusive and plaintiff failed to undergo furthering testing. Id. In 2013, plaintiff attributed her problems to defendant’s product which was partially removed in another surgery in 2014. Id. Plaintiff filed suit in 2016. Id. at *1.

Maine’s statute of limitations for all civil actions is 6 years from when the cause of action accrues. Id. at *3. Further, Maine follows the date-of-injury rule when it comes to accrual. “[M]ere ignorance of a cause of action does not prevent the statute of limitations from running.” Id. In other words, generally Maine does not apply the “discovery rule” to determine when the statute starts to run (in states that do, a claim does not accrue until the plaintiff discovers or should have discovered the wrongdoing or misconduct). There are, however, exceptions where Maine has expressly applied the discovery rule: legal malpractice, foreign object and negligent diagnosis medical malpractice; and asbestosis. Id. General products liability claims not included.

Maine has also acknowledged the continuing tort doctrine where the alleged tort occurs over a series or chain of incidents. In such cases, the claim would not accrue until the last act in the chain – such as cases of pollution or contamination. Id. at *4. The continuing tort doctrine does not apply in cases where plaintiff’s alleged injuries, while occurring or perhaps worsening over time, are allegedly caused by a single act of negligence. Id.

Because plaintiff filed suit in 2016, her claims are time-barred if they accrued before 2010. As we noted above, her surgery was in 2004 and her complications appear to have started within the first year thereafter. So, unless the court applied the discovery rule, her claims would be barred.

Plaintiff’s first argument was that the presence of the defendant’s medical device in her body constituted a continuing tort that didn’t end until the product was removed in 2014. Id. at *5. But the continuing tort doctrine isn’t about continuing harm. What plaintiff here, or in almost any drug or device products liability case is alleging is a “finite act or set of acts (manufacture, design, inadequate warning, or misrepresentation) that led to her injuries.” Id. Once the device was implanted, the alleged wrongful act was over.

[Plaintiff] underwent only one, readily-identifiable exposure to the [device] (her surgery), and all of [defendant’s] allegedly tortious conduct took place before that point. . . . [defendant’s] wrongful conduct may have caused the [device] to deteriorate, which in turn may have caused injuries over time. However, once those injuries had manifested, the fact that their full scope remained unknown did not stop the statute of limitations from running.

Id. at *9, n.6.

Plaintiff’s second argument was that there was a genuine dispute regarding whether her earlier symptoms, pre-2006, were caused by the defendant’s medical device. Perhaps plaintiff should have thought of that argument before submitting an expert report tying those early symptoms to the medical device. Id. at *6. Nor could plaintiff rely on her surgeon not identifying a connection between the device and her symptoms when his tests were only inconclusive and plaintiff opted not to do further testing. Id. For a jury to conclude that plaintiff’s early injuries were not caused by defendant’s product would require “complete speculation.” Id. The statute started to run when plaintiff first experienced symptoms, regardless of how minor those symptoms were. Id. at *9, n.7.

While the statute of limitations did away with almost all of plaintiff’s claims, her fraud based claims remained. On those, as well as any other claim based on a failure to warn, defendant argued plaintiff failed to meet her burden to prove causation – plaintiff had no evidence that a different warning or information would have changed her surgeon’s decision to implant the device. Id. at *7. First, it is noteworthy that the court applied the learned intermediary doctrine. Id. at *8. Maine’s high court has never discussed the rule. The court relied on other federal courts interpreting Maine law on the issue.

So, applying the learned intermediary, the court’s focus correctly shifted to plaintiff’s surgeon. Plaintiff did not dispute that her doctor was aware of various risks, including those experienced by plaintiff. Id. Instead, plaintiff’s tried to meet their causation burden by arguing that the doctor “may very well have decided” not to implant the device if he had been provided different warnings. Id. But, that is either an unsupported fact or mere speculation and neither are evidence. Id. Plaintiff next showed the court some medical literature concerning the risks of the medical device and the doctor’s deposition transcript. But offered no connection between the two.

[The doctor’s] deposition transcript reflects that [plaintiff’s] counsel failed to ask him whether additional information would have altered his decision to go ahead with [plaintiff’s medical device] surgery.

Id. at *9. While not discussed directly in the opinion, requiring affirmative evidence that the doctor would have changed his use of the product for plaintiff to survive summary judgment is certainly an implicit rejection of the heeding presumption. Nor was it defendant’s obligation to ask these questions at the doctor’s deposition. Id. at *9, n.14.

So, while Maine may more quickly bring to mind images of butter poached crustaceans or mysterious floating red balloons, it’s not a bad place for prescription medical products cases either.

This should not be controversial. It has been settled since Hahn v. Richter, 673 A.2d 888 (Pa. 1996) that in Pennsylvania prescription drugs are exempt from strict liability. And since Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014) re-worked Pennsylvania’s strict liability law, we’ve only reported one federal court decision that erroneously, in our opinion, concluded that Tincher allowed a strict liability manufacturing defect claim in a prescription medical device case. But that hasn’t stopped plaintiffs from continuing to try to pursue strict liability under Pennsylvania law. The most recent federal court to be confronted with the argument rejected it outright. Some TwIqbal and preemption are in the mix too so this one really hits on some of our favorites.

Plaintiff alleged he developed an acute kidney injury as a result of taking the prescription drug Jardiance. Bell v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 U.S. Dist. LEXIS 24802, *1 (W.D. Pa. Feb. 15, 2018). Defendants moved to dismiss the complaint on three grounds: 1) Pennsylvania law bars all non-negligence based claims; 2) the complaint fails to satisfy TwIqbal across the board; and 3) the claims against the non-NDA holding entity are preempted. Id. at *2-3.

Defendants’ first argument sought to dismiss not only strict liability design defect and failure to warn, but also gross negligence, breach of express and implied warranty, and all fraud and misrepresentation claims. Plaintiff’s response on strict liability was that Hahn is “antiquated.” Id. at *7. Hahn may be about to turn 22, but that means it’s only been legally drinking in bars for a year. Hardly over the hill. Not to mention, antiquated isn’t a legal standard that would allow a federal court to simply ignore the controlling law as announced by a state Supreme Court. Further, the court points out that Tincher expressly recognized the Hahn prescription drug exception (as did Lance v Wyeth, 85 A.3d 434 (Pa. 2014) which demonstrates that the Pennsylvania Supreme Court has not changed its position – Hahn is still good law. See Bell at *7-8.

But Hahn doesn’t just say no strict liability, it says “that negligence is the ‘only’ recognized basis of liability” in prescription drug cases. Id. at *8. So, on that basis, and ample federal precedent, the court dismissed plaintiff’s breach of warranty claims. Id. at *8-9. The case law applying Hahn to fraud and misrepresentation claims appears to be more divided and on this one the court opted to follow the cases that adopted a more narrow interpretation. Id. at *9-10. We think Hahn’s negligence only holding could easily be read as a bar to intentional misrepresentation and fraud which do not sound in negligence. The Bell court, however, concluded that because Hahn requires manufacturers to warn of both risks that should have been known as well as risks that were known, the latter is akin to a claim of intentional concealment of a known risk which would support a fraud or misrepresentation claim. So, those claims were not barred by Hahn.

The last challenge was to plaintiff’s gross negligence claim which the court dismissed as not recognized as an independent cause of action in Pennsylvania. Id. at *11.

But we need to quickly return to plaintiff’s surviving negligence and fraud/misrepresentation claims. They aren’t barred, but neither were they adequately pleaded. Apparently plaintiff’s counsel did not do a good job proofing the complaint because the court pointed out it appeared to be cut and paste from another complaint filed by a woman. Id. at *13 (complaint uses “her” and “she” pronouns). Cookie cutter complaints don’t survive under TwIqbal because they lack any of the necessary factual detail to support plaintiff’s claims. This complaint contained

no factual details about when Bell contracted diabetes, whether he has type I or type II diabetes, whether he has other medical conditions, who his treating physicians were, why he decided to take Jardiance, what alternatives to Jardiance were discussed, whether he read the warnings, how long he took Jardiance or at what dose or why he believes his acute renal failure was caused by Jardiance.

Id. The complaint was equally lacking regarding defendants. There were no specific allegations concerning how the warnings “fell below the standard of care,” how any defendant’s alleged breach of duty caused plaintiff’s injury, how the design was defective, or what safer alternatives existed. Id. at *13-14. The court was unwilling to “infer defectiveness” based only on “a generic description of how [the class of drugs] work[s]” and “formulaic legal conclusions.” Id. at *15.

All claims were dismissed under TwIqbal, but plaintiff only gets to amend his complaint to try to state a claim for those that survived the first part of the court’s analysis as recognized under state law.

So, that brings us to the final question – are the claims against the non-NDA holder preempted on the grounds that it had no ability to change the drug’s label or design. The plaintiff seemingly concedes that post-approval design defect claims would be preempted, but that he is making a claim that the defendant should have designed a safer product before approval. Id. at *17-18. The court briefly discussed some cases that have dealt with the issue of pre-approval design defect claims. We cover it here, along with our analysis that there is no such valid claim. But, because none of plaintiff’s claims survived TwIqbal, the court didn’t have to decide the preemption issue. Defendant can re-raise it after plaintiff files his amended complaint.


Aren’t we all guilty of having that drawer, that shelf, that cabinet, maybe even a whole closet where things just get dumped. And as new stuff gets dumped, the old stuff gets pushed to the back. Then one day the space simply can’t hold anymore and you reach to the back to see just what’s there. What do you find? Old empty checkbooks. Gift card to a restaurant that closed two years ago. Any variety of expired items from coupons to salad dressing to cough medicine. And of course that half-eaten bag of cookies that are so stale you can use them as coasters. But, sometimes you also find a hidden gem. Like the cord to charge your radio that you haven’t been able to use for the last 6 months. Or the great family photo from Aunt Susie’s 80th birthday. Or your favorite pair of socks. How did they get there?

Well cases, just like socks and salad dressing, can get pushed to the back of the shelf – where they too get stale. And if courts still used paper dockets, the file in Beswick v. Sun Pharmaceutical Industries, Ltd., 2018 U.S. Dist. LEXIS 15012 (W.D.N.Y. Jan. 30, 2018) would be covered in an inch of dust with discolored pages stuck together from sitting at the bottom of a pile in a basement storeroom. The decision rendered just last week is on a motion that was filed in June 2012 on the basis of the Supreme Court’s ruling in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011). A 5 ½ year old motion based on a 6 ½ year old ruling. Fortunately, the decision is to dismiss the case, but it’s a decision that could have been entered a long time ago. We imagine the delay has not been without some financial consequences to the defendant. Indeed, plaintiff’s counsel withdrew back in 2015, likely recognizing the folly of pursuing what is essentially a failure to warn case against a generic drug manufacturer. But still the case sat.

The complaint, alleging plaintiff suffered from Stevens Johnson Syndrome as a result of using defendant’s generic anticonvulsant drug to treat his epilepsy, was filed in 2010. Id. at *1, *4-5. In early 2011, the court granted defendant’s motion to dismiss all claims except those alleging breach of express and implied warranty. Id. at *2. The case was then stayed pending the Supreme Court’s decision in Mensing. Id. A year after Mensing, defendant file a motion for judgement on the pleadings on the two remaining claims and the motion was fully briefed by August 2012. Defendant then filed supplemental declarations in support of its motion in November 2012 and again in August 2013. In 2015, defendant formally requested that the stay be lifted and filed yet another supplemental declaration in support of its motion. Id. at *3-4. The supplements we assume necessitated by the development of the law over the years the motion was pending. And finally, three years later the motion was ruled on.

It should come as little surprise that the warranty claims, premised on a failure to warn, were found to be preempted.  Plaintiff alleged that defendant breached its express warranty that the drug was safe and effective by failing to disclose known risks of side effects including SJS. Id. at *6-7. Plaintiff similarly alleged that defendant breached the implied warranties of merchantability and fitness for the drug’s intended use by failing to warn about the drug’s side effects and risks. Id. at *7-8.

The court then analyzed both claims in light of Mensing and Bartlett (5 years old itself) which we know held that because generic drug manufacturers are prohibited from making any unilateral change to the drug’s label, federal law “preempts any duty the generic drug manufacturer otherwise would have under state law to provide additional warnings.” Id. at *18. Therefore, because plaintiff’s warranty claims are essentially “state law tort claims attacking a drug label warning as insufficient” they are preempted. Regardless of the theory, if the claim is premised on a failure to warn, it is preempted. See id. at *22.

Plaintiff attempted to advance two arguments to avoid preemption. First, plaintiff argued that defendant didn’t have to change its label but rather could have sent out Dear Doctor letters containing additional warnings. The Supreme Court deferred to the FDA that such letters would be misleading because they would imply a “therapeutic difference” between the brand and generic drugs. Id. Second, plaintiff argued that defendant should have pulled the drug off the market. This too has been rejected by the Supreme Court. When faced with a conflict between federal and state law, the manufacturer is not obligated to stop selling. If that were the case, “impossibility preemption would be all but meaningless.” Id. at *23 (citing Mensing).

There is nothing new or novel about the court’s decision other than the amount of time it took to be entered. The case simply hung around for way too long and could have been disposed of five years ago. Like the receipt for the gloves you bought your mom for Christmas 2014.

Jurisdiction is hardly the spiciest of topics we discuss on this blog and yet it definitely qualifies for frequent-blogging status. That’s likely because as defendants, we don’t get first choice of jurisdiction. We get hauled into the court of plaintiff’s preference after which we are afforded some ability to change jurisdiction but that often requires putting up a fight – such as challenging fraudulent joinder or misjoinder. So, jurisdiction becomes a recurring theme. An undertaking at the start of each new case. Do I want to be in this court? If not, do I have a viable alternative?

Those questions predominately involve whether the federal courts have some basis for subject matter jurisdiction. Today’s case, while about jurisdiction, is about a type we rarely, if ever, have discussed here or have much experience with – the boundaries of tribal court jurisdiction. And while the case involves pharmacies and wholesalers, the court’s rationale for its decision would apply to other non-tribal entities sued on similar theories, such as drug and device manufacturers.

In McKesson Corp. v. Hembree, 2018 WL 340042 at *2 (N.D. Okla. Jan. 9, 2018), three pharmacies and three wholesalers who had been sued by the Cherokee Nation in the District Court for the Cherokee Nation filed for a petition for a preliminary injunction to halt the underlying action on the ground that the Cherokee Nation lacked jurisdiction. There are two components to the underlying lawsuit. First, the Cherokee Nation brought a parens patriae action on behalf of tribal members for violations of the Cherokee Nation Unfair and Deceptive Trade Practices Act (“CNUDPA”). Id. at *1-2. Second, the Cherokee Nation also asserted common law claims for nuisance, negligence, unjust enrichment, and civil conspiracy. Id. at *2. All of the claims are based on allegations that the pharmacies and wholesalers either knowingly or negligently distributed or dispensed prescription opioid drugs to the detriment of the tribe and its members. Id.

The defendants sought the injunction in federal court because the scope of a tribal court’s jurisdiction is a federal question. Id. at *3. The opinion contains a discussion of whether defendants were required to seek relief from the tribal court first and also examines whether defendants met the requirements for a preliminary injunction. We won’t address those aspects of the decision here, but wanted you to know they existed if you are interested. We focus on the substance of the ruling that the tribal court did not have jurisdiction.

Indian tribes in the United States have a recognized type of self-government but it is limited to “managing tribal land, protecting tribal self-government, and controlling internal relations.” Id. (citation omitted). The exercise of trial power is limited and tribal courts are not courts of general jurisdiction. One major limitation is that tribal jurisdiction does not extend to nonmembers of the tribe, with two narrow exceptions:

[a] tribe may regulate, through taxation, licensing, or other means, the activities of nonmembers who enter consensual relationships with the tribe or its members, through commercial dealings, contracts, leases, or other arrangements. [And]

[a] tribe may also retain inherent power to exercise civil authority over the conduct of non-Indians on fee lands within its reservation when that conduct threatens or has some direct effect on the political integrity, the economic security, or the health or welfare of the tribe.

Id.  Essentially there is a “presumption against tribal civil jurisdiction over non-Indians.” Id. at *4.  In this legal framework, the court analyzed whether the Cherokee Nation had jurisdiction over the two types of claims brought by plaintiff – CNUDPA and common law.

In its complaint, the Cherokee Nation alleged that the pharmacies and wholesalers violated the CNUDPA by violating the federal Controlled Substances Act (“CSA”). The CSA, however, like the FDCA, does not provide a private right of action. Id. at *5. So, we would say the claim is facially invalid regardless of jurisdiction. But that wasn’t the question the before the court and regardless of whether the claim was valid, the tribal court had no jurisdiction over a CSA claim, because there is no provision in the CSA that provides a tribal court jurisdiction over such a claim. Id. Remember, tribal courts are not courts of general jurisdiction. So, for example, the CSA differs from federal statutes the specifically allow tribal court jurisdiction over matters such as child custody disputes and mortgage foreclosure actions. Without such a provision, the court found that the tribe lacked jurisdiction over the CNUDPA claim because it was an unauthorized attempt to privately enforce the CSA. Id.

As to the common law claims, because they were being brought against non-tribe members, the court looked to see if they fit one of the two exceptions to the rule prohibiting such jurisdiction. The first exception is based on consensual relations which the Cherokee Nation said the pharmacies and wholesalers entered in with the tribe and its members by distributing products within the tribe’s jurisdictional area. But the exception is not so broad as to allow jurisdiction for any dealings with non-members:

Because nonmembers have no say in the laws and regulations that govern tribal territory[,] … those laws and regulations may be fairly imposed on nonmembers only if the nonmember has consented, either expressly or by his actions. Even then, the regulation must stem from the tribe’s inherent sovereign authority to set conditions on entry, preserve tribal self-government, or control internal relations.

Id. at *6 (citation omitted). The opinion details the extent, or lack thereof, of the relationship between the defendants and the Cherokee Nation, concluding that “at most, any relationships between Plaintiffs and the Cherokee Nation or its members are simply routine business or consumer transactions.” Id. (“the mere act of doing business with a tribe or its members even on tribal land, does not subject a nonmember to broad tribal civil authority”). Given that drug and device manufacturers are even more removed from direct dealings with individuals and health care plans, they would have an even more attenuated relationship that should not fit within this exception.

This first exception typically applies to a tribe’s right to tax or regulate business activities of nonmembers on tribal lands, not to claims of negligence or unjust enrichment. The pharmacies and wholesalers did not have contractual relationships with the Cherokee Nation relating to opioids and their conduct was not specifically directed at the Cherokee Nation or its members. Finally, there is no nexus between the allegations of the complaint and the Cherokee Nation’s sovereign authority over conditions on entry, self-government, or control of internal relations. Id. at *7.

The second exception has to do with conduct that threatens or directly impacts “the right of reservation Indians to make their own laws and be ruled by them.” Id. The Cherokee Nation offered declarations attesting to the harm done to tribe members from the opioid epidemic arguing that the conduct alleged in the complaint rises to a “mass tort.” Id. The court was sympathetic, as we all are, to the damage being done by opioid abuse. “However, a generalized threat of injury to the tribe or to its members for tortious conduct is not enough to confer tribal jurisdiction.” Id. at *8. The threat which invokes the exception is a threat to “tribal sovereignty.” Therefore, even if the conduct occurred on tribal lands, it does not constitute a threat to the tribe as a whole and the second exception does not apply.

With no applicable exception, the court granted the preliminary injunction to prevent the case against the pharmacies and wholesalers from moving forward. This is a completely legal analysis, with broad applicability in any alleged “mass tort.” Therefore, another significant jurisdictional victory for defendants.

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.

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

Be specific. Be focused. Be detailed. All good things to keep in mind when requesting just about anything, including relief from a court. That is what today’s decision got us thinking about. It’s a Daubert ruling from the Bard IVC Filters MDL and it’s a bit of a mixed bag. In re Bard IVC Filters Prods. Liab. Litig., 2017 U.S. Dist. LEXIS 211400 (D. Ariz. Dec. 22, 2017). What caught our attention the most, however, was the number of times the court reflected that the specific opinions or documents he was being asked to rule on were not specified. We are NOT taking issue with how defendants handled the motion. First, we don’t know enough. Second, the requests may have been broadly presented because the expert reports were simply that deficient or that improper. We just thought it worth pointing out that the court seemed to have some difficulty making definitive rulings citing a lack of specificity in the request. It’s not that unusual for courts to defer some rulings for trial wanting context to support the decision. What we don’t want is for the lack of ruling to be due to a lack of detail that could have been provided (again, not saying that is what happened here).

We often struggle with the proper level of detail to provide a court. Too much can be overwhelming; too little and you haven’t made your case. Too narrow and specific of a request risks an overly narrow or specific ruling and perhaps missing something altogether.  We don’t have a magic formula that solves this problem. So, we offer our observation and reflection and with that move onto the substance of the ruling.

Defendants in the Bard IVC Filter MDL challenged four categories of opinions offered by plaintiffs’ interventional radiologist experts which the court ruled on as follows:

Reliance on Other Experts’ Reports: While addressed in the opinion as a fairly broad request, we gather this had a lot to do with medical experts parroting the conclusions of plaintiffs’ regulatory expert Dr. David Kessler. See In re Bard IVC Filters, 2017 U.S. Dist. LEXIS 211400 at *280-82. It appears Dr. Kessler’s report discussed a litany of internal company documents – the types of documents an interventional radiologist would never see or be asked to interpret. But citing cases that allow experts to rely on other expert’s conclusions, the court denied defendant’s motion to exclude on this basis. While the Federal Rules are liberal regarding what an expert can rely on, including things like business records, we posit that the appropriate limitation on that be things that are within the expert’s area of expertise. Simply because another expert relies on the documents doesn’t make them something germane to or within the expertise of another expert.

Summaries and Editorials of Deposition Testimony and Company Documents: Defendants asked the court to prohibit this type of testimony by plaintiffs’ experts, but the court found it couldn’t rule on the issue because no specific testimony was identified that should be excluded. Id. at *283-84. So, the court instead offered an advisory opinion stating that experts “will not be permitted to engage in lengthy factual narratives that are not necessary to the jury’s understanding of their opinions, nor will they be permitted to gratuitously comment on factual evidence or present what are essentially lawyer arguments with regard to factual testimony.” Id. at *284.

Reasonable Physician Opinions: Plaintiffs sought to offer testimony from their experts both on what a reasonable physician expects to be told about risks and what a reasonable physician would do upon receipt of that information. Defendants challenged these opinions as not tested or peer reviewed, not published, and not generally accepted in the medical community. Id. at *285. But the court determined that was the wrong analysis. Rather, plaintiff’s experts are relying on personal knowledge and experience which can be an acceptable basis for certain types of opinions, such as professional medical opinions. Id. at *286. Because the experts are practicing radiologists, what type of information a physician expects to receive about a product is within their knowledge and therefore, the court concluded was permissible expert testimony. Id. at *289. However, what a reasonable expert would do in response to receiving certain risk information is “more problematic.” Id. at *289-90.

Whether and when to use a particular product appears to be a more fact- and patient-specific decision, not amenable to broad generalizations. The propriety of testimony on this subject will depend heavily on the context and relevancy of the question. The Court will need to draw these lines during trial.

Id. at *290.

Engineering and Testing Opinions: Certainly these are topics outside the expertise of clinical physicians. For the most part, the court agreed. The court exclude testimony on straightforward technical issues. Id. at *292. But was unwilling to say that some technical matters wouldn’t be within the doctor’s expertise – technical issues that they are familiar with based on their experience “implanting, monitoring, and removing IVC filters.” Id. at *293. Unfortunately, the court found it couldn’t be more specific before trial.

Although not much was excluded pre-trial, the forecasting on how the court would rule and limit plaintiffs’ experts at trial is mostly favorable. While the court seems to have wanted more details about the opinions defendants wanted to exclude, it’s hard to know if that would have made any difference. More details may just have meant more complexities that couldn’t be resolved pretrial. So, the devil is certainly in the details and there is simply no way of knowing what the devil might lead to.

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

When we say Nebraska, what comes to mind? Cornhusker football? Warren Buffet, the Wizard of Omaha? Buffalo Bill’s Wild West Show? Mutual of Omaha’s Wild Kingdom? An amazingly haunting album by Bruce Springsteen? As the Jersey Girl blogger on this site, it should be no surprise that those ten songs go right to the top of the list. And, if you too are a true fan you’ll already know that Nebraska is actually mostly demos that Springsteen recorded as an experiment on a four-track cassette recorder. When the songs were tried later with the full power of the E Street Band behind them – most of them didn’t work. Born in the USA, Downbound Train, Pink Cadillac, and Working on the Highway found a home on later albums. But for songs like Atlantic City, Highway Patrolman, and My Father’s House – a guitar and a harmonic sold those songs more than a heavy back beat. Nebraska isn’t Springsteen’s only stripped-down album (The Ghost of Tom Joad and Devils & Dust), but for this Jersey Girl, it’s the one with the power. And it was recorded in a New Jersey bedroom one day in January 1982.

Nowhere in any of that did we connect Nebraska to preemption. That is until now. Until Ideus v. Teva Pharmaceuticals USA, Inc., 2017 WL 6389630 (D. Neb. Dec. 12, 2017). Based on our review, and please correct us if we’ve missed something, this is the first case to find a complaint was deficient for failure to plead any facts to establish why the warning claim involved “newly acquired evidence” that would allow it to escape preemption under Wyeth v. Levine, 555 U.S. 555 (2009).

Plaintiff alleged that defendant failed to warn about the risks of an intrauterine device. While the device was being removed, a piece of it broke off and embedded in plaintiff’s uterus. The broken piece later had to be surgically removed. Ideus, at *1. To support her claim, plaintiff alleged that the device’s brochure and package insert, lacked any warning that the device “could break during removal, or that smaller pieces of the device (as opposed to the device as a whole) could separate and become embedded.” Id. A quick aside. This distinction between the device as a whole and a piece of the device made us look at the device’s label. As a disclaimer, we simply looked at the available label on line, but it appears that product contains a warning that the device can become embedded and require surgery to remove. So, in essence, plaintiff’s claim is that while the manufacturer did warn of embedding and surgery as to the whole device, it didn’t warn about those things with a piece of the device. And plaintiff’s other claim is that the manufacturer didn’t warn the device could break. From our perspective, that’s a claim for something that was warned about and something that is a general risk of every product in the world. We don’t think much of plaintiff’s claims.

But we told you this was about preemption, so let’s get back to that. Defendant challenged plaintiff’s claims on the grounds of preemption. The warnings were FDA approved and therefore, plaintiff’s claims don’t survive conflict preemption. Id. As non-surprising as a Jersey Girl loving Springsteen, is a plaintiff raising the FDA’s Changes Being Effected (“CBE”) regulations in response to a failure to warn preemption challenge. Because CBE regulations allow a manufacturer to change the device’s warning without prior FDA approval, per Wyeth, it is possible for a manufacturer to change its warning and not run afoul of federal law. Hence, no preemption. But, what the court said in Ideus is that CBE isn’t a “magic” word that gets plaintiff around preemption even at the pleadings stage. More is required.

A CBE is only allowed based upon “newly acquired information,” not previously submitted to the FDA. “In the absence of such information, the [manufacturer] cannot alter its product’s labeling, and any state regulation or law requiring it to do so is necessarily preempted.” Id. at *2. The court in Ideus, therefore concluded that because “newly acquired information” is a pre-requisite for a valid CBE, facts to support the existence of such new information must be affirmatively pleaded in the complaint. The court cites three cases in support of its finding. We’ve discussed all three on this blog here, here, and here. The difference between those cases and Ideus is that in the prior cases the plaintiff had alleged some facts regarding “new” evidence. The courts were able to examine those allegations and reach conclusions regarding whether they demonstrated new information sufficient to support a CBE. They did not address the specific question of “whether the plaintiff must affirmatively plead the existence of “newly acquired information” to state a cognizable claim for relief.” Id. The closest earlier case was Utts v. BMS, 251 F.Supp.3d 644, 661 (S.D.N.Y 2017) which said:

In sum, if the plaintiff can point to the existence of “newly acquired information” to support a labeling change under the CBE regulation, the burden then shifts to the manufacturer to show by “clear evidence” that the FDA would not have approved the labeling change made on the basis of this newly acquired information.

Sounds like a pleading requirement to us.  Even construing the allegations in a light most favorable to plaintiff, “dismissal is nonetheless appropriate . . . if the facts alleged in the complaint do not plausibly give rise to a claim that is not preempted.” Ideus, at *3 (citations omitted). Because “some indication of newly acquired information [is required] to trigger the applicability of the CBE regulation,” those allegations are required to be in the complaint. Id.

And, of course, they must then meet the requirements of TwIqbal. So, while plaintiff is being given an opportunity to amend her complaint, she “must plead with specificity any newly acquired evidence which may have warranted a change” in the device’s warning after the device was approved but before it was implanted in plaintiff.” Id.  Given our earlier aside about the substance of the claims, we wonder if there was nothing in plaintiff’s complaint because there is nothing. We’ll wait and see, but in the meantime Nebraska, in addition to lending its name to a classic rock album, has given us a significant ruling in our preemption arsenal.