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Second chances, sure.  Two bites at the apple, we see it all the time.  Three strikes before you are out, fairly common.  But a fourth amended complaint to cure basic pleading deficiencies?  That seems overly generous by any standards.  Well, almost any standards because that is what plaintiff got in Greenwood v. Arthrex, Inc., 2023 U.S. Dist. LEXIS 40815 (W.D.N.Y. Mar. 10, 2023). 

Plaintiff originally filed her suit in New York state court against the manufacturer of a medical device that she alleges caused her injury.  While still in state court, plaintiff filed her first amended complaint adding component part manufacturers as additional defendants.  Those defendants removed the case to federal court and then moved to dismiss.  That motion was mooted by plaintiff filing a second amended complaint, presumably to attempt to correct the deficiencies pointed out in the motion to dismiss.  The component part defendants then moved to dismiss the second amended complaint which motion the court granted dismissing those defendants with prejudice.  Id. at *3-4.  Apparently concerned that her allegations would not withstand a motion to dismiss by the manufacturer defendant either, plaintiff filed a third amended complaint alleging four modified causes of action for negligence, strict liability design and manufacturing defect, breach of express and implied warranty, and failure to warn.  The manufacturer defendant then moved for judgement on the pleadings.  This time the court gave plaintiff her a fourth chance to plead something that would meet the TwIqbal standards. 

As recounted in the decision, the sum total of plaintiff’s allegations on her negligence cause of action are (i) the device was either defectively designed or manufactured to cause overheating, (ii) defendant manufactured and distributed the device, and (iii) months after plaintiff’s surgery defendant issued a recall of the device.  Id. at *13.  The court found that plaintiff alleged “circumstantial evidence” that was enough to allow the claim to survive.  Id. at *14. 

Plaintiff’s second cause of action alleged that it was feasible for defendant to design the product differently but does not allege what the alternative design is.  Plaintiff also alleges defendant failed to conduct adequate testing and/or failed to use proper materials or insulation in the device.  Id. at *5.  That was enough for the court to find it could “draw a reasonable inference” that defendant is liable for a product defect.  But that requires quite a leap from an unsupported claim that the product could have been designed differently to a finding that an unidentified feasible alternative design exists.

Next was plaintiff’s manufacturing design claim.  Here, plaintiff’s claims in her third amended complaint seem to be nearly identical to those dismissed in her second amended complaint.  Plaintiff did not compare the device used in her surgery to other devices, specify the malfunction, or allege a deviation from design specifications.  Id. at *15-16.  See Greenwood v. Arthrex, Inc., 2022 WL 211763, *12 (W.D.N.Y Jun. 13, 2022) (Greenwood I) (plaintiff did not allege the heat shrinking tube “deviated from similar part” and failed to identify a malfunction attributable to defendant’s parts; therefore manufacturing claim dismissed with prejudice).  This time, however, the court gave plaintiff another attempt to plead manufacturing defect by adding “a comparison of the . . . device used on her compared with others.”  Greenwood, 2023 U.S. Dist. LEXIS 40815, at *18.  This is already what the court told plaintiff was wrong in her second amended complaint and plaintiff did not fix it in the third amended complaint.  That should have been her third strike.

Fortunately, on plaintiff’s warranty claims that court decided three attempts to plead the required pre-suit was enough.  Under New York law, to state a claim for either express or implied warranty plaintiff must plead that she gave pre-suit notice to defendant.  That was missing in all three versions of the complaint.  In denying the request to amend this claim, the court acknowledged that plaintiff failed to address the same argument advanced in the prior motion to dismiss.  The court seemed to read between the lines and find that plaintiff must not have such proof of notice if she failed to plead it after being told it was a fatal deficiency to her claim.  We think the same logic should have applied to manufacturing defect. 

That left only plaintiff’s failure to warn claim.  Here plaintiff alleged that defendant failed to warn about the risk of overheating, but did not allege what warning should have been given.  Id. at *24.   That was not fatal to her claim.  However, failing to plead whether the overheating risk was knowable by the defendant was.  Plaintiff relied only on the post-surgery voluntary recall without even identifying the reason for the recall.  Plaintiff’s complaint did not allege whether the risk was “so apparent as to require a warning” or whether defendant had knowledge of the risk before plaintiff’s surgery.  Again, this is the same reason that led to the dismissal with prejudice last year.  See Greenwood I, at *12 (dismissing failure to warn because plaintiff failed to allege the reason for the recall, the recall was post-surgery, and, it was unclear whether defendant should have known of the danger).  But, again, this time the court is allowing plaintiff to amend.  Plaintiff, on her fourth try, may be able to plead facts of defendant’s prior notice. 

We are highly skeptical that plaintiff will be able to do in round 4 what it failed to do in all prior rounds – especially having already been advised of these same defects before round 3.  Stay tuned.  Maybe a fourth motion to dismiss will be the bite that finally swallows the whole apple.

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At some point, early in the pelvic mesh litigation, some genius on the other side decided it would be a good idea to include a stand-alone claim for “defective product” in at least one of the plaintiffs’ standard complaints.  “Defective product” was pleaded as some generic form of strict liability, separate and apart from the three accepted theories of manufacturing, design, and warning defect.  We have no idea where this concept of “defective product” came from.  It’s not adopted by the law of any state as far as we can tell.

Continue Reading Defective Claims for “Defective Product”
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Thanks to our friend Adam Masin for sending us today’s hot-off-the-presses case, and a shout-out to Adam and his colleague Nancy Kelly, both of Gordon Rees Scully Mansukhani, for the great result.  We’ll get to that in a moment.

First, we ask your indulgence as we report that our baby is leaving the nest this week.  No, not the Drug and Device Law Rock Climber – she is fully launched (even off of our phone plan).  We refer to our gorgeous standard poodle puppy, Luca, now seven months old, whom blog readers have known since he was in utero.  We drop him off this Sunday to his show handler, who will have him on the show circuit for the next few months, until he finishes his AKC championship.  (We already have plane tickets and hotel reservations to see him in the “6- to 9-month puppy” class at the Poodle Club of America National Specialty Show , next month in Missouri.)  This was part of the deal when we got him, and we knew it was coming, and we are beyond excited for this next phase.  But we can’t deny that a piece of our heart is going with him, along with the giant stuffed Lamb Chop toy he carries all around the house and brings into bed. Watch this space for updates on Luca’s show career, and cross your fingers for his success and quick return home. 

Back to today’s case.  Rivers v. Nice Recovery Systems LLC, et al., 2023 WL 2525209 (D.R.I. Mar. 15, 2023), is a smart, sensible, and correct personal jurisdiction decision with implications for all of us who represent manufacturers of prescription drugs and medical devices.  In Rivers, the plaintiff alleged that he was injured by a cold compression system prescribed for him after bunion surgery.  He sued in the District of Rhode Island, asserting the usual litany of product liability claims and naming a list of defendants that included the device’s manufacturer, a distributor with which the manufacturer contracted to market and distribute the device, and (significantly) the doctor who prescribed the device for the plaintiff.  The manufacturer moved to dismiss the claim for lack personal jurisdiction, and the plaintiff was granted leave to conduct limited jurisdictional discovery.  Here are the relevant jurisdictional facts:

The manufacturer/movant is a Delaware company “with its principal place of business, sole office, and manufacturing facility in Colorado.  It does not have any operations, locations, or employees in Rhode Island.”  Rivers, 2023 WL 2525209 at *1.  The manufacturer does business with a Connecticut distributor that distributes the products in the six New England states (including Rhode Island) along with New York and New Jersey.  As the court emphasized, there was “no evidence that [the manufacturer] directed [the distributor’s] marketing practices in Rhode Island or itself took part in any” at any time relevant to the plaintiff’s claims.  Id.   The only defendants with Rhode Island presences are the prescribing doctor and his medical practice.  The plaintiff, a Massachusetts resident, traveled to Rhode Island to see the defendant doctor for pain in his big toe.  The doctor diagnosed bunions, recommended surgery (later performed in Massachusetts) and prescribed the defendant’s cold compression device for use after surgery.

As the court explained, “the Supreme Court recognizes two kinds of personal jurisdiction: general (sometimes called all-purpose) and specific (sometimes called case-linked) jurisdiction.”  Id. at *3 (internal punctuation and citations omitted).  The plaintiff conceded that Rhode Island could not exercise general jurisdiction over the manufacturer, so the arguments and analysis addressed only specific jurisdiction.  In Rhode Island, the relevant framework includes three categories:  1) relatedness (the claim directly arises out of or relates to the defendant’s forum-state activities); 2) purposeful availment (the defendant’s contacts with the forum state represent a purposeful availment of the privilege of conducting activities in the state); and 3) reasonableness (the exercise of jurisdiction is ultimately reasonable).  “Failure to make any one of these [three] showings dooms any effort to establish specific personal jurisdiction.”  Id. (citations omitted). 

The court began its analysis with the “relatedness” prong, citing the SCOTUS’s BMS decision for the proposition that, for a plaintiff’s causes of action to “arise out of or relate to” a defendant’s forum conduct, “there must be an affiliation between the forum and the underlying controversy, principally, an activity or an occurrence that takes place in the forum State and is therefore subject to the State’s regulation.”  Id. (internal punctuation and citation to BMS omitted).  The court emphasized that, although this is a “flexible, relaxed standard,” the court may not exercise specific personal jurisdiction “where the connection between the cause of action and the defendant’s forum-state contacts seems attenuated and indirect.”  Id. (citations omitted).  In other words, “the defendant’s in-state conduct must form an important, or at least material, element of proof in the plaintiff’s case.”  Id. (internal punctuation and citations omitted).  In Rivers, the plaintiff was a Massachusetts resident who used the product and sustained his injury in Massachusetts, not Rhode Island.  The product was designed and manufactured in Colorado, not Rhode Island.  “Indeed,” the court stated, “it [was] very likely that the product never entered Rhode Island.”  Id. at *4.

The only connection to Rhode Island was the fact that the plaintiff’s doctor prescribed the device during a pre-surgery visit in Rhode Island.  The plaintiff, not the manufacturer defendant, created that contact.  (The plaintiff filled the prescription in Massachusetts.).  Even if the plaintiff had to come to Rhode Island to obtain jurisdiction over the doctor, he was still a litigation tourist from the perspective of jurisdiction over the manufacturer.  The court held, “[t]his Rhode Island contact is not an important or material element of proof of the plaintiff’s claims against [the moving defendant] and it is attenuated and indirect connection between Rhode Island and the litigation.”  Id. (citation omitted).  “In other words,” the court concluded, “there is not an adequate link between [the moving defendant’s (indirect) contacts with the forum (Rhode Island) and the litigation (the plaintiff’s specific claims against [the moving defendant] to satisfy the relatedness factor.”  Id. (citation omitted). 

The court noted that much of the argument and the jurisdictional discovery focused on the “purposeful availment” and “reasonableness” prongs; however, because the plaintiff not satisfied the relatedness factor, the court did not need to consider the remaining factors.  Motion to dismiss granted (without prejudice, because it was on jurisdictional grounds).

Rivers is important, with potential implications anytime a plaintiff was prescribed a drug or device in one state but used it (and claimed to suffer injury) in another state.  Plaintiffs who obtain health care from out-of-state doctors cannot claim their prescriptions as in-state jurisdictional contacts.  We love decisions that limit forum shopping on tenuous jurisdictional grounds, and Rivers is squarely in that category.  We’ll keep you posted on further developments. In the meantime, stay safe out there, and root for Luca!

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We have made no secret of our long-held views that “failure to withdraw” or “stop selling” theories of liability for FDA-authorized medical products are unwarranted perversions of state design defect law and preempted anyway.  When we say long-held, we mean it, because we had a few of the first cases where this theory was put forward in earnest.  Back during the diet drug litigation, we had cases with very significant alleged injuries and a colorable argument that the label was inaccurate as to the risk of the plaintiffs’ injuries.  However, their lawyers were a bit nonplussed when each prescribing physician testified that even the plaintiff’s desired warning would not have changed the decision to prescribe the medication to the plaintiff.  So, the lawyers came up with a way to get around the obvious lack of proximate cause for failure to warn (and other impediments under the laws of Pennsylvania and Ohio).  If the drug had not been sold at the time, then it did not matter what the prescribers thought.  The failure to withdraw the drug was, they reasoned, the proximate cause of each plaintiff’s injuries.  In two of these cases, our client won summary judgment at the trial court level and an appellate court ended up creating a new cause of action to accommodate the plaintiff’s theory (and lack of helpful testimony from the prescribing physician).

In one of our longest non-Bexis posts, we detailed the ten year journey from the rejection of this claim, to its limited acceptance, to the recognition that such a claim would be preempted.  The short version is that the Sixth Circuit in Wimbush v. Wyeth, 619 F.3d 632 (6th Cir. 2010) (Ohio law), and the Pennsylvania Supreme Court in Lance v. Wyeth, 85 A.3d 434 (Pa. 2014) (Pennsylvania law), mucked things up and cases like Yates v. Ortho-McNeil-Janssen Pharms., Inc., 808 F.3d 281 (6thCir. 2015), Tersigni v. Wyeth Ayerst Pharms., Inc., 817 F.3d 364 (1st Cir. 2016), and In re Zantac (Ranitidine) Prods. Liab. Litig., 510 F. Supp. 3d 1034 (S.D. Fla. 2020), helped restore some sanity.  The Supreme Court provided strong assists with PLIVA v. Mensing, 564 U.S. 604 (2011), and Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013).  Since the appellate decisions in Wimbush and Lance, few courts have expressly recognized a “stop selling” cause of action for FDA-authorized medical products.  Others have gone straight to finding that any such claim would be preempted.  [A listing of these decisions in the context of generic drugs is included here.] Relatively few have recognized a claim and found it not preempted, but they have generally analyzed preemption first, which is not how you do it.  [Some discussion of preemption of state “stop selling” actions outside of product liability are here, here, and here.]  Sometimes, the analysis is broken up between pre-approval and post-approval periods, with courts being somewhat more likely to find pre-approval claims preempted.  A post-approval “stop selling” claim is pretty much indistinguishable from a “failure to recall” claim, which had been pretty widely rejected by various states as to various types of products before Wimbush and Lance.

Plaintiffs rarely stop trying just because the weight of authority is against them.  In Beaver v. Pfizer Inc., No. 1:22-cv-00141-MR, 2023 WL 2386776 (W.D.N.C. Mar. 6, 2023), the plaintiff faced a motion to dismiss on her proposed claims for post-approval failure to recall and failure to warn with a well-known prescription anti-inflammatory medication.  She lost, but two wrinkles make this extra interesting to us.  First, she was pro se, which means she benefitted from a more liberal pleading standard.  Second, her case was dismissed with prejudice on her first complaint.  The de facto three strike rule has been one of our bête noires for a while.  The Beaver judge deserves a warm hand clap (or tail thwack) for not falling for either trap.

Plaintiff claimed to have taken took defendant’s medication for fifteen years before she was diagnosed with chronic kidney disease.  Apparently having nothing to allege related to studies suggesting the drug causes chronic kidney disease or that defendant should have included more or different warning about kidney risks, she based her allegations on the risk of heart attacks and strokes, neither of which she had.  Indeed, she claimed FDA told the defendant to remove the drug from the market because of those risks in 2005, the year she was first prescribed it.  Plaintiff might have spent a few minutes on the internet before drafting her complaint or responding to the motion to dismiss, because her allegations were clearly bunk.  Although the notorious Public Citizen group had filed a citizen’s petition in January 2005 to have all COX-2 inhibitors, including defendant’s medication, removed from the market, FDA followed the vote of an advisory committee and kept the medication on the market with changes to the label and a recommendation of a post-marketing study.  There was a similar endorsement in 2018.  There were also warnings about kidney risks in the physician labeling and a medication guide through plaintiff’s use of the drug, contrary to her allegation that the label did not “contain a warning about potential kidney damage.”  The Beaver court might have taken judicial notice of some or all of these facts (easily ascertainable from https://www.fda.gov), but it did not need to do that to kick the case.

On the stop selling claim, Beaver went right to preemption without evaluating whether North Carolina has such a claim or conducting an Erie analysis to predict whether it would adopt it.  That gnaws at us, but the preemption analysis was simple and toothsome.  It quoted from Bartlett on impossibility preemption and the rejection of the argument that it “could be avoided because [the] pharmaceutical company could comply with seemingly irreconcilable state and federal laws by ceasing production of the drug altogether.” 2023 WL 2386776, *3.  Because the drug “was and continues to be an FDA-approved medication [] allowing a state law duty to nonetheless prohibit sale would frustrate the purposes of the FDA’s regulatory scheme.”  Id. (citing Gross v. Pfizer, Inc., 825 F. Supp. 2d 654, 659 (D. Md. 2011)).  Thus, plaintiff asserted “the precise ‘stop-selling’ rationale explicitly rejected by the Supreme Court and, accordingly, the Plaintiff has failed to state a claim of negligence based on this theory.”  Id.  Direct and, as we noted above, with prejudice.

The failure to warn claim fared no better.  North Carolina law requires unreasonable conduct and, of course, proximate cause, but the complaint mere offered “formulaic recitation of the third element [risk of harm from an inadequate warning] of the failure to warn test under North Carolina law, which is inadequate to state a claim.”  Id. (citing Twombly).  North Carolina has also adopted the learned intermediary doctrine by statute, with an exception when the FDA requires “direct consumer warnings or instructions.”  Plaintiff did not allege the exception or the basic elements of a physician-focused warnings claim.  So, this claim was also dismissed with prejudice.

We cannot say the Beaver plaintiff would have gotten past a motion to dismiss had she retained a competent lawyer.  Such a lawyer might have told her not to sue at all.  But sue she did, so Beaver ends up as another case rejecting the silly stop selling theory of liability for an FDA-approved drug.

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In our first appellate oral argument we found ourselves in front of a very hot Ninth Circuit panel (that means lots of questions).  We danced our hardest to affirm the district court’s denial of a criminal defendant’s motion to suppress. The problem was that the lower court had wandered onto shaky ground.  We knew it.  We had tried to avoid it.  We knew our best chance for affirmance was persuading the Ninth Circuit to affirm on alternative grounds (the ones we had urged below). Thankfully, they did it.  For some reason, winning on alternative grounds made us feel extra proud.  At least the appellate section nerds in the U.S. Attorney’s office would continue to let us handle our own appeals. 

In Azurity Pharmaceuticals, Inc. v. Edge Pharma, LLC, 2022 WL 3335823 (1st Cir. Aug. 12, 2022), the appellee managed to save most of the lower court’s decision in its favor by resorting to alternative grounds.   That must have made the appellee’s lawyers feel pretty good.  But note that we said “most.”  There was a partial reversal, and that must have made the appellee lawyers feel pretty bad.  And we feel pretty bad about that, because we like the lower court decision to the extent it chose to defer to the Food and Drug Administration (FDA). If that sort of deference was more prevalent, we could get rid of a lot of silly food and drug litigation from our courts, leaving those courts to handle the things that really matter — you know, like criminal cases and celebrity defamation lawsuits.  

The Azurity case was a beef between a specialty pharmaceutical company that sold an FDA premarket approval drug and a drug compounding company that sold a competing drug that had not been given FDA premarket approval.  Section 503B of the Food, Drug and Cosmetic Act permits drug compounders to market their compounded drugs without FDA approval as long as they meet certain conditions.  On its website, the compounder stated that it complied with FDA regulations, that it was a registered and inspected FDA outsourcing facility, and that “commercially available options are not ideal for use in the hospital setting.”  That last point was a shot at the premarket approval drug.  The manufacturer of that premarket approval drug alleged that the statement was an inaccurate superiority claim, and that, in fact, much of what was on the compounder’s website was either flat-out false or misleading.  These allegations resided in a complaint that included causes of action under both the Lanham Act and a Massachusetts consumer protection law.

The district court granted the compounder’s motion to dismiss, holding that the claims would require the court to interpret section 503B “in a way that would interfere with the FDA’s authority to administer and enforce the FDCA.”  The court referred to “FDA preclusion,” which is not the same thing as FDA preemption (an argument that was not raised by the plaintiff).  The district court also premised its dismissal on primary jurisdiction.  In short, let the FDA sort these issues out, because they seem too gnarly for the court.  

The First Circuit disagreed with the district court’s fundamental rationale that the issues in the case called for FDA expertise.  To the appellate court, the FDA issues were fairly straightforward (but go ahead and read the First Circuit’s lengthy opinion and see if you agree — we’ve read epidemiology and epistemology and eschatological (but not scatological) articles that were less dense and dull), and handling the Lanham Act analysis was a walk in the park.  For the most part, that Lanham Act analysis still worked in the defendant compounder’s favor.  The plaintiff argued that the compounder was not in compliance with FDA rules because its compounded drug was essentially a copy of the premarket approval drug — which would yank the compounder out of section 503B eligibility — but the First Circuit held that the plaintiff had not plausibly shown that the compounder “made any literally false description or representation of fact.”  The plaintiff relied on an FDA non-binding guidance to explain what it meant for a compound to be “essentially a copy” of another drug, but there was some looseness in the non-binding guidance, plus it was … non-binding.  Similarly, the First Circuit concluded that the compounder’s statement that other drugs were “not ideal” was not a superiority claim.  What it was, dear reader, was “nonactionable puffery.”

We will pause for a moment to allow you to rinse out of your mind bad memories of your law school first year contracts class.  Remember how ridiculous advertising escaped the clutches of the law by riding the greasy wheels of “puffery”?  For that matter, do you remember the room said to offer a view of the King’s coronation?  What about that pregnant cow? And what exactly is a chicken? 

But we digress.

Anyway, up to this point, the First Circuit upheld the dismissal of the complaint (both the Lanham Act and Massachusetts consumer act claims, since they traveled together and tested on the same theories) but on different grounds from those relied upon by the district court.   But here is where the First Circuit parted company with the district court, revived the lawsuit, sent things back, and brought woe upon the compounder:  the plaintiff alleged that the bulk substance used by the compounder was not on the section 503B bulk substance list (which appears to focus on clinical needs and/or shortages).  The compounder had some decent arguments why that issue should be punted to the FDA, based on FDA practice and policy, but the First Circuit said that nothing sufficiently on point supporting that notion had been identified, that the court was in a solid enough position to look at the issue, and what the court saw was (and now, given that it is now March, we will shift the sports analogy from football to basketball) a jump ball.  Maybe the plaintiff was right, maybe the plaintiff was wrong, but there was inadequate basis, at least at the point of a motion to dismiss, to throw the plaintiff out of court.

As we said, we rather liked the defendant’s and the district court’s reliance on deference to the FDA.  The First Circuit’s opinion was certainly thoughtful and thorough.  It might even be right. But even that very thoughtfulness and thoroughness might make one wish for more deference to the FDA.  

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Today’s message is a reminder that specific personal jurisdiction is just that – both specific and personal.  That means plaintiffs can’t group plead their way around personal jurisdiction lumping parents and subsidiaries together.  Plaintiffs must identify each defendant’s individual role in causing the alleged harm.  If plaintiffs seek to impute the jurisdictional contacts of one corporate defendant to another, they must first plead sufficient facts to raise a colorable claim that the companies are alter egos and the corporate veil should be pierced.  And in Texas, common use of a trade name by affiliated companies doesn’t meet that threshold.

In LaRocca v. Invasix, Inc., 2023 WL 2391012 (S.D. Tex. Mar. 7, 2023), plaintiff sued the manufacturer of a body contouring product that was used during a medical procedure alleging it caused her injury.  Plaintiff filed the suit against both the parent, an Israeli corporation, and its US subsidiary.  The foreign parent moved to dismiss asserting a lack of personal jurisdiction.  For specific jurisdiction to exist, a defendant must “purposefully avail itself of the privilege of conducting activities within the forum” and plaintiff’s claims must “arise out of or relate to” the defendant’s forum contacts.  Id. at *2-3. 

To start, the court quickly rejected plaintiff’s alter ego argument.  All of the proffered evidence supported that the defendants observed separate corporate formalities such as maintaining separate bank accounts and business records, separate offices, and separate employees.  Id. at *1 & *3.  So, to establish personal jurisdiction over the foreign defendant, plaintiff had to demonstrate that specific defendant “purposely directed its activities toward the forum state.”  Id.  But, it had no property, employees, or office in Texas; no agent for service in Texas; never marketed in Texas; had no contracts with anyone in Texas; and derived no revenue from Texas.  Id.  

That left plaintiff to focus on the trade name.  The foreign defendant was InMode Ltd.  The US defendant was Invasix, Inc.  The trade name by which the companies’ products are known is InMode.  Plaintiff pointed to two Invasix Texas employees who used InMode on their LinkedIn profiles and a LinkedIn position announcement that refers to InMode and a position in Texas.  Plaintiff also argued that a purchase agreement that used the name InMode was evidence that InMode Ltd entered into contracts in Texas.  But use of the common trade name, absent any evidence that corporate formalities were disregarded, is not sufficient to impute jurisdictional contacts.  Id. While this decision reached the right conclusion given the circumstances, this case warrants a reminder of our prior warning to our readers to make sure that their employees’ LinkedIn profiles are accurate and do not overstate potentially jurisdictionally relevant connections.  This is not the first plaintiff to make use of LinkedIn to try to establish jurisdiction. 

With the court unwilling to find that InMode the trade name meant InMode Ltd the company, plaintiff’s final effort was to argue that InMode Ltd.’s website established jurisdiction because it has a function that allows users to search for healthcare providers who use the company’s products.  But that too was an insufficient jurisdictional contact because it was not “directed to Texas in particular.”  Id. at *4.  As this is a common feature on product websites, this ruling establishes good precedent for an argument we expect we will see again.   With no purposeful contacts to support specific personal jurisdiction, the claims against the foreign defendant were dismissed.

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Starting with our comprehensive post lambasting Schrecengost v. Coloplast Corp., 425 F. Supp.3d 448 (W.D. Pa. 2019), for ignoring 75 years of hitherto unbroken Pennsylvania precedent and allowing a “strict liability” design defect claim against an FDA-regulated prescription medical product, we have both chronicled and opposed the other side’s attempt to infiltrate strict liability into Pennsylvania litigation involving such products (primarily medical devices). That attempt disregards seven Pennsylvania Supreme Court decisions between 1948 (Henderson) and 2014 (Lance), as well as the Pennsylvania Superior Court (an intermediate appellate court in Pennsylvania) (Creazzo), all rejecting application of strict liability principles to prescription medical products.  For the gory details, see the prior post.

Continue Reading Pennsylvania Law, Federal Rules, and FDA Standards
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We have never been sued in Hawaii.  At least not yet.  It could be that someday someone will call us to task for eating too much shave ice or using the word “mahalo” incorrectly.  But so far we have traversed the Aloha State unscathed by legal exposure.  Our favorite Hawaiian island is Kauai, the Garden Isle (not to be confused with the Garden State, New Jersey), and we count hiking Kauai’s Waimea Canyon as one of the highlights of our vacation lives. 

The defendants in Yamashita v. LG Chem, Ltd., No. 20-17512, 2023 U.S. App. LEXIS 5268 (9th Cir. Mar. 6, 2023), were not so fortunate.  They got sued, but the news here is that the district court dismissed the claims for lack of personal jurisdiction, and the Ninth Circuit affirmed.  Moreover, the Ninth Circuit’s opinion very helpfully clarifies the Supreme Court’s most recent opinion on personal jurisdiction, Ford v. Montana. 

We wrote on the Supreme Court’s recent activity on personal jurisdiction just one week ago.  In a nutshell, the Supreme Court decided Bauman in 2014 and held that general personal jurisdiction would lie only where the defendant was “at home,” which for a corporation generally means the state of incorporation or its principal place of business.  By limiting general personal jurisdiction to those places, Bauman struck a blow against forum-shopping plaintiffs.  For specific personal jurisdiction, we have credited the Supreme Court’s opinion in Bristol-Myers Squibb in 2017 as restoring discipline in cases involving non-resident defendants and striking another blow against litigation tourism. 

Then came Ford, which held (in a case involving resident plaintiffs, i.e., not forum shoppers) that a court could take personal jurisdiction over claims that “arise out of or relate to” the defendant’s forum contacts.  That gloss on specific personal jurisdiction is not new, but what Ford added is that “arise out of” and “relate to” are alternatives, with “relate to” allowing a pathway to jurisdiction even absent a direct, causal nexus between the defendant’s forum contacts and the plaintiff’s claims.  In our view, the practical consequence of Ford is that forum residents bringing claims arising within the forum receive some leeway in establishing specific personal jurisdiction over non-resident defendants. 

The Supreme Court famously cautioned, however, that “relate to” does not mean “anything goes.”  Ford Motor Co. v. Montana Eighth Jud. Dist., 141 S. Ct. 1017, 1026 (2021).  To the contrary, the “relate to” prong still requires a close connection between the forum contacts and the injury.  In Ford, the plaintiffs resided in the forum and alleged injury in the forum, and the defendant had extensively marketed, sold, and serviced the exact product models at issue in the forum.  That was enough, even though the plaintiffs had purchased their specific cars in other states. 

The Ninth Circuit’s opinion in Yamashita provides a very useful comparison.  A Hawaii resident alleged an injury from a lithium battery that allegedly malfunctioned in a consumer device.  One defendant, however, was in South Korea and the other was a Delaware corporation with its principal place of business in Georgia.  Yamashita, at *6-*7.  Because neither defendant was “at home” in Hawaii (thus no general personal jurisdiction), the primary issue was specific personal jurisdiction. 

But unlike Ford, this forum resident alleging an injury within the forum fell short.  The plaintiff cited four “contacts”:  First, the defendants shipped products through the port of Honolulu, and some contained lithium batteries.  Second, one defendant sold residential solar batteries (i.e., a different product) in Hawaii.  Third, various consumer products sold in Hawaii contained the defendants’ lithium batteries.  Fourth, a third-party website sold the defendants’ batteries throughout the Internet-connected world, presumably including Hawaii. 

None of those contacts supported specific personal jurisdiction.  The shipment of products through the port of Honolulu constituted purposeful availment of the laws of Hawaii, but the record did not show whether any of those shipments included the battery model at issue.  The sale of residential solar batteries likewise was purposeful availment, but those were altogether different products, i.e., “as different as sedans and 18-wheelers.”  Id. at *20-*21.  Neither could satisfy the “arise out of” or “relate to” tests.

The other alleged contacts were even less relevant.  The sale of consumer products in Hawaii containing the defendants’ batteries (even if they were the exact same model as the battery at issue) shows only that the defendants placed their batteries in the stream of commerce somewhere.  The record did not show that the defendants “deliberately navigate[ ] the stream of commerce towards Hawaii, either by introducing these batteries into Hawaii [themselves] or by ‘creat[ing], control[ling], or employ[ing] the distribution systems’ which does so.”  Id. at *14 (quoting Asahi Metal).  Allegations that the defendants sold the batteries through a third-party website were not purposeful availment either.  The defendants denied that they authorized such third-party sales, and even if they had, there was no indication they targeted Hawaii.

The Ninth Circuit concluded that the plaintiff’s claims clearly did not “arise out of” these forum contacts, since there was no but-for causation link.  The plaintiff did not allege that the defendants shipped the subject battery into the port of Honolulu, and the one defendant’s solar batteries sold in Hawaii were completely different.  Id. at *19-*20.  The claims did not “relate to” the forum contacts either.  As the Ninth Circuit observed, “There is little reason to believe that either firm’s port contacts or [one firm’s] solar contacts have anything to do with Hawaii residents’ acquisition of [these particular] lithium-ion batteries.” 

The cherry on top is that the Ninth Circuit also affirmed the district court’s order denying jurisdictional discovery as unjustified:  “In sum, Yamashita has no viable route to establish personal jurisdiction.  Jurisdictional discovery would be little more than a fishing expedition seeking support for jurisdictional theories one of which is farfetched, and the other of which [the defendants] have specifically denied via sworn statements. . . .  [H]e has only a mere hunch that jurisdictional discovery will allow him to meet his burden.”  Id. at *25-*26. 

We like Yamashita because we take seriously the Supreme Court’s admonition in Ford that its opinion “does not mean anything goes.”  Whatever that means, we know at least two things in the Ninth Circuit.  First, while Ford might allow some leeway for forum residents alleging a forum injury, there are limits.  Mr. Yamashita resided in Hawaii and alleged an injury in Hawaii, but he still could not haul these defendants into Hawaii’s courts.  Second, to justify specific personal jurisdiction, a plaintiff’s claims must have a close connection to the defendant’s forum contacts, if not a but-for causal nexus.  This should certainly preclude the blatant forum shopping at which Bauman and Bristol-Myers Squibb took aim. 

Photo of Eric Alexander

Duh.  We apologize for the depth of our profundity, but there are some legal principles we think are really obvious.  So obvious, in fact, that we might respond to question about these principles with this most dismissive of (clean) interjections.  (We were somewhat surprised to learn from the interwebs that duh was supposedly first used in 1943 as a demeaning imitation of an unintelligent person and sometime later as an interjection.  We cannot fathom how deprived tweens and teens of past generations were by their lack of duh as a standalone comeback, particularly to an older person.)  The issue teed up in Campbell v. Depuy Orthopaedics, Inc., No. 3:23-cv-00029, 2023 U.S. Dist. LEXIS 31015 (M.D. Tenn. Feb. 24, 2023), drew this response from us.  Considering the “ink spilled” on this issue in this more than a decade-old case made us shake our heads.

The issue at hand is whether a plaintiff should win partial summary judgment on an element of her case as to which she bears the burden of proof—in this case, medical causation—when the defendant does not have an expert on that element.  Of course not.  Pattern jury instructions often include some version of the phrase “the defendant does not have to prove anything.”  The Federal Rules for Civil Procedure include a provision for judgment as a matter of law, colloquially known as directed verdict.  Defense trial lawyers with a lot of, er, gumption have been known to rest at the end of plaintiff’s case without presenting any witnesses.  So, does a defendant have to present witnesses, expert or otherwise, on every issue as to which plaintiff bears the burden of proof?  Does something about Fed. R. Civ. P. 56 change the dynamic so an unopposed expert turns into partial summary judgment for the plaintiff?  No and no.

Frankly, the more interesting flip side to this coin is when the plaintiff files a “reverse Daubert” motion on the defense medical causation expert or otherwise seeks to require that the defense expert offer an opinion to a reasonable degree of medical probability/certainty as to what other than the defendant’s product caused the plaintiff’s alleged injuries.  The First Circuit addressed the latter issue well in Wilder v. Eberhart, 977 F.2d 673 (1st Cir. 1992), and courts usually get both of these issues right.  Taking this all a bit further (or nerdier), the burden on the plaintiff to prove her case by a preponderance of evidence connects to the requirement from Daubert II and Havner that epidemiologic studies supporting general causation must have statistically significant relative risk (or odds ratios) greater than 2.0.  A relative risk of exactly 2.0 indicates that half of the cases in a population will be due to the exposure and half will not.  But we digress from our digression.

The presented facts and procedural history of Campbell are simple.  Plaintiff had a hip implant in 2009, had pain beginning in 2011 that led to a surgical intervention, sued over alleged metallosis, had the case docketed in an MDL for a long time, relied on the implanting surgeon for her causation case, moved for partial summary judgment on causation when the defendant did not name an expert on causation, and had her case remanded from the MDL a while later.  It was unclear whether the defendant chose not to name an expert like an orthopedic surgeon to address case-specific medical causation or there was the sort of oversight by the defendant of the type that plaintiffs are permitted to wiggle out of far too often.  (We perused the docket for some more information, which we will discuss later.  The MDL was the Pinnacle Hip MDL, notorious for a very large verdict that was reversed by the Fifth Circuit.)  In any event, the remand court’s consideration of the plaintiff’s motion was mercifully succinct.

Citing a range of Tennessee cases, the Campbell court rejected plaintiff’s argument with “it is only the Plaintiffs who are required to present expert testimony to establish causation in cases where the plaintiff has suffered a complex medical injury.”  2023 U.S. Dist. LEXIS 31015, *5-6.  Plaintiff tried to rely on two federal cases applying Tennessee substantive law to grant a defendant’s motion for summary judgment because plaintiff did not have the requisite expert testimony, in one, and to deny a plaintiff’s motion “seeking relief from its obligation to submit case-specific medical expert testimony to prove causation of medical injuries,” in the other.  Id. at *6-7.  The court was having none of it.  More generally, a defendant can rely on the jury to reject plaintiff’s expert’s testimony, especially when aided by effective cross-examination.  Moreover, the implanting surgeon who tried to offer expert opinions for plaintiff noted “no significant metallosis” in the report for his revision surgery and otherwise lacked facts in the case supporting his opinion.  Id. at *9-10.  So, summary judgment was rightly denied.

That is all well and good, but we do have a gripe.  We have less than complete information on the history of the Pinnacle MDL and this particular case, but it looks like a poster child for some of the problems with MDLs.  The case was filed back on October 13, 2011, sat around inactive for most of the next eleven years, and ended up back in the local federal court on January 19, 2023, with plaintiff’s motion for partial summary judgment pending.  In the MDL, after plaintiff dropped out of the court’s mediation program, there was a flurry of activity starting with a show cause order on plaintiff’s failure to prosecute and ending with a suggestion of remand on December 30, 2022.  According to the JPML website, the Pinnacle MDL opened in May 2011, had about 10,500 cases in it, and is now down to 0 cases (but has not yet been terminated).  That history, even without the notoriety to which we alluded previously, does not speak to the “the just and efficient conduct of such actions” in § 1407.  By contrast, the remand court ruled on a pending motion for summary judgment within five weeks of transfer.  That is efficient no matter how obvious the outcome was.

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The plaintiffs in Acosta-Aguayo v. Walgreen Co., 2023 U.S. Dist. LEXIS 34836  (N.D. Ill. March 2, 2023), visited their friendly neighborhood drug store and bought a lawsuit.  Well, first they bought pain relief patches.  Those patches were over the counter (OTC) products.  No prescriptions were required.  Maybe those pain patches worked and maybe they didn’t.  We do not know.  We cannot tell from the court’s opinion.  But we do know that the plaintiffs decided to deliver some pain themselves, in the form of a putative class action (actually four classes – nationwide, multi-state, California, and Illinois) alleging that the drug store falsely trumpeted some of its pain-relief products (in both patch and cream form) as being “maximum strength” when, in fact, there were other products with higher concentrations of the pain medicine.  The plaintiffs brought claims for breach of warranties, unjust enrichment, common law fraud, and violations of various state consumer protection statutes.  The defendant moved to dismiss the case.  The court’s opinion was like a bag of stuff you might bring back from a drug store – some goodies and some stuff that might make you embarrassed.  

Yes, for the millionth time you’ve seen the phrase in this blog, the Acosta–Aguayo decision was a veritable mixed bag.

The court began with the issue of standing, so we will do the same.  The lawsuit addressed three products – two patches and one cream.  The plaintiffs alleged that they bought one of the patches, did not buy the other patch, and did not buy the cream.  The court held that the plaintiffs had standing to assert claims for the products they actually purchased, plus other “substantially similar products.”  The two patch products looked the same, so both remained in the case, but the cream product was different and was dressed in labels with different colors, images, and product descriptions.  The cream product’s packaging was a different size and shape, and its text bullet points and bubbles were different from the patches.  You might think the court is making solid points here, or you might think it is dancing on the head of a pin, but the truth is that the plaintiffs never explained exactly how the cream label was substantially similar to the patch labels.  That failure led the court to dismiss the claims regarding the cream products.

The defendant made another argument that related to standing, though the Acosta-Aguayo court dealt with it in a different section of the opinion.  The plaintiffs alleged 12 statutory consumer protection claims on behalf of the multi-state class under the laws of 12 states. So far, so good.  But the plaintiffs were not personally injured in and did not reside in most of those states.  So claims under those state laws should be dismissed, right?  Wrong, said the Acosta-Aguayo court.  It read cases in the Seventh Circuit and Northern District of Illinois to reflect a “prevailing view” that efforts to strike class allegations should be reserved for the class certification stage.  They would survive the pleading stage.  No pain relief there.

The most interesting issue in Acosta-Aguayo was whether the product labels were misleading.  According to the defendant, the OTC patches did contain the “maximum strength” of pain reliever medication in OTC products.  There were prescription products that contained higher doses, but so what? The defendant asserted that the OTC patches contained the maximum concentration permitted by the FDA in nonprescription external analgesics.  The label was not misleading.  Rather, the label was fully accurate.  Consumers coming into pharmacies without a prescription would not be able to buy any product that is stronger.  This argument by the defendant thoroughly persuaded our biased, flinty, defense-hack noggins.  But it did not persuade the Acosta-Aguayo court.  Here is the court’s answer to a defense argument that we thought was unanswerable:  “Yet Defendant does not argue that a reasonable consumer would know this fact.”  Our eloquent answer to this answer follows thusly:  Huh?  We simply do not get the court’s point.  It gives us a headache.  And anything less than maximum strength will not suffice to send such headache away.  But we will not get too exasperated by the Acosta-Aguayo’s leaps of illogic, because the court also says that at this pleading stage the plaintiffs “have raised a reasonable inference that for the Patch products, similar 5% lidocaine OTC products are available.  Whether Plaintiffs can prove this is a matter for another day.”  We don’t see how the plaintiffs managed to raise such an inference, but we’ll happily seize upon this alleged point as a point of distinction.  In the meantime, look for more class action strike suits over “maximum strength” product descriptions.  And while we are in such a jolly, life-affirming, constructive mood (the pain reliever must be working), we suggest that manufacturers use language (which we think we have seen) specifying that the product contains the maximum strength a consumer can get without a prescription.  The idea behind this language is to head off idiocy, but we will not specify whose.

And now that we’ve pulled out the grimmer items from the drugstore bag (the stuff that stings, pokes, and smells bad), let’s grab the candy.  In Acosta-Aguayo court dismissed the claim alleging that the defendant acted “unfairly,” because the plaintiffs mentioned no violation of any statutory or administrative rule.  The warranty claims flunked because the plaintiffs furnished no pre-suit notice.  The common-law fraud claim failed for lack of intent, since plaintiffs plead only negligence, and also because there is no duty to disclose in an ordinary buyer/seller relationship.  In a desperate attempt to fend off dismissal, the plaintiffs suggested that the drug store was a fiduciary, which seems patently silly, but the court rejected the argument not only on silliness grounds (no special relationship) but also because it is an “axiomatic rule that a plaintiff may not amend his complaint in his response brief.”  Finally, the court dismissed the claim for injunctive relief because there was no likelihood of future injury.  The plaintiffs “do not claim that they will purchase the allegedly mislabeled Products in the future.  Plaintiffs’ awareness of the alleged deceptive practice undermines the notion that they will likely sustain imminent injury.”  There is a price to enlightenment.

As we told you, Acosta-Aguayo is a mixed bag.  While the best parts of it do not completely erase the pain of the worst, we are, at this point, comfortably numb. 

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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