Cases out of New York involving food products catch our eye these days, as NY threatens to become the new “food court.”  Today’s post involves Eric Parham  v. ALDI, Inc., No. 19 CIV. 8975 (PGG), 2021 WL 4296432 (S.D.N.Y. Sept. 21, 2021).

Plaintiff asserted false advertising claims under New York General Business Law (“GBL”) §§ 349 & 350 against defendant pertaining to an unsweetened vanilla almond milk product.  The complaint was dismissed without leave to file a second amended complaint.

Plaintiff claimed he purchased an organic unsweetened almond milk purporting to be flavored only with vanilla at various Aldi stores, including an Aldi store in the Bronx.   Plaintiff alleged he purchased “the Product because he liked the product type for its intended use and expected its vanilla flavor to not to be enhanced by artificial flavors….” The front label of the Product contains the brand name “Friendly Farms” at the top, along with a banner that says “Organic.”  Under the banner is the word “Almond” in larger font, below which the words “unsweetened” and “vanilla” appear. Plaintiff contended that the label’s representations were misleading because although the characterizing flavor is represented as vanilla, its flavor is  not derived exclusively from vanilla beans, contains non-vanilla artificial flavors that are not disclosed to consumers on the front label or ingredients list.

To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face. Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)).  A complaint is inadequately pled if it tenders naked assertions devoid of ‘further factual enhancement, Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 557), and does not provide factual allegations sufficient to give the defendant fair notice of what the claim is and the grounds upon which it rests. Port Dock & Stone Corp. v. Oldcastle Northeast, Inc., 507 F.3d 117, 121 (2d Cir. 2007).

To successfully assert a claim under either GBL §§ 349 or 350, a plaintiff must allege that a defendant has engaged in (1) consumer-oriented conduct that is (2) materially misleading and that (3) plaintiff suffered injury as a result of the allegedly deceptive act or practice. Beck v. Manhattan Coll., 20 Civ. 3229 (XLS), 2021 WL 1840864, at *5 (S.D.N.Y. May 7, 2021), An act is deceptive within the meaning of the New York statute only if it is likely to mislead a reasonable consumer. Id.  Additionally, under either provision, it is well settled that a court may determine as a matter of law that an allegedly deceptive advertisement would not have misled a reasonable consumer. Chufen Chen v. Dunkin’ Brands, Inc., 954 F.3d 492, 500 (2d Cir. 2020) (citation, quotation marks, and alteration marks omitted).

Here the magistrate judge recommended and the district court agreed that Defendant’s labeling was not misleading, because a reasonable consumer would understand that the word vanilla on the front of the carton describes how the Product tastes, not what it contains, especially in circumstances where the ingredients listed on the Product container do not mention vanilla at all.  See, e.g., Twohig v. Shop-Rite Supermarkets, Inc., 519 F. Supp. 3d 154, 158-61 (S.D.N.Y. 2021).

The most interesting part of the opinion, perhaps, was the discussion of the request for leave to amend; often complaints are dismissed with or without prejudice and the opinions offer little discussion why,  Although Rule 15(a) of the Federal Rules of Civil Procedure provides that leave to amend shall be freely given when justice so requires, it is within the sound discretion of the district court to grant or deny leave to amend. A district court has discretion to deny leave for good reason, including futility, bad faith, undue delay, or undue prejudice to the opposing party. McCarthy v. Dun & Bradstreet Corp., 482 F.3d 184, 200 (2d Cir. 2007) (citing Foman v. Davis, 371 U.S. 178, 182 (1962)). An amendment is futile if the proposed claim could not withstand a motion to dismiss pursuant to Fed. R. Civ. P. 12(b)(6). Lucente v. Int’l Bus. Machs. Corp., 310 F.3d 243, 258 (2d Cir. 2002).

Plaintiffs’ proposed new allegations addressed the results of a consumer survey concerning Defendant’s “vanilla” labelling and “the labeling of the Product in the marketplace vis-à-vis its competitors’ products.  Plaintiff argued that the survey showed that like himself, the vast majority of  consumers surveyed understood the “Vanilla” representation as not being solely about the flavor of the Product.  The court concluded that the survey commissioned by Plaintiffs’ counsel does not salvage their claim.  The survey did not demonstrate that the respondents believed the flavor in Defendant’s product came predominantly or exclusively from vanilla beans – which is what Plaintiffs alleged. In actuality, the way the questions were worded did not clearly address the issue.  Plaintiffs constructed the survey, noted the court. If they wanted to ascertain whether respondents thought the flavor came 100% from the vanilla plant, that would have been an easy enough response to draft. The survey seemingly presumed that the label conveyed something about that origin, and asked what it conveyed; it did not give participants the option of stating that they believed that the label conveyed nothing about the origin of the vanilla taste.  So the survey here – designed at the behest of counsel who apparently has brought nearly 100 similar lawsuits challenging the labeling of vanilla flavored products and presumably has given significant thought to the questions, observed the court – was sufficiently flawed that it did not contribute enough to render the claims plausible. See Procter & Gamble Co. v. Ultreo, Inc., 574 F. Supp. 2d 339, 352 (S.D.N.Y. 2008) (“A survey is not credible if it relies on leading questions which are inherently suggestive and invite guessing by those who did not get any clear message at all.”).

Plaintiff also asserted that his understanding of Defendant’s representation was reasonable in light of marketplace practice. Plaintiff pointed to federal regulations, arguing these regulations “effectively establish custom and practice in the industry,”  But even if Plaintiffs were correct about what the federal regulations require – a point Defendants disputed – the complaint did not allege that reasonable consumers are aware of these complex regulations, much less that they incorporate the regulations into their day-to-day marketplace expectations. There is no extrinsic evidence that the perceptions of ordinary consumers align with these various complicated labeling standards. See also Twohig, 519 F. Supp. 3d at 164 (quoting Wynn v. Topco Associates, LLC, No. 19-CV-11104, 2021 WL 168541, at *3 (S.D.N.Y. Jan. 19, 2021)); see also Clark v. Westbrae Nat., Inc., No. 20-cv-3221-JSC, 2020 WL 7043879, at *1, 4 (N.D. Cal. Dec. 1, 2020).  In sum, Plaintiff’s argument in the proposed SAC about the federal regulations also provided no basis for granting leave to amend, which would have been futile.

The Class Action Fairness Act has had a noticeable effect on class action practice.  One aspect of CAFA involves the need to assert jurisdictional minimums, as recently reaffirmed by the Eighth Circuit in Penrod v. K&N Eng’g, Inc., No. 20-1355, 2021 WL 4177761 (8th Cir. Sept. 15, 2021). The appeals court concluded that the plaintiffs failed to plausibly allege damages in excess of $5 million, as required for jurisdiction under the Class Action Fairness Act.

Plaintiffs are three individuals who purchased oil filters designed by defendant. They sought to represent a nationwide class of all purchasers of three styles of  oil filters that they alleged share a common defect that can cause these oil filters to suddenly separate or fracture. According to plaintiffs, the defect made the oil filters susceptible to failure and increased the risk of catastrophic failure such that, had defendant disclosed the defect, purchasers would have found the risk unacceptable, and not purchased.

Plaintiffs asserted a number of different claims, including breach of warranty, fraud, negligence, and strict liability. Each claim was dependent upon CAFA as the source of federal jurisdiction. The district court found that plaintiffs’ reliance on CAFA was ineffectual because they failed to plausibly plead an aggregate amount in controversy exceeding $5 million. Plaintiffs appealed, arguing they plausibly pleaded an amount in controversy in excess of $5 million.

Under CAFA, federal courts have jurisdiction over class actions in which the amount in controversy plausibly exceeds $5 million in the aggregate. 28 U.S.C. § 1332(d)(6); see also Raskas v. Johnson & Johnson, 719 F.3d 884, 888 (8th Cir. 2013). The district court found that most of plaintiffs’ proposed class members did not have a filter failure and thus did suffer any cognizable injuries or damages, and that the remaining class members did not plausibly allege total damages in excess of $5 million. Plaintiffs contended the district court erred in its analysis because the proper measure of damages here was the monetary difference between what the proposed class members should have paid for the potentially defective oil filters, in light of the alleged design defect and increased risk of catastrophic failure, and what they actually paid for them.

The court concluded that plaintiffs’ contention was unavailing as contrary to the long-standing rule that no tort claim for economic damages lies when a product is merely at risk of failing. Briehl v. General Motors Corp., 172 F.3d 623 (8th Cir. 1999).  Under 8th Circuit precedent, a cognizable tort claim arises when a defective product has actually malfunctioned or failed, not merely when a defect poses a risk or possibility of injury or damage.
According to its plain language, plaintiffs’ complaint alleged a defect in the oil filters makes them “susceptible” or at “risk” to fail.  Oil filters being susceptible to fail, or at risk of failing, is not the same thing as having failed, or being sure to fail. Cf. In re Zurn Pex Plumbing Prod. Liab. Litig., 644 F.3d 604, 617 (8th Cir. 2011).

Here, the determinative issue was whether the plaintiffs had alleged an aggregate injury sufficient to confer jurisdiction.  Plaintiffs tried to rely on various contract theories to argue that the uninjured class members did, in fact, have cognizable injuries. The plaintiffs, however, did not allege a claim for breach of contract in their complaint. They in essence tried to recast their product liability claim into a non-existent breach of contract claim. Plaintiffs also referred to an alleged economic injury that was suffered based on the difference in the price between the defective oil filter and a non-defective one. The court noted that unless/until the product fails or causes injury, the purchasers have received the benefit of their bargain. See
In Re: Polaris Marketing, Sales Practices and Products Liab, Litig., 2021 WL 3612758, at *3 (8th Cir. Aug. 16, 2021).

In this case, most of the oil filters at issue never failed. Plaintiffs could not simply “recast their product liability claim in the language of contract” to state a claim. Rivera v. Wyeth-Ayerst Lab’ys., 283 F.3d 315, 320 (5th Cir. 2002); see also Wallace v. ConAgra Foods, Inc., 747 F.3d 1025, 1030 (8th Cir. 2014).  Excluding the “no-injury” proposed class members, and even accepting as plausible plaintiffs’ estimation of the oil filters at issue that actually were defective and failed, they simply could not meet the jurisdictional threshold for damages. Of the three named class members, only one sustained engine failure that cost $10,000. The filter failure on the other two motorcycles resulted simply in oil leaking onto their rear tires. The math just didn’t work for plaintiffs with so many non-defective, non-failing filters.

We want to point out the cogent Comments by Lawyers for Civil Justice to the Advisory Committee on Evidence Rules in response to the Request for Comments on the Committee’s proposed amendment to Federal Rule of Evidence 702. Readers may know that LCJ is a national coalition of corporations, law firms, and defense trial lawyer organizations that promotes excellence and fairness in the civil justice system to secure the just, speedy, and inexpensive determination of civil cases. For over 30 years, LCJ has been closely engaged in reforming federal procedural rules in order to: (1) promote balance and fairness in the civil justice system; (2) reduce costs and burdens associated with litigation; and (3) advance predictability and efficiency in litigation.

Many courts have held that the critical questions of the sufficiency of an expert’s basis, and the application of the expert’s methodology, are questions of weight and not admissibility, but these rulings are an incorrect application of Rules 702 and 104(a).  The misunderstanding that underlies these rulings persists because Rule 702 clearly assumes, but does not explicitly state, that the court should apply Rule 104(a)’s preponderance standard to the question of whether proffered evidence is admissible before allowing the jury to determine what weight to give that evidence. The caselaw is replete with decisions based on this misunderstanding which in turn result in courts’ failure to exercise their “gatekeeping” responsibility. The Proposed Amendment, which would clarify that the proponent of expert opinion testimony must demonstrate the admissibility requirements “by a preponderance of the evidence,” is a much-needed and appropriate solution for this serious and widespread confusion.

Worth a read. LCJ Public Comment on Rule 702 Amendment Sept 1 2021.

The Ninth Circuit recently decertified a class of consumers claiming Coca-Cola falsely labelled its drinks as having no artificial flavors when they contain phosphoric acid.  In re Coca-Cola Prod. Mktg. & Sales Pracs. Litig. (No. II), No. 20-15742, 2021 WL 3878654, at *1 (9th Cir. Aug. 31, 2021).  Plaintiffs had sought injunctive relief, and the court of appeals concluded they lacked standing to bring such a claim. Accordingly the court did not need to reach the further argument that plaintiffs have no risk of injury because Coke’s ingredients appear on the label.  Yes, dear readers, another case which common sense might tell you a consumer’s “relief” if they don’t like an ingredient, is to read the label, see the ingredient, and buy something else.  What are labels for anyway?  Coke of course is the iconic flagship brand of a company that started in 1886 and has grown to encompass more than 500 brands with over 700,000 people at work.

“To establish injury in fact [for Article III standing], a plaintiff must show that he or she suffered ‘an invasion of a legally protected interest’ that is ‘concrete and particularized’ and ‘actual or imminent, not conjectural or hypothetical.’ ” Spokeo, Inc. v. Robins, 578 U.S. 330, 136 S. Ct. 1540, 1548, 194 L.Ed.2d 635 (2016) (quoting Lujan v. Defs. of Wildlife, 504 U.S. 555, 560, 112 S.Ct. 2130, 119 L.Ed.2d 351 (1992)); see also TransUnion LLC v. Ramirez,  141 S. Ct. 2190, 2200 (2021). Although one would think that a consumer who knew enough about an allegedly falsely labeled product to bring a federal lawsuit ought to know enough not to be injured by it in the future, the Ninth Circuit has identified examples of threatened future harm a consumer complaining of assertedly false labeling might plausibly allege: “she will be unable to rely on the product’s advertising or labeling in the future, and so will not purchase the product although she would like to” and “she might purchase the product in the future, despite the fact it was once marred by false advertising or labeling, as she may reasonably, but incorrectly, assume the product was improved.”

However attenuated, dare we say artificial, those examples may be, here none of the plaintiffs alleged a desire to purchase Coke as advertised, that is, free from what they believe to be artificial flavors or preservatives, nor did they allege in any other fashion a concrete, imminent injury. Instead, as plaintiffs explained in their brief, they had merely “stated that if Coke were properly labeled, they would consider purchasing it.” Under governing law, such an abstract interest in compliance with labeling requirements is insufficient, standing alone, to establish Article III standing. See Spokeo, 136 S. Ct. at 1550. Moreover, the imminent injury requirement is not met by alleging that the plaintiffs would consider purchasing Coke.

Two of the class reps testified in fact that they were not concerned with phosphoric acid, but rather with whether Coca-Cola was in their view “telling the truth” on its product’s labels. (Forgetting about the pesky ingredients list.)  Both asserted that they would be interested in purchasing Coke again if its labels were “accurate,” regardless of whether it contained chemical preservatives or artificial flavors. A plaintiff cannot satisfy the demands of Article III by alleging a bare procedural violation. Spokeo, 136 S. Ct. at 1550. And such an asserted informational injury that causes no adverse effects cannot satisfy Article III.

Words matter, and never is that more accurate than in a breach of express warranty claim. Plaintiffs were current and former employees of Delta Air Lines who wore uniforms manufactured by defendant Lands’ End. Plaintiffs originally alleged that the uniforms were defective because they transferred dye onto clothing and other property, and because they caused health problems, including skin rashes, hair loss, and headaches. Plaintiffs then moved to certify classes under Federal Rule of Civil Procedure 23 for two of their claims: (1) breach of an express warranty guaranteeing 100% satisfaction with the uniforms; and (2) breach of an express warranty guaranteeing that the uniforms would be free of defects in material and workmanship.

Some background: in 2016, Lands’ End contracted with Delta to manufacture uniforms for Delta employees.  Lands’ End warranted that the Delta uniform would:
(1) Conform to the d Samples, general specifications, and meet the wear life expectancies for each Product as specified….;
(2) Meet all applicable regulatory requirements;
(3) Be suitable for its intended use before the public; and
(4) Be free of defects in material and workmanship.

Lands’ End then manufactured nearly 100 different garments as part of the Delta uniform, including dresses, skirts, shirts, blouses, sweaters, jackets, and pants. Various chemical additives and finishes were used during the manufacturing process to make the garments stretchy, wrinkle- and stain-resistant, waterproof, anti-static, and deodorizing. Different chemical treatments were applied to different garments comprising the Delta uniform.

Since the Delta uniform launch in May 2018, the uniforms have been worn by approximately 64,000 Delta employees.  But between June 2018 and July 2019, Lands’ End received 2,470 complaints from Delta employees about the uniforms. Lands’ End divided the complaints into the following categories: skin irritation (1,192); allergies (419); and crocking (358). Lands’ End also received complaints that did not fall into these categories, including complaints about hair loss and headaches.

Plaintiffs sought certification of a nationwide class of Delta employees who were not 100% satisfied with the uniforms provided by Lands’ End. Both sides sought summary judgment on this breach of warranty claim.

In some cases, courts decide motions for class certification before ruling on summary judgment. Costello v. BeavEx, Inc., 810 F.3d 1045, 1057 (7th Cir. 2016). But courts may consider a dispositive motion before deciding class certification when doing so would be more efficient. Id. at n.3. See also Cowen v. Bank United of Texas, FSB, 70 F.3d 937, 941 (7th Cir. 1995) (explaining that it was appropriate for court to consider defendant’s summary judgment motion before deciding class certification). In this instance, the court concluded it was more efficient to consider the parties’ cross-motions for summary judgment on plaintiffs’ 100% guarantee claim.

Plaintiffs’ argument in support of summary judgment on this claim was straightforward. Plaintiffs were unsatisfied with the uniforms provided by Lands’ End. And because they were unsatisfied, Lands’ End had breached the express warranty provision by failing to provide them with refunds.
But, said the court, plaintiffs’ argument ignored the other language of the express warranty provision.   The contract stated that an unsatisfied, active Delta employee could obtain a refund or exchange from Lands’ End by returning the uniform piece to Lands’ End with a return or exchange form. Lands’ End would then process the return within four business days, providing the employee either a monetary refund or allotment credit, depending on how the uniform item was purchased. So to succeed on a breach of warranty claim under this provision, plaintiffs would need to show that they were active Delta employees who returned their uniform pieces with the proper form, but Lands’ End refused to provide them a refund or exchange.

Here, plaintiffs did not even allege that they tried to return their uniforms, let alone submit evidence showing that Lands’ End refused to provide them a refund. In contrast, Lands’ End submitted evidence showing that it never denied a refund or exchange to any named plaintiff who asked for one according to the proper procedures.  And that employees who did follow the process were able to exchange or receive refunds for their uniform pieces. Because plaintiffs have submitted no evidence showing that that any Delta employee returned a uniform piece according to the UAA return procedures but was denied a refund by Lands’ End, Lands’ End was entitled to summary judgment on this claim.

Interestingly, plaintiffs then suggested that the court could grant “conditional summary judgment,” and require plaintiffs to return their uniforms to Lands’ End before receiving a refund. Plaintiffs cited no legal authority that would permit a court to condition summary judgment on the parties performing specific acts. And plaintiffs did not explain why they need a court order to direct Lands’ End to comply with a warranty provision that they have agreed to comply with already.

Plaintiffs also contended that Lands’ End breached another express warranty —that the Delta uniforms would be “free from defects in material and workmanship”—by providing uniforms that crocked and transferred dye onto clothing and other personal property. Lands’ End did not move for summary judgment on this claim, so the court did address plaintiffs’ motion for class certification of this claim.

Plaintiffs’ effort to certify a nationwide class of Delta employees who have experienced the bleeding of colors and/or crocking onto their personal property from the uniforms floundered as plaintiffs had not shown that the proposed class meets the commonality requirements of Rule 23(a)(2). Under that requirement, a class action must involve “questions of law or fact common to the class.” Closely related is Rule 23(b)’s requirement that common questions predominate over questions affecting individual class members. An issue of fact or law is common only if it is capable of classwide resolution. Bell v. PNC Bank, Nat. Ass’n, 800 F.3d 360, 374 (7th Cir. 2015). In other words, class certification is appropriate only if the common questions have common answers. Wal-Mart Stores, Inc. v. Dukes, 564 U.S. 338, 349–50 (2011) (citation omitted).  Neither plaintiffs’ nor their expert’s assertion that the uniforms were defective was sufficient to establish a breach of warranty on a classwide basis. Plaintiffs pointed to nothing in the warranty promising that the garments will never crock nor that any amount of crocking is a defect. With respect to crocking, the specifications actually stated that the uniforms would meet certain testing standards relating to crocking and would be colorfast within industry tolerances. Even plaintiff’s expert admitted that it is impossible to totally avoid crocking with some colors, and that some amount of crocking is acceptable within the industry. So plaintiffs could not rely on their assertion of defectiveness to prove their claim on a classwide basis. And plaintiffs failed to put forth any other evidence that would help them prove, on a classwide basis, that each class member who experienced crocking had a uniform piece that failed to meet industry tolerances and testing requirements.

At this stage, the court made clear it was not evaluating plaintiffs’ evidence to determine whether plaintiffs are likely to succeed on their claims. Plaintiffs do not need to prove that they will prevail on the merits to establish that there are issues are common to the class. See Messner v. Northshore Univ. HealthSystem, 669 F.3d 802, 811 (7th Cir. 2012). But plaintiffs must show that the requirements of Rule 23 are met, and the court must make whatever factual and legal inquiries are necessary to determine if the requirements of Rule 23 are met, even if those inquiries overlap with the merits. Am. Honda Motor Co. v. Allen, 600 F.3d 813, 815 (7th Cir. 2010). This requires the court to “walk a balance between evaluating evidence to determine whether a common question exists and predominates, without weighing that evidence to determine whether the plaintiff class will ultimately prevail on the merits.” Bell, 800 F.3d at 377.

Plaintiffs’ ability to show a defect on a classwide basis was also complicated by the fact that Lands’ End provided nearly 100 different uniform pieces, produced by different manufacturers, to different specifications, and made with varying fabrics, dyes, and performance finishes. The various garments were worn by Delta employees in a variety of work situations, and the vast majority of them did not have crocking problems. Lands’ End also submitted evidence showing that crocking can be caused by misuse of a garment, such as by failing to follow laundering instructions. So plaintiffs had not made a convincing argument that common issues could be resolved on a classwide basis in light of these numerous individualized differences. Plaintiffs’ proposed classwide resolution could not account for what uniform piece class members wore, how the class members treated their garments, the amount of crocking class members experienced, the amount of property damage that occurred, if any, or whether the class members already received compensation from Lands’ End for damaged property.

Finally, under the superiority prong, plaintiffs’ plan for identifying class members presented “significant challenges.” Plaintiffs proposed that they would identify class members by reviewing employee complaints about crocking, employee lawsuits about crocking, and employee requests for reimbursement for damage to personal property from crocking. But admitted this wouldn’t be enough. Although they don’t say so explicitly, plaintiffs seemed to be proposing that they would need to send out notices to the approximately 64,000 Delta employees who have worn the Lands’ End uniform to determine which employees experienced crocking. This proposed individualized inquiry would present a significant burden that is not justified in light of the problems with the proposed class identified above. For all of these reasons, plaintiffs’ motion to certify the crocking class under Rule 23 was denied.

Here is one to watch.  The Pennsylvania Supreme Court has agreed to hear a case on recommendation from the Third Circuit dealing with when state law bars negligent design and strict liability claims related to medical devices. Melissa Ebert v. C.R. Bard Inc., No. 26 EAP 2021 (Pa.).

A little background. Ever since the Tincher case updated Pennsylvania’s product liability doctrine (erasing the old Azzarello doctrine), Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014), plaintiffs have attempted to muddy the prescription product waters given the Supreme Court’s decision to leave the precise contours of its rulings to the lower courts.  For example, the federal courts here are split over whether the “unavoidably unsafe product” exception of comment k to Section 402(A) to the Restatement (Second) of Torts, which expressly bars strict liability design defect claims against manufacturers of prescription drugs, also bars those claims against manufacturers of prescription medical devices. This despite the fact there is no principled distinction between prescription drugs and prescription medical devices for purposes of comment k analysis.

The district court in this matter got the comment k question wrong, but did recognize that in a negligent design claim against a prescription device, another contested area, the relevant duty of care is narrow,  A manufacturer breaches the duty only if it introduces a product too dangerous to be used by any patients. Ebert v. C.R. Bard, 2020 WL 2332060 (E.D. Pa. May 11, 2020).  The Third Circuit certified both questions. Petition for Certification of Questions of State Law, Ebert v. C.R. Bard, Inc., 2021 WL 2656690, at *6 (3d Cir. June 24, 2021).

The Court will consider the following issues: (1) Under Pennsylvania law, must a plaintiff bringing a negligent design claim against a prescription medical device manufacturer prove that the device was too harmful to be used by anyone, or may the plaintiff also prevail on other theories of liability where appropriate? (2) Under Pennsylvania law, are prescription implantable medical devices categorically subject to strict liability, categorically immune from strict liability, or immune from strict liability on a case-by-case basis? If they are immune on a case-by-case basis, what test should a court apply to determine whether a particular device is immune?

Stay tuned.

Readers may be interested in the new U.S. Chamber Institute for Legal Reform report, “The Food Court: Developments in Litigation Targeting Food and Beverage Marketing.”  The paper was authored by my colleagues Cary Silverman, Jim Muehlberger, and Adriana Paris.

It can be found online and deals with the increasing number of consumer class actions targeting food and beverage marketing; the rising trend in lawsuits targeting product flavoring or ingredients; the upsurge in “greenwashing” litigation alleging that company claims about eco-friendly practices are overstated; and the shift from California to New York of the dubious distinction of the nation’s most popular “food court” jurisdiction.

Worth a read.

 

The MDL court in the 3M Earplug litigation recently rejected defendant’s motion to delay a bellwether trial.  See In Re: 3M Combat Arms Earplug Products Liab. Lit., Case No. 3:19md2885 (N.D. Fla.).   Bellwether plaintiff Taylor had been set to go to trial in September, but voluntarily dismissed his claims on the eve of trial, after significant trial preparation and costs for this specific matter.  The court then substituted in another plaintiff (Adkins) from the bellwether pool on the same trial date, observing that the new plaintiff alleged similar claims of hearing loss and bilateral tinnitus while using 3M’s combat earplugs. Order.

The court said the parties should have anticipated from the beginning of the bellwether process that there would be instances where a bellwether alternate plaintiff would necessarily take the place of a bellwether plaintiff. “Thus, both sides already have all of the information they need to designate deposition testimony and create exhibit lists, and should have anticipated the possibility that Adkins would go to trial.” Id. at 2.

While the desire of the MDL court to keep the trains running and adhering to the trial schedule is understandable, the “anticipation” cannot reasonably mean that the parties should at all times be prepared to try every bellwether case on the first or next trial date.  It is typical for significant case-specific work be left to finalize, including the time-consuming work of preparing deposition designations, exhibit lists, and a pretrial stipulation.   The defendant argued that a better way to fill the void was to move up the next schedule plaintiff (set for October) with the thought that this case was much closer to ready.

Which brings your humble blogger to a more general point: in MDLs that have adopted the bellwether trial approach, the door is open for strategic manipulation by the PSC, as ultimately each plaintiff has the right to dismiss its case.  While there may, rarely, be valid reasons to dismiss a bellwether case voluntarily, much more common is for plaintiffs to do so to manipulate the takeaways from the bellwether process and avoid adverse outcomes.  Recognize where such a case typically sits.  It was investigated pre-complaint; it was filed in good faith and subject to Rule 11; it had been vetted for consideration of inclusion in the bellwether TRIAL pool; it may have already been subject to case specific motions to dismiss.  And then it was well into discovery, fact and expert.  Simply put, plaintiffs will often dismiss what they view as weak bellwether cases, whether they were originally selected by the court, or are a defense pick, or even a plaintiff mistaken selection.

For the MDL to work properly and fairly, the transferee court has to take steps to deter such manipulation, or mitigate it when it occurs.  Courts — and there is no silver bullet here — have  tried any number of responses.  These include dismissal with prejudice only, see In re FEMA Trailer Formaldehyde Prod. Liab. Litig., 628 F.3d 157 (5th Cir. 2010). Or when a defense pick is dismissed, allowing defendants to strike a plaintiffs’ selection. See In re Mirena IUD Prods. Liab. Litig., No. 13-md-2434, Case Management Order re: Second Disposition Pool Selection Process (S.D.N.Y. Apr. 20, 2015).
Costs and fees is another approach. See In re Zofran, No. 1:15-md-2657-FDS, MDL Order No. 27 (D. Mass. Oct. 9, 2019)(considering motions for fees and expenses for voluntarily dismissed bellwether cases)(note we were involved in that one).

A more far-reaching reaction was found in  In re Cook Filter MDL (amended bellwether), No. 1:14-ml-02570 (MDL S.D. Ind.)(Third Amended CMO #27, 10/26/2020), where the court had granted the defendants’ motion for summary judgment in the first case, based primarily on the statute of repose. Plaintiff voluntarily dismissed the second bellwether, citing rulings on statute of limitations in other IVC Filter cases. And then the MDL court granted a motion to voluntarily dismiss the third bellwether in line, with prejudice (which is essential to help avoid gamesmanship). After discussion, and with due consideration given to the impact of COVID-19 on the ability of the courts to conduct a jury trial in the near term, the MDL court then concluded that the MDL would benefit from a new staged approach to resolving the cases, including enhanced initial screening, hearings on the issue of whether cases in the pool presented a compensable injury, and only then moving to new bellwether trials. To make this happen, the court directed plaintiffs to conduct a thorough review of the pool of cases to determine if they were barred by the applicable statute of repose or statute of limitations, in light of the prior rulings in the litigation. Those cases get taken out of the pool. Then, before further significant pre-trial activity occurs, the court will address general procedural and/or substantive issues raised by the parties that may inform the parties of the merit of certain cases, and with the further goal of reducing the number of new filings, resolving certain sub-groups of cases, and thus avoiding unnecessary trial-related expenses.

Because some of the pool cases implicated the defendant’s position that a certain alleged injury did not constitute a compensable injury as a matter of law, the court would tackle this as the next stage, with dismissals to follow if the court should find that the allegations did not constitute a compensable injury. After that, the parties will designate their entries into a new pool, and the court will use random selection to identify 32 cases from the pool lists constituting the new “Initial Bellwether Discovery Cases.” After an update of records, the parties will get a chance to “strike” 8 cases each from the pool. Interestingly, any case in the pool as to which a party refuses to waive the venue rights recognized under Lexecon, such a refusal will constitute a strike for that side. This is perhaps a kind of unfair penalty or condition on a party exercising its constitutional rights, but may be an effective tactic. Following that, each side will get to submit a single brief on the parties’ positions on why any of the remaining cases should or should not be selected as a bellwether trial case.  Complex, but arguably needed given the dismissals.

MDL courts need to be creative and aggressive in dealing with such tactics which can undermine the bellwether procedures.

 

Personal jurisdiction — the issue of where a defendant can be sued — seems like it should be a straightforward issue.  But of course it is not, as the Supreme Court evolves its understanding of minimum contacts, the notion of doing business over the internet develops, state courts apply and misapply ancient “consent” to do business rules, and various jurisdictions decide as a policy matter to be open or closed to litigation tourism.

Today’s case is one we wished we would see more often. In Kingston v. Angiodynamics, Inc., 2021 WL 3022320 (D. Mass. Jul. 16, 2021), plaintiff sued alleging injuries from an implantable medical device manufactured by defendants, specifically a high-radiopacity catheter, comprised of a polymeric mixture of silicone and barium sulfate.  Barium sulfate is thought to contribute to the reduction of the mechanical integrity of silicone in vivo as the particles of barium sulfate dissociate from the surface of the catheter over time. Plaintiff asserted  that defendants’ manufacturing process involved too high a concentration of barium sulfate particles, leading to the improperly high viscosity of the raw silicone before polymerization and causing improper mixing of barium sulfate particles within the silicone matrix.

Defendants stood behind the product, and also moved to dismiss based on the absence of personal jurisdiction.  Kingston was a resident of Kentucky; the allegedly defective product was used in Kentucky, and the injury was suffered in Kentucky.  Plaintiff alleged in the complaint that AngioDynamics’ principal place of business and headquarters are in New York, but in seeking remand to state court, asserted that defendants’ core operations were actually in Massachusetts.  However, while there was some indication of some business  done in Massachusetts, this did not indicate Massachusetts was defendants’ principal place of business.  The defendants were a parent and subsidiary company both of which were incorporated in Delaware.  The parent corporation was headquartered in New York where  all significant corporate decisions for both the parent and subsidiary were being made. The court concluded that defendants’ principal place of business is not in Massachusetts. It made no difference which test was used to determine where defendants’ principal place of business was, the so-called  “nerve center test;” “center of corporate activity test;” or “locus of operations test.”  The answer was the same.

Some of these remand observations are on point for the motion to dismiss as well.  In determining whether a non-resident defendant is subject to its jurisdiction, a federal court exercising diversity jurisdiction is the functional equivalent of a state court sitting in the forum state. Daynard v. Ness, Motley, Loadholt, Richardson & Poole, P.A., 290 F.3d 42, 51 (1st Cir. 2002)  Accordingly, this district court could only exercise personal jurisdiction within the limits set by Massachusetts’ long-arm statute and the due process clause of the Constitution.

Kingston argued that the court had jurisdiction over defendants pursuant to a section of the Massachusetts long-arm statute which provides for the exercise of personal jurisdiction over an individual in a cause of action “arising from the person’s … transacting any business in this commonwealth.” Mass. Gen. L. c. 223A, § 3(a).  For jurisdiction to exist under this provision, the facts must satisfy two requirements—the defendant must have transacted business in Massachusetts, and the plaintiff’s claim must have arisen from the transaction of business by the defendant.” Exxon Mobil Corp. v. Attorney Gen., 479 Mass. 312, 317, 94 N.E.3d 786 (2018). The statute’s “arising from” requirement means a claim arises from a defendant’s transaction of business in the forum state if the claim was made possible by, or lies in the wake of, the transaction of business in the forum state.  The inquiry ultimately boils down to a but for causation test which asks, did the defendant’s contacts with the Commonwealth constitute the first step in a train of events that resulted in the personal injury.

On the specific jurisdiction prong, the court noted that plaintiff had adduced some evidence to support the assertion that defendants have a Massachusetts location at which some  employees conduct business, but she failed to support the assertion that “but for” defendants’ activities in Massachusetts, her injury would not have occurred. Defendants’ corporate decisions were made at its global headquarters in New York and their products—including the device at issue in this litigation—were manufactured in New York, which was also AngioDynamics’ sole United States manufacturing location. Plaintiff provided no evidence to support the contention that Defendants’ activities specific to Massachusetts caused the harm.

Even beyond the reach of the statute, under the due process clause, specific jurisdiction “may only be relied upon where the cause of action arises directly out of, or relates to, the defendant’s forum-based contacts.”  Pritzker v. Yari, 42 F.3d 53, 60 (1st Cir. 1994)). “In contrast to general, all-purpose jurisdiction, specific jurisdiction is confined to adjudication of issues deriving from, or connected with, the very controversy that establishes jurisdiction.” Goodyear Dunlop Tires Operations, S.A., 564 U.S. at 919. The specific jurisdiction inquiry is threefold: relatedness, purposeful availment and reasonableness.  Here, plaintiff’s attempt to rely on the Court’s recent decision in Ford Motor Co. v. Montana Eighth Jud. Dist. Ct., ––– U.S. ––––, 141 S. Ct. 1017, 1026, 209 L.Ed.2d 225 (2021) to support her argument was to no avail. Unlike here, the plaintiffs there were residents of the forum states, used the allegedly defective products in the forum states and suffered alleged injuries when those products malfunctioned in the forum states. Id. at 1031.

The court then turned to the general jurisdiction prong, and the due process limitations therein. Even if Kingston had satisfied her showing under the long-arm statute, which she did not, plaintiff  also failed to satisfy the due process analysis. “For jurisdiction to be proper, constitutional requirements of due process must be met.” Shipley Co. v. Clark, 728 F. Supp. 818, 822 (D. Mass 1990). General jurisdiction applies when the defendant’s contacts with the forum state have been “so ‘continuous and systematic’ as to render them essentially at home in the forum State.” Goodyear Dunlop Tires Ops., S.A. v. Brown, 564 U.S. 915, 919 (2011). Neither defendant could be characterized as “at home” in Massachusetts; conducting some business in the Commonwealth was inadequate for general jurisdiction purposes.

Plaintiff also sought leave to conduct jurisdictional discovery, but the court found that her allegations, even if proven, were too attenuated to state a valid claim and therefore such discovery would be futile.

Today’s post involves Couturier v. Bard Peripheral Vascular, Inc.,  2021 WL 2885903 (E.D. La. Jul. 8, 2021).  This products liability action was remanded from the MDL In re: Bard IVC Filters Products Liability Litigation, MDL 2641 (D. Az.).  Plaintiff alleged injuries suffered after being implanted with an Inferior Vena Cava (“IVC”) filter medical device manufactured by defendants.  An IVC filter is a device that is designed to filter or “catch” blood clots that may travel from the lower portions of the body to the heart and lungs.  IVC filters have been on the market for decades but were limited to patients who could not manage their DVT/PE with prescribed medications.  Defendants were the first medical device manufacturer to obtain FDA clearance for marketing a “retrievable” IVC filter in July 2003.

Defendants moved for summary judgment on all claims asserting a lack of proof of causation.  Plaintiff’s suit was governed by Louisiana law which means his exclusive cause of action was under the Louisiana Products Liability Act (LPLA).  To prevail under any theory under the LPLA, a plaintiff must establish four elements: (1) defendant manufactured the product at issue; (2) plaintiff’s injury was proximately caused by a characteristic of the product; (3) this characteristic made the product unreasonably dangerous; and (4) plaintiff’s injury arose from a reasonably anticipated use of the product by plaintiff or someone else. Stewart v. Capital Safety USA, 867 F.3d 517, 520 (La. 2017) (citing Stahl v. Novartis Pharm. Corp., 283 F.3d 254, 260-61 (5th Cir. 2002)). A “proximate cause” is generally defined as any cause which, in natural and continuous sequence, unbroken by an efficient, intervening cause, produces the result complained of without which the result would not have occurred. Marable v. Empire Truck Sales of Louisiana, LLC., 221 So. 3d 880, 901 (La. Ct. App. 2017). Under Louisiana law, plaintiff bringing products liability action must prove not only causation-in-fact, but also that product was most probable cause of injury. Wheat v. Pfizer, Inc., 31 F.3d 340, 342 (5th Cir. 1994) (citing Brown v. Parker-Hannifin Corp., 919 F.2d 308, 311 and n.9, 312 (5th Cir. 1990)).

The court first addressed the design defect claim, noting the plaintiff must show that an alternative design existed for the product at the time it left the manufacturer’s control, and the alternative design was capable of preventing the plaintiff’s damage. Bernard v. Ferrellgas, Inc., 689 So. 2d 554, 558 (La. Ct. App. 1997). If there was no alternative way to make the product safer, the defendant could not have prevented plaintiff’s injuries and therefore, the defendant is not liable under a design defect theory.  Louisiana courts have determined whether an alternative design was capable of preventing plaintiff’s damage through a cause-in-fact analysis,  Defendant argued that plaintiff’s experts conceded that all IVC filters can fracture and perforate. As these are known risks, warned about on the label, they cannot constitute design defects.  Because plaintiff failed to provide evidence of a design defect or of an alternative filter that could have prevented his injuries, defendants were entitled to summary judgment on plaintiff’s design defect claims.

Turning to the failure to warn count, the court noted that a manufacturer’s duty to warn is a continuing one; the court concluded that a genuine issue of material fact existed whether the alleged  increased rate of failure of the filter rendered defendants’ warnings inadequate. Therefore, summary judgment was denied on  this question.

Defendants’ motion was granted on the warranty count, as plaintiff failed to provide sufficient evidence that any statements by defendants ever induced the use of the filter. In fact, the prescriber testified that the only factor causing him to use the specific filter was the fact that it was the only IVC filter the hospital had available.  Therefore, plaintiff’s breach of express warranty claim failed.

Finally, the court denied plaintiff’s motion for summary judgment on defendant’s affirmative defenses.

Failure to mitigate and comparative fault-  The plaintiff had failed to seek treatment for five years after the IVC filter was implanted and ignored his physician’s recommendations after the perforation was first discovered.

Comparative fault of non-parties: This defense was supported by adequate evidence to create an issue of fact based on the surgeon’s testimony that he did not follow the manufacturer’s guide in several material ways.  He conceded that he did not measure plaintiff’s inferior vena cava prior to implanting the filter.  And that he could not remember the amount of pressure that was used when injecting the contract medium through the dilator and thus could not confirm if it was more or less than specified.

Assumption of the risk: Plaintiff’s spouse had signed an informed consent form acknowledging  that plaintiff’s surgeon advised him of all known risks and that plaintiff accepted all those risks by undergoing the surgery.

Nearly a clean sweep.