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It is hard to imagine a less qualified expert witness than the one retained by plaintiff in Krom v. Smith & Nephew, Inc., 2024 U.S. Dist. LEXIS 121618 (N.D.N.Y Jul. 11, 2024).  And since truth is often stranger than fiction, we are just going to give it to you straight.

Plaintiff, a 73-year-old, morbidly obese man, underwent a hip replacement and six months later, the implanted device fractured.  Id. at *3-4, *8.  Plaintiff retained a mechanical engineer to opine, ostensibly, on design and manufacturing defect.  That expert’s report offered three opinions:  the device did not meet certain industry standards; defendant failed to provide adequate warnings; and defendant “deceived” the FDA.  Id. at *10. 

Starting with qualifications, the court provides a laundry list of all the ways this expert was unqualified.  We’ll offer some highlights:

  • She is not a biomechanical engineer nor a medical doctor;
  • She has never worked for a medical device company or the FDA – in fact she didn’t the know difference between a 510(k) clearance and PreMarket Approval;
  • Her litigation consultant experience was almost completely related to lithium-ion battery failures and her only other medical device case was about the battery in a pacemaker;
  • Her only warnings experience was for a technology company and not related to a medical device.

Id. at *18-22.  Leading the court to find her unqualified “by experience, knowledge, skill, training, or education to offer any opinion regarding the medical device at issue.”  Id. at *22. 

And, as if that was not enough, the expert’s opinions were also unreliable.  To the extent any methodology was described, it consisted “primarily of speculation based on her personal and non-medical device experience.”  Id. at *23. 

First, she testified at her deposition that she was not offering an opinion that the device had either a manufacturing or a design defect.  Id. at *11.    So what purpose was this engineer supposed to serve?

Her only “defect” opinion was as to warnings.  She opined that, based on her experience at a technology company, additional information should have been provided to doctors in a “kind of like semi-secret chart.”  Id.  Maybe with a decoder ring too?

Even more unbelievable, plaintiff’s expert’s opinion on what information should have been provided by the hip implant manufacturer to the implanting surgeon was based on her personal experience with her father’s heart surgery.  She believed it was “normal procedure” for surgeons to ask sales representatives for detailed information and get their recommendations on what devices to use because that is what her father’s surgeon told her he did.  Id. at *23-25.  That’s as much an “expert” opinion as Aunt Betty’s opinion that eating carrots improves your eyesight because her 65-year-old neighbor loves carrots and still has 20/20 vision.   

Plaintiff’s expert’s industry standards opinion was based on applying a set of standards that she thought maybe were used by device manufacturers and that she did not know whether they were required by the FDA.  Id. at *12.   Maybe is never good enough for expert testimony.

And, finally on misleading the FDA, plaintiff’s expert had to admit that the information she was fussing over was provided to the FDA, but maybe the FDA missed it because it was “small.”  Id. at *13-14.  We warned you–you can’t make this stuff up.

Not surprisingly, the court went on to grant defendant’s summary judgment motion.  First, plaintiff had to abandon his design and manufacturing defect claims because, after all, his expert said she wasn’t offering those opinions.  And an attempt to offer an new affidavit by the expert in response to the motion that directly contradicts her prior testimony is a sham affidavit that the court was free to ignore.  Id. at *30, n.13.

That meant that plaintiff’s negligence and strict liability claims were based only on failure to warn.  While plaintiff tried to argue that was a fact-intensive inquiry, the “facts” were that plaintiff’s surgeon testified he did not review the manufacturer’s Instructions for Use which contained numerous warnings and that he had independent knowledge of the risks, including the risk of fracture.  Id. at *33-34.   Therefore, plaintiff’s failure to warn claims fail for lack of evidence of causation.  His surgeon was a learned intermediary and he “was sufficiently warned.”  Id. at *34.  Plaintiff failed to oppose defendant’s summary judgment motion as to breach of warranty claims and so the court also considered those abandoned and dismissed them.  Id. at *35.  They likely would have been dismissed for lack of reliance even if opposition had been lodged because plaintiff admitted he had no contact with the defendant, received no information from the defendant, and was unaware of any warranty by the defendant.  Id.

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As many of you no doubt already know, the federal judiciary’s Committee on Rules of Practice & Procedure gave its final approval to new Fed. R. Civ. P. 16.1, concerning MDL practice, on June 4.  Here’s some commentary.  We’ve also mentioned the proposed rule here on the Blog.  Bexis went so far as to file an extensive comment on the proposed rule, primarily decrying the frequency with which MDL judges simply ignored the existing federal rules – most significantly (although hardly exclusively) those rules that act to weed out meritless claims in non-MDL situations.

Throughout the process that led to new Rule 16.1, the drafters consistently refused to impose any mandatory procedures at all for early vetting of the hordes of meritless to utterly frivolous claims that are routinely filed in mass tort MDLs.  Thus, we bloggers were skeptical that all the effort to create a new, entirely voluntary list of potential MDL management tools was worth the candle.  Indeed, new Rule 16.1 stands out like a sore thumb among the Federal Rules of Civil Procedure, precisely because it lacks any mandatory requirements.  The new rule has lots of “shoulds” but practically no “shalls.”  See Approved Committee Note and Text of Fed. R. Civ. P. 16.1.

Taking a closer look, we now believe that, if used according to its terms, new Rule 16.1 would actually be better than no rule at all, albeit not by a lot.  MDL cases now comprise over 70% of the total federal caseload, so we still believe it is ludicrous that those cases are not subject to a single mandatory MDL-specific rule.  But Rule 16.1 it is what it is.

Continue Reading New Rule 16.1 – Better Than Nothing, But Not by a Lot
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We have been to Montana only once.  Through various life events, we have traveled by highway from the San Francisco Bay Area to the Midwest multiple times, so we are somewhat familiar with the mountains of Utah, western railroad towns like Cheyenne and North Platte, and the long rolling expanse known as Nebraska.  We never ventured into Montana, however, until just a few years ago, when the Drug and Device Extended Family needed a pandemic get away.  So we climbed in our cars and caravanned more than 1000 miles to a rented house near a town called Big Sky.  It was just what we needed—remote and lovely by equal measures. 

Montana is perhaps best known as the home of Yellowstone National Park (at least part of it) and the location of General Custer’s last stand at Little Bighorn.  It has, however, much more to offer.  Glacier National Park is a destination of its own, and the Gallatin River has some of the best fly fishing in the world (which we did not try) and terrific whitewater rafting (which we did).  Montana is, of course, the fourth largest U.S. state, but also one of the least densely populated, with nearly as many deer, elk, and antelope as people.  We are told that famous people from Montana include daredevil Evil Knieval and football legend Joe Montana.  For Knieval, we believe it.  But Joe Montana from Montana?  We don’t think so.  We will need to see a birth certificate before we buy that one, preferably the long form.  Perhaps the best fun fact about Montana is that it is the only state with a so-called “triple divide,” which allows water to flow into the Pacific, Atlantic, and Hudson Bay. 

One thing that Montana surely lacks is an Attorney General with authority to enforce the Food Drug and Cosmetic Act.  This is not unique.  No more than any other non-federal entity, a state AG cannot privately litigate an alleged violation of the FDCA.  Take for example a recent Montana case involving tobacco, Grand River Enterprises Six Nations, Ltd. v. Knudsen, No. CV-23-48, 2024 WL 3228181 (D. Mont. June 28, 2024).  The plaintiff sold cigarettes in Montana under an agreement with the state, but the state sent the plaintiff a letter noting that the plaintiff had withdrawn certain tobacco products from FDA substantial equivalence review, resulting in them being considered misbranded and adulterated.  The state ultimately sent all Montana wholesalers a notice prohibiting them from selling the plaintiff’s products, which the plaintiff did not like.  Id. at *1-*2. 

The plaintiff cigarette seller therefore sued the state, and after multiple motions and a trip to the Ninth Circuit, the plaintiff won an order restoring its right to sell tobacco under its agreement with Montana.  Why?  Because the Montana AG expressly based its action against the plaintiff on purported violations of the FDCA, which is not allowed: 

The FDCA speaks in no uncertain terms concerning enforcement power: “. . . all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.” 

Id. at *4 (quoting 21 U.S.C. § 337(a)) (emphasis added).  This is one of our favorite provisions of the FDCA, and this district court faithfully applied it.  As a result, federal law preempted the Montana AG’s action because the AG was purporting to enforce the FDCA:

Federal law preempts the Attorney General’s removal of [Plaintiff] from the Montana Tobacco Directory in this instance . . . because an alleged violation of the FDCA served as the basis for the removal when the FDCA provides no private right of action. 

Id.  Moreover, the state could not bootstrap its way into an enforcement action by asserting that it was actually enforcing state law.  That is because its communications to the plaintiff had all stated that the plaintiff’s conduct was “in violation of federal law.”  As the court ruled,

The Attorney General’s post hoc justification that [Plaintiff] was removed from the Montana Tobacco Directory for violating state law and the [agreement with the state] proves unavailing when the Attorney General’s . . . notice of removal letter lists only a violation of federal law as the basis for [Plaintiff’s] removal.

Id.  This is the correct result for the correct reason.  The district court relied heavily on Buckman and its holding that the FDCA impliedly preempts state law claims based solely on a violation of the FDCA.  The result is also relevant to our drug and device world, where state AGs sometimes form views on what drugs should be sold within their states’ borders and which drugs should not.  In the absence of federal FDA enforcement, the message is nothing doing. 

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Two years ago, in Nexus Pharmaceuticals, Inc. v. Central Admixture Pharmacy Services, Inc., 48 F.4th 1040 (9th Cir. 2022), the Ninth Circuit held that the FDCA impliedly preempts private suits brought under state statutes that “rel[y] on the [FDCA], not traditional state tort law theory,” to define state-law requirements. We were so pleased with the Nexus decision that we designated it one of our top-ten decisions in 2022. At the time, we thought that defendants could use Nexus to win dismissal of “much, if not all, of the economic-loss food litigation” brought under California’s Sherman Law—a statute that incorporates by reference the food-labeling requirements adopted under the FDCA.

Alas, our optimism may have been premature.

Last week, in Davidson v. Sprout Foods, Inc., — F.4th —-, 2024 WL 3213277 (9th Cir. 2024), a divided Ninth Circuit panel reversed a trial court decision we had applauded and held that the FDCA does not impliedly preempt food-labeling claims brought under California’s Sherman Law. As the dissenting judge explained, the majority opinion is contrary to Nexus and, more fundamentally, to 21 U.S.C. § 337(a) as construed in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).

Section 337(a) states that, subject to certain exceptions, all actions to enforce the Food, Drug, and Cosmetic Act “shall be by and in the name of the United States.” This provision, said the Supreme Court, “leaves no doubt that,” as a general matter, “it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the [FDCA’s] provisions.” Buckman, 531 U.S. at 349 n.4.

Under Buckman, whether a particular state-law claim is impliedly preempted by § 337(a) depends on the origin of the duty that the claim seeks to enforce. Private claims that seek to enforce duties that “exist solely by virtue of the FDCA” are preempted, while claims that rely exclusively “on traditional state tort law which … predate[s]” the FDCA are not. Buckman, 531 U.S. at 352–53.

Despite acknowledging that the food-labeling requirements imposed by California’s Sherman Law are, by definition, the requirements established by the FDCA, the Davidson majority held that § 337(a) does not preempt private suits to enforce those requirements because, it said, “plaintiffs are claiming violations of California law, the Sherman Law, not the federal FDCA.” 2024 WL 3213277, at *6. According to the majority, § 337(a) has no bearing on private actions to enforce California’s Sherman Law because it “addresses only enforcement of the federal law.” Id. at *7.

In the eyes of the Davidson majority, it would make no sense to hold private Sherman Law claims impliedly preempted when a provision of the FDCA—namely, the express-preemption clause of the Nutrition Labeling and Education Act (NLEA)—allows states to adopt food-labeling requirements “identical” to those adopted under the NLEA. 21 U.S.C. § 343-1(a). There is, the majority said, “no reason … why Congress would permit states to enact particular legislation and then deny enforcement by their citizens.” Davidson, 2024 WL 3213277, at *6.

But, as the dissent notes, that logic suffers from several flaws.

First, “the majority’s reasoning wrongly equates the scope of the FDCA’s express preemption with the scope of its implied preemption.” Davidson, 2024 WL 3213277, at *16 (Collins, J., concurring in part and dissenting in part). Buckman “held that the plaintiffs’ … claims were impliedly preempted without regard to whether the alleged state-law duty on which they rested was expressly preempted by the FDCA.” Id. Thus, “the crucial question remains whether private enforcement of the non-expressly-preempted state statute is impliedly preempted due to the fact that the state cause of action, as in Buckman and Nexus, parasitically relies on the FDCA.” Id. at *17. “By wrongly equating express preemption and implied preemption here, the majority’s opinion simply begs that critical question and thus provides no answer to it.” Id.

Second, “the majority’s rhetorical question—why would Congress ‘permit states to enact particular legislation and then deny enforcement by their citizens[?]’—has an obvious answer.” Davidson, 2024 WL 3213277, at *17 (Collins, J., concurring in part and dissenting in part). Although 21 U.S.C. § 337(a) gives the federal government exclusive authority to enforce most provisions of the FDCA, § 337(b) creates an exception that allows states to enforce select provisions, including the food-labeling requirements adopted pursuant to 21 U.S.C. § 343(r). Notably, however, § 337(b)(1) allows only a “State” to bring such an enforcement action and only “in its own name.” There is, therefore, nothing “anomalous” in limiting the enforcement of identical state-law labeling requirements to “the same public enforcement mechanisms.” Davidson, 2024 WL 3213277, at *17.

Third, the majority’s holding is contrary to congressional intent. “Had it wanted to do so, Congress could have added private enforcement authority to the new food-labeling provisions, but it did not.” Davidson, 2024 WL 3213277, at *18 (Collins, J., concurring in part and dissenting in part). In allowing private actions to enforce requirements taken directly from the FDCA’s food-labeling requirements, Davidson permits “precisely the private enforcement remedy that Congress deliberately withheld when it enacted the NLEA.” Id.

We hope that Judge Collins’ forceful dissent leads the Ninth Circuit to reconsider Davidson en banc. The prerequisites for en banc review are present: the panel decision, which implicates an important statutory question, conflicts with not only prior Ninth Circuit precedent but also Buckman, which squarely held that the FDCA impliedly preempts any state-law claim that—like a claim under California’s Sherman Law—“exists solely by virtue of the FDCA.” 531 U.S. at 353.

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When Summer temperatures rise, our analytical ambitions drop. Torpor sets in, and it sets in hard. It is no accident that it is in July and August when our posts are most likely to contain more pop culture than precedent. (Here is one of our favorite examples.) Meanwhile, this is also the time of year when we tinker with the lesson plan for the litigation strategy class we teach each Fall at the University of Pennsylvania Law School. One of the points we’ve been pounding home in that class over the last thirteen years is that lawyers can learn a lot from other occupations.

Lawyers, more than other learned professionals, seem allergic to systems.  But systems, routines, habits, etc. can be useful, even vital. For example, we’ve tried to show our students how lawyers can apply the medical profession’s SOAP (subjective, objective, assessment, plan) process when advising clients.  We also discuss the utility of the sorts of checklists that airline pilots go through when they climb into the cockpit. It is useful to have ready-made checklists at hand for responding to complaints, preparing deposition outlines, and putting on presentations before mediators and judges. And then there are the SWOT (strengths, weaknesses, opportunities, threats) analyses that even a wet-behind-the-ears MBA holder can deploy, while most attorneys have no clue about them. A cogent SWOT analysis can both frame a litigation strategy and guide a productive dialogue with the client.

What about chefs? Can/should lawyers adopt any of their practices?  Should we start our oral arguments with an amuse bouche?  Push the daily specials? There are some commonalities between the culinary and legal crafts.  Both are service industries.  Client satisfaction is essential to stay in business.  In the last episode of the most recent (the third) season of the Hulu/FX television show, The Bear, the great chef Thomas Keller (French Laundry, Per Se) says that running a restaurant is about nurturing. There’s some nurturing in the law, too, and not only with pro bono clients. Lawyers do their best to get clients through tough times. Preparing a C-suite witness for a hostile deposition involves more than a little hand-holding.

There is another commonality between lawyers and chefs: running a restaurant, like running a law firm, is a team effort. There is a division of labor.  There is hierarchy.  At the same time, there is plenty of room – sometimes too much – for individual expression. And, as Samuel Goldwyn bemoaned about movie studios, the key assets of law firms and restaurants go home every night. It takes only one disgruntled team member to undermine the entire effort, ruin team dynamics, or leave the rest of the team members hanging.  What good is whipping up a perfect souffle if it ends up in the diner’s lap?

All of which brings us to the question of whether we lawyers can learn anything from The Bear.  Larry David and Jerry Seinfeld famously decreed that there would be no learning allowed in the Seinfeld sitcom.  But we think it is possible to learn from almost anything, especially something as well conceived as The Bear.  If you haven’t seen the show, you should give it a try. One taste of it will likely have you coming back for more.  We know people who binge an entire season at a time.  Perhaps that is a bit gluttonous. 

The Bear won the Emmy award for best Comedy, which seems like a category error, even if the show has some humorous moments. The show is about a tortured, world class chef, Carmy Berzatto (nicknamed The Bear), who inherits an Italian Beef joint in Chicago.  (The details of how that inheritance happened is one of the crucial and continuing backstories in the show.) There are plenty of such casual sandwich restaurants in Chicago. Residents of the Windy City debate about which one is the best, just like people in our town choose sides over cheesesteaks.  We think Italian beef sandwiches are pretty darned tasty.  But Carmy has higher aims in mind.  After getting the employees into shape to elevate Italian beef, he pivots to turning the place into a fine dining experience.  Carmy’s aim is to earn at least one Michelin star. 

It reminds us of a couple of law firm leaders we worked with who were determined to elevate their firms into the top tier (measured by some combination of prestige, quality, and the inevitable profits-per-equity-partner).  It takes vision.  It takes commitment.  It takes work.  It is not easy.

Seasons one and two of The Bear gave us some of the best television episodes in recent memory. The show can be riveting and surprising.  It can also be stressful. In season one, we squirmed during an episode where too many orders came in too fast via an automated system.  There was too much for the staff to do in too little time.  The click-a-click-a-click-a of the incoming orders became maddening. One of the themes of The Bear is that “every second counts.”  Time is short.  Getting things right under time pressure is hard, but it is necessary.

The best episode in season two showed how a rough-around-the-edges-‘cousin’ discovered the meaning of service by working one week at a Michelin starred restaurant. Everything had to be perfect.  Forks were polished and placed just so.  (It was a real Chicago restaurant — Ever.) in another episode, the quiet, contemplative dessert chef honed his craft during a brief sojourn at Noma, the Copenhagen restaurant that often topped Best Restaurant in the World lists. And then there was the fan favorite episode when a family Feast of the Seven Fishes turned crazy and violent. 

The Bear treats all of its characters with respect.  But if we had to single out one obsession in the show, it is the exploration of what inspires Carmy’s drive to sling excellent, astonishing, thrilling food (e.g., lemon chicken piccata, cola-braised short ribs with risotto, plum gelee, a perfect donut, and an even more perfect omelet) — and what costs are associated with such a drive. Stress is clearly a cost. We know many viewers of The Bear who reported that some episodes took their blood pressures on roller coaster rides.

Season three is more of a mixed bag. Maybe that is because it seems designed to set up season four, which was filmed simultaneously with three. In the first episode of season three, Carmy sets out his rules for the restaurant.  He calls those rules “Non-Negotiables.”  Several critics have asserted that season three failed one of those rules: “Less is more.”  Or, as a tyrannical chef who trained Carmy said in one unpleasant teaching moment, “Subtract.”There does seem to be a bit too muchness this season.  A lot of emotional plate-spinning takes place. 

The ideas of “less is more” and “subtract” can apply to the law as well.  At a bench-bar conference we attended a couple of weeks ago, and which we alluded to here, plaintiff lawyers and judges poked fun at defense hacks for filing Rule 702 motions against every plaintiff expert on every ground in every case.  We’ve also heard judges criticize legal briefs for loading up on too many arguments, as opposed to prioritizing the strongest or most important ones.  And who hasn’t heard a judge complain that the parties were “overtrying” a case? To be sure, the sin of too muchness is not confined to the right side of the v.  We have posted on instances (here, for example) in which plaintiffs put too much in their complaints, effectively pleading themselves out of court.

So “less is more” is a good rule in the kitchen and the courtroom.  Do not bury the wagyu strip under a pile of creamed corn.  Do not bury your best argument under a pile of trivial or weak points.

Another of Carmy’s Nonnegotiables is “Focus,” which seems to be the right corrective for too muchness. The applications to the law of other Nonnegotiables such as “Pursuit of excellence,” “Always improving,” and “Know your s****,” seem self-evident.  Law firms sometimes simply assume that graduates of top-flight law schools will come on board with all those virtues in place.  They are wrong.  Training is needed.  Do not fool yourself into thinking that throwing young lawyers into the deep end will turn them into Michael Phelps.  In real life, people do occasionally drown.  Carmy also insists on “Consolidation and speed” and “In and out service.”  He is not running a fast food outlet, so why all the insistence on celerity?  The answer is that there is a lot to do in the kitchen, and customers do not like to be kept waiting.  We think “In and out service” does not refer to the SoCal burger chain (splendid though it may be), but, rather, to the concept of rendering superior service during every aspect of the work.  A long time ago, we heard that Joe Flom, the lawyer whose vision turned Skadden into a premier law firm, had a policy of answering his own phone and of returning every client call promptly.  If Joe Flom could do that, what could possibly be our excuse for not doing it?  Fast responses and the ability to produce first rate work product quickly are hallmarks of a successful law firm.  We wish we could say that the key is to work smarter, not harder.  The reality is that good lawyers must work smarter AND harder.

Carmy’s list includes the rule that “Details matter.”  We remember when “attention to detail” had its own section on law firm internal evaluation forms.  We want young lawyers to display analytical ability and creativity.  But, at a minimum, we need young lawyers to make sure all the details are considered and handled correctly. Citing overruled cases, citing cases for basic propositions even though those same cases are adverse on more important points, ignoring Local Rules, and spelling the client’s name wrong are wonderful ways to lose credibility.  It’s like ordering a salad with the dressing on the side, and then getting your plate with greens swimming in vinaigrette.  You just know the meal is going to be subpar.

The relevance of other Nonnegotiables is a bit more obscure.  The first Nonnegotiable on Carmy’s list is “of the place.” Huh?  We are not even sure what that means in terms of food preparation. Maybe it refers to local ingredients. More than once, characters in the show say that “what grows together goes together.”  The best we can do in terms of a legal analogy is the importance of understanding the rules in specific jurisdictions.  There are lots of local traps for the unwary out there, so don’t be unwary.  For example, we found out that how one argues for exclusion of experts in Illinois state court (they are called Frye motions, not Daubert motions there) is very specific and very different from other courts, including other courts that purport to apply the Frye standard. Also, before you defend a deposition, make sure you know what the local rule is as to whether you can confer with the witness during breaks. (Luckily for you, we have some posts on precisely that issue.)

We do not agree with every one of Carmy’s rules.  He forbids repeat ingredients and wants a new menu every day.  For the legal profession, we need to repeat arguments.  It is hard to ask a judge to do something that has never been done before.  Then again, we should never develop arguments simply by rote.  There is room for innovation.  But innovation for the sake of innovation might just be showing off, and that is counterproductive.  In The Bear, Carmy’s insistence on never repeating menu items creates problems.  The Chicago Tribune sent a photographer to the restaurant to take pictures that would accompany an upcoming review.  The photographer wanted to snap a picture of a duck dish that the reviewer had tried.  Guess what?  Duck was off the menu the day the photographer was on site. Not good.   

In real life, we complain when we see the same menu month after month, and year after year.  At the same time, customers hear about superb dishes and want to try them.  When we went to Paul Bocuse’s restaurant many years ago, we were salivating at the prospect of trying his famous fish-in-pastry recipe.  It did not disappoint.  If it was not available, we would have felt cheated. 

Our favorite Nonnegotiable is “vibrant collaboration.” The beauty of The Bear is that we come to admire and care about all the employees at the restaurant.  They each get their moments to shine. They are motivated by Carmy’s vision. But does Carmy practice what he preaches?  He is too often dismissive of suggestions by his sous chef, Sydney. That dismissiveness, plus Carmy’s monomania, might result in his loss of his most important coworker — and he does not have a clue that her departure is in motion.  Carmy also does a lot of yelling, and he chases away his only shot at a love interest. After a point, the viewer wonders whether Carmy is the hero of the show.  Or is he the latest in the line of “difficult men” who populate prestige television (Tony Soprano, Don Draper, Jimmy McNulty)?

How did Carmy get the way he is – so talented, so wounded?  Carmy had several chef mentors throughout his career.  We mentioned Thomas Keller above. Carmy also worked with Daniel Boulud, one of New York’s finest chefs.  He also worked with another, fictional chef, played by Olivia Colman.  Keller, Boulud, and Colman are all shown in flashbacks to be gentle, supportive, albeit firm, teachers.  But the chef who seems to have made the biggest mark on Carmy is a fictional chef played by Joel McHale.  McHale’s method of instruction is harsh and demeaning.  He might have been “vibrant,” but there does not appear to have been much collaboration.  In the finale of season three, Carmy confronts McHale to gripe about past cruelties. McHale smugly says, “You’re welcome.”  McHale tells Carmy that Carmy got great at what he does because McHale set such high, unforgiving standards. Maybe that is so, but the cost seems too high.  Carmy apparently gets no satisfaction from his wonderful cooking, and manages to repel colleagues and loved ones. 

It used to be well accepted that law students and young lawyers had to run a gauntlet of brutality.  Law professors eviscerated students with the Socratic method of guess-what-I’m-thinking.  First and second year associates pulled all-nighters and were berated for any shortcomings.  We blogged a couple of years ago about a lawyer who made us better – a better researcher, better writer, and better thinker – by setting expectations in the stratosphere and then verbally blasting us if we fell short of such expectations.  Thank goodness we had the opportunity to work with him, but also thank goodness he wasn’t the only mentor we had.  One can certainly learn from a tough, taskmaster boss. But one wouldn’t want to spend one’s entire career at the mercy of a shouter.  And we wouldn’t want to be that shouter.  “Vibrant collaboration” must consist of more kindness than cruelty. 

We suspect that in season four of The Bear Carmy will come to understand what vibrant collaboration means.  The chef played by Olivia Colman says that customers at a restaurant end up remembering more about how well they were treated and less about the particulars of the food. People matter more than things. That’s a lesson we all can learn, whether we dish out Beef Wellington or preemption arguments. And then perhaps we will achieve another one of Carmy’s Nonnegotiables — “joy.”

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The plaintiff in Pachecho v. Johnson & Johnson, 2024 WL 3260883 (M.D. Ga. Jul. 1, 2024), both over-pleaded her causes of action and under-pleaded their factual support (at least as to manufacturing defect).  Both errors led the court do a little pruning.  And while the cases continues, we hope in its uncluttered state, the weakness of the surviving claims more readily stands out.

First up were plaintiff’s over-pleaded negligence and gross negligence claims.  Plaintiff alleged defendant was negligent or grossly negligent in “the design, manufacture, testing, inspection, processing, advertising, marketing, labeling, assembling, packaging, distribution, detailing, promotion and sale of the Product.”  Id. at *1.  Defendants argued that the only potentially viable negligence-based claims were for the “three recognized” products liability claims—design defect, manufacturing defect, and failure to warn.  Id. at *3.  Looking to decisions by other district courts on the issue and the Third Restatement of Torts, the court here agreed.  Id. at *4. 

Of particular importance is the court’s rejection of a claim for failure to test.  Georgia law does not recognize such a claim.  Therefore, an allegation that a defendant failed to adequately test a product is merely a sub-part of one of one of the recognized duties.  Id. In other words, there can be no liability for failure to test absent proof of a design, manufacturing, or warning defect.  Think of it this way, a plaintiff can argue that additional testing should have been done, but if she cannot establish a defect in the product that caused her alleged injury, whether and how much testing a defendant did is irrelevant because the lack of testing itself cannot be the cause of the injury.  Id.  Therefore, plaintiff cannot have an independent claim for failure to test.  Or for that matter, for failure to inspect, failure to process, and so on.  Plaintiff’s negligence claims are limited to design, manufacturing, and warning. 

Defendants next argued that because plaintiff’s negligence, gross negligence, and strict liability claims are all based on the same grounds, they should be consolidated.  Here the court only agreed in part.  Under Georgia law, strict liability design defect claims are subject to a risk-utility analysis, “which incorporates the concept of reasonableness”—a negligence principle.  Id. at *5.  Therefore, the difference between a strict liability design defect claim and a negligent design defect claim is one of “semantics.”   Id. Since duplicative claims should be consolidated, the court granted that portion of defendants’ request.  However, because reasonableness is not an element of plaintiff’s strict liability manufacturing defect and failure to warn claims, or any of her gross negligence claims, the court did not agree to consolidate those.  Id. at *6. 

Which brings us to plaintiff’s under-pleading.  Unlike a design defect claim, a manufacturing defect claim must plead a “deviation” from a standard or a departure in the manufacturing process.  Id. at *7.    While plaintiff’s complaint contained the word “deviated,” it lacked any “facts . . . supporting the bare legal assertion that they were “deviat[ions] … from Defendants’ design and manufacturing specifications.”  Id. at *8.  Plaintiff failed to plead any facts showing what the product’s intended design or specifications were, how defendants deviated from those specifications, or how such a deviation caused plaintiff’s injury.  Therefore, she has not stated a manufacturing defect claim—in strict liability, negligence, or gross negligence.  Id.

In sum, plaintiff lost all her manufacturing defect claims and her failure to test claims. Leaving only design defect and warning claims which historically post-remand plaintiffs in the mesh litigation have struggled with.  Limited to these pared down claims is certainly not where plaintiff wanted to be.

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This is from the non-Dechert and non-Reed Smith side of the Blog.

We are not bankruptcy lawyers.  So, even though we are discussing a Supreme Court decision on the powers of a bankruptcy court, we are not purporting to be experts in that area.  The decision, of course, is Harrington v. Purdue Pharma L.P., 603 U.S. –, 2024 WL 3187799 (June 27, 2024), and it relates to a bankruptcy pursued in relation to actual and potential liabilities from a range of opioid litigation.  We have discussed opioid litigation quite a bit, within the bounds of frequent disclaimers.  While public discourse about the most recent opioid epidemic in the United States has generally addressed the human cost of opioid abuse and its persistence despite a variety of governmental actions and policy initiatives, our focus has been on the use of public nuisance as the basis for many governmental suits that threatened huge liability for a range of defendants to essentially reimburse governmental entities for expenditures allegedly tied to the epidemic.  After a number of trial courts, including MDL No. 2804, greatly expanded the scope of public nuisance compared to how it had been applied for centuries, the clear trend has been for appellate courts to reverse.  Simply put, a county utilizes tax revenues to provide governmental services, including social services, operating a morgue and coroner’s office, offering emergency medical services, and sometimes offering drug rehabilitation services.  It is not entitled to get reimbursement for its expenditures from a person or entity it claims necessitated them, any more than it would be entitled to the costs of repairing a guard rail or repainting the road after a traffic accident.  Of course, causation is also extremely tricky in part because a large number of criminal actors—from cartels to dealers to those who divert prescription drugs to those who illegally purchase a street drug or a prescription drug without an actual prescription—play a role in the epidemic.  Without arguing for or against the role of any prescription drug manufacturer, any distributor, or any retailer in the epidemic, it is hard to pretend that responsibility for the epidemic writ large, or any small slice of it, is simple.  (We could probably say the same about the crack epidemic or other periods of significant problems in the U.S. with a particular street or diverted drug, none of which led to an attempt by struggling governmental entities to use public nuisance as a means to get at deep pockets.)

This is part of what struck us about the Harrington decision.  The majority opinion used the term “victim” nineteen times in referring to opioid litigation plaintiffs, potential creditors of Purdue, and those who would receive compensation according to the bankruptcy plan that it overturned.  The 184 uses of “victim” in the much longer dissent covered these categories as well as those whose claims might be addressed in the bankruptcy of any entity subject to a mass tort.  By contrast, there was no mention in either opinion of public nuisance, in pari delicto, or any non-bankruptcy decision in connection with opioid litigation.  The majority opinion, in particular, seemed not particularly well-versed in the details of opioid litigation, suggesting that the liability for Purdue and its owners, officers, and directors related to product liability suits by individuals who abused opioids or were affected by the abuse of family members.  Direct product liability actions like that, including a wave against Purdue in the early 2000s related to Oxycontin, have generally been unsuccessful.  As one court put it in granting summary judgment against plaintiffs (previously purportedly on behalf of a class) asserting product liability claims related to Oxycontin, “[t]his Court, however, will not accept the plaintiffs’ ‘victimization’ mentality.”  Foister v. Purdue Pharma, LP, 295 F. Supp. 2d 693, 695 (E.D. Ky. 2003).  The criminal acts of the plaintiffs and their decedents, along with “the warnings and instructions provided by the defendants and by other third party intermediaries” severed any proximate cause for the purported injuries.  They still usually do.  (See here, here, here, here, and more generally here.)

This is why the expanded version of public nuisance was so popular to opioid plaintiffs.  Faced with huge potential liability to governmental entities, the Purdue bankruptcy estate offered to provide compensation for certain individuals who would never have been able to recover directly.  Litigants often settle to avoid the cost and uncertainty of trial.  Litigants who become claimants when the defendant seeks bankruptcy protection may get less than they would have had they won a trial, but they avoid the cost and uncertainty of pursuing a case to a successful trial verdict and possible appeal.  As the Harrington dissent put it,

Bankruptcy seeks to solve a collective-action problem and prevent a race to the courthouse by individual creditors who, if successful, could obtain all of a company’s assets, leaving nothing for all the other creditors. The bankruptcy system works to preserve a bankrupt company’s limited assets and to then fairly and equitably distribute those assets among the creditors—and in mass-tort bankruptcies, among the victims.

2024 WL 318779, *12.  As non-bankruptcy lawyers who defend drug and medical device companies in mass torts and write about developments in the field, this description certainly squares with the practice we have observed.

The primary issue in Harrington was that the bankrupt company that sought protection, Purdue, also sought protection for its primary owners, directors, and officers, collectively “the Sackler Family.”  While there may be some circumstances in this case that set it apart from the usual mass tort bankruptcy discussed by the dissent, the focus on owners, directors, and officers of a business entities as being distinct from the bankrupt company that sought protection seems strange to us.  Absent proof that the corporate veil should be pierced, a lawsuit against a company does not open the door to the assets of its owners.  Also, in product liability and, we suspect, actual public nuisance, it is rare that officers and directors of large corporations have personal liability.  Under Supreme Court authority on personal jurisdiction, which generally respects corporate form (e.g., not inferring a subsidiary’s jurisdictional contacts to its parent), an individual who, for example, lives and works in New York is unlikely to be amenable to suit in Oklahoma, Kentucky, or West Virginia simply because of the contacts of a New York-based company of which she is a partial owner, officer, and/or director.  As both opinions discuss, any claims against the Sackler Family would likely be subject to indemnity from Purdue, so such claims could be seen for bankruptcy purposes as claims against Purdue.  In this way, the majority opinion seems off.

Others will write and have written about the proper interpretation of a bankruptcy court’s authority under 11 U.S.C. § 1123, which the 5-4 majority in Harrington held did not support extinguishing claims against the Sackler Family.  The issue for us is what this decision means for the use of bankruptcy in the mass tort context.  As the dissent noted,

For decades, bankruptcy courts and courts of appeals have determined that non-debtor releases can be appropriate and essential in mass-tort cases like this one. Non-debtor releases have enabled substantial and equitable relief to victims in cases ranging from asbestos, Dalkon Shield, and Dow Corning silicone breast implants to the Catholic Church and the Boy Scouts. As leading scholars on bankruptcy explain, “the bankruptcy community has recognized the resolution of mass tort claims as a widely accepted core function of bankruptcy courts for decades”—and they emphasize that a “key feature in every mass tort bankruptcy” has been the non-debtor release.

Id. at *13 (citation omitted).  Is that all gone after Harrington?  Maybe not. 

After all, there was “nearly universal” support for the plan that discharged the Sackler Family, including “virtually all of the opioid victims and creditors” and “all 50 state Attorneys General . . . a rare consensus.”  Id. at *12.  (DOJ also resolved all of its criminal and civil investigations as to Purdue and civil investigations as to the Sackler Family subject to the bankruptcy court’s approval.)  If the frequent use of the word “victim” were insufficient to show what justices in both camps felt about the underlying litigation, then check out the references to the Sackler Family being responsible for a wide range of harms without specifying legal theories, courts, or other details.  Both opinions also declared that Congress was the appropriate forum for the change in law for which the corresponding adverse opinion allegedly advocated.  (We note that the majority implicitly advocated for an expansion of state tort law, something best left to state legislatures.)  The Court clearly did not view this as a typical mass tort that might lead to a request for bankruptcy protection for a defendant.  In addition, the majority opinion described more than a decade of the systematic transfer of assets from Purdue to the Sackler Family in connection with predicted liabilities from litigation.  We hazard that allegations of fraudulent transfers out of a company that is going bankrupt due to product liability or mass tort litigation are exceedingly rare at a level close to what was alleged here.

Focusing back on the “typical” mass tort that could result in a defendant seeking bankruptcy protection, nothing in Harrington limits the ability of the logical corporate defendant—for example, the entity that designs, manufactures, and sells a prescription medical product—from utilizing chapter 11 for protection for itself.  The change relates to entities or individuals that would not be the petitioner/debtor, but could conceivably have liability in the litigation.  That would include individual or corporate owners—but not random minority shareholders of a public company—directors, and officers.  Except in rare instances where the parent company has no assets except for the debtor company, we do not see many of these individuals or entities choosing to be additional debtors.  Instead, it may be advisable to get rulings that the individuals and entities do not have any liability to the various plaintiffs.  Given the “case or controversy” requirement, such rulings would likely require being added to lawsuits in courts of competent jurisdiction, permitting enough discovery to determine the issues (e.g., following corporate formalities and proper accounting practices to avoid piercing the corporate veil), and getting favorable rulings affirmed on appeal.  If bankruptcy courts cannot do what they have been doing for quite some time in terms of bankruptcies driven by mass tort liability, then there would need to plenty of extra work to get to the same place and avoid second rounds of litigation against targets not covered by the debtor’s plan.

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This post is not from the Reed Smith, Dechert, or Holland & Knight side of the blog.

We’re pretty sure no one teaches about MDL census registries in law school. They’re a relatively new creation, and we previously blogged about them here. Essentially, registries create a mechanism where plaintiffs’ counsel can park potential claims without paying a filing fee while records are collected to determine if the claimant can establish Rule 11 basics like product use and injury.  Records are typically collected by a vendor—for which the MDL defendants pay half the costs. The benefit defendants receive is a commitment that, if the claim is ultimately filed, it has to be filed in the MDL or other federal court.

Continue Reading More from the Zantac MDL – Census Registries and Enforcement of Forum Selection Certifications
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 Lokkart v. Aziyo Biologics, Inc., 2024 U.S. Dist. LEXIS 111265 (C.D. Cal.  May 29, 2024), is yet another case arising from the unfortunate contamination of a batch of tissue allograft with a disease. We have written about similar cases before. These cases have consistently produced favorable precedent concerning state human tissue shield statutes (in this instance, in California). 

In Lokkart, the plaintiff alleged that she was infected with tuberculosis from a human tissue allograft that was implanted in her foot during bunion correction surgery. The plaintiff alleged that she suffered serious and continuing injuries from that infection. She and her husband filed a complaint against the defendants. The complaint included causes of action for strict products liability, negligence, and breach of the implied warranty of merchantability. 

The defendants moved for partial summary judgment. The central legal issue was whether California’s human tissue shield statute (Cal. Health & Safety Code section 1635.3) barred the strict liability and warranty claims.  

The court dismissed the strict  liability and warranty actions because the state’s blood shield statute facially applied. The statute characterizes the processing, storage, distribution, etc. of tissue for the purpose of transplantation to be a service that is not subject to the sales and warranty provisions of the state’s Commercial Code. California courts have held that the explicit exclusion of warranty liability was also an implicit exclusion of strict liability. 

Against what appears to be controlling precedent, the plaintiffs argued that whether the product implanted in this case met the definition of “tissue” under the statute was open to question and required a factual analysis that could not be resolved at the pleading stage. But the problem for the plaintiffs is that their own pleading – the complaint – repeatedly referred to the product at issue as being a human cellular and tissue based product harvested from cadavers.  That description matches the language in the California shield statute.  

The plaintiffs’ attempt to “sidestep their own allegations” was premised on the theory that the implanted product had been so heavily manipulated, altered, and processed such that it no longer met the statutory definition of human cells.  The court disagreed. That human tissue is processed into a product before being used does not make it any less human tissue.  The terms of the statute do not admit of such an exception, since the statute actually includes “processing.”  Moreover, there is no inherent contradiction between something being both “tissue” and “manufactured.”  Plenty of other courts held that human tissue allografts fall under the California human tissue shield statute, “even when they have been processed and altered.”

Further, the product packaging, which was quoted and incorporated by reference in the complaint, recited that the product was regulated as a “Human Cellular and Tissue Based Product” (HCT/P) under 21 C.F.R. section 1271. The only fair reading of the federal regulations is that the defendants’ product was human tissue.  Under those regulations, an HCT/P must be “minimally manipulated,” which is defined as “processing that does not alter the relevant biological characteristics of the cells or tissues.”  Given that standard, the court rejected the plaintiffs’ hypothetical argument that the allograft product no longer  qualified as a “group of [human] cells.”  

Accordingly, the court dismissed the plaintiffs’ claims for strict liability and breach of warranty.  Presumably, all that is left is a claim for negligence. 

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How is the Georgia General Assembly like Dr. Seuss’s kind-hearted Horton the Elephant?  They both meant what they said and said what they meant.  Horton was talking about an elephant’s faithfulness (being 100%).  The Georgia General Assembly was talking about requiring that product liability claims be initiated within ten years from “the first sale for use or consumption” of the product allegedly causing injury.  Unlike Dr. Seuss who delivers Horton’s heroic tale in anapestic tetrameter, the court in L’Oreal USA, Inc. v. Burroughs, 2024 GA App. LEXIS 250, *14 (GA Ct. App. Jun. 21, 2014), limited its poetic meter to that one line.  And so, will this post.

Burroughs isn’t a drug or device case.  But as is often the case with prescription drugs, plaintiff alleged that she purchased and used certain cosmetic products over many years.  Her first purchase was in 1995 and her last was in 2014.  Plaintiff alleges she suffered an injury in 2018 caused by her prior use of those products and she filed suit against the manufacturers in 2022.  Id. at *22.

In response to defendants’ motion to dismiss her claim as barred by Georgia’s 10-year statute of repose, plaintiff argued that each purchase and use of the products “constituted a new exposure to a new product.”    Id. at *5.  An argument the trial court accepted, ruling that the “last sale” triggered the statute of repose.  Id.  Fortunately, the Court of Appeals disagreed.

Nowhere does the Georgia statute of repose mention application or use of a product.  Its sole triggering event is “first sale for use or consumption.”  To interpret the statute as plaintiff urges would make the word “first” “mere surplusage.”  Id. at *14-15.  Had the General Assembly wanted to allow “any” sale to be the trigger, rather that the “first” sale, it would have said so. 

In focusing on the “last” sale, the trial court misapplied an earlier decision by the Court of Appeals in which that court held that the “last sale” of a finished product to a consumer, rather than inter-manufacturer sales of component parts, was the relevant sale.  Id.at *9. 

Plaintiff next tried to argue that her claims should survive dismissal because the question was really one of causation.  She should be given the opportunity to prove that it was a product purchased within the repose period that caused the injury.  Id. at *13.  Not only did the court disagree, but it pointed out that plaintiff’s complaint made no allegations that would support this new theory.  Plaintiff did not allege that the products changed over time nor that it was the products she used within ten years of filing her claim that caused her injury.  Id. at *15.  If plaintiff wanted to make a run at bypassing the statute of repose, she needed to introduce supporting allegations into the “framework of her complaint.”  Id.

The trial court also made a passing reference to the statute of repose possibly triggering from plaintiff’s date of injury.  But the appellate court simply pointed out that statutes of repose are not statutes of limitations, and the former are not triggered by the injury.  Id.at *9.              

By no means did we undertake a complete survey of all products liability statutes of repose, but a quick search did reveal that several use the same “first sale” language as Georgia’s.  So, we hope that other courts would likewise hold that successive uses of the same product by the same person for which injury is claim do not restart the repose period.  While that is the message relevant to prescription drug litigation, we can’t help but end our post with Horton’s more profound and globally noteworthy lesson – A person’s a person, no matter how small.