Photo of Susanna Moldoveanu

This post is from the non-Reed Smith, non-Dechert , and non-Holland & Knight side of the blog. Everyone else is involved.

The Good, the Bad, and the Ugly is a classic Clint Eastwood spaghetti Western where even the Good may not be all good.  In California state court, a demurrer sustained is a defense win, right?  Although there are some bright spots, In re Ranitidine Cases is one of the ugliest defense wins we have seen in a while, providing leave to amend and a roadmap for further expansion of the Gilead duty-to-innovate.

Continue Reading Post-Gilead Heartburn in the California Ranitidine Litigation
Photo of Lisa Baird

Every once in a while, we find ourselves on a federal government corner of the internet, and we usually are surprised to discover (or are reminded) that these webpages often have materials that are worth knowing about, even downright useful, for our type of practice. 

These sites are not always easy to navigate, however, so we put together some links that you may find handy one day.

The Federal Judicial Center

The first is the Federal Judicial Center’s site.  As they put it,

The Center educates federal judges and judiciary staff on law, case management, leadership, ethics, and court administration, using in-person programs, online resources, videos, and publications.

Do you want to know what your federal judges are being taught about case management, scientific evidence, appellate jurisdiction, mass torts, and litigation funding?  This is your place to find those nuggets of information.  Federal Judicial Center publications include:

The Federal Judicial Center and the Administrative Office of the U.S. Courts also maintain the “IDB”, a database of every federal district and appellate matter filed since 1977.  Did you strike out looking on Lexis or Westlaw matters to see if your assigned district court judge ever handled a particular type of case, say a product liability or Civil RICO case?  Search the database using “Nature of Suit” (for example, code 245 for “Tort Product Liability” or code 470 for “Civil (RICO)”) and add your relevant district and date limitations.  Get back a handful of results, pull the cases up in PACER and peruse for your judge and similarities to your case and issues.

The Federal Judicial Center also has a number of active projects that may result in significant publications or rules changes in the coming months and years, including:

  • Revising the Reference Manual on Scientific Evidence;
  • Revising the Manual for Complex Litigation;
  • Examining whether the electronic filing deadline should be changed from midnight to 5 p.m. (Noooooooooooooo!!!!!!);
  • Case study research regarding practical problems stemming from consolidation of cases under Federal Rule of Civil Procedure 42 (consolidation of actions involving a common question of law or fact);
  • A study into how many additional 28 USC § 1292(b) interlocutory appeals would result if the federal rules permitted more interlocutory appeals from case-determinative MDL rulings; and
  • A study of the “incidence and duration” of Federal Rule of Civil Procedure 23(f) appeals from orders granting or denying class actions.

The Federal Judicial Center site also has its final report on what has been an area of interest on this blog, the “Mandatory Initial Discovery Pilot” (“MIDP”) Project.  The MIDP was an experiment launched in the District of Arizona and the Northern District of Illinois to replace the ordinary initial disclosures required by Federal Rule of Civil Procedure 26(a)(1) with more onerous rules requiring:

  • Broad disclosure of all facts that are relevant to the parties’ claims and defenses, whether favorable or unfavorable, and regardless of whether the party intends to use the information in presenting their claims and defenses at trial;
  • The disclosures be made within a very short time after initiation of the case, regardless of pending motions to dismiss or other preliminary motions; and
  • Defendants to file answers regardless of whether a motion to dismiss or other preliminary motion was, or would be, filed. 

Early on, we had early concerns with the MIDP requirement that mandatory discovery exchanges had to occur regardless of whether a motion to dismiss was pending, in part because the Supreme Court in Ashcroft v. Iqbal, 556 U.S. 662 (2009), informed federal courts that an inadequate complaint “does not unlock the doors of discovery.”  Fortunately attorney complaints led to a relaxation of the requirement of disclosures irrespective of pending motions to dismiss half-way through the pilot project. 

In the end, the Federal Judicial Center’s final report on the MIDP suggests that the pilot project was a bit of a dud:

The findings of the Center study are mixed. With respect to disposition times, pilot cases were resolved in [slightly –ed.] less time, all else equal, than non-pilot cases. Still, to the extent the pilot did result in shorter disposition times, neither attorneys for plaintiffs nor those for defendants were particularly enthusiastic about the pilot in their responses to the surveys.  

The Administrative Office of the U.S. Courts

Our next government corner of the internet belongs to the Administrative Office of the U.S. Courts (“AOC”).  Technically, all of https://www.uscourts.gov/ is run by the AOC, but today we are interested in their “Analysis & Reports” pages.  This is where the data lives. 

How many federal civil trials were completed in 2023?  Only 3,303.  For the whole country! 

Does your federal district court judge leave a lot of fully-briefed motions pending without decision for more than six months?  Find the list sorted by district and judge name, and the reasons provided for the delay in ruling on each motion.

How many federal cases were pending as of last year?  A lot.  The Courts of Appeal seem to have it under control, the District Courts less so:

JUDICIAL CASELOAD INDICATORS

12-MONTH PERIODS ENDING SEPTEMBER 30, 2014, 2019, 2022, AND 2023

  Judicial Caseload  2014  2019  2022  2023Percent Change Since 2014Percent Change Since 2019Percent Change Since 2022
U.S. Courts of Appeals       
Cases Filed54,98848,48641,83939,987-27.3-17.5-4.4
Cases Terminated55,21647,88944,90240,636-26.4-15.1-9.5
Cases Pending41,75138,83732,51232,039-23.3-17.5-1.5
U.S. District Courts       
Civil       
Cases Filed295,310297,877274,771339,73115.014.123.6
Cases Terminated258,477311,900308,326293,67713.6-5.8-4.8
Cases Pending337,302357,566596,136642,01390.379.67.7

***

That is it for today’s tour of two federal government websites that we find interesting.  One of these days, we will do a tour of our favorite places on www.fda.gov.  Talk about a site with a lot of information, often buried in hard to find places!

Photo of Stephen McConnell

A long time ago, when we were wet behind the ears and still nervous about the prospect of drafting and arguing dispositive motions, we worked for a senior partner who taught us that clear writing flowed from clear thinking.  If that is true (and it is), then the opinion in McKnight v. Amazon.com Inc., 2024 U.S. Dist. LEXIS 86501 (E.D. Pa. May 14, 2024), must have been authored by a mind with shimmering clarity (and it was).  Judge Pratter was one of our favorite judges anywhere. We grieve at the use of “was.” We were shocked and saddened to learn that Judge Pratter passed away last Friday. Her death is an enormous loss for the Philadelphia legal community and beyond. Judge Pratter ran the University of Pennsylvania Inn of Court with uncommon grace.  She loved to see young lawyers get a chance to shine.

Judge Pratter’s writing always sparkled with lightning clarity. It also occasionally thundered with devastating humor.

Here is how the McKnight opinion begins:  

“Amazon.com is a website that has oftentimes been called “The Everything Store.” See, e.g., Brad Stone, The Everything Store: Jeff Bezos and the Age of Amazon (Hachette Book Group 2013). Jamie McKnight,when he went to visit his barber Tyrese Skinner in Philadelphia, allegedly suffered injuries when Mr. Skinner applied a mole removal cream to his scalp.

Mr. McKnight alleges that Mr. Skinner bought the mole removal cream from Amazon.com. Or if not from Amazon, then he bought it from WalMart. Or if not from Amazon, then from Target. Or if not from Amazon, then from eBay. In other words, Mr. McKnight has fashioned his complaint as its own type of everything store, where each retailer must have been the one who sold the mole removal cream. In doing so, Mr. McKnight has only marginally pled a sufficient case against Amazon, and as for the others, Mr. McKnight’s cart includes only speculation and implausibility. Thus, the Court grants Target’s, WalMart’s, and eBay’s motions to dismiss.” 

Some judges just know how to write.  (Good writing is not tied to ideology.  The two best writers on SCOTUS over the last couple of decades have been Justices Kagan and Scalia, and it is hard to think of judges more different in outlook.) 

So we have a plaintiff who claimed that he bought what sounds like an OTC drug (“mole removal cream”) from no fewer than four different and independent retailers.  That claim defies the law of TwIqbal and the law of physics.  He sued the barber and the manufacturer, along with the retailers. The case was originally filed in the Philadelphia Court of Common Pleas and then was removed to federal court.  The court denied the plaintiff’s motion to remand to state court. The plaintiff amended the complaint – more than once.  Now in front of the court was the plaintiff’s Second Amended Complaint, which included strict liability claims and “negligence and recklessness” claims against the retailer defendants.  The retailers moved to dismiss the Second Amended Complaint.

When the court held that the claims against Amazon were “marginally” plausible, the word “marginally” was doing a lot of work. To the extent the Second Amended Complaint’s naming of multiple retailers reached toward a theory of market share liability – which “Pennsylvania courts are reluctant to apply” – the plaintiff created enough uncertainty to make the claims against Amazon look rickety.  But the plaintiff did at least refer to some stray facts suggesting that the barber received delivery of the mole removal cream from Amazon (the cream was allegedly purchased on an Amazon website and was delivered on an Amazon truck), so the claim lived to see another day.  But as to the other three alleged sellers, no facts were pleaded.  All the plaintiff offered were a series of identical recitations of the elements of the cause of action, with a conclusion that each retailer “more likely than not” was a seller.  That is not close to being sufficient.  The plaintiff must identify the seller of the allegedly defective product. While alternative pleading can be fine and good, it must meet the general plausibility standard.  The plaintiff tried to preserve his claims against the non-Amazon retailers by insisting that those defendants had “not provided any verifiable proof” that they were not the sellers of the product.  That formulation (redolent of discredited market share liability) gets the burden all backwards of course.  The court raised a “judicial eyebrow” at this argument, and rejected it because it could not overcome the absence of facts in the Second Amended Complaint.   Accordingly, the court dismissed the claims against the non-Amazon retailers.  That dismissal was with prejudice because further amendment would be futile.

Then the McKnight court set about trimming away some of the claims against Amazon.  For example, the plaintiff alleged that Amazon continued to sell the cream after the plaintiff’s incident, despite allegedly being aware of the dangers posed by the cream.  But “Pennsylvania law does not recognize a duty to recall or retrofit products,” so allegations regarding post-sale conduct were stricken.  The plaintiff also included a claim that Amazon was reckless, but there is no separate cause of action for recklessness under Pennsylvania law.

Finally, the court addressed the plaintiff’s claim for punitive damages.  The only basis cited by the plaintiff for this claim was that Amazon’s webpage allegedly “deliberately hid/concealed or made less visible reviews which revealed that the [mole removal cream] causes burning and scarring….”  Once again, the court raised a judicial eyebrow at this assertion.  (Which is not to say that the court was being supercilious.) The court had “significant reservations” that the punitive damages claim could survive.  Only “extreme and brazen circumstances would support a claim for punitive damages based on the default methodology Amazon uses to sort product reviews.”  It is hard to believe that Amazon would, in an “online marketplace that sells hundreds of millions of products” [our household personally accounts for approximately half of them] bother or manage to “hide negative reviews of this one specific item,” but the plaintiff would get the chance to try.

We share the court’s skepticism as to whether the plaintiff will ultimately be able to deliver the goods.  .

We will miss Judge Pratter. We already do.     

Photo of Michelle Yeary

The 2024 Annual Meeting of the American Law Institute (“ALI”) got under way yesterday.  Therefore, based on what happened last year (described in detail here), we assume we are on the brink of the ALI taking the monumentally non-restating step of recognizing no-injury medical monitoring.  In a case of twisted timing, as we await this travesty to befall us, a contrary opinion was entered last week in Sommerville v. Union Carbide Corporation, 2024 WL 2139394 (S.D.W.Va. May 13, 2024).

Plaintiff, on behalf of herself and a purported class of neighbors, alleges that a manufacturing plant near her home has been emitting ethylene oxide, a carcinogen, for over forty years.  Therefore, plaintiff claims she has “suffered significant exposure” to the gas and is at an increased risk of developing cancer requiring her to undergo routine medical monitoring.  Id. at *1.  Defendant moved for summary judgment on the grounds that plaintiff does not have standing to bring her claims.

Before addressing the standing argument, the court runs through the history of medical monitoring claims.  First in federal courts which reject medical monitoring in the absence of present physical injury. Metro-North Commuter Railroad Co. v. Buckley, 521 U.S. 424, 439-40 (1997).  Then in West Virginia where the state Supreme Court of Appeals “created a state cause of action for medical monitoring allowing for unrestricted relief absent present physical injury.”  Sommerville, 2024 WL 2139394, at *3, citing Bower v. Westinghouse Elec. Corp., 522 S.E.2d 424 (W. Va. 1999).  For a complete rundown of which states require a present injury and which do not, see our 50-state survey

Seemingly not enthusiastic about applying West Virginia’s out-of-whole-cloth medical monitoring law, the court hopped onboard defendant’s standing argument and rode it all the way to a dismissal.  For a plaintiff to have Article III standing, she must show she suffered an injury-in-fact that is concrete, particularized, and actual or imminent (among other things).  Id. at *5.  This is “to ensure that the judiciary, and not another branch of the government, is the appropriate forum in which to address a plaintiff’s complaint.”  Id. (citations omitted).  Plaintiff here only passed the particularization requirement.  To be particularized, the claim was “affect the plaintiff in a personal and individual way.”  Id. at *6.  Personal or not, the court could not find an alleged injury that was actual or imminent.

Which standard applies—actual or imminent—depends on the relief requested.  A request for damages requires a present injury, whereas injunctive relief can be based on an imminent threat.  Id. Here, plaintiff was seeking monetary damages and therefore Article III requires a present injury.  Plaintiff’s claim of increased risk is based entirely on expert opinions, which the court properly notes are not facts and, more importantly, which the court already excluded as based on “patently unreliable data and methods.”  Id. at *7.  Standing cannot be premised on an “unreliable model” that was “used to assume that a speculative disease might someday materialize in some unknown person.”  Id.  Further undermining plaintiff’s speculative increased risk theory is the fact that plaintiff alleges that the period of exposure is forty-one years, yet in that entire time neither plaintiff nor any member of the class is alleged to have experienced even symptoms of a disease, let alone been diagnosed with cancer.  Id. at *8.  So plaintiff cannot even establish that it is more likely than not that she will develop cancer.  An injury must be more than conjectural to confer federal standing. 

Plaintiff also fails to meet the requirement that her injury be concrete—“real and not abstract.”  Id.  The court starts its analysis by pointing out that medical monitoring is not supported by any legislative enactment.  While Congress cannot grant standing to a plaintiff who does not have it, Congressional recognition of a cause of action would be “instructive.”  No medical monitoring instruction has been given. 

Next the court looked at the “vague” risk quantification standard under West Virgnia law.  To bring a no-injury medical monitoring claim in West Virginia, plaintiff must demonstrate a “significant increased risk of future disease.”  But the court in creating this state law claim did not offer any guidance on what constitutes a “significant” increased risk.  Plaintiff tried to use the Environmental Protection Agency’s one-in-a-million standard, but as the court points out in any other context a one-in-a-million chance is the exact opposite of significant.  So whether it is Article III’s requirement that the injury be more than a mere possibility or West Virginia’s requirement that the risk be significant, plaintiff fails under either standard.  Id. at *9. 

As if that was not enough, the court also found that plaintiff’s claims were not ripe.  While a claim can be based on an anticipated future injury, that future injury “cannot be wholly speculative” or rest on events that may not occur at all.  Id. at *10.   “Where a plaintiff has alleged that a hypothetical number of people may become injured at some time in the future to a hypothetical degree and thus will incur hypothetical damages,” that claim is not ripe for adjudication.  Id.  Since that is all plaintiff and her experts can say, plaintiff’s claim is not ripe. 

What does all this mean?  If followed, the decision means that West Virginia medical monitoring, and by extension, other states’ no-injury medical monitoring claims based on mere increased risk, cannot be adjudicated in federal court, even though substantive state law allows them.  So, can plaintiffs simply refile in state court and be immune from any basis for removal to federal court?  Or would the West Virginia high court–with completely different personnel and partisan makeup than in 1999, when it adopted no-injury medical monitoring, decide to retreat from that position?   Big questions that deserve big answers that we will have to watch and wait for. 

But we want to leave you with this.  The opinion finishes with one of the best rejections of what we have called “judicial triumphalism” that we have ever read in a judicial opinion:

A grave and persistent concern of this court is the metastasis of the malignant belief that courts are the solution to all problems recognized but unaddressed by the other two branches of government. It is not the province of federal courts to usurp the power of the other branches of government to solve social problems with legislatively phrased directives disguised in judicial language. “[N]o matter how admirable the result may seem[,] unless change occurs through legitimate means, it disparages the image of the judiciary and the principles of our system of government.”

Id. at *12 (citations omitted).

Photo of Bexis

It seems like once every couple of weeks, we see a story about some plaintiff (such as this one) suing, or threatening to sue, a defendant product manufacturer over some product that, according to the plaintiff, “the company should have recalled sooner.”

That’s garbage.

There is no such claim.  Rather failure-to-recall theories are among the most widely debunked purported “torts” ever.  Today we present Part I of a two-part series on just why that is.  This post looks at state law.

The common law does not impose any duty on a manufacturer of any type of products to recall its products in the absence of a government order to do so.  The law does not require a defendant  to remove a product from the market entirely, or else face universal liability simply for selling that product.  The Third Restatement of Torts addresses recall-related liability, and for once it accurately restates the law.

Restatement (Third) of Torts, Products Liability §11 (1998) comprehensively reviewed the law and determined that recall-based liability has never been recognized outside of two limited situations:  (1) noncompliance following a government ordered recall, or (2) negligently conducting a recall that the defendant voluntarily undertook:

One engaged in the business of selling or otherwise distributing products is subject to liability for harm to persons or property caused by the seller’s failure to recall a product after the time of sale or distribution if:

(a)(1) a governmental directive issued pursuant to a statute or administrative regulation specifically requires the seller or distributor to recall the product; or

(a)(2) the seller or distributor, in the absence of a recall requirement under Subsection (a)(1), undertakes to recall the product; and

(b) the seller or distributor fails to act as a reasonable person in recalling the product.

Restatement Third §11 (emphasis added).

Thus, the Third Restatement’s black letter law rejects any purported common-law obligation either to recall a product in the absence of any governmental order, or for the anticipatory removal of products from the market earlier than any governmental recall required.  Sound reasons support these constraints.  An unlimited duty to recall would impose “significant burdens” on commerce:

Duties to recall products impose significant burdens on manufacturers.  Many product lines are periodically redesigned so that they become safer over time.  If every improvement in product safety were to trigger a common-law duty to recall, manufacturers would face incalculable costs every time they sought to make their product lines better and safer.

Restatement Third §11, comment a.  Further, decisions about whether the public as a whole should be deprived of access to otherwise legal products should not be the province of judges and juries in common-law tort litigation:

[A]n involuntary duty to recall should be imposed on the seller only by a governmental directive issued pursuant to statute or regulation.  Issues relating to product recalls are best evaluated by governmental agencies capable of gathering adequate data regarding the ramifications of such undertakings.

Id.

For similar reasons, in state after state, in both common-law and statutory product-liability regimes, and whether the state otherwise follows the Second or Third Restatement, courts have refused to expand liability by including claims that legal products should not have been sold, but rather should have been recalled.

For instance, in California, where strict liability was invented, no duty to recall an FDA-regulated product (an over-the-counter medicine) exists unless the FDA has decided to authorize such action:

We conclude … as a matter of law, that defendant may not be held liable for failing to withdraw its product from the market….  A few scientific studies had shown [the risk plaintiffs allege] but … the FDA had determined that further studies were needed to confirm or disprove the association.  Pending completion of those studies, the FDA concluded that product warnings were an adequate public safety measure.  Although the FDA’s conclusion is not binding on us, we think it deserves serious consideration.

Ramirez v. Plough, Inc., 863 P.2d 167, 177-78 (Cal. 1993) (citations omitted) (emphasis added).  Even if there were “a court judgment or administrative order for the removal of [a] drug from the market, … it would apply only for the time frame after the judgment or order.”  In re Ranitidine Cases, 2024 WL 2115449, at *16 (Cal. Super. April 23, 2024).

The New York Court of Appeals similarly rejected a purported “post-sale duty to recall or retrofit a product” in Adams v. Genie Industries, Inc., 929 N.E.2d 380, 385 (N.Y. 2010).  Adams involved a lift truck, rather than an FDA-regulated product.  The court found “no justification for creating” a duty to recall, since – again as here – “plaintiff merely asserted that [defendant] should have recalled or retrofitted the [product] for the same reasons that it should not have sold it in the first place[.]”  Id. at 386.  Like Adams, most of the cases rejecting failure-to-recall claims do not involve FDA-regulated products.

Likewise, Illinois law rejects both post-sale warning and recall duties.  Jablonski v. Ford Motor Co., 955 N.E.2d 1138, 1160 (Ill. 2011).  As to recalls, specifically:

A duty may be imposed upon a manufacturer by a statute or administrative regulation which mandates the recall of the product….  However, in the absence of such an obligation, or a voluntary undertaking, Illinois has not imposed such a duty on a manufacturer[.]

Id. at 1160 n.1 (citing Third Restatement §11).  Jablonski also approvingly cited Modelski v. Navistar International Transportation Corp., 707 N.E.2d 239 (Ill. App. 1999), which held:

The consequences of imposing upon manufacturers an extrastatutory duty to recall … would be the equivalent of mandating that manufacturers insure that their products will always comply with current safety standards.  This we are unwilling to do.

Id. at 247.

California, New York, and Illinois are hardly outliers.  “[V]irtually every court that has confronted the issue head-on has reached the same conclusion”:  “‘that it is unnecessary and unwise to impose or introduce an additional duty to retrofit or recall a product’ separate and apart from those duties to which manufacturers are already subject.”  Tabieros v. Clark Equipment Co., 944 P.2d 1279, 1298 (Haw. 1997).  Tabieros quoted Gregory v. Cincinnati, Inc., 538 N.W.2d 325, 333-34 (Mich. 1995), thus adding two more state supreme courts to the list of recall-based tort deniers,  since Gregory “did not recognize any theory that would impose a postmanufacture duty to … recall a product.”  Klein v. Caterpillar, Inc., 2023 WL 4760707, at *5 (E.D. Mich. July 26, 2023), aff’d, 2024 WL 1574672 (6th Cir. April 11, 2024).  That’s hardly all.

The Kentucky Supreme Court reached the same conclusion, rejecting liability “by judicial fiat” for alleged failure to recall products in Ostendorf v. Clark Equipment Co., 122 S.W.3d 530, 534 (Ky. 2003).  Product recalls “are properly the province of administrative agencies, as the federal statutes that expressly delegate recall authority to various agencies suggest,” and courts should not “arrogate to themselves a power equivalent to that of requiring product recall.”  Id.

As Congress has recognized, administrative agencies have the institutional resources to make fully informed assessments of the marginal benefits of recalling a specific product.

Id. at 434-35 (citation and quotation marks omitted).

The Kansas Supreme Court agrees:

[P]roduct recalls are properly the business of administrative agencies as suggested by the federal statutes that expressly delegate recall authority….  The decision to expand a manufacturer’s post sale duty beyond implementing reasonable efforts to warn … should be left to administrative agencies and the legislature.  These institutions are better able to weigh the benefits and costs involved in locating, recalling, and retrofitting products.

Patton v. Hutchinson Wil-Rich Manufacturing Co., 861 P.2d 1299, 1315-16 (Kan. 1993).  Patton quoted V. Schwartz, “The Post–Sale Duty to Warn:  Two Unfortunate Forks in the Road to a Reasonable Doctrine,” 58 N.Y.U.L. Rev. 892, 901 (1983).  Accord Loredo v. Solvay America, Inc., 212 P.3d 614, 632 (Wyo. 2009) (quoting and following Ostendorf); Lovick v. Wil-Rich, 588 N.W.2d 688, 696 (Iowa 1999) (affirming that a manufacturer “ha[s] no duty to recall or retrofit” a product).

Other states’ intermediate appellate courts have also held that failure-to-recall claims would create excessive and unmanageable liability.  The most thorough discussion is in Ford Motor Co. v. Reese, 684 S.E.2d 279 (Ga. App. 2009), cert denied (Ga. Feb. 8, 2010).  Reese followed Restatement Third §11 and rejected failure-to-recall claims absent a government-mandated or negligently undertaken voluntary product recall.  Id. at 284-85.  “Georgia common law does not impose a continuing duty upon manufacturers to recall their products.”  Id. at 285.  Reese also invoked “important public policy concerns” that support leaving recall decisions to administrative agencies.  Id.

Because the cost of locating, recalling, and replacing mass-marketed products can be enormous and will likely be passed on to consumers in the form of higher prices, the recall power should not be exercised without extensive consideration of its economic impact.

Id. (citation and quotation marks omitted).  Cf. Ontario Sewing Machine Co. v. Smith, 572 S.E.2d 533, 535 (Ga. 2002) (“disapprov[ing]” of decision that had allowed a failure-to-recall claim, but not reaching issue).

Other intermediate appellate decisions to the same effect are: Lance v. Wyeth, 4 A.3d 160, 167 (Pa. Super. 2010) (“this Court is persuaded by the majority of modern jurisdictions that have decided not to impose a common law duty to recall on a manufacturer”) (citations omitted) (prescription drug case), aff’d in part & rev’d in part on other grounds, 85 A.3d 434 (Pa. 2014).  Bragg v. Hi-Ranger, Inc., 462 S.E.2d 321, 331 (S.C. App. 1995) (following the “law adopted by a majority of jurisdictions concerning a manufacturer’s duty to recall or retrofit its products”); Morrison v. Kubota Tractor Corp., 891 S.W.2d 422, 429 (Mo. App. 1994) (finding “no such duty absent a state or federal law mandating a recall of the product”), transfer denied (Mo. Feb. 12, 1995); Lynch v. McStome & Lincoln Plaza Associates, 548 A.2d 1276, 1281 (Pa. Super. 1988) (finding no “precedent that imposes such a broad duty on a manufacturer, nor do we think that the imposition of such a duty would be appropriate”).

Literally scores of federal courts have made state-law predictions that reject failure-to-recall claims under the laws of many other states.  The sheer range of products against which recall claims have been asserted demonstrates how radical a legal change recall-based liability would entail, were it to be accepted.

  • Alabama: Wilhite v. Medtronic, Inc., 2024 WL 968867, at *6 (N.D. Ala. March 6, 2024) (“no duty to recall under Alabama law”) (medical device); Harman v. Taurus International Manufacturing, Inc., 661 F. Supp.3d 1123, 1133 (M.D. Ala. 2023) (“no such duty exists under Alabama law” to “proactively recall[]” a product) (firearm); Harris v. Raymond Corp., 2018 WL 6725329, at *9 (N.D. Ala. Dec. 21, 2018) (“there is no duty to recall”) (pallet jack).
  • AlaskaNelson v. Original Smith & Wesson Business Entities, 2010 WL 7125186, at *3-4 (D. Alaska May 18, 2010) (following “the weight of jurisdictions that have previously determined that failure to recall … is not a valid cause of action”), aff’d, 449 F. Appx. 581, 584 (9th Cir. 2011) (firearm).  Cf. Jones v. Bowie Industries, Inc., 282 P.3d 316, 335 n.70 (Alaska 2012) (clarifying that recognizing a post-sale duty to warn does not include any duty to recall) (mulching machine).
  • ColoradoPerau v. Barnett Outdoors, LLC, 2019 WL 2145467, at *2-3 (M.D. Fla. May 15, 2019) (excluding all failure-to-recall evidence) (crossbow) (applying Colorado law).
  • DelawareSmith v. Daimlerchrysler Corp., 2002 WL 31814534, at *6 (Del. Super. Nov. 20, 2002) (“There is also no duty under Delaware law to recall defective [products]”) (automobile).  Yes, this is a state trial court decision, but we didn’t have any better place to put it.
  • FloridaHowey v. Pirelli Tire, LLC, 2017 WL 10978505, at *2 (S.D. Fla. Oct. 31, 2017) (following Wright) (tire); Wright v. Howmedica Osteonics Corp., 2017 WL 4555901, at *4 (M.D. Fla. Oct. 12, 2017) (“find[ing] no Florida case recognizing a cause of action for breach of the duty to recall”) (medical device), aff’d, 741 F. Appx. 624 (11th Cir. 2018); Thomas v. Bombardier Recreational Products, Inc., 682 F. Supp.2d 1297, 1302 (M.D. Fla. 2010) (“Florida law does not recognize that a manufacturer has a post-sale duty to recall or retrofit a product”) (personal watercraft).
  • GeorgiaClayton v. Alliance Outdoor Group, Inc., 2021 WL 1947886, at *2 (M.D. Ga. March 30, 2021) (“Georgia law generally does not recognize a cause of action based upon a manufacturer’s failure to recall a product”) (tree stand); Williamson v. Walmart Stores, Inc., 2015 WL 1565474, at *6 (M.D. Ga. April 8, 2015) (quoting and following Reese, supra) (gas container); Yarbrough v. Actavis Totowa, LLC, 2010 WL 3604674, at *4 (S.D. Ga. Sept. 13, 2010) (“product sellers are not required to issue recalls for defective products”) (pre-Reese) (prescription drug).
  • IndianaTimm v. Goodyear Dunlop Tires North America Ltd., 309 F. Supp.3d 595, 602 (N.D. Ind. 2018) (finding no “support” for a “claim of negligent recall”) (tire); Cincinnati Insurance Companies. v. Hamilton Beach/Proctor-Silex, Inc., 2006 WL 299064, at *3 (N.D. Ind. Feb. 7, 2006) (“no Indiana state law cases indicate the existence of a separate negligent recall cause of action”) (citations omitted) (toaster); Tober v. Graco Children’s Products, Inc., 2004 WL 1987239, at *9 (S.D. Ind. July 28, 2004) (rejecting “the existence of a separate ‘negligent recall’ cause of action”), aff’d, 431 F.3d 572 (7th Cir. 2005) (baby swing).
  • IowaBurke v. Deere & Co., 6 F.3d 497, 510 (8th Cir. 1993) (“we find no independent duty to retrofit or recall under Iowa law”) (combine); Doe v. Baxter Healthcare Corp., 2003 WL 27384538, at *5 (S.D. Iowa June 3, 2003) (“no court interpreting Iowa law has recognized a duty to recall”), aff’d, 380 F.3d 399 (8th Cir. 2004) (blood product).
  • LouisianaWeams v. FCA US L.L.C., 2019 WL 960159, at *23 (M.D. La. Feb. 27, 2019) (“failure to recall is not a theory of liability under the” exclusive Louisiana product-liability statute) (automobile).
  • MassachusettsAhern v. Sig Sauer, Inc., 2021 WL 5811795, at *4 (D. Mass. Dec. 7, 2021) (plaintiff “cites no legal duty to impose a mandatory recall”) (firearm); National Women’s Health Network, Inc. v. A.H. Robins Co., 545 F. Supp. 1177, 1181 (D. Mass. 1982) (“[n]o court has ever ordered a notification and recall campaign on the basis of state law”) (contraceptive device).
  • MinnesotaKladivo v. Sportsstuff, Inc., 2008 WL 4933951, at *5 (D. Minn. Sept. 2, 2008) (“Minnesota courts have not recognized a cause of action for negligent recall”) (inflatable swimming tube); Hammes v. Yamaha Motor Corp., 2006 WL 1195907, at *11 (D. Minn. May 4, 2006) (“this Court declines to impose a separate duty to recall”) (motorcycle); Berczyk v. Emerson Tool Co., 291 F. Supp.2d 1004, 1016 (D. Minn. 2003) (quoting McDaniel) (power saw); McDaniel v. Bieffe USA, Inc., 35 F. Supp.2d 735, 743 (D. Minn. 1999) (“Minnesota would refuse to impose a duty on manufacturers to recall and/or retrofit a defective product because the overwhelming majority of other jurisdictions have rejected such an obligation”) (motorcycle helmet).
  • MississippiGoodwin v. Premier Ford Lincoln Mercury, Inc., 2020 WL 3621317, at *4 n.2 (N.D. Miss. July 2, 2020) (“there is no post-sale duty to warn or recall in Mississippi”) (automobile); Clark v. General Motors, 2016 WL 3574408, at *7 (S.D. Miss. June 23, 2016) (same) (automobile); Murray v. General Motors, 2011 WL 52559, at *2 (S.D. Miss. Jan. 7, 2011) (plaintiffs “cannot show that [defendant] breached its duty by not recalling their vehicle”), aff’d, 478 F. Appx. 175 (5th Cir. 2012) (automobile).
  • MissouriHorstmyer v. Black & Decker, (U.S.), Inc., 151 F.3d 765, 774 (8th Cir. 1998) (finding “no indication … that the Missouri Supreme Court would create a common law duty to recall under these circumstances”) (power saw); Smith v. Firestone Tire & Rubber Co., 755 F.2d 129, 135 (8th Cir. 1985) (“Since no duty to recall was established, a fundamental prerequisite to establishing negligence was absent”) (tire); Haskell v. PACCAR, Inc., 2021 WL 5407853, at *3 (W.D. Mo. Nov. 18, 2021) (“There is no common law duty to recall under Missouri law absent a mandated recall by a governmental agency.”) (citations omitted) (commercial truck); Hackethal v. Harbor Freight Tools USA, Inc., 2016 WL 695615, at *1 (E.D. Mo. Feb. 22, 2016) (“[t]here is no duty under Missouri law to recall”) (blow gun); Ardito v. ITW Food Equipment Group, LLC, 2016 WL 10677591, at *7 (W.D. Mo. Feb. 8, 2016) (“there is no general duty to recall”) (commercial mixer); Simon v. Select Comfort Retail Corp., 2014 WL 5849243, at *4 (E.D. Mo. Nov. 12, 2014) (“there is no common law duty to recall under … Missouri law”) (mattress); Dejana v. Marine Technology, Inc., 2013 WL 6768407, at *3 (E.D. Mo. Dec. 20, 2013) (same as Haskell) (boat); Stanger v. Smith & Nephew, Inc., 401 F. Supp.2d 974, 982 (E.D. Mo. 2005) (“under Missouri law, there is no cause of action for negligent recall”) (medical device); Efting v. Tokai Corp., 75 F. Supp.2d 1006, 1010-11 (W.D. Mo. 1999) (“no duty in Missouri to recall”) (lighter).
  • NebraskaAnderson v. Nissan Motor Co., 139 F.3d 599, 602 (8th Cir. 1999) (“limiting [Nebraska] products liability law to actions or omissions which occur at the time of manufacture or sale”) (forklift); Dubas v. Clark Equipment Co., 532 F. Supp.3d 819, 830 (D. Neb. 2021) (“claims asserting post-sale duties to … recall … are dismissed”) (forklift).
  • New HampshireBartlett v. Mutual Pharmaceutical Co., 2010 WL 3659789, at *10 (D.N.H. Sept. 14, 2010) (“‘almost all of the opinions which have addressed the issue have found that there is no common law duty to recall’ products from the market, even if they are unreasonably dangerous”) (quoting 5 L. Frumer & M. Friedman, Products Liability, §57.01[4], at 57–9 (2010)) (generic prescription drug)
  • New JerseyLeslie v. United States, 986 F. Supp. 900, 913 (D.N.J. 1997) (“no authority … requires manufacturers of legally distributed [products] to ensure instantaneous removal of their products”) (ammunition), aff’d mem., 178 F.3d 1279 (3d Cir. 1999).
  • New MexicoMorales v. E.D. Etnyre & Co., 382 F. Supp.2d 1285, 1287 (D.N.M. 2005) (rejecting a “duty to retro-fit or recall”; following Third Restatement §11) (road paving machine).
  • North DakotaEberts v. Kawasaki Motors Corp., 2004 WL 224683, at *2-3 (D.N.D. Feb. 2, 2004) (following Third Restatement §11 and “the overwhelming majority of other jurisdictions [that] have refused to impose a duty on manufacturers to recall … a defective product”) (ATV).
  • OhioKondash v. Kia Motors America, Inc., 2016 WL 11246421, at *14 (S.D. Ohio June 24, 2016) (given the weight of contrary precedent, “[t]he Court cannot conclude that Ohio law recognizes a duty in negligence to recall”) (automobile).
  • PennsylvaniaMcKnight v. Amazon.Com Inc., 2024 WL 2156223, at *6 (E.D. Pa. May 14, 2024) (quoting Liebig) (OTC drug); Liebig v. MTD Products, Inc., ___ F. Supp.3d ___, 2023 WL 5517557, at *4 n.6 (E.D. Pa. Aug. 25, 2023) (“Pennsylvania law does not recognize a duty to recall or retrofit products”) (snow blower); Bradley v. Amazon.com, Inc., 2023 WL 4494149, at *5 (Mag. E.D. Pa. July 12, 2023) (quoting and following Boyer) (phone charger), certif. denied, 2023 WL 7196427 (Mag. E.D. Pa. Sept. 20, 2023); Cleaver v. Honeywell International, LLC, 2022 WL 2442804, at *4 (E.D. Pa. March 31, 2022) (“Under Pennsylvania law, manufacturers and distributors do not have a duty to recall or retrofit products.”) (vacuum truck); Talarico v. Skyjack, Inc., 191 F. Supp.3d 394, 401 (M.D. Pa. 2016) (no “independent negligence cause of action exists in Pennsylvania under a duty to recall”) (forklift); Padilla v. Black & Decker Corp., 2005 WL 697479, at *7 (E.D. Pa. March 24, 2005) (Pennsylvania law “does not, however, extend to the duty to recall”) (miter saw); Boyer v. Case Corp., 1998 WL 205695, *2 (E.D. Pa. Aug. 28, 1998) (“Pennsylvania does not recognize a duty to recall”) (industrial equipment).
  • South CarolinaAndrews v. CBS Corp., 2015 WL 12831309, at *1 (D.S.C. June 24, 2015) (“there is no-post sale duty to recall or retrofit products”; citing and following Bragg, supra) (asbestos containing products).
  • South DakotaRobinson v. Brandtjen & Kluge, Inc., 2006 WL 2796252, at *8 (D.S.D. Sept. 27, 2006) (“[n]othing … indicates that South Dakota permits a claim based on a manufacturer’s duty to recall”; citing Restatement Third §11), aff’d, 500 F.3d 691 (8th Cir. 2007) (printing press).
  • TennesseeSpence v. Miles Laboratories, Inc., 810 F. Supp. 952, 959 (E.D. Tenn. 1992) (product-liability statute did not “require manufacturers and suppliers of [their] products to recall and test a product already on the market”) (blood product).
  • TexasSyrie v. Knoll International, 748 F.2d 304, 311-12 (5th Cir. 1984) (“Texas does not impose on manufacturers the duty … to recall products”) (stool); Gomez v. ALN International, Inc., 2021 WL 3774221, at *8 (S.D. Tex. March 24, 2021) (“there is no general, post-sale, duty to retrofit or recall under Texas law”) (medical device); Nester v. Textron, Inc., 2015 WL 9413891, at *13 (W.D. Tex. Dec. 22, 2015) (Texas rejects failure-to-recall claims prior to any actual recall) (utility vehicle); Hernandez v. Ford Motor Co., 2005 WL 1574474, at *1 (S.D. Tex. June 28, 2005) (“Texas law generally does not recognize a common law post-sale duty … to recall defective products”) (automobile); Flock v. Scripto-Tokai Corp., 2001 WL 34111725, at *8-9 (S.D. Tex. Sep. 11, 2001) (following Restatement Third §11) (cigarette lighter).
  • UtahMarcovecchio v. Wright Medical Group, Inc., 2019 WL 1406606, at *7 (D. Utah March 28, 2019) (“Plaintiff has alleged only that [defendant] failed to recall the product, which is insufficient to state a claim”; following Restatement Third §11) (medical device); Dowdy v. Coleman Co., 2011 WL 6151432, at *3 (D. Utah Dec. 12, 2011) (“declin[ing] to recognize a post-sale duty to recall or retrofit”; citing Restatement Third §11) (propane heater).
  • VirginiaBoyer v. Abbott Vascular Inc., 2023 WL 4269764, at *2 (N.D. Cal. June 29, 2023) (predicting that Virginia would follow Restatement §11 and dismissing recall claim; quoting Powell, supra) (catheter) (applying Virginia law); Putman v. Savage Arms, Inc., 2019 WL 1007527, at *9 (W.D. Va. March 1, 2019) (“no such duty to recall is recognized under Virginia law”) firearm); In re General Motors LLC Ignition Switch Litigation, 202 F. Supp.3d 362, 371-72 (S.D.N.Y. 2016) (same) (automobile) (applying Virginia law); Powell v. Diehl Woodworking Machinery, Inc., 198 F. Supp.3d 628, 634 (E.D. Va. 2016) (“Virginia law does not recognize a duty to recall”) (ripsaw); Paschall v. CBS Corp., 2011 WL 4345283, at *4 n.2 (E.D. Va. Sept. 15, 2011) (“a duty to recall [is] not recognized under Virginia law”) (asbestos products).
  • WashingtonBear v. Ford Motor Co., 2007 WL 870344, at *3 (E.D. Wash. March 20, 2007) (failure-to-recall claim does not exist because “the issue of recall is not addressed in the Washington Products Liability Act”) (automobile).
  • Wisconsin:  Carlson v. Triton Industries, Inc., 605 F. Supp.3d 1124, 1138 (W.D. Wis. 2022) (rejecting “failure to recall” theory as “much more drastic” than anything Wisconsin law has permitted) (boat).

That’s not even everything.  Where we have state high court authority, we haven’t looked for decisions by other courts bound by such precedent.  Nor have we included any related “duty to retrofit” cases.  For additional precedent, see our prior recall-related posts here and here.

It is quite clear to us that the  overwhelming weight of precedent nationwide rejects failure-to-recall claims except in the limited circumstances mentioned in Restatement Third §11.  That a recall occurred later, or was “voluntary,” does not matter.  Recall-based claims go far beyond ordinary negligence and strict-liability theories.  They usurp executive and legislative powers to regulate the public’s access to lawful products.  Moreover, even if a failure-to-recall claim did exist against an FDA-regulated product, it would be preempted – which will be the subject of our forthcoming Part II (hint, see our New Hampshire law citation), above).

Photo of Steven Boranian

The PREP Act is having a moment.  Congress enacted the Public Readiness & Emergency Preparedness Act (“PREP Act”) in 2005 to ensure the availability of effective countermeasures in the event of public health emergencies.  The declaration of COVID-19 as an “emergency” has thus thrust the PREP Act into the limelight.  Heck, when you’re a federal statute and Bexis has started a scorecard to track your progress, you know you’ve arrived! 

Despite the PREP Act’s remarkably straightforward rules, some courts insist on getting it wrong.  That is what happened recently in Coleman v. Sharp Memorial Hospital, No. 37-2023-00033307-CU-PO-CTL, 2024 Cal. Super. LEXIS 10893 (Cal. Sup. Ct. Mar. 29, 2024), where a California trial court refused to apply the PREP Act to claims arising from the use the antiviral medication Remdesivir to treat COVID-19. 

To review, when the Secretary of the Department of Health and Human Services declares a public health emergency (such as COVID-19), the Act provides that a “covered person” shall be immune from liability under state and federal law with respect to all claims relating to “covered countermeasures.”  Rather than allowing such claims, the Act establishes a fund to compensate “eligible individuals for covered injuries” through an administrative remedy.  There is only one exception:  The PREP Act provides “an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct.”  See 42 U.S.C. § 247d-6d(d)(1)) (emphasis added).  The Act also expressly preempts contrary state law, so long as the Secretary’s emergency declaration is in place.  See 42 U.S.C. § 247d-6d(b)(8).

The Prep Act should have shut down the state-court claims in Coleman.  The hospital and physician defendants were covered persons under the Act, and Remdesivir is a covered countermeasure.  The plaintiff therefore had two options:  File an administrative claim for compensation, or file a lawsuit for willful misconduct under federal law in federal court. 

This plaintiff chose neither, and instead pressed a state-law fraud claim in California state court.  To avoid the PREP Act, the plaintiff argued that her claims did not pertain to a covered countermeasure, but instead alleged that the defendants fraudulently concealed “other treatments that could have been available.”  Coleman, at *3. 

The order does not disclose what those “other treatments” would have been, but it doesn’t matter.  The plaintiff was claiming compensation for harm (death) caused by administration of a covered countermeasure (Remdesivir) prescribed by a covered person (a physician in a hospital).  That is the exact scenario that the PREP Act was enacted to address, no matter how many alternate treatments “could have been available.”  The exclusive civil action under the Act is a federal action for willful misconduct, and the Act expressly preempts contrary state law.  This action therefore was boxed out, without regard to how many other ways the defendants “could have” treated this plaintiff’s decedent. 

The trial court, however, bought the plaintiff’s argument and allowed the claim, reasoning that “[t]he complaint may reasonably be read to allege a claim not based on the countermeasure, but rather on the alleged concealment of facts.”  Id. at *4.  This outcome might reflect more on California’s liberal pleading standards than on the underlying substantive law, but that does not make it any more palatable. 

Photo of Eric Alexander

Those of us who took Con Law as first year law students may recall Marbury v. Madison as an early test of the Supreme Court’s place in our nascent republic.  Alliteration being a mnemonic device, some may recall that Madison was Secretary of State James Madison and the decision was written by Chief Justice John Marshall, both Founding Fathers and fairly famous fellows.  The other M was petitioner William Marbury, an erstwhile Justice of the Peace in recently created D.C.  Fewer will remember that the Supreme Court helped cement its role as an independent branch of government by denying jurisdiction through application of the political question doctrine in this seminal case.  Fewer still will actually remember the details of the case and decision.  We need not delve into those details for the purposes of this post, but we will pose one not-so-rhetorical question:  Isn’t just about everything at issue in just about every lawsuit a political question to some extent?

This reminds us of a scene from Fiddler on the Roof, a musical turned movie based on a collection of short stories by Shalom Aleichem that was set in a fictional town in what is now part of Ukraine (and is now the name of a real town founded to house refugees from the Russian invasion of Ukraine).  We will set aside discussion of the relevance of this tale in light of current events, but there is another connection to Marbury v. Madison:  the Ukrainian embassy in Washington, D.C., is located in a building once owed by William Marbury.  In any event, in the scene, an ardent socialist proposes to one of the titular character’s daughters:

Perchik:  There’s a question … A certain question I want to discuss with you.

Hodel: Yes?

Perchik:  It’s a political question.

Hodel:  What is it?

Perchik:  The question of … marriage.

Hodel:  Is that a … political question?

Perchik:  Well, yes. Yes, everything’s political. Like everything else, the relationship between a man and a woman has a socioeconomic base. Marriage must be founded on mutual beliefs. A common attitude and philosophy towards society…

Hodel:  And affection?

Perchik:  Well, yes, of course. That is also necessary. Such a relationship can have positive social values. When two people face the world with unity and solidarity …

Hodel:  And affection?

Perchik:  Yes, that is an important element! At any rate, I … I personally am in favor of such a socioeconomic relationship.

In a sense, a proposal of marriage is not a political question.  In another, it sure is, especially if you consider the number of state laws governing and referencing marriage.  Among the line of Supreme Court decisions on substantive due process that the overturning of Roe by Dobbs cast in doubt, multiple relate to state laws on marriage that undoubtedly reflected legislative answers to political questions.  Griswold related to Connecticut laws on the use of hormonal contraception by a married woman.  Loving related to Virginia’s laws on interracial marriage.  Bowers v. Hardwick related to Georgia’s disparate application of sodomy laws to married heterosexual and unmarried homosexual couples.  We could go on.

What about product liability claims?  Clearly, many political decisions are inherent in the laws that affect product liability claims.  For the sort of litigation involving medical products that we do, and this Blog discusses, decisions made by FDA are often at issue.  Similarly, decisions of other agencies feature prominently in litigation involving other kinds of products, such as decisions by EPA in connection with pesticides and herbicides.  The reality is that, shifting back to our kind of cases, one side—usually the plaintiff—is typically second-guessing some decisions made by FDA, whether product-specific or broader.  If those agency decisions involve answers to political questions, then should not the federal court apply Marbury v. Madison to refuse to allow a party to premise its relief on second-guessing the correctness of the agency’s answer to a political question, as doing so would deprive the court of subject matter jurisdiction?  If, as Perchik maintained, “everything is political,” then this should come up all the time.  But it does not.  Indeed, the decision in Caston v. F. Hoffman-La Roche, Inc., No. 23-cv-0092-TLT, 2024 WL 1548649 (N.D. Cal. Apr. 8, 2024), is the only decision we can recall that applied the doctrine to kick a product liability claim as to a prescription drug.  So why did the court in Caston decline jurisdiction over certain asserted product liability claims and how broadly applicable will this decision be?

As a preliminary matter, Caston was essentially the re-filing of a prior case called Nelson (which we discussed here).  The details of the claims asserted by the different plaintiffs and against the different defendants in Nelson and Caston would require some serious unpacking, which we will not do here.  Beyond the political question analysis, Caston is commendable for getting it right on personal jurisdiction and the preemption of warnings and misrepresentations claims against generic manufacturers.  On the former, there was no general jurisdiction over New Jersey entities because a related California entity’s contacts could not be imputed and there was no specific jurisdiction based on entering a distribution agreement with the Department of Defense that covered California bases along with all other U.S. military locations everywhere else.  Id. at *9-12.  On the latter, the plaintiffs who took generic drugs could not plead their way around the duty of sameness for labeling and the resultant impossibility conflict preemption.  Id. at *12.  For design defect claims, as to both the branded and generic drugs, the court did not analyze preemption.

Boiled down, those design claims were that mefloquine, whether branded or generic, allegedly had undue risks of a wide range of neurotoxic and psychiatric problems and that the use by plaintiffs in the 1990s or 2000s allegedly caused them to develop a wide range of neurotoxic and psychiatric problems.  (Statute of limitations would seem to be another huge issue for the plaintiffs because their alleged injuries were long before they initiated suit and the risks of this class of drugs was allegedly well-known for decades before they used the drugs.)  The commonality is that the mefloquine was prescribed to each plaintiff as an anti-malarial agent by military providers in connection with deployments to areas with high risks of malaria, pursuant to established military policy.

The defendants moved to dismiss on both the political question doctrine and the government contractor defense.  Looking at the motions to dismiss in Caston and Nelson, which was adopted by reference, the two arguments were paired together and the relief sought under the political question doctrine was the dismissal of the entire case for lack of subject matter jurisdiction.  The arguments were also focused on the issue of second-guessing the judgment of the U.S. military, with limited discussion of FDA decisions in connection with the government contractor defense only.  The Caston court, however, did not address the government contractor defense and focused its analysis of the political question doctrine on FDA more than on the U.S. military.  With assistance from our crack associate Avery Holloman, we checked to see if our instinct on the novelty of the conclusion reached in Caston was correct.  It seems to have been.  While the government contractor defense comes up relatively often in product liability and toxic tort cases, the few published decisions that analyzed the political question doctrine in product liability cases rejected it.  In In re Methyl Tertiary Butyl Ether (MBTE) Prods. Liab. Litig., 438 F. Supp. 2d 291, 300 (S.D.N.Y. 2006), the MDL court followed the general rule that “[e]ven when products are heavily regulated under federal law, tort suits involving those products may be brought absent a congressional injunction prohibiting such suits.” 

Defendants’ arguments boil down to the claim that holding manufacturers, refiners, and sellers responsible for MTBE contamination is highly controversial and thus should be left to the Congress, the EPA, and the President. But, the fact that the issues arise in a “politically charged context” does not convert this tort suit into a non-justiciable political question, given that there is no evidence that Congress has decided that it would resolve the issues. While regulation of the national fuel supply is surely not an issue for the judicial branch, these suits seek abatement and damages in addition to a ban on further contamination. Weighing the issues in a products liability claim is a quintessential judicial function.

Id. at 304.  In Lofgren v. Polaris Indus. Inc., 509 F. Supp. 3d 1009 (M.D. Tenn. 2020), which concerned product liability claims over an ATV accident in connection with Army training, the defendant raised the political question doctrine.  However, the record indicated that “the military was not controlling Defendant’s actions, but instead making mere suggestions and requests for certain design features. Defendant has repeatedly characterized the interactions with the military as a ‘collaboration,’ and the military as having ‘requests.’”  Id. at 1026.

Caston applied the same test from Baker v. Carr, 369 U.S. 186 (1962), as in Lofgren to reach a different conclusion.  It was also different than the same court had reached in Nelson.  As it explained, the difference was that the design defect claims in Caston “effectively challenge the safety and efficacy of active ingredients [and] implicate nonjusticiable political questions outside the scope of the Court’s Article III jurisdiction.”  2024 WL 1548649, *4 n.2.  Of course, FDA had made those decisions initially, even if military policy and individual prescribing decisions for each plaintiff agreed with them.

Pharmaceutical design defect claims challenging active ingredients necessarily implicate a nonjusticiable political question under the appropriate jurisdiction of the FDA because the FDA is a highly technical, scientific, and medical agency whose mission is to safeguard the public health by ensuring safety and efficacy of human drugs.

Id. at *8 (citing FDA mission statement).  The Caston court considered itself “unfit to review” FDA’s decisions on safety and efficacy because it “lacks the scientific and clinical expertise of the FDA.”  Id.  FDA’s decisions are “multifaceted,” considering things like public health and the “demand for a particular therapy at a given point in time,” rendering those decisions “heavily scientific, and indeed economic and political, but not judicial.”  Id. 

If adjudicated here, the Court would need to consult the broader scientific literature, and the content submitted to the FDA, and make its own determination of whether the studies submitted in the NDA were enough to warrant approval in 1989, a question designated for the FDA. The FDA has exclusive jurisdiction over the approval of New Drugs, including the designs of those drugs, pursuant to the FDCA.

Id.  “[A] contrary ruling would potentially call into question the FDA’s credibility. It would be inappropriate for the court to obfuscate a decision made more than thirty years ago by a federal government agency.”  Id. (citation omitted).

On first and perhaps second blush, the Caston court’s analysis of the nonjusticiability of design defect claims for an approved drug should apply broadly.  We have been saying for a long time that design claims for prescription drugs are almost always unsupportable and preempted, like here, here, and here, in part because of some of the same indisputable observations from Caston.  Yet, the political question doctrine has not been successfully applied to those claims before, at least in any published decision we could find.  The difference may rest on the timing.  The NDA held by one of the defendants was approved 1989 and the first ANDA was approved in 2002.  (It even appears that “U.S. Army Walter Reed” held the first NDA for the drug.  Dr. Reed earned his fame with yellow fever, but his namesake has apparently been working on malaria for quite some time.)  The plaintiffs’ use of the drug, which provides the relevant timeframe for analyzing design defect claims, was roughly 20-27 years ago.  Plaintiffs contended medical literature since the 1940s was relevant to the risks of the drug.  In short, proceeding with the case would involve quite a long look back in time.  Avoiding such a squinting look through the retrospectoscope is part of the reasoning for having statutes of limitations and repose, but the timing in Caston would clearly also make any second-guessing of FDA inherent in adjudicating plaintiffs’ design defect claims much more difficult and less reliable.  That may be why Caston was a good case to make new law.

The case is currently on appeal, so we expect to hear more on these issues, even if we do not see political question shots taken by other defendants with regulatory histories for their medical products going back decades and/or some military overlay in their fact pattern.  Litigation over those medical products certainly exists.  It will be interesting to see how this highest level of deference to governmental decision making–the court does not even have jurisdiction–plays out, especially at a time when the general issue of deference to governmental agencies is very much up in the air.

Photo of Stephen McConnell

We don’t get blood shield statute cases very often, but here is one involving a human tissue-based spinal bone graft.  In Sherrill v. Spinalgraft Technologies, LLC, et al., 2024 WL 1979452 (W.D.N.C May 3, 2024), the plaintiff had undergone spinal surgery. That surgery included the use of processed bone graft material, which is “made from human tissue consisting of cancellous bone particles with preserved living cells, combined with demineralized cortical fiber.”  The plaintiff alleged that the bone graft material was infected with tuberculosis, causing her to contract that disease plus other injuries. Not too long after the plaintiff’s surgery, the Food and Drug Association issued a voluntary recall of the bone graft material in response to reports of patients testing positive for tuberculosis and other post-surgical infections following surgical implantation of the bone material.  

The defendants filed a motion to dismiss the breach of warranty claims.  The issue was whether those claims were barred by the North Carolina Blood and Tissue Shield Statute (the Statute), which shields “every participating person or institution” involved in “the procurement, processing, distribution or use of whole blood, plasma, blood products, blood derivatives and other human tissues such as corneas, bones or organs for the purpose of injecting, transfusing or transplanting any of them into the human body” from warranty liability.  A warranty claim is the only form of strict liability in North Carolina, so application of the Statute would be a very big win for the defendants.

They got that big win.  The plaintiff’s main contention was that the Statute did not shield a “tissue-based product” like the bone graft material.  The court disagreed, finding that the bone graft material was processed human tissue (remember that the Statute explicitly reaches “processing”) and was covered by the Statute.  Nor did it matter that preservatives were used.  

There was another, perhaps more interesting, support for dismissal of the warranty claims.  The bone graft’s use was “incidental” to the surgery.  Accordingly, “North Carolina law categorizes the procurement, processing, distribution, or use of human tissue for injection or transplanting as a service, precluding warranty claims.”

The plaintiff endeavored to stave off dismissal by requesting discovery to ascertain “the true composition and makeup” of the bone graft material.  But the court found the plaintiff’s argument “unpersuasive given the detailed understanding” of the bone graft material found in the plaintiff’s papers.  

We’re not sure whether that last bit means that the plaintiff erred by inserting too much detail in its argument, or whether there was no other way for the plaintiff to argue its way out of the Statute.  Either way, the court dismissed the warranty claims.  

Photo of Michelle Yeary

Generally, there is no medical basis for most claims on homeopathic product labels.  But thousands if not millions of people use and find value in homeopathic products, apparently regardless of the fact that the science underpinning the products is shaky at best and possibly non-existent.  However, just because one of these pseudo-remedies doesn’t work for you doesn’t you mean have a consumer protection claim.

This was essentially what the court told plaintiff in Jordan v. CVS Pharm., Inc., 2024 U.S. Dist. LEXIS 84048 (W.D.N.Y. May 8, 2024), when it dismissed her claims.  Plaintiff purchased eye drops that were described as a “homeopathic formula that stimulates the body’s ability to relieve redness, burning, watery discharge, and sensations of grittiness.”  Id. at*2.  Plaintiff alleges that the product’s labeling was false and misleading, including causing consumers to believe the eyedrops were a “drug,” and that she paid a premium price as a result.  Id.  Plaintiff also alleges that the product did not work to relieve her symptoms and that the eyedrops contained an unsafe preservative.  Id. at *8. 

Because New York law recognizes claims for false and deceptive representations to consumers, plaintiff’s claim had an independent basis in state law and dd not depend on a violation of the FDCA.  Therefore, plaintiff’s claim was not implied preempted.  Id. at *8-9.  But in examining New York law, the court found plaintiff had not done enough to state a viable claim.

New York has established three requirements for a consumer protection claim:  the challenged practice/statement must be consumer-oriented; the act/statement must be materially misleading; and the plaintiff has to have suffered an injury.  Id. at *10.  The test for materially misleading is an objective one—“whether the misrepresentation or omission is likely to mislead a reasonable consumer.”  Id.  This is something more than the possibility that a label may be misunderstood by a “few consumers viewing it in an unreasonable manner.”  Id.  Importantly, FDA regulations do not factor into the reasonable-consumer analysis.  So, the court ignored plaintiff’s extensive reliance on an FDA warning letter as evidence of deception.

That left as plaintiff’s primary argument that the product’s statement that it would relieve certain symptoms was false and misleading because it did not relieve plaintiff’s symptoms.  However, plaintiff makes that allegation without offering any facts in support, such as what symptoms she had, what relief she expected, and what she experienced when she used the product.  Plaintiff’s unsupported allegation was made even more dubious by the fact that she used the product “over a three-year period.”  Id. at *11 (emphasis in original).  Fool me once, shame on you.  Fool for me three years, shame on me.  Similarly, whether one experiences “relief” is completely subjective.  Plaintiff offered no legal support for her “did-not-relieve” theory.  So, the court examined plaintiff’s claim in the context of the product’s label.

The front of the package said it was a homeopathic product.  The back of the package stated: “Claims based on traditional homeopathic practice, not accepted medical evidence.  Not FDA-evaluated.”  Id. at *13-14.  The court found that was enough to conclude that a reasonable consumer would not be misled into believing the product “carried an official regulatory imprimatur or guarantee.”  Id. at *14.  In other words, the label tells you this is not a drug or a medically accepted remedy, but rather pseudoscience that may provide some relief or may be the same thing as walking to your sink and splashing cold water on your face.  The choice is yours.

Finally, plaintiff tried to state a claim on not knowing the product contained the preservative silver sulfate.  But silver sulfate is listed right on the label as an inactive ingredient (preservative).  So, the court found this claim implausible. 

Overall, the opinion reads as sort of a buyer beware for homeopathic products.  If a homeopathic product, which by definition has no supporting evidence of efficacy (this one even said it on the label), doesn’t work for you—you haven’t been misled.  You got exactly what you paid for.

Photo of Bexis

Over the last month, Bexis attended both the Hollingsworth Firm’s annual toxic tort litigation defense seminar and the Lawyers for Civil Justice spring meeting.  Both meetings featured discussions on how the new amendments to Fed. R. Evid. 702 were faring in court.  We’ve also written several blogposts (links below) about favorable applications of the new rule, which became effective December 1, 2024.  The amendments having been in effect now for several months, we decided to see whether they were having the Rules Committee’s desired effect of toughening up judicial consideration of expert testimony under Rule 702.  So we’re taking a more systematic look at the judicial response to the 2023 amendments.

Continue Reading How Are the Recent Rule 702 Amendments Faring in Court?