Friday, January 23, 2015

Putting Ascertainability into Rule 23

Following the completion of its overhaul of Rules 26(b)(1) and 37(e) (see our most recent post here), the federal Advisory Committee on Civil Rules is set to take up Fed. R. Civ. P. 23, concerning class actions.  Sadly, our preferred outcome abolishing Rule 23 altogether and allowing Congress and state legislatures to determine the availability of class actions on a subject-by-subject basis – is not on the table.  One thing that is on the agenda (in addition to cy pres, which we’ve discussed a lot lately) is ascertainability.

Ascertainability is the subject of this post.

“Ascertainability” is the radical proposition that the definition of the class in a class action ought actually to specify who is in the class.  After all, no individual action would be allowed to proceed without the defendant knowing who was suing s/he/it.  First, Rule 23 is not supposed to change substantive legal requirements.  Second, the federal rules do not (except in rare cases involving threats or humiliation) allow John Doe pleadings.  Third, any certification order “must define the class.”  Fed. R. Civ. P. 23(c)(1)(B).  A class action has no business being certified if nobody can tell who will be bound by a judgment or who the defendant will have to pay.

Unfortunately, all too many class action plaintiffs fail to follow this seemingly simple principle, and sue on behalf of classes similar to “everybody who was uncomfortable while riding the Broad Street Line during” some particular time.  Particularly where the claim purports to seek damages, that’s ridiculous.  How can membership be proven, other than by each would-be class member’s bald, ipse dixit say-so?  This combination of need for individualized proof of class membership and lack of any conceivable kind of documentary proof comes up all the time.

And gets shot down most of the time.  Hence, the “implicit” ascertainability requirement under Rule 23.

It’s time to make it explicit.  That’s why the Advisory Committee will be considering a proposal to add a new Rule 23(a)(5):

(5) the court can readily identify the class members in reference to existing objective criteria

This change would largely ratify existing case law.  As stated in Moore’s Federal Practice, “The identity of class members must be ascertainable by reference to objective criteria.”  5 James W. Moore, Moore’s Federal Practice, §23.21[1] (2001).  The case law is overwhelmingly in favor of an ascertainability requirement under Rule 23.  Leading the charge is the Third Circuit, with its Carrera v. Bayer Corp., 727 F.3d 300 (3d Cir. 2013), and Marcus v. BMW of North America, LLC, 687 F.3d 583, 593 (3d Cir. 2012), decisions.  We discussed Carrera here.  “[A]n essential prerequisite of a class action . . . is that the class must be currently and readily ascertainable based on objective criteria.”  Carrera, 727 F.3d at 305.  “If class members are impossible to identify without extensive and individualized fact-finding or ‘mini-trials,’ then a class action is inappropriate.”  Marcus, 687 F.3d at 593 (3d Cir. 2012).  The rationale for ascertainability is: 

First, [the ascertainability requirement] eliminates serious administrative burdens that are incongruous with the efficiencies expected in a class action by insisting on the easy identification of class members.  Second, it protects absent class members by facilitating the best notice practicable . . . .  Third, it protects defendant by ensuring that those persons who will be bound by the final judgment are clearly identifiable.

Carrera, 727 F.3d at 305-06 (quoting Marcus, 687 F.3d at 593).

Thus, ascertainability, as applied in the Third Circuit has two primary attributes:

[A]scertainability entails two important elements. First, the class must be defined with reference to objective criteria.  Second, there must be a reliable and administratively feasible mechanism for determining whether putative class members fall within the class definition.

Hayes v. Wal-Mart Stores, Inc., 725 F.3d 349, 355 (3d Cir. 2013).  Cf. Shelton v. Bledsoe, ___ F.3d ___, 2015 WL 74192, at *5 (3d Cir. Jan. 7, 2015) (“a judicially-created implied requirement of ascertainability − that the members of the class be capable of specific enumeration − is inappropriate for (b)(2) classes”).

But support for a “threshold ascertainability test” under Rule 23 is hardly limited to the Third Circuit.  Berger v. Home Depot USA, Inc., 741 F.3d 1061, 1071, n.4 (9th Cir. 2014).  A few months ago, the Ninth Circuit (which has an annoying habit of putting important statements in unpublished decisions) affirmed denial of class certification because “central criterion of class membership” could not be ascertained in an “administratively feasible manner”:

Because [plaintiff] has not demonstrated that it would be administratively feasible to determine which individuals used personal, and not business, credit cards to purchase parking, the district court did not abuse its discretion in concluding that the proposed class was not ascertainable.

Martin v. Pacific Parking Systems, Inc., 583 F. Appx. 803, 804 (9th Cir. 2014).  Nobody was going to keep 4-year-old parking receipts, so there was no way to ascertain class membership save plaintiff “self-identification.”  Id. at 804 & n.3.  See Bruton v. Gerber Products Co., 2014 WL 2860995, at *10 (N.D. Cal. June 23, 2014) (plaintiff “failed to propose a class definition that is precise, objective, and presently ascertainable . . . so that it is administratively feasible to determine whether a particular person is a class member”); In re POM Wonderful LLC, 2014 WL 1225184, at *6 (C.D. Cal. March 25, 2014) (“where purported class members purchase an inexpensive product for a variety of reasons, and are unlikely to retain receipts or other transaction records, class actions may present such daunting administrative challenges that class treatment is not feasible”; finding class unacertainable); Sethavanish v. ZonePerfect Nutrition Co., 2014 WL 580696, at *5-6 (N.D. Cal. Feb. 13, 2014) (absent receipts, “[p]laintiff has yet to present any method for determining class membership. . . .  Without more, the Court cannot find that the proposed class is ascertainable”); Astiana v. Ben & Jerry's Homemade, Inc., 2014 WL 60097, at *3 (N.D. Cal. Jan. 7, 2014) (“the class must be adequately defined and clearly ascertainable before a class action may proceed”); Xavier v. Philip Morris USA Inc., 787 F. Supp. 2d 1075, 1089, (N.D. Cal. 2011) (“for a proposed class to satisfy the ascertainability requirement, membership must be determinable from objective, rather than subjective, criteria”). Because class actions are out of control in California, there are lots more ascertainability cases in Ninth Circuit district courts that we haven't cited. 

The other circuits agree.

In a relatively old decision, the First Circuit has recognized ascertainability (the “precise definition of the members of the suggested class”) as “important to certification of a subdivision (b) (3) class” but not for an injunctive class under Rule 23(b)(2).  Yaffe v. Powers, 454 F.2d 1362, 1366 (1st Cir. 1972).  A class whose “members [are] impossible to identify prior to individualized fact-finding and litigation . . . fails to satisfy one of the basic requirements for a class action,”  Crosby v. Social Security Administration, 796 F.2d 576, 580 (1st Cir. 1986).  More recently the court held that “objective criteria” are necessary to “overcome[] the claim that the class in unascertainable.”  Matamoros v. Starbucks Corp., 699 F.3d 129, 139 (1st Cir. 2012).  “The ascertainability requirement is not satisfied when the class is defined simply as consisting of all persons who may have been injured by some generically described wrongful conduct allegedly engaged in by a defendant.”  Van West v. Midland National Life Insurance Co., 199 F.R.D. 448, 451 (D.R.I. 2001).

In the Second Circuit, “ascertainability of the class is an issue distinct from the predominance requirement for a (b)(3) class.”  In re Initial Public Offerings Securities Litigation, 471 F.3d 24, 45 (2d Cir. 2006).  “Although Rule 23(a) does not expressly require that a class be definite in order to be certified, Second Circuit courts have implied a requirement that a class be identifiable before it may be properly certified.  This requirement is often referred to as ‘ascertainability.’”  Friedman-Katz v. Lindt & Sprungli (USA), Inc., 270 F.R.D. 150, 154 (S.D.N.Y. 2010).

Whether a proposed class is ascertainable is fundamental to certification.  Class membership must be readily identifiable such that a court can determine who is in the class and bound by its ruling without engaging in numerous fact-intensive inquiries.

Bakalar v. Vavra, 237 F.R.D. 59, 64 (S.D.N.Y. 2006) (citations omitted).  See Enea v. Bloomberg, L.P., 2014 WL 1044027, at *3 (S.D.N.Y. Mar. 17, 2014) (“many courts have read an implicit requirement of class definiteness and ascertainability into the Rule”); Weiner v. Snapple Beverage Corp., 2010 WL 3119452, at *13 (S.D.N.Y. Aug. 5, 2010) (absent receipts, plaintiffs “failed to show how the potentially millions of putative class members could be ascertained using objective criteria that are administratively feasible”); Charron v. Pinnacle Group LLC, 269 F.R.D. 221, 229 (S.D.N.Y. 2010) (“courts recognize an implied requirement of ascertainability, which turns on the definition of the proposed class”); Hnot v. WillisGroup Holdings Ltd., 228 F.R.D. 476, 481 (S.D.N.Y. 2005) (“[t]he requirement of ascertainability, though not expressly mentioned in Rule 23, is fundamental”); People United for Children, Inc. v. City of New York, 214 F.R.D. 252, 256 (S.D.N.Y.2003) (“courts should ensure that the class definition is precise, objective, and presently ascertainable”).

The Fourth Circuit likewise recognized ascertainability as a prerequisite to class certification.  “Rule 23 contains an implicit threshold requirement that the members of a proposed class be readily identifiable.  Our sister circuits have described this rule as an “ascertainability” requirement.  EQT Production Co. v. Adair, 764 F.3d 347, 358 (4th Cir. 2014).  Thus, “if class members are impossible to identify without extensive individualized fact-finding or ‘mini-trials’, then a class action is inappropriate.”  Id. (quoting Marcus, 687 F.3d at 593).  See In re A.H. Robins Co., 880 F.2d 709, 728 (4th Cir. 1989) (“Though not specified in [Rule 23], establishment of a class action implicitly requires . . . that there be an identifiable class”); Kingery v. Quicken Loans, Inc., 300 F.R.D. 258, 264 (S.D.W. Va. 2014) (“[t]he proposed class definition must not depend on subjective criteria or the merits of the case or require an extensive factual inquiry to determine who is a class member”); Rhodes v. E.I. du Pont de Nemours & Co., 253 F.R.D. 365, 370 (S.D.W. Va. 20080 (“there is an implied requirement that the proposed class be ascertainable”).

In the Fifth Circuit, it has long been “elementary that in order to maintain a class action, the class sought to be represented must be adequately defined and clearly ascertainable.”  DeBremaecker v. Short, 433 F.2d 733, 734 (5th Cir. 1970); accord Union Asset Management Holding A.G. v. Dell, Inc., 669 F.3d 632, 639  (5th Cir. 2012) (quoting and following DeBremaecker).  “A precise class definition is necessary to identify properly ‘those entitled to relief, those bound by the judgment, and those entitled to notice.’”  In re Monumental Life Insurance Co., 365 F.3d 408, 413 (5th Cir. 2004) (quoting 5 Moore’s Federal Practice §23.21[6]).  “The existence of an ascertainable class of persons to be represented by the proposed class representative is an implied prerequisite of [Rule 23].”  John v. Nat’l Security Fire & Casualty Co., 501 F.3d 443, 445 (5th Cir. 2007).  See Johnson v. Kansas City Southern, 224 F.R.D. 382, 389 (S.D. Miss. 2004) (no ascertainability where determining class membership “would require individualized review” and analysis of title documents”), aff’d, 208 Fed. Appx. 292 (5th Cir. 2006).

Class certification in the Sixth Circuit requires:

[T]he class definition must be sufficiently definite so that it is administratively feasible for the court to determine whether a particular individual is a member of the proposed class. . . .  [A] class must not only exist, the class must be susceptible of precise definition.  There can be no class action if the proposed class is amorphous or ‘\imprecise.

Young v. Nationwide Mutual Insurance Co., 693 F.3d 532, 537-38 (6th Cir. 2012) (citations and quotation marks omitted).  “[T]he existence of an ascertainable class of persons to be represented by the proposed class representative is an implied prerequisite of [Rule 23].”  Romberio v. Unumprovident Corp., 385 F. Appx. 423, 431 (6th Cir. 2009) (citation and quotation marks omitted).  See In re Skelaxin (Metaxalone) Antitrust Litigation, 299 F.R.D. 555, 567 (E.D. Tenn. 2014) (“the identity of class members must be ascertainable by reference to objective criteria.”).

The Seventh Circuit has likewise recognized the “implicit” threshold Rule 23 requirement that the class definition must be “sufficiently definite that its members are ascertainable.”  Jamie S. v. Milwaukee Public Schools, 668 F.3d 481, 493 (7th Cir. 2012).  “[M]any courts have held that there is a ‘definiteness’ requirement implied in Rule 23(a).”  Alliance to End Repression v. Rochford, 565 F.2d 975, 977 (7th Cir. 1977).  In Oshana v. Coca-Cola Co., 472 F.3d 506 (7th Cir. 2006), the court affirmed refusal to certify based on the class’ ascertainability:

Such a class could include millions who were not deceived and thus have no grievance. . . .  Countless members of [plaintiff’s] putative class could not show any damage, let alone damage proximately caused by [defendant’s] alleged deception.

Id. at 514.  See Balschmiter  v. TD Auto Finance LLC, ___ F.R.D. ___, 2014 WL 6611008, at *5 (E.D. Wis. Nov. 20, 2014) (“[a]scertainability is inexorably tied with the plaintiff’s class definition”); Bridgeview Health Care Center Ltd v. Clark, 2011 WL 4628744, at *2 (N.D. Ill. Sept. 30, 2011) (“To be ascertainable, a class must be identifiable as a class and membership within it must be determined by application of precise, objective criteria.”).

In the Eighth Circuit, certification cannot be granted where the plaintiff “could not show . . . the existence of any identifiable class.”  Thompson v. Sun Oil Co., 523 F.2d 647, 648 (8th Cir. 1975).  “It is elementary that in order to maintain a class action, the class sought to be represented must be adequately defined and clearly ascertainable.”  Ihrke v. Northern States Power Co., 459 F.2d 566, 573 (8th Cir.), vacated as moot, 409 U.S. 815 (1972).  See Sandusky Wellness Center LLC v. Medtox Scientific, Inc., 2014 WL 3846037, at *3 (D. Minn. Aug. 5, 2014) (“[b]efore considering the explicit requirements set forth in Rule 23, however, the court must be satisfied that the proposed class is ascertainable”); Eastwood v. Southern Farm Bureau Casualty Insurance Co., 291 F.R.D. 273, 289 (W.D. Ark. 2013) (“in addition to Rule 23’s explicit requirements, there is an implicit requirement that class membership be ascertainable by some objective standard”); Barfield v. Sho-Me Power Electric Co-op., 2013 WL 3872181, at *12 (W.D. Mo. July 25, 2013); Brown v. Kerkhoff, 279 F.R.D. 479, 496, 2012 WL 987591 (S.D. Iowa 2012) (“whether the class is ascertainable” is an “implicit factor” of Rule 23(a)); In re Teflon Products Liability Litigation, 254 F.R.D. 354, 360 (S.D. Iowa 2008) (“numerous courts also have recognized [the] “implicit” prerequisite[] . . .: that the class definition is drafted to ensure that membership is capable of ascertainment under some objective standard”); Powell v. Nat’l Football League, 711 F. Supp. 959, 966 (D. Minn. 1989) (“[f]or implicit requirements of Rule 23(a), the Court must find . . .  the existence of a precisely defined class”).

The Tenth Circuit recognizes that “lack of identifiability is a factor that may defeat Rule 23(b)(3) class certification,” although not injunctive (23(b)(2)) classes.  Shook v. El Paso County, 386 F.3d 963, 972 (10th Cir. 2004).

A class definition should be precise, objective and presently ascertainable. . . .  Thus, the class must meet a minimum standard of definiteness which will allow the trial court to determine membership in the proposed class.  If the court must undertake individualized inquiries in order to determine whether a person is a member of the class, the class is not appropriate.

Warnick v. Dish Network LLC, 301 F.R.D. 551, 556 (D. Colo. 2014).  “The “rigorous analysis” applicable to Rule 23’s [formal] requirements apply to the ascertainability requirement.”  Id.

“[A]scertainability entails two important elements.  First, the class must be defined with reference to objective criteria.  Second, there must be a reliable and administratively feasible mechanism for determining whether putative class members fall within the class definition.

In re Cox Enterprises, Inc. Set-Top Cable Television Box Antitrust Litigation, 2014 WL 104964, at *2 (W.D. Okla. Jan. 9, 2014).

Likewise the Eleventh Circuit has held, “[o]ne threshold requirement is not mentioned in Rule 23, but is implicit in the analysis: that is, the plaintiff must demonstrate that the proposed class is ‘adequately defined and clearly ascertainable.’”  Little v. T-Mobile USA, Inc., 691 F.3d 1302, 1304 (11th Cir. 2012).  “[A]n identifiable class exists if its members can be ascertained by reference to objective criteria.”  Bussey v. Macon County Greyhound Park, Inc., 562 Fed. Appx. 782, 787 (11th Cir. 2014).  See Walewski v. Zenimax Media, Inc., 502 F. Appx 857, 861 (11th Cir. 2012) (“the district court did not abuse its discretion by concluding that the class was not adequately defined or clearly ascertainable and denying class certification”); Randolph v. J.M. Smucker Co., ___ F.R.D. ___, 2014 WL 7330430, at *3 (S.D. Fla. Dec. 23, 2014) (“[i]f a plaintiff fails to demonstrate that the putative class is clearly ascertainable, then class certification is properly denied”); Hurt v. Shelby County Bd. of Education, 2014 WL 4269113, at *5 (N.D. Ala. Aug. 21, 2014) (“[a]nother threshold requirement Rule 23 implies is that the plaintiffs’ proposed class be adequately defined and clearly ascertainable”); Bryant v. Southland Tube, 294 F.R.D. 633, 635 (N.D. Ala. 2013) (“the first essential ingredient to class treatment is the ascertainability of the class”); Grimes v. Rave Motion Pictures Birmingham, L.L.C., 264 F.R.D. 659, 664 (N.D. Ala. 2010) (“the named plaintiff must define the proposed class in a manner that adequately identifies its members.  Who, exactly, are they, and how can they be located?”); Conigliaro v. Norwegian Cruise Line Ltd., 2006 WL 7346844, at *2 (S.D. Fla. Sept. 1, 2006) (“[w]here it is not administratively feasible for the court to identify class members, no class will be deemed to exist”); Adair v. Johnston, 221 F.R.D. 573, 578 (M.D. Ala. 2004) (“Because [plaintiff’s] putative class is not adequately definite and ascertainable . . . [t]he court need not reach” any “other requirements of [Rule 23]”); Pottinger v. City of Miami, 720 F. Supp. 955, 957 (S.D. Fla. 1989) (class definition must be “sufficiently definite” and “clearly ascertainable”).

Finally, district judges in the DC Circuit have also recognized ascertainability.  “Definiteness is not mandated by Rule 23 but is a judicial creation requiring that the class be (1) ‘adequately defined;’ and (2) ‘clearly ascertainable.’”  DL v. D.C., 302 F.R.D. 1, 16, (D.D.C. 2013) (“precise ascertainability” not required for (b)(2) injunctive classes).  “While Federal Rule of Civil Procedure 23 does not contain a requirement that a class be ‘ascertainable’ or ‘clearly defined,’ such a requirement has been ‘routinely require[d]’ in order to ‘help the trial court manage the class.’”  Lightfoot v. D.C., 246 F.R.D. 326, 334 (D.D.C. 2007) (quoting Pigford v. Glickman, 182 F.R.D. 341, 346 (D.D.C. 1998)).

Given that ascertainability is recognized by courts in every circuit as an “implicit” requirement under Rule 23, it only makes sense to amend the rule after all these years to make that requirement explicit.  We’re hoping that this happens during the upcoming consideration of amendments to the rule.

Thursday, January 22, 2015

Homeopathic Drugs – Eh, We Don’t Know



It’s difficult to draw concrete conclusions in the world of homeopathic drugs.  It seems that we don’t know exactly what they are, why they work or whether they even do work.  We’re not exactly sure why we take them, but our friend at the yoga studio said they worked and so did Dr. Oz.  So we take them, hoping that they’re more fix than fairy dust.

In the preemption and FDA world, it’s even more difficult to draw concrete conclusions when homeopathic drugs are involved.  The FDA recognizes these drugs and has in fact devoted a section of its Compliance Policy Guide (“CPG”) to them.  CPG § 400.400, “Conditions Under WhichHomeopathic Drugs May be Marketed."  But after reading it, it’s not entirely clear how much the FDA is regulating these drugs.  For OTC homeopathic drugs, it’s even less clear.  For the most part, these drugs must comply with labeling requirements, meaning that their labels must include directions for use, ingredients, the dilution and the indication.  Id.; see also 21 C.F.R. §§ 201.5, 201.10, 201.61, 201.62.  Depending on certain particulars, homeopathic drugs must also be recognized by and comply with requirements of the Homeopathic Pharmacopeia of the United States, the United States Pharmacopeia, or the National Formulary.  But none of that means that the drugs will perform as indicated or are not misbranded.  CPG § 400.400.

Given this almost half-hearted regulation, it’s not all that surprising that certain courts see a way around preemption when it comes to state-law claims against homeopathic drugs.  In Forcellati v. Hyland’s, Inc., 2015 U.S. Dist. LEXIS 3867 (C.D. Cal Jan. 12, 2015), a putative class sued the manufacturer of homeopathic cold medicines, seeking financial damages under the usual trio of claims based on the California Legal Remedies Act, False Advertising Law and Unfair Competition Law, as well as warranty claims and a claim for violation of the Magnusson-Moss Act.  The FDCA has an express preemption clause for OTC homeopathic drugs that applies if the claims touch upon the same subject matter as FDA regulations and seek to impose a requirement that is “different from or in addition to, or that is otherwise not identical with” FDA regulations.  21 U.SC. §379r(d)(1).  It’s similar to the FDCA preemption clause that applies to medical devices.  While there is an exception to preemption for product liability claims, that preemption exception doesn’t apply to claims like these seeking only financial damages.

So in Forcellati, the plaintiffs’ claim was that the homeopathic drugs didn’t work and that plaintiffs could prove it through clinical trial results and other evidence.  Forcellati, 2015 U.S. Dist. LEXIS 3867 at *13-18.  Defendants argued that such a claim is expressly preempted because the FDA doesn’t require clinical trials for OTC homeopathic drugs.  And so, the defendants argued, plaintiffs’ claims would improperly impose a requirement different from and in addition to those imposed by the FDA.  Id. at *8.  At first blush, that certainly seems right.  The FDA doesn’t require clinical trials, yet plaintiffs are seeking financial damages for the failure of the drugs to successfully complete a clinical trial.  

But the court saw a way around that, explaining that the plaintiffs were not arguing that the manufacturer should have conducted a clinical trial and that its failure to do so constitutes the basis for their claim.  Rather, they were claiming that the manufacturer’s claim that the drugs were effective is disproved by clinical trial results: 

Defendants’ argument fails from the outset because Plaintiffs are not making a substantiation claim.  Plaintiffs are not arguing that Defendant’s use of the word “effective” is false or misleading because Defendants did not conduct tests to substantiate their claim before marketing their product.  Rather, Plaintiffs claim that using the word “effective” is false because Defendants’ products are not effective, period. 

Id.  

Okay.  The more we think about it, the more we get it.  The state law claim isn’t imposing a requirement that manufacturers of homeopathic drugs conduct clinical trials.  It simply asserts that, if the manufacturer make a claim that the drugs are effective, plaintiffs may try to prove that they aren’t effective (through clinical trials and other evidence) and collect financial damages if they do.  

Further supporting this notion is the FDA’s statement in its Compliance Policy Guide that, even if a homeopathic drug’s label satisfies labeling requirements, it can still be misbranded.  And so, we guess, these state law claims are more akin to parallel claims than preempted claims.  

Maybe.  We can't help but think, though, that this decision was somewhat influenced by the product involved and came with a bit of fairy dust sprinkled on top.  Okay.  We get it.

Wednesday, January 21, 2015

One Mississippi, Two Mississippi: Dismissal of Claims against Brand Name Reglan and Generic Metoclopramide Manufacturers


We normally prefer to trumpet birthday wishes rather than deathday anniversaries. But the guillotining of King Louis XVI was such a huge moment in Western history, not just French history, that we cannot let the event of January 21, 1793, go unremarked.  It is only a series of tiny conceptual steps to go from the French Revolution to nationalism, to total war, to the Napoleonic Code, to the metric system, and then to a weird overestimation of the films of Jerry Lewis.

 

Today is also National Hug Day in the United States.  Surely, Louis and Marie Antoinette could have used a hug as they rode toward the Place de la Revolution, which is now called the Place de la Concorde.  (In the Star Trek universe, the President of the United Federation of Planets is officed in the Place de la Concorde.  What other legal blog supplies that sort of crucial context?)   If we were discussing an especially lousy case today, we might say that we could use a hug, too.  But that turns out not to be necessary, because we are today reporting on a perfectly sensible case that rejected the Conte infamy.  It comes from the land of magnolias and Faulkner, of Robert Johnson and the International Ballet Competition, of Blind Melon and Viking Ranges. It comes from Mississippi.

  

The case is Truddle v.Wyeth,LLC, 2015 U.S. Dist. Lexis 4563 (N.D. Miss. Jan. 12, 2015).  Being long-time blues lovers, we cannot resist mentioning that the Truddle case resided in the Delta Division of N.D. Mississippi.  None of the courts in our burg has a title nearly so colorful.  (We could see Philly courts conducting proceedings in a Schuykill Division, Hoagie Division, Mummers Division, and, in honor of the Sixers basketball team, Tankers Division.) Truddle was a pro se case and, as with so many of the cases we discuss, it arose from very sad circumstances.  A young man suffering from gastritis and related conditions was prescribed Reglan/metoclopramide.  He subsequently committed suicide.  That is not the typical injury alleged in Reglan/metaclopramide cases.  His relatives sued both the manufacturers of brand name Reglan as well as the manufacturers of generic metoclopramide.  Earlier in the proceedings, the court had dismissed the claims against the generic manufacturers based on Mensing preemption.  Then the brand name manufacturers moved for summary judgment on the ground that there was no evidence that the decedent had ever taken brand name Reglan.  Thus we have the ‘one-two punch’ we have written about several times before, including here and here and here, among others.  The Truddle court followed the analysis of almost every other court in deciding that a brand name manufacturer cannot be held liable for injuries suffered by someone who never ingested the brand name product.  Put another way, the Truddle court rejected the Conte craziness that came out of California and that has been rejected by every right-thinking court (though, sadly, incoherently, maddeningly, it has been embraced by Mississippi’s neighbor to the immediate east).     

 

The Truddle court afforded “greater latitude to pro se plaintiffs,” but the factual record was bereft of evidence that the decedent had ever taken Reglan.  Truddle, 2015 U.S. Dist. Lexis 4563 at *6.  The plaintiffs asserted such brand name usage in a response to a Request for Admission, but the medical records were to the contrary.  That fact, or lack of fact, ends the failure to warn claim against the brand name companies, because holdings from the Fifth Circuit and Mississippi consistently make clear that in a product liability claim the plaintiff must “prove it was the defendant’s product that caused the injury.”  Id. at *10.  Mississippi product liability laws “shield the companies from liability for products they did not create.”  Id.  Mississippi gets it right.  (More vital Star Trek trivia:  the chief medical officer on the USS Enterprise, Bones McCoy, attended medical school in Mississippi.)  Though it did not really need to, the Truddle court also cited similar holdings from Florida, Arkansas, Tennessee, and Kentucky.  That makes for an interesting map.  It is as if every representative of the glorious Southeastern Conference is on the side of reason and justice, with the solitary exception of Alabama.  If we didn’t have so many friends who played or root for the Crimson Tide, this Conte issue would almost make us glad that Nick Saban’s team lost on New Year’s day.  But not so; we will continue to admire Alabama football, even as we pray for the courts or legislators in that great state to restore common sense to product liability law.  (We acknowledge that courts within Alabama's borders are perfectly capable of producing sound product liability decisions.  Take a look at yesterday's post, for example.)

 

Back to Truddle.  The only issue left was the plaintiffs’ claim for fraud.  Here is what they alleged:  the defendants “misrepresented to the FDA, [the decedent], and the health care industry the safety and effectiveness of Reglan/metoclopramide and/or fraudulently, intentionally[,] and/or negligently concealed material safety information, including adverse information regarding the safety and effectiveness of Reglan/metoclopramide.”  Id. at *11.    Those are naked allegations devoid of support or specificity.  They definitely do not supply the specific who, what, where, when, and how that are required by Fed. R. Civ. P. 9(b).   Accordingly, the court, aside from an expression of sympathy, had no hesitation granting summary judgment and dismissing the case.  The court did not mention that the allegation also seems to run afoul of Buckman, but we will.

 

The Truddle decision is hardly revolutionary.  What it is is straightforward, logical, and reassuring.  It is certainly no cause for anyone who cares about the law to sing the blues.    

 

 

 

  

Tuesday, January 20, 2015

Risks Don't Make Drugs Un-Merchantable in Alabama



            Way back in 2007 we said this:  “We really don’t see the purpose in a separate cause of action for breach of implied warranty in a case involving a prescription medical product. Warranty claims are for ham sandwiches and lawn chairs, where the term “merchantable” has some coherent meaning. . . . Except in unusual situations, where there’s physical contamination or a counterfeit product, an implied warranty of merchantability makes no sense and adds nothing except a different statute of limitations.”  We still feel the same way.  Fortunately, so do a lot of courts. 

            In some states breach of implied warranty claims have been merged with other warning-based theories of liability (like in New Jersey where all products claims other than breach of express warranty have been subsumed under the Products Liability Act).  In states where a breach of implied warranty claim remains as an independent cause of action, some courts have ruled that such claims are not allowed in the context of prescription drugs and devices.  The reasons vary but most often include application of the learned intermediary doctrine (see post here) or the unavoidably unsafe product doctrine. 

            And while at a quick glance, Alabama appears to be one of the states that generally doesn’t recognize a cause of action for breach of implied warranty of merchantability for inherently dangerous products – the law on the issue has become muddled over time.  So, in Collins v. Novartis Pharma. Corp., slip op., No. 2:08-cv-438-MHT-PWG (M.D. Ala. Jan. 14, 2015), the court tried to sort it all out.

            Collins is an Aredia case.  As in other Aredia cases, plaintiff was prescribed Aredia as part of his treatment for myeloma. When defendant moved for summary judgment, the undisputed facts included that Aredia is effective in preventing some of the serious side effects of myeloma such as fractures, spinal cord compression and pain; that some patients treated with Aredia, such as plaintiff Collins, have developed osteonecrosis of the jaw; that Plaintiff Collins had not suffered any new fractures or spinal compressions while taking Aredia; that Aredia was the standard of care when prescribed to plaintiff; and that plaintiff’s prescriber continues to use Aredia after learning about the risks of osteonecrosis and believes the benefits outweigh the risks.  Slip op. at 4-6. 

             While the facts are straightforward, Alabama law is anything but.  The question of whether Alabama recognizes breach of implied warranty of merchantability for drugs was first answered by the Alabama Supreme Court in the context of an over-the-counter medication and an idiosyncratic reaction.  The answer was:  “a product must adversely affect at least some significant number of persons before a question of merchantability arises.”  Griggs v. Combe, Inc., 456 So.2d 790, 793 (Ala. 1984).  So, Griggs created the “significant number of persons” exception.  Significantly, no Alabama state court has ever allowed a breach of implied warranty claim under the Griggs exception.  Collins, slip op. at 15. 

            Two years later, the Alabama Supreme Court seemingly rejected all breach of implied warranty of merchantability claims in cases involving “inherently dangerous” products when it made the “blanket statement that the contention that a product was unreasonably dangerous would not be viable as a breach of warranty of merchantability.”  Id. at 9 (referencing Shell v. Union Oil Co., 489 So.2d 569 (Ala. 1986).  Based on this decision, most courts interpreting Alabama law held that Alabama had merged breach of implied warranty with liability under the Alabama Extended Manufacturers’ Liability Doctrine (“AEMLD”), essentially doing away with the former. 

            But the Alabama Supreme Court again took up the question in 2003 in Spain v. Brown & Williamson Tobacco, Corp., 872 So.2d 101 (Ala. 2003) in which the court acknowledged its previous combining of UCC and tort concepts which sometimes go “hand in hand” but ultimately held that “the determination [of] whether there was a breach [of implied merchantability] requires a fact-intensive analysis.”  Collins, slip op. at 10 (quoting Spain).    

            So, with the door to breach of implied warranty of merchantability re-opened, even if slightly, plaintiffs ever since have been trying to use the Griggs exception and the Spain case-by-case determination requirement to maintain merchantability claims in prescription medical product cases.  For some courts, the decision turns on whether there is evidence that the product was fit for its intended purpose even though it might also be inherently dangerous.  See Bodie v. Purdue Pharma Co., 236 F. App’x 511 (11th Cir. 2007) (no breach of implied warranty where OxyContin, while dangerous, is fit for intended purpose of treatment for chronic pain).  For others, the focus is on the purpose of the product.  For instance, if a product’s only purpose is consumption, like food, plaintiff may have a viable breach of warranty claim “because it is the act of consumption not use that makes the product dangerous.”  Collins, slip op. at 13 n.11.  Conversely,

[i]f . . . there is some other purpose such as treating the symptoms of disease, the implied warranty applies only to that purpose and any unreasonable danger of the product must be addressed by the AEMLD.

Id. (quoting Houston v. Bayer Healthcare Pharma., Inc., 16 F.Supp.3d 1341 (N.D. Ala. 2014).

            Taking in all the varied analyses, the Collins court reached the conclusion that

in almost every case, a claim for alleged breach of implied warranty of merchantability under the UCC is subsumed by AEMLD except for a theoretical possibility which has only been applied on summary judgment to the consumption of food products and never to prescription drugs.

Id. at 14.    Applying this interpretation of Alabama law to the facts of the case, the court found that at the most, plaintiff showed “there are potential adverse consequences associated with the use of the drug.”   Id. at 17.  That is not enough:

The question of proof in this context is not merely whether there is sufficient evidence for a jury to decide the question but the more fundamental one of whether [plaintiff] can establish as a matter of law this his claim is shrouded in the ethereal mist of a Griggs UCC cause of action.  The Alabama courts have never permitted such a claim to advance.  . . . A drug product is fit for the purpose intended even when there is a serious health consequence for some users when the product is shown to achieve its commercial purpose.  This presumption of merchantability cannot be overcome merely by demonstrating that there are risks associated with the use by a particular patient or group of patients.  . . . [T]his legal standard does not mean that manufacturers are free to produce products that cause harm and remain unaccountable.  Alabama law provides a complete remedy for such occurrences under the AEMLD.

Id. at 17-18.  Unless something unfavorable happens to this case in the appellate courts (and given that it is Alabama nothing is a certainty), Collins is a very strong statement about the lack of viability of breach of implied warranty claims in prescription drug and device cases in Alabama.     

            Usually breach of implied warranty claims are bit players in prescription medical product cases; upstaged and out shined by the stars of the tort world – failure to warn and design defect.  But as we alluded at the top of this post, sometimes plaintiffs are relying on the longer UCC statute of limitations.   That seems to be the case in Collins where the lawsuit was filed a little more than four years after plaintiff’s injury first manifested.  So, if plaintiff had a statute of limitations problem with even his breach of warranty claim, he was certainly out of time for a tort claim.  The rest of the Collins decision finds the breach of warranty claim time-barred.  Another good result, but not one we are going to elaborate on today.  The opinion is here if you want to read more.