Friday, November 30, 2012

Supreme Court to Hear Bartlett

As we had hoped, the United States Supreme Court agreed today to review the First Circuit's remarkable ruling in Mutual Pharmaceutical Co. v. Bartlett, that a state court plaintiff can argue that an FDA approved drug should be removed from the market altogether.  The Supreme Court's order granting certiorari is here.

Thanks to a bunch of people for letting us know.

Lone Pine Cheat Sheet

            Whenever we learn about the entry of a Lone Pine order, we take the opportunity to extoll the virtues of Lore v. Lone Pine Corp., 1986 WL 637507 (N.J. Sup. Ct. Nov. 18, 1986) in which a New Jersey state court judge ordered plaintiffs to offer proof connecting the defendant's product to the plaintiff's alleged injury.  And with the recent entry of another Lone Pine order in In re Fosamax Products Liability Litigation, 2012 U.S. Dist. LEXIS 166734 (S.D.N.Y. Nov. 20, 2012), we thought it made sense to start keeping track of these orders.  So, here you have our Lone Pine cheat sheet.  Like with our other cheat sheets, this is an attempt to collect all the favorable decisions entering or upholding Lone Pine orders and we’ll do our best to keep it updated (we’ve included toxic tort cases as well because they are helpful). 
            Although the specifics can vary, typically a Lone Pine order requires the plaintiff to prove that he or she was exposed to the defendant's product, to identify the precise alleged injury resulting from the exposure, and to offer some sort of proof that the exposure caused the disease.  Huh?  Isn’t that part of plaintiffs’ burden in every products liability case?  Well, yes.  But as we all well know, in the context of a mass tort or multidistrict litigation (or a toxic tort) hundreds, maybe thousands, of plaintiffs’ cases sit idly on the court’s docket with virtually no case-specific discovery while millions of dollars of discovery directed to defendants goes on for years.  And that means meritless and frivolous cases (it’s no secret that with mass solicitation by plaintiffs’ lawyers many, many non-legitimate cases get filed) go along for the ride and are still hanging around when a mature mass tort moves toward remanding individual cases or settlement discussions begin.
            So it can hardly come as a surprise that we favor a case management mechanism that puts plaintiffs to some level of proof early on in the proceedings.  “Early on” being a relative term as courts seem more willing to enter Lone Pine orders after a litigation has been around a while.  But, even after a few years of general discovery, a Lone Pine order is certainly better for defendants than collecting medical records, deposing plaintiffs and health care providers, retaining experts, deposing opposing experts, and drafting summary judgment motions in one case, let alone hundreds.  All to cause a court to dismiss a claim that was meritless or fraudulent from the start.
            Lone Pine orders are permitted by the broad discretion given to federal courts by FRCP 16(c)(2)(L) to control mass torts and complex litigation.  State courts generally have their own discretion to employ such case management techniques.  Further, as alluded to above, Lone Pine orders “impose a minimal burden on plaintiffs, as it merely asks them to produce information they should already have.”  In re Fosamax Products Liability Litigation, 2012 U.S. Dist. LEXIS 166734 at *6.  The Fosamax court seemed particularly persuaded by the fact that the majority of cases set for trial and/or selected for discovery were dismissed:  “Plaintiffs’ habit of dismissing cases after both parties have expended time and money on case-specific discovery demonstrates that this MDL is ripe for a Lone Pine order.”  Id. at *7.  While a Lone Pine order is not always a slam dunk for the defense, there is certainly enough precedent to argue that entry is grounded in ample law. 
  • Lore v. Lone Pine Corp., 1986 WL 637507 (N.J. Super. Nov. 18, 1986).
  • Eggar v. Burlington Northern Railroad Co., 1991 WL 315487, at *4 (D. Mont. Dec. 18, 1991) (granting summary judgment under prior case management order requiring plaintiffs to produce an medical expert's affidavit “specify[ing], for each test plaintiff, the precise injuries, illnesses or conditions suffered by that plaintiff; the particular chemical or chemicals that, in the opinion of the physician, caused each injury, illness or condition; and the scientific and medical bases for the physician's opinions.  It will not be sufficient for the affidavit to state a 'laundry list' of injuries and chemicals; each injury, illness or condition must be itemized and specifically linked to the chemical or chemicals believed to have caused that particular injury, condition or illness. Moreover, the statement of scientific and medical bases for the opinion shall include specific reference to the particular scientific and/or literature forming the basis for the opinion”), aff’d, 29 F.3d 499 (9th Cir. 1994)
  • Cottle v. Superior Court, 3 Cal. App. 4th 1367 (Cal. App. 1992) (upholding trial court order requiring plaintiffs to identify product, exposure, alleged injury and the identity of a medical expert who will support the plaintiff's personal injury claim”).
  • Atwood v. Warner Electric Brake & Clutch Co, 605 N.E.2d 1032 (Ill. App. 2d 1992) (upholding trial court order requiring plaintiffs to produce case-specific medical reports and submit to defense expert medical examinations before the depositions of the plaintiffs were scheduled).
  • Schelske v. Creative Nail Design, Inc., 933 P.2d 799, 802-05 (Mont. Jan. 2, 1997) (affirming district court's dismissal of plaintiffs who failed to comply with trial court order requiring product identification; use and exposure; and causation linking product defect to an identifiable injury).
  • Acuna v. Brown & Root, Inc., 1998 WL 35283824, at *5-6 (W.D. Tex. Sept. 30, 1998) (dismissing plfs who failed to comply with Lone Pine order requiring an expert report listing all injuries, illnesses or conditions suffered by the plaintiff that were caused by exposure to materials or substances from defendant's operations, specifying what substances caused each injury, identifying the particular activity that was the source of the materials or substances, describing the exposures with specific dates, times, circumstances, incidents and dosages; and
    statng the scientific and medical bases for the expert's opinions), aff’d, 200 F.3d 335 (5th Cir. 2000) (holding no abuse of discretion by trial court in entering Lone Pine orders;
    “the scheduling orders issued below essentially required that information which plaintiffs should have had before filing their claims pursuant to FRCP 11(b)(3)”).
  • Adjemian v. American Smelting & Refining Co., 2002 WL 358829, at *1-6 (Tex. App. March 7, 2002) (affirming district court's dismissal of plaintiffs who failed to comply with trial court order requiring production of information about the specific toxic substances to which they were exposed, the particular injuries that resulted from the exposure, and the medical evidence that supported each claimant's case).
  • In re Baycol Litig., November Term, 2001, No. 0001, Order (Ct. Com. Pl. Phila. Co. Dec. 12, 2003) (entering Lone Pine order in Pennsylvania state court coordinated Baycol proceeding)
  • In re Baycol Prods. Liab. Litig., MDL No. 1431, 2004 WL 626866, at *1 (D. Minn. Mar. 18, 2004) (entering initial Lone Pine order, which was later amended, for numerous purposes including toidentify . . . the claims of those plaintiffs who have and those who do not have factually and legally sufficient support for their alleged claims and injuries or damages”).
  • In re 1994 Exxon Chemical Plant Fire,  2005 WL 6252312, at *1-2 (M.D. La. April 7, 2005) (entering Lone Pine order requiring plaintiffs to produce evidence linking their alleged exposures to a particular substance with an identified injury).
  • In re: N.Y. Rezulin Prods. Liab. Litig., slip op., Master Index No. 752,000/00, Order (N.Y. Sup. Ct. N.Y. Co. Aug. 7, 2004) (entering Lone Pine order in New York state court coordinated Rezulin proceeding).
  • In re Rezulin Prods. Liab. Litig., MDL No. 1348, 2005 WL 1105067 (S.D.N.Y. May 9, 2005) (ordering plaintiffs to serve case-specific expert reports, failure to do so may result in sanction of dismissal with prejudice).  See 441 F.Supp.2d 567, 507 (dismissing plaintiffs whose reports were inadequate)
  • In re Silica Prods. Liability Litig., 398 F. Supp. 2d 563, 576 (S.D. Tex. 2005) (entering Lone Pine type order requiring each plaintiff to submit specific information about his exposure to silica dust and detailed medical information concerning each alleged injury).
  • In re 1994 Exxon Chemical Plant Fire, 2005 WL 6252312 (M.D. La. Apr. 7, 2005) (entering Lone Pine order, finding that if plaintiff is unable to comply “the court should be concerned with the viability of that plaintiff’s claims” and that the Lone Pine order “would reduce costs and save time.”)
  • Baker v. Chevron USA, Inc., 2007 WL 315346, at *1 (S.D. Ohio Jan. 30, 2007) (dismissing plaintiffs who failed to comply with Lone Pine case management order requiring them to produce "an affidavit from a qualified expert or experts setting forth for each Plaintiff the specific illness allegedly sustained, the date the illness was diagnosed, the name and address of the medical provider who made the diagnosis, the toxic chemical which allegedly caused the illness, the alleged manner of exposure, and the date, duration, and dose of the exposure").
  • Burns v. Universal Crop Protection Alliance, 2007 WL 2811533, at *2-3 (E.D. Ark. Sept. 25, 2007) (entering Lone Pine order in products liability action brought by 82 cotton farmers against five herbicide manufacturers, finding “a preliminary showing on causation is necessary for efficient case management”).
  • In re Vioxx Prods. Liab. Litig., 557 F. Supp. 2d 741, 743-44 (E.D. La. 2008) (denying plaintiffs’ motion to stay Lone Pine order finding “it is not too much to ask a Plaintiff to provide some kind of evidence to support their claim that Vioxx caused them personal injury . . . Surely if Plaintiffs' counsel believe that such claims have merit, they must have some basis for that belief; after all this time it is reasonable to require Plaintiffs to come forward and show the basis for their beliefs and show some kind of basic evidence of specific causation.”); dismissal of plaintiffs for failure to comply with Lone Pine order affirmed by 388 Fed.Appx. 391, 2010 WL 2802352 (5th Cir. Jul. 16, 2010).
  • In re Bextra and Celebrex Mktg. Sales Practices and Prod. Liab. Litig., MDL No. 1699, slip op., (N.D. Cal. Aug. 8, 2008) (Lone Pine order containing step-by-step enforcement enforcement procedures leading to dismissal for failure to comply).
  • Abbatiello v. Monsanto Co., 569 F. Supp. 2d 351, 353-54 (S.D.N.Y. 2008) (in toxic tort action involving multiple parties, court denied plaintiffs’ request to stay previously entered Lone Pine order finding reason for “requiring early individual causation expert evidence, is to protect defendants and the Court from the burdens associated with potentially non-meritorious mass tort claims”).
  • Arias v. Dyncorp, 2008 WL 9887418, slip op. (D.D.C. Oct. 21, 2008) (entering Lone Pine order in toxic tort case involving herbicide exposure, requiring detailed exposure information, including map with location of each exposure event and submission of medical records as prerequisite to discovery).  Dismissal of noncompliant plaintiffs affirmed, ___ F.3d ___, 2014 WL 2219109, at *3 (D.C. Cir. May 30, 2014).
  • Wilcox v. Homestake Mining Co., 2008 WL 4697013, at *1 (D.N.M. Oct. 23, 2008) (dismissing plaintiffs for noncompliance with Lone Pine order requiring “expert affidavits which make a prima facie showing of harmful exposure and specific causation for each injury the particular Plaintiff claims was caused by the Defendants' alleged contamination”), aff’d on other grounds, 619 F.3d 1165 (10th Cir. 2010) (Lone Pine noncompliance dismissals not appealed).
  • McManaway v. KBR, Inc., 265 F.R.D. 384 (S.D. Ind. 2009) (entering Lone Pine order requiring plaintiffs to serve case-specific expert reports on exposure, injury and causation, but due to the early stage of the litigation “failure to address the causation issue will not be grounds for immediate dismissal” but may warrant awarding defense costs and fees if summary judgment later granted on that basis).
  • In re Asbestos Products Liability Litigation (No. VI), MDL No. 875, Admin. Order #12, slip op., at sec. 5 (E.D. Pa. Sept. 3, 2009) (current version of Asbestos MDL Lone Pine order, requires disclosure of expert reports supporting causation for both malignant and non-malignant cases, “objective and subjective” data on which reports are based must be "identified and descriptively set out within the report or opinion").  Dismissals based on AO #12 affirmed, see below).
  • In re Avandia Mktg., Sales Practices and Prods. Liab. Litig., MDL No. 1871, 2010 WL 4720335 (E.D.Pa. Nov. 15, 2010) (entering Lone Pine order court noted it was concerned by unsupported Plaintiff Fact Sheets and the need to “objectively identify which of the many thousand plaintiffs have injuries which can credibly be attributed to Avandia usage.”  Further, the order “merely requires information which plaintiffs and their counsel should have possessed before filing their claims: proof of Avanida usage, proof of injury, information about the nature of the injury, and the relation in time of the injury to the Avandia usage.”).
  • Avila v. Willits Envtl. Remediation Trust, 633 F.3d 828, 833-34 (9th Cir. Jan. 27, 2011) (upholding entry of Lone Pine order "requir[ing] written statements setting forth “all facts” supporting non-resident and post–1988 resident plaintiffs' claimed exposure, together with a written statement from an expert describing the condition for which recovery was sought, identifying the chemical to which the plaintiff was exposed, explaining the route of exposure, opining on causation, and setting forth the scientific and medical basis upon which the opinion was basedas to exposure and causation," and affirming dismissal of plaintiffs whose proffered expert report failed to satisfy Daubert).
  • Pinares v. United Technologies Corp., 2011 WL 240512, at *1 (S.D. Fla. Jan. 19, 2011) (entering Lone Pine order requiring plaintiffs to demonstrate a prima facie case that their property has been contaminated by the defendants’ conduct).
  • Strudley v. Antero Resources Corporation, No. 2011CV2218, slip op.  (Denver County, CO May 12, 2012) (court entered Lone Pine order requiring plaintiffs to produce admissible expert evidence to establish a prima facie showing of exposure and causation; then dismissed case because plaintiffs' expert could not establish causation).  The order was reversed, 2013 WL 3427091 (Colo. App. July 3, 2013), but the Colorado Supreme Court granted an appeal from the reversal.  2014 WL 1357327 (Colo. April 7, 2014).
  • Baker v. Anschutz Exploration Corp., No. 11-Civ.-6119-CJS, slip op. (W.D.N.Y. Sept. 25, 2012) (entering Lone Pine order requiring plaintiffs to produce expert reports quantifying property contamination and alleged contaminants).  Order deemed complied with at Baker v. Anschutz Exploration Corp., 2013 WL 3282880, at *5 (W.D.N.Y. June 27, 2013).
  • In re Fosamax Products Liability Litigation, 2012 WL 5877418 (S.D.N.Y. Nov. 20, 2012) (entering Lone Pine order for particular alleged injuries to “target potentially spurious claims without imposing undue obligations upon other plaintiffs.”).
  • Asarco LLC v. NL Industries, Inc., 2013 WL 943614, at *3 (E.D. Mo. March 11, 2013) (court entered Lone Pine order requiring plaintiffs to “establish (a) the identity of each hazardous substance from each Defendant's activities that resulted in exposure and which [plaintiff] claims has caused environmental injury, (b) whether any and each of these substances can cause the type(s) of environmental injuries [plaintiff] claims occurred and for which it seeks contribution (general causation), (c) the dose or other quantitative measurement of the concentration, timing, and duration of exposure, (d) the precise location of each exposure, (e) an identification, by way of reference to scientifically based studies, of the specific environmental harms that have allegedly occurred, (f) quantification of contamination to property attributable to each Defendant's operations, and (g) a conclusion that such harm was in fact caused by exposure from each separate Defendant's operations”).
  • In re Asbestos Products Liability Litigation (No. VI), 718 F.3d 236, 244-45 (3d Cir. May 31, 2013) (Lone Pine order (AO 12 affirmed.  MDL court properly required all asbestos plaintiffs to “submit to the court a copy of the medical diagnosing report or opinion upon which the plaintiff now relies,” and “requir[e] a complete exposure history.”  Noncompliant plaintiffs were properly dismissed).
  • Abner v. Hercules, Inc., 2014 WL 5817542, at *2-6 (S.D. Miss. Nov. 10, 2014) (entering Lone Pine order requiring plaintiffs to demonstrate a prima facie case that their property has been contaminated by the defendants’ conduct).

Thursday, November 29, 2012

Bulking Up


We’ve been thinking lately about the bulk supplier doctrine in the context of prescription drugs.  We haven’t discussed this topic at any length, although we did touch upon aspects of it some time ago here and here.  It’s due for another, more detailed, look.  Also, thanks to Reed Smith's Melissa Wojtylak for research assistance in the preparation of this post.

The doctrine generally comes into play when the manufacturer of an allegedly defective prescription drug or medical device is out of the picture – judgment-proof, protected by preemption, etc. – and the enterprising plaintiff in search of a deep pocket has instead sued a company that supplied an active ingredient or component part to the manufacturer.  Section 5 of the Restatement (Third) of Torts addresses the liability of bulk suppliers and suppliers of component parts, and provides:

One engaged in the business of selling or otherwise distributing product components who sells or distributes a component is subject to liability for harm to persons or property caused by a product into which the component is integrated if:

 (a) the component is defective in itself . . . and the defect causes the harm; or

 (b)(1) the seller or distributor of the component substantially participates in the integration of the component into the design of the product; and

(b)(2) the integration of the component causes the product to be defective . . .; and

(b)(3) the defect in the product causes the harm.

In the context of prescription drugs, FDA regulations exempt bulk suppliers from liability for failure to warn claims if the packaging for the bulk product contains certain language indicating that the contents are for use in manufacturing, processing, or repacking, and/or is for prescription use only.

A drug in a bulk package, except tablets, capsules, or other dosage unit forms, intended for processing, repacking, or use in the manufacture of another drug shall be exempt from section 502(f)(1) of the act [involving requirements for labeling] if its label bears the statement “Caution: For manufacturing, processing, or repacking”; and if in substantially all dosage forms in which it may be dispensed it is subject to [the prescription drug provisions] of the act, the statement “Rx only”. . . .

21 C.F.R. §201.122.  There follow several involved exceptions (§201.122(a-c)) for “new drugs” (those not yet FDA approved)), but this language is the generally applicable bulk drug FDA regulation.

In addition, the Biomaterials Assurance Act of 1998, 21 U.S.C. § 1601 et seq., discussed here, protects suppliers of materials used in the manufacture of implantable medical devices by preempting claims against them.  See Marshall v. Zimmer, 1999 WL 34996711, at *3 (S.D. Cal. Nov. 5, 1999) (applying statute).  This act was the direct consequence of the jaw implant litigation discussed below.

In the failure to warn context, the rationale for these sorts of statutory provisions is simple: generally, bulk suppliers are not well situated to give any kind of warning to end users – or even learned intermediaries – about the characteristics of their product.  Even if they could, differing warnings from different sources would be confusing.  As recognized years ago by one appellate court, “[t]he rigorous testing and reporting required of final manufacturers by federal law . . . renders superfluous detailed warning by bulk suppliers to those same manufacturers.”  White v. Weiner, 562 A.2d 378, 385 (Pa. Super. 1989), aff’d without op., 583 A.2d 789 (Pa. 1991).  “It is the final manufacturer and the medical community, however, who are in a better position to assess the risks associated with the administration of the prescription drug.”  Id., at 386. 

Thus, courts have found that compliance with the FDA’s bulk drug component labeling regulation satisfies common-law warning duties as a matter of law.  George v. Parke-Davis, 733 P.2d 507, 515-16 (1987); White, 562 A.2d at 382-385; Sokoloski v. American Home Products Corp., 59 Pa. D. & C.4th 225, 237-40 (Pa. C.P. Philadelphia Co. 2003); Kalinowski v. E.I. DuPont de Nemours & Co., 851 F. Supp. 149, 156 (E.D. Pa. 1994); Styck v. E.I. DuPont de Nemours & Co., 1993 WL 761301, at *4 (C.D. Ill. Nov. 12, 1993), aff’d, 41 F.3d 1103 (7th Cir. 1994); Veil v. Vitek, Inc., 803 F. Supp., 229, 235-37 (D.N.D. 1992).  The bulk supplier must, of course, be able to establish compliance.  See Fisher v. Professional Compounding Centers, Inc., 311 F. Supp.2d 1008, 1021-22 (D. Nev. 2004) (defendant’s compliance with §201.122 raised issues of fact).

Notably, federal bulk labeling standards have been adopted as coextensive with the common law not by way of federal preemption, but rather through voluntary “deference” to federal law (akin to, but not quite the same as "primary jurisdiction") in this heavily regulated area.  At the time White was decided (and also today) Pennsylvania’s own statutes had explicitly adopted FDA drug standards, so the court held “[o]ur legislature unequivocally has expressed a policy of deference to the federal scheme in the area of drug labeling, and we can ascertain no reason not to extend that policy to civil cases.”  562 A.2d at 383.  The FDA’s extensive labeling requirements for drug manufacturers mean that there’s no reason for the common law to impose any safety-related parallel duty on bulk suppliers.

[T]he United States [FDA] requires the tablet manufacturers . . . to account for and warn of a drug’s properties.  It would therefore be anomalous to require the raw manufacturer to conduct separate tests to determine the adverse effects of the drug when by federal statute, the tablet manufacturer bears this responsibility.

George, 733 P.2d at 515; accord White, 562 A.2d at 385 ("[i]n light of federal law . . . a separate warning from a bulk supplier to the medical community would be duplicative”); Sokoloski, 59 Pa. D. & C.4th at 239 (a duty that there be separate bulk supplier warnings would be “superfluous”).

George and White were also applied in the context of medical devices, where after the manufacturer of a defective jaw implant went bankrupt, the plaintiffs en masse went after the bulk supplier of a chemical (Teflon) used to make the device:

[W]e agree with [the bulk supplier] that it owed no duty to [plaintiff] to assure the safety of [the manufacturer’s] specialized use of its raw material. . . .  The supplier of a raw material which is not inherently dangerous or defective cannot reasonably be held liable for injuries caused by a purchaser's subsequent manufacturing of the raw material into a defective or dangerous product. [The device manufacturer], designed, formulated, tested, manufactured, advertised, and sold [the device].  [The bulk supplier] had no duty to assure the safety of [the] implants.

Nor did [the bulk supplier] have a duty to warn the plaintiff here. Such a duty is imposed on the manufacturer of a product which is incorporated into a second product only if the manufacturer knows or has reason to know that the product is likely to be dangerous for the use for which it is being supplied, and has no reason to believe that the eventual user will realize the dangerous condition of the product. . . .  [T]here was nothing about which [the bulk supplier] had a duty to warn [plaintiff].  [The manufacturer] as the inventor, manufacturer, patent-holder and federal licensee [footnote about FDA approval] of [the device], knew more about its product and applications of its product than [the bulk supplier] did.  Any duty to warn [plaintiff] was owed by [the device manufacturer].

Collins v. E.I. DuPont de Nemours & Co., 1993 WL 521229, at *2 (Ariz. App. Oct. 26, 1993) (unpublished).  See also Parker v. E.I. DuPont de Nemours & Co., 909 P.2d 1, 10 (N.M. App. 1995) (“it is clear that the FDA had regulatory authority over the sale of the [medical device] and [the bulk supplier] received written assurances from [the manufacturer]  that it would comply with FDA requirements”); Bond v. E.I. DuPont De Nemours & Co., 868 P.2d 1114, 1121 (Colo. App. 1993) (“there is again even less reason to impose such a duty when, as here, the designer of the final product presumably possesses highly specialized knowledge of the field in which the product exists and that designer is under a duty imposed by the government to conduct specific tests and provide particular warnings”); Anguiano v. E.I. DuPont de Nemours & Co., Inc., 808 F. Supp. 719, 726 (D. Ariz. 1992) (“it was enough that the bulk supplier comply with the labelling requirements”; [the bulk product] is not a medical device and [its supplier] is not a manufacturer of medical devices  . . . [t]he reasoning in both the George and White cases is applicable”), aff’d, 44 F.3d 806 (9th Cir. 1995); In re TMJ Implants Products Liability Litigation, 872 F. Supp. 1019, 1033 (D. Minn. 1995) (“Similarly [to George], it would be anomalous to require [a bulk supplier] to conduct separate tests to determine the potential risks of using [its product] in [a medical device] when [the manufacturer] was already required [by the FDA] to do so”), aff’d 97 F.3d 1050 (8th Cir. 1996).

In addition, the learned intermediary rule has been cited as a basis for barring product liability claims involving components used in drugs and medical devices – there’s no duty to warn end users, and physicians have other sources of information.  Even more remotely situated bulk suppliers have no duty to circumvent the learned intermediary rule with direct warnings.  White, 562 A.2d 378, 385-86; Lyons v. Premo Pharmaceutical Labs, Inc., 406 A.2d 185, 191-92 (N.J. Super. App. Div. 1979); Sokoloski, 59 Pa. D. & C.4th at 240-42; Kalinowski, 851 F. Supp. at 156-57; Baker v. E.I. DuPont de Nemours & Co., 1994 WL 762406, at *2-3 (M.D. Pa. Feb. 7, 1994); Veil, 803 F. Supp. at 234-37.

This combination of FDA regulations adopted by the states and the learned intermediary rule distinguishes prescription medical product cases from other bulk supplier situations.  In a recent opinion, issued earlier this year, Union Carbide Corp. v. Aubin, 97 So.3d 886 (Fla. App. 2012), the court held that, theoretically (the plaintiff ultimately failed to prove causation), a bulk supplier of asbestos could be liable for a “design defect” because the “design” (not a pure raw material because it had been processed) was “manifestly unreasonable” – i.e., “the extremely high degree of danger posed by its use . . . so substantially outweighs its negligible social utility that no rational, reasonable person, fully aware of the relevant facts” would choose to use it.  Id. at 897 (applying Restatement Third §2, comment e).  A pure (that is, properly manufactured) drug or device component, sold in bulk in compliance with FDA regulations, would have no basis for falling within this comment – particularly given the labeling requirements imposed upon the manufacturers of finished drugs.  Indeed, the court in Aubin recognized that “products are not generically defective merely because they are dangerous.”  Id. at 898. 

Aubin’s treatment of failure to warn is also of interest.  The plaintiff’s failure to warn claim could go to the jury under the Third Restatement because a bulk supplier had to warn the ultimate user of the product if it was reasonably feasible to do so – a question it found was clearly reserved for the trier of fact.  Id. at 898-99.  Notably, the court distinguished asbestos from a drug or medical device manufacturer’s duty to warn a learned intermediary:

Florida courts are clear that prescription drug manufacturers may discharge their duty to warn end-users as a matter of law by adequately warning physicians regarding the hazards associated with prescription drugs.  See Felix [v. Hoffmann-LaRoche, Inc.], 540 So.2d [102,] 104 [(Fla.1989)] (determining that while drug companies have the duty to warn of a drug's dangerous side effects, that duty to warn is directed to physicians rather than patients under the ‘learned intermediary’ doctrine); see also Hoffmann-LaRoche Inc. v. Mason, 27 So.3d 75, 77 (Fla. [App.] 2009) (‘[T]he duty of a drug manufacturer to warn of the dangers involved in the use of a drug is satisfied if it gives an adequate warning to the physician who prescribes the drug.’).

In Florida, a variant of the learned intermediary doctrine has been extended outside of the prescription drug context, although not as a complete defense.  Instead, the intermediary's level of education, knowledge, expertise, and relationship with the end-users is informative, but not dispositive.

Aubin, 97 So.3d at 899-900 (emphasis added).  Thus unlike other bulk suppliers, who are not subject to the unique regulatory and distribution system that applies to prescription medical products, the “education, knowledge, expertise, and relationship” id. at 900, of licensed physicians is recognized as satisfying those elements of the bulk supplier defense as a matter of law.

Bulk supplier liability is one of those novel and expansive causes of action that we’ve been trying to keep out of product liability litigation involving prescription medical products for much longer than we’ve been blogging (White was Bexis' first ever appellate argument).  Because the other side is still trying – we’ll keep trying as well.

Wednesday, November 28, 2012

Primary Jurisdiction: A Natural Alternative to Preemption


 

There was much gnashing of teeth among members of the defense bar in the wake of Wyeth v. Levine's curtailment of FDA preemption.  It felt like a missed opportunity.   But some of our more persistent and creative colleagues insisted that a lot of the facts and factors we typically seized upon to argue for preemption - extensive FDA regulation, the need for expertise and uniformity -- might still be helpful in setting up other defenses.  What other defenses, you ask?  Primary jurisdiction is the first one that comes to mind. 

 

Last week supplied a short and adorable example in Astiana v. The Hain Celestial Group, Inc., 2012 U.S. Dist. LEXIS 165368 (N.D. Cal. Nov. 19, 2012).  The plaintiffs contended that the defendants' use of the word "natural" on their cosmetic products was false and misleading.  The plaintiffs asserted causes of action under California law for common law fraud, unlawful, unfair, and fraudulent business practices in violation of California's Unfair Competition Law, false advertising, and violation of California's Consumer Legal Remedies Act.  That's a familiar face, isn't it? 

 

Of course, we normally talk about the "D" in FDA - drugs.  Sometimes, when we hunger for adventure, we chew on a case involving the "F" - food.  There is no C-word in FDA, but there is in the FDCA, the Food, Drug, and Cosmetic Act.   We do not often discuss cosmetics cases, but since the theme of today's post is putting lipstick on the Wyeth v. Levine pig, maybe it is appropriate that the Astiana case concerns cosmetics. 

 

No matter the subject matter, we have all seen Astiana-type assertions before.  Look here, for example.   Come to think of it, we had the feeling that we have seen similar allegations before with a plaintiff named Astiana.  It is not as if it is a common name.  After a little Googling, we confirmed our suspicion.  It turns out that Astiana has gone around suing various companies in California courts for adorning their product labels with the word "natural."  Naturally, we wondered how the same person can be constantly fooled in exactly the same way. It is like that old gag where it is reported that every day a man gets run over by a bus.  A wag then exclaims how awful it must be to be that unfortunate man.  Well, here it apparently really is the same person. In one case, Astiana complained about the use of the word "natural" on an ice cream container.  In its defense, the manufacturer pointed out, perhaps reluctantly, that ice cream does not exist at all in nature.  

 

The FDCA governs the labeling of cosmetics, but does not say much beyond a general prohibition on labels that are "false and misleading in any particular."  21 U.S.C. section 362.  The FDA has issued no policy, informal or otherwise, regarding use of the term "natural" in cosmetics.  Not surprisingly, the plaintiffs argued that the court did not need to await any guidance from the FDA, because courts routinely decide what is misleading.

 

But in the wonderful Pom Wonderful case (which we blogged about several times, including here), the occasionally wonderful Ninth Circuit held that courts should not decide such issues when such a decision would "undermin[e], through private litigation, the FDA's considered judgments. " Pom Wonderful LLC v. Coca-Cola Co., 679 F.3d 1170, 1178 (9th Cir. 2012).  Last week, we griped about a not-so-wonderful lower court decision that failed to apply Pom Wonderful with appropriate vigor.  But Astiana is a much better decision.  It is, not to put too fine a point on it, simply wonderful.  All it has to do is flutter its fattened eyelashes at us and we swoon.  It had us at Hello.  Actually, it had us at the all caps “DISMISSES” near the end.  Astiana is like a makeup call for last week’s Pom Wonderful not-quite-progeny. 

 

The Astiana court read Pom Wonderful to stand for the proposition that courts should not butt in where Congress had entrusted the task of guarding against deception to the FDA.  According to the Astiana court, Pom Wonderful was not about preemption.  Rather, it was about primary jurisdiction.   The doctrine of primary jurisdiction applies when there is (1) a need to resolve an issue that (2) has been placed by Congress within the jurisdiction of an administrative body having regulatory (3) pursuant to a statute that subjects an industry or activity to a comprehensive regulatory authority that (4) requires expertise or uniformity in administration.   Astiana, 2012 U.S. Dist. LEXIS 165368 at *6. 

 

The Astiana court concluded that all of those factors applied to the issue of whether a cosmetics label was false or misleading.  It did not matter that the FDA has so far been silent as to what the word "natural" means in the context of cosmetics.  Every once in a while the FDA drops hints as to what it takes to call a food "natural," but the FDA has never done so for cosmetics. Moreover, cosmetics are regulated separately from food, and cosmetics, unlike foods, "are by their nature artificial and/or synthetic." Id. at *8.   Why is the FDA so coy about the meaning of the word “natural”?   Is it playing hard to get?  Is it just busy washing its hair?  Whatever the reason for the FDA's reticence on what a "natural" cosmetic is, the court declined to fill in the vacuum.   The court believed that imposing its judgment on whether "natural" was misleading would undercut the FDA's judgments and authority.   Id. at *9, citing Pom Wonderful.  And then the court gives us that same feeling that Chris Matthews says candidate Obama gave him in 2008 when it “DISMISSES the complaint.”   Id.  But the dismissal is without prejudice.  Darn it.  Sometimes we have to wonder whether  the Astiana case loves us as much as we love it.     

 

What animated Pom Wonderful and Astiana was deference to the FDA.   Naturally, we wonder why such deference is not equally warranted with respect to drugs and medical devices. Surely, drugs and devices require as much expertise and uniformity as fruit juice, ice cream or eyeliner. 

 

Tuesday, November 27, 2012

Causation and Plaintiff's Conduct in Pennsylvania Strict Liability


The Pennsylvania Supreme Court decided a product liability case yesterday:  Reott v. Asia Trend, Inc., Nos. 27-30 WAP 2011, slip op. (Pa. Nov. 26, 2012).  First of all – no, Reott did not answer, or even mention, the foundational Restatement (Second) vs. Restatement (Third) question, since the case:  (1) involved only a manufacturing defect (missing stitching), as to which both restatements agree strict liability should apply, and (2) the element of product defect was not even at issue, since a directed verdict on manufacturing defect had been entered and not appealed.  Actually, the point about no mention is not exactly right, since Justice Saylor’s concurring opinion made clear that as to other types of “defects” that question remains open.

The second thing to note about Reott, from our perspective, is that its holdings about plaintiff conduct and causation issues are relevant to prescription medical product cases mostly by analogy because in Hahn v. Richter, 673 A.2d 888 (Pa. 1996), the same court barred strict liability (at least for design and warning – manufacturing defect claims are uncertain) in cases involving such products.  But there are occasional manufacturing defect cases involving prescription drugs, and principles of sole causation and superseding cause are also found in negligence, so Reott is worth a look, particularly by Pennsylvania practitioners.

Reott involved that most non-prescription sort of product – a tree stand.  If you don’t hunt, then that product name probably doesn’t do much for you either.  A tree stand is just what it sounds like, a collapsible platform placed in a tree as a location from which hunters can watch for game (usually, but not always deer).  To fit around the tree, a tree stand has a locking strap.  The plaintiff, an experienced hunter, had devised his own method to take the slack out of a locking strap so that the tree stand wouldn’t wiggle.  In the words of the court:

[W]hile bear hugging the tree, [plaintiff] raised himself on his toes and came down on the platform.  According to [plaintiff], this self- taught maneuver, known as “setting the stand,” is used to secure the stand firmly in the tree by taking any slack out of the locking strap.  [Plaintiff][ had performed this maneuver, in his estimation, hundreds of times on other stands.

Reott, slip op. at 3-4.  Unfortunately, this time the locking strap (with the undisputed manufacturing defect) “broke, and [plaintiff] fell to the ground.”  Id. at 4.  Even more  unfortunately, plaintiff was 25 feet up in the tree when that happened.

With the manufacturing defect not seriously disputed (plaintiff owned a second tree stand of the same make and presumably an expert compared the two and found the missing stitching), the issue at trial was causation.  As far as we can tell, the plaintiff’s practice of slamming his weight down on the newly placed stand to force the slack out of the strap was something he devised and was not recommended by the manufacturer or anybody else.  How, then, did the plaintiff’s conduct affect causation?

Well, in Pennsylvania strict liability, the mere comparative negligence of the plaintiff isn’t a defense/admissible evidence.  However, under a series of lower court decisions, a plaintiff’s “highly reckless” conduct can be the “sole cause” of an accident and is admissible.  Thus, under these decisions, a jury gets to hear about a plaintiff’s Darwin Award-worthy conduct.  Daddona v. Thind, 891 A.2d 786, 810-11 (Pa. Commw. 2006) (failure to use available safety device, among several other things); Coffey v. Minwax Co., 764 A.2d 616, 621 (Pa. Super. 2000) (use of electricity in presence of inflammable fumes); Frey v. Harley Davidson Motor Co., 734 A.2d 1, 6-8 (Pa. Super. 1999) (driving without lights at night); Madonna v. Harley Davidson, Inc., 708 A.2d 507, 508-09 (Pa. Super. 1998) (driving while intoxicated); Gallagher v. Ing, 532 A.2d 1179, 1182 (Pa. Super. 1987) (same); Foley v. Clark Equipment Co., 523 A.2d 379, 394 (Pa. Super. 1987) (failure to watch where plaintiff was driving); Keirs v. Weber National Stores, Inc., 507 A.2d 406, 409 (Pa. Super. 1986) (not changing out of gasoline-soaked clothing); Gottfried v. American Can Co., 489 A.2d 222, 227 (Pa. Super. 1985) (sticking hand without looking into jagged container); Bascelli v. Randy, Inc., 488 A.2d 1110, 1114 (Pa. Super. 1985) (speeding in excess of 100 m.p.h.); Moyer v. United Dominion Industries, Inc., 473 F.3d 532, 542-45 (3d Cir. 2007) (gross failure to maintain product) (applying Pennsylvania law); Wilson v. Vermont Castings, Inc., 170 F.3d 391, 395-96 (3d Cir. 1999) (failure to read owner’s manual; standing near open flame in loose clothing) (applying Pennsylvania law).

The Supreme Court had never considered whether the “highly reckless” exception to the exclusion of a plaintiff’s contributory fault existed at all, much less how to apply it.  In Reott, the majority recognized the exception and held that, like related defenses (assumption of the risk, superseding cause) it was an affirmative defense available to defendants in strict liability actions:

[W]e hold that a defendant in a §402A action must plead and prove, as an affirmative defense, that the plaintiff acted in a highly reckless manner, if such conduct is asserted. . . .  [H]ighly reckless conduct is that which occurs when the plaintiff would have been injured despite the curing of any alleged defect, or is so extraordinary and unforeseeable as to constitute a superseding cause. . . .  [B]ecause highly reckless conduct, by its very nature, is that which is essentially unforeseeable and outrageous, if it truly exists in a case, it must be the cause of the injuries sustained. . . .  [S]hould such an affirmative defense be pursued, the burden of proof is on the defendant to show that the highly reckless conduct was the sole or superseding cause of the injuries sustained.

Reott, slip op. 21-22 (various things omitted).  The intermediate court had held that, because there was no evidence that the plaintiff’s conduct would have collasped a non-defective tree stand, the defense should not have gone to the jury.  Id. at 7.  The Supreme Court, without re-examining the evidence, affirmed after concluding that the Superior Court more or less got the standard correct.  Id. at 22.

So what about it?

First, we’re somewhat relieved.  This quasi-superseding cause standard is pretty rigorous, but we were not at all sure that the Supreme Court – short of adopting the Third Restatement − would allow in any evidence that could otherwise be characterized as “contributory fault.”  Earlier courts, with different justices, probably would not have done so.  So, to get the “highly reckless” exception formally recognized by the Supreme Court is something of a defense win (even if the defendant in this particular case lost).

What else?

Defendants need to make sure to plead the exception (it apparently doesn’t fall within Rule 1030(b)), which as the court noted, can be pleaded in the alternative.  Slip op. at 20.  Importantly, there is no requirement, in establishing the defense, that the plaintiff be aware of any product defect.  Id. at 15 (“assumption of the risk involves knowledge of the product’s defect where highly reckless conduct does not”).  So the general takeaway is that if the plaintiff’s conduct was stupid enough that it can be presented as a “sole cause,” the jury gets to know about it.

In the case of a defectively manufactured drug or device (arguably subject to the same rules), what kind of plaintiff conduct could qualify?  Looking at the cases above, we’d say that patient non-compliance – ignoring doctor’s orders, including those to watch for specific adverse effects – would fit.  So would, in the case of an OTC product, ignoring instructions (such as dosing/frequency of use) would also fall within this rubric.  Using someone else’s prescription, or using a drug in an illegal fashion (often seen in cases involving painkillers) would also seem to qualify.  Physician misuse – ignoring a contraindication – would be in the same ballpark.  Finally, there are cases of simple stupidity, standing on a wheelchair, or the weird Hawaii case where the doctor substituted a screw driver for a spinal rod, that (like the 100 m.p.h. plaintiff in Bascelli) that a jury could find sole cause.

Anyway, so while Reott could have been better, is also could have been worse.  There is no blanket rule in Pennsylvania strict liability that precludes jury consideration of a plaintiff’s improper conduct.  Rather, such conduct is admissible as long as it creates a jury submissible case that the plaintiff caused his/her own injuries.

Monday, November 26, 2012

Fraudulent Joinder of a Distributor – Consider an Affidavit

Here’s a little more on fraudulent joinder, which for those who don’t recall frequently involves a product liability plaintiff suing a non-diverse local distributor of the product to negate the  diversity that exists between the plaintiff and manufacturer and keep the case in state court.  It’s an issue that is often at the center of the first big battle in single cases, or that can shift the balance of cases pending in federal versus state courts in mass torts. 
While defendants initially raise this issue in their removal papers, the battle won’t begin, if at all, until the plaintiff files a motion to remand to state court.  We’ve already addressed here and here considerations that then arise, including whether the court will apply federal or state standards on the remand motion and, if federal, whether it will be a TwIqbal-like standard.
Today we’re addressing a tactical consideration: whether to give the court an affidavit from the distributor.  Earlier this year in Johnson v. DePuy Orthopaedics, Inc., 2012 U.S. Dist. LEXIS 74450 (N.D. Oh. May 30, 2012), the court in the hip implant MDL considered a remand motion centered on whether a non-diverse local distributor was fraudulently joined.  The dispositive issue – as is often the case – was whether the distributor satisfied the “seller’s exception” to liability, which is a state-law exception that gets distributors out of a case if they can identify the product’s manufacturer and, depending on the state, meet certain other requirements.  If they can, however, a plaintiff can still keep the distributor in the case by sufficiently alleging or showing that the distributor knew about the defect. 
The Johnson court, applying a TwIqbal-like standard, denied remand and kept the case in federal court.  The plaintiffs’ allegations to negate the seller’s exception failed to parse the wrongful acts supposedly performed by the distributor, offering only general, non-specific allegations that the distributor sold, promoted and labeled the product.  Id. at *9-11.  Interestingly, the court noted that it could have considered supplemental affidavits as part of the motion.  Id. at *5.  Of course, it turned out that the defendants didn’t need them.
Fast forward six months, however, to the same litigation and the same court considering another remand motion involving a distributor and the seller’s exception.  See Hilgers-Luckey v. DePuy Orthopaedics, Inc., 2012 U.S. Dist. LEXIS 164069 (N.D. Oh. Nov. 16, 2012).  This time the court ordered a remand.  What was different?  Well, this plaintiff, at least in the eyes of the court, made particular allegations, claiming that the distributor – Premier – knew certain facts that supported plaintiff’s defect theory:
A. Premier, at the time of the insertion of the ASR Prosthesis into the Plaintiff, knew one or more of the following:
(i) that very high revision rates were being reported in patients with the ASR Prosthesis;
(ii) that patients were experiencing high levels of metal particles or ions entering into surrounding tissues from the ASR Prosthesis;
(iii) that patients were experiencing deterioration of body tissues from metal particles or ions from the ASR Prosthesis; and
(iv) that patients were experiencing high levels of metal particles or ions from the ASR Prosthesis entering into the bloodstream through which they were distributed throughout various parts of the body.
Id. at *10-11.  To the court, this was enough to “withstand a challenge to the viability of the pleadings” and keep Premier in the case, thereby eliminating diversity and requiring remand.
Now, we don’t believe that these allegations are much, if at all, better than those in the Johnson case.  They simply take the allegations underlying plaintiff’s defect theories – the type that arise in every mass tort – and claim that the distributor knew of them.  Those strike us as boilerplate.  They can be made about any distributor in any mass tort. 
But our disagreement with the court’s reasoning is not our takeaway from this decision.  Our concern is a tactical one.  The court said, just as it did in Johnson, that the parties could have provided supplemental affidavits.  Id. at *5.  There’s often good reason to do so.  The stakes are high – federal or state court – and the task is often not difficult. 
Distributors, who generally have no meaningful knowledge of alleged defect or labeling deficiencies, want to get out of these litigations as much as we want them out, and they are often happy to provide affidavits.  Ideally, it would say something like this: the distributor knew nothing about the alleged defect, had no involvement in the design, manufacture, marketing or labeling of the product, and, instead, simply received the product fully packaged and labeled after the manufacturer had independently developed it.  We’ve written about such successful affidavits in the past.  Such an affidavit may expose the plaintiff’s allegations as boilerplate and re-focus the court on a TwIqbal-like standard that requires more from them, something they often can’t provide.
Now, we know that there could have been any number of good reasons why such affidavits weren’t used in the Hilgers-Luckey case.  This is, after all, the very same defense that has successfully fought off remand motions in this same litigation.  This is not a critique of the defense, but rather a tactical reminder of what may work in other cases.  Providing the court with appropriate affidavits and reminding it of the TwIqbal-like standards to which the plaintiffs should be held can be a powerful opposition to a motion to remand – all the more so as the allegations by the plaintiff in the complaint become more particular.

Friday, November 23, 2012

TwIqbal for Catch-All


What are we thankful for?  How about TwIqbal?  One of our colleagues the other day asked us what to do about a catch-all “otherwise negligent” language in a complaint removed to federal court from Pennsylvania, and we immediately said “TwIqbal.”

Personal note: we’ve hated these catch-all allegations ever since Connor v. Allegheny General Hospital, 461 A.2d 600, 602 (Pa. 1983), in which the since-impeached Rolf Larsen relied on such blatant boilerplate to let plaintiffs with new theories escape the statute of limitations – thereby giving rise to innumerable time-wasting “Connor” preliminary objections.

But we also thought “blogpost,” since we haven’t before covered that precise question.

So let’s find out if our kneejerk reaction was right or not.

The answer is yes (our knees still jerk properly).

We’ll start with Reed v. Pfizer, Inc., 839 F. Supp.2d 571 (E.D.N.Y. 2012), where one of the allegations that was TwIqballed was that the product – a prescription drug − “was otherwise negligently and recklessly advertised, marketed, promoted, distributed, and sold.”  Id. at 573.  The court reamed out plaintiff’s warning-related claims (and everything else, actually) under TwIqbal:

Pointedly, these allegations do not include any factual content regarding what the misrepresentations were or how the provided warnings and information failed to “accurately reflect” reality; they do not provide a plausible basis to support an inference [defendants] misrepresented anything.

Id. at 576.  Since Reed is a drug case, it’s closest in terms of subject matter to where we play.

Next we like Gority v. Norfolk Southern Railway Co., 2011 WL 4542676 (W.D. Pa. Sept. 28, 2011), because it’s closest substantively – not only is it another Pennsylvania complaint with the Connor boilerplate, but the court takes care of the TwIqbal issue most pithily:

Plaintiff asserts that Defendant “[w]as otherwise negligent . . . in ways not specifically alleged.”  This barebones, catch-all assertion of negligence provides no information as to what duties existed or how Defendant may have breached them.  Absent such information, there is no way that Defendant can reasonably prepare a response.  If Plaintiff plans to rely on other theories of negligence not specifically pled in the Complaint, he must state them.

Id. at *7 (citation to complaint omitted).  So there.

In the interests of completeness (we hate doing research for nothing) here are some more cases that get rid of “otherwise” catchall allegations.  In Rua v. Glodis, 2012 WL 4753279, *4 (D. Mass. Oct. 3, 2012), the court held that “Plaintiff's mere assertion that [defendant's] conduct was negligent or otherwise violated his rights is insufficient to satisfy the minimal pleading requirements of Rule 8(a)” – that is to say TwIqbal.  Similarly, in Grieser v. Montgomery, 2012 WL 1906379 (N.D. Ohio May 25, 2012), the plaintiff alleged (among other things) that the defendants “otherwise were negligent.”  The allegations received judicial opprobrium:

These are bare legal conclusions, clearly insufficient under Twombly and Iqbal.  Without more factual matter alleged, these claims are not facially plausible. . . .  Plaintiff does not even allege all the elements of these causes of action, let alone factual matter supporting a reasonable inference about each element, and this alone is fatal.

Id. at *6.  See Dominguez v. Corbett, 2010 WL 3619432, at *5 (D. Ariz. Aug. 5, 2010) (allegation that defendant acted “negligently or otherwise” “does not provide fair notice of the grounds upon which it rests” and was “a threadbare recital of the element of a cause of action . . . insufficient to survive a motion to dismiss”); Lawrence v. City Cadillac, 2010 WL 5174209, at *8 (S.D.N.Y. Dec. 9, 2010) (a “catchall claim, without facts other than a clause incorporating the plaintiff's prior allegations by reference, is insufficient to show the plaintiff is entitled to relief”)

Be thankful.  Whether or not catch-all “otherwise negligent” allegations have any substantive effect under federal practice (against the statute of limitations or in any other way), there’s no need to risk exposing your client to it.  Such allegations are vulnerable to TwIqbal.

Wednesday, November 21, 2012

More Closure of the Learned Intermediary Frontier

Last year, we blogged about the "closing of the learned intermediary frontier," in that the last state in the union not to take a position about the learned intermediary rule - Rhode Island - had finally done so.  It was a bit of a stretch, our citation was to an oral transcript, but the trial court's ruling was quite definitive.

Well, by way of blog reader Adam Michael at Pepper, now we can do better than that.  Yesterday, the Second Circuit - in a completely different case - agreed with the prediction that Rhode Island would adopt the learned intermediary rule:

Here, for substantially the same reasons as those stated in the district court’s decision, we conclude that the Rhode Island Supreme Court would likely adopt the learned intermediary doctrine if faced with the question of whether to do so under circumstances similar to these.

Greaves v. Eli Lilly & Co., No. 11-5346, slip op. at 3 (2d Cir. Nov. 20, 2012) (citation and footnote omitted).  Uufortunately, Greaves is not a precedential decision, but that doesn't prevent it from being another step in the right direction.

Hail! Hail! To Michigan

Here's another guest post this time by Clem C. Trischler and Jason M. Reefer, of Pietragallo Gordon, about a recent litigation involving the Michigan immunity statute and when a "drug" (according to plaintiffs) isn't a "drug."  You'll like it - the plaintiff lost.

As always our intrepid contributors deserve all the credit, and any blame, although there's not likely to be any this time around.

**********

We cheer them again

We cheer and cheer again

For Michigan, we cheer for Michigan

We cheer with might and main

We cheer, cheer, cheer

With might and main we cheer!

 Those words were written in 1898 by Louis Ebel after the University of Michigan’s football team defeated the heavily-favored Maroons by one point.  But if you didn’t know the history of “The Victors,” you might have thought the lyrics were written by Bexis.  That is because “[i]n 1995, the [Michigan] Legislature amended M.C.L. 600.2946 to provide immunity for products-liability claims against a manufacturer or seller of a drug that was approved for safety and efficacy by the FDA and labeled in compliance with FDA standards.”  Attorney Gen. v. Merck Sharp & Dohme Corp., 807 N.W.2d 343, 347 (Mich. Ct. App.), appeal denied, 803 N.W.2d 696 (2011). 

 
Quite simply, “the Michigan Legislature made a policy judgment intending to shield drug manufacturers from liability.”  Devore v. Pfizer Inc., 58 A.D.3d 138, 141 (N.Y. App. Div. 2008).  Accord Taylor v. Smithkline Beecham Corp., 658 N.W.2d 127, 131 (Mich. 2003) (“[T]he Legislature has determined that a drug manufacturer or seller that has properly obtained FDA approval of a drug product has acted sufficiently prudently so that no tort liability may lie.”).  As such, unless a plaintiff alleges and proves an exception, “MCL 600.2946(5) now establishes an absolute defense for drug manufacturers and sellers in a product liability action . . . .”  Duronio v. Merck & Co.,, No. 267003, 2006 WL 1628516, at *3 (Mich. Ct. App. June 13, 2006).

 
Those exceptions are (1) selling the drug after the FDA withdraws it from the market; (2) bribing an FDA official; and (3) committing fraud on the FDA.  See M.C.L. §600.2946(5)(a)-(b).  The first two should rarely arise, and the third is preempted by federal law.  See Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961, 966 (6th Cir. 2004) (holding that a drug manufacturer is immune from suit unless “the FDA itself determines that a fraud has been committed on the agency during the regulatory-approval process”) citing Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 350 (2001) (emphasis in original). 


The Western District of Michigan aptly summarized what remains the current state of Michigan law:

As a result of [M.C.L. § 600.2946(5)] and [Garcia], most [product liability claims] in Michigan against drug manufacturers are functionally foreclosed.  In order to maintain a product liability suit against a drug manufacturer under Michigan law, a plaintiff need allege more than the elements of the common law tort.  A plaintiff must also allege the federal government has established that the drug manufacturer either committed fraud against the FDA or bribed an FDA official.

White v. SmithKline Beecham Corp., 538 F. Supp. 2d 1023, 1029 (W.D. Mich. 2008) (dismissing all claims and denying motion to amend as “futile”) (emphasis supplied). 


(For those interested, there’s a string cite of additional cases at the conclusion of this post applying Michigan’s absolute immunity and dismissing all claims.)

 
Against this avalanche of authority, you’d expect pharmaceutical litigation in Michigan to have disappeared.  You’d be wrong. 

 
In a last-gasp effort to salvage their claims, it appears that Michigan plaintiffs have only two options: (1) argue that Michigan law doesn’t apply; or (2) argue that the claims do not involve a drug.  But as Bexis has observed, forum-shopping plaintiffs have been almost-universally unsuccessful in arguing Michigan law does not apply. 

 
That leaves only the question of whether the product at issue is a “drug.”  In cases involving noninvasive peroral formulations (e.g., pills, capsules, tablets), this question won’t even arise, as those products fit squarely into a layperson’s understanding of the term.  But there are many less traditional formulations that nonetheless meet the definition – intramuscular, transmucosal (nasal), and topical products, to name a few.  Fentanyl transdermal delivery systems – i.e. patches – are another example. 

 
Yet because the common conception of “drug” might not include these products, some have suggested that they are not drugs at all, but rather “a combination drug and device – the drug is the opioid fentanyl and the device is the delivery system that time releases the drug for absorption into the body.”  (A similar observation could be made about any controlled-release formulation.)

 
But this is not true, at least as far as the FDCA is concerned.  See Miller v. Mylan Inc., No. 12-11684, 2012 WL 5300721, at *8 (E.D. Mich. Oct. 25, 2012) (dismissing all claims against the manufacturer of a fentanyl patch, because the product is a “drug” under the FDCA and, therefore, entitled to the benefit of Michigan’s statutory immunity).

 
Under Michigan law, the distinction between a drug and a device is significant.  That is because, while drug manufacturers are afforded absolute immunity, device manufacturers are not.  See M.C.L. § 600.2945(b).  (Of course, that says nothing about the broad preemption afforded by the Medical Device Amendments.  See Riegel v. Medtronic, Inc., 552 U.S. 312, 317 (2008).)

 
Miller was a wrongful death action involving alleged defects in Mylan’s fentanyl patch, a generic version of Duragesic®.  As a preliminary matter, the plaintiff conceded that her failure-to-warn claims failed under Mensing.  Miller, 2012 WL 5300721, at *1 n.1.  She also did not contest the dismissal of her Michigan Consumer Protection Act claim based on the “authorized conduct” exception thereto.  Id.  See, also MCL 445.904(1)(a); Duronio, 2006 WL 1628516, at *7 (holding that the authorized conduct exception applies to claims involving FDA-approved products); Merck Sharp & Dohme Corp., 807 N.W.2d at 349 n.7 (holding that the appellate court in Duronio “correctly dismissed the plaintiff’s MCPA claim because an exemption within the MCPA statute applied, MCL 445.904(1)(a)”); and Alexander v. Del Monte Corp., No. 09-12303, 2011 WL 87286, at *2–3 (E.D. Mich. Jan. 11, 2011) (“This Court has previously held that where the FDA specifically authorizes the conduct at issue, the MCPA is inapplicable.”).

 
Mylan moved to dismiss the remaining design and manufacturing defect claims pursuant to Michigan’s statutory immunity.  The plaintiff agreed that Michigan law provides an “absolute defense” in claims involving drugs and that none of the exceptions to M.C.L. § 600.2946(5) applied, Miller, 2012 WL 5300721, at *5, but argued

 
that her product liability claim is not premised on defects of the pharmacologically active ingredient of the [Mylan patch], i.e. fentanyl, but on defects in the delivery system, i.e. the surrounding “film” or “adhesive” layers, that are pharmacologically inactive components of the patch.  Plaintiff claims that these “layers” are not a “drug,” but are more akin to a medical device, and therefore her claims are not subject to Michigan’s drug immunity law.

 
Id. at *1.  Thus, the “sole remaining issue before the Court [was] whether the [Mylan patch] is a ‘drug’ as that term is defined for purposes of the immunity afforded by Mich. Comp. Laws § 600.2946(5).”  Id. 

 
By analogizing a patch to a syringe, id. at *6, the plaintiff maintained that her claims were not based on the active pharmaceutical ingredient (“API”) itself, but rather on the structure of the patch that delivered the API.  The plaintiff in Miller, therefore, tried to distinguish the case from those involving oral-dose formulations, which really just take issue with inherent risks associated with the API. 

 

Fortunately, the Court made quick work of this flawed argument.


First, the Court rejected the proposition that the definition of drug is limited to the API of a product.  Pursuant to M.C.L. § 600.2945(d), if a product is considered a drug under federal law, it thereby falls within Michigan’s absolute defense.  The FDCA, in turn, defines “drug” as:


(A) articles recognized in the official United States Pharmacopœia, official Homœopathic Pharmacopœia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C).


21 U.S.C. § 321(g)(1) (emphasis supplied).  Accordingly, “drug” is not synonymous with API, but also includes any and all “components” thereof. 


Based on this definition, the FDA approved the Mylan fentanyl patch as a drug.  Miller, 2012 WL 5300721, at *6.  Moreover, the label for the Mylan fentanyl patch “expressly defines the [layers of the patch], which Plaintiff claims were defective, as components of the . . . system,” such that the patch itself falls squarely within the definition of drug in the FDCA.  Id. at *6–7. 


The Court, therefore, rejected the plaintiff’s comparison of a fentanyl patch to a syringe, stating instead that the argument is “more analogous to separating the non-pharmacologically active components of a gel cap in a time-release capsule . . . from the active pharmacologic ingredient it encapsulates, an obvious absurdity.”  Id. at *7 (emphasis supplied).


Finally, the Court noted that prior attempts to draw a distinction between claims based on active and inactive ingredients were roundly rejected.  Id. at *7–8.  For example, courts had previously applied Michigan’s statutory immunity to cases involving the Ortho-Evra® patch.  See, e.g. Bower v. Johnson & Johnson, 795 F. Supp. 2d 672, 677 (N.D. Ohio 2011) (dismissing all claims). 


More to the point, the precise argument raised by the plaintiff in Miller had been discarded by the United States District Court for the District of Utah.  See Lake-Allen v. Johnson & Johnson, L.P., No. 2:08CV00930DAK, 2009 WL 2252198 (D. Utah July 27, 2009) (discussed by the blog here).  The plaintiff in Lake-Allen alleged defects in the brand-name, Duragesic® fentanyl patch.  The defendant-manufacturer moved to dismiss plaintiff’s design defect claims based on, inter alia, comment k.  Utah is an across-the-board comment k state, such that all strict liability design claims involving “prescription drugs” must be dismissed.  See Grundberg v. Upjohn Co., 813 P.2d 89 (Utah 1991).  To avoid this result, the Lake-Allen plaintiff suggested that a fentanyl patch is not a drug, but rather is “more akin to a drug container.”  Lake-Allen, 2009 WL 2252198, at *2.  The plaintiff, therefore, asserted that her lawsuit was not based on the fentanyl itself, but rather the structure of the patch, thereby avoiding comment k’s sweep.  The federal court rejected this “nonsensical” argument:


Plaintiffs’ argument that the patch is more akin to a container is unpersuasive.  The Duragesic® patch was approved by the FDA as a drug and to categorize it as a container is akin to categorizing any substance available in a time release capsule as a container.  In the case of prescription pharmaceutical patches, it is nonsensical to separate the liability of the overall product and the substance that it releases.


Id. at *3 (emphasis supplied).


The Miller Court agreed, concluding that the plaintiff “offered no basis, legal or otherwise, on which the Court can embrace the suggestion that the ‘non-pharmacologic’ ‘film’ or ‘adhesive’ layers of the patch can be viewed as a separate ‘medical device,’ distinct from the pharmacologically active ingredient fentanyl, for purposes of this product liability claim.”  Miller, 2012 WL 5300721, at *8.  Thus, Michigan’s statutory immunity applied and all remaining claims were dismissed with prejudice.  Id.

 
In the end, Miller reinforces the proposition that the Michigan legislature meant what it said: if the FDA approved the product as a drug, all claims based thereon are meritless.   


And that’s music to all defense attorneys’ ears.

 

 

As promised, and because this is a full-service blog, here’s a string cite of additional cases to help with your research: Marsh v. Genentech, Inc., 693 F.3d 546, 555 (6th Cir. 2012) (affirming dismissal of all claims under Michigan’s statutory immunity and rejecting plaintiff’s attempt to distinguish Garcia); In re Aredia & Zometa Products Liab. Litig., 352 F. App’x 994, 995 (6th Cir. 2009) (holding that Garcia is “binding precedent” such that, absent a finding of fraud by the federal government, all claims fail under Michigan law); Blair v. Genentech, Inc., No. 1:11-CV-482, 2011 WL 5088969, at *4 (W.D. Mich. Oct. 26, 2011) (granting motion to dismiss all claims against a pharmaceutical manufacturer); Muniz v. Genentech, Inc., No. 1:11-CV-683, 2011 WL 5089289, at *5 (W.D. Mich. Oct. 26, 2011) (same); Marsh v. Genentech, Inc., No. 1:11-CV-688, 2011 WL 5089467, at *6 (W.D. Mich. Oct. 26, 2011) (same); Tiefenthal v. Genentech, Inc., No. 1:11-CV-689, 2011 WL 5089468, at *5 (W.D. Mich. Oct. 26, 2011) (same); Borycz v. Johnson & Johnson, 796 F. Supp. 2d 878, 883 (N.D. Ohio 2011) (interpreting Michigan law and dismissing claims for (1) failure to warn; (2) breach of express and implied warranties; (3) negligence; (4) fraud, misrepresentation, suppression and concealment; and (5) wantonness, because the product “was subject to and successfully completed the FDA approval process”); Shannon v. Johnson & Johnson, No. 1:09 OE 40043, 2011 WL 2471921, at *5 (N.D. Ohio June 21, 2011) (same); In re Trasylol Products Liab. Litig., 763 F. Supp. 2d 1312, 1324 n.14 (S.D. Fla. 2010) (referring to the “general immunity” provided by Michigan law); In re Baycol Products Litig., MDL NO.1431, No. 04–3667 (MJD/SRN), 2009 WL 7836091, at *3–4 (D. Minn. Feb. 13, 2009) (interpreting Michigan law and granting manufacturer-defendant’s motion for summary judgment on all claims, including (1) strict liability – failure to warn; (2) strict liability – design defect; (3) negligent failure to warn; (4) negligence per se; (5) implied warranty; (6) unjust enrichment; (7) medical monitoring; and (8) punitive damages); Devore v. Pfizer Inc., 58 A.D.3d 138, 139, 867 N.Y.S.2d 425, 426 (2008) (interpreting Michigan law and affirming grant of motion to dismiss all claims, including (1) fraud, (2) negligent representation, (3) strict liability – failure to warn, strict liability – design defect, (5) breach of the implied warranty of merchantability, and (6) fraudulent concealment); In re Aredia & Zometa Products Liab. Litig., No. 3:06-MD-1760, 2008 WL 913087, at *1–2 (M.D. Tenn. Apr. 2, 2008) (granting motion for summary judgment on all claims and denying request for additional discovery as “futile”) aff’d, 352 F. App’x 994 (6th Cir. 2009); Zammit v. Shire US, Inc., 415 F. Supp. 2d 760, 769 (E.D. Mich. 2006) (dismissing all claims against drug manufacturer); Griffus v. Novartis Pharmaceuticals Corp., No. 06-10891, 2006 WL 2583129, at *2 (E.D. Mich. Sept. 6, 2006) (dismissing claims for (1) negligence, (2) implied warranty, and (3) express warranty, pointing out that plaintiff’s “negligence and warranty claims are simply disguised product liability claims”); Ammend v. BioPort, Inc., No. 5:03-CV-31, 2006 WL 1050509 (W.D. Mich. April 19, 2006) (granting motion for summary judgment, because the plaintiff did not show “the FDA has made its own determination of fraud or bribery”); Henderson v. Merck & Co., Inc., No. 04-CV-05987-LDD, 2005 WL 2600220, at *8–12 (E.D. Pa. Oct. 11, 2005) (granting motion for judgment on pleadings on claims for (1) negligence; (2) products liability-defective design; (3) products liability-failure to warn; (4) breach of express warranty; (5) fraudulent misrepresentation; (6) fraud; and (7) negligent misrepresentation); Norris v. Pfizer Inc., No. 109847/06, 15 Misc.3d 1114(A), at *1, 839 N.Y.S.2d 434 (N.Y. Sup. Ct. 2007) (dismissing all claims with prejudice); and Hohendorf v. Pfizer Inc., No. 109845/06, 2007 WL 7628983 (N.Y. Sup. Ct. March 22, 2007) (same).