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A few weeks ago a regular reader, and occasional correspondent, Prof. Ralph Hall at the University of Minnesota Law School asked us if there had been any “meaningful cases” in the drug/device field on emotional distress.  We didn’t have much to offer him, but that struck us at the time as an interesting topic for a blog post.  Unfortunately, we were jammed up with our year-end lists at the time.  Then came those appellate preemption cases….
Anyway, now we’re finally getting around to it (sorry, Ralph).  After actually taking a look, here’s what we know.
First of all, there are two broad types of emotional distress claims.  There’s “intentional infliction of emotional distress” (“IIED”), which as the name indicates, requires “outrageous” conduct intended to cause emotional distress.  This cause of action was recognized by the ALI in Restatement (Second) of Torts §46 (1965).  The second claim is for “negligent infliction of emotional distress” (“NIED”), which – duh – doesn’t require intent.  NIED is typically (but not always) limited to specific types of situations out of concern that emotional distress, since it isn’t a physical injury, could be faked.  NIED wasn’t recognized in the Second Restatement, but it could well be in the Third Restatement (which is currently under consideration).

Intentional Infliction of Emotional Distress

There aren’t all that many intentional infliction cases in the prescription drug/medical device field.  One reason is that it’s hard to muster viable claims of “outrageous” conduct because of the life-saving nature of these products:

[I]f the enormity of the outrage carries conviction that there has been severe emotional distress, bodily harm is not required.  Whether intentional conduct or reckless conduct is involved, a requisite for liability to be imposed is knowledge on the part of the actor that severe emotional distress is substantially certain to be produced by his conduct.  With these guidelines in mind . . . it is preposterous to suggest that a manufacturer of a product which is obviously intended to save lives deliberately engaged in conduct specifically calculated to cause emotional distress to some particular person.

Brinkman v. Shiley, Inc., 732 F. Supp. 33, 35 (M.D. Pa. 1989) (citation and quotation marks omitted), aff’d mem., 902 F.2d 1558 (3d Cir. 1989); accord Keath v. Shiley, Inc., 1991 WL 11242191, at *5 (N.D. Ohio Dec. 17, 1991); Lauterbach v. Shiley, Inc., 1991 WL 148137, at *4 (S.D. Tex. March 29, 1991).  IIED, after all, requires conduct “so extreme and outrageous that it exceeded all possible bounds of decency and was furthermore atrocious, and utterly intolerable in a civilized community.”  Jones v. Danek Medical, Inc., 1999 WL 1133272, at *6 (D.S.C. Oct. 12, 1999) (quoting Restatement §46; dismissing claim for failure of proof); cf. Kemp v. Pfizer, Inc., 851 F. Supp. 269, 275 (E.D. Mich. 1994) (not “outrageous’ for defendant to deny defect and causation), vacated on other grounds, 91 F.3d 143 (6th Cir. 1996); In re TMJ Implants Products Liability Litigation, 872 F. Supp. 1019, 1037 (D. Minn. 1995) (usual product liability allegations fail to establish outrageousness) (applying North Carolina law), aff’d, 97 F.3d 1050 (8th Cir. 1996).
Not only that, but all these products require approval/clearance by the FDA before they can be sold at all.  This requirement of FDA approval is not exactly compatible with the Restatement’s requirement that the defendant engage in “outrageous” conduct.

[P]laintiffs cannot establish that defendants engaged in “extreme and outrageous conduct” or that defendants intended or knew that there was a high probability that their conduct would cause severe emotional distress. . . .  Prior to that time [that plaintiff used the vaccine], it is undisputed that these vaccines were FDA-approved in accordance with a national public health policy.
Plaintiffs’ allegation that defendants knew by 1982 that thimerosal was a toxic substance cannot alone support extreme and outrageous conduct where . . . under the requisite federal regulations, the FDA determined that the amount of thimerosal used was “sufficiently nontoxic.”  Thus, it cannot be said that defendants’ actions in manufacturing or distributing FDA-approved vaccines to [plaintiff] rose to the level of extreme and outrageous conduct or that severe emotional distress was substantially certain to result from their conduct.

Reilly v. Wyeth, 876 N.E.2d 740, 756 (Ill. App. 2007) (all citations and quotation marks omitted).  FDA product approval thus should insulate defendants from allegations that their marketing of products was “outrageous.”  Fisher v. American Red Cross Blood Services, 745 N.E.2d 462, 465 (Ohio App. 2000) (“following the regulations, dictated by the FDA” could not constitute “outrageous” conduct); Haughton v. Hill Laboratories, Inc., 2007 WL 2484889, at *3 (D. Mass. Aug. 30, 2007) (FDA compliance precludes conduct being outrageous).
More generally, IIED claims have been dismissed against drug/device manufacturers because IIED is seen as a tort involving personal affront.  The impersonalized mass marketing of products, with no face-to-face interactions with would-be plaintiffs, just doesn’t present the type of conduct necessary to be “outrageous” conduct under §46.

[W]e are convinced that [§46 does] not apply . . . in a situation in which the alleged wrongdoing was directed at a class of consumers rather than a particular plaintiff.  If [a court] recognized a cause of action for intentional infliction of emotional distress on the allegations of [plaintiff’s] complaint, it effectively would sanction a large, if not vast, number of lawsuits by consumers who obtained properly functioning valves.

Angus v. Shiley, Inc., 989 F.2d 142, 148 (3d Cir. 1993) (applying Pennsylvania law); Lauterbach, 1991 WL 148137, at *4 (plaintiff’s “alleged emotional distress was not caused by the actual operation [implanting the device], but was triggered by an ABC-TV 20/20 segment”).
Finally, IIED has been asserted against non-manufacturers.  Persons who did not even make the product that allegedly injured the plaintiff have not been held to have engaged in “outrageous” conduct:

[Defendant] did not manufacture or sell Plaintiffs their implants, nor have Plaintiffs alleged any other contact between themselves and [defendant].  Therefore, [defendant] could not have engaged in extreme or outrageous conduct towards Plaintiffs, and the intentional infliction of emotional distress claim against [defendant] is dismissed.

In re Minnesota Breast Implant Litigation, 36 F. Supp.2d 863, 876 (D. Minn. 1998) (applying Arizona law); accord McConkey v. McGhan Medical Corp., 144 F. Supp.2d 958, 965 (E.D. Tenn. 2000) (the defendant “did not manufacture or design the products in question”; plaintiffs “failed to prove” any conduct “that would allow this court to sustain a claim for either intentional or negligent infliction of emotional distress”).

Negligent Infliction of Emotional Distress

Turning to NIED, as we mentioned NIED isn’t in the Restatement (yet), and certainly isn’t universally recognized, e.g., Woodill v. Parke Davis & Co., 374 N.E.2d 683, 688 (Ill. App. 1978), aff’d, 402 N.E.2d 194 (Ill. 1980) (not recognized in Illinois); Miller v. Bristol-Myers Squibb Co., 121 F. Supp.2d 831, 839 (D. Md. 2000) (not recognized in Maryland).  Because of this variance, NIED does not give rise to common legal questions so as to support a class action:

Negligent infliction of emotional distress claims vary greatly among the states. Some states require a physical impact or physical contact; and others do not recognize the cause of action at all.

Blain v. Smithkline Beecham Corp., 240 F.R.D. 179, 195 (E.D. Pa. 2007) (citations omitted).  Indeed, in Louisiana, and probably elsewhere, emotional distress claims are subsumed by product liability statutes.  Gallien v. Procter & Gamble Pharmaceuticals, Inc., 2010 WL 768937, at *2 (S.D.N.Y. March 5, 2010); Vitatoe v. Mylan Pharmaceuticals., Inc., 696 F. Supp.2d 599, 606-07 (N.D.W. Va. 2010); Ivory v. Pfizer Inc., 2009 WL 3230611, at *7 (W.D. La. Sept. 30, 2009); Grenier v. Medical Engineering Corp., 99 F. Supp.2d 759, 763 (W.D. La. 2000) (all holding that IIED/NIED claims subsumed by Louisiana product liability statute).
Some states allow NIED claims to be brought by bystanders who watched a violent accident.  That type of claim hasn’t worked well in drug/device cases because use of prescription medical products simply isn’t “traumatic” and/or “contemporaneous” enough to cause emotional distress.  The ingestion of a drug “is not an injury-causing event by which a claimant is contemporaneously aware that the event caused harm to the direct victim.”  Ivory, 2009 WL 3230611, at *6-7.  “[T]here is no evidence that [plaintiffs] were aware their son was being administered a drug that wasn’t recommended for use with children-and that could be potentially lethal-at the time it was given to him.”  Coutu v. Tracy, 2006 WL 1314261, at *7 (R.I. Super. May 11, 2006).

Here, Plaintiffs clearly did not witness and perceive the type of shocking accident contemplated by the bystander theory of recovery. Rather, Plaintiffs witnessed the routine vaccination of their children and the children’s subsequent medical problems. . . . Moreover, Plaintiffs did not even learn of the children’s alleged [injury] until [it was] were diagnosed by a physician, well after the suspect vaccines were administered. However anguishing these belated circumstances may have been, the bystander theory is inapplicable to the facts of this case.

Owens v. American Home Products Corp., 203 F. Supp.2d 748, 758 (S.D. Tex. 2002); see Maurice v. Eli Lilly & Co., 2005 WL 3542902, at *5 (E.D. La. Nov. 7, 2005) (plaintiff parents were not present when child was vaccinated nor aware that any harm was being done); Murphy v. Aventis Pasteur, Inc., 270 F. Supp.2d 1368, 1377 (N.D. Ga. 2003) (“plaintiff has failed to allege any impact”); Case v. Merck & Co., 2002 WL 31478219, at *4 (E.D. La. Nov. 5, 2002) (same).  “[W]e decline to apply the tort of negligent infliction of emotional distress beyond the situation where a plaintiff witnesses negligent injury to a third person and suffers mental disturbance as a result.”  Gillett v. Sofamor, S.N.C., 2001 WL 1135304, at *8 (E.D. Mich. Sept. 13, 2001); see Plummer v. Abbott Laboratories, 568 F.Supp. 920, 924 (D.R.I. 1983) (“there was no episodic single incident to be witnessed; there was merely the insidious development – or, as to many of the targeted plaintiffs, only the threatened development – of a disease process”).
Nor is learning about/encountering an injury after the fact (such as discovering someone’s body) satisfy the requirement of contemporaneous observation.  Taylor v. Albert Einstein Medical Center, 754 A.2d 650, 653 (Pa. 2000) (plaintiff did not witness insertion of device that allegedly killed decedent); Schilf v. Eli Lilly & Co., 2010 WL 3909909, at *2 (D.S.D. Sept. 30, 2010) (“Plaintiffs did not contemporaneously observe [the] suicide”); Ivory, 2009 WL 3230611, at *7 (ingestion of drug not witnessed by plaintiff, nor was there any awareness of harm); Colacicco v. Apotex, Inc., 432 F. Supp.2d 514, 553 (E.D. Pa. 2006) (“Whatever act or omission was allegedly undertaken by Defendants did not occur in Plaintiff’s presence”), aff’d and then vacated on other grounds, 129 S. Ct., 1578 (2009) (preemption); Richardson v. Advanced Cardiovascular Systems, Inc., 865 F. Supp. 1210, 1219 (E.D. La. 1994) (“[p]laintiffs do not assert that they viewed the surgical procedure or came upon the scene soon thereafter”); Keath, 1991 WL 11242191, at *5 (contemporaneous observation not alleged in implanted device case).
Some other NIED jurisdictions restrict the tort to plaintiffs who were actually threatened with injury by an accident, but fortuitously avoided being harmed.  Prescription medical products, however, do not put non-users in any zone of danger.

[A] manufacturer of medical devices may be able to foresee harm to patients and medical personnel who are placed at risk of harm or peril by devices negligently manufactured. However, the manufacturer cannot reasonably foresee the extent to which persons who operate or administer these devices will suffer emotional distress upon witnessing injury to patients when they are not themselves placed at risk of injury. The manufacturer’s potential liability for emotional distress extends only to direct victims, not bystanders.

Straub v. Fisher & Paykel Health Care, 990 P.2d 384, 389 (Utah 1999); accord Goldberg v. Mallinckrodt, Inc., 792 F.2d 305, 310 (2d Cir. 1986) (physician who administered allegedly defective device that injured patients “was never himself exposed to risk of serious bodily injury from [the product], and thus was outside the ‘zone of danger’”) (applying New York law); Schilf, 2010 WL 3909909, at *2 (plaintiffs “were not in the zone of danger”);  Erony v. Alza Corp., 913 F. Supp. 195, 201 (S.D.N.Y. 1995) (plaintiff’s “emotional damage stems solely from finding [his son] unconscious [from misusing a drug] and witnessing his death.  At no point was [he] in the zone of danger”); Silber v. Walgreen Co., 2005 WL 1273969, at *1 (Conn. Super. May 4, 2005) (parents were not in zone of danger created by erroneous filling of drug prescription for child).
As with IIED, sometimes plaintiffs have asserted NIED claims against manufacturers whose products they did not use. Such claims have failed for lack of duty.

Plaintiffs’ claim[] for (1) negligent infliction of emotion distress . . . [is] apparently based upon Plaintiffs’ contention that [defendant] breached its duty to warn Plaintiffs about the dangers of thimerosal. . . .  North Carolina law does not support Plaintiffs’ contention that [defendant] owes a duty to warn even though it did not actually manufacture or license the thimerosal [plaintiffs’ children ingested].  Accordingly, Plaintiffs’ claims for negligent infliction of emotional distress . . . must also be dismissed because Plaintiffs have failed to adequately allege any negligent conduct by [defendant] against Plaintiffs.

Doe 2 v. Ortho-Clinical Diagnostics, Inc., 335 F. Supp.2d 614, 629 (M.D.N.C. 2004); accord Moretti v. Wyeth, Inc., 2009 WL 749532, at *5 (D. Nev. March 20, 2009) (branded manufacturer not liable where plaintiff took generic; same as to IIED as well); Murphy, 270 F. Supp.2d at 1377 (“plaintiff has not directed the court to any authority expanding this duty beyond the manufacturer of the product in question”; holder of expired patent not liable); McConkey, 144 F. Supp.2d at 965.
Another ground for lack of duty in NIED cases is where the connection between the product and the plaintiff’s emotional distress is remote.  In Huggins v. Longs Drug Stores, Inc., 862 P.2d 148 (Cal. 1993), a pharmacist was not liable as a matter of law to the parents of an injured child for a negligently filled prescription because the purported duty – potentially applicable to “all providers of medical goods” – was simply too broad:

Nothing in those duties imposes any legal responsibility upon pharmacists for the emotional well-being of the patient’s parents, even if the pharmacist knows the patient is an infant and that the parents will be administering the medication. . . .  [E]ven if it were deemed reasonably foreseeable to . . . a pharmacist that a parent’s realization of unwitting participation in the child’s injury would by itself be a source of significant emotional distress from guilt, anxiety, or otherwise, that foreseeability would not warrant our establishing a new right of recovery for intangible injury.  Th[at] duty . . . would inevitably enlarge the potential liabilities of practically all providers of medical goods and services obtained by parents solely for the treatment of their children, or by other caregivers solely for the treatment of dependent family members.  All those providers . . . would be exposed to new claims of emotional distress allegedly incurred in administering the prescribed medication or treatment to the patient.

Id. at 154.  See Friedman v. Merck & Co., 131 Cal. Rptr.2d 885, 899-900 (Cal. App. 2003) (emotional distress of a vegan exposed to animal products was “not reasonably foreseeable” to “[a] corporation responding to an inquiry as to the contents of its product”); Khan v. Shiley Inc., 266 Cal. Rptr. 106, 111 (Cal. App. 1990) (“[i]n the absence of product malfunction, [plaintiff] cannot establish defendants breached any duty owed to her”).
In particular, physicians have not been permitted to bring NIED actions over their alleged reactions to injuries to their patients.  In Washington State Physicians Insurance Exchange & Ass’n v. Fisons Corp., 858 P.2d 1054, 1065 (Wash. 1993), the court held that “liability would potentially be endless” if a physician could recover for NIED on account of his/her prescription of an allegedly defective drug to a patient.  Accord Goldberg, 792 F.2d at 310 (“the persons whose injuries have allegedly caused the emotional distress . . . were patients, not immediate family members”); Vitolo v. Dow Corning Corp., 634 N.Y.S.2d 362, 367 (N.Y. Sup. 1995) (physician’s “emotional harm” was “not recoverable”), aff’d, 651 N.Y.S.2d 104 (N.Y.A.D. 1996).  Cf. Kennedy v. McKesson Co., 448 N.E.2d 1332, 1335 (N.Y. 1983) (baring physician’s NIED claim based upon alleged negligent repair of medical equipment by manufacturer).
Remoteness sufficient to defeat an NIED claim can also occur by virtue of passage of time or change in circumstances:

While it is reasonably foreseeable that the negligent injection of . . . into a seventeen year old woman could result in the eventual loss of consortium by her children, it is simply not reasonably foreseeable that, nineteen years after the injection, [plaintiff’s] mother would be subject to a hyped-up television report . . . and would thereby be rendered such an “emotional wreck” as would cause separation anxiety on the part of her then seven year old son.

Lareau v. Page, 840 F. Supp. 920, 931 (D. Mass. 1993), aff’d, 39 F.3d 384, 391 (1st Cir. 1994) (plaintiff “cannot show physical or temporal proximity to [the] 1970 operation, in which [his mother] was allegedly negligently injected”); Sill v. Shiley, Inc., 735 F. Supp. 337, 340 (W.D. Mo. 1989) (no duty owed by manufacturer that fixed defect to warn buyers that its former design, no longer being sold and not sold to this plaintiff, was defective), aff’d mem., 909 F.2d 508 (8th Cir. 1990); DeMayo v. Schmitt, 5 Pa. D. & C.4th 197, 204-05 (Pa. C.P. 1989) (rejecting, on grounds of remoteness, NIED claim based on “third-generation” DES injury), aff’d mem., 570 A.2d 593 (Pa. Super. 1989).
And if someone else’s taking a drug can’t put a bystander into a “zone of danger,” it certainly can’t result in any physical “impact.”  Hahn v. Sterling Drug, Inc., 805 F.2d 1480, 1483 (11th Cir. 1986) (parents not impacted by daughter’s accidental ingestion of drug) (applying Georgia law).
Some other jurisdictions require a “special relationship” before a NIED claim is allowed.  The sale and use of FDA-approved prescription medical products does not give rise to any such relationship.  Descoteau v. Analogic Corp., 2010 WL 325933, at *7 (Mag. D. Me. Jan. 21, 2010) (the law “has not to date recognized a ‘special relationship’ for purposes of NIED claims between a manufacturer or seller of medical equipment and an end user”), report accepted in pertinent part, rejected in part on other grounds, 696 F. Supp.2d 138 (D. Me. 2010); In re Rezulin Products Liability Litigation, 2003 WL 367117, at *1 (S.D.N.Y. Feb. 20, 2003) (no NIED “where plaintiff claims emotional distress not as a result of a negligent exposure to a toxic substance, but as a result of taking an FDA-approved medication upon the prescription of his physician”) (applying New Mexico law).

Lack of Cognizable Injury – Both NIED and IIED

Probably the most common reason why claims for both IIED and NIED claims being rejected in prescription medical product liability actions is because the plaintiffs are trying to sue despite suffering no physical injury.  Lots of courts have dismissed these claims because, under one rationale or another, they do not involve compensable injury.  Oftentimes, alleged emotional harm is, in and of itself, not recoverable:

[Plaintiffs’] alleged physical injuries suffer from the same conceptual problems.  First, there is no evidence that plaintiffs’ alleged injuries have manifested any clinically observable detriment. Indeed, there is no evidence that plaintiffs’ alleged mitochondrial damage was permanent or irreversible.  Second . . ., any future consequences from plaintiffs’ alleged injuries are purely speculative. Plaintiffs’ alleged mitochondrial damage therefore is not a manifest injury.

In re Rezulin Products Liability Litigation, 361 F. Supp.2d 268, 278 (S.D.N.Y. 2005) (applying Louisiana law).  See Nesom v. Tri Hawk International, 985 F.2d 208, 211 (5th Cir. 1993) (no recovery absent proof of exposure to dangerous agent; “allow[ing] someone to recover merely because he fears that he may have been exposed to a dangerous substance goes too far”) (applying Louisiana law); Sykes v. Bayer Pharmaceuticals Corp., 548 F. Supp.2d 208, 217 (E.D. Va. 2008) (plaintiffs “have specifically alleged that they were physically injured by any emotional distress that was caused by [defendant’s] conduct,” therefore their NIED claim was “futile”); Taylor v. Pharmacia-Upjohn Co., 2005 WL 3502052, at *2 (S.D. Miss. Dec. 19, 2005) (“recovery for a future illness must await a manifestation of that illness”); Lester v. Danek Medical Inc., 1999 WL 1061973, at *5 (M.D.N.C. April 16, 1999) (NIED requires medical documentation of alleged emotional distress); Cheek v. Danek Medical, Inc., 1999 WL 613321, at *6 (M.D.N.C. March 9, 1999) (same); Wiggins v. Boston Scientific Corp., 1999 WL 200672, at *4 (E.D. Pa. April 8, 1999) (plaintiff “has not suffered from a compensable physical injury even though his chances of heart failure or a stroke have been increased by the presence of the” device); Wiggins v. Boston Scientific Corp., 1999 WL 94615, at *3 (E.D. Pa. Jan. 7, 1999) (“[a]lthough the [device] was not intended to remain in [plaintiff], he currently suffers no objective and identifiable injury” and “is precluded from introducing evidence of emotional damage”); Doe v. Irvine Scientific Sales Co., 7 F. Supp.2d 737, 741 (E.D. Va. 1998) (the complaint “does not allege a physical injury from which a claim for emotional distress can be traced”); Burk v. Sage Products, Inc., 747 F. Supp. 285, 288 (E.D. Pa. 1990) (no recovery where “plaintiff’s only injuries stem from his fear that he has been exposed”); Poole v. Alpha Therapeutic Corp., 698 F. Supp. 1367, 1371 (N.D. Ill. 1988) (“courts have consistently refused to allow recovery for mental or emotional distress in the absence of a physical injury or illness”); Plummer, 568 F. Supp. at 925 (state law “would not, based upon its established precedents, permit recovery for emotional distress without the accompaniment of physical symptomatology”); Mink v. University of Chicago, 460 F. Supp. 713, 716 n.2 (N.D. Ill. 1978) (“The damage alleged . . . is mental distress to the plaintiffs and an increased risk of cancer. . . .  These allegations are insufficient to support a claim for negligence.”); Wood v. Wyeth-Ayerst Laboratories, 82 S.W.3d 849, 853-54 (Ky. 2002) (“a plaintiff must have sustained some physical injury before a cause of action can accrue”); Fetick v. American Cyanamid Co., 38 S.W.3d 415, 419 (Mo. 2001) (“emotional distress, to be compensable as damages. . ., must be medically diagnosable and significant”); Payton v. Abbott Labs, 437 N.E.2d 171, 181 (Mass. 1982) (“in order for any of these plaintiffs to recover for negligently inflicted emotional distress, she must allege and prove she suffered physical harm as a result of the conduct which caused the emotional distress”); Aberbach v. Biomedical Tissue Services, Ltd., 854 N.Y.S.2d 143, 145-46 (N.Y.A.D. 2008) (“the complaint fails to allege a cognizable injury suffered as a result of the appellants’ alleged negligence”); Friedman, 131 Cal. Rptr.2d at 909 (“California law does not recognize a cause of action for negligent misrepresentation involving a risk of emotional injury”); Searfoss v. Johnson & Johnson, 2003 WL 23785715, at *5 (Pa. C.P. May 29, 2003) (“Plaintiffs are not entitled to compensation for the period of time that they alleged that they were at risk, because no injury existed”), aff’d mem, 847 A.2d 766 (Pa. Super. Jan. 8. 2004).  Cf. In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2007 WL 1725289, at *18 (D. Minn., June 12, 2007) (medically recommended explant surgery to remove recalled device constituted cognizable injury) (applying California and Minnesota law).
Finally we found one weird case where the plaintiff tried to claim, in a medical device case, that purely emotional distress was recoverable in fraud.  The court said no.  Hilt v. Johnson & Johnson, Inc., 2005 WL 40067, at *2 (D. Me. Jan. 7, 2005) (applying Maine law) (under Maine law, “‘pecuniary loss is an essential element of a fraud action and . . . damages for emotional or mental pain and suffering are not recoverable’”).
Anyway, with belated apologies to Prof. Hall, we hope this helps.  If a plaintiff alleges NIED or IIED in a product liability action involving a prescription drug, medical device, or vaccine, chances are it’s not a viable claim.