First, we’ve endured MDL courts messing around with Utah law and ignoring the usual congruence in the treatment of prescription drugs and prescription medical devices under Restatement (Second) of Torts §402A, comment k (1965).  We covered that kerfuffle here, here, here, and here.  More recently, the Fifth Circuit in In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Product Liability Litigation, 888 F.3d 753 (5th Cir. 2018), outright refused – based on zero precedent – to predict that Texas would follow the overwhelming majority rule that comment k applies equally to both prescription drugs and medical devices.  Id. at 772.  Texas and Utah are two relatively conservative states when it comes to tort law.  Both have applied comment k “across the board” to prescription drugs.

We don’t think that it’s proper for federal courts, particularly in MDLs, to cut plaintiffs unprecedented breaks on substantive state law and apply comment k less strongly to prescription medical devices than to prescription drugs.  Practically no court has done that – treating prescription drugs and prescription medical devices differently under comment k – before.  Comment k is certainly not limited to prescription drugs.  The comment explicitly references vaccines, something which the United States Supreme Court has recognized.  Bruesewitz v. Wyeth LLC, 562 U.S. 223, 234 (2011).

Moreover, these recent MDL decisions appear to be  a pro-plaintiff one-way street.  Every time, the rulings are that an otherwise “across the board” comment k state (for drugs) would nonetheless apply comment k “case-by-case” to medical devices, even though no state court has done so.  We have yet to see an MDL court take the opposite position, that comment k “across-the-board” is proper for devices in a “case-by-case” state for drugs).  We know what we’re seeing – MDL courts seeking to increase settlement pressure by weaponizing novel state-law issues through pro-plaintiff legal rulings.

Here at the Blog, we’ve never examined how comment k is treated in medical device cases in depth.  Until these recent decisions, the precedent in favor of treating all prescription medical products the same under comment k – whether “same” means across-the-board, or the other (and majority) “case-by-case” application – was virtually unanimous, so we took congruity for granted.  Not any more.  We’re rectifying that situation now.

First, to reiterate, the proposition we’re supporting is, with apologies to generic preemption, “sameness.”  We consider decisions:  (1) applying comment k “across-the-board” to both prescription drugs and devices and, (2) applying comment k “case-by-case” to both prescription drugs and devices, as equivalent in this context – employing “sameness” in applying comment k similarly to all prescription medical products.

We start looking is the Restatement of Torts.  Comment k, obviously, is from the Second Restatement.  The Third Restatement, which was adopted by ALI in 1998, after product liability law became more developed, has a similar, but not identical restriction on design defect claims involving prescription medical products.  But one thing is clear – the same rules apply to all prescription medical products:

(a) A manufacturer of a prescription drug or medical device who sells or otherwise distributes a defective drug or medical device is subject to liability for harm to persons caused by the defect.  A prescription drug or medical device is one that may be legally sold or otherwise distributed only pursuant to a health-care provider’s prescription.

*          *          *          *

(c) A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.

Restatement (Third) of Torts, Products Liability §6(a, c) (1998) (emphasis added).  Thus the Restatement provides strong support for applying the same standards for both prescription drugs and medical devices.

Second, as to whether a state is an “across-the-board” or a “case-by-case” comment k jurisdiction, we rely upon our prior analysis of that question in our 2011 “Comment K Some of the Way” post, except where noted herein (as with Washington State).

Alabama

We considered Alabama to be an “across-the-board” comment k state in 2011. The same standard was applied to medical devices in Emody v. Medtronic, Inc., 238 F. Supp.2d 1291 (N.D. Ala. 2003):

According to [defendant], under [the Alabama Extended Manufacturer’s Liability Doctrine], prescription medical devices are unavoidably unsafe products, and where inherent risks are at issue, the only other permissible theory of liability is inadequate warning.  [Plaintiff] claims that the application of the unavoidably unsafe products doctrine should not apply to an implantable, prescription-only medical device.  The court agrees with [defendant]. The [product] is a prescription-only medical device that has an unavoidably unsafe characteristic.

Id. at 1296. Emody followed Stone v. Smith, Kline, & French Laboratories, 447 So.2d 1301 (Ala.1984), a prescription drug case, and was in turn followed in Cooper v. Bristol-Myers Squibb Co., 2013 WL 85291, at *10 (D.N.J. Jan. 7, 2013) (applying Alabama law), another prescription drug case.

Alabama does not distinguish between prescription drugs and medical devices in applying comment k.

Alaska

Neither does Alaska, but that is because Alaska is one of the few states that – at least a long time ago – refused to adopt comment k altogether.  Shanks v. Upjohn Co., 835 P.2d 1189, 1197-98 (Alaska 1992).  Shanks was a drug case, but we don’t know of any medical device case applying comment k either.

Arizona

We learned in 2011 that Arizona has applied the “case-by-case” approach to both prescription drugs and medical devices.  The first case to address comment k was Gaston v. Hunter, 588 P.2d 326, 340 (Ariz. App. 1978), a drug case.  Gaston has been followed in medical device cases applying Arizona law.  See Miller v. Stryker Instruments, 2012 WL 1718825, at *19 (D. Ariz. March 29, 2012) (prerequisites to comment k not established); Conklin v. Banner Health, 2015 WL 10688305, at *4 (Ariz. Super. Oct. 30, 2015) (prerequisites to comment k established).

However, Arizona now may well adhere to the Third Restatement’s restrictions on design defect claims involving prescription medical products, rather than to comment k.  See Watts v. Medicis Pharmaceutical Corp., 365 P.3d 944, 949 (Ariz. 2016) (adopting Restatement (Third) of Torts, Products Liability §6 (1998)) (prescription drug case); Harrison v. Howmedica Osteonics Corp., 2008 WL 906585, at *21 (D. Ariz. March 31, 2008) (applying Restatement §6 to medical device case); Gebhardt v. Mentor Corp., 191 F.R.D. 180, 185-86 (D. Ariz. 1999) (same), aff’d, 15 F. Appx. 540 (9th Cir. 2001).  Again, the same standard is applied to both prescription drugs and medical devices in Arizona.

Arkansas

As our 2011 post describes, Arkansas courts have adopted a “case-by-case” approach to comment k in prescription drug cases. Predicting Arkansas law, the Eighth Circuit adopted this construction of comment k in a medical device case, Hill v. Searle Laboratories, 884 F.2d 1064, 1067-68 (8th Cir. 1989).  The Arkansas Supreme Court, citing favorably to Hill, took the same approach in West v. Searle & Co., 806 S.W.2d 608, 612-13 (Ark. 1991), a prescription drug case.  Both Hill and West involved contraceptive products.  We haven’t seen an Arkansas device case addressing comment k since, but there’s no reason to believe Arkansas law would apply one way to prescription drugs, and another way to prescription medical devices.

California

As our earlier post discussed at length, California is the epitome of the “across-the-board” approach to comment k.  See Brown v. Superior Court, 751 P.2d 470, 475-83 (Cal. 1988).  Time and again, courts applying California law have likewise applied comment k “across the board” to medical devices.

[W]e find the important considerations underlying Brown apply with equal force to implanted medical devices which, like prescription drugs, are available only through a physician and can save lives or reduce pain and suffering.  Such products are commonly crucial to the well-being of the patient.  Some devices are so important that, as is the case with prescription drugs, the patient faces death without them.  Other devices, such as the intrauterine device, provide important family planning benefits and may have direct or indirect effects on the patient’s physical, mental or emotional health as well. Still other devices . . . serve the salutary purposes of restoring a degree of normalcy to the lives of those who suffer organic dysfunctions and an impaired quality of life. . . .

We perceive the risks attendant to implanted medical devices are akin to those of prescription drugs. Just as drugs and vaccines are injected or ingested into the body, implant devices must be “plugged in” to the individual, to work their effect upon or respond to complex systems imperfectly understood by medical science.  Just as with drugs and vaccines, the result may be dependent upon the peculiar physical characteristics of the individual, as is graphically illustrated in this case. . . .  Thus, when distinctions are made among medical products, implanted medical devices must be placed in a category with prescription drugs. . . .

The Brown court observed that even though a medical product with dangerous side effects may fairly be “characterized” as defectively designed, strict liability should apply only if it would serve the public interest.  We believe the public’s interest in development, availability and affordability of medical devices demands rejection of strict liability and adoption of the comment k standard.  As with prescription drugs, the harsher rule of strict liability may discourage manufacturers from researching and marketing new medical devices due to realistic fear of substantial adverse judgments, the high cost of strict liability insurance and the uncertainty that such insurance will even be available.  The costs involved may well place the products beyond the reach of those who need [them] most.  Public interest is served, rather than thwarted, by relieving the manufacturer of strict liability for injuries resulting from implanted medical devices that have been properly fabricated and marketed.

Hufft v. Horowitz, 5 Cal. Rptr. 2d 377, 383-84 (Cal. App. 1992) (citations and quotation marks omitted).

[T]he entire category of medical implants available only by resort to the services of a physician are immune from design defect strict liability.  There is no contention anywhere in the record of these coordinated cases that any of the [devices], the subject of the various claims, were obtained other than by the services of a physician.  Therefore, the determination that strict liability based on design defect is unavailable for all such claims is one to be made as a matter of law, and without the benefit of any factfinding, except for the sole factual determination, made without dispute in these cases, that the [devices] are all physician-directed and physician-applied.  Summary adjudication was therefore appropriate.

Artiglio v. Superior Court, 27 Cal. Rptr. 2d 589, 593-94 (Cal. App. 1994). Accord Garrett v. Howmedica Osteonics Corp., 153 Cal. Rptr.3d 693, 701 (Cal. App. 2013) (“the reasoning of Brown and Hufft applies to an implanted medical device . . .  regardless of whether, strictly speaking, it was available only by prescription and regardless of whether it is properly characterized as a ‘prescription’ implanted medical device”) (citations omitted); Plenger v. Alza Corp., 13 Cal. Rptr.2d 811, 818 (Cal. App. 1992) (“[w]e as well are unable to make any principled distinction in terms of policy considerations between prescription drugs and prescription implanted medical devices”); Paturzo v. Boston Scientific Corp., 2017 WL 8220600, at *3 (C.D. Cal. April 21, 2017) (“California law does not permit strict liability claims for design defects of implanted medical devices”; “the standard of liability in that context is the ‘comment k’ standard”) (citation omitted); Markowitz v. Davol, Inc., 2015 WL 12696031, at *2 (C.D. Cal. June 19, 2015) (“similar to prescription drugs, public interest favors the development, availability and affordability of such implanted medical devices”); Anderson v. Medtronic, Inc., 2015 WL 2115342, at *7 (S.D. Cal. May 6, 2015) (“to the extent these claims allege strict liability based on a design defect, they are barred by Comment K”); Sukonik v. Wright Medical Technology, Inc., 2015 WL 10682986, at *10 (C.D. Cal. Jan. 26, 2015) (a plaintiff may not maintain a strict liability claim against the manufacturer of an implanted prescription medical device on the basis of an alleged design defect”); Tucker v. Wright Medical Technology, Inc., 2013 WL 1149717, at *5 (N.D. Cal. March 19, 2013) (“the unavoidably unsafe defense set forth in Comment k act[s] as a complete bar to Plaintiffs’ strict liability design defect claim”); Currier v. Stryker Corp., 2011 WL 4898501, at *2 (E.D.Cal. Oct.13, 2011) (“California law prohibits strict liability claims for design defect against manufacturers of prescription implantable medical devices”); Mitchell v. Acumed LLC, 2011 WL 2433038, at *4 (N.D. Cal. June 13, 2011) (“it has long been the law that implanted medical devices are exempted from strict liability for design defects”); Rhynes v. Stryker Corp., 2011 WL 2149095, at *7 (N.D.Cal. May 31, 2011) (“California law categorically protects manufacturers of prescription medical devices from strict liability for design defects”); Adams v. I-Flow Corp., 2010 WL 1339948, at *6 (C.D.Cal. March 30, 2010) (“design defect theories of products liability . . . are unequivocally barred by California law”); In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2007 WL 1725289, at *18 (D. Minn. June 12, 2007) (“California exempts manufactures of prescription drugs and medical devices from design defect claims”) (applying California law); Yalter v. Endocare, Inc., 2004 WL 5237598, at *4 (C.D. Cal. Nov. 8, 2004) (“prescription drugs and medical devices are considered to be unavoidably unsafe products”), aff’d, 220 F. Appx. 657 (9th Cir. 2007); Hanohano v. Uppal, 1997 WL 33426414, at *1 (Cal. Super. June 3, 1997) (“[u]nder Comment k, manufacturers of implanted medical devices cannot be strictly liable for design defects”). See also Sanchez v. Boston Scientific Corp., 38 F. Supp.3d 727, 736 (S.D.W. Va. 2014) (“California does not recognize strict liability for defective design of implantable medical devices”) (applying California law); Centeno v. Bayer Healthcare Pharmaceuticals, Inc., 2014 WL 4809565, at *4 (S.D. Ill. Sept. 26, 2014) (“To the extent that plaintiff seeks recovery in strict liability for design defects, her . . . Cause of Action is not cognizable under California law”) (applying California law).

Further, as discussed at length here, California (and other states’) law does not require an “implanted” device to apply comment k across the board.  In Armstrong v. Optical Radiation Corp., 57 Cal. Rptr.2d 763, 772 (Cal. App. 1996), a case involving “a thick, transparent jelly-like fluid” that is “a surgical aid,” the court applied comment k and held:

[W]e note that California law precludes strict liability for a design defect in a medical device. In the context of medical devices, design defects must be pursued under a negligence theory.

Id. at 772 (citation omitted).

As we complained above, the only contrary decision comes from an MDL, where state law was improperly manipulated as a settlement tool. See In re DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation, 2016 WL 9559961, at *2-3 (N.D. Tex. Sept. 20, 2016) (ignoring “several decisions from California’s intermediate appellate courts”; creating distinction between different FDA classes of medical devices despite numerous California cases applying comment k to both Class II and Class III devices).

Colorado

Our 2011 post assigned Colorado to the “case-by-case” approach.  As to medical devices, Wollam v. Wright Medical Group, Inc., 2012 WL 45106955 (D. Colo. Sept. 30, 2012), applied the same case-by-case method to medical devices:

In asserting this defense, [defendant] bears the burden of establishing that the [device’s]“utility must greatly outweigh the risk created by its use, the risk must be a known one; the product’s benefits must not be achievable in another manner; and the risk must be unavoidable under the present state of knowledge.”

Id. at *5.  Wollam relied on a couple of prior cases involving neither drugs nor devices, but blood products.  In Hawkinson v. A.H. Robins Co., 595 F. Supp. 1290 (D. Colo. 1984), involving a pre-MDA medical device, the court similarly held, “to rely on comment k, a manufacturer must show that the product was properly prepared, and properly marketed, accompanied by appropriate warnings and directions for use.”  Id. at 1308.

However, the most recent decision out of Colorado, Haffner v. Stryker Corp., 2014 WL 4821107 (D. Colo. Sept. 29, 2014), applied Restatement Third §6, rather than comment k, so it is open to question which standard is currently Colorado law.  Id. at *3.  In no instance has a distinction been drawn between prescription drugs and prescription medical devices.

Connecticut

While not addressing the “across-the-board”/”case-by-case” distinction directly the Connecticut Supreme Court in Vitanza v. Upjohn Co., 778 A.2d 829, 837 (Conn. 2001), held that “the policy considerations contained in comment (k) to §402A are persuasive and are in accord with this state’s product liability jurisprudence.”  In Hurley v. The Heart Physicians, P.C., 898 A.2d 777, 783 (Conn. 2006), the court applied the same policies to a prescription medical device.

In Vitanza, we adopted comment (k) to § 402A of the Restatement (Second) of Torts, concluding that the policy considerations set forth therein are persuasive and in accord with this state’s product liability jurisprudence. . . .  Numerous courts have determined that they [policy considerations] are applicable to prescription medical device cases.

Id. at 784 (citations and quotation marks omitted).  See also Breen v. Synthes-Stratec, Inc., 947 A.2d 383, 388 (Conn. App. 2008) (“under Connecticut law, comment (k) is not limited to prescription drugs but also is applicable to medical devices”).  Notably, Breen also “decline[d],

to accept the plaintiff’s invitation to draw a bright line distinction between class II and class III medical devices in determining the applicability of comment (k). . . .  The plaintiff has failed to provide any persuasive reason why a blanket rule excepting all class II medical devices from the application of these doctrines is appropriate or necessary.  Indeed, beyond the plaintiff’s mere reference to the portion of the definition of a class III device, . . . the plaintiff has failed to explicate his argument as to why only class III devices should fall within the ambit of comment (k). . . .  Moreover, the plaintiff has not cited any cases in which such a distinction has been applied, and we decline to draw a distinction here.

Id. at 390 (citations and quotation marks omitted).  For other Connecticut cases applying comment k to medical devices, see:  Allen v. Mentor Corp., 2006 WL 861007, at *7 (D. Conn. March 31, 2006) (applying comment k to medical device); Ferrari v. Johnson & Johnson, Inc., 2017 WL 6389870, at *4 (Conn. Super. Nov. 28, 2017) (observing that Hurley “extended” comment k to prescription medical devices); Wegryn v. Smith & Nephew, Inc., 2008 WL 803405, at *3 (Conn. Super. March 5, 2008) (“there is no persuasive reason to distinguish between a prescription implantable medical device and prescription drugs when raising . . . Section 402A, of the Restatement (Second) of Torts comment (k)”); see also Havanick v. C. R. Bard, Inc., 2016 WL 7116138, at *3-4 (S.D.W. Va. Dec. 6, 2016) (“Connecticut courts consider comment k as a defense against strict liability to manufacturers of medical device companies”) (applying Connecticut law).

Delaware

Delaware has never adopted strict liability or Restatement (Second) of Torts §402A (1965).  Thus, the comment k question cannot arise.

District of Columbia

We put the District in the “across-the-board” category in 2011 due to the lack of any “case-by-case” adjudication in this jurisdiction’s case law.  Both then, and now, there is no medical device precedent in the District, however, the unavoidably unsafe product doctrine has been applied in the same fashion to blood products.  Fisher v. Sibley Memorial Hospital, 403 A.2d 1130, 1134 (D.C. 1979); Kozup v. Georgetown University, 663 F. Supp. 1048, 1058-59 (D.D.C. 1987), aff’d in pertinent part, vacated on other grounds, 851 F.2d 437 (D.C. Cir. 1988).  There is no basis to conclude that medical devices would be treated any differently.

Florida

We considered Florida law comment k law unsettled in 2011, but since then most of the cases have utilized a “case-by-case” approach.  One thing that is not unsettled, however, is that whatever Florida law is, it applies to prescription drugs and medical devices equally.  “Florida courts apply the basic elements of a strict liability claim with equal force to medical device and prescription drug manufacturers.” Bailey v. Janssen Pharmaceutica, Inc., 288 F. Appx. 597, 607 (11th Cir. 2008) (applying Florida law).  Bailey, a drug case, cited and followed Adams v. G.D. Searle & Co., 576 So.2d 728 (Fla. App. 1991), which involved a medical device.  Adams applied a “case-by-case” approach. Id. at 733 (“We therefore reject a blanket approach and decline to apply comment k to all prescription products.  Instead, we follow those courts which hold that comment k is an affirmative defense to a strict liability claim.”).

Other Florida law cases have applied comment k to medical devices in a similar fashion.  Tillman v. C.R. Bard, Inc., 96 F. Supp.3d 1307, 1341 (M.D. Fla. 2015) (following Adams; “[t]o receive the protection of comment k, [defendant] must show that ‘the product is as safe as current testing and research permit” at the time of distribution’”); Byrnes v. Small, 60 F. Supp.3d 1289, 1299 (M.D. Fla. 2015) (following Adams; “[c]omment k . . . has been adopted by Florida courts as an affirmative defense to a strict products liability claim for medical devices”); Ocasio v. C.R. Bard, Inc., 2015 WL 3496062, at *5-6 (M.D. Fla. June 3, 2015) (following Adams); Brady v. Medtronic, Inc., 2014 WL 1377830, at *6 (S.D. Fla. April 8, 2014) (the device “is an unavoidably unsafe product that falls within the purview of comment k”); Mardegan v. Mylan, Inc., 2012 WL 12850781, at *6-7 (S.D. Fla. Jan. 31, 2012) (following Adams; transdermal patch with attributes of both a drug and a medical device); Duncan v. Iolab Corp., 1991 WL 544617, at *1 (M.D. Fla. Nov. 18, 1991) (applying comment k to bar strict liability against medical device), aff’d, 12 F.3d 194 (11th Cir. 1994).

Georgia

In 2011, we had Georgia as trending towards “case-by-case” application of comment k.  None of the cases we cited involved medical devices, and no new decision does so either.  The most in-depth discussion of comment k occurred in Bryant v. Hoffmann-La Roche, Inc., 585 S.E.2d 723, 726-28 (Ga. App. 2003), and we think it’s significant that Bryant relied on cases involving prescription drugs, prescription medical devices, and prescription vaccines, without drawing any distinctions between them.

Hawaii

Hawaii applied comment k on a “case-by-case” basis to a medical device in Larsen v. Pacesetter Systems, Inc., 837 P.2d 1273 (Haw. 1992), finding a device that had “many different types” on the market was “sufficiently analogous to a new and experimental drug to warrant comment k exemption from strict products liability.”  Id. at 1286.  Since 2011Larsen’s approach was likewise applied to prescription drugs under Hawaii law.  Segovia v. Bristol-Myers Squibb Co., 2016 WL 1587220, at *4-5 (D. Haw. April 19, 2016); Forsyth v. Eli Lilly & Co., 1998 WL 35152135, at *3-4 (D. Haw. Jan. 5, 1998).  Once again, there is no precedent for treating prescription drugs and prescription medical devices differently under comment k.

Idaho

As we discussed at length in our 2011 post, Idaho was the poster child for the “case-by-case” approach.  The case that made it so, however, Toner v. Lederle Laboratories, 732 P.2d 297 (Idaho 1987), was not a prescription drug case, but instead involved a vaccine.  Only recently, was the first Idaho law case involving a medical device decided.  See Hepburn v. Boston Scientific Corp., 2018 WL 2275219 (D. Idaho May 17, 2018).  Not surprisingly, Hepburn applied Toner’s construction of comment k to medical devices.  Id. at *6.

Illinois

In 2011, we concluded that Illinois was a “case-by-case” state for comment k purposes.  That is just as true for medical devices as for drugs.  The earliest decision to apply comment k, Greenberg v. Michael Reese Hospital, 415 N.E.2d 390 (Ill. 1980), contained a lengthy policy discussion before concluding that “public policy dictates against the imposition of strict liability in tort for injuries resulting from the administration of X-radiation treatments.”  Id. at 393-95.  See also:  Mele v. Howmedica, Inc., 808 N.E.2d 1026, 1042 (Ill. App. 2004) (Illinois . . . require[s] trial courts to determine on a case-by-case basis whether any medical device or other product qualifies as unavoidably dangerous”); Huskey v. Ethicon, Inc., 848 F.3d 151, 157-58 (4th Cir. 2017) (“under Illinois law, courts determine ‘on a case by case basis’ if a particular product falls within comment k”) (applying Illinois law).  Huskey cited an Illinois prescription drug case, Glassman v. Wyeth Laboratories, Inc., 606 N.E.2d 338, 342 (Ill. App. 1992), finding no difference between drugs and devices for comment k purposes.

Indiana

In 2011, we noted confusion in Indiana comment k jurisprudence, with courts going both ways – all in cases involving prescription drugs.

Citing the “dearth” of decisions concerning “dangers in the use of medical devices,” the Seventh Circuit “f[ou]nd no principled basis for such a distinction” between the two types of prescription medical products in Phelps v. Sherwood Medical Industries, 836 F.2d 296, 299, 303 (7th Cir. 1987) (applying Indiana law).  Phelps, however, did not directly address comment k.  In Parks v. Danek Medical, Inc., 1999 WL 1129706 (N.D. Ind. June 17, 1999), the court analogized to those cases applying the “across the board” approach:

[S]trict liability design claims for “unavoidably unsafe” products are barred, pursuant to the Restatement (Second) of Torts §402A cmt. k (1965).  “The legal effect of finding a product to be ‘unavoidably unsafe’ under comment k is that a plaintiff may recover based on improper or negligent preparation or inadequate warning, but not on the basis that the design of the product was defective.”  Unavoidably unsafe products include prescription drugs.  It is undisputed that the device at issue was available only by prescription and comment k has been held to apply to prescription medical devices, as well as to prescription drugs.

Id. at *6 (citing Phelps; other citations and footnote omitted).  Cf. McAfee v. Medtronic, Inc., 2015 WL 3617755, at *3 (N.D. Ind. June 4, 2015) (plaintiff essentially conceded comment k barring strict liability warning claim), on reconsideration on other grounds, 2016 WL 2588807 (N.D. Ind. May 5, 2016).

Iowa

As we pointed out in 2011, Iowa appellate authority had applied comment k without case-specific risk/benefit balancing in cases involving both prescription drugs, Moore v. Vanderloo, 386 N.W.2d 108, 116 (Iowa 1986), and vaccines, Petty v. United States, 740 F.2d 1428, 1439 (8th Cir. 1984).  In addition to those cases, Iowa law had applied the “unavoidably unsafe” principle to an over-the-counter medical device, a tampon . See Kehm v. Procter & Gamble Manufacturing Co., 724 F.2d 613, 621 (8th Cir. 1983) (“where the product is inherently unavoidably unsafe, liability hinges on the adequacy of the warning to users, an issue which, like negligence in non-products cases, turns on the reasonableness of the defendant’s responses to foreseeable dangers”) (applying Iowa law).

We still haven’t found an Iowa law case applying comment k/unavoidably unsafe to a prescription medical device, but we have no reason to believe such devices would be treated differently than the other types of medical products, prescription and otherwise, to which this principle has been applied.

Kansas

In 2011, we concluded Kansas was a “case by case” jurisdiction for comment k.

Kansas courts appear to have applied this comment k standard identically to medical devices and vaccines, in addition to prescription drugs.  See Humes v. Clinton, 792 P.2d 1032, 1039 (Kan. 1990) (applying unavoidably unsafe exception to medical device); Johnson v. American Cyanamid Co., 718 P.2d 1318, 1323-24 (Kan. 1986) (same, vaccine); Graham v. Wyeth Laboratories, 906 F.2d 1399, 1406 (10th Cir. 1990) (same; vaccine) (applying Kansas law); Graham v. Wyeth Laboratories, 666 F. Supp. 1483, 1496-97 (D. Kan. 1987) (earlier ruling in same case).   We see no basis under Kansas law for disparate standards depending on the type of prescription medical product.

Kentucky

In 2011, Kentucky appeared to be moving away from early precedent suggesting “case-by-case” application of comment k to a broader approach.  The critical case involved prescription drugs, Larkin v. Pfizer, Inc., 153 S.W.3d 758, 761, 770 (Ky. 2004), in which Kentucky adopted both comment k and the Third Restatement’s version of the learned intermediary rule.  Since Larkin repeated the Third Restatement’s equivalence between “drugs” and “medical devices” several times, id. at 761-62, 763, taking the decision at its word indicates that these two types of prescription medical products are to be treated the same.  We’re not sure any longer about Kentucky backsliding from “case by case,” but we are pretty sure that the same standards apply to both prescription drugs and medical devices.

In Prather v. Abbott Laboratories, 960 F. Supp.2d 700 (W.D. Ky. 2013), the court answered this question affirmatively:

At issue is whether . . . a prescription medical device, is within comment k’s purview.  As stated in the comment, unavoidably unsafe products “are especially common in the field of drugs.”  Though that may be the case, comment k certainly does not foreclose the possibility of extending its reach to medical devices.  Rather, comment k operates when the product at issue is unavoidably unsafe − that is, it is both useful and desirable, but marked by a known, reasonable risk.

*          *          *          *

The Court does not discern a meaningful difference between this device and a prescription drug, and does not believe the framers of comment k would exclude such a product.  [It] is highly useful and desirable product used for postoperative pain management.  As will be discussed, to the extent scientifically knowable at the time, the risk of injury posed by the [device] was marginal.  Therefore, the Court finds that the [device is within the ambit of comment k.

Id. at 707 (numerous citations omitted).  Prather went on to apply the same “case by case” approach previously used with prescription drugs.  Id. (citing Weiss v. Fujisawa Pharmaceutical Co., 2006 WL 3533072, at *3 (E.D. Ky. Dec. 7, 2006)).  See also Clark v. Danek Medical, Inc., 1999 WL 613316, at *4 (W.D. Ky. March 29, 1999) (“Plaintiffs’ claims are most appropriately considered in that [comment k] context”).

Louisiana

Although Louisiana courts had not discussed comment k in such terms, their application looked like “across-the-board” to us in 2011.

The only case directly applying comment k to Louisiana law is questionable precedent indeed, since the opinion in McPheron v. Searle Laboratories, Inc., 888 F.2d 31 (5th Cir. 1989), certified the question to the Louisiana Supreme Court, but was later vacated on grounds that sounded like a settlement.  See McPheron v. Searle Laboratories, 904 F.2d 251 (5th Cir. 1990).  Bearing that in mind, the Fifth Circuit in McPheron stated:

{Plaintiff] contends that the court below erred in applying this doctrine to [a medical device that] is not a “true” prescription drug, which is taken into and absorbed by the body.  The great weight of the authority in other jurisdictions is to the contrary. . . .  The minority view is that the question of whether a prescription medical device is an unavoidably unsafe product entitled to comment k protection is a question of fact for the jury.

Id. at 33 (citations omitted).  At least, that’s what the Fifth Circuit thought in 1989.  We’ve not seen a Louisiana law case involving comment k and medical devices since.

Also indicative that there are no differences in the application of comment k to various prescription medical products is Chauvin v. Sisters of Mercy Health Systems, Inc., 818 So. 2d 833 (La. App. 2002), which “strongly agree[d] with the need to consider comment k and the ‘unavoidably unsafe’ defense” in a blood products case.  Id. at 840.   Accord Bourque v. Louisiana Health Systems Corp., 956 So. 2d 60, 65 (La. App. 2007) (“agree[ing] with . . .  the reasons enunciated in Chauvin”) (blood product case).

Maine

We viewed Maine as “wobbly” in the “case-by-case” approach back in 2011, chiefly on the discussion in Violette v. Smith & Nephew Dyonics, Inc., 62 F.3d 8, 13 n.3 (1st Cir. 1995) (applying Maine law), a medical device case.  A similar result was reached in a drug case in Doe v. Solvay Pharmaceuticals, Inc., 350 F. Supp. 2d 257, 267-68 (D. Me. 2004), aff’d, 153 F. Appx. 1, 2005 WL 2837538 (1st Cir. 2005), which also relied on the Third Restatement.  No reason exists to think Maine would apply comment k differently to prescription drugs than to medical devices.

Maryland

Mostly on the basis of the Court of Appeals’ language in Miles Laboratories, Inc. v. Doe, 556 A.2d 1107 (Md. 1989), a blood products case, we concluded in 2011 that Maryland applied comment k “across the board.”  Id. at 1121 (citing “the singular medical utility” of such products generally).  See also Doe v. Miles Laboratories, Inc., 927 F.2d 187, 191-93 (4th Cir. 1991) (likewise applying comment k in blood product case).

However, several Maryland law cases since then have weighed in on the side of “case-by-case.”  Allen v. Boston Scientific Corp., 2015 WL 5838511, at *3 (S.D.W. Va. Oct. 5, 2015) (applying Maryland law); Stidham v. Boston Scientific Corp., 2015 WL 2452984, at *4 (S.D.W. Va. May 22, 2015) (applying Maryland law); Grinage v. Mylan Pharmaceuticals, Inc., 840 F. Supp.2d 862, 869 n.5 (D. Md. 2011) (generic drug).

There is no indication in any of these cases that Maryland law would apply different standards to different types of prescription medical products.

Massachusetts

“Massachusetts court decisions have consistently hewed to the letter of comment k.”  Tersigni v. Wyeth-Ayerst Pharmaceuticals, Inc., 2014 WL 7464759, at *1 (D. Mass. June 25, 2014).  Massachusetts was another “wobbly” “across-the-board” state in 2011, based in part on Lareau v. Page, 840 F. Supp. 920 (D. Mass. 1993), aff’d, 39 F.3d 384 (1st Cir. 1994), a medical device (contrast dye) case, that applied comment k and unavoidably unsafe doctrine without individualized adjudication. Id. at 933.  The same rather wobbly approach, without case-specific adjudication, was applied to a prescription biologic in Calisi v. Abbott Laboratories, 2013 WL 5441355, at *15 (D. Mass. Sept. 27, 2013).  Cf. Nickerson v. G.D. Searle & Co., 900 F.2d 412, 422 (1st Cir. 1990) (pre-trial defense reliance on comment k was not an “admission” that medical devices were unavoidably unsafe).

Michigan

Based on a very small sample of one case, we thought Michigan was an “across-the-board” state in 2011.  Since then, a similarly small sample of one case, Michigan law was applied in a manner that looks more “case-by-case” in Davis v. C.R. Bard, Inc., 2012 WL 6082933, at *8 (E.D. Mich. Dec. 6, 2012), an medical device case.

Based on more thorough investigation, we’re not sure Davis is accurate, though, since in Antcliff v. State Employees Credit Union, 327 N.W.2d 814, 821 n.10 (Mich. 1982), the Michigan Supreme Court referred prescription drugs as a class as “an unavoidably unsafe product.”  See also Dunn v. Lederle Laboratories, 328 N.W.2d 576, 579 (Mich. App. 1982) (declaring vaccine to be “an unavoidably unsafe product” without case-by-case evaluation).

Minnesota

Unusually, for most states, Minnesota’s comment k law developed mostly in the context of medical devices.  As the law appeared in 2011, Minnesota was a “case-by-case” state.  Kociemba v. G.D. Searle & Co., 680 F. Supp. 1293, 1300-01 (D. Minn. 1988) (involving pre-Medical Device Amendments medical device); see Woodard v. Stryker Corp., 2012 WL 12860868, at *7 (D. Wyo. Feb. 9, 2012) (submitting comment k inquiry to the jury under Kociemba) (applying Minnesota law); Johnson v. Zimmer, Inc., 2004 WL 742038, at *8 nn.5-6 (D. Minn. March 31, 2004) (citing to both comment k and the Restatement Third).

The same “case-by-case” approach has been applied in Minnesota prescription drug product liability cases. Schedin v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 776 F. Supp.2d 907, 914 (D. Minn. 2011).  Once again, there is no reason to believe that comment k is applied differently to different types of products.

Mississippi

Mississippi was a “case-by-case” jurisdiction in 2011.

A very early Mississippi law case also applied this approach to vaccines.  Alman Brothers Farms & Feed Mill v. Diamond Laboratories, Inc., 437 F.2d 1295, 1302-03 (5th Cir. 1971) (applying Mississippi law).  We haven’t seen a Mississippi case on comment k and medical devices, but we see no basis for treating them differently under the law.

Missouri

In 2011, we classified Missouri as a “case-by-case” state.

That includes medical devices.  Racer v. Utterman, 629 S.W.2d 387, 393 (Mo. App. 1981) (“On the record before us we find the surgical drape here to be an “unavoidably unsafe” product.  It is a highly useful product. . . .”); Joyce v. Davol, Inc., 2016 WL 775183, at *2-3 (E.D. Mo. Feb. 29, 2016) (finding comment k to be an affirmative defense in medical device case); In re NuvaRing Products Liability Litigation, 2013 WL 3716389, at *9 (E.D. Mo. July 12, 2013) (finding comment k defense not established on case-by-case analysis).  Cf. Kirsch v. Picker International, Inc., 753 F.2d 670, 671 (8th Cir. 1985) (applying learned intermediary rule to medical devices because “[p]rescription drugs and [this device] are marketed in similar fashion”) (applying Missouri law).

Montana

Back in 2011 we found only one prescription medical product/comment k case in the history of Montana law – from 1968 that applied the unavoidably unsafe defense without considering case-specific facts. Davis v. Wyeth Laboratories, Inc., 399 F.2d 121, 129 (9th Cir. 1968).

That’s still the case today.  We have no reason to believe that prescription medical devices – or prescription drugs for that matter – will be treated differently than vaccines for comment k purposes.

Nebraska

Nebraska is another “case-by-case” jurisdiction.  Freeman v. Hoffman-La Roche, Inc., 618 N.W.2d 827, 835-40 (Neb. 2000).  In its lengthy discussion, Freeman cited cases from other jurisdictions involving both prescription drugs and medical devices without distinguishing between those types of products.  The unavoidably unsafe doctrine has also been employed by Nebraska courts in medical device cases.  See Uribe v. Sofamor, S.N.C., 1999 WL 1129703, at *13 (D. Neb. Aug. 16, 1999).  There’s nothing new since 2011, and no reason to expect Nebraska courts to draw such distinctions going forward.

Nevada

The splintered decision in Allison v. Merck & Co., 878 P.2d 948 (Nev. 1994), as we discussed in more detail in 2011, makes it unclear whether, let alone how, Nevada applies comment k.  A footnote, citing comment k, but not discussing it in any detail, in Klasch v. Walgreen Co., 264 P.3d 1155, 1158 n.7 (Nev. 2011), provides some basis to believe that comment k could reappear, but so far that hasn’t happened.

There sure hasn’t been anything approaching a comment k discussion in a medical device case since Allison – suggesting that prescription drugs and medical devices rise or fall together on this issue.

New Hampshire

Since we wrote our post in 2011 the United States Supreme Court has declared, “New Hampshire takes a case-by-case approach to comment k.”  Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472, 505 (2013) (generic drug case).  That was essentially what we had thought before.

We haven’t seen a medical device/comment k case under New Hampshire law, but we have no reason to suspect that a different standard applies.

New Jersey

As we pointed out in 2011, by statute, it is now a complete defense (“shall not be liable”) that “[t]he harm was caused by an unavoidably unsafe aspect of the product and the product was accompanied by an adequate warning.”  N.J.S.A. 2A:58C-3(a)(3).

The statute draws no distinctions between prescription drugs and medical devices.  See Perez v. Wyeth Laboratories Inc., 734 A.2d 1245, 1251 (N.J. 1999) (statute applied; using “terminology relevant to prescription drugs” even though product was “a hybrid prescription medical device”).  It has been applied in medical device cases. See In re Panacryl Sutures Product Liability Cases, 263 F.R.D. 312, 319 (E.D.N.C. 2009) (applying New Jersey law).

New Mexico

We discussed in 2011 that comment k was applied with no case-specific analysis in Jones v. Minnesota Mining & Manufacturing Co., 669 P.2d 744, 759-60 (N.M. App. 1983), and Perfetti v. McGahn Medical, 662 P.2d 646, 649-50 (N.M. App. 1983), both medical device cases.

Both of these decisions were relied on extensively in Rimbert v. Eli Lilly & Co., 577 F. Supp. 2d 1174, 1201-04 (D.N.M. 2008), a prescription drug case.  So there doesn’t seem to be any basis for applying different tests to different types of prescription products in New Mexico.

New York

As discussed in our 2011 post, New York has never required “case-by-case” adjudication of the applicability of comment k to prescription medical products.  See, e.g., Martin v. Hacker, 628 N.E.2d 1308, 1311 (N.Y. 1993) (“even though its side effects may cause injury, a prescribed drug, accompanied by adequate warnings, is ‘not defective, nor is it unreasonably dangerous’”) (quoting comment k).  The Second Circuit applied comment k to a medical device in Bravman v. Baxter Healthcare Corp., 984 F.2d 71, 76 (2d Cir. 1993) (applying New York law):

The district court, however, was correct in dismissing [plaintiff’] product and design defect claims.  [Plaintiff] contends that the district court dismissed these claims because it had erroneously concluded that the [medical device] is an “unavoidably unsafe” product.  Unavoidably unsafe products are those that “in the present state of human knowledge, are quite incapable of being made safe for their intended ordinary use.”  Restatement (Second) of Torts § 402A cmt. k (1979).  Under New York law, unavoidably unsafe products “are not deemed defective or unreasonably dangerous so long as they are accompanied by proper directions for use and adequate warnings as to potential side effects.”

Id. at 75-75 (quoting Lindsay v. Ortho Pharmaceutical Corp., 637 F.2d 87, 90 (2d Cir. 1980) (prescription drug case)).  See Militrano v. Lederle Laboratories, 769 N.Y.S.2d 839, 846-47 (N.Y. Sup. 2003) (applying comment k across-the-board in vaccine case), aff’d, 810 N.Y.S.2d 506 (N.Y. App. Div. 2006).

Here we run into see some slippage at the trial court level, as pro-plaintiff courts have partially subverted New York law by not enforcing comment k at the pleading stage.  Williamson v. Stryker Corp., 2013 WL 3833081, at *7-8 (S.D.N.Y. July 23, 2013) (refusing to follow Bravman; design defect claim survives because plaintiff pleaded failure to warn); Henson v. Wright Medical Technology, Inc., 2013 WL 1296388, at *7 (N.D.N.Y. March 28, 2013) (warning claim precludes comment k dismissal on pleadings); cf. Gensler v. Sanofi-Aventis, 2009 WL 857991, at *6 (E.D.N.Y. March 30, 2009) (same dodge with prescription drug).  The slippage however, is not peculiar to medical devices, just as the appellate authority applying comment k “across-the-board” comes from both prescription drug and medical device product liability litigation.

North Carolina

As discussed in 2011, comment k is not an issue in North Carolina because strict liability is statutorily barred.  N.C. Gen. Stat. §99B-6(d).

North Dakota

What little law that exists in North Dakota on comment k/unavoidably unsafe suggests that comment k is to apply on a “case by case” basis – both now, and in 2011.

Ohio

As we indicated in 2011, an Ohio statute mandates application of the unavoidably unsafe doctrine to all drugs and medical devices across the board.  Ohio Rev. Code. §2307.75(D) (“An ethical drug or ethical medical device is not defective in design or formulation because some aspect of it is unavoidably unsafe, if the manufacturer of the ethical drug or ethical medical device provides adequate warning and instruction).”  “Unavoidably unsafe” means “that, in the state of technical, scientific, and medical knowledge at the time a product in question left the control of its manufacturer, an aspect of that product was incapable of being made safe.”  Ohio Rev. Code § 2307.71(A)(16).  See Aaron v. Medtronic, Inc., 209 F. Supp.3d 994, 1014 (S.D. Ohio 2016) (“Plaintiffs’ strict liability claims are barred . . . due to the fact that [the device] is an ‘unavoidably unsafe product’”); Yanovich v. Sulzer Orthopedics, Inc., 2006 WL 3716812, at *11 (N.D. Ohio Dec. 14, 2006) (“an adequate warning is a defense to design defect claims”), aff’d, 255 F. Appx. 957 (6th Cir. 2007) but see Thompson v. DePuy Orthopaedics, Inc., 2015 WL 7888387, at *15 (S.D. Ohio Dec. 4, 2015) (“not all prescription medical devices are deemed unavoidably unsafe”; requiring “no alternative design which would have as effectively accomplished the same purpose or result with less risk”).

Before the statute, Ohio common law had applied comment k in a “case-by-case” fashion.  Once again, however, it did so to all prescription medical products, without exception:

[W]e hold that a prescription drug, vaccine, or like product is not “unavoidably unsafe” per se under Comment k to Section 402A. . . .   Whether such a product qualifies as “unavoidably unsafe” under Comment k is a determination to be made on a case-by-case basis.

White v. Wyeth Laboratories, Inc., 533 N.E.2d 748, 752 (Ohio 1988) (emphasis added) (vaccine case); see Burwell v. American Edwards Laboratories, 574 N.E.2d 1094, 1098 (Ohio App. 1989) (court properly “determined that the [medical device] belonged in the category of unavoidably unsafe products”) (relying on prescription drug cases).

Oklahoma

Several medical device cases supported our 2011 conclusion that Oklahoma was a “case-by-case” comment k state.  See Edwards v. Basel Pharmaceuticals, 933 P.2d 298, 300 (Okla. 1997) (patch); Tansy v. Dacomed Corp., 890 P.2d 881, 885-86 (Okla. 1994) (implant); McKee v. Moore, 648 P.2d 21, 24 (Okla. 1982) (IUD).  See also Littlebear v. Advanced Bionics, LLC, 896 F. Supp.2d 1085, 1092 (N.D. Okla. 2012); Reed v. Smith & Nephew, Inc., 527 F. Supp.2d 1336, 1354 (W.D. Okla. 2007); Alexander v. Smith & Nephew, P.L.C., 98 F. Supp.2d 1310, 1317 (N.D. Okla. 2000) (all applying same standard in medical device cases).

The identical standard has been applied in Oklahoma cases involving prescription drugs.  E.g., Eck v. Parke, Davis & Co., 256 F.3d 1013, 1017-18 (10th Cir. 2001) (applying Oklahoma law); Agee v. Purdue Pharmaceuticals, Inc., 2004 WL 5352989, at *4 & n.12 (W.D. Okla. Nov. 22, 2004), aff’d, 242 F. Appx. 512 (10th Cir. 2007).

Oregon

We concluded that Oregon was a “case-by-case” jurisdiction in 2011.  Two of the three relevant cases involved prescription medical devices – specifically IUDs.  Coursen v. A.H. Robins, 764 F.2d 1329, 1337 (9th Cir. 1985); Allen v. G.D. Searle & Co., 708 F. Supp. 1142, 1148-49 (D. Or. 1989).  The same standard applies to vaccines. Senn v. Merrell-Dow Pharmaceuticals, Inc., 751 P.2d 215, 218 n.4 (Or. 1988).  Once again there is no reason to believe that different standards apply to different types of prescription medical products.

Pennsylvania

As discussed in Hahn v. Richter, 673 A.2d 888, 889-91 (Pa. 1996), Pennsylvania has always applied comment k “across the board” in prescription drug cases.  See our 2011 discussion for more details on other Pennsylvania appellate authority doing so.  By the way, the then “pending” Pennsylvania Supreme Court appeal continued this application.  Lance v. Wyeth, 85 A.3d 434, 442 n.11 (Pa. 2014) (some jurisdictions “including Pennsylvania, have taken a blanket approach applying comment k to preclude strict-liability design-defect claims for all prescription drugs”).

While the Pennsylvania Supreme Court has never decided a comment k case involving a medical device, the intermediate appellate court did in Creazzo v. Medtronic, Inc., 903 A.2d 24 (Pa. Super. 2006):

[Plaintiffs] challenge the trial court’s determination that their strict liability claim is barred by Restatement 2d of Torts section 402A, comment k.  Comment k excludes certain products from the definition of “unreasonably dangerous” used in section 402A on the basis that they are incapable of being made safe for their intended use, but are useful nonetheless. . . .  [comment k quotation omitted]

In this case, the trial court applied this section to the [medical device], citing our Supreme Court’s decision in Hahn v. Richter [citation omitted], in which the high court adopted comment k. . . .  In applying comment k here, the trial court reasoned that given the potential utility of the [device], no significant distinction can be drawn between the device and the drug upon which the Supreme Court based its decision in Hahn.  The court concluded accordingly that strict liability could not be a basis for liability in this case. [Plaintiffs] contend that . . . comment k does not apply to medical devices because the comment text does not mention them.  They cite no authority, however, for so restrictive an interpretation either of comment k or of Hahn, nor do they provide significant analysis of the language they seek to apply. We find no reason why the same rational applicable to prescription drugs may not be applied to medical devices.

Creazzo, 903 A.2d at 30-31 (citations omitted) (emphasis added).

Plaintiffs have tried and tried to avoid application of Pennsylvania’s “across-the-board” rule to medical devices, to no avail − the only area of significant disagreement concerns manufacturing, not design, defect claims.  See Lawrence v. Synthes Inc., 2002 WL 32747667, at *24 n.101 (Pa. C.P. July 25, 2002) (“[p]rescription medical devices must be analyzed similarly” to Hahn), aff’d mem., 860 A.2d 1142 (Pa. Super. 2004) (table); Ideluca v. C.R. Bard, Inc., 2018 WL 807158, at *3 (W.D. Pa. Feb. 9, 2018) (strict liability warning and design claims properly dismissed); Smith v. Howmedica Osteonics Corp., 251 F. Supp.3d 844, 848 (E.D. Pa. 2017) (“[w]here Comment k applies, its plain language bars strict liability claims that assert a design defect”); Wagner v. Kimberly-Clark Corp., 225 F. Supp.3d 311, 316 (E.D. Pa. 2016) (“Pennsylvania law prohibits strict liability claims based on a ‘design’ defect or a ‘failure to warn’ . . . against medical device and drug manufacturers”); Carson v. Atrium Medical Corp., 191 F. Supp.3d 473, 477 (W.D. Pa. 2016) (“the Court will apply Comment k, without exceptions, to medical devices”); McLaughlin v. Bayer Corp., 172 F. Supp.3d 804, 833 (E.D. Pa. 2016) (“Comment k’s prohibition of strict liability-design defect and strict liability-failure to warn claims for prescription drugs should also apply to medical devices”); Wilson v. Synthes United States Products, LLC, 116 F. Supp.3d 463, 465 (E.D. Pa. 2015) (comment k “has been consistently applied by Pennsylvania state and federal courts to medical device cases, leading to a finding that plaintiffs may not assert strict liability claims against medical device manufacturers”); Runner v. C.R. Bard, Inc., 108 F. Supp.3d 261, 266 (E.D. Pa. 2015) (following “the settled doctrine among our colleagues that comment k bars the imposition of strict liability against medical device manufacturers”); Cutruzzula v. Bayer Healthcare Pharmaceuticals, 2015 WL 8488670, at *3 (Mag. W.D. Pa. Nov. 17, 2015) (in face of defendant’s motion, “removing Plaintiff’s strict liability claims in light of Lance and Hahn”), adopted, 2015 WL 8492767 (W.D. Pa. Dec. 10, 2015); Kramme v. Zimmer, Inc., 2015 WL 4509021, at *4-5 (M.D. Pa. July 24, 2015) (“we predict that the Pennsylvania Supreme Court would apply comment k to prescription medical devices, as it is applied to prescription drugs”; Tincher did not change the existing jurisprudence concerning strict liability with respect to prescription drugs and medical devices”); Cogswell v. Wright Medical Technology, 2015 WL 4393385, at *3 (W.D. Pa. July 16, 2015) (“Plaintiff’s argument that exceptions be made is unpersuasive, and the Court will apply Comment k to medical devices”); Terrell v. Davol, Inc., 2014 WL 3746532, at *5 (E.D. Pa. July 30, 2014) (“in the case of prescription drugs and devices, strict liability claims based on all three defective conditions, including manufacturing defects, are barred in Pennsylvania”) (footnote omitted); Stout v. Advanced Bionics, LLC, 2013 WL 12133966, at *8 (W.D. Pa. Sept. 19, 2013) (“claims based upon strict product liability are barred by comment k”); Shelley v. Ethicon, Inc., 2013 WL 3463505, at *2 (E.D. Pa. July 10, 2013) (“Hahn has been broadly applied to both prescription drugs as well as prescription medical devices.”); Kline v. Zimmer Holdings, Inc., 2013 WL 3279797, at *6 (W.D. Pa. June 27, 2013) (“the motion to dismiss should be granted with respect to Plaintiffs’ strict liability design defect and failure to warn claims”); McPhee v. DePuy Orthopedics, Inc., 989 F. Supp.2d 451, 461 (W.D. Pa. 2012) (“agree[ing] with the prediction of our sister courts in this Circuit that the Supreme Court of Pennsylvania would extend this holding to medical device manufacturers”); Kee v. Zimmer, Inc., 871 F. Supp.2d 405, 409 (E.D. Pa. 2012) (“as a matter of Pennsylvania law, there is no strict liability for harm caused by medical devices”); Gross v. Stryker Corp., 858 F. Supp.2d 466, 481 (W.D. Pa. 2012) (courts “have continued to apply comment k to medical devices”); Killen v. Stryker Spine, 2012 WL 4498865, at *3-4 (E.D. Pa. Sept. 28, 2012) (comment k precludes strict liability design and warning claims in medical device cases); Doughtery v. C.R. Bard, 2012 WL 2940727, at *3 (E.D. Pa. July 18, 2012) (following “numerous courts in this district [that] have predicted that the Supreme Court would extend comment k to prescription medical devices”; Horsmon v. Zimmer Holdings, Inc., 2011 WL 5509420, at *2 (W.D. Pa. Nov. 10, 2011) (“[w]hile other jurisdictions might recognize caveats to Comment k’s exclusion of strict liability claims, this Court must apply Pennsylvania law, which does not recognize such caveats”); Esposito v. I-Flow Corp., 2011 WL 5041374, at *4 (E.D. Pa. Oct. 24, 2011) (“[p]rescription drugs and medical devices . . . are unavoidably dangerous products”); Riley v. Medtronic, Inc., 2011 WL 3444190, at *10 (W.D. Pa. Aug. 8, 2011) (“comment k applies to medical devices”); Geesey v. Stryker Corp., 2010 WL 3069630, at *5 (E.D. Pa. Aug. 4, 2010) (“comment k applies to medical devices”); Kester v. Zimmer Holdings, 2010 WL 2696467, at *9 (W.D. Pa. June 16, 2010) (Hahn “‘unambiguously’ denies the application of strict liability”); Halsel v. Zimmer, Inc., 2009 WL 10689768, at *3 (W.D. Pa. March 25, 2009) (“the Pennsylvania Supreme Court likely would find that comment k to §402A is applicable to prescription medical devices and would bar strict liability claims”); Giacalone v. Lacrimedics, Inc., 2008 WL 11365183, at *5 n.6 (E.D. Pa. Nov. 24, 2008) (noting the “many” Pennsylvania decisions applying comment k to medical devices); Soufflas v. Zimmer, Inc., 474 F. Supp.2d 737, 750 (E.D. Pa. 2007) (“predicting, based on its reasoning in Hahn, that Pennsylvania Supreme Court would extend §402A’s comment k to exclude prescription medical devices from strict liability”); Parkinson v. Guidant Corp., 315 F. Supp.2d 741, 747 (W.D. Pa. 2004) (“the same considerations exempting prescription drugs from the ambit of §402A equally apply to prescription medical devices”); Davenport v. Medtronic, Inc., 302 F. Supp.2d 419, 442 (E.D. Pa. 2004) (“Comment k precludes application of Section 402A to prescription medical devices”); Murray v. Synthes U.S.A., Inc., 1999 WL 672937, at *7 (E.D. Pa. Aug. 23, 1999) (“the same reasoning underlying Comment k that excludes prescription drugs from Section 402A should also apply to prescription medical devices”); Burton v. Danek Medical, Inc., 1999 WL 118020, at *7 (E.D. Pa. March 1, 1999) (“the same reasoning underlying Comment k that excludes prescription drugs from Section 402A should also apply to prescription medical devices”); Taylor v. Danek Medical, Inc., 1998 WL 962062, at *7 (E.D. Pa. Dec. 29, 1998) (“predict[ing] that the Pennsylvania Supreme Court will determine, pursuant to its reasoning in Hahn, that prescription medical devices are likewise not covered by” strict liability).

Courts in other states, likewise interpreting Pennsylvania law, have also applied comment k across the board to medical devices:

Lance’s recognition that negligent design claims are available in a pharmaceutical products liability case does nothing to upset [general] rule precluding strict liability claims against pharmaceutical drug manufacturers. . . .  Pennsylvania uses a “blanket approach applying comment k to preclude strict-liability design-defect claims for all prescription drugs.”  Lance, 85 A.3d at 442 n.11.  This court concludes that Plaintiff . . . may bring negligence claims predicated on failure to warn, design defect, or other negligence-based theories, but she cannot bring strict liability claims. . . .

Plaintiffs other arguments fare no better. . . .  [C]ertain generic prescription drugs are allowed to be sold even though they do not go through the FDA’s pre-market approval process, and these drugs retain their exemption from strict liability. . . .  Simply put, Plaintiff’s arguments about the level of regulatory scrutiny brought to bear on drugs and medical devices do not satisfy the court that they fare differently under comment k of the Second Restatement.

In re Zimmer NexGen Knee Implant Products Liability Litigation, 2015 WL 3669933, at *35-36 (N.D. Ill. June 12, 2015) (applying Pennsylvania law) (citations omitted).  Accord Delaney v. Stryker Orthopaedics, 2009 WL 564243, at *6 (D.N.J. March 5, 2009) (“Comment k of Section 402A denies application of strict liability to products considered ‘unavoidably unsafe’”; “[t]his prohibition has been extended to medical devices”) (applying Pennsylvania law).

Finally, in the one pre-Hahn case to consider a medical device, Ford v. McGhan Medical Corp., 142 Pitts. Leg. J. 201 (Pa. C.P. Allegheny Co. 1994), the court decided, again that prescription drugs and medical devices were treated the same, but applied a “case-by-case” approach.  Ford no longer accurately states Pennsylvania law, but does illustrate the principle at issue here – that whatever substantive approach that courts take towards comment k, that approach should apply to all types of prescription medical products.

Puerto Rico

Our 2011 comment, “[t]here’s no comment k law that we know of in Puerto Rico,” remains accurate today.

Rhode Island

We classified Rhode Island as “case-by-case” in 2011.  We have found no Rhode Island cases discussing comment k, one way or the other, as to any prescription medical product other than a prescription drug.

South Carolina

Based solely on Brooks v. Medtronic, Inc., 750 F.2d 1227 (4th Cir. 1984) (applying South Carolina law), a medical device case, we concluded in 2011 that South Carolina treated comment k in an “across-the-board” fashion. Id. at 1230-31 (prescription medical products ““are deemed ‘unavoidably unsafe,’ but are not defective or unreasonably dangerous if they are marketed with proper directions for use or include adequate warnings of potential side effects”).

So the reverse of the common situation has been true in South Carolina – medical device precedent has been applied in prescription drug cases.  See Carnes v. Eli Lilly & Co., 2013 WL 6622915, at *3-4 (D.S.C. Dec. 16, 2013) (applying Brooks to prescription drug case; rejecting plaintiff’s attempt to distinguish between drugs and devices).

South Dakota

In another N = 1, situation, in 2011, we concluded that the only available South Dakota comment k precedent applied it in an “across-the-board” fashion.

The number of relevant comment k cases still equals one in South Dakota.

Tennessee

The only comment k language out of Tennessee in 2011 sounded like “across-the-board” to us.  See also Laws v. Johnson, 799 S.W.2d 249, 252 (Tenn. App. 1990) (holding, without individualized analysis that comment k “governs the case at bar” involving prescription drug).

Since then, in Rodriguez v. Stryker Co., 680 F.3d 568 (6th Cir. 2012) (applying Tennessee law), the court agreed with the application of comment k to medical devices:

In rejecting [plaintiff’s] strict liability claim, the district court invoked comment k . . ., which insulates from liability manufacturers of unavoidably unsafe products that are properly prepared and accompanied by an adequate warning.  [Plaintiff] does not argue that the district court erred in applying comment k to his claim. . . .  Because plaintiff’s] duty-to-warn arguments fail, this argument necessarily fails as well.

Id. at 575. See Isbell v. Medtronic, Inc., 97 F. Supp. 2d 849, 861 (W.D. Tenn. 1998) (labeling  medical devices as “unavoidably unsafe products” based on prescription drug precedent); Harwell v. American Medical Systems, Inc., 803 F. Supp. 1287, 1300 (M.D. Tenn. 1992) (applying comment k to medical device without individualized application, beyond citing to another case similarly holding).

Texas

And now for one of the states that prompted this post.  As we stated in 2011:

Texas is a comment k/unavoidably unsafe product across-the-board state.  Centocor, Inc. v. Hamilton, 310 S.W.3d 476, 516 (Tex. App. 2010) (comment k “provide[s] a defense to a design defect claim”), app. pending; Schwarz v. Block Drug Co., 180 F.3d 261, 1999 WL 274409, at *1 (5th Cir. 1999) (“Under comment K of the Restatement of Torts (Second) § 402A, a drug manufacturer is responsible in damages only if it failed to warn of a defect of which it knew or should have known.”) (unpublished); Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1273-74 (5th Cir. 1974) (applying unavoidably unsafe standard without individualized assessment); Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *3 (N.D. Tex. Nov. 15, 2007) (“[p]rescription drugs are not susceptible to a design defect claim where, as here, the drug is “accompanied by proper directions and warning”); Carter v. Tap Pharmaceuticals, Inc., 2004 WL 2550593, at *2 (W.D. Tex. Nov. 2, 2004) (“[u]nder Texas law, all FDA-approved prescription drugs are unavoidably unsafe as a matter of law”); Hackett v. G.D. Searle & Co., 246 F. Supp.2d 591, 595 (W.D. Tex. 2002) (“[t]he Court thus holds that under Texas law and comment k of the Restatement, Defendants can only be held strictly liable if the drug was not properly prepared or marketed or accompanied by proper warnings”); cf. Brockert v. Wyeth Pharmaceuticals, Inc., 287 S.W.3d 760, 770-71 (Tex. App. 2009) (affirming summary judgment against design defect claim involving prescription drug on ground of lack of alternative design); Gerber v. Hoffmann-La Roche Inc., 392 F. Supp.2d 907, 922 (S.D. Tex. 2005) (same).

To these we would include the additional citations that we found when we researched our prior post discussing the legal rulings in Pinnacle Hip:

Pinnacle Hip complained, in a footnote, that “Texas caselaw offers almost no guidance on how to go about that case-by-case inquiry.”  Id. at [772] n.22.  There is good reason for that lack of precedent – because Texas law has not employed tests that require such inquiry.  See . . . Gonzalez v. Bayer Healthcare Pharmaceuticals, Inc., 930 F. Supp.2d 808, 817-18 (S.D. Tex. 2013) (applying comment k to prescription drug without case-by-case analysis); Woodhouse v. Sanofi-Aventis United States LLC, 2011 WL 3666595, at *3-4 (W.D. Tex. June 23, 2011) (holding, without further analysis, that “comment k applies to products such as [defendant’s prescription drug]”). . . .

Omitting substantially identical citations to Reyes, Holland, Carter, and Hackett.

Since 2011, the most noticeable development was the Texas Supreme Court’s reversal in Hamilton and its resounding adoption of the learned intermediary rule, which we celebrated here.  The discussion of the unavoidably unsafe doctrine in Hamilton certainly sounds “across-the-board,” since it does not draw any product-specific distinctions, and equates unavoidably unsafe with availability only by a physician’s prescription:

[A]s the official comment to the Restatement (Second) of Torts notes, the learned intermediary doctrine applies particularly to the medical field and unavoidably unsafe products like prescription drugs, which, by law, cannot go from the manufacturer to the end user except through a prescribing physician.  In other products-liability contexts, such as the sophisticated user or bulk supplier scenarios, however, the doctrine could apply to any type of product, not just those that are unavoidably unsafe, and the applicability of the learned intermediary doctrine in those contexts turns on whether the manufacturer’s or supplier’s reliance on the intermediary to warn the end user is reasonable.

Id. at 165 (comment k citation omitted) (emphasis added).

Further, with respect to the Fifth Circuit’s supposed distinction between prescription drugs and medical devices, Hamilton cited and relied on medical device (and vaccine) cases, in addition to prescription drug decisions, interchangeably throughout its discussion of learned intermediary principles.  Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 155 n.16, 159-60, 170 (Tex. 2012).  If Hamilton had thought there was some fundamental divide between types of prescription medical products, as Pinnacle Hip supposed, 888 F.3d at 772, surely the Texas Supreme Court would have included something, anything – not even a footnote – containing a caveat leaving open that possibility.  Nothing.  Instead, where Hamilton mentioned medical devices, it treated them as equivalent to prescription drugs.

  • 372 S.W.3d at 155 n.16 (including “medical device” case in string citation of Texas cases following learned intermediary rule).
  • Id. at 157 (applying Restatement §6, which as discussed above, treats drugs and devices identically).
  • Id. at 158 n.17 (including at least five medical device decisions among the “prescription drug” cases adopting rule).
  • Id. at 159 (more reliance on Restatement §6).
  • Id. at 166 (discussing as one “informational materials provided by healthcare providers, pharmaceutical and medical-device manufacturers”).

Also, since 2011, “Texas courts have applied Comment k to exempt prescription drugs from strict liability under a design defect theory.”  Anastasi v. Wright Medical Technology, Inc., 16 F. Supp.3d 1032, 1041 (E.D. Mo. 2014) (“Texas courts have applied Comment k to exempt prescription drugs from strict liability under a design defect theory”).  See Robles v. C.R. Bard, Inc., 2015 WL 11120857, at *3 (N.D. Tex. March 23, 2015 (“agree[ing] with Defendants that comment k applies to medical devices as well as pharmaceutical drugs”; only surviving claim requires inadequate warnings); Friske v. ALZA Corp., 2011 WL 13233327, at *12 (N.D. Tex. April 29, 2011) (“the Court acknowledges and agrees with the widespread interpretation that comment k provides that prescription drugs in general are unavoidably dangerous as a matter of law”; refusing to distinguish between drug and medical device attributes of drug-eluting skin patch).

So, that’s the Texas law that we have.  What law did Pinnacle Hip offer to support a different interpretation?

Zilch.  Not even a “lone federal district court decision,” 888 F.3d at 772 n.19 – which as just discussed is hardly “lone” at all.  Pinnacle Hip cites not one Texas law decision either:  (1) applying comment k on a “case by case” basis; or (2) distinguishing between medical devices and prescription drugs for comment k/unavoidably unsafe product purposes.  888 F.3d at 772.  Yet Pinnacle Hip has the gall to state that the defense position is “based on conjecture.”

Once again, we’re dealing with the improper MDL phenomenon of construing state product liability law far more expansively than any state court has ever done, in order to maximize settlement pressure. Nor is the Pinnacle Hip MDL the only source of such abuse.  See Adams v. Boston Scientific Corp., 177 F. Supp.3d 959, 965 (S.D.W. Va. 2016), and numerous similar decisions from the same MDL. Adams refused to apply comment k “across the board” to medical devices that were “neither FDA-approved nor a prescription drug.” Id. at 965.  No Texas court has ever drawn the first distinction, which appears to be between FDA “approval” and “clearance,” and the distinction is meaningless since design defect claims involving Class III medical devices are preempted.  The second point is simply bogus.  The case cited, Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 682 F. Supp.2d 662, 679 (N.D. Tex. 2010), doesn’t even involve a prescription medical product, but rather OTC medication, so it has no relevance to the reasons that real Texas law has applied comment k to all prescription medical products without distinction.  As again, the only contrary precedent to treating prescription medical products equally under comment k is a consequence of MDL abuse.  Don’t mess with Texas law.

Utah

Utah is another state where MDL abuse is threatening established across-the-board application of comment k by drawing spurious distinctions between different types of prescription medical products.  As discussed in 2011, the Utah Supreme Court emphatically adopted “across-the-board” application of comment k in Grundberg v. Upjohn Co., 813 P.2d 89, 95 (Utah 1991), a prescription drug case.  Utah decisions involving medical devices (drug-eluting patches for the most part) have mostly applied Grundberg, and thus comment k “across-the-board”).  Elkins v. Mylan Laboratories, Inc., 2013 WL 3224599, at *4 (D. Utah June 25, 2013) (“[b]ased on this clear authority [Grundberg], Plaintiff’s design defect strict liability claim must be dismissed”); Stanley v. Mylan Inc., 2010 WL 3718589, at *5 (D. Utah Sept. 17, 2010) (“allow[ing] the case to proceed on the understanding that Plaintiffs will not press for a strict-liability design-defect claim”); Lake-Alien v. Johnson & Johnson, L.P., 2009 WL 2252198, at *3 (D. Utah July 27, 2009) (rejecting distinctions between product type; “In the case of prescription pharmaceutical patches, it is nonsensical to separate the liability of the overall product and the substance that it releases.”); Grange v. Mylan Laboratories, Inc., 2008 WL 4813311 (D. Utah Oct. 31, 2008) (“Plaintiffs’ strict liability claim is dismissed to the extent that it is based on an alleged design defect”).  But see Creech v. Stryker Corp., 2012 WL 33360, at *5 n.6 (D. Utah Jan. 6, 2011) (refusing to apply Grundberg to medical devices).

The footnote in Creech was itself critiqued by a footnote in In re Wright Medical Technology, Inc. Conserve Hip Implant Products Liability Litigation, 178 F. Supp. 3d 1321 (N.D. Ga. 2016):

The Creech court’s interpretation of Grundberg overreaches. . . .  The Creech court’s footnote regarding Comment k is inconsistent with the Utah Supreme Court’s holding in Grundberg and, to the extent it concludes that, in Utah, Comment k has been found not to apply to medical devices, the Creech decision misinterprets Grundberg.

In its August 31, 2015, Order, the Court reached a conclusion consistent with the Utah Supreme Court’s decision in Grundberg, and further noted that most courts that had considered the issue have concluded that Comment k applies to medical devices. . . .  The Court concludes again that Utah state courts, when presented with the issue, will conclude that Comment k applies to prescribed medical devices.

Id. at 1350 n.17.  However, that earlier ruling, incorrectly utilized a sub rosa “case-by-case” approach to comment k.  See In re Wright Medical Technology, Inc. Conserve Hip Implant Products Liability Litigation, 127 F. Supp.3d 1306, 1357 (N.D. Ga. 2015) (“[f]or Comment K to apply, a device design ‘must be as safe as the best available testing and research permits’”) (quoting Tansy v. Dacomed Corp., 890 P.2d 881, 885 (Okla. 1994)).  As stated above, however, Oklahoma, unlike Utah, is a “case by case” state.

On appeal, in a decision we didn’t like for a variety of other reasons, the Eleventh Circuit agreed in Christiansen v. Wright Medical Technology, Inc., 851 F.3d 1203 (11th Cir. 2017) (applying Utah law), quoted extensively from Grundberg , found it error to apply what amounted to a case-by-case approach to comment k in a medical device case, but held that the error was “harmless” because the defendant had failed to establish that its device had in fact undergone FDA scrutiny. Id. at 1217 (“the record is silent as to whether that device had obtained FDA approval”).  As you might expect this whole episode also involves an MDL, and incredible pressure to affirm to avoid overturning a great deal of MDL time and effort – but at least the Eleventh Circuit called out the “error” for what it was.  Cf. Cook v. Boston Scientific Corp., 2015 WL 5842744, at *3-4 (S.D.W. Va. Oct. 6. 2015) (avoiding Grundberg by distinguishing between PMA and 510(k) devices that no Utah court has ever drawn).  The pattern of MDL abuse through novel, expansive construction of comment k is quite clear.

In any event, as we discussed recently, the issue of comment k, unavoidably unsafe products and medical devices under Utah law, has now been certified to the Utah Supreme Court, which has the opportunity to sort things out. See Burningham v. Wright Medical Group, Inc., 2018 WL 922362 (D. Utah Feb. 15, 2018).

Vermont

In 2011, we wrote, “There’s nothing about comment k in Vermont.”  There still isn’t.

Virginia

Likewise, what we said about Virginia in 2011 still stands:

Virginia’s never adopted any part of Restatement (Second) of Torts §402A (1965), and rejects strict liability altogether, so it’s also not adopted comment k.  Abbot v. American Cyanamid Co., 844 F.2d 1108, 1115 (4th Cir. 1988).

Virgin Islands

Three in a row.  In 2011, and now, “There’s no comment k law in the Virgin Islands that we know of.”

Washington

We discussed in 2011 how, for a long time, Washington had been an “across the board” comment k state in cases involving both prescription drugs and medical devices.  See Young v. Key Pharmaceuticals, Inc., 922 P.2d 59, 63 (Wash. 1996) (under comment k, a prescription drug manufacturer is liable “only if it failed to warn of a defect of which it either knew or should have known . . . it is liable in negligence and not in strict liability”) (prescription drug case); Terhune v. A.H. Robbins Co., 577 P.2d 975, 977-78 (Wash. 1978) (“the duty of the manufacturer to warn of dangers involved in use of a product is satisfied if he gives adequate warning to the physician who prescribes it”) (pre-Medical Device Amendments device case); Transue v. Aesthetech Corp., 341 F.3d 911, 916 (9th Cir. 2003) (“comment k provides a blanket exemption from strict liability for design defect claims on all prescription medical products”) (medical device case); Adams v. Synthes Spine Co., 298 F.3d 1114, 1117 (9th Cir. 2002) (“Washington applies this [comment k] rule not only to such medical products as vaccines for deadly diseases, but . . . much more broadly, to medical products where the physician acts as a learned intermediary”) (medical device case); Payne v. Paugh, 360 P.3d 39, 50, 53 (Wash. App. 2015) (“comment k establishes an exception to strict liability for unavoidably unsafe products’ such as prescription drugs and medical devices”; “for a design defect claim against a medical device manufacturer of an unavoidably unsafe product under comment k, . . . the standard is negligence”); Kaspers v. Howmedica Osteonics Corp., 2015 WL 12085853, at *8 (W.D. Wash. Oct. 23, 2015) (comment k precludes strict liability as “to [plaintiff’s] two remaining strict liability claims − design defect and failure to warn”). See also Rogers v. Miles Laboratories, Inc., 802 P.2d 1346, 1350-51 (Wash. 1991) (applying comment k to biological).

Most recently, in Taylor v. Intuitive Surgical, Inc., 389 P.3d 517 (Wash. 2017), the court “h[e]ld that the comment k exception is not available to a manufacturer who fails to adequately warn.”  Id. at 528.  That starts to sound more like “case-by-case,” but it’s too soon to tell.  While the product in Taylor was a medical device, the court’s rationale for limiting comment k was not peculiar to medical devices, so we still think that however comment k is going to be applied in Washington, it will applied the same to all prescription medical products.

West Virginia

As of 2011, we found two federal district court cases in West Virginia predicting adoption of a “case-by-case” approach to comment k’s unavoidably unsafe product principle. Both involved vaccines.

Since then, another West Virginia federal district court launched a diatribe against comment k in a medical device case, calling it a “useless relic” and “redundant”:

[W]hat is a defective product must be analyzed in traditional tort terminology.  Through subsequent interpretations . . ., West Virginia has effectively rid itself of the need for the useless relic that is comment k.  Accordingly, there is no reason to apply comment k separately in this case, as its principles have become a part of West Virginia law.  I find additional support in the fact that West Virginia courts have never discussed or applied comment k.

Mullins v. Ethicon, Inc., 117 F. Supp. 3d 810, 820 (S.D.W. Va. 2015) (citations, quotation marks and footnote omitted).  As for the two contrary decisions, “[b]oth cases dealt with vaccines . . . where the quintessential example used by comment k was at issue.”  Id.  Mullins is, we believe, unique in this respect, being the only court in the nation to employ a categorical separation of vaccines from all other prescription medical products.  But that singular distinction was secondary to its main holding, which is that “the West Virginia Supreme Court of Appeals has not and would not adopt comment k” in any situation, id.,which would make West Virginia the fourth state to disregard comment k altogether (not counting those states that reject strict liability).

Whatever West Virginia does, there is little support for treating prescription drugs separately from prescription medical products.

Wisconsin

As we observed in 2011, Wisconsin is another of the few states that does not follow comment k at all.  Collins v. Eli Lilly & Co., 342 N.W.2d 37, 52 (Wis. 1984).  Subsequent tort reform required a risk/utility approach to design defects, but did not include a unavoidably unsafe product exception. See Wis. Stat. §895.047(1)(a).

Wyoming

We concluded in 2011 that Wyoming did not require individual adjudication of whether products were unavoidably unsafe under comment k.  See Thom v. Bristol-Myers Squibb Co., 353 F.3d 848, 852 (10th Cir. 2003) (“Comment k to § 402A establishes that this rule [strict liability] does not apply to ‘unavoidably unsafe products’”) (prescription drug case); Tobin v. Smithkline Beecham Pharmaceuticals, 164 F. Supp.2d 1278, 1288 (D. Wyo. 2001) (“’unavoidably unsafe’ products simply refers to that area of the law regarding those products, such as pharmaceutical drugs, which despite the manufacturers best efforts and intentions contain an unavoidable risk”).  All of this sounds “across the board.”  Nothing in any of these decisions suggests that prescription drugs and medical devices would be subject to different standards.

Strict liability is not the same as absolute liability.  We learned that truth in law school, but too many plaintiff lawyers and judges seem to have unlearned it along the way.  The key separator between strict liability and absolute liability is comment k to section 402A of the Restatement (Second) of Torts (1965), which observes that “[t]here are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use.”  Think of dynamite, for example.  More pertinent to our practice area, comment k included prescription drugs and vaccines among its examples.  But it did not mention medical devices.  That is probably because comment k antedated anything approximating the degree of regulation of medical devices we enjoy today.  In any event, we are left with this question: does comment k apply to medical devices?  If so, which ones?

This is not the first time that we have faced this issue.  Back in 2011, we authored a magnum opus called “Comment k, Some of the Way.”  To this day, it is one of our most widely read posts.  The question keeps cropping up, as product liability plaintiffs keep trying to minimize the scope of comment k.  One simple way of bifurcating judicial treatment of comment k is “across-the-board” versus “case-by-case,” but that misses some nuances.  In 2015, in a post charmingly entitled “How Does a Bad Idea Get Implanted?” we blasted the commonplace California plaintiff argument that comment k applied to medical devices only if they were implantable.  As we demonstrated, that argument lacked sense and support, and the real issue should be whether the medical device required a doctor’s prescription. Tongue depressors come with neither prescriptions nor comment k protection, but, say, medical lasers should come with both.  In 2017, we revisited the issue to look beyond California, finding cases in other jurisdictions applying comment k to medical devices. It is an important issue, and it keeps surfacing.  Here is another post where we scrutinized the contours of comment k. So, is it unusual for courts to apply comment k to medical devices?  Not at all.  Take a look at our favorite reference book, Beck/Vale, Drug and Medical Device Product Liability Deskbook, section 2.02[2] and footnote 14.  There are literally hundreds of cases that have applied comment k to medical devices, in the same way they apply it to prescription drugs. 

Recently, the scope of comment k surfaced in Burningham v. Wright Med. Grp., Inc., 2018 U.S. Dist. LEXIS 10726 (D. Utah Jan. 23, 2018).  In that case, the plaintiff alleged injuries from an implanted hip device.  The design defect claims were premised on a theory of strict liability.  The defendants argued that the hip implant was an “unavoidably unsafe” product and was, therefore, categorically barred from design defect claims. Utah law controlled and the Utah Supreme Court has adopted the comment k “unavoidably unsafe products” exception to strict products liability.  But while the Utah Supreme Court has explicitly applied comment k to prescription drugs (categorically, not case-by-case), it has thus far been silent on whether comment k reached medical devices.  The defendant in Burningham argued that the doctrine regarding unreasonably unsafe products should apply equally to the medical device at issue.   

The Burningham case has traveled a circuitous path through the judicial system.  It was filed in California state court, then became part of a coordinated proceeding, then was released from that proceeding, then was moved by consent to the federal court in Utah.  Meanwhile, there is a federal MDL in Georgia dealing with design defect claims against these same hip implants.  Not so long ago, we authored a screed against a decision in that litigation involving what we saw as a complete misreading of Utah law on … wait for it .. comment k.  The Georgia federal court did not apply comment k to the medical devices and, just for good measure, completely mangled Utah law on design defect.  We were disappointed. Then the Eleventh Circuit affirmed the horrible result and wretched reasoning.  We were disappointed again.

So we have some history with this topic.

You will not be surprised to hear that we agree with the defense argument that Utah law should and would include hip implant medical devices as “unavoidably unsafe” products warranting comment k protection. The Burningham court stated that the defendant pointed “to decisions from courts in Oklahoma, Washington, California, and Pennsylvania, which do apply the doctrine to implanted medical devices.”  Yikes – there’s that unnecessary/wrong restriction to implanted devices, but since the devices in Burningham definitely were implanted one can see why the defendant in that case would take the most conservative approach.  If the federal court was going to try to predict which way the Utah Supreme Court would go, the broader reading of comment k, which would include medical devices, would probably prevail. But because the “question of whether the categorical exception applies to implanted medical devices is a question of first impression for Utah courts,” the federal court sua sponte (on its own) decided to issue an order certifying the issue to the Utah Supreme Court.  Our bet is that the defense will persuade the Utah court to extend comment k to medical devices.  Just don’t dig in too hard on the question of implantation.  Leave us room later to argue that comment k should apply to all prescription medical devices, please-and-thank-you.

Meanwhile the federal court was in a perfectly fine position to dismiss the misrepresentation and breach of warranty claims for lack of reliance.  The complaint supplied conclusory allegations of generalized reliance, but never listed any factual allegations that the plaintiff or his doctors “actually read or saw Defendant’s misrepresentations” and the complaint contained “no allegation that the Defendants’ express warranties were ever communicated to Plaintiffs or Mr. Burningham‘s physicians.”  The complaint could not “withstand the Twombly/Iqbal analysis.”  So much for those claims, and now it is up to the Utah Supreme Court to read comment k correctly and pave the way for dismissal of the strict liability claims. 

 

We have a guest post today, from Luther Munford of Butler Snow.  He’s been doing some thinking about how something analogous to the “two schools of thought” medical malpractice doctrine should apply to medical product liability cases.  As always with out guest posts, our posters deserve 100% of the credit, and any blame, for their posts.

**********

When the law addresses medical judgment directly, it allows room for reasonable physician choice.  It is ironic then, that a product liability suit over design defect may not allow any such room.  In order to protect physician choice, courts need to resist the temptation to turn product liability disputes into a contest in which reasonable physician choice has no place.

In medical malpractice litigation, where the standard of care is directly in issue, there is room for diversity of opinion.  The jury focuses on the doctor’s choices.  And if, in the light of a diversity of medical opinion, the doctor’s conduct was reasonable, there is no liability.  Steven. E. Pegalis, 1 Am. Law Med. Malp. § 3:3 (2017) (“reasonably applicable alternative methods of diagnosis or treatment” allowed).  As it is phrased in Pennsylvania, if there are “two schools of thought,” the doctor is free to pick one over the other.  Jones v. Chidester, 610 A.2d 964, 969 (Pa. 1992) (“school of thought” means “a considerable number of recognized and respected professionals”).  See also Velazquez ex rel. Velazquez v. Portadin, 751 A.2d 102, 107-108 (N.J. 2000) (allowing practice with “substantial support as proper practice by the medical profession”) (quoting Schueler v. Strelinger, 204 A.2d 577, 585 (N.J. 1964)).

But in a product liability case over defective design, there may be no room for reasonable choice.  Design defect law may ask a jury whether there is any “safer alternative” to a defendant’s device, and, if the jury believes there is, the defendant’s device may be found defective and presumably unsuitable for sale to anyone.  In fact, this question can arise whether or not there is a specific “safer alternative design” requirement in state law because the plaintiff may simply offer such a design as evidence of unreasonable risk. In answering the question, the jury will be asked to choose which expert witness is “most credible” without any allowance for reasonable differences of opinion.

If the law is going to protect a doctor’s ability to exercise reasonable medical judgment in choosing among available devices and surgeries, the question is what needs to be done to keep the unsuitable instrument of design defect litigation – where the doctor may not even be a witness and there is no pre-suit screening panel — from taking away those choices.  Only if the doctor has a choice can the doctor have the ability to determine the best method of treating the patient.

There are at least five ways design defect law can be shaped to protect doctor choice.

First, there is the question of actual doctor choice.  Where the surgeon has chosen not to employ an alternative, perhaps because of the surgeon’s education, training and experience, the jury should not be allowed to find the manufacturer liable because a choice the surgeon rejected might be deemed by the jury to be  “safer.”  See Anderson v. PA Radocy & Sons, Inc., 865 F. Supp. 522, 531 (N.D. Ind. 1994) (manufacturer not liable for employer’s decision to purchase uninsulated fiberglass bucket rather than insulated one); James. A. Henderson & Aaron. D. Twerski, Optional Safety Devices: Delegating Product Design Responsibility to the Market, 45 Ariz. St. L.J. 1399, 1417 (2013) (delegation to learned intermediary defeats design liability).

Second, a court should apply established product liability law principles and exclude from any list of “safer alternatives” those alternatives that present different advantages and disadvantages that require doctor choice, such as a different treatment or different surgery.

This is consistent with the way product liability generally protects consumer choice.  It is generally accepted that, to be a “safer alternative design,” the design must be for the same product, not a different one.  A different product may be safer in one respect, but if it serves different distinct purposes, it cannot provide a basis for finding the less safe product defective.  Informed consumers remain free to choose, and manufacturers are allowed to innovate.  The issue comes up in a variety of product liability contexts.

For example, the Fourth Circuit held in an early negligence case that, given the “peculiar purposes of [the] design” of a Volkswagen bus to provide room for passengers and cargo by placing the driver in front of the engine, a plaintiff could not argue that the design was unsafe because it was not as crashworthy as that of a passenger sedan.  The court granted judgment as a matter of law for the defendant.  Dreisonstok v. Volkswagenwerk, A.G., 489 F.2d 1066, 1074 (4th Cir. 1974), followed in Restatement (Third) of Torts: Product Liability § 2, cmt. f, illus. 9 (1998).  Similarly, a safer bullet proof vest does not make a bullet proof vest with less coverage unreasonably dangerous when the vest allows a greater range of motion.  Linegar v. Armour of Am., Inc., 909 F.2d 1150, 1154 (8th Cir. 1990); see also Hosford v. BRK Brands, Inc., 223 So.3d 199, 208 (Ala. 2016) (smoke alarm not defective just because a more expensive dual-sensor alarm was sold).

This principle is particularly apt in the field of medical devices where different products offer different sets of benefits and complications and whose “safety” depends on professional judgment and, in the case of devices, surgical skill.  Like the learned intermediary doctrine, device defect law should recognize that the doctor relies not only on what the manufacturer has supplied, but also “other medical literature, and any other source available to him, and … the personal medical history of his patient.”  Lebowitz v. Ortho Pharmaceutical Corp, 307 A.2d 449, 457 (Pa. Super. 1973).  The Texas Court of Appeals so held in a hormone therapy case:

[A] plaintiff cannot prove that a safer alternative design exists by pointing to a substantially different product, even when the other product has the same general purpose as the allegedly defective product . . .  Thus, a safer alternative design must be one for the product at issue . . . [Plaintiff] does not explain how [the drug] could have been modified or improved . . .  In essence, [plaintiff] argues that the [drug] should have been a different product . . .  But, as the supreme court has explained, Texas law does not recognize this sort of categorical attack on a product.

Brockert v. Wyeth Pharm., Inc., 287 S.W.3d 760, 770-71 (Tex. App. 2009). See also In re Propulsid Prod. Liab. Litig., No. MDL 1355, 2003 WL 367739, at *3-4 (E.D. La. Feb. 18, 2003) (alternative or different methods of treatment insufficient to prove alternative design).

In medical device cases, courts have held that different devices which perform in different ways cannot be treated as safer alternatives. The principal authorities come from the pedicle screw cases where the courts refused to accept other fixation devices, such as those involving hooks and wires, as presenting safer alternative designs.  The Fifth Circuit explicitly gave doctor choice as a primary reason for its holding.  It said:

[Plaintiff] therefore argues that other products that do not use pedicle screws should be considered as alternative designs . . .  Underlying this argument is the assumption that all pedicle screws are defective and there can be no system using pedicle screws that would be an acceptable product.  The problem with this argument is that it really takes issue with the choice of treatment made by [plaintiff’s] physician, not with a specific fault of the pedicle screw sold by [defendant].

Theriot v. Danek Med., Inc., 168 F.3d 253, 255 (5th Cir. 1999).

Similarly, in other device cases it has been held that a treatment that uses no device at all cannot be considered as a safer alternative.  As the United States District Court for the District of Nevada explained:

Neither is the Court swayed by Plaintiff’s argument that the testimony of [the expert] to the effect that Plaintiff’s [surgery] could have been accomplished without use of [the product].  The fact that an alternative method of [surgery] was potentially available does not support Plaintiff’s design defect claim.  As argued by Defendants, non-mesh repair is not an alternative design and does not meet Plaintiff’s burden to support this particular claim.

Schmidt v. C.R. Bard, Inc., No. 2:11-CV-00978-PMP, 2013 WL 3802804, at *2 (D. Nev. July 22, 2013).

While this rule would have its most direct application in states with a safer alternative design requirement, it would not be limited to those states.  It should apply wherever alternative design is used as a basis for declaring a device unreasonably dangerous.  In Driesenstock, the Fourth Circuit’s Volkswagen bus case, the issue was whether the alternative could be used to prove the defendant’s negligence.  And in Linegar, the Eighth Circuit’s bullet-proof vest case, the question was whether the vest was unreasonably dangerous.  In neither case was there a specific safer alternative design requirement.  See James Beck (“Bexis”), On Alternative Design, Take Two – Negligence, Drug and Device Law Blog (Feb. 27, 2017) (use of alternative design in negligence cases).

[Editorial note:  The Massachusetts Niedner decision (discussed here) is also an excellent example of this application]

Third, even where the products might be very similar, the jury should not be asked to choose between two products where either one is supported by a “school of thought” or “substantial medical opinion.”  From the “doctor’s choice” perspective, it is error for a court to intervene in the diagnosis and treatment of a patient in order to dictate the treatment of a patient when reasonable medical professionals could disagree.  For example, one court recognized the “same product” requirement but nevertheless said a jury could find that an alternative was safer if it did not alter “a fundamental and necessary characteristic of the product.”  Hines v. Wyeth, No. CIV. A. 2:04-0690, 2011 WL 1990496, at *8 (S.D.W. Va. May 23, 2011) (citing Torkie-Tork v. Wyeth, 739 F. Supp. 2d 895, 900 (E.D. Va. 2010)).  In that case the court said it was for the jury to decide whether natural progestin and synthetic progestin were different products. Id. at *9.  But if either choice would be within the doctor’s standard of care, that difference should not matter.

Fourth, the principle of reasonable doctor choice could also be used to interpret comment k to the Restatement (Second) of Torts §402A.  That comment rules out design defect liability for medical products if a proper warning is given and the device is “unavoidably unsafe.”  This has sometimes been incorrectly said to simply import a risk-utility test.  Mullins v. Ethicon, Inc., 117 F. Supp. 3d 810, 818-819 (S.D.W. Va. 2015).  But a better reading would be to say that a medical product is “unavoidably unsafe” and so qualifies for comment k protection if its use, within the professional standard of care, presents a risk of injury to the patient.  That would, for example, be true of nearly all implantable medical devices. See James Beck (Bexis), Unavoidably Unsafe PMA Medical Devices, Drug and Device Law Blog (Nov. 30, 2017).

Finally, the principle of doctor choice might be a basis for excluding from evidence actions of the federal Food and Drug Administration based on a comparison of one treatment to another if both treatments were considered to be within the doctors’ standard of care.  Congress has told the FDA that it is not to “limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient….”  21 U.S.C. § 396 (2009).  Nevertheless, the FDA does take regulatory actions based not on independent judgments about safety and effectiveness but rather upon comparisons among methods of treatment.  A negative comparison that failed to recognize reasonable doctor choice should be just as inadmissible as expert testimony that failed to apply the correct liability standard.  See, e.g., United States v. Wintermute, 443 F.3d 993, 1001 (8th Cir. 2006).

If the principle of doctor choice were applied in design defect law, it would be necessary to decide what theories of design defect liability would survive.  Certainly a device not considered to be within the standard of care would face liability if it were so egregiously dangerous as not to have any justifiable therapeutic use.  Or if scientific testing proved a way to design the same product so that it was both safer and equally effective, that might be considered in some jurisdictions.

And none of this would directly affect liability for failure to warn, because any rule that rests on doctor’s choice has to assume that doctors are aware of the complications that may arise out of use of the device.

When it comes to design defect claims and FDA pre-market approved (“PMA”) medical devices, “preemption” is our reflexive reaction. That’s entirely reasonable, given the many decisions that preempt state-law design-related claims since Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  We collect then all here.

Nevertheless, there are some judges, particularly (but not all) in state court, who react negatively to the very concept of preemption.  Thus, a word to the wise is not to put all your dismissal eggs in one basket.  One logical alternative argument starts with the same premise as preemption – that “the FDA requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application.”  Riegel, 552 U.S. at 323.

The “almost no deviations” limitation, of course applies to device design.  E.g., Walker v. Medtronic, Inc., 670 F.3d 569, 580 (4th Cir. 2012); Blunt v. Medtronic, Inc., 760 N.W.2d 396, 409 (Wis. 2009); McLaughlin v. Bayer Corp., 172 F. Supp. 3d 804, 810 (E.D. Pa. 2016); Kitchen v. Biomet, Inc., 2014 WL 694226, at *3 (E.D. Ky. Feb. 21, 2014); Miller v. DePuy Spine, Inc., 638 F. Supp. 2d 1226, 1229 (D. Nev. 2009).

Which brings us to Restatement (Second) of Torts §402A, comment k (1965), “which insulates from liability manufacturers of unavoidably unsafe products that are properly prepared and accompanied by an adequate warning.”  Rodriguez v. Stryker Corp., 680 F.3d 568, 575 (6th Cir. 2012) (applying Tennessee law).  Putting aside the separate (albeit important) issue whether comment k applies to prescription medical products generally or only on a case-by-case basis, courts on both sides of that question equate “unavoidably unsafe” with the absence of an alternative design:

[N]umerous state and federal courts ha[ve] interpreted comment k to mean that a product is “unavoidably unsafe” when, given proper manufacture and labeling, no feasible alternative design would reduce the safety risks without compromising the product’s cost and utility.

Bruesewitz v. Wyeth LLC, 562 U.S. 223, 256 (2011) (Breyer, J. concurring) (footnote containing string citation omitted) (emphasis added).  In other words, “a defendant seeking to invoke the [comment k] defense must first show that the product is highly useful and that the danger imposed by the product could not have been avoided through a feasible alternative design.”  Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466, 2487 (2013) (applying New Hampshire law).  To avoid a claim of “unavoidable risk, there must be, at the time of the subject product’s distribution, no feasible alternative design which on balance accomplishes the subject product’s purpose with a lesser risk.”  Toner v. Lederle Laboratories, 732 P.2d 297, 306 (Idaho 1987).  “The purpose of comment k is to protect from strict liability products that cannot be designed more safely.” Grundberg v. Upjohn Co., 813 P.2d 89, 92 (Utah 1991).  Grundberg and Toner don’t agree on much when it comes to comment k, but they agree on the importance of alternative design.

Thus, that a PMA-approved device must be made with “almost no deviations” from its specified design means (in addition to preemption) that there is no legal alternative design that would allow the plaintiff to avoid a manufacturer’s comment k defense.  To use a non-approved alternative design would be illegal – and illegal designs cannot serve as “feasible” alternative designs.  See Lewis v. American Cyanamid Co., 715 A.2d 967, 981 (N.J. 1998} (“plaintiff may not succeed on an alternative design theory that would have required the defendant manufacturer to violate the law”); White v. Wyeth Laboratories, Inc., 533 N.E.2d 748, 753-54 (Ohio 1988) (alternative design not feasible where “it was not possible for [defendant] to have legally marketed a [product] design using [the alternative design] at the time [plaintiff] was inoculated”); Ackley v. Wyeth Laboratories, Inc., 919 F.2d 397, 401 (6th Cir. 1990) (following White; alternative designs did not “exist[]” where it was “indisputable” that “[w]ithout an FDA license to produce another design, [defendant] was legally prohibited from distributing” those designs) (applying Ohio law); Wolfe v. McNeil-PPC, Inc., 773 F. Supp.2d 561, 572 (E.D. Pa. 2011) (when “[t]here exists no FDA-approved alternative form of [the product],” “there is no available alternative design”); Militrano v. Lederle Laboratories, 769 N.Y.S.2d 839, 847-48 (N.Y. Sup. 2003) (where plaintiff proposed a non-FDA-approved alternative, defendant “could not have marketed a reasonable alternative”), aff’d, 810 N.Y.S.2d 506 (N.Y.A.D. 2006); In re Alloderm Litigation, 2015 WL 5022618, at *12 (N.J. Super. Law Div. Aug. 14, 2015 (no feasible alternative where design plaintiff advocated “was not approved by the Food and Drug Administration until” after plaintiffs’ surgeries); Totterdale v. Lederle Laboratories, 2008 WL 972657 (W.Va. Cir. Mar. 19, 2008) (where FDA approval not until after plaintiff’s injury plaintiff did “not provide[] any new material facts to raise a genuine issue as to whether [the product] was avoidably unsafe”).

Thus, in Gross v. Stryker Corp., 858 F. Supp.2d 466 (W.D. Pa. 2012), comment k applied to “a Class III medical device which received FDA approval pursuant to the PMA process.” Id. at 481 (footnote omitted).

Moreover, the inherently rigorous nature of the premarket approval process and the contraindications, warnings, and precautions described in the [device’s] Summary of Safety and Security Data all suggest that [it] is an “unavoidably unsafe” product to which strict liability does not apply.

Id. at 482.  “As a result, the [device] can be considered a prescription medical device that falls within the scope of comment k to § 402A.”  Id.

Similarly, the court employed the non-preemption path of comment k in Aaron v. Medtronic, Inc., 209 F. Supp.3d 994 (S.D. Ohio 2016).  While Ohio (at the relevant time, this has now changed, Ohio Rev. Code Ann. §2307.75(D)) was a case-by-case comment k state, the PMA approved nature of the device, and the constraints the FDA’s approval placed on alternative designs, meant that comment k had to apply:

Defendant argues . . . that [the device’s] classification by the FDA as a Class III medical device inherently means that it is unavoidably unsafe and that Comment K’s prohibition of strict liability claims therefore applies. Defendant’s argument is well taken.  Class III devices . . . are, as relevant here, defined as devices that are “for a use which is of substantial importance in preventing impairment of human health, or…present[] a potential unreasonable risk of illness or injury.”  21 U.S.C. §360c(a)(1)(C)(ii). . . .

[T]here is no alternative design for [the device] that could lawfully be marketed.  “Once a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications…that would affect safety or effectiveness.” There is therefore no basis for an in-depth evidentiary inquiry into alternative designs.

Aaron, 209 F. Supp.3d at 1013-14 (quoting Riegel, 552 U.S. at 319) (other citations omitted).

So while preemption should do the trick with design defect claims involving PMA approved medical devices, courts may sometimes have an easier time with alternative, non-constitutional arguments such as the lack of any legal alternative design under Restatement §402A, comment k.  Consider giving judges this other way to the end result that we all want – dismissal of design defect claims.

About two years ago, in our post “How Does a Bad Idea Get Implanted,” we discussed what at the time seemed a California peculiar argument that the “unavoidably unsafe” product doctrine epitomized by Restatement (Second) of Torts §402A, comment k (1965) was somehow limited to implantable – as opposed to non-implantable – medical devices.  While most medical device litigation has historically involved implants, in that post we saw nothing in comment k, or the broader concept that prescription-only products have inherent risks (why their availability requires a doctor’s prescription in the first pace), that is logically limited to implantable devices.

We pointed out in that post that this rather weird argument apparently originated in ill-considered dictum in Chandler v. Chiron Corp., 1997 WL 464827, at *4 (N.D. Cal. July 28, 1997), a case which ultimately dismissed the plaintiff’s design defect claim on causation grounds (and was affirmed on that basis, see 176 F.3d 481 (9th Cir. 1999)), and was directly refuted by controlling California appellate authority: Armstrong v. Optical Radiation Corp., 57 Cal. Rptr.2d 763, 772 (Cal. App. 1996), which applied the comment k unavoidably unsafe rationale to intraocular fluid, a non-implanted surgical aid.  As we put it then:

The issue is not whether the device is implanted, it is whether the device unavoidably poses risks even as it must be used by physicians to “save lives or reduce pain and suffering.”

Quoting Brown v. Superior Court, 751 P.2d 470, 479 (Cal. 1988)).

We were recently contacted by fellow defense counsel about a similar argument being made by plaintiffs in a Pennsylvania case, since Pennsylvania, like California, also applies comment k across the board.  We took a look at the case law and let them know that Pennsylvania precedent likewise has not recognized any artificial distinction between implanted and non-implanted prescription medical devices.  Rather, in Wagner v. Kimberly-Clark Corp., 225 F. Supp.3d 311, 315 (E.D. Pa. 2016), a Pennsylvania court applied comment k/the unavoidably unsafe doctrine to bar strict a liability claims involving a prescription device that wasn’t an implant. Wagner involved a temporary feeding tube used while the plaintiff was in intensive care, and the court dismissed strict liability design and warning defect claims, but not manufacturing defect claims, under Pennsylvania’s broad reading of comment k.  225 F. Supp.2d at 315 & n.4.  Indeed, Wagner essentially took the application of the unavoidably unsafe doctrine to design and warning claims as a given, as 9/10 of the opinion was about whether or not strict liability manufacturing defect claims could survive (which is a different issue we addressed here).  Id. at 316-18.

Maybe a feeding tube, although not technically an implant, still seems “close enough,” since such tubes do extend inside the body, albeit quite temporarily.  OK, but there’s plenty of precedent out there about devices that don’t even temporarily penetrate the body.

In Racer v. Utterman, 629 S.W.2d 387 (Mo. App. 1981), the plaintiff was injured when “a disposable drape manufactured by defendant . . . caught on fire resulting in serious burns.”  Id. at 391.  “The purpose of the surgical drape is to provide a sterile field and to serve as a barrier to prevent bacteria from reaching the operation site.”  Id. at 391-92.  The appellate court affirmed application of comment k to this product:

Comment k to the Restatement recognizes that “unavoidably unsafe” products achieve protection despite their danger “when accompanied by proper directions and warning”. . . .  On the record before us we find the surgical drape here to be an “unavoidably unsafe” product.  It is a highly useful product which affords substantially increased protection against infection during surgical procedures.  Its water-repellant attributes increase these protections.  In the state of knowledge at the time of the injury no method of making the product fire-resistant was available which did not adversely affect its barrier against infection or create potential injury to the patient from allergy or disease.

Id. at 393.  The defendant still lost, but on warnings, id. at 395, not because comment k didn’t apply to the drape because it wasn’t implanted.

The Illinois Supreme Court applied comment k’s unavoidably unsafe rationale to therapeutic x-ray radiation equipment in Greenberg v. Michael Reese Hospital, 415 N.E.2d 390, 394-95 (Ill. 1980).

The possibility that in certain cases protection of human life and health might be diminished by the imposition of liability has been recognized in section 402A of the Restatement. Comment k indicates that certain products, though dangerous, are necessarily so and do not warrant the imposition of liability. . . .  [C]omment k presume[s] in their treatments that the denomination “product” has already been applied to the matter in question.  Nevertheless, imposition of strict liability is a question of policy, and often the same policy concerns are involved in discussions which are ostensibly diverse, for example: the meaning to be given such terms as “product,” “defective,” “unreasonably dangerous,” and “business of selling.”  For the reasons stated we conclude that public policy dictates against the imposition of strict liability in tort for injuries resulting from the administration of X-radiation treatments by a hospital.

Id. at 394-95 (citations and quotation from Prosser’s On Torts omitted).

Two other cases have applied comment k’s analysis to external patches that release drugs that are absorbed through the skin.  In Edwards v. Basel Pharmaceuticals, 933 P.2d 298 (Okla. 1997), the court cited and quoted comment k (“the law regarding such products appears at Comment k”) in a case involving nicotine patches.  These were products “incapable of being made safe, but are of benefit to the public dispute the risk.  Id. at 300.  Likewise, in Mardegan v. Mylan, Inc., 2012 WL 12850781, at *6-7 (S.D. Fla. Jan. 31, 2012), a fentanyl “pain patch” was considered to be within the scope of comment k.  The court refused to grant summary judgment, but only because it found “genuine issues of material fact . . . as to whether the patches at issue were incapable of being made safe,” not because comment k was categorically inapplicable to non-implanted products.  Id. at *7.

Most recently, in Taylor v. Intuitive Surgical, Inc., 389 P.3d 517 (Wash. 2017), the court applied comment k to a surgical robot – a piece of equipment that assists in the conduct of surgery and is never implanted in the body.  The court applied comment k analysis to the liability questions.  Id. at 526-28.  As in Racer, Taylor found that the comment k exception did not apply on the facts of the case, because it could not be said that the product warnings were adequate as a matter of law.  Id. at 528 (“[e]xemption from strict liability under comment k is expressly limited to products accompanied by adequate warnings”).  Once again, there was not a hint in Taylor that the fact that the robot was not an implant made comment k ipso facto inapplicable.  Washington law “safeguard[ed] the public to the greatest extent possible without discouraging the development and marketing of unavoidably unsafe products.”  Id.

The great majority of product liability litigation involving prescription medical devices happens to involve implants.  However, that descriptive fact is of no legal consequence to the applicability, or not, of the comment k/unavoidably unsafe product doctrine.  That doctrine is interpreted in a variety of different ways – most notably case-by-case versus across-the-board application to prescription medical products.  But no matter which way the doctrine is interpreted, its application is not dependent upon whether or not a medical device is implanted in the body.  At least three state high courts, two state intermediate appellate courts, and a couple of federal district court agree.  There is no contrary precedent, only the aforementioned dictum in Chandler, a 20-year-old district court case, the reasoning of which has never been adopted by any subsequent decision, and (as we already discussed) is refuted by the Cal. App. Armstrong decision.

A funny thing happened on the way to a defense verdict last year—after the jury decided that the defendant’s product was not defective, the MDL judge told the jurors that perhaps they did not “fully understand” and instructed them to try again. So the jury went back into the jury room, and having been duly admonished by the court, the jury changed its mind and returned a verdict for the plaintiff.  We commented fully on the proceedings here, and while we will not repeat all the gory details, trust us, the proceedings were odd.

The Eleventh Circuit has now affirmed the plaintiff’s verdict, and the defendant has valid reasons to be unhappy. Not only did the Eleventh Circuit place its stamp of approval on the do-over verdict, it applied a hopelessly muddled view of comment k.

The case is Christiansen v. Wright Medical Technology, Inc., No. 16-12162, 2017 WL 1046088 (11th Cir. Mar. 20, 2017).  The plaintiff alleged that a defect in the defendant’s metal-on-metal hip replacement device caused him an injury, and he asserted product liability claims governed by Utah law. Id. at *1.  As luck would have it, the case was selected as a “bellwether” trial case in the Conserve Hip Implant MDL, and after a trial that lasted about a week, the jury returned a verdict finding that the product was not defectively designed. Id. The jury also found that the defendant had made negligent misrepresentations and awarded compensatory and punitive damages. Id.

Under Utah law, this is a defense verdict. The Utah Products Liability Statute covers all claims for injuries allegedly caused by defective products, and it requires proof of a product defect.  As a result, once the jury found that the product was not defective, nothing else mattered.  The defendant won.  The court, however, ruled that the verdict was “inconsistent” because the jury found no defect on the one hand, but also found negligent misrepresentation on the other. Id. That is why the court re-instructed the jury, resulting in the second verdict finding a product defect. Id.

The Eleventh Circuit affirmed this result, and its opinion relies on the assumption that the first verdict was “inconsistent.” Id. at **5-7.  But what inconsistency?  The jury made two core findings—no defect and negligent misrepresentation.  Maybe the evidence supported those findings and maybe it did not, but it is very possible for a defendant to make a misrepresentation and also sell a product that is free from design defects.  (There were no manufacturing or warning-based defect claims, in case you were wondering.)  The finding of no defect makes the misrepresentation finding meaningless under Utah law.  They are not “inconsistent.”  The former just deprives the latter of any legal consequence.

For whatever reason, the district judge saw an “inconsistency,” and the Eleventh Circuit deferred. The Eleventh Circuit tries to explain the proceedings in the district court, but in the end, it really did not explain why the initial verdict called for further deliberation.  It seems to have taken that for granted.

There is a second problem with the Eleventh Circuit’s opinion—it declined to apply Utah’s adoption of Comment k and gave a reason that simply does not hold up. Comment k to section 402A of the Restatement (Second) or Torts provides protection against strict liability claims involving “unavoidably unsafe products.”  Nearly all states have adopted some version of Comment k—some apply it on a case-by-case basis; some treat it as an affirmative defense; some apply Comment k as a matter of law in all cases involving prescription medical products, recognizing that all drugs and medical devices have both benefits and risks.

Utah has adopted Comment k, but has placed the burden on the defendant to prove certain elements to invoke Comment k as a defense. However, in cases involving prescription medical products, the Utah Supreme Court has “rejected the case-by-case approach and adopted Comment k as a categorical bar against strict liability.” Id. at **7-8 (quoting Grundberg v. Upjohn Co., 813 P.2d 89 (Utah 1991)).  Comment k therefore applies in Utah across the board, and the Defendant justifiably argued to the Eleventh Circuit that Comment k applied and that it should result in a judgment for the defense.

The Eleventh Circuit “predicted” Utah law differently. According to the Eleventh Circuit, the Utah Supreme Court applied Comment k to prescription drugs because they are FDA approved. Id. at *8.  It therefore held that the Utah Supreme Court would not apply comment k categorically to medical devices. Id. at **8-9.  It further held that, even if Comment k applied to “FDA-approved medical devices,” the defendant had not carried its burden of proving that the product was FDA approved. Id. at **8-9.

There is so much wrong with this holding. To start, with the Utah Supreme Court having decided that Comment k applies to prescription drugs, there is no basis on which to predict that Utah law would be different for prescription medical devices.  The rationale for applying Comment k is the same—no matter how you design a drug or medical device, there will always be risks. (See here for our research post on comment k, including a 50-state survey.)  In addition, the Eleventh Circuit’s fixation on FDA approval to distinguish prescription drugs from prescription medical devices ignores that the FDA regulates medical devices, too.  It also ignores that drugs are approved for marketing in different ways—some through full-blown new drug applications, some under pre-NDA rules, some through a showing of substantial equivalence, etc.  Comment K applies to all of them, and the Utah Supreme Court has never drawn a distinction.  There is no reason to believe it would draw a distinction between drugs and medical devices because of their respective regulatory pathways either.

Finally, the Eleventh Circuit held that Comment k would not help the defendant in any event because the defendant did not prove that the product was approved by the FDA. This is wrong.  Utah’s version of Comment k requires the defendant to prove certain elements, but FDA approval is not one of them.  Neither the Utah pattern jury instruction nor the instruction given by the district court called for the defendant to prove FDA approval.  Yet, the Eleventh Circuit based its opinion on this purported failure of proof.

We can’t help but consider the possibility that this plaintiff’s judgment had more staying power because it came out of an MDL “bellwether” trial. Maybe.  Maybe not.  It seems to us that if you assume that “bellwether” verdicts actually help the parties value other cases, a defense verdict is as useful as a plaintiff’s verdict.  Both have dollar amounts attached to them, and the number attached to the defense verdict is zero, plus the defendant’s costs.  That should have been the result in Christiansen.

Bexis, who took some lumps in probably the worst Wisconsin product liability decision ever (he filed PLAC’s amicus brief in Thomas v. Mallett, 701 N.W.2d 523 (Wis. 2005)), just read what we believe is the best Wisconsin law decision ever – at least in the drug/medical device sandbox that we inhabit. The decision is In re Zimmer Nexgen Knee Implant Products Liability Litigation, 2016 WL 6135685 (N.D. Ill. Oct. 21, 2016) (since the caption is a mouthful, we’ll call it “ZNKI“).

Here’s why ZNKI is favorable on Wisconsin legal issues.

First, as our longstanding 50-state survey on the learned intermediary rule points out, Wisconsin is one of nine states in which only federal courts predicting state law have had occasion to adopt the learned intermediary rule.  Looking more closely at these nine, Wisconsin is one of only two states (South Dakota being the other) where only federal district courts have reached this holding.  What isn’t there, but is discussed in ZNKI, is that some courts have (without much reasoning) refused to predict Wisconsin’s adherence to the rule.  Refusing to dodge the issue, ZNKI forthrightly examines both Wisconsin precedent and the general state of the law and concludes that Wisconsin would join the nationwide learned intermediary consensus:

[F]ederal courts applying Wisconsin law have reached different conclusions about the doctrine’s applicability.  The vast majority of states, however, do employ some version of the doctrine.  In addition, this court’s research suggests that those courts that have declined to apply the doctrine under Wisconsin law have done so in cases involving prescription drugs, not medical devices, and those courts offer no reason to believe that the Wisconsin Supreme Court would not adopt this majority rule if presented with the issue.

In the context of . . . surgery, a patient must rely on the experience and judgment of his or her surgeon, who selects the appropriate implant and educates the patient about the particular risks − based on the patient’s particular circumstances and physiology. . . .  Given that context, and given the widespread acceptance of the doctrine throughout the country, the court believes it is likely that the Wisconsin Supreme Court would apply the learned intermediary doctrine in this case.

ZNKI, 2016 WL 6135685, at *19-20 (numerous citations omitted).  As we’ve pointed out recently, the learned intermediary rule is, if anything, enjoying a renaissance, with thirteen straight state high court adoptions since the infamous Karl case (since overruled by statute) was the only supreme court to go the other way.

Continue Reading Probably the Best Wisconsin Law Decision We’ve Ever Seen

This post is from the non-Reed Smith side of the blog.

We found it strange that last month’s decision in Jenkins v. Boston Scientific Corp., 2016 WL 1448867 (S.D.W. Va. April 12, 2016), held – almost as a throw-away point – that Texas law wouldn’t apply Restatement (Second) of Torts §402A, comment k (1965) to medical devices as it does to prescription drugs. That’s a notable, indeed almost unprecedented, result.

Jenkins did recognize that Texas law has, for a long time, applied comment k across-the-board to bar design defect claims against all prescription drugs. Id. at *5, citing Carter v. Tap Pharmaceuticals, Inc., 2004 WL 2550593, at *5 (W.D. Tex. Nov. 2, 2004) (“Under Texas law, all FDA-approved prescription drugs are unavoidably unsafe as a matter of law.”). Carter is hardly the only Texas case for applying comment k generally to bar design defect claims. We collected that law in our 2011 Comment K,Some of the Way post: Centocor, Inc. v. Hamilton, 310 S.W.3d 476, 516 (Tex. App. 2010) (comment k “provide[s] a defense to a design defect claim”), rev’d on other grounds, 372 S.W.3d 140 (Tex. 2012); Schwarz v. Block Drug Co., 1999 WL 274409, at *1 (5th Cir. 1999) (“Under comment K of the Restatement of Torts (Second) § 402A, a drug manufacturer is responsible in damages only if it failed to warn of a defect of which it knew or should have known.”) (unpublished, in table at 180 F.3d 261); Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1273-74 (5th Cir. 1974) (applying unavoidably unsafe standard without individualized assessment); Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *3 (N.D. Tex. Nov. 15, 2007) (“[p]rescription drugs are not susceptible to a design defect claim where, as here, the drug is “accompanied by proper directions and warning”); Hackett v. G.D. Searle & Co., 246 F. Supp.2d 591, 595 (W.D. Tex. 2002) (“[t]he Court thus holds that under Texas law and comment k of the Restatement, Defendants can only be held strictly liable if the drug was not properly prepared or marketed or accompanied by proper warnings”).

However, after recognizing Texas law with respect to comment k and prescription drugs, Jenkins declined to apply comment k in the same fashion to medical devices:

I reject [defendant’s] contention that Texas’s absolute bar for FDA-approved prescription drugs, applies here, given that the products are neither FDA-approved nor prescription drugs. See Lofton v. McNeil Consumer & Specialty Pharm., 682 F. Supp.2d 662, 679 (N.D. Tex. 2010) (refusing to “take a leap not taken by Texas courts” in applying comment k categorically outside the prescription drug context).

2016 WL 1448867, at *5 (citation omitted).

That’s it. The entire extent of the discussion of Texas law on this point is one sentence and one citation. Absent is any discussion of why the policy reasons that have led Texas courts to apply comment k in every prescription medical product case over the last forty years don’t apply to prescription medical devices.

But what about Lofton?

Continue Reading Don’t Mess With Texas

In Hawaii, from whence today’s case comes, tourists are encouraged to try poi, mashed up taro root, which looks like purple wallpaper paste and tastes like, well, purple wallpaper paste. The term is also used as a friendly descriptor of ethnically ambiguous looking people, whose roots have been mashed together to form something not readily identifiable by traditional visual stereotypes. (At least it seemed friendly when we heard it applied to our own offspring.) Personally, we think it is a nice concept and the less that categorizing people to determine their rights, opportunities, and expectations happens, the better. For a number of aspects of product liability law, however, the decision on whether to proceed categorically or case-by-case is still hotly contested. This is particularly true for comment k to the Restatement (Second) of Torts, § 402A, which forms the meat of the decision in Segovia v. Bristol-Myers Squibb Co., CV. No. 15-00519 DKW-RLP, 2016 U.S. Dist. LEXIS 52405 (D. Haw. Apr. 19, 2016).

Segovia involves a fatal hemorrhagic stroke with an anticoagulant prescribed and used for atrial fibrillation. We are not sure what was different from the first complaint, but the second try made vague allegations about misrepresentations to FDA and others that it was “tested and found to be safe and effective for its indicated uses” and that FDA and others had not been told of the drug’s “defects” in support of allegations of strict liability and negligent failure to warn and design defect theories. While it seems like this complaint asserted claims based on non-existent duties and clearly preempted claims, the only issues addressed by the court on the motion to dismiss were whether Hawaii law took comment k to preclude design defect claims for all prescription drugs categorically and whether any fraud-based claims had been pleaded with sufficient particularity.

As to the first question, the court did not look to our relatively recent discussions on this issue, but generally looked to older cases to find the public policy rationale for taking a case-by-case approach for prescription drugs—which was essentially determinative on a motion to dismiss. But we are getting ahead of ourselves. The first step was determining what Hawaii case law already said about comment k and only two cases were discussed. Larsen v. Pacesetter Sys., Inc., 837 P.2d 1273, 1286 (Haw. 1992), involved a pacemaker—not a drug—and concluded that summary judgment based on comment k was inappropriate where there was evidence that the “pacemaker was demonstrably capable of being made safe for its intended use.” Forsyth v. Eli Lilly & Co., 1998 WL 35152135, **3-4 (D. Haw. Jan. 5, 1998), involved a prescription drug, but did not decide the issue of categorical or case-by-case because a genuine issue as to the adequacy of warnings was sufficient to preclude summary judgment. Rather than view these cases are leaving the issue open, the Segovia court found “neither Larsen nor Forsythe create a blanket rule of design defect immunity for pharmaceutical manufacturers, and the Court declines to extend comment k in a fashion that the Hawaii courts themselves have thus far declined to do.” 2016 U.S. Dist. LEXIS 52405, *11. We think this misconstrues comment k, which does not provide “immunity,” and what it means to conclude that all prescription drugs are “unavoidably unsafe.”

Continue Reading Some Case-by-Case Comment K Mixed with Some Insufficient Pleading of Fraud

We aren’t going to mince words today. We don’t like Christiansen v. Wright Medical Technology Inc., MDL 2329, 2016 U.S. Dist. LEXIS 46409 (N.D. Ga. Apr. 5, 2016). It is an opinion on post-trial motions in a case that went to trial in the Conserve Hip Implant Products Liability Litigation. It’s a beautiful spring day here in the Mid-Atlantic and we hope that’s true where you are. If it is, and if anything in this post makes you interested in the greater details and nuances of the decision, we recommend taking it outside, sitting under a tree, and enjoying some fresh air. You should at least have pleasant surroundings while you try to get through it. It’s long, and tedious, and frankly, muddled. So, we are going to try to focus in on the key parts – so that we might also try to get out and enjoy some of this fine weather.

Christiansen is a hip implant case. It went to trial on 5 theories of liability: strict liability design defect, negligent design defect, fraudulent misrepresentation, fraudulent concealment, and negligent misrepresentation. Id. at *2-3. Apparently the court had dismissed plaintiff’s failure to warn claim on summary judgment. Id. at *69 n.18. The jury ultimately returned a verdict finding the hip implant was defectively designed and caused plaintiff’s injuries and awarded $550,000 in compensatory damages. The jury also found in favor of the defendant on the fraudulent misrepresentation and concealment claims, but awarded another $450,000 to plaintiff on his negligent misrepresentation claim and $10 million in punitives. Id. at *18.

But that wasn’t the jury’s first verdict. It’s first verdict, delivered days earlier, answered the first question on the Verdict Form – do you find the hip implant was defectively designed – in the negative. Id. at *6. While that should have been the end of the inquiry, the jury didn’t understand the instruction to not go any further and they kept answering the verdict form. So, they went on to find that defendant had made negligent misrepresentations and awarded plaintiff $662,500 in compensatory damages and $2.5 million in punitives. Id. at *7.

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