Law

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 (unpublished, in table at 180 F.3d 261); Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1273-74 (5th Cir. 1974) (applying unavoidably unsafe standard without individualized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:

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?

Of course we took a look.  Lofton involved an OTC product – not a prescription product of any sort.  Here's the full quote from Lofton:

Lofton, with its repeated emphasis on comment k's "prescription" language, is hardly a basis for the almost unique holding that, in a jurisdiction that has adopted comment k (not all have, as we discuss in the "Some of the Way" post) in prescription drug cases, comment k does not apply in the same way to medical devices that likewise require a doctor's prescription before use.  In this respect, Jenkins is way out on a limb.

Exactly how far out is indicated by another federal court recently asked to make the same prediction.  In Anastasi v. Wright Medical Technology, Inc., 16 F. Supp.3d 1032 (E.D. Mo. 2014), the court was also asked to dismiss a design defect claim against a medical device under comment k in a case that applied Texas law.  The court recognized that Texas applied comment k broadly.  Id. at 1041.  Anastasi applied comment k to medical devices but held that dismissal was "premature" at the motion to dismiss stage due to a need to "weigh evidence":

Three other legal aspects also indicate to us that the result in Jenkins is erroneous.

First, that holding is contrary to the Restatement (Third) of Torts, which explicitly applies the same liability standards to both prescription drugs and medical devices:

We also note that a Texas appellate court has emphatically rejected an analogous argument that the learned intermediary rule shouldn't apply to medical devices.  Bean v. Baxter Healthcare Corp., 965 S.W.2d 656, 662 (Tex. App. 1998).  As with Lofton, the prescription nature of the device was dispositive:

Collectively, strike one.

Second, Texas' rejection of design defect claims involving prescription medical products is also reflected in that state's product liability statute.  For all other products, the design defect standard is set by Tex. Civ. Prac. & Rem. Code Ann. §82.005.  However, prescription medical products are exempt:

Since we're dealing with the common law, we should point out that, with respect to design defects, the Third Restatement approaches them differently from the Second Restatement's comment k – barring liability unless "the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits" that no "reasonable" physician would "prescribe the drug or medical device for any class of patients."  Restatement (Third) of Torts, Products Liability §6(c) (1998).  The Texas Supreme Court has never expressly adopted §6(c), and in Hamilton it followed comment k instead:

Strike two.

Third, we looked to see what courts in other states have held when addressing the same question.  Jenkins cited no other law on this point, but Bexis has it in his book.  "Almost all courts have extended the unavoidably unsafe product doctrine to medical devices."  Beck & Vale, Drug & Medical Device Product Liability Deskbook §2.02[2], at 2.02-12 (Supp. 2014).  The accompanying footnote collects the cases that support this statement − where courts across the country have applied comment k to medical devices.  There are literally scores of such decisions.  Rather than list them all, we're including only the top couple from each jurisdiction that has decided this question.

Alabama:  Emody v. Medtronic, Inc., 238 F. Supp.2d 1291, 1296 (N.D. Ala. 2003) ("prescription medical devices are unavoidably unsafe products, and where inherent risks are at issue, the only other permissible theory of liability is inadequate warning").

Arizona:  Gebhardt v. Mentor Corp., 191 F.R.D. 180, 185 (D. Ariz. 1999) (applying Restatement Third §6(c) equally to medical devices), aff'd mem., 15 F. Appx. 540 (9th Cir. 2001); Conklin v. Banner Health, 2015 WL 10688305, at *4 (Ariz. Super. Oct. 30, 2015) (applying comment k equally to medical devices).

Arkansas:  Hill v. Searle Laboratories, 884 F.2d 1064, 1067-70 (8th Cir. 1989) (applying comment k equally to intrauterine devices).

California: Garrett v. Howmedica Osteonics Corp., 153 Cal. Rptr.3d 693, 701 (Cal. App. 2013) ("The public interest in the development, availability and affordability of implanted medical devices justifies an exemption from design defect strict products liability for all implanted medical devices that are available only through the services of a physician."); Plenger v. Alza Corp., 13 Cal. Rptr.2d 811, 818 (Cal. App. 1992) (applying comment k equally to medical devices; we "are unable to make any principled distinction in terms of policy considerations between prescription drugs and prescription implanted medical devices"); Hufft v. Horowitz, 5 Cal. Rptr.2d 377, 3823 (Cal. App. 1992) ("the important considerations underlying [comment k] apply with equal force to implanted medical devices, which like prescription drugs, are available only through a physician").

Colorado:  Haffner v. Stryker Corp., 2014 WL 4821107, at *3 (D. Colo. Sept. 29, 2014) (applying comment k and Restatement Third §6(c) equally to medical devices; "[p]rescription medical devices are not the same as ordinary consumer products"); Wollam v. Wright Medical Group, Inc., 2012 WL 4510695, at *5 (D. Colo. Sept. 30, 2012) (applying comment k equally to medical devices).

Connecticut:  Hurley v. The Heart Physicians, P.C., 898 A.2d 777, 784 (Conn. 2006) ("we can see no principled reason to distinguish between a prescription implantable medical device like a pacemaker and a prescription drug"); Breen v. Synthes-Stratec, Inc., 947 A.2d 383, 388 (Conn. App. 2008) ("comment (k) is not limited to prescription drugs but also is applicable to medical devices such as the plates implanted in the plaintiff's body").

Florida: Adams v. G.D. Searle & Co., 576 So.2d 728, 731-33 (Fla. App. 1991) (applying comment k equally to medical devices); Small v. Amgen, Inc., 134 F. Supp.3d 1358, 2015 WL 5687668, at *10 (M.D. Fla. 2015) (same).

Illinois:  Greenberg v. Michael Reese Hospital, 415 N.E.2d 390, 394-95 (Ill. 1980) (applying "public policy" of comment k to a medical device); Mele v. Howmedica, Inc., 808 N.E.2d 1026, 1041 (Ill. App. 2004) ("Comment k . . . provides further support for use of risk-benefit analysis for evaluating the danger of the medical device defendant made") (later overruled on other grounds).

Indiana:  Parks v. Danek Medical, Inc., 1999 WL 1129706, at *6 (N.D. Ind. June 17, 1999) ("comment k has been held to apply to prescription medical devices, as well as to prescription drugs").  See also Ind. Code Ann. §34-20-4-4 (codifying comment k and applying it to all products)

Kentucky: Cales v. Medtronic, Inc., 2014 WL 6600018, at *15 (Ky. Cir. Nov. 21, 2014) (applying comment k equally to medical devices), reconsideration denied, 2014 WL 6600018 (Ky. Cir. Nov. 21, 2014); Prather v. Abbott Laboratories, 960 F. Supp.2d 700, 707 (W.D. Ky. 2013) ("[t]he 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").

Louisiana:  McPheron v. Searle Laboratories, Inc., 888 F.2d 31, 33 (5th Cir. 1989) (rejecting argument against applying comment k to medical devices; finding "[t]he great weight of the authority in other jurisdictions is to the contrary") (later vacated due to settlement, 904 F.2d 251).

Massachusetts:  Lareau v. Page, 840 F. Supp. 920, 933 (D. Mass. 1993) (applying comment k equally to medical device).

Minnesota:  Johnson v. Zimmer, Inc., 2004 WL 742038, at *8 n.5 (D. Minn. March 31, 2004) (applying comment k equally to medical devices).

Missouri:  Racer v. Utterman, 629 S.W.2d 387, 393 (Mo. App. 1981) (applying comment k equally to medical devices); Joyce v. Davol, Inc., 2016 WL 775183, at *2-3 (E.D. Mo. Feb. 29, 2016) (same).

New Mexico:  Perfetti v. McGahn Medical, 662 P.2d 646, 649-50 (N.M. App. 1983) (rejecting argument against extending comment k to medical devices).

New York:  Bravman v. Baxter Healthcare Corp., 984 F.2d 71, 75-76 (2d Cir. 1993) (district court was "correct" in considering medical device to be a "unavoidably unsafe" product under comment k).

Ohio:  Burwell v. American Edwards Laboratories, 574 N.E.2d 1094, 1098 (Ohio App. 1989) (applying "the standard to be applied in cases involving unavoidably unsafe products" to a medical device).

Oklahoma:  Edwards v. Basel Pharmaceuticals, 933 P.2d 298, 300 (Okla. 1997) (applying comment k equally to medical devices under Tansy); Tansy v. Dacomed Corp., 890 P.2d 881, 885-86 (Okla. 1994) (rejecting argument against extending comment k to medical devices; "[m]ost courts which have considered the question have found that Comment k applies to medical devices") (collecting cases).

Oregon: Coursen v. A.H. Robins, 764 F.2d 1329, 1337 (9th Cir. 1985) (applying comment k equally to medical devices), corrected, 773 F.2d 1049 (9th Cir. 1985); Allen v. G.D. Searle & Co., 708 F. Supp. 1142, 1148-49 (D. Or. 1989) (same).

Pennsylvania: Creazzo v. Medtronic, Inc., 903 A.2d 24, 30-31 (Pa. Super. 2006) ("We find no reason why the same [comment k] rationale applicable to prescription drugs may not be applied to medical devices"); Kee v. Zimmer, Inc., 871 F. Supp.2d 405, 409 (E.D. Pa. 2012) ("Numerous federal district courts, including this Court, have predicted that the Pennsylvania Supreme Court would, if faced with the issue, similarly extend comment k to prescription medical devices.") (collecting cases); Soufflas v. Zimmer, Inc., 474 F. Supp.2d 737, 749-50 (E.D. Pa. 2007) (same; rejecting attempt to distinguish medical devices).

South Carolina:  Brooks v. Medtronic, Inc., 750 F.2d 1227, 1230 (4th Cir. 1984) ("Certain products, particularly . . . medical devices, often cause unwanted side effects despite the fact that they have been carefully designed and properly manufactured.  In section 402A terminology, such products are deemed "unavoidably unsafe") (citing comment k); Correa v. Bon Secours St. Francis Xavier Hospital, Inc., 2013 WL 5925733, at *3 (S.C.C.P. April 26, 2013) (courts "appl[y] the unavoidably unsafe doctrine in a variety of medical contexts including prescription drugs, implantable medical devices, surgical tools, hospital equipment, and hand-held medical devices").

Tennessee:  Rodriguez v. Stryker Co., 680 F.3d 568, 575 (6th Cir. 2012) (affirming dismissal of strict liability claims against medical device under comment k); Harwell v. American Medical Systems, Inc., 803 F. Supp. 1287, 1300 (M.D. Tenn. 1992) (dismissing medical device strict liability claims under comment k; collecting medical device cases).

Utah:  In re Wright Medical Technology Inc. Conserve Hip Implant Products Liability Litigation, 127 F. Supp.3d 1306, 1357 (N.D. Ga. 2015) (applying Utah law) ("The Court concludes, notwithstanding Creech, that Utah state courts would recognize that Comment K's concern about ensuring that the social need for medical products is satisfied and would follow other jurisdictions and apply Comment K to prescribed medical devices that are implanted in the human body").

Washington:  Terhune v. A.H. Robins Co., 577 P.2d 975, 977-80 (Wash. 1978) (adopting comment k in medical device case; "The principles stated in comment k do not rest upon a finding or an assumption that all drugs, vaccines or other products obtainable only through a physician have been tested by the Food and Drug Administration"); Payne v. Paugh, 360 P.3d 39, 53 (Wash. App. 2015) ("an unavoidably unsafe product such as a medical device is incapable of being made completely safe"); Taylor v. Intuitive Surgical, Inc., 355 P.3d 309, 317 (Wash. App. 2015) ("The presence of the physician as learned intermediary places medical products in a class of their own, and justifies the "blanket exemption" of comment k; rejecting attempt to distinguish medical devices), review granted (Wash. Feb. 9, 2016); Transue v. Aesthetech Corp., 341 F.3d 911, 914-15 (9th Cir. 2003) ("comment k provides an exemption for medical products generally").

Strike three.

Only two cases we know of are to the contrary.  One of them, Creech v. Stryker Corp., 2012 WL 33360, at *5 n.6 (D. Utah Jan. 6, 2011), mentioned the issue only in a footnote, and its reasoning was found wanting in Wright Medical, cited above.  See also In re Wright Medical Technology Inc. Conserve Hip Implant Products Liability Litigation, ___ F. Supp.3d ___, 2016 WL 1367747, at *18 n.17 (N.D. Ga. April 5, 2016) (reiterating rejection of Creech concerning comment k) (applying Utah law).

The second decision, Larsen v. Pacesetter Systems., Inc., 837 P.2d 1273 (Haw. 1992), amended, 843 P.2d 144 (Haw. 1992), held that "we do not believe this [device] was sufficiently analogous to a new and experimental drug to warrant comment k exemption from strict products liability."  Id. at 1286.  While that can be read as a rejection of comment k to medical devices, it can also be read as specific to the particular device in question (most of the surrounding discussion involves pacemakers), and thus as being no more than an oddly phrased application of the case-by-case approach to comment k generally.  Certainly, the Hawaii case we blogged about last week, Segovia v. Bristol-Myers Squibb Co., 2016 WL 1587220 (D. Haw. April 19, 2016), treated Larsen as an exemplar of a case-by-case approach to comment k and applied the same rationale to a drug, id. at *4 – which was our major complaint about Segovia.  Id. at *4.  But even considering Larsen as an outright rejection of the application of comment k to medical devices, it remains an extreme outlier.

Larsen, moreover, was a state supreme court.  Whether we like it or not, a state supreme court has the inherent power (barring legislation) to interpret that state's common law in whatever fashion it desires.  Whether or not we agree with the result, we have no doubt of such a court's authority to reach it.  The same is not true of a federal district court.  As we have pointed out many times before, in the posts under our Erie Doctrine topic heading, a federal court sitting in diversity is not supposed to make novel predictions of state law that expand tort liability.  That violates the state sovereignty assured by our federal system.  This principle is as true in the Fourth Circuit as it is in any other federal circuit.