Photo of Michelle Yeary

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 (unpublished, in table at 180 F.3d 261); Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1273-74 (5th Cir. 1974) (applying unavoidably unsafe standard without individualized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

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:

Defendants have cited no cases applying comment k to an over-the-counter drug; the cases cited all apply it only to prescription drugs. Comment k itself refers to drugs, “many of which … cannot be legally sold except to physicians, or under the prescription of a physician.” Restatement (Second) of Torts § 402A cmt. k. The court will not take a leap not taken by Texas courts and apply this exception to an over-the-counter drug, even if at one time ibuprofen was a prescription drug. At the time Decedent took the drug it was not.

682 F. Supp.2d at 679 (emphasis added).

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. The Texas rule applying comment k across the board has been applied, for example, in the case of prescription biologics. Massa v. Genentech Inc., 2012 WL 956192, at *5 (S.D. Tex. March 19, 2012). Biologics – requiring a prescription – are a lot closer to prescription medical devices, than the non-prescription OTC drug in Lofton, as Lofton’s own analysis demonstrates. 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”:

Only if the product is determined not “unreasonably dangerous per se” does the analysis proceed to the “unreasonably dangerous as marketed” inquiry, at which point Comment k becomes applicable. Because the prerequisite “unreasonable dangerous” determination involves weighing of evidence, consideration of the applicability of Comment k’s bar to Plaintiff’s strict liability design defect claim is not appropriate in a motion to dismiss.

Id. (citations omitted).

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:

§6 Liability of Commercial Seller or Distributor for Harm Caused by Defective Prescription Drugs and Medical Devices

(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.

Restatement (Third) of Torts, Products Liability §6(a) (1998) (emphasis added). As we discussed in our “What’s Up With the Third Restatement” post, the Texas Supreme Court was an early adopter of the Third Restatement generally. See Hernandez v. Tokai Corp., 2 S.W.3d 251, 257-58 (Tex. 1999); General Motors Corp. v. Sanchez, 997 S.W.2d 584, 592 (Tex. 1999); Hyundai Motor Co. v. Rodriguez, 995 S.W.2d 661, 666-67 (Tex. 1999); Uniroyal Goodrich Tire Co. v. Martinez, 977 S.W.2d 328, 335 (Tex. 1998). Since that 2010 post, we can add a direct citation to §6. See Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 157, 159 (Tex. 2012) (citing §6; also citing comment b).

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:

Appellants also contend, correctly, that Texas courts have applied the doctrine only to prescription drugs and not to medical devices. Importantly, however, the doctrine has not been rejected by a Texas court under these circumstances. Furthermore, other jurisdictions have applied the doctrine in failure to warn cases involving [the same medical device]. In addition, other jurisdictions have approved the doctrine’s application in cases involving other medical devices. . . . Certainly, in the context of [this device], there is a patient-physician relationship, as is necessary to apply the doctrine. The evidence establishes the implanting physicians were integrally involved in determining which implants to use, as appellants relied on them to choose the appropriate implant and give them information regarding the surgery and the product. Further, the doctors were clearly in a better position than the patient to weigh the benefits of the implant against the harm they posed, if any. In addition, we see no basis for distinguishing [medical devices] from prescription drugs for purposes of applying the doctrine; in both instances, the product is manufactured for administration only by a physician or other authorized person.

Id. at 663 (many citations omitted) (emphasis added). For other Texas (and other states’) cases applying the learned intermediary rule to prescription medical devices, see our post here.

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:

This section does not apply to: . . . (2) a drug or device, as those terms are defined in the federal Food, Drug, and Cosmetic Act.

Id. §82.005(d)(2) (emphasis added). Rather, “with respect to any product which is not subject to this section, the “common law,” as “develop[ed]” by the courts, applies. Id. §82.005(e). Thus, the Texas tort reform statute, like the Third Restatement, expressly treats prescription drugs and medical devices identically with respect to design defect claims. That the legislature chose to treat prescription drugs and prescription medical products in the same fashion is also a strong indication of what Texas law is.

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:

[D]octors have a legal duty to pass prescription drug warnings on to their patients. And as 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. See Restatement (Second) of Torts § 402A cmt. k.

372 S.W.3d 140, 165 (other citation omitted). Whatever might be the ultimate outcome of the design defect debate in Texas (§6(c) or §402A, comment k), it looks to us that – contrary to Jenkins – the same standard will apply to all prescription products. There is simply no Texas law, from any Texas court, to the contrary.

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.

[O]ur role in the exercise of our diversity jurisdiction is limited. A federal court acting under its diversity jurisdiction should respond conservatively when asked to discern governing principles of state law. Therefore, in a diversity case, a federal court should not interpret state law in a manner that may appear desirable to the federal court, but has not been approved by the state whose law is at issue. Mindful of this principle, we decline the plaintiffs’ invitation to predict that the [relevant state high court] would adopt the specific provisions of the Restatement advanced by the plaintiffs.

Rhodes v. E.I. du Pont de Nemours & Co., 636 F.3d 88, 96 (4th Cir. 2011) (citing Day & Zimmermann, Inc. v. Challoner, 423 U.S. 3, 4 (1975)).

For all of these reasons, we respectfully dissent from the result in Jenkins. We know of no basis for predicting that the Texas Supreme Court would apply Restatement §402A, comment k any differently to prescription medical devices than Texas courts have routinely applied it to prescription drugs over the past four decades.