Thursday, January 12, 2012

That's A Spicy (Specious?) Footnote!

We recently read the pain pump decision, Creech v. Stryker Corp., 2012 WL 33360, at *5 n.6 (D. Utah Jan. 6, 2011).  Most of the opinion addresses pretty much mundane disputes on heavily fact-bound questions:  (1) whether the risk was scientifically knowable as of the date of this plaintiff’s injury, and (2) whether the prescriber’s treatment would have changed had an “adequate” warning been given.  Id. at *4-6.  On the facts, the court found triable issues of fact.  Id.

But sandwiched in between those arguments in Creech was a brief (2 paragraph) discussion of “strict liability.”  The opinion, without much discussion, again concluded that fact issues existed as to warning and design defects.  Id. at *5.  But then, almost casually, the court drops this footnote:

Despite [defendant’s] argument to the contrary, comment K offers no protection to [it]. In Grundberg v. Upjohn Co., the Utah Supreme Court ruled that comment K to section 402A provided protection to prescription drug manufacturers.  Grundberg v. Upjohn Co., 813 P.2d 89, (Utah 1991).  The court limited this ruling to design defect claims against prescription drug manufacturers.  Id. at 92, 95.  Utah law does not preclude strict liability design defect claims against medical product manufacturers.
2012 WL 33360, at *5 n.6.

Say what?  Comment k applies to drugs, but not medical devices?  Why?

No rationale – other than the Grundberg decision, which factually involved a drug, did not also mention “medical devices.”  (A bit of background – in Grundberg the Utah Supreme Court concluded as a matter of law that Restatement (2d) §402A, comment k applied “across the board” and barred assertion of any and all strict liability, design defect claims).

This footnote strikes us as frankly bizarre.  There’s practically no authority – and none at all in practically two decades – distinguishing among types of prescription medical products with respect to the applicability of comment k.  There’s certainly none under Utah law, and as a federal court, Creech was not supposed to make Erie predictions that expand liability under state law.  Taylor v. Phelan, 9 F.3d 882, 887 (10th Cir. 1993) (“[a]s a federal court, we are generally reticent to expand state law without clear guidance from its highest court”); Aclys International v. Equifax, 438 Fed. Appx. 689, 693 (10th Cir. 2011) (Phelan principle “ is especially true when a federal court is asked to make a policy laden choice for the State of Utah”); Northern Natural Gas Co. v. Nash Oil & Gas, Inc., 526 F.3d 626, 631 (10th Cir. 2008) (quoting and applying Phelan); Orr v. Brigham Young University, 108 F.3d 1388 (10th Cir. 1997) (“[a]s a federal court, we are reticent to expand state law in the absence of clear guidance from Utah's highest court, or at least a strong and well-reasoned trend among other courts which Utah might find persuasive, in favor of such expansion”).

So what law is there on whether comment k applies to anything other than the “prescription drugs” mentioned in Grundberg and in the comment itself?

Well, we can start with the comment itself.  After explaining that unavoidably unsafe products are “especially common in the field of drugs,” the comment gives an example:  “[a]n outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences.”

O-kay....  A vaccine isn’t a drug.  Technically it’s a “biologic” – a product consisting of large-molecule derivatives from living tissue, rather than the small molecules used to formulate drugs.

But then, the ALI wrote comment k in the early 1960s (§402A was adopted in 1965), and the concept of a "medical device" wasn't much developed.  Congress, for example, didn't give the FDA explicit authority over medical devices until 1976.

For purposes of this post, what’s important is the comment k doesn't address particular categories of products, but enunciates a principle:  that a lot of products “in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use.”  That’s why, for instance, prescription medical products are prescription-only in the first place.  They have inherent risks that laypeople aren’t qualified to evaluate.  Because of such risks, the FDA forces people to jump through the hoop of visiting a doctor before these products are made available to them.

With that in mind, we next look at Grundberg.  Is its rationale somehow limited to drugs, as opposed to devices?  Is there something beyond the FDA at work?

Doesn’t seem to be.  There’s simply no mention of medical devices at all, one way or the other.  As to comment k, the court first endorses and adopts its principles without reference to drugs – or to any other particular product:

Comment k, however, defines a category of “unavoidably unsafe” products that “when properly prepared, and accompanied by proper directions and warning, [are] not defective, nor ... unreasonably dangerous.”  (Emphasis in original.)  We agree with comment k’s basic proposition-that there are some products that have dangers associated with their use even though they are used as intended.  We also agree that the seller of such products, when the products are properly prepared and marketed and distributed with appropriate warnings, should not be held strictly liable for the “unfortunate consequences” attending their use.  Thus, we adopt comment k’s basic policy as the law to be applied in this state.
Grundberg v. Upjohn Co., 813 P.2d 89, 92 (Utah 1991).  Then the court goes on to reject making the comment k/unavoidably unsafe determination on a case-by-case basis with respect to the product before it – a prescription drug (Halcion).
  • “[W]e are troubled by the lack of uniformity and certainty inherent in the case-by-case approach and fear the resulting disincentive for pharmaceutical manufacturers to develop new products.”  Id. at 94-95.
  • “[A] defendant would have an easier time rebutting a plaintiff’s prima facie case of design defect under the traditional standard than meeting the tough burden of “earning” the comment k exemption.”  Id. at 95.
  • “We are persuaded that all prescription drugs should be classified as unavoidably dangerous in design because of their unique nature and value, the elaborate regulatory system overseen by the FDA, the difficulties of relying on individual lawsuits as a forum in which to review a prescription drug’s design, and the significant public policy considerations.”  Id.
  • “[Drugs] will almost always pose some risk of side effects in certain individuals.  Despite these risks, new drugs are continually approved by the FDA because of their social benefit in saving lives and alleviating human suffering.”  Id.
  • “The structured follow-up program imposed by law ensures that drugs are not placed on the market without continued monitoring for adverse consequences that would render the FDA’s initial risk/benefit analysis invalid.”  Id. at 97.
  • “The legislature has also acknowledged the important role of governmental standards in Utah Code Ann. section 78-15-6(3) . . . declar[ing] that there is a rebuttable presumption that a product which fully complies with the applicable government standards at the time of marketing is not defective.  Id. (footnote omitted).
  • “[I]f a manufacturer knows or should know of a risk associated with its product, it is directly liable to the patient if it fails to adequately warn the medical profession of that danger.”  Id.
  • “[W]e do not believe that a trial court in the context of a products liability action is the proper forum. . . .  Although the FDA may have internal differences of opinion . . ., the individuals making the ultimate judgment will have the benefit of years of experience in reviewing such products, scientific expertise in the area, and access to the volumes of data they can compel manufacturers to produce.  Nor is the FDA subject to the inherent limitations of the trial process.”  Id. at 98.
  • “In light of the strong public interest in the availability and affordability of prescription medications, the extensive regulatory system of the FDA, and the avenues of recovery still available to plaintiffs by claiming [non-design-related claims], we conclude that a broad grant of immunity from strict liability claims based on design defects should be extended to FDA-approved prescription drugs in Utah.  Id. at *99.

Looking at all these passages from Grundberg, we can’t see that it makes a difference whether the prescription-only product is a drug, a device, or a vaccine.  Devices, from pacemakers to pain pumps, save lives and alleviate suffering – even though they have inherent risks and don’t work perfectly all the time.  The drawbacks and uncertainties of a scattershot and unpredictable litigation and trial process are the identical, whether the defendant made a drug or a device.  The FDA’s expertise and adverse event reporting requirements likewise encompass both drugs and devices.  Identically, the statutory presumption for government compliant products applies to both devices and drugs.

Nope, we can’t find in Grundberg a single policy reason that medical devices shouldn’t enjoy the same comment k protections as prescription drugs .

Thus, with respect to determining whether products are unavoidably unsafe under comment k, we don't see any relevant difference between a drug and a device (or a vaccine).  If the product is restricted by the FDA to prescription-only status, that’s because it has significant inherent risks, which the Agency requires be stated in the product’s labeling (warning claims explicitly exist under comment k).  For that reason, comment k’s exception to design defect claims should apply equally to both prescription drugs and prescription medical devices – whether the jurisdiction chooses to use Grundberg’s across-the board approach, or adopts the competing case-by-case rationale that Grundberg rejected.  There’s no meaningful basis for distinguishing, as Creech did, simply between all drugs on one hand and all medical devices on the other.

Looking around, we find that this is indeed overwhelmingly how other courts in other jurisdictions have ruled.  Regardless of what comment k is held to mean (that is, across-the board vs. case-by-case), it applies in the same fashion and to the same extent in medical device cases as it does in cases involving prescription drugs.

The Connecticut Supreme Court held that medical devices share the same liability principles with prescription drugs in Hurley v. Heart Physicians, P.C., 898 A.2d 777 (Conn. 2006), having previously in a drug case “adopted comment (k) . . . [and] concluding that the policy considerations set forth therein are persuasive and in accord with this state's product liability jurisprudence.”  Id. at 784.  The court found no reason to differentiate between drugs and medical devices:
Numerous courts have determined that they are applicable to prescription medical device cases.  The parties have not pointed us to any case . . . and we can see no principled reason to distinguish between a prescription implantable medical device like a pacemaker and a prescription drug.

Id.  Accord Breen v. Synthes-Stratec, Inc., 947 A.2d 383, 386-88 (Conn. App. 2008) (“[i]n light of existing case law and the language of comment (k) itself, we conclude that the application of comment (k) is not limited to prescription drugs only”); Wegryn v. Smith & Nephew, Inc., 2008 WL 803405, at *2 (Conn. Super. March 5, 2008); Allen v. Mentor Corp., 2006 WL 861007, at *7 (D. Conn. March 31, 2006) (“[m]edical products properly prepared, and accompanied by proper directions and warning [are] not defective, nor . . . unreasonably dangerous” under comment k; breast implant case).

Similarly, the Oklahoma Supreme Court held, in Tansy v. Dacomed Corp.:

While products liability law seeks to protect the public from unreasonably dangerous products, Comment k seeks to protect another facet of the public’s interest-that of having available new products whose benefits are great enough as to justify associated risks.  It protects certain manufacturers who develop new products which at the time of manufacture are incapable of being made totally safe, and shields certain products by classifying them as “unavoidably unsafe” rather than as “defective.”  Public policy favors the development and marketing of new beneficial drugs and devices because they can save lives, reduce pain and improve the quality of life. . . .  Most courts which have considered the question have found that Comment k applies to medical devices, especially those which are implanted in the human body. . . .  Following the guidance of our prior case law as well as that of other jurisdictions, we hold that Comment k can apply to medical devices, particularly those which are implanted.

890 P.2d 881, 885-86 (Okla. 1994 (lots of citations omitted).  Accord McKee v. Moore, 648 P.2d 21, 23 (Okla. 1982) (comment k applies to IUD; it may be an “unavoidably unsafe” product, and thus not “defective”).

Likewise, the Washington Supreme Court held, in a Dalkon Shield IUD case:
While a sound public policy might indeed dictate that such testing be undertaken before any product to be used on the human body is released in commerce, a decision of that kind rests with the legislative body.  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.  Rather they have their basis in the character of the medical profession and the relationship which exists between the manufacturer, the physician and the patient.

Terhune v. A. H. Robins Co., 577 P.2d 975, 978 (Wash. 1978); see id. at 979 (lower court “quite properly held as a matter of law that the shield was not unreasonably dangerous or defective, as defined in comment k”).  Accord Transue v. Aesthetech Corp., 341 F.3d 911, 915 (9th Cir. 2003) (“comment k provides an exemption for medical products generally”) (applying Washington law); Adams v. Synthes Spine Co., 298 F.3d 1114, 1118 (9th Cir. 2002) (“comment k applied (which is to say that strict liability did not apply) to prescription medical products without any separate determination”) (applying Washington law).

The Illinois Supreme Court, in a case involving an x-ray machine, also invoked comment k principles:
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 . . . .  [W]e conclude that public policy dictates against the imposition of strict liability in tort for injuries resulting from the administration of X-radiation treatments.

Greenberg v. Michael Reese Hospital, 415 N.E.2d 390, 394-95 (Ill. 1980).  Accord Mele v. Howmedica, Inc., 808 N.E.2d 1026, 1041-42 (Ill. App. 2004) (“Comment k . . . provides further support for use of risk-benefit analysis for evaluating the danger of the medical device defendant made”).

In California – another state that, like Utah, applies comment k across the board, any general distinction between drugs and medical devices has been flatly rejected.  In Plenger v. Alza Corp., 13 Cal. Rptr.2d 811 (Cal. App. 1992), the court held:

[T]he exemption from strict liability for design defect for prescription drugs is based primarily, if not exclusively on public policy considerations.  It is not, as implicitly contended by plaintiffs, based on any inherent distinction between a drug and a device which makes design defect analysis unworkable with respect to prescription drugs. . . .  The question, therefore, is not whether the [product] is a prescription drug or a device but rather whether the policy considerations . . . should be applied.

Id. at 817.  Similarly, in Hufft v. Horowitz, 5 Cal. Rptr.2d 377 (Cal. App. 1992), the court held:

The differences . . . do not mandate rejection of the comment k standard. . . .  [T]he important considerations underlying [comment k] 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.

Id. at 383.  Accord Mitchell v. Acumed LLC, 2011 WL 2433038, at *4 (N.D. Cal. June 13, 2011) (“Plaintiff's argument to be wholly devoid of merit; Plaintiff makes no logical argument that [comment k precedent] should not cover the surgical screw at issue here”).

A similar result was reached here in Pennsylvania, which also applies an across-the board approach:

In applying comment k here . . . no significant distinction can be drawn between the device and the drug upon which the Supreme Court based its decision in Hahn [adopting comment k in a drug 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 rationale applicable to prescription drugs may not be applied to medical devices.

Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa. Super. 2006).  Both before and after Creazzo, Pennsylvania courts routinely applied comment k in medical device product liability cases – holding repeatedly that the same considerations applied to all prescription medical products.  See Horsmon v. Zimmer Holdings, Inc., 2011 WL 5509420, at *2 (W.D. Pa. Nov. 10, 2011) (comment k principles “extend[] to medical devices”); Esposito v. I-Flow Corp., 2011 WL 5041374, at *4 & n.4 (E.D. Pa. Oct. 24, 2011) (agreeing with Geesey); Geesey v. Stryker Corp., 2010 WL 3069630, at *4-5 (E.D. Pa. Aug. 4, 2010) (“the Pennsylvania Supreme Court would apply comment k to medical devices”); Delaney v. Stryker Orthopaedics, 2009 WL 564243, at *6 (D.N.J. March 5, 2009) (comment k “has been extended to medical devices”) (applying Pennsylvania law); Soufflas v. Zimmer, Inc., 474 F. Supp.2d 737, 749-50 (E.D. Pa. 2007) (“predicting . . . 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, 746-748 (W.D. Pa. 2004) (“the court agrees . . . that 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, 441-442 (E.D. Pa. 2004) (“[c]omment 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) (“medical devices present[] the same or very similar risks and benefits” as prescription drugs, so comment k applies); 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) (comment k applies to medical devices because they present the same “unique set of risks and benefits” as prescription drugs in that “what may be harmful to one patient may be beneficial to another”); 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”), aff’d mem., 860 A.2d 1142 (Pa. Super. 2004); Ford v. McGhan Medical Corp., 142 Pitts. Leg. J. 201, 214 (Pa. C.P. Allegheny Co. 1994).

Other cases applying comment k equally to medical devices:

Adams v. G.D. Searle & Co., 576 So.2d 728, 731-33 (Fla. App. 1991) (IUD case; applying comment k on case-by-case basis); Burwell v. American Edwards Laboratories, 574 N.E.2d 1094, 1098 (Ohio App. 1989) (heart valve case; comment k is “the standard to be applied in cases involving unavoidably unsafe products”); Perfetti v. McGahn Medical, 662 P.2d 646, 649-50 (N.M. App. 1983) (IUD case; “the trial court properly instructed concerning unavoidably unsafe products”); Racer v. Utterman, 629 S.W.2d 387, 395 (Mo. App. 1981) (surgical drape case; Restatement “afford[s] protection to products of this nature whose value is recognized and whose dangers are not only unknown but incapable of determination”); Bravman v. Baxter Healthcare Corp., 984 F.2d 71, 75-76 (2d Cir. 1993) (medical device “may be treated . . . as an unavoidably unsafe product” under comment k cases involving drugs) (applying New York law); Coursen v. A.H. Robins, 764 F.2d 1329, 1337 (9th Cir. 1985) (“If the prerequisites to establish a Comment k defense are met, the defense applies to Dalkon Shield cases”) (applying Oregon law); Brooks v. Medtronic, Inc., 750 F.2d 1227, 1230 (4th Cir. 1984) (“products, particularly ethical drugs and 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’,”) (applying South Carolina law); 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”); 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”); Clark v. Danek Medical, Inc., 1999 WL 613316, at *4 (W.D. Ky. March 29, 1999) (the “implant is the sort of desirable but unavoidably unsafe product described by . . . comment k); Harwell v. American Medical Systems, Inc., 803 F. Supp. 1287, 1300 (M.D. Tenn. 1992) (“Several courts have applied Comment k to prescription medical devices. . . .  Under Comment k, the manufacturer of an unavoidably unsafe product is not liable for injuries arising from the product, if the manufacturer properly designed and manufactured the drug or device and provided adequate warnings”); Duncan v. Iolab Corp., 1991 WL 544617, at *1 (M.D. Fla. Nov. 18, 1991), aff’d mem., 12 F.3d 194 (11th Cir. 1994); Allen v. G.D. Searle & Co., 708 F. Supp. 1142, 1148-1149 (D. Or. 1989) (IUD case, applying comment k).

Thus, in summation:  (1) comment k itself does not distinguish between prescription drugs and medical devices; (2) all the policy arguments in Grundberg for adoption of comment k apply analogously to medical devices; and (3) scores of courts across the country recognize that all prescription medical products are equally subject to comment k – regardless of how they interpret the comment itself.  There is, in short, no legal basis whatsoever for the peculiar footnote in Creech v. Stryker.