Friday, April 29, 2011

A Good Idea (Really) From New Jersey

The theme of this week's PLAC ("Product Liability Advisory Council") Spring Meeting is social media and its impact on product liability litigation.  That's given us some ideas for posts down the line, but one of the presentations was about what to do (if there's anything that really can be done about jurors who use social media, or the Internet generally) after they've been sworn in as jurors during the course of the trial.  Such juror (mis)conduct runs the gamut from using the Internet for independent research - independent juror research being a long-time no-no that the Internet makes so much easier to do - to tweeting, blogging, etc. about the case, or even their own vote or deliberation

Stories about jurors doing this sort of thing are quite common these days.  Sometimes it's a matter of jurors simply taking their online habits for granted and not realizing there's anything "wrong" with telling all their Facebook friends about this latest activity.  Other times it's a juror who's bound ang determined that s/he's not going to let lawyers and judges keep him/her in the dark about what really happened.  The latter mindset probably should not have been let on the jury in the first place, but jury selection is fundamentally an art, not an exact science.

Courts have been struggling with how to deal with this, and one obvious approach (short of confiscating devices or sequestering the jury in an unwired facility) is our old friend the jury instruction.  Anyway, one of the PLAC presentations was on the various jury instructions that courts have used to tell jurors that they shouldn't google the lawyers, check out internet maps of the scene, tweet about what the jury's doing, or put the case up for a vote on Facebook.  The best one we saw was a proposed civil instruction on the Internet that's scheduled to go into effect in New Jersey next month.  Here's a copy of it as it appears on the New Jersey courts' website for this sort of thing.  We like this one best because, not only does it tell jurors that they're not supposed to google, blog, tweet, etc., but it explains to them why internet self-help and social media is considered inconsistent with a juror's function.

Juror use of the internet and other social media creates problems for the jury system and for both plaintiffs and defendants in all sorts of cases, not just product liability.  Not only does it implicate the deliberative process, but it costs time, money, and finality, as it becomes yet another tactical weapon for lawyers to use when they don't like a verdict.  Addressing it is something about which most judges would welcome bright ideas from both sides.  So we're happy to offer the New Jersey proposed standard instruction as something of a "best practice" that other courts might want to emulate.

Thursday, April 28, 2011

Comment K, Some of the Way

By now Restatement (Second) of Torts §402A (1965) is so old as to be thought of as somewhat antediluvian.  The American Law Institute’s unfortunate adoption of “strict liability” (sufficiently unfortunate, the ALI has done away with it except for manufacturing defect) missed a lot of product liability issues – the learned intermediary rule for one – that have become extremely widespread and important in product liability over the last 45 years.  To rectify this situation, and deal with all the issues unanticipated in 1965, the ALI in 1997 adopted what amounts to a book in and of itself:  the Restatement (Third) of Torts, Products Liability.

One place where the ALI was prescient in 1965 was in recognizing that some products had inherent risks that, no matter what, could not be designed away.  Such products, the ALI recognized, were “especially common” in the context of prescription drugs:

There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. . . .  Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.  The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. . . .  The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.
Restatement (Second) of Torts §402A, comment k (1965) (emphasis added).

Comment k thus says a lot of things.  Prescription medical products – those “which for this very reason [that is, because they are “quite incapable of being made safe”] cannot legally be sold except . . . under the prescription of a physician” – aren’t “defective” unless there’s something wrong with their “preparation” or “warnings.”  Thus, the unavoidably unsafe concept is inherently incompatible with the concept of design defect because no matter what their design they are “incapable of being made safe.”

Then there’s the question of scope.  Comment k says unavoidably unsafe products are “especially common” in the context of prescription medical products (actually, it says “drugs” but “medical devices” weren’t recognized as a separate category of products in the early 1960s – the Medical Device Amendments still being more than a decade in the future).  So there’s the question of whether all prescription drugs are unavoidably unsafe, or only some of them.  If only some, then there’s the additional question of how much effort the legal system should expend, or force the parties to expend, in sorting one from the other.

We thought we’d explore that question today, and we start by comparing arguably the most pro-plaintiff state in the country – Idaho – on comment k issues with the most pro-defense state – California.  Obviously, if we’re calling California conservative and Idaho liberal, then the issues associated with comment k don’t fit well into the usual legal cubby holes.

Idaho, then – holding our noses all the way.  In Toner v. Lederle Laboratories, 732 P.2d 297 (Idaho 1987), a vaccine case, the state’s highest court answered some certified questions from a federal court of appeals.

As an aside, we have serious qualms about the psychology of certified questions.  They often come without much of a record, and thus seem more like an academic exercise than a real case.  For that reason, we think that certified questions tend to tempt courts into more liability-expanding rulings than might occur with a fuller record and messy facts.  But again, it might just be our admittedly pro-defense perspective.

Anyway, back to Toner.  One important thing to note is that it was a vaccine case, not a drug case.  Usually that’s a good thing – because it’s hard to come up with a product that has provided more benefit to the human race than vaccines – but not this time.  That’s because a vaccine isn’t a simple chemical compound, like most drugs, but rather a complex biologic made up of a lot of things.  As a result, the plaintiff was able to offer a plausible alternative design (albeit one not approved by the FDA). 732 P.2d at 300-01.

The Idaho court first considered comment k as a defense to a strict liability cause of action under §402A, and in particular design defect claims:

By its terms, comment k excepts unavoidably unsafe products from strict liability only where the plaintiff alleges a design defect, and not where the plaintiff alleges a manufacturing flaw or an inadequate warning.  Comment k intends to shield from strict liability products which cannot be designed more safely; however, if such products are mismanufactured or unaccompanied by adequate warnings, then the seller may be liable.
Toner, 732 P.2d at 305 (footnote omitted).  Going beyond the terms of comment k, the Idaho court next decreed that “a seller next must establish that the product’s risk is in fact ‘unavoidable.’”  Id. at 305-06. Why not the plaintiff having to establish that an alleged risk is avoidable?  Dunno.  In any event, Toner made comment k into something of an affirmative defense.  Having done that, Toner went on to hold that absence of a feasible alternative design was at the core of comment k:

As an additional element of an “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. If there were, then the risk would not be “unavoidable” or “apparently reasonable.”
Id. at 306 (citation omitted).  Thus, it's even odder that the burden is placed on the defendant, since in most states, and certainly in the Third Restatement, an alternative design is an essential element of a design-related cause of action.

Then the court really veered off.  Even where a product’s risks were unavoidable, it required an independent balancing of risks and benefits – the kind of thing the FDA does – before the risks involved would be considered “apparently reasonable.”  Not only that, but the balance must “clearly tip”:

[T]he comment contemplates a weighing of the benefit of the product against its risk. Obviously, for comment k to apply, the benefit must outweigh the risk. This weighing process should consider the value of the benefit, the seriousness of the risk, and the likelihood of both. . . . Consequently, the scales must clearly tip in favor of the benefits for comment k to apply.
Toner, 732 P.2d at 306.  At least the state of the art at the time of the plaintiff’s use applies – unknown and later discovered risks are irrelevant.  Id. at 307 (“strict liability will not attach when an unexpected and unknown risk injures a user”).

But the worst part of Toner is the uncertainty of a case-by-case approach.  Each case involves the reweighing of risks and benefits in light of “new information” or a “new . . . safer design.”  Id.  Thus “[w]e do not believe comment k was intended to provide nor should it provide all ethical drugs with blanket immunity from strict liability design defect claims.”  Id. at 308.  Rather, “[c]ourts must decide the applicability of comment k case-by-case, and only after taking evidence related to the various factors.”  Id. at 309.  Such a determination “would require a full evidentiary hearing” – although by a court or a jury the court did not decide.  Id. at 308 & n.9.  Thus, the Toner decision consistently seems to go out of its way to make the comment k defense as costly and time consuming as possible.

As for negligence, while the Toner court held that comment k did not “literally” apply (it being a comment to strict liability), the same general principles were the same in negligence law:

In a general sense, however, the comment k concerns and its required balancing between risks and benefits are similar to those involved in a negligence claim. . . .  [T]he determination under comment k that the design of a product is unavoidably unsafe and yet affords benefits outweighing its risks varies little from the determination under negligence law that the designing and marketing of the product was reasonably done. . . .  We conclude that the principles of comment k do not literally apply to negligence claims . . . [but] in a general sense, the principles of comment k relate to the negligence concepts.
Toner, 732 P.2d at 310-11 (various citations omitted).

Toner relied heavily on then-California law, as decided by intermediate California courts, especially Kearl v. Lederle Laboratories, 218 Cal. Rptr. 453 (Cal. App. 1985).  Toner, 732 P.2d at 305-11 (citing Kearl seventeen times, as well as three other California cases).  But when the California Supreme Court took a look at Kearl and the case-by-case approach to comment k, the court recoiled.  Brown v. Superior Court, 751 P.2d 470, 477 (Cal. 1988) (specifically "disapprov[ing]" Kearl).

Instead, Brown viewed Restatement §402A, comment k as precluding strict liability design claims against all prescription drugs.  “The comment provides that the producer of a properly manufactured prescription drug may be held liable for injuries caused by the product only if it was not accompanied by a warning of dangers that the manufacturer knew or should have known about."  751 P.2d at 745.  Comment k was a negligence principle engrafted into strict liability:

[T]here is a general consensus that, although it [comment k] purports to explain the strict liability doctrine, in fact the principle it states is based on negligence. . . .  That is, comment k would impose liability on a drug manufacturer only if it failed to warn of a defect of which it either knew or should have known.  This concept focuses not on a deficiency in the product – the hallmark of strict liability – but on the fault of the producer in failing to warn of dangers inherent in the use of its product that were either known or knowable.
Id. at 475-76 (citations omitted).  Brown chose between three options:  (1) rejecting comment k and allowing strict liability design defect claims generally against prescription drugs; (2) construing comment k to prohibit design defect claims across the board because the prescription-only status of a drug meant it was unavoidably unsafe; or (3) the Kearl/Toner case-by-case approach requiring a unavoidably unsafe determination in every case.  Id. at 477.

Brown chose the approach that all prescription drugs were unavoidably unsafe.  Prescription drugs didn’t ordinarily have alternative feasible designs:

[A] test, which calls for the balancing of risks and benefits, is inapposite to prescription drugs, according to defendants, because it contemplates that a safer alternative design is feasible.  While . . . mechanical devices might be “redesigned” by the addition of safety devices, there is no possibility for an alternative design for a drug like DES, which is a scientific constant compounded in accordance with a required formula.  We agree with defendants. . . .
751 P.2d at 478.  Also the societal benefits from the development of prescription drugs were such that a constant rebalancing of risks and benefits through litigation was a bad idea:

[U]nlike other important medical products (wheelchairs, for example), harm to some users from prescription drugs is unavoidable.  Because of these distinctions, the broader public interest in the availability of drugs at an affordable price must be considered in deciding the appropriate standard of liability for injuries resulting from their use.  Perhaps a drug might be made safer if it was withheld from the market until scientific skill and knowledge advanced to the point at which additional dangerous side effects would be revealed.  But in most cases such a delay in marketing new drugs . . . would not serve the public welfare.  Public policy favors the development and marketing of beneficial new drugs, even though some risks, perhaps serious ones, might accompany their introduction, because drugs can save lives and reduce pain and suffering.
Id. at 478-78.

Like Toner, Brown also rejected the notion of liability for unknown and unknowable risks – even in the context of failure to warn (Brown, a real case with a full record, involved a wider array of issues than Toner):

[W]e reject plaintiff's assertion that a drug manufacturer should be held strictly liable for failure to warn of risks inherent in a drug even though it neither knew nor could have known by the application of scientific knowledge available at the time of distribution that the drug could produce the undesirable side effects suffered by the plaintiff.
751 P.2d at 480.

The Kearl test, which the Idaho Supreme Court found so attractive in Toner, was also evaluated and found wanting in Brown.  It was wildly expensive to redetermine risk-benefit anew in every case:

[W]e know of no means by which this can be accomplished without substantially impairing the public interest in the development and marketing of new drugs, because the harm to this interest arises in the very process of attempting to make the distinction.
751 P.2d at 481; see id. at 482 (“attendant litigation costs” include “two risk/benefit challenges,” one by a judge and a second by a jury).  Constant re-evaluation also engendered pervasive uncertainty:

[D]ifferent trial judges might reach different conclusions as to whether the same drug should be measured by strict liability principles, because the determination in each case depends on the evidence as well as the subjective determination of the judge regarding such matters as what constitutes an “exceptionally important benefit” of a drug.
Id. at 482.  Finally, by requiring consideration of “alternative products” when “alternative designs’ were not available, the case-by-case approach allowed liability on the basis of unpredictable future events:

A manufacturer . . . might be held strictly liable for harmful side effects because a trial court could decide, perhaps many years later, that in fact another product which was available on the market would have accomplished the same result.  Further, the question of the superiority of one drug over another would have to be decided . . . in reference to the plaintiff, since the advantages of a drug cannot be isolated from the condition of a particular patient.  Thus, in one case the drug that injured the plaintiff might be the better choice, while this would not be true as to another user.

Thus, the court in Brown broadly rejected design-based liability in the field of prescription drugs, in the absence of manufacturing (drug must be “properly prepared”) or warning defects involving “dangerous propensities that were either known or reasonably scientifically knowable at the time.”  Id. at 483.

Toner and Brown thus, for the most part (except on the issue of state of the art, where both reject liability for unknowable future developments), represent broadly divergent approaches to the unavoidably unsafe product principle expressed in Restatement §402A, comment k.  Recently this divergence led the Supreme Court in Bruesewitz v. Wyeth LLC, 131 S. Ct. 1068 (2011), to shie away from the issue altogether:
Comment k exempts from this strict-liability rule “unavoidably unsafe products.”  An unavoidably unsafe product is defined by a hodge-podge of criteria and a few examples. . . .  Despite this lack of clarity, petitioners seize upon one phrase in the comment k analysis, and assert that by 1986 a majority of courts had made this a sine qua non requirement for an “unavoidably unsafe product”:  a case-specific showing that the product was “quite incapable of being made safer for [its] intended ... use."
Bruesewitz, 131 S. Ct. at 1077.  The Court also noted that “a large number of courts disagreed with that reading of comment k, and took it to say that manufacturers did not face strict liability for side effects of properly manufactured prescription drugs that were accompanied by adequate warnings.”  Id. at 1077 n.41 (collecting cases).

Boldly going where the Supreme Court refused to tread, we thought we’d take a brief look at where the other states fell between these poles.


Alabama applies comment k to all prescription drugs.  Stone v. Smith, Kline & French Laboratories, 447 So.2d 1301, 1303 (Ala. 1984) (“[c]omment k provides for drugs and vaccines an exception to the strict liability defined in Section 402A”); see id. at 1304 (“in the case of an ‘unavoidably unsafe’ yet properly prepared prescription drug, the adequacy of the accompanying warning determines whether the drug, as marketed, is defective, or unreasonably dangerous”).  Beyond that, Alabama has a somewhat peculiar Alabama Extended Manufacturers Liability Doctrine (“AEMLD”) that has sometimes (but sometimes not) been interpreted as eliminating altogether a separate negligence claim for design defects – that is, not limited to prescription drugs.  Wakeland v. Brown & Williamson Tobacco Corp., 996 F. Supp. 1213, 1217-18 (S.D. Ala. 1998) (“no separate action for negligence will lie when a plaintiff claims he is injured by a defective and unreasonably dangerous product [as, under AEMLD,] the strict liability and negligence claims merge”); Veal v. Teleflex, Inc., 586 So.2d 188, 191 (Ala. 1991) (“the fault or negligence of the defendant is that he conducted himself in a negligent manner by placing a product on the market causing personal injury or property damage, when used to its intended purpose . . . This is a claim under the AEMLD, and the trial court did not err in refusing to charge the jury with regard to negligence and wantonness”).  However; that’s probably not so any longer.

Alabama remains a common-law state, and therefore common-law tort actions so far as [they are] not inconsistent with the Constitution, laws and institutions of this state shall continue in force, except as from time to time may be altered or repealed by the Legislature.  We will not presume to so define the boundaries of the judicially created AEMLD so that it subsumes the common-law tort actions of negligence and wantonness against the retailer defendants.
Tillman v. R.J. Reynolds Tobacco Co., 871 So.2d 28, 34-35 (Ala. 2003) (citations and quotation marks omitted).


Alaska rejected comment k in Shanks v. Upjohn Co., 835 P.2d 1189, 1197-98 (Alaska 1992).  However, the net result in Shanks is admittedly similar to the case-by-case approach to comment k:

We recognize that . . . we are taking a position similar to those jurisdictions which apply comment k to prescription drugs on a case-by-case basis.  However, we arrive at this result without specifically relying on comment k.
Id. at 1198.


Long ago, an Arizona intermediate court followed the case-by-case approach to comment k:

We interpret comment K to mean that for experimental drugs, the manufacturer must clearly advise that the drug is experimental, and must warn of known risks and those risks that should be known through the exercise of reasonable care.  In the case of prescription drugs (and especially for investigational drugs, which can be prescribed only by selected physician investigators) the manufacturer’s duty to warn is ordinarily satisfied if a proper warning is given to the prescribing physician.
Gaston v. Hunter, 588 P.2d 326, 340 (Ariz. App. 1978).

More recent Arizona federal precedent has followed Restatement (Third) of Torts, Products Liability §6(c) (1998), which allows a design defect claim only in the very limited circumstance where no doctor would prescribe a drug or device to any class of patients.  Harrison v. Howmedica Osteonics Corp., 2008 WL 906585, at *21 (D. Ariz. March 31, 2008); Gebhardt v. Mentor Corp., 191 F.R.D. 180, 185-86 (D. Ariz. 1999), aff’d, 15 Fed. Appx. 540 (9th Cir. 2001);


Arkansas is a case-by-case jurisdiction.  Comment k is considered an affirmative defense, and for the unavoidably unsafe product defense to apply:

there must be no feasible alternative design which accomplishes the product’s purpose at lesser risk. The evaluation of a purported alternative design and the product’s actual design should focus on: (1) the magnitude of the product’s risk that the alternative avoids; (2) the costs of the two designs; (3) the benefits of the two designs; and (4) the relative safety of the two designs.
In addition, for the [defense] to protect the designer of the product, the benefit of the product must outweigh the risk.  This weighing process must consider the value of the benefit, the seriousness of the risk, and the likelihood of both.  However, in the weighing process it should be remembered that [the defense] only requires that the balance ‘apparently’ tip toward the benefit of a product at the time of distribution.
West v. Searle & Co., 806 S.W.2d 608, 612-13 (Ark. 1991).  See Hill v. Searle Laboratories, a Division of Searle Pharmaceuticals, Inc., 884 F.2d 1064, 1067-68 (8th Cir. 1989) (same; also noting that comment k applies to statutory product liability that subsumes both negligence and strict liability); Bearden v. Wyeth, 482 F. Supp.2d 614, 618 n.5 (E.D. Pa. 2006) (Arkansas “applie[s] comment k to design claims-not manufacturing or warning claims – and only as “an affirmative defense requiring proof that the drug product is indeed unavoidably dangerous”) (applying Arkansas law).


As we’ve already described, California is the poster child for across-the-board application of comment k and the unavoidably unsafe product doctrine.  In addition to Brown, seeCarlin v. Superior Court, 920 P.2d 1347, 1358 (Cal. 1996) (“comment k reflects a recognition that imposing strict iability on manufacturers of prescription drugs would harm the public interest by discouraging the development and availability of medications”); Carmichael v. Reitz, 95 Cal. Rptr. 381, 400 (Cal. App. 1971) (“[i]f the vendor has properly prepared the product and has accompanied its sale with proper directions and warnings, he will not be held to strict liability”).  There is some goofy dictum, contrary to Brown’s policy-based rationale, suggesting that California might somehow recognize some sort of negligent design defect theory in Artiglio v. Superior Court, 27 Cal. Rptr.2d 589, 591 (Cal. App. 1994) (“Liability for defective design could not be premised on strict liability, but would require proof of negligence”).


Colorado follows a case-by-case approach to whether prescription medical products are unavoidably unsafe, based on a four-part test:

The product’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.
Ortho Pharmaceutical Corp. v. Heath, 722 P.2d 410, 415 (Colo. 1986) (quoting Belle Bonfils Memorial Blood Bank v. Hansen, 665 P.2d 118, 122 (Colo. 1983)). Where there is evidence, albeit conflicting, on each of these points, a jury question is created and the defendant is entitled to a comment k jury instruction.  Id. at 416.  See Hawkinson v. A.H. Robins Co., 595 F. Supp. 1290, 1308 (D. Colo. 1984) (“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”).


Connecticut has never required an individualized assessment of whether a particular drug qualifies for the unavoidably unsafe product rule and comment k.  Hurley v. The Heart Physicians, P.C., 898 A.2d 777, 783 (Conn. 2006) (“[a] manufacturer of an unavoidably unsafe product can avoid strict liability if the product is properly prepared, and accompanied by proper directions and warning”); Vitanza v. Upjohn Co., 778 A.2d 829, 837 (Conn. 2001) (“the policy considerations contained in comment (k) to §402A are persuasive and are in accord with this state's product liability jurisprudence”); Basko v. Sterling Drug, Inc., 416 F.2d 417, 426 (2d Cir. 1969) (“there is no strict liability under comment k unless the consumer first establishes a breach of the manufacturer’s duty to warn”); Goodson v. Searle Laboratories, 471 F. Supp. 546, 548 (D. Conn. 1978) (under comment k “such a [prescription] drug is neither ‘defective’ nor ‘unreasonably dangerous' in the §402A sense if the manufacturer gives an adequate warning of the risks involved").


There’s nothing in Delaware law one way or the other about Restatement (Second) of Torts §402A, comment k (1965).

District of Columbia

Federal courts applying D.C. law have not required case-by-case adjudication of the unavoidably unsafe/comment k issue.  Dyson v. Winfield, 113 F. Supp. 2d 35, 39-40 (D.D.C. 2000) (summary judgment against “design defect count” because “[c]omment k’s association with strict liability may be misleading.  As one court has noted, ‘[m]ost jurisdictions . . . rely on Comment k as authority for applying what is effectively a negligence standard’”), aff’d, 21 Fed. Appx. 2 (D.C. Cir. 2001); Chambers v. G.D. Searle & Co., 441 F. Supp. 377, 380-81 (D. Md. 1975) (“[c]omment (k) is pertinent in this case both as to plaintiff’s claim based on strict liability and to plaintiff’s claim based on negligence” and “as long as proper warnings are given, the manufacturer cannot be held responsible for an illness such as resulted here”) (applying District of Columbia law), aff’d per curiam, 567 F.2d 269 (4th Cir. 1977).


Florida law is somewhat inconsistent.  No individualized application of the unavoidably unsafe principle was required in Buckner v. Allergan Pharmaceuticals, Inc., 400 So.2d 820, 823 (Fla. App. 1981).  However, several more recent cases have followed a case-by-case approach.  Adams v. G.D. Searle & Co., 576 So.2d 728, 733 (Fla. App. 1991) (“Comment k protects manufacturers from strict liability only for design defects”; “a product which is not as safe as current technology can make it should not be protected”); Zanzuri v. G.D. Searle & Co., 748 F. Supp 1511, 1520 (S.D. Fla. 1990) (adopting case-by-case approach based on the drug in question being “(1) incapable of being made safe; (2) properly prepared and marketed; and, (3) accompanied by a proper warning”); Amore v. G.D. Searle & Co., 748 F. Supp. 845, 854 (S.D. Fla. 1990) (same; identical opinion).


There’s conflicting precedent in Georgia, but the case-by-case approach has the advantage.  An intermediate Georgia appellate court has required individualized assessment.  Bryant v. Hoffmann-La Roche, Inc., 585 S.E.2d 723, 728 (Ga. App. 2003) (adopting “balancing test for unavoidably unsafe analysis and “agree[ing] with the majority of courts that Comment k serves as an affirmative defense and that the defense has no application to claims of manufacturing defect or failure to warn”).  By contrast, a federal district court applied comment k without individual balancing.  Walker v. Merck & Co., 648 F. Supp. 931, 933 (M.D. Ga. 1986) (in a “products liability suit, involving what may be categorized as an ‘inherently dangerous’ or ‘unavoidably unsafe’ drug, the manufacturer’s duty is to properly prepare and properly market the drug, and to adequately warn about all inherent risks”), aff’d without op., 831 F.2d 1069 (11th Cir. 1987).


Hawaii is a case-by-case state for comment k.  Larsen v. Pacesetter Systems, Inc., 837 P.2d 1273, 1286 (Haw. 1992) (applying aspects of comment k specifically to product at issue), amended, 843 P.2d 144 (1992).


Idaho is the epitome of the strict case-by-case approach.  See Toner, discussed above.  There's no law since.


Illinois follows comment k, Lawson v. G. D. Searle & Co., 356 N.E.2d 779, 783 (Ill. 1976).  Both Illinois intermediate appellate courts and federal courts applying Illinois law have adopted a case-by-case approach.  Mele v. Howmedica, Inc., 808 N.E.2d 1026, 1042 (Ill. App. 2004 (individualized product information held admissible as relevant to comment k defense); Glassman v. Wyeth Laboratories, 606 N.E.2d 338, 342 (Ill. App. 1992) (“not all prescription drugs per se fall under comment k, and comment k’s applicability must be decided on a case by case basis”); Kunnemann v. Janssen Pharmaceutica Products, L.P., 2008 WL 5101116, at *13 (N.D. Ill. Dec. 2, 2008) (“not all drugs fall within the purview of comment k; rather, the application of comment k must be decided on a case-by-case basis”); Woodbury v. Janssen Pharmaceutica, Inc., 1997 WL 201571, at *5-6 (N.D. Ill. April 10, 1997) (quoting Glassman); Martinkovic v. Wyeth Laboratories, Inc., 669 F. Supp. 212, 216-17 (N.D. Ill. 1987) (“[a]s a precondition to pursuing a comment k defense, however, [defendant] must establish that the vaccine was both ‘properly prepared, and accompanied by proper directions and warning’”).


Some Indiana courts have applied comment k/unavoidably unsafe product without individualized product assessment.  Ortho Pharmaceutical Corp. v. Chapman, 388 N.E.2d 541, 545-46 (Ind. App. 1979) (“strict liability is avoided only when the product is accompanied by proper warnings”); First National Bank & Trust Corp. v. American Eurocopter Corp., 378 F.3d 682, 690 n.4 (7th Cir. 2004) (a prescription drug “properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous”); In re Eli Lilly & Co., Prozac Products Liability Litigation, 789 F. Supp. 1448, 1453 (S.D. Ind. 1992) (“the court in [Chapman] understood Comment k to apply to all prescription drugs”).  However, other Indiana law casess have gone for case by case.  Singer v. Sterling Drug, Inc., 461 F.2d 288, 290-91 (7th Cir. 1972) (“there is insufficient evidence in this case to show that [the drug] fell into [the comment k] category of drugs which are exceptions to the strict liability doctrine”); Koehler v. Wyeth Laboratories Division of American Home Products Corp., 1987 WL 47831, at *3 (S.D. Ind. Sept. 8, 1987) (finding , on the basis of facts unique to the vaccine in question, that it was a unavoidably unsafe product within comment k).


The Iowa Supreme Court concluded that a drug was unavoidably unsafe without individualized balancing in Moore v. Vanderloo, 386 N.W.2d 108, 116 (Iowa 1986) (prescription drugs “are not held to be defective or unreasonably dangerous so long as they are accompanied by proper directions for use and adequate warnings as to potential side effects”).  A similar result was reached, under Iowa law, in Petty v. United States:

Comment k recognizes that some products, such as drugs, are unavoidably unsafe; however, because their benefits outweigh the risks, if properly prepared and accompanied by proper warnings, the product is, by definition, neither defective nor unreasonably dangerous.  The swine flu vaccine would thus be classified as a justified, but unavoidably unsafe product.
740 F.2d 1428, 1439 (8th Cir. 1884).


In Kansas “the application of Comment k is made on a case-by-case determination.”  Savina v. Sterling Drug, Inc., 795 P.2d 915, 924 (Kan. 1990).  “The policy considerations underlying strict liability and Comment k would apply to a diagnostic drug as well as to a drug used for treatment.”  Id. at 927.  Kansas followed the Kearl approach rejected in Brown:

A trial court should take evidence as to: (1) whether, when distributed, the product was intended to confer an exceptionally important benefit that made its availability highly desirable; (2) whether the then-existing risk posed by the product was both ‘substantial’ and ‘unavoidable’; and (3) whether the interest in availability (again measured as of the time of distribution) outweighs the interest in promoting enhanced accountability through strict liability design defect review.
Id. at 925 (quoting Kearl).  See Graham v. Wyeth Laboratories, 666 F. Supp. 1483, 1496 (D. Kan. 1987) (same), aff’d in pertinent part, rev’d on other grounds, 906 F.2d 1399 (10th Cir. 1990).


The Kentucky Supreme Court felt no need for Toner-style individualized risk/benefit balancing in the one case it’s had that involved comment k issues.  Larkin v. Pfizer, Inc., 153 S.W.3d 758, 762 (Ky. 2004) (“the fact that a particular drug might produce unfortunate side effects makes it 'unavoidably unsafe' but not 'unreasonably dangerous,''' and strict liability will not obtain if “proper warning is given, where the situation calls for it”) (emphasis original); see Larkin v. Pfizer, Inc., 2001 WL 34065029, at *2-3 (W.D. Ky. Feb. 8, 2001) (also following comment k without drug-specific analysis).  Thus, the status of pre-Larkin federal precedent predicting the use of the case-by-case approach, Tobin v. Astra Pharmaceutical Products, Inc., 993 F.2d 528, 540 (6th Cir. 1993); Weiss v. Fujisawa Pharmaceutical Co., 2006 WL 3533072, at *3 (E.D. Ky. Dec. 7, 2006), is doubtful.


A Louisiana appellate court held a prescription medical product to be unavoidably unsafe without need for product-specific adjudication:

As comment k to Section 402A instructs, an unavoidably unsafe product is neither defective nor unreasonably dangerous if such a product is ‘properly prepared, and is accompanied by proper directions and warning.  Consequently, the statement requires a seller who has reason to believe that danger may result from a particular use of his product to provide adequate warning of the danger in order that the product's potential for harm may be reduced.  Failure to give such a warning when it is required will itself present a ‘defect’ in the product and will, without more, cause the product to be ‘unreasonably dangerous as marketed.
Kinney v. Hutchinson, 468 So.2d 714, 718 (La. App. 1985) (citation and quotation marks omitted).  So has a federal district court applying Louisiana law.  Williams v. Ciba-Geigy Corp., 686 F. Supp. 573, 577 (W.D. La.) (“[i]n light of the wise principles embodied in comment k, it is presumptively inappropriate for a jury to apply the pure risk-utility test”), aff’d without op., 864 F.2d 789 (5th Cir. 1988).  Williams, as well, did not require product-specific analysis before holding that comment k applied – but only afterwards, in evaluating the product’s warnings.  Id. at 577-78.  This looks like the across-the-board approach to us.


The only case on comment k under Maine law is a footnote declining to decide the issue but nonetheless implying that Maine would follow a case-by-case approach.  Violette v. Smith & Nephew Dyonics, Inc., 62 F.3d 8, 13 n.3 (1st Cir. 1995) (evidence of “an alternative safe method of surgery” defeated unavoidably unsafe claim; “we need not decide” if “comment k accurately reflects Maine common law”).  In Doe v. Solvay Pharmaceuticals, Inc., 350 F. Supp.2d 257, 267-68 (D. Me. 2004), aff’d, 153 Fed. Appx. 1 (1st Cir. 2005), the court jumbled together citations to cases applying both case-by-case and across-the-board approaches before dismissing a design defect claim for lack of evidence.  On this basis, we put Maine rather wobbily in the case-by-case category.


In Miles Laboratories, Inc. v. Doe, 556 A.2d 1107 (Md. 1989), Maryland’s highest court appeared to apply comment k across-the-board to all blood products, id. at 1121 (citing “the singular medical utility” of such products generally).  However, Miles was decided against the backdrop of a state “blood shield statute,” so its reasoning may not extend to other prescription medical products.  However, in Doe v. Miles Laboratories, Inc., 927 F.2d 187, 191-93 (4th Cir. 1991), the court conducted an in depth product specific analysis before affirming the applicability of comment k, utilizing four factors specific to blood cases:

(1) the nonexistence of any scientific test capable of detecting the viral agent which contaminated the blood at the time of injury; (2) the great utility of the product; (3) the lack of any substitute for the product; and (4) the relatively small risk of the disease being transmitted by the product.
To ensure “legal consistency,” the court treated comment k analysis as a policy-based question of law.  Id. at 191.  That's not usually done in case-by-case jurisdictions.

Federal authority in Maryland as to drugs, as opposed to blood products, sounds a lot like across-the-board, but the law can hardly be called settled.  Ames v. Apothecon, Inc., 431 F. Supp.2d 566, 573-74 (D. Md. 2006) (“Consumption of [the drug] caused [plaintiff’s] tragic blindness.  This does not mean that the drug was defective.  Prescription drugs are defective only if the risks are inadequately disclosed.”); Fellows v. USV Pharmaceutical Corp., 502 F. Supp. 297, 300 (D. Md. 1980) (“prescription drugs are not considered unusually dangerous under section 402A, and the manufacturer will not incur liability under that section, unless the manufacturer has failed to provide adequate warnings of the drug’s possible dangers”).


In Lareau v. Page, the court held that Massachusetts applies comment k and unavoidably unsafe doctrine without individualized adjudication. 840 F. Supp. 920, 933 (D. Mass. 1993), aff’d, 39 F.3d 384 (1st Cir.1994).  A Massachusetts trial court similarly stated:

There does not exist a mixture of ingredients capable of alternative design and, consequently, plaintiff’s claim of negligent design must, as a matter of law, be dismissed [because the drug] is created from a single, active ingredient and only has one possible formulation. Furthermore, under these circumstances, plaintiff’s defective design claim is actually a claim that [the drug] should never have been designed or manufactured at all.
Sprague v. Upjohn Co., 1995 WL 376934, at *1-2 (D. Mass. May 10, 1994).  We somewhat wobbily put Massachusetts in the across-the-board category.


There’s not much prescription drug litigation in Michigan anymore, but when there was, Michigan appeared to be an across-the-board state on comment k issues.  Nichols v. McNeilab, Inc., 850 F. Supp. 562, 570 (E.D. Mich. 1993) (“Prescriptions drugs . . . are characterized as ‘unavoidably unsafe’ products and a manufacturer can be held liable for their side effects only if the manufacturer failed to supply an adequate warning in light of the information then available”).

One federal court predicted, a fairly long time ago, that Minnesota would apply the unavoidably unsafe product principle/comment k on a case-by-case basis.  Kociemba v. G.D. Searle & Co., 680 F. Supp. 1293, 1301 (D. Minn. 1988) (“reject[ing] defendant's contention that comment k was intended to provide all prescription drugs with blanket immunity from strict liability claims”) (citing Toner).

Factors that must be considered in deciding whether a product is unavoidably unsafe include: (i) whether the product could have been designed in a safer manner; (ii) whether a safer alternative product could have been available at that time to accomplish the same intended purpose as the product in question; and (iii) whether the benefits of the product outweigh the interest in promoting enhanced accountability on the part of the manufacturer.
Id.  The court did not decide whether comment k applied to negligent design claims.  Id. at 1301 n.5.  Without directly addressing the issue, another federal court conducted a product specific comment k analysis in Johnson v. Zimmer, Inc., 2004 WL 742038, at *8-9 (D. Minn. March 31, 2004).


Mississippi adopted the case-by-case approach to comment k in Bennett v. Madakasira, 821 So.2d 794, 809 (Miss. 2002) (comment k “does not provide a blanket immunity from strict liability for prescription drugs, as not all prescription drugs are ‘unavoidably unsafe’”) (citation omitted).


Missouri is a case-by-case state, although its supreme court hasn’t ruled.  In Pollard v. Ashby, 793 S.W.2d 394, 400 (Mo. App. 1990), the court held that comment k was an affirmative defense and ruled that, because it wasn’t pleaded it was waived.  In Racer v. Utterman, 629 S.W.2d 387, 393-94 (Mo. App. 1981), the court conducted a product-specific analysis of a medical device and held that strict liability “could attach to the [product] because of its flammable nature, in the absence of a warning of the danger.”  Federal courts have applied case-by-case analysis to comment k under Missouri law.  Hill v. Wyeth, Inc., 2007 WL 674251, at *4-5 (E.D. Mo. Feb. 28, 2007) (“whether a product is within the scope of comment k should be determined on a case-by-case basis”); Lachance v. American Home Products Corp., 2006 WL 89850, at *4-5 (W.D. Mo. Jan. 13, 2006) (submitting comment k issues to jury).


A very early federal case applied comment k without individualized adjudication under Montana law.  Davis v. Wyeth Laboratories, Inc., 399 F.2d 121, 129 (9th Cir. 1968) (“[a]s the comment stresses, however, strict liability is avoided in these situations only where sale is accompanied by proper directions and proper warnings”).  There hasn't been a comment k related peep out of Montana since.


The Nebraska Supreme Court has adopted the case-by-case approach to unavoidably unsafe product determinations.

[C]omment k., applies as an affirmative defense to except prescription drug products from strict liability when it is shown that (1) the product is properly manufactured and contains adequate warnings, (2) its benefits justify its risks, and (3) the product was at the time of manufacture and distribution incapable of being made more safe.
Freeman v. Hoffman-La Roche, Inc., 618 N.W.2d 827, 831 (Neb. 2000).


A plurality of the Nevada Supreme Court rejected comment k altogether in Allison v. Merck & Co., 878 P.2d 948, 953-55 (Nev. 1994).  A concurring justice would have adopted comment k generally, apparently across the board.  Id. at 961 (Rose, C.J., concurring).  The dissent would have applied a case-by-case approach to comment k.  Id. at 695-96.  Allison left Nevada law a mess.  In Fisher v. Professional Compounding Centers of America, Inc., 311 F. Supp.2d 1008, 1018 (D. Nev. 2004), the court followed the Allison plurality and refused to consider comment-k-based arguments.

New Hampshire

Federal courts have held that New Hampshire would recognize design defect claims against prescription drugs, thus implicitly rejecting an across the board application of comment k.  Brochu v. Ortho Pharmaceutical Corp., 642 F.2d 652, 655 (1st Cir. 1981) (“We are unwilling to say that under New Hampshire's balancing test no drug can ever be classified as unreasonably dangerous”); Bartlett v. Mutual Pharmaceutical Co., 731 F. Supp.2d 135, 150-51 (D.N.H. 2010) (“courts generally place the initial burden of proving the various [comment k] factors on the defendant”; holding plaintiff’s design defect claim survived summary judgment).

New Jersey

New Jersey has adopted the case-by-case approach to comment k.  Feldman v. Lederle Laboratories, 479 A.2d 374, 380 (N.J. 1984) (“[w]e do not agree that the protective shield of comment k immunizes all prescription drugs”)

Comment k immunizes from strict liability the manufacturers of some products, including certain drugs, that are unavoidably unsafe.  However, we see no reason to hold as a matter of law and policy that all prescription drugs that are unsafe are unavoidably so.  Drugs, like any other products, may contain defects that could have been avoided by better manufacturing or design.  Whether a drug is unavoidably unsafe should be decided on a case-by-case basis; we perceive no justification for giving all prescription drug manufacturers a blanket immunity from strict liability manufacturing and design defect claims under comment k.
Id. at 383.

The New Jersey legislature, however, responded with a statute providing a rebuttable presumption of non-defectiveness to FDA-approved products, N.J.S.A. §2A:58C-4.  Since then, prescription drug cases have been litigated under substantive rubric of the statute rather than comment k.  E.g., Perez v. Wyeth Laboratories Inc., 734 A.2d 1245, 1259 (N.J. 1999).

New Mexico

New Mexico swings both ways.  The court in Davila v. Bodelson, 704 P.2d 1119, 1127 (N.M. App. 1985), submitted a comment k question to the jury.  However, the court in Perfetti v. McGahn Medical, 662 P.2d 646, 650 (N.M. App. 1983), did not rely on any product-specific rationale in holding breast implants to be unavoidably unsafe products.  New Mexico law remains uncertain.

New York

New York law cases apply comment k to all prescription medical products simply because that’s what they are.  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); Wolfgruber v. Upjohn Co., 423 N.Y.S.2d 95, 97 (N.Y. App. Div. 1979) (“[t]he scope of the warning is the key factor in a drug products liability suit because prescription drugs are ‘unavoidably unsafe products’”) (following comment k), aff’d mem., 417 N.E.2d 1002 (N.Y. 1980) (for reasons in lower court opinion); Samuels v. American Cyanamid Co., 495 N.Y.S.2d 1006, 1011 (N.Y. Sup. 1985) (“ethical or prescription drugs, although properly manufactured, may be ‘[u]navoidably unsafe products’, due to potential side effects, but are not considered defective or unreasonably dangerous when accompanied by proper directions for use and adequate warnings”); Bravman v. Baxter Healthcare Corp., 984 F.2d 71, 76 (2d Cir. 1993) (“following majority rule that medical devices that must be prescribed and inserted by a physician are unavoidably unsafe products”); Lindsay v. Ortho Pharmaceutical Corp., 637 F.2d 87, 90 (2d Cir. 1980) (prescription “drugs, aptly described as ‘(u)navoidably unsafe products’, are not deemed defective or unreasonably dangerous so long as they are accompanied by proper directions for use and adequate warnings”) (citing Wolfgruber and comment k); Gensler v. Sanolfi-Aventis, 2009 WL 857991, at *6 (E.D.N.Y. March 30, 2009) (“where there is a proper warning, design defect liability is barred”); Larkins v. Glaxo Wellcome, Inc., 1999 WL 360204, at *9 (E.D.N.Y. May 20, 1999) (quoting and following Martin v. Hacker); cf. Militrano v. Lederle Laboratories, 769 N.Y.S.2d 839, 846-847 (N.Y. Sup. 2003) (concluding the Congress intended an across-the-board application of comment k in vaccine cases), aff’d, 810 N.Y.S.2d 506 (N.Y. App. Div. 2006).

North Carolina

N.C. Gen. Stat. §99B-6(d) extends the unavoidably unsafe doctrine to all prescription drugs.  “No manufacturer of a prescription drug shall be liable in a product liability action on account of some aspect of the prescription drug that is unavoidably unsafe, if an adequate warning and instruction has been provided.”  Id.

North Dakota

A federal court has suggested in dictum that North Dakota would apply comment k on a case-by-case basis.  Ehlis v. Shire Richwood, Inc., 233 F. Supp.2d 1189, 1191 (D.N.D. 2002) (“comment k provides an affirmative defense rather than provides absolute immunity”), aff’d, 367 F.3d 1013 (8th Cir. 2004). However, the discussion in Ellis came in the context of strict liability under Restatement §§519-20, rather than §402A.


A tort reform statute, Ohio Rev. Code Ann. §2307.75(D), extends the unavoidably unsafe doctrine to all prescription drugs and medical devices.  “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.”  Id.  The statute reverses Ohio’s previous reliance on a case-by-case approach.  See White v. Wyeth Laboratories, Inc., 533 N.E.2d 748, 753 (Ohio 1988); Ackley v. Wyeth Laboratories, Inc., 919 F.2d 397, 399 (6th Cir. 1990).


Oklahoma adopted the case-by-case approach to comment k in Tansy v. Dacomed Corp.:

Comment k serves as an affirmative defense when the product is incapable of being made safe under present technology, but the social need for the product warrants its production.  The design must be as safe as the best available testing and research permits.  There must be at the time of manufacture and distribution no feasible alternative design which on balance accomplished the subject product's purpose with a lesser risk.
890 P.2d 881, 885-886 (Okla. 1994) (citations and quotation marks omitted); see Alexander v. Smith & Nephew, P.L.C., 98 F. Supp.2d 1310, 1317 (N.D. Okla. 2000) (under Tansy, “a risk-benefit analysis must be performed before applying cmt. k”).


Oregon has adopted Restatement §402A and its comments by statute.  Or. Rev. Stat. §30.920.  The Oregon Supreme Court has suggested, in a footnote, that comment k applies on a case-by-case basis.  Senn v. Merrell-Dow Pharmaceuticals, Inc., 751 P.2d 215, 218 n.4 (Or. 1988) (citing Toner).  Federal courts applying Oregon law have done so.  Coursen v. A.H. Robins Co., 764 F.2d 1329, 1337 (9th Cir. 1985) (holding comment k to be an affirmative defense; requiring product specific proof), corrected, 773 F.2d 1049 (9th Cir. 1985); Allen v. G.D. Searle & Co., 708 F. Supp. 1142, 1149 (D. Or. 1989) (comment k requires the defendant to show “that the product is incapable of being made safe for its intended and ordinary use; that the benefits of the product justify its marketing and use despite the unavoidable risks; that the product is properly prepared and marketed; and that the product is accompanied by proper directions and warnings”).


Pennsylvania has always applied comment k and the unavoidably unsafe rationale to all prescription medical products without individualized adjudication.  Pennsylvania law is “clear that where the adequacy of warnings associated with prescription drugs is at issue, the failure of the manufacturer to exercise reasonable care to warn of dangers, i.e., the manufacturer’s negligence, is the only recognized basis of liability.”  Hahn v. Richter, 673 A.2d 888, 8991 (Pa. 1996).

The Restatement reaches the same conclusion as to a product which is incapable of being made safe for its intended use, such as new or experimental drugs. . . .  “The seller of such products,” concludes this comment, “again with the qualification that they are properly prepared and marketed and proper warning is given . . . is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product attended with a known but apparently reasonable risk.”
Incollingo v. Ewing, 444 Pa. 206, 282 A.2d 206, 219-220 (Pa. 1971) (quoting and following comment k); accord Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1385-87 (Pa. 1991) (recognizing general applicability of comment k); Baldino v. Castagna, 478 A.2d 807, 811-12 (Pa. 1984) (“Where warning is given . . . a product bearing such a warning, which is safe for use if it is followed, is not in defective condition nor is it unreasonably dangerous. . . . [T]he Restatement reaches the same conclusion as to drugs which serve a useful purpose notwithstanding a medically recognizable risk.”).  However, recently a case we can’t discuss due to our own involvement recognized a negligent design claim – while precluding all forms of strict liability – in a prescription drug case.  Lance v. Wyeth, 4 A.3d 160, 165-66 (Pa. Super. 2010).  Lance is in front of the Pennsylvania Supreme Court at present.

Puerto Rico

There’s no comment k law that we know of in Puerto Rico.

Rhode Island

Rhode Island is case-by-case, based upon the same sort of certified question that produced TonerCastrignano v. E.R. Squibb & Sons, Inc., 546 A.2d 775, 781 (R.I. 1988) (“we believe the societal interest in the development and marketing of prescription drugs will be adequately served by extending comment k to prescription drugs on a case-by-case basis”); see Castrignano v. E.R. Squibb & Sons, Inc., 900 F.2d 455, 457 (1st Cir. 1990) (applying Castrignano).

South Carolina

Under South Carolina law, prescription drugs and medical devices “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.”  Brooks v. Medtronic, Inc., 750 F.2d 1227, 1230-31 (4th Cir. 1984) (following comment k).  That sounds like across-the-board to us.

South Dakota

A federal court applying South Dakota law made an across-the-board sounding statement in McElhaney v. Eli Lilly & Co., 575 F. Supp. 228, 230 (D.S.D. 1983) (prescription drugs “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”), aff’d without op., 739 F.2d 340 (8th Cir. 1984).


There’s not a whole lot to go on, but the Tennessee Supreme Court once stated, that manufacturers of prescription drugs “may discharge their duty by distributing the drugs with proper directions and adequate warnings to those who foreseeably could be injured by the use of their products ”  Pittman v. Upjohn Co., 890 S.W.2d 425, 428 (Tenn. 1994).  That’s across-the-board language.  Thus, in Rodriguez v. Stryker Corp., 2011 WL 31462 (M.D. Tenn. Jan. 5, 2011), the court recently held:

Comment K imposes a well-recognized exception for “unavoidably unsafe products,” such as prescription medical devices.  An action in strict liability does not lie against the manufacturer of such a product if the product was properly prepared and accompanied by proper directions and warning. Therefore, to the extent that the plaintiff has a viable strict liability claim, it would arise under a failure-to-warn theory.
Id. at *6 (citations, quotation marks, and footnote omitted).


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).


Utah is firmly in the across-the-board application camp.  In Grundberg v. Upjohn Co., 813 P.2d 89 (Utah 1991), the Utah Supreme Court held:

We agree with Brown that the case-by-case method first articulated in Kearl is unworkable, even in light of Toner’s refinement of the test.  We find the Brown result more in line with the public policy considerations in the important area of pharmaceutical product design.  We do not agree, however, with the Brown court’s apparent attempt to use the plain language of comment k as the vehicle for exempting all prescription drugs from strict liability rather than relying on the policies underlying that comment. . . .

We agree with the principle comment k embodies, that manufacturers of unavoidably dangerous products should not be liable for a claim of design defect.  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 noted in Brown.
813 P.2d at 95.  See Schaerrer v. Stewart’s Plaza Pharmacy, Inc., 79 P.3d 922, 928 (Utah 2003) (“under Utah law, comment k shields manufacturers and sellers of prescription drugs from strict liability based on allegations of a design defect”); Stanley v. Mylan Inc., 2010 WL 3718589, at *5 (D. Utah Sept. 17, 2010) (“the Court will allow the case to proceed on the understanding that Plaintiffs will not press for a strict-liability design-defect claim”).  Nevertheless, a federal court refused to dismiss a negligent design claim in Lake-Allen v. Johnson & Johnson L.P., 2009 WL 2252198, at *2-3 (D. Utah July 27, 2009), finding comment k “limited to strict liability.”  Given the policy-based thrust of Grundberg, we think that ruling’s mistaken.


There’s nothing about comment k in Vermont.


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

There’s no comment k law in the Virgin Islands that we know of.


Washington was an early across-the-board state for comment k, and has remained so.  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”); 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”); 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”); 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”); Dalke v. Upjohn Co., 555 F.2d 245, 247 (9th Cir. 1977) (under comment k “unavoidably unsafe products are not defective or unreasonably dangerous if properly prepared and accompanied by adequate directions and warnings”).

West Virginia

Federal courts predicting West Virginia law opted for the case-by-case approach to comment k, at least in vaccine cases where plaintiffs asserted an alternative design.  Smith v. Wyeth Laboratories, Inc., 1986 WL 720792, at *5 (S.D.W. Va. Aug. 21, 1986) (“courts have recognized that not all prescription drugs should be considered “unavoidably unsafe products”); see Rohrbough v. Wyeth Laboratories, Inc., 719 F. Supp. 470, 476-77 (N.D.W. Va. 1989) (placing burden to prove comment k on defendants; plaintiff created a jury question as to alternative design), aff’d mem., 916 F.2d 970 (4th Cir. 1990).


Wisconsin doesn’t follow comment k at all.  Collins v. Eli Lilly & Co., 342 N.W.2d 37, 52 (Wis. 1984) (“rule embodied in comment k is too restrictive and, therefore, not commensurate with strict products liability law in Wisconsin”).  However Wisconsin recently passed a statute completely rejiggering of the fundamentals of design defect liability, so that might at some point lead to a change of heart on comment k.


Wyoming applies comment k without individualized adjudication.  Jacobs v. Dista Products Co., 693 F. Supp. 1029, 1031 (D. Wyo. 1988) (“manufacturers of prescription drugs cannot be held accountable under a strict liability theory for injuries which might result from their use so long as adequate warnings are provided to enable a prescribing physician to weigh on a patient-by-patient basis the benefits of a drug’s use against the attendant risks”).

Wednesday, April 27, 2011

First Amendment Looks Strong In Sorrell

We’ve been interested in IMS Health, Inc. v. Sorrell, 630 F.3d 263 (2d Cir. 2010), since literally the day after the Second Circuit decided that case.  Our interest is not as much in the particular facts of the case, which involves data mining and prescribing statistics (although this is interesting in its own right), as in the context that those statistics are used.

The State of Vermont imposed the restrictions at issue in Sorrell – and did so rather explicitly – to interfere with their use by drug companies in promoting their drugs to prescribing physicians.  Thus, as we said in our original post, part and parcel of the Sorrell decision has to be a holding that pharmaceutical promotion is protected commercial speech:  “Hello the Supreme Court getting another chance to review governmental speech restrictions on pharmaceutical detailing.”  Since truthful promotion of off-label use is also pharmaceutical promotion, a finding of First Amendment commercial speech protection in Sorrell necessarily implicates the off-label use question.  We mentioned that in our initial post, too: “Can the off-label promotion ban be far behind?”

Well, as we thought it might, the Supreme Court accepted an appeal in Sorrell. The Court held oral argument in Sorrell yesterday, and we have to say, we think that the First Amendment question of pharmaceutical detailing as a form of protected corporate speech came through looking pretty good.  Here’s a link to the transcript, so you don’t just have to take our word for it.

Here’s a brief Justice-by-Justice breakdown of what we thought was interesting, with transcript page numbers:

Chief Justice Roberts

(14-15) The state wants to lower health care costs by censoring drugmakers.  (15) Restrictions disproportionately burden one class of speakers.  (17-18) Why is the state making judgments about what commercial speech is effective?  (27) It’s problematic to let the state choose the uses of speech, particularly when the state is financially interested.  (28) What if the statute only prohibited use of the information for criticizing the state of Vermont?  (38-39) Statute allows the information to be sold to journalist for public dissemination, so it doesn’t do much for privacy.  (59) Does your argument turn on all the exceptions and the state’s counter-detailing?  (59-60) How would you write a statute to protect a physician’s privacy?  (62) How is this different from selling tax returns?  (65-66) How do you explain the legislative finding about an imbalance in the marketplace of ideas?

Justice Scalia

(4, 6) The law picks out one use of the information and restricts it.  (5) Its “obvious” purpose is to impede pharmaceutical marketing.  (7) The prescribing information is public, not private, knowledge.  (7-8, 11, 31) The same thing could be achieved (without a restriction on speech) by doctors saying that they’re not interested in sales pitches.  (11) How is privacy benefitted when the data can be given away, but not sold?  (12) There is no legitimate privacy purpose.  (16-17) The law restricts “effective” speech.  (19-20) Are you changing your rationale from what you argued below?  (24-25) The statute doesn’t protect a physician’s privacy.  (30) Can the state bar petition gatherers from only approaching people who have previously consented to being approached?  (43) This isn’t a case about false advertising.

Justice Kennedy

(9) The data could be sold to universities.  (16) Aren’t you favoring one commercial interest over another by restricting speech?  (19) Are you changing your rationale from what you argued below?  (29) Are you saying the state can prohibit the most effective form of speech?  (52) What if the statute prohibited selling the information to anybody at all?  (61) How much does improper legislative intent factor into the First Amendment analysis?

Justice Thomas

Silence, as always, was golden.

Justice Ginsburg

(14) Vermont is also trying to promote generics over other drugs, so doesn’t that contravene precedent that the state cannot restrict one speaker so other speakers can be better heard?  (31) Who owns a physician’s prescribing records?  (49-50) How is this different from HIPAA?

Justice Breyer

(40-42) Could the FTC issue a general rule banning certain pharmaceutical detailing practices as false and misleading, including use if data mining?  (41) Nobody says the First Amendment doesn’t apply.  (42) Why can’t Vermont regulate false and misleading practices?  (44) How is this different from false advertising?  (51) Could the government collect and keep confidential information about the use of products?  (58) Are you questioning restrictions on selling by regulated industries?

Justice Alito

(8) The statute would allow Vermont to use the same information in run a “counter-detailing” program – that is, to debunk drugmakers’ claims – should it choose to do that.  (18-19, 20-21) Are you changing your rationale from what you argued below?  (26) Does the statute protect a doctor who doesn’t want the information given to anyone?

Justice Sotomayor

(12-13, 46) Isn’t having an opt-out option a less restrictive alternative to the current restrictions on speech?  (49) Why is this not just a consumer statute about control over information?  (54) Are what you saying is that the government cannot try to stop the spread of information?  (55) Are you hinging your argument on viewpoint discrimination?

Justice Kagan

(21) How are you (Vermont) interpreting the statute now?


Reading through the transcript, we don’t really see any votes for the proposition that pharmaceutical detailing isn’t protected commercial speech.  Even the justices whom we’ve found least congenial to pharmaceutical interests in other cases had problems with the discriminatory manner in which this statute operates (and was intended to operate), the existence of less restrictive alternatives, and the State of Vermont’s positional flip flops.

Whether any of this will ultimately translate into success on the issue of off-label promotion, we don’t know, but we don’t think there’s much sympathy on this Court for a state deciding to restrict the dissemination of information to promote viewpoint-related discrimination against drug detailing by pharmaceutical companies.

We don’t think there’s a lot to be said for the Vermont’s statute at issue in Sorrell.  There seem to be a solid six or seven votes to declare it unconstitutional, and the Court could even be unanimous on that point.  To us, the more interesting aspect is how broadly or narrowly it will be struck down.

Tuesday, April 26, 2011

Score One-Half For IDE Preemption

It’s a little stale, by our standards at least, but we thought we ought to say something about Burgos v. Satiety, Inc., 2011 WL 1327684 (E.D.N.Y. April 5, 2011).  It’s got some good things about it – especially that it’s another case recognizing broad preemption in the context of investigational (“IDE”) medical devices.  Id. at *2 (“negligent manufacture is one of the many state law tort claims that is preempted by the federal regulatory scheme that governs the testing and approval process for experimental medical devices”).  Since there are still some plaintiffs who argue that Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), doesn’t apply to IDE devices, Burgos is OK to that extent.

The decision also kicks out a somewhat bizarre claim based on purported improper record-keeping that, while invoking 21 C.F.R. §§812.110, 812.140, sounds like a disguised claim for spoliation.  The court holds that the allegations don’t parallel anything at state law because of remoteness.  Burgos, 2011 WL 1327684, at *3 (plaintiff “cannot establish that her injury was ‘substantially caused’ by [defendant’s] alleged breach of its record-keeping duties”).

But then the Court goes all flabby.  Plaintiff alleges “adulteration” because the defendant somehow violated the terms of its IDE.  How?  The court admits that, from the complaint, it has no idea.  Plaintiff “does not allege how the . . . device's manufacture violated the IDE, nor does she specify the terms, conditions, standards, or specifications that she claims were violated.”  Burgos, 2011 WL 1327684, at *3.  The court cuts the plaintiff a break, saying that because the IDE documents are non-public, plaintiff can’t be expected to plead anything specific:

[A]t this stage of the proceedings she cannot reasonably be expected to do so [plead what violation happened], because the information she requires to provide the requisite degree of specificity – the IDE documentation submitted by [the defendant] to the FDA – is confidential and not available to the public.
Id. at *4 (relying on dissent in Sprint Fidelis).  Instead, plaintiff gets “cabined” discovery in order to engage in a pure fishing expedition to “explore” whether there’s anything she can gin into a regulatory violation:

[Plaintiff] is entitled to a brief and strictly-cabined period of discovery in order to determine the terms of [defendant’s] IDE, and to explore whether or not the specific device used in her procedure was manufactured in accordance with the IDE.
Id. at *5.


“Cabined discovery”…. Let’s see, where have we heard that phrase before?

Oh, right.  That’s what the plaintiffs claimed they should get in Ashcroft v. Iqbal, 129 S. Ct. 1937 (2009), because – surprise, surprise – the government defendants were also engaged in secret conspiracy to violate the law.  The Supreme Court said “no,” no discovery before actually pleading a claim:

We decline respondent’s invitation to relax the pleading requirements on the ground that the Court of Appeals promises petitioners minimally intrusive discovery. . . .  Because respondent’s complaint is deficient under Rule 8, he is not entitled to discovery, cabined or otherwise.
Id. at 1953-54 (emphasis added).

So there you have it – the spectacle of a plaintiff being allowed in Burgos to get exactly what the Supreme Court held in Iqbal she was “not entitled” to.

Sure, courts thumb their noses at Supreme Court precedent they don’t like all the time, but rarely do they do so in such a blatant fashion.

Monday, April 25, 2011

Gelber: The Narrow Gap Between Medtronic and Bausch?

There have been some great duels throughout history: Plato-Aristotle, Stalin-Trotsky, Jolie-Aniston, us vs the Drug-and-Device Teenaged Daughter. It's hard not to root for one vs the other. (We pick Aristotle, Trotsky, Aniston, and us).

Lately, we've said a few things about the Medtronic (8th Cir.) vs Bausch (7th Cir.) holdings on the parallel requirements exception to Riegel preemption. (Here, for example.) Medtronic applies TwIqbal and actually insists that the plaintiff plead facts and a specific federal violation. Bausch allows plaintiffs to allege general, factless violations, on the theory that the confidentiality of company documents makes it hard for plaintiffs to be specific - at least until plaintiffs get the opportunity to take expensive, settlement-extorting discovery.

Last week, an opinion emerged from SDNY, and we think the court mostly sided with Medtronic - though not as much as we'd have liked. Gelber v. Stryker Corp., 2011 WL 1483927 (SDNY April 18, 2011) is yet another Trident hip replacement case. The plaintiff underwent the hip arthroplasty on July 21, 2004. The plaintiff started feeling pain in 2007 She had a hip revision surgery on January 26, 2009, where the Trident system was removed. Upon inspection, the surgeon saw a stripe on the ceramic head component, as well as wear on the ceramic insert.

The plaintiff filed a complaint in New York state court in 2009, it was removed to federal court, and it was dismissed on preemption grounds. But the court granted leave to amend the complaint. So the plaintiff amended. We mean, really amended. The amended complaint alleged multiple federal violations wholly absent from the original complaint. There were claims for strict liability based on defective manufacturing, negligence, breach of warranty, and loss of consortium. There were also factual allegations that the court generously construed as a claim for failure to warn.

It's hardly surprising that the defendant again moved to dismiss on the grounds of preemption. It worked once and it looked like it should work again. The Gelber court begins by saying a lot of the right things. It quotes the Medtronic district court language about how "Riegel and Buckman create a narrow gap through which a plaintiff's state-law claim must fit if it is to escape express or implied preemption." It also quotes the Medtronic language that "Plaintiffs cannot simply incant the magic words 'defendants violated FDA regulations' in order to avoid preemption.".

But the Gelber court also starts quoting Bausch. Uh oh. And then Gelber cites Bausch and the dissent in Medtronic about how critical information needed for specific pleading is kept confidential as a matter of federal law. Yikes. It's as if Gelber is trying to bridge the "narrow gap" between Medtronic and Bausch.

Some of that is good and some of that is bad. The bad part is that the court preserved the manufacturing defect claim on the theory that the plaintiff had adequately alleged a violation of FDA current good manufacturing practices (CGMP) requirements - specifically, the court construed the amended complaint "liberally" to allege that the Trident system was defective because it was manufactured with "manufacturing residuals" and was therefore "adulterated". What facts underly such allegations? Not much. The plaintiff pointed to a 2007 warning letter and a 2008 voluntary recall at a manufacturing facility. Again, construing things "liberally," the court concluded that the plaintiff "plausibly alleged that the excessive levels of manufacturing residue was one of the 'several different factors' that ultimately led to breaks in the lubrication layer and the stripe found" on the implanted system.

Look: we don't think a CGMP violation is enough for a parallel violation. Other courts, including Medtronic, have said so, pointing how they are simply too generic. But even aside from that doctrinal point, the facts of Gelber (the stripe) should make a factual distinction - dare we say it? - plausible.

The Gelber court gets more right than it gets wrong. The court dismisses the failure to warn claims for lack of causation, lack of any applicable federal regulation, and for preemption. The court holds that Buckman preempts the plaintiff's claim that the defendant failed to report certain clinical findings to the FDA. The plaintiff also claimed violations of CGMP requirements to identify and correct device problems, but here the court read the relevant CGMP requirements closely and found that the plaintiff's interpretation wasn't just liberal - it was a rewrite. Similarly, the court rejected the plaintiff's "vague and conclusory allegations" that the defendant "failed to develop practices and procedures" to assure compliance with multiple federal regulations. That sounds like bootstrapping. It is also madness to say that private citizens can become roaming enforcers of federal regulations. The court dismissed those claims.

In effect, the Gelber court splits the difference between Bausch and Medtronic. (It also splits the difference on the warranty claims in a way that is not especially interesting or useful). So maybe what we said at the outset is wrong; not everybody feels the need to pick sides. But law, like sports, is more fun when there's a rooting interest.

Friday, April 22, 2011

That Giant Sucking Sound You Hear….

…Is the sound of corporate America being drawn into the vortex of mass tort litigation in the Philadelphia Court of Common Pleas.

It’s not even necessary to be sued anymore.  Just an agent for service of process is enough.  The case is Branham v. Rohm & Haas Co., ___ A.3d ___, 2011 WL 1366494, slip op. (Pa. Super. April 21, 2011).  It all started when Dow Chemical, a Delaware/Michigan corporation, bought Philadelphia-based Rohm & Haas.

Dow couldn’t have had any idea what it was getting into (at least in terms of litigation hassles).  If it had, maybe it wouldn’t have put “Dow” signs on the old Rohm & Haas plant – something the Superior Court seemed to find more important (2011 WL 1366494, at *1, *7, *8) than the fact that Dow at all times maintained Rohm & Haas as a separate corporate subsidiary – plaintiffs not even making a contrary claim.

Rohm & Haas was involved in personal injury litigation in Philadelphia concerning vinyl chloride.  As is typical, Philadelphia’s pro-plaintiff reputation attracted plaintiffs from all over the country, including plaintiff Branham, who was from Illinois.  Utilizing one of the procedures that has earned Philadelphia that reputation, the court ordered consolidated trials right off the bat, with the “first eight actions” to be tried together and Branham’s case designated “lead.”  2011 WL 1366494, at *1.

Probably as a device intended to induce settlement (by increasing the litigation's annoyance factor), plaintiffs went after Rohm & Haas’ new parent, Dow, and demanded discovery into the manner in which Dow conducted its own studies (studies unconnected with Rohm & Haas) about vinyl chloride.  Plaintiffs intended to use this discovery to discredit Dow’s studies.  Id. (discussing plaintiff’s intent to attack the inclusion/exclusion criteria of Dow’s studies).

Dow was not a party to the Branham litigation, and except through its newly acquired Rohm & Haas subsidiary, it had no facilities in Pennsylvania.  Like almost any major manufacturing corporation, however, Dow maintained an agent for service of process in Pennsylvania, as it undoubtedly did in quite a few (if not all) states, because all major corporations get sued in a lot of places fairly frequently.

At first plaintiffs went about out-of-state discovery in the usual, correct way – they sought a commission in Michigan, where Dow was based, and made their demands through the Michigan courts.  Trouble was, Dow won.  The Michigan courts ruled that Pennsylvania plaintiffs could not demand discovery from a non-party until they exhausted remedies within the Pennsylvania litigation (even though the plaintiff was actually from Illinois):

[T]he [trial] court merely gave some deference to Dow’s legitimate confidentiality concerns and noted that such information was presumably discoverable through the normal course of the Philadelphia County proceedings.  It determined that, for those reasons, compelling Dow to disclose such information was not proper unless and until there was a showing that such information was not otherwise available.  Significantly, on appeal plaintiff does not argue that any of the information relating to environmental and remediation issues at the Ringwood, Illinois plant has not been discoverable through ordinary procedures in the Pennsylvania litigation.
Branham v. Rohm & Haas Co., 2010 WL 935650, at *3 (Mich. App. March 16, 2010).  The Michigan courts also held that the plaintiffs could not demand production of burdensome technical information that had the effect of drafting the producer (Dow) as an unpaid technical consultant/expert for the plaintiffs:

[P]laintiff argues that the circuit court erred in its conclusion that the subject subpoena was, in connection with the request for information concerning the carcinogenicity of vinyl chloride, seeking to compel Dow to share its information in order to bolster its expert's expertise or to turn Dow into an unpaid expert.  Instead, plaintiff contends she is not seeking to conscript Dow as her expert, but instead merely seeks studies Dow may have conducted about the toxicity of vinyl chloride.  We find that to be a distinction without a difference.

A defendant sued over pollution-related issues may not resist disclosure of studies and related such documentation relating to the pollution on the policy ground that such a duty would discourage efforts to investigate and remediate pollution.  However, “an expert is one who gives opinion testimony, and not testimony concerning ‘relevant facts,’ “and thus an expert “has a property right in his opinion and cannot be made to divulge it in answer to a subpoena.”  Klabunde v. Stanley, 384 Mich. 276, 282, 181 N.W.2d 918 (1970).  In this case, Dow is a nonparty to the underlying litigation who is being asked for information relating to cancer risks in general, rather than to the individual circumstances causing the death of plaintiff's decedent.  The circuit court’s decision to quash the subpoena in relation to such information pending plaintiff’s attempts to obtain it through less burdensome means did not lie outside the range of principled outcomes, and thus was not an abuse of discretion.
Id. at *4 (other citations omitted).

Having litigated and lost in the Michigan courts, plaintiffs chose to ignore the Michigan result, and took a second bite at the Dow apple back in the friendly confines of Philadelphia.

They got what they wanted – here in Philadelphia plaintiffs obtained an order that Dow, a Michigan non-party, provide the demanded discovery, the Michigan courts’ rulings notwithstanding.

Dow appealed. We’re not going into the ins and outs of what’s a properly appealable order, because the merits are bad enough.

The Superior Court of Pennsylvania – an intermediate appellate court that generates statewide binding precedent – held that any non-party corporation can be ordered to give discovery in a Pennsylvania court, as long as any significant part of its overall corporate structure (ignoring the separateness of subsidiaries) is located in Pennsylvania.

To get to that result, first, the court declared that it wasn’t bound by the ins and outs of statutes governing discovery subpoenas. “[N]o statute was needed for the court to issue subpoenas. . . . [A]s a necessary incident to its power to adjudge, a court of justice, within the sphere of its jurisdiction, has inherent power to compel the attendance of witnesses in proceedings before it.”  Branham, 2011 WL 1366494, at *5.  Statutory limits to out-of-state subpoenas are irrelevant because “no statute is needed for a court to issue a subpoena, which is within the inherent power of a court.”  Id. at *7.

Who needs statutes?

Next, the court declared that it wasn’t bound (nor very impressed) by all the federal, Pennsylvania trial court, and out-of-state precedent that Dow had amassed in support of its position.  These “purported authorities” were non-binding, and the court “disregard[ed] Dow’s argumentation that is not supported by pertinent, controlling Pennsylvania authority” – "authority" that, of course, does not exist.  2011 WL 1366494, at *6.

Appellant further argues that case law supports its contention that subpoena power is not co-extensive with general personal jurisdiction.  As previously noted, Appellant cites cases from other jurisdictions, including Mississippi, Louisiana, Oklahoma, and North Carolina, to conclude that “based on settled Pennsylvania law” it was not properly served.  However, Dow offers no pertinent Pennsylvania authority which actually holds the principles it proposes. FN15

FN15. Dow merely states it was unable to find any appellate cases applying §5301 to non-parties.

[Dow’s] limited choice of Pennsylvania case law is equally problematic. I n the chief Pennsylvania case it cites, Taylor v. Fedra Int'l, Ltd., 828 A.2d 378, 381 (Pa. Super. 2003) this Court found that the defendant . . . which was not qualified as a foreign corporation, nevertheless had sufficient activities to be amenable to suit in Pennsylvania.  Id. at 382–83.  Dow’s other Pennsylvania cases are no more persuasive of its argument. Dow’s first issue does not merit relief.
Branham, 2011 WL 1366494, at *8 (other footnote distinguishing other Pennsylvania cases omitted).  Having rejected all of Dow’s precedent as non-binding, what precedent did the Superior Court rely upon?


That’s right. The Superior Court did not cite a single case – from Pennsylvania or elsewhere – allowing one state's courts to subpoena directly (without going through the other state's courts) material possessed by a non-party in another state.

Who needs precedent?
Thus, the Superior Court found it perfectly OK for a Pennsylvania court to subpoena a non-party’s records in another state whenever the non-party has:  (1) a Pennsylvania agent for service of process “within the territorial limits of the Commonwealth,” or (2) “carr[ied] on of a continuous and systematic part of Dow’s general business within this Commonwealth.”  2011 WL 1366494, at *6, 7.  The second “continuous and systematic” prong was satisfied by the presence of Dow’s subsidiary, Rohm & Haas:

The installation of a high corporate executive, the erection of prominent signage, and the establishment of ongoing marketing efforts under the Dow brand are not isolated, sporadic acts. The trial court did not abuse its discretion in concluding that they constituted the carrying on of a continuous and systematic part of Dow's general business within this Commonwealth.
Id. at *7.  Dow's corporate structure - maintaining Rohm & Haas as a separate corporate entity - didn't matter.  See id. at *7 n.13 (declining to address “whether the trial court improperly imputed to Dow corporate ‘residence’ in Pennsylvania, based on activities solely attributable to its wholly owned subsidiary, Rohm and Haas”).

And, of course, Branham found no need to respect Michigan law about not drafting non-parties as expert witnesses.  “[W]e need not consider the Michigan decisions in our review, particularly on the issue of whether the discovery requested constitutes expert testimony.”  2011 WL 1366494, at *11.  After all, it’s only a Michigan resident’s information kept in its ordinary course of business in Michigan.  How could Michigan law possibly be relevant?  That compilation of the information demanded would take “a witness with technical proficiency” “several hundred hours” to compile doesn’t make it the equivalent of expert testimony under Pennsylvania law (even though the plaintiff is from Illinois).  Id. at *12 (relying on no precedent).  If a Philadelphia judge says it's not "expert" evidence, then it isn't.  Id.

Thus, comity went right out the window, too.  The court affirmed an order directing a Michigan non-party to compile and produce material kept in Michigan that the Michigan courts, in a prior proceeding in the same case, had ruled non-producible.  The Michigan decision wasn’t good enough for this Pennsylvania court:

Accordingly, we must determine if application of the principle of comity is appropriate in this case, rather than merely invoking it ipso facto.  Here, we find that Branham v. Rohm & Hass does not address the majority of issues raised in the instant appeal, and is of dubious reliability on the underlying discovery issues which it does address.  For example, on the issue of expert versus factual testimony, in a one paragraph treatment which merely summarizes Branham’s arguments, the court of appeals cites to no authority at all (not even to Michigan decisions), to dismiss Branham’s issue with a curt and conclusory single sentence, “We find that [the contention Branham was seeking Dow studies of vinyl chloride toxicity rather than seeking ‘to conscript Dow as her expert’] to be a distinction without a difference.”  Branham v. Rohm and Hass; supra at *5.

We conclude that on the few issues raised in both the Michigan subpoena and in the instant appeal (expert testimony, burdensomeness), even when not mere dicta, the Michigan decision does not contain the indicia of reliability which are a necessary threshold to our consideration of whether its decision has persuasive value for our review. Dow’s comity argument does not merit relief.
Branham, 2011 WL 1366494, at *10.

Who needs comity?

Given that the Pennsylvania Superior Court doesn’t even allow its own unpublished opinions to be cited (just try finding them on Lexis or Westlaw) see Superior Court I.O.P. 65.37, it’s peculiar indeed for that court to be criticizing the thoroughness of the decisions of another court that does.  The Pennsylvania pot’s a lot blacker than the Michigan kettle.

But Branham isn’t unpublished – unless granted discretionary review by the Pennsylvania Supreme Court, Branham’s going to be binding precedent on every trial court in Pennsylvania.  So what do we have?

After Branham, it appears that any corporate non-party – anywhere in the country – is potentially subject to a discovery subpoena directly issuing from a Pennsylvania court if that company either has an agent for service of process in Pennsylvania or has any significant facilities in Pennsylvania, even if those facilities are owned by a separate corporate subsidiary.  Not only that, it doesn’t matter if the material in question is not discoverable under that non-party’s home state’s rules.  Pennsylvania courts are now free to demand discovery from non-parties, even after their home state’s courts declare the same material non-discoverable.  But that won’t happen again.  After Branham, who’s going to bother going to the target’s home state?

After all, while all states’ courts are equal, following Branham, Pennsylvania’s courts are more equal than others.