Rules Matter, Part 2

Dr. Martin Luther King, Jr. once said, “Justice denied anywhere diminishes justice everywhere.” Maybe simply setting out that quotation, and not-so-simply meditating on it, would constitute an appropriate gesture on this day of service.


But, as usual, we have a few extra words to say before returning to the observances and pleasures of the holiday. Justice is not exactly the same thing as following rules. In fact, Dr. King showed that justice sometimes requires one not to follow the rules. That being said, the concepts of justice and consistent adherence to rules certainly reside in close quarters.



We’ve been thinking about rules while we spent much of the last few days watching contact sports. The National Football League had its best weekend of the year, and Ricky Gervais did his usual, tasteful job of hosting the Golden Globes. Rules played a big role for both. In football we expect enforcement of the rules. The Golden Globes is all about the violation of the rules (mostly by drunken entertainers and journalists whose immigration documents should be carefully checked -- perhaps twice). Nothing makes any sense without rules, even if those rules operate arbitrarily. Coloring outside the lines is cute only because there are lines. But, as lawyers, we're not out for cuteness. (Yes, we know: it shows.) We talk about the rule of law.



Understanding and following the rules is supposed to be a big part of what we do. That being said, it's almost surprising when judges enforce technical rules against plaintiffs who claim serious injuries. Sometimes the enforcement process threatens to become like the National Basketball Association, where referees don't call travelling or carrying if it looks like the player didn't obtain any advantage from the violation. In some courtrooms, the only thing judges ask about is whether there's any prejudice from a violation, not so much whether there was a violation. By contrast, last week we were pleased to report about a judge in the Aredia/Zometa litigation who actually followed the rules and employed them.



Well, the Aredia/Zometa defendants are on a roll. Our friends Joe Hollingsworth and Robert Johnston sent us another example where a fastidious federal judge applied the rules to dismiss a complaint. This happened on January 12, and what the judge specifically did was reject a plaintiff's untimely effort to designate a retained expert witness on specific causation. Harvey v. Novartis Pharms. Corp., No. 2:06-CV-1140-VEH (N.D. Ala. Jan. 12, 2012). The Harvey case was, for a time, part of the Aredia/Zometa MDL in Nashville, for which the appellate court is the Sixth Circuit. Later, the case was remanded to S.D. Alabama. While this case was still part of the MDL, it was subject to the case management order, which controlled the key deadlines. Pursuant to the CMO, the plaintiff in Harvey (originally Ms. Harvey, who suffered from cancer, and subsequently, after she died from cancer, her son) was required to file expert reports by February 21, 2011. The plaintiff (at that point Ms. Harvey's son) complied with the expert designation deadline by naming only the treating oral surgeon to testify about specific causation. That is, the plaintiff declined to designate a retained expert on the issue of specific causation, i.e., whether the drugs caused Ms. Harvey to develop osteonecrosis of the jaw. Op. at 3.



At the time that expert designations were due, the Aredia/Zometa MDL judge had already granted summary judgment in several other MDL cases in which the plaintiffs were represented by the same counsel as Ms. Harvey on the ground that those plaintiffs had not established that their treating physicians were qualified to provide specific causation evidence and had failed to designate any retained experts on that issue. Those summary judgments were later affirmed by the Sixth Circuit. Thomas v. Novartis Pharmaceuticals Corp., Nos. 09-6147, 09-6272, 09-6274, 2011 WL 3701816 (6th Cir. Aug. 23, 2011). We blogged about Thomas here. The Harvey case was remanded to S.D. Alabama on July 26, 2011. Alabama is in the Eleventh Circuit, not the Sixth Circuit.



Following remand, and following the Thomas decision (though not immediately following), the plaintiff moved pursuant to Fed. R. Civ. P. 16(b)(4) to modify the schedule to name a new expert. Op. at 4. Rule 16(b)(4) provides that “[a] schedule may be modified only for good cause and with the judge’s consent.” Under Eleventh Circuit precedent, a schedule should not be modified unless it cannot be met despite the due diligence of the party seeking the extension. So it all comes down to diligence. The plaintiff argued that he had no reason to believe that he needed to retain an expert witness on specific causation until after the Sixth Circuit affirmed the judgment in Thomas and stressed the importance of testimony on specific causation to the viability of his case.



The district court rejected these arguments, concluding that the plaintiff had not shown diligence sufficient to establish "good cause" under the rule. Op. at 8. Instead the court held that at the time expert disclosures had been due in the MDL, the plaintiff's counsel had "firsthand knowledge of potential obstacles pertaining to expert testimony on specific causation" due to his direct involvement in the Thomas cases. Op. at 8. Moreover, the Sixth Circuit decision was an unpublished opinion that was not controlling on the S.D. Alabama and, in any event, it’s not as if it was a bolt from the blue for a court to hold that treating doctors cannot opine on causation unless they are qualified to do so.



The court also observed that several other plaintiffs in the same group of cases had sought additional time to name a retained specific causation experts in the MDL given the Thomas rulings. Op. at 9. The “reactive” nature of the plaintiff’s motion in the wake of Thomas did not support a finding of due diligence. Id. The court stated that "any litigation tactic or strategy, such as waiting on an appellate decision" needed to be made within the time limits imposed by the MDL court. Op. at 10-11. The court also rejected the suggestion that the importance of the testimony to the plaintiff's case could substitute for a diligent effort to comply with the rules Op. at 10. In the end, the court found no evidence of diligence on the part of plaintiff and denied the motion. Op. at 11. Rules are rules.


We also think that justice was done in that case.


Happy Martin Luther King, Jr. Day.

Foreseeability Gets Its Wings Clipped In California

Late last night we received this message from a correspondent (who will remain anonymous since we lack permission):

Hopefully the groundwork for getting Conte thrown-out has been laid.  Only a matter of time.  And with any luck we’ll have an opportunity some day soon.

Getting a message like that makes us sit up a little straighter.  So we took a look at the attached case, O’Neil v. Crane Co., S177401, slip op. (Cal. Jan. 12, 2011), and we can see what she’s talking about.

As readers may recall from our original rants about Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299 (Cal. App. 2008), we think that decision is just flat wrong.  The California Supreme Court’s unanimous decision in O’Neil only reinforces that view.

O’Neil involved asbestos.  The plaintiff worked on an aircraft carrier.  Decades before the plaintiff was aboard ship, one class of defendants made the carrier’s propulsion system.  Those defendants supplied products that had no asbestos at all, but were manufactured to specifications that required addition of asbestos insulation from other sources.  Slip op. at 2. They were sued because it was “foreseeable” that asbestos would be used in conjunction with their products.

A second group of defendants made the asbestos-containing gaskets that were components of the ship’s engines.  These gaskets wore out and were replaced by similar products made by others well before plaintiff was aboard ship.  Id.  They were sued because it was “foreseeable” that their products would wear out and be replaced by other asbestos-containing products.

In neither case did plaintiff allege that he was exposed to asbestos from any products actually sold by the defendants.  Slip op. at 6.

In O’Neil the court unanimously held that “foreseeability” did not trump the other policies animating product liability – and did so for both strict liability and negligence.

As to strict liability the court stated:

We have never held that strict liability extends to harm from entirely distinct products. . . . Instead, we have consistently adhered to the Greenman formulation requiring proof that the plaintiff suffered injury caused by a defect in the defendant’s own product.

Slip op. at 10.

There is no duty to warn in California about defects in another supplier’s product, even though the defendant also failed to warn about similar risks in its own product:

[Defendants] gave no warning about the dangers of asbestos . . . in their products.  However, [plaintiff] never encountered these original parts. His exposure to asbestos came from replacement gaskets and packing and external insulation added to defendants’ products long after their installation. . . .  There is no dispute that these [other] products were made by other manufacturers.  No case law supports the idea that a manufacturer, after selling a completed product to a purchaser, remains under a duty to warn the purchaser of potentially defective additional pieces of equipment that the purchaser may or may not use to complement the product bought from the manufacturer.

Slip op. at 15 (citation, quotation marks, and footnote omitted).  Substitute a prescribing physician for the navy in O’Neil and you’ve got Conte.

Imposition of warning duties relating solely to other manufacturers’ products goes “too far”:

An interpretation of [the law] that would require a manufacturer to warn about all potentially hazardous conditions surrounding the use of a product, even when those hazards arise entirely from the product of another manufacturer, reaches too far.  There is no precedent in California law for such a broad expansion of a product manufacturer’s duty.

Slip op. at 25-26.

Where the exposure comes solely from subsequent exposure to other manufacturer’s products, there is no warning liability based on “foreseeability.”  “California law does not impose a duty to warn about dangers arising entirely from another manufacturer’s product, even if it is foreseeable that the products will be used together.”  Slip op. at 27.  “[T]he foreseeability of harm, standing alone, is not a sufficient basis for imposing strict liability on the manufacturer of a nondefective product, or one whose arguably defective product does not actually cause harm.”  Id. at 28.

We reaffirm that a product manufacturer generally may not be held strictly liable for harm caused by another manufacturer’s product.  The only exceptions to this rule arise when the defendant bears some direct responsibility for the harm, either because the defendant’s own product contributed substantially to the harm, or because the defendant participated substantially in creating a harmful combined use of the products.

Id. (citations omitted).

Public policy requires that product liability be limited to the manufacturers of products that actually cause harm.

• “[A] manufacturer cannot be expected to exert pressure on other manufacturers to make their products safe.” Slip op. at 30.
• Non-manufacturers “will not be able to share the costs of ensuring product safety with these other manufacturers.”  Id.
• “It is also unfair to require manufacturers of nondefective products to shoulder a burden of liability when they derived no economic benefit from the sale of the products that injured the plaintiff.”  Id.
• “[I]mpos[ing] on manufacturers the responsibility and costs of becoming experts in other manufacturers’ products . . . would impose an excessive and unrealistic burden.”  Id. (citation omitted).

Now, Conte involved a “negligent misrepresentation” claim rather than strict liability, but that won't save it from O'Neil.  See 85 Cal. Rptr.3d at 310 (“this is a case involving legal principles of negligent misrepresentation, and not a products liability action”), 310 n.7 (“negligent misrepresentation will subsume intentional fraud”).

O’Neil goes on to reach the same result – holding that there is no equivalent non-manufacturer liability claim in negligence.  The California Supreme Court directly addresses “foreseeability” and its limits, applying the public policy factors that Conte refused to address.  “[I]n strict liability as in negligence, foreseeability alone is not sufficient to create an independent tort duty.” O'Neil, slip op. at 29 (citation and quotation marks omitted) (emphasis added).  “Duty” in negligence “is not an immutable fact of nature but only an expression of the sum total of those considerations of policy which lead the law to say that the particular plaintiff is entitled to protection.”  Id. at 30-31.

The plaintiff in O'Neil argued foreseeability uber alles.  The court did not agree:

[F]oreseeability alone is not sufficient to create an independent tort duty. Instead, the recognition of a legal duty of care depends upon the foreseeability of the risk and a weighing of policy considerations for and against imposition of liability.

Slip op. at 31 (citations and quotation marks omitted).  Rather, “when the consequences of a negligent act must be limited to avoid an intolerable burden on society, policy considerations may dictate a cause of action should not be sanctioned no matter how foreseeable the risk.  Id. (citation and quotation marks omitted).

These “policy considerations” (the same Rowland v. Christian factors that Conte ignored, 85 Cal. Rptr.3d at 814) mandate no liability where product-related claims are being made against non-manufacturers.

• The connection between defendants’ conduct and [plaintiff’s] injury is extremely remote because defendants did not manufacture, sell, or supply any . . . product that may have caused his [injury].”  O’Neil, slip op. at 32.
• Plaintiff’s injury is “attenuated,” as it occurred decades after the allegedly negligent conduct  Id.
• “[L]ittle moral blame can attach to a failure to warn about dangerous aspects of other manufacturers’ products.”  Id.
• “There is no reason to think a product manufacturer will be able to exert any control over the safety of . . . products made by other companies.”  Id.
• “Manufacturers may also have scant ability to influence their customers’ choices about other products.”  Id.
• “[R]ecognizing a duty of care would clearly impose a significant burden on defendants and all other companies that could potentially be held liable for injuries caused by products they neither made nor sold.”  Id. at 33.
• “[R]ecognition of such a duty could lead to an overabundance of potentially conflicting product warnings.”  Id.
• “[I]t is doubtful that manufacturers could insure against the “unknowable risks and hazards” of other manufacturers’ products used decades later.  Id.

For all these reasons, the court in O’Neil unanimously held that, regardless of foreseeability, there should be no negligence liability against the manufacturer of one product for injuries caused by similar products manufactured by other companies:

[E]xpansion of the duty of care as urged here would impose an obligation to compensate on those whose products caused the plaintiffs no harm. To do so would exceed the boundaries established over decades of product liability law. [S]ocial policy must at some point intervene to delimit liability even for foreseeable injury. The same policy considerations that militate against imposing strict liability in this situation apply with equal force in the context of negligence.

Slip op. at 33 (citations and quotation marks omitted).

We hope, as did our anonymous correspondent, that O’Neil spells the beginning of the end for Conte.

That's A Spicy (Specious?) Footnote!

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

 

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

 

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

2012 WL 33360, at *5 n.6.

 

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

 

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

 

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

 

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

 

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

 

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

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

 

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

 

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

 

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

 

Comment k, however, defines a category of “unavoidably unsafe” products that “when properly prepared, and accompanied by proper directions and warning, [are] not defective, nor ... unreasonably dangerous.”  (Emphasis in original.)  We agree with comment k’s basic proposition-that there are some products that have dangers associated with their use even though they are used as intended.  We also agree that the seller of such products, when the products are properly prepared and marketed and distributed with appropriate warnings, should not be held strictly liable for the “unfortunate consequences” attending their use.  Thus, we adopt comment k’s basic policy as the law to be applied in this state.

Grundberg v. Upjohn Co., 813 P.2d 89, 92 (Utah 1991).  Then the court goes on to reject making the comment k/unavoidably unsafe determination on a case-by-case basis with respect to the product before it – a prescription drug (Halcion).

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

 

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

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

 

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

 

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

 

The Connecticut Supreme Court held that medical devices share the same liability principles with prescription drugs in Hurley v. Heart Physicians, P.C., 898 A.2d 777 (Conn. 2006), having previously in a drug case “adopted comment (k) . . . [and] concluding that the policy considerations set forth therein are persuasive and in accord with this state's product liability jurisprudence.”  Id. at 784.  The court found no reason to differentiate between drugs and medical devices:

Numerous courts have determined that they are applicable to prescription medical device cases.  The parties have not pointed us to any case . . . and we can see no principled reason to distinguish between a prescription implantable medical device like a pacemaker and a prescription drug.

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

 

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

 

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

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

 

Likewise, the Washington Supreme Court held, in a Dalkon Shield IUD case:

While a sound public policy might indeed dictate that such testing be undertaken before any product to be used on the human body is released in commerce, a decision of that kind rests with the legislative body.  The principles stated in comment k do not rest upon a finding or an assumption that all drugs, vaccines or other products obtainable only through a physician have been tested by the Food and Drug Administration.  Rather they have their basis in the character of the medical profession and the relationship which exists between the manufacturer, the physician and the patient.

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

 

The Illinois Supreme Court, in a case involving an x-ray machine, also invoked comment k principles:

The possibility that in certain cases protection of human life and health might be diminished by the imposition of liability has been recognized in section 402A of the Restatement.  Comment k indicates that certain products, though dangerous, are necessarily so and do not warrant the imposition of liability . . . .  [W]e conclude that public policy dictates against the imposition of strict liability in tort for injuries resulting from the administration of X-radiation treatments.

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

 

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

 

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

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

 

The differences . . . do not mandate rejection of the comment k standard. . . .  [T]he important considerations underlying [comment k] apply with equal force to implanted medical devices, which like prescription drugs, are available only through a physician and can save lives or reduce pain and suffering.  Such products are commonly crucial to the well-being of the patient.  Some devices are so important that, as is the case with prescription drugs, the patient faces death without them.

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

 

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

 

In applying comment k here . . . no significant distinction can be drawn between the device and the drug upon which the Supreme Court based its decision in Hahn [adopting comment k in a drug case]. . . .  [Plaintiffs] contend that . . . comment k does not apply to medical devices because the comment text does not mention them.  They cite no authority, however, for so restrictive an interpretation either of comment k or of Hahn, nor do they provide significant analysis of the language they seek to apply.  We find no reason why the same rationale applicable to prescription drugs may not be applied to medical devices.

Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa. Super. 2006).  Both before and after Creazzo, Pennsylvania courts routinely applied comment k in medical device product liability cases – holding repeatedly that the same considerations applied to all prescription medical products.  See Horsmon v. Zimmer Holdings, Inc., 2011 WL 5509420, at *2 (W.D. Pa. Nov. 10, 2011) (comment k principles “extend[] to medical devices”); Esposito v. I-Flow Corp., 2011 WL 5041374, at *4 & n.4 (E.D. Pa. Oct. 24, 2011) (agreeing with Geesey); Geesey v. Stryker Corp., 2010 WL 3069630, at *4-5 (E.D. Pa. Aug. 4, 2010) (“the Pennsylvania Supreme Court would apply comment k to medical devices”); Delaney v. Stryker Orthopaedics, 2009 WL 564243, at *6 (D.N.J. March 5, 2009) (comment k “has been extended to medical devices”) (applying Pennsylvania law); Soufflas v. Zimmer, Inc., 474 F. Supp.2d 737, 749-50 (E.D. Pa. 2007) (“predicting . . . that Pennsylvania Supreme Court would extend §402A’s comment k to exclude prescription medical devices from strict liability”); Parkinson v. Guidant Corp., 315 F. Supp.2d 741, 746-748 (W.D. Pa. 2004) (“the court agrees . . . that the same considerations exempting prescription drugs from the ambit of §402A equally apply to prescription medical devices”); Davenport v. Medtronic, Inc., 302 F. Supp.2d 419, 441-442 (E.D. Pa. 2004) (“[c]omment k precludes application of Section 402A to prescription medical devices”); Murray v. Synthes U.S.A., Inc., 1999 WL 672937, at *7 (E.D. Pa. Aug. 23, 1999) (“medical devices present[] the same or very similar risks and benefits” as prescription drugs, so comment k applies); Burton v. Danek Medical, Inc., 1999 WL 118020, at *7 (E.D. Pa. March 1, 1999) (“the same reasoning underlying comment k that excludes prescription drugs from Section 402A should also apply to prescription medical devices”); Taylor v. Danek Medical, Inc., 1998 WL 962062, at *7 (E.D. Pa. Dec. 29, 1998) (comment k applies to medical devices because they present the same “unique set of risks and benefits” as prescription drugs in that “what may be harmful to one patient may be beneficial to another”); Lawrence v. Synthes Inc., 2002 WL 32747667, at *24 n.101 (Pa. C.P. July 25, 2002) (“[p]rescription medical devices must be analyzed similarly”), aff’d mem., 860 A.2d 1142 (Pa. Super. 2004); Ford v. McGhan Medical Corp., 142 Pitts. Leg. J. 201, 214 (Pa. C.P. Allegheny Co. 1994).

 

Other cases applying comment k equally to medical devices:

 

Adams v. G.D. Searle & Co., 576 So.2d 728, 731-33 (Fla. App. 1991) (IUD case; applying comment k on case-by-case basis); Burwell v. American Edwards Laboratories, 574 N.E.2d 1094, 1098 (Ohio App. 1989) (heart valve case; comment k is “the standard to be applied in cases involving unavoidably unsafe products”); Perfetti v. McGahn Medical, 662 P.2d 646, 649-50 (N.M. App. 1983) (IUD case; “the trial court properly instructed concerning unavoidably unsafe products”); Racer v. Utterman, 629 S.W.2d 387, 395 (Mo. App. 1981) (surgical drape case; Restatement “afford[s] protection to products of this nature whose value is recognized and whose dangers are not only unknown but incapable of determination”); Bravman v. Baxter Healthcare Corp., 984 F.2d 71, 75-76 (2d Cir. 1993) (medical device “may be treated . . . as an unavoidably unsafe product” under comment k cases involving drugs) (applying New York law); Coursen v. A.H. Robins, 764 F.2d 1329, 1337 (9th Cir. 1985) (“If the prerequisites to establish a Comment k defense are met, the defense applies to Dalkon Shield cases”) (applying Oregon law); Brooks v. Medtronic, Inc., 750 F.2d 1227, 1230 (4th Cir. 1984) (“products, particularly ethical drugs and medical devices, often cause unwanted side effects despite the fact that they have been carefully designed and properly manufactured.  In section 402A terminology, such products are deemed ‘unavoidably unsafe’,”) (applying South Carolina law); Emody v. Medtronic, Inc., 238 F. Supp.2d 1291, 1296 (N.D. Ala. 2003) (“prescription medical devices are unavoidably unsafe products, and where inherent risks are at issue, the only other permissible theory of liability is inadequate warning”); Parks v. Danek Medical, Inc., 1999 WL 1129706, at *6 (N.D. Ind. June 17, 1999) (“comment k has been held to apply to prescription medical devices, as well as to prescription drugs”); Clark v. Danek Medical, Inc., 1999 WL 613316, at *4 (W.D. Ky. March 29, 1999) (the “implant is the sort of desirable but unavoidably unsafe product described by . . . comment k); Harwell v. American Medical Systems, Inc., 803 F. Supp. 1287, 1300 (M.D. Tenn. 1992) (“Several courts have applied Comment k to prescription medical devices. . . .  Under Comment k, the manufacturer of an unavoidably unsafe product is not liable for injuries arising from the product, if the manufacturer properly designed and manufactured the drug or device and provided adequate warnings”); Duncan v. Iolab Corp., 1991 WL 544617, at *1 (M.D. Fla. Nov. 18, 1991), aff’d mem., 12 F.3d 194 (11th Cir. 1994); Allen v. G.D. Searle & Co., 708 F. Supp. 1142, 1148-1149 (D. Or. 1989) (IUD case, applying comment k).

 

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