Tuesday, January 31, 2012

Guest Post - Never Odd or Even, Just Preempted

Oh wait a minute.... That's the "pamidronate," not the "palindromate" MDL....  In any event, we have a guest post today from Joe Hollingsworth, of (the not coincidentially named) Hollingsworth LLP.  Joe represents one of the successful moving defendants in the very recent decision that's described below.

Take it away Joe:

On January 30, 2012, the United States District Court for the Eastern District of New York granted summary judgment in favor of Sandoz Inc., APP Pharmaceuticals, Inc., Ben Venue Laboratories, Inc., Teva Parenteral Medicines, Inc., and Hospira, Inc. with respect to all remaining plaintiffs in the generic pamidronate multidistrict litigation.  In re: Pamidronate Products Liab. Litig., No.1:09-MD-2120 (KAM), slip op. (E.D.N.Y. Jan. 30, 2012).  Judge Kiyo Matsumoto found that all of the plaintiffs’ claims were preempted by federal law under the Supreme Court’s recent decision in Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011).

The Pamidronate MDL was formed in December 2009 to address claims that the drug, the generic form of the bisphosphonate cancer treatment Aredia®, causes osteonecrosis of the jaw.  The MDL included claims by as many as 134 plaintiffs, who had sued some or all of the four manufacturers of generic pamidronate.  The defendants had moved to dismiss the claims of the majority of plaintiffs based on their failure to identify which generic pamidronate product they allegedly had taken.  Following the Supreme Court’s ruling in Mensing, the court stayed further briefing and consideration of the pending product identification motions to consider the impact of generic preemption.  A number of plaintiffs agreed to voluntarily dismiss their claims with prejudice, and the defendants moved for summary judgment with respect to the remainder.  In her decision, Judge Matsumoto found that the plaintiffs’ failure-to-warn claims were squarely preempted under Mensing and that this ruling extended to the plaintiffs’ negligence and breach of express warranty claims too, which are warnings-based claims.  Judge Matsumoto further found the plaintiffs’ design defect claims preempted because the Supreme Court found that a generic drug’s design, like its label, is subject to a “sameness” requirement with respect to the reference brand drug.  Consequently, the court granted summary judgment with regard to all remaining claims.

Monday, January 30, 2012

When an Expert Spreads it on Too Thick

This is the Drug and Device Law blog, but sometimes we discuss cases that do not involve drugs or medical devices. We do so when the cases offer some sort of principle or object lesson that might prove useful. Such is the case with Kidd v. Conagra Foods, Inc., 2012 U.S. Dist. LEXIS 2725 (N.D. Ga. Jan. 9, 2012). It is from the peanut butter MDL.

Truth be told, we've always loved peanut butter. It's a yummy source of protein. It also carries a whiff of nostalgia. It seemed to the Drug and Device Law Toddler that a peanut butter and jelly sandwich was an absolutely unimproveable lunch item, especially with the chunky version of peanut butter. Our dietary proclivities have acquired more sophistication over the years, but old habits and tastes die hard. Once we were defending a criminal case and the prosecutor proposed to resolve the case by giving us a PBJ. Wow - not only would our client avoid jail time, but we'd get a scrumptious snack out of the deal. Turns out we were right about no jail time, but wrong about the culinary component -- PBJ meant "probation before judgment." Like peanut butter itself, the outcome seemed bittersweet.

Peanut butter is more complicated now. The peanut allergy is far and away the most common serious adverse food reaction. About one percent of kids are allergic to peanuts, and today the use of peanuts and peanut butter in schools is subject to all sorts of restrictions. The Drug and Device Law Daughter told us that there's either one peanut-butter-friendly table or one no-peanut-butter table at her school cafeteria -- we cannot remember which it is. Either way, it's nothing like our simple peanut butter days (definitely not salad days) munching PBJs en masse during the Johnson administration. Who knew that peanut butter would become the stuff of product liability?

The Kidd case is not about an allergy. Instead, it is a personal injury action where the plaintiff alleged that he contracted salmonella from peanut butter. (And not just any salmonella -- Salmonella Tennessee. Query whether a state wants a disease strain named after it. This is hardly Chamber of Commerce stuff.) The defendants filed a motion for summary judgment, which was denied because the testimony of the plaintiff doctor expert "created an issue of fact as to the cause of the Plaintiff's illness." 2012 U.S. Dist. LEXIS 2725 at *20. The court then ordered that the allegedly contaminated peanut butter be tested. Guess what? It tested negative for salmonella. That should end the case, right? Would you be surprised to learn that the plaintiff expert explicitly based his opinion "on the assumption that the Plaintiff's peanut butter was contaminated"? Id. at *21. Would you be surprised to learn that the plaintiff expert testified that if the peanut butter in question "tested negative for salmonella, he would change his opinion."? Id. at *22.

Would you be surprised to learn that the expert turned out to be utterly shameless?

After the peanut butter tested negative, the plaintiff's expert submitted a second affidavit, now saying that the negative test was unreliable. For instance, he opined, maybe the salmonella contaminated only a small portion of the plaintiff's peanut butter.

Is it any wonder that some people call some expert witnesses jukeboxes or saxophones, because they play any tune requested?

Perhaps it was the sheer effrontery of the expert's contradictory opinions, but the court was having none of it. First, the court held that the expert's opinion was untimely. The MDL had set forth deadlines for filing global expert opinions, and an opinion on the reliability of salmonella testing was deemed to be global rather than case-specific. Id. at *23. Second, the expert was simply not qualified to opine on the reliability of salmonella testing. He was "a medical doctor, not a microbiologist or an expert on food testing." Id. Third, the plaintiff's new opinion asserted "that 87% of peanut butter tests result in false negatives for salmonella contamination," but supplied no authority for that statistic. Id. at *24. Thus, the opinion was unreliable. And now going back to the original opinion, since it "was based upon the false assumption that the Plaintiff's peanut butter was contaminated by salmonella," the expert's opinion would now be entirely disregarded. Id.

We like the court's opinion for a couple of reasons. As in the cases we discusssed in our Rules Matter posts (here and here), the court gave real teeth to its deadlines. Further, the court resisted the matador technique of waving issues by, leaving it to the jury to decide whether the expert was more strumpet than scientist. Instead, the court actually performed its role as gatekeeper. Of course, it's possible that the court was emboldened to do the right thing because an additional fact surfaced after the original summary judgment motion: the plaintiff's treaters testified that "they did not diagnose the Plaintiff with Salmonella because there was no evidence to support such diagnosis." Id. at *25. The case, in short, was an outrage and needed to go.

A court is smart to shut down an expert who blatantly speaks out of both sides of his mouth. It's even easier for the court to do that when it is so obvious that the truth is sticking to the roof of the expert's mouth.

Friday, January 27, 2012

Who Are We/What Can We Do?

We’ve been blogging now, with one lineup or another, since November of 2006 – over five years.  As we’ve said on a number of occasions, such as here, our philosophy has always been that a rising tide lifts all boats.  It’s the nature of stare decisis (that earlier court decisions are the precedent on which later decisions rest) that defense wins anywhere tend to help other defendants everywhere.  We thus strive to keep the pharmaceutical/medical device defense community abreast of new decisions, new arguments, and (when we’re lucky) new strategies that can help win cases.

We’re big firm lawyers.  We have big firm clients and big firm resources.  Not everybody is or does.  But cases not involving big/big/big can be every bit as important as those that do.  For instance, the two major product liability cases that established the (we’d say unfortunate) course of strict liability here in Pennsylvania are Azzarello v. Black Brothers Co., 480 Pa. 547, 391 A.2d 1020 (1978), and Berkebile v. Brantly Helicopter Corp., 462 Pa. 83, 337 A.2d 893 (1975).  Everyone who’s heard of the Black Brothers Co. or the Brantly Helicopter Corp. other than in connection with these cases raise your hands.

We thought so.

Those cases handled for those clients have screwed up the law in Pennsylvania since before some of us started practicing it.  We don’t think Pennsylvania’s unique.  The Fortune 500 and the AmLaw 100 aren't anywhere near all that matters.

Thus, as much as we want to reach – and be thought well of by – our big firm colleagues around the country (and globe), we believe it’s probably even more important to reach the folks in the regional firms, and defending the smaller companies, who are involved in prescription medical product liability litigation.  Because those folks, and their clients, might not have the resources to do the kind of comprehensive research that we're used to, we try to make what we do on this blog as helpful as possible, and we have even taken research requests on occasion.  That’s probably the chief reason we keep our scorecards and cheat sheets.  These concern important or current subjects, and provide (we hope) comprehensive and up-to-date legal research that anybody can use and craft to their particular cases.

For these five+ years, we’ve always had a Google Groups subscribe feature on the right hand side of our blog, near the bottom, that allows anybody who wants to receive all of our posts by email.  Over those five years, 784 people have signed up (actually, more, but we periodically delete group members whose emails are reported as “bouncing” – meaning invalid).  That gives us some data to indicate who the subscribers to this blog, the “we,” are.

We have to discard, at the outset, 229 subscribers whose emails end in “yahoo,” “gmail,” or various other nonspecific domains (that’s what our Google analytics call them, anyway).  Anybody who doesn’t want us to know where s/he is affiliated is certainly free to do so.  We’re not nosy.

Of the remaining 555 subscribers, 365 of them (one for each day of the year, except this is 2012) are with identifiable defense firms.  We have subscribers, who get all of our posts, at 116 different defense firms – from names that anybody would recognize, to names that even we had to check out online to figure out what side of the “v.” they were on.  To us, the number of firms is more satisfying than the number of subscribers, because any subscriber can pass any of our posts around internally.  The more defense counsel we reach, directly or indirectly, the better we like it.

Some firms, of course, have a lot more subscribers than others.  We’d like to give a shout out to our most numerous supporters:

Tucker, Ellis & West – 40 individual subscribers
Shook Hardy & Bacon – 33 individual subscribers
Reed Smith – 20 individual subscribers
Drinker Biddle – 18 individual subscribers
Dechert – 12 individual subscribers (including us)
Sidley & Austin – 10 individual subscribers

We set the cut off at ten.  Why?  Probably because we have ten fingers.

Another 156 of our subscribers are in house.  We’re not going to identify even company names here, but we’re pleased to count among our number practically every well known name in the pharmaceutical and medical device business.  We’ve also been invited into many smaller manufacturers, for a total of 66 different recognizable corporate domains.

There are also a handful of subscribers from other manufacturing companies that, as far as we know, don’t make prescription medical products.  Some of our interests – class action tolling and removal before service to name a couple – do have impact that extends beyond companies who have to jump when the FDA says so.

We also count 34 plaintiff-side subscribers.  Yes, we know who you are (that is, if you sign up from work).  No, we’re not going to delete you or anything like that.  We don’t work that way.  Frankly, we’re rather flattered when those on the other side think we’re saying things that are worth knowing about – even if at times we’re sure we make our opposing colleagues want to pound their keyboards to bits, put their fists through their screens, or throw their PDAs as far as they can.

The remainder of our subscribers come from a variety of related interests and fields.  Trade associations – both PhRMA and AdvaMed have subscribers.  Folks from both Lexis and Westlaw have signed up.  We have subscribers from the FDA and other governmental entities, both federal and state.  There are some academics on the list, or at least their email addresses end in “.edu” (they might be law students).  We also have various consultants, members of the press (including the medical press), CLE providers, insurance company people, contract researchers, and other health related businesses.

So once you’re here, what can you do?  Well, if you’re here to take advantage of our legal research over the years, we put up a post less than a year ago that compiles quite a bit of that in one place (with links).  We’ve already mentioned our cheat sheets and scorecards.  Briefly, scorecards contain all cases, pro and con.  Cheat sheets include only decisions favorable to our (the defense) side.

Each one of these posts is strictly in chronological order and is accessible via a separate link on the right-hand side of the blog, under the category helpfully called “Links.”  We’re not known for creativity – except that there are two successive “Links” sections on the blog.  Our internal links are in the second of these.  The first serves as our blogroll (links to other blogs/websites of interest).

The blog’s basic Google Blogger software (we’re not into pictures and other extraneous stuff here at DDLaw) also provides some tools to help find things.

The blog has an “archive” that includes every post we've ever written – all 1700+ of them.  That can be useful, but you first have to know the date or name of the post.

If you don’t know the date or the name (and we, ourselves, are quite forgetful), there’s an internal blog search function in the blog’s extreme upper left-hand corner.  It’s not labeled (probably should be) but it has a clickable white space for typing followed by what’s supposed to look like a hand magnifying glass.  That search function is good enough for searching relatively unusual terms (such as “conveniens”) or case names (such as “Mensing”), but less useful when trying to accomplish anything more sophisticated.  When we require more involved searching, we simply go to Google and search for “druganddevicelaw” along with whatever other terms we want to find.

On the right-hand side, below our “Archive” is a long list of terms called “Topics.”  Each one is clickable, and will produce a list of every one of our posts that we’ve decided (in our utterly unreviewable discretion) belongs under that heading.  We can use as many headings as we want, and some of our posts are listed in as many as a half-dozen different Topics.  The number of posts in a topic range from one (a lot of things) to over 100 (preemption, class actions).  While we might have something on the topic of cancer, we won't have anything on the topic of capricorn.

Finally, most people know this already, but in case somebody doesn’t, on just about any internet page, including our blog, you can use “control f” to search for particular words, phrases or sequences of characters that appear on that page.

So thanks to all our loyal subscribers, and to everybody else whom we reach through RSS feed, Twitter, Lexology, and of course those who simply click to our site (over 500 a day according to Google analytics).

The State-of-the-Art Conte Defense

Because of Dechert's involvement in Reglan litigation, we can't say as much as we'd like to (or used to) about so-called "Conte" liability - that is theories by which plaintiffs who only took generic drugs attempt to impose liability on the manufacturer of a branded bioequivalent that they neither bought nor consumed.  As we mentioned previously, that issue is currently pending in the Alabama Supreme Court in Wyeth v. Weeks, its first appearance in a state high court.

We're willing to bet that the defense briefing in Weeks represents the current state of the art in defending/arguing against Conte-style liability.  For the benefit of everyone out there who is arguing against Conte, we're therefore providing four publicly filed briefs from the Weeks case:  those filed by defendant/appellant Wyeth (be patient, this one takes a while to download), amicus Product Liability Advisory Council, amicus Defense Research Institute, and amicus Pharmaceutical Research & Manufacturers of America.

Thanks to Kevin Newsom at Bradley Arent for the Wyeth brief, to Chilton Varner, at King & Spalding for the PLAC brief, and to Paul Schmidt and Mike Imbroscio at Covington & Burling for the PhRMA brief.  We grabbed the DRI brief from its website.

Thursday, January 26, 2012

On Performance Standards and Preemption

As we’ve mentioned before, the supposed “parallel violation claim” exception to medical device preemption has been frustratingly vague.  That’s because it originated in a complaint’s vague language that Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) – decided on a motion to dismiss – speculated might have stated such a claim.  A single paragraph of dictum in Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008), seemingly recognizing the exception in the course of explaining that the plaintiffs had waived it, only made things worse.  So the question of when a claim of a "violation" of FDA regulations is actually "parallel" to the FDA's actual requirements is probably the hottest topic in PMA preemption-land right now.

A new case, Walker v. Medtronic, Inc., No. 10-2219, 2012 WL 206036, slip op. (4th Cir. Jan. 25, 2012), is the first court of appeals case that really takes a close look at what “parallel” claims entail post-Riegel.  While we’d prefer that this phantom exception not exist at all, the court’s discussion keeps it tightly constrained and thus gets a thumbs up from us.  Perhaps it was fitting that Walker was decided on Bexis’ birthday.

Walker involved what’s essentially a spinal version of a pain pump – designed to infuse a preset amount of specific drugs into the fluid that surrounds the spinal cord.  It’s supposed to be accurate within ± (that’s “plus or minus”) 15% of whatever it’s set for, but both the FDA’s approval letter, and the FDA-approved materials that accompany the pump make clear that this 15% is not some kind of absolute guarantee, but only a best estimate, and there are a lot of problems that can lead to a deviation (such deviations being reportable to the FDA as adverse events).  Slip op. at 7-8, 14-15.

The pump was “undisputedly a Class III device.”  Slip op. at 7.  Cf. Duggan v. Medtronic, Inc., ___ F. Supp.2d ___, 2012 WL 45503, at *5 (D. Mass. Jan. 10, 2012) (rejecting argument that based upon claim that not all components of different pump system weren’t all originally PMAed).  Thus Riegel preemption applied.

Because Walker is a product liability case, it doesn’t take much to describe what happened.  The decedent was taking a bunch of painkilling drugs at the same time and died from “[c]ombined hydromorphone, hydrocodone, diazepam, and venlafaxine intoxication."  Slip op. at 9. Only one – hydromorphone – was being infused using the pump, so that’s the one the plaintiff targeted.  Plaintiff obtained some sort of "expert" who, through some unexplained process (probably assuming the pump had been filled to the brim when it wasn’t) claimed there had been an overdose.  Id.

Whether there was or was not an overdose was not germane to the preemption summary judgment motion.  Slip op. at 9-10 n.3.  That underscores why preemption is so powerful.  It applies irrespective of the merits of the underlying litigation.

Trying to turn the ±15% language in the product literature into a “guarantee of performance,” slip op. at 17, plaintiff argued that she had stated some sort of unpreempted “parallel” violation claim because she had some evidence that the device was outside this range.  The court held that no such claim existed.

In so doing, Walker had to decide how broadly to construe the “parallel” claim loophole to preemption.  Fortunately its construction was relatively restrictive.  The FDA has a formal type of specification, called a “performance standard,” under which a manufacturer must guarantee a particular level functioning upon pain of violating the Medical Device Amendments:

The FDA may condition its grant of premarket approval upon certain requirements.  Significantly for our purposes, the FDA may require that a device meet certain performance standards if it “determines that a performance standard is necessary to provide reasonable assurance of the safety and effectiveness of the device.”  21 U.S.C. §360d(a)(1).

The establishment of a performance standard is a formal process specifically governed by the MDA.  It requires publication of a notice of proposed rulemaking in the Federal Register setting forth justification why the performance standard is necessary, “proposed findings with respect to the risk of illness or injury that the performance standard is intended to reduce or eliminate,” and invitation for comments from interested persons.  Id. at §360d(b)(1)(B). . . .  When the FDA establishes a performance standard for a Class III device, it does so as a precursor to the grant of premarket approval.  21 C.F.R. §861.1(b)(3).
Walker, slip op. at 5-6 (footnote omitted) (emphasis added).

When a plaintiff, under state law, tries to take some statement, or other device attribute, that hasn’t jumped through the hoops to become a “performance standard,” and through litigation tries to make it into such a mandatory standard is something that's “different from or in addition to” within the meaning of the Act’s preemption clause.  Therefore, preemption bars the claim:

Whether the plus or minus 15 percent specification is a formal performance standard is pertinent because only such a performance standard could create the type of binding requirement that would make [plaintiff’s] claims impose requirements parallel to, as opposed to more restrictive than, those imposed by the FDA.
Slip op. at 14 (emphasis added).  The court revisits the same point, at greater length, a little later:

[It] is incontrovertible under FDA regulations:  the only mechanism for creating a binding, ongoing performance requirement is the creation of a performance standard.  And [plaintiff] does not dispute that, here, the plus or minus 15 percent specification is not a performance standard. . . .  [I]f we were to treat the flow rate as a requirement, we would be imposing a heightened standard beyond that of the FDA – which is impermissible under Riegel.  Moreover, as we have noted, such a holding would upend the carefully calibrated construct Congress created in the MDA, balancing the potential rewards of such devices following the rigorous process of FDA approval against the cost of preempting common law claims based on standards different than those imposed by the FDA.

Id. at 15 (emphasis added).  No formal "performance standard" – that's simple, easy to apply, and above all, rare.

The device in question was manufactured sold, etc. in full compliance with everything the FDA required, including those aspects that underlay the expected ±15% flow rate.  Plaintiff did not contest that.  E.g. slip op. at 16 n.5.  But that expectation was not the same as a real FDA requirement that the device could not, for any reason, ever deviate from that rate.  For plaintiff to use state law to convert any deviation into a “violation” that did not, in fact, exist was dissimilar from what the FDA required and therefore preempted:

[N]othing in the [device’s] premarket approval application – which was approved in its entirety by the FDA – purported that the device would always dispense medication within the range of the plus or minus 15 percent. . . .  To the extent that [plaintiff] interprets the plus or minus 15 percent specification as a guarantee of performance, she seeks to impose a more demanding standard than that of the FDA, rather than a parallel one.
Id. at 17.

As anyone reviewing the cases on our device preemption scorecard can attest, this is one version – and a rather restrictive one – of the elusive “parallel” violation claim that post-Riegel courts have adopted.  While not tying the analysis explicitly to “performance specifications,” numerous courts have rejected the theory that underlay the plaintiff’s arguments in Walker, which is that the mere malfunction of a device somehow establishes a non-preempted violation claim.  See Carrelo v. Advanced Neuromodulation Systems, 777 F. Supp.2d 303, 314 (D.P.R. 2011) (“the failure of a Class III medical device does not establish the existence of a manufacturing defect”); Haynes v. Cyberonics, Inc., 2011 WL 3903238, at *3 (N.D. Ga. Sept. 6, 2011) (“a manufacturer could comply with all FDA regulations, but nevertheless produce a product containing an unintended flaw or abnormal condition”); Timberlake v. Synthes Spine, Inc., 2011 WL 711075, at *9 (S.D. Tex. Feb. 18, 2011), (“plaintiff “must plead and prove the specific way in which Defendants’ manufacturing process differed from that approved by the FDA in order to show that his manufacturing defect claim is truly ‘parallel’”); Cafferty v. Cayuga Medical Center, 2011 WL 541809, at *5 (N.D.N.Y. Feb. 8, 2011) (“under the federal law governing the PMA process, there is no demand that a product be risk-free, only that its benefits, if manufactured according to specifications, outweigh its risks”; res ipsa loquitur is “refuted by Riegel”); Gelber v. Stryker Corp., 752 F. Supp.2d 328, 334 (S.D.N.Y. 2010) (preemption because plaintiffs “have not pointed to evidence of device-specific violations of federal law”); Rankin v. Boston Scientific Corp., 2010 WL 672135, at *4 (E.D. Ky. Feb. 19, 2010) (“[defendant] received premarket approval”; “that the [device] allegedly failed during normal use does not override the clear language of §360(a) or . . . Riegel”); Banner v. Cyberonics, Inc., 2010 WL 455286, at *4 (D.N.J. Feb. 4, 2010) (“FDA approves the process by which a Class III device is manufactured, but it does not guarantee that every device manufactured in that process will work”; “if the FDA approves a manufacturing process and the defendant-manufacturer conforms with it, a [malfunction] does not give rise to liability”); Ilarraza v. Medtronic, Inc., 677 F. Supp.2d 582, 588 (E.D.N.Y. 2009) (“vague and open-ended . . . regulations . . . cannot serve as the basis for a parallel claim[, s]ince these regulations are open to a particular manufacturer’s interpretation”); Funk v. Stryker Corp., 673 F. Supp.2d 522, 532 (S.D. Tex. 2009) (plaintiff “essentially relies on a circular argument that because he was injured and because the device (allegedly) contained impurities, [it] therefore violated FDA regulations.  Such reasoning is contrary to the holding in Riegel”), aff’d, 631 F.3d 777 (5th Cir. 2011); Williams v. Cyberonics, Inc., 654 F. Supp. 2d 301, 306, 308 (E.D. Pa. 2009) ("[t]o avoid federal preemption, a plaintiff must make some showing that the medical device was not manufactured in accordance with FDA standards”; “[w]ithout proof that the [device] did not adhere to the premarket approval, [plaintiffs’] claim must fail”), aff’d, 388 Fed. Appx. 169 (3d Cir. 2010); Miller v. DePuy Spine, Inc., 638 F. Supp.2d 1226, 1230 (D. Nev. 2009) (preemption where there is “no evidence to show that the [device] was manufactured out of conformity with the materials or manufacturing specifications approved by the FDA”); In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147, 1158 (D. Minn. 2009) (“In the absence of any specific requirement . . . holding [defendant] liable for such a [specific] ‘defect’ would impose requirements ‘different from, or in addition to’ those under federal law”), aff’d, 623 F.3d 1200 (8th Cir. 2010); Delaney v. Stryker Orthopaedics, 2009 WL 564243, at *6 (D.N.J. March 5, 2009) (plaintiff “does not specify in what way [device] deviated from the manufacturing process that the FDA approved”; “mere occurrence of an accident” insufficient for preemption); Clark v. Medtronic, Inc., 572 F. Supp. 2d 1090, 1094-95 (D. Minn. 2008) (“[p]laintiff is ultimately wrong when he assumes that premarket approval guarantees the device is completely safe”; his “claims are not based on a breach of the MDA as enforced by the FDA”; “[t]hus plaintiff’s claims are preempted”); In re Medtronic Sprint Fidelis Lead Products Liability State Court Litigation, 2009 WL 3417867 (Minn. Dist. Oct. 29, 2009) (“that the FDA specifically approved the design and proposed manufacturing processes” requires preemption); Colombini v. Westchester County Health Care Corp., 2009 WL 2170230, at *4 (N.Y. Sup. July 6, 2009) (“plaintiffs cite to no document from the FDA which specifically mandates [the items at issue] as the only solutions to the problems.  Plaintiffs therefore have not demonstrated that they have any parallel claims”) (in table at 899 N.Y.S.2d 58).

As the court in Walker observed, “[n]either [plaintiff] nor the dissent point to any case law, nor have we found any, in which a court has reached a contrary conclusion.”  Slip op. at 19.  We haven't seen any either.

So Walker is the first appellate court explicitly to hold that the mere assertion of a device malfunction is not, at least under anything approaching ordinary circumstances, enough to establish a “parallel” violation claim.  The court provides a narrow escape hatch – that a parallel claim would be established if the FDA had adopted a “performance standard” that set a particular characteristic as an absolute floor, the non-attainment of which, without more, constitutes a violation.  That’s all well and good, but such device-specific “performance standards,” if not quite as rare as hen’s teeth, come close.  We’ve only seen one even asserted in any of the post-Riegel device preemption cases we’ve read (and we think we’ve read them all).  Burgos v. Satiety, Inc., 2011 WL 1327684, at *5 (E.D.N.Y. Apr. 5, 2011), and even there it wasn’t sufficiently described that we could be sure such a thing actually existed.

Thus, while we’d rather not have a “parallel” requirement exception to preemption at all (they’re disguised attempts at private enforcement of the FDCA, which the statute bans), if we have to have one, the articulation in Walker – requiring the presence of a “performance standard” – is the kind of bright line we can live with.

Wednesday, January 25, 2012

A Quick Boles Update

            When last we left Boles v Merck, the case had been tried twice and the trial court had certified for appeal its decision denying defendant’s motion for judgment as a matter of law or in the alternative for a new trial.  In denying the defense motion, the court saw fit to reduce the verdict, which the plaintiff rejected in favor of seeking a new trial.  See posts here and here.

While we are still waiting to see if the Second Circuit will accept that appeal, it did have something to say about plaintiff’s counsel’s attempt to appeal the order imposing minimal sanctions against him for his outrageous conduct in Boles II.  Douglas v. Merck & Co., Inc., No. 10-4196-cv, slip op. (2d Cir. Jan 23, 2012) .  They quashed it and told Douglas he had to wait until the trial court’s decision to reduce the verdict was before the appellate court – something we hope happens sooner rather than later.

And, while this is really a non-event, what it reminds us is that we needn’t be talking about appeals of remittiturs and sanctions – what we should really be seeing is a new trial.  So, since it is a slow news days, we’ll take a minute to stand on our soap box and once again advocate that courts should be more willing to toss out verdicts that are a product of juror passion and prejudice rather than simply remitting them.  Just looking at Boles II as an example, in ruling sua sponte on remittitur, the court said that it “believes the $8 million verdict is unreasonably high, but cannot point definitively to anything in the records that caused the surplus.” In re Fosamax Products Liability Litigation, 742 F. Supp. 2d 460, 484 (S.D.N.Y. 2010) If the jury awarded the plaintiff over five times the maximum amount of justifiable compensatory damages, isn’t that sufficient proof that the verdict was tainted?   And where there is taint, a new trial should follow.

We understand that new trials based on attorney misconduct and subsequent jury passion are rare because generally courts afford lawyers latitude when representing their clients.  But lawyers need to be held accountable when they go too far.   There is a limit to what lawyers can do in the courtroom when advocating on behalf of their clients.  When plaintiffs’ attorneys – in pursuit of excessive verdicts -- are allowed to vilify defense witnesses, attack defense counsel and distort and mischaracterize the evidence to the jury, the basic tenets of fairness and impartiality in litigation go out the window. 

Jurors are people too.  As such they, we all know that they are influenced by things like whether they connect to a particular witness, fun demonstratives, and well even if their seats are comfortable.  All that aside, juries primarily should be focused on the facts and their verdicts should be supported by the facts in evidence.  When they aren’t, new trials are warranted.  That should be true if the evidence just isn’t there or if the evidence has been so diluted by attorney misconduct that that misconduct affected the outcome of the trial.    

Where an excessive verdict is given under the influence of passion and prejudice (which seems to have been the conclusion of the trial court in Boles II), remittitur isn’t enough.  The misconduct should be seen as not simply tainting the amount of the verdict, but indeed the finding of liability itself.  Boles itself proves this point considering that without the disingenuous antics of plaintiff’s counsel, the jury in Boles I found in favor of the defendant.  While remitting the verdict helps, it doesn’t take away the bad precedent set by a plaintiff verdict in any amount.

Also, Happy Birthday Bexis!

Tuesday, January 24, 2012

Whether Medical Device or Meat, It’s Preempted

For this one, we go to the wisdom of Homer:
(Lisa)      “I’m going to become a vegetarian”
(Homer)  “Are you saying you're never going to eat any animal again? What about bacon?”
(Lisa)      “No”
(Homer)  “Ham?”
(Lisa)      “No.”
(Homer)  “Pork Chops?”
(Lisa)      “Dad, those all come from the same animal.”
(Homer) “Heh, heh, heh. Ooh, yeah, right, Lisa. A wonderful, magical animal.”
("The Simpsons" Lisa the Vegetarian (1995).)  That wonderful, magical animal yesterday helped forge a unanimous preemption decision from the Supreme Court that is, in our view, helpful and comforting with regard to medical device preemption. 
The Supreme Court ruled that a California statute that outlawed certain treatment and uses of non-ambulatory (basically, they can’t move) animals by slaughterhouses was preempted.  National Meat Assoc. v. Harris, No. 10-224, slip op. (U.S. Jan. 23, 2012).  After some nasty undercover video, California enacted the statute, which made it a crime for slaughterhouses to accept non-ambulatory animals.  They couldn’t buy them, sell them, handle them, or sell meat or other products made from such animals.  Slaughterhouses were required to euthanize in a humane manner any non-ambulatory animals in their possession.  This regulation, of course, seems well intentioned. 
The problem is that someone else was already doing it – the federal government.  Similar journalism, a century ago, inspired the 1906 Federal Meat Inspection Act (FMIA).  Read Upton Sinclair’s novel, The Jungle, if you don’t believe us.  Congress later expanded FMIA to include humane standards for the treatment and slaughter of animals (while humane slaughter seems like a prickly, almost oxymoronic, concept, that’s an issue for some other blog). 
FMIA’s regulation is extensive.  The Dep’t of Agriculture’s inspection arm examines animals before they are slaughtered and, for diseases or afflictions – including inability to move – says what can be done with them.  Most important, for our purposes, FMIA has an express preemption provision that is almost spot-on to the one contained in the Medical Device Amendments of 1976.  Here it is:
Requirements within the scope of this [Act] with respect to premises, facilities and operations of any establishment at which inspection is provided under . . . this [Act] which are in addition to or different than those made under this [Act] may not be imposed by any State.
That’s the same preemption language (“different from or in addition to”) in the Medical Device Amendments.  Only the order’s been reversed and “from” changed to “than.”
Seems pretty straightforward, doesn’t it?  But like inventive plaintiffs’ lawyers, California and other advocates crafted a number of arguments to try to get around preemption.  California’s main argument, which actually won in the Ninth Circuit, was to redefine the reality of what the federal scheme actually regulates, something we’ve seen from plaintiffs’ lawyers in medical device cases.  California argued for instance that the FMIA scheme applies only to the group of “animals that are going to be turned into meat,” while the California statute on the other hand simply excludes certain animals from that group.  The Ninth Circuit may have bought this one, but it was roadkill in the Supreme Court:
According to the Court of Appeals, “states are free to decide which animals may be turned into meat.” . . . We think not.  The FMIA’s scope includes not only “animals that are going to be turned into meat,” but animals on a slaughterhouse’s premises that will never suffer that fate.
That kind of argument by redefinition recalls the plaintiffs’ arguments in cases like Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), over whether tort claims could be “requirements” within the meaning of the statute. 
Some of California’s other arguments are also similar to those we’ve seen from medical device plaintiffs’ lawyers, who often lower a microscope to a regulatory scheme and stare only at certain granules of it, hoping to blur any focus on the regulatory scheme as a whole, leaving it unrecognizable and applicable to almost nothing.  For instance, California argued that the portion of its statute that prohibits the sale of meat taken from non-ambulatory animals is not preempted because FMIA doesn’t apply to the sale of meat, only its processing.  More roadkill for the Court, which rejected California’s offer to look at a single tree and lose focus on the forest of the FMIA’s regulatory scheme.  The Court instead determined that the California statute’s sales ban is aimed at prohibitions within the slaughterhouse: “The idea—and the inevitable effect—of the provision is to make sure that slaughterhouses remove non-ambulatory pigs from the production process . . . by criminalizing the sale of their meat.”  Accordingly, “the sales ban regulates how slaughterhouses must deal with non-ambulatory pigs on their premises.” 
Importantly, the Court rejected California’s argument that its statute is not preempted because it neither prohibits something required by FMIA nor requires something prohibited by FMIA.  The Court said that this doesn’t matter.  That sounds like impossibility, which as much as we liked it in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), has nothing to do with express preemption.  Direct conflict is not the issue: “FMIA’s preemption clause covers not just conflicting, but also different and additional state requirements.”  As those of us in the business of defending medical device companies know, that is essentially the same language in the preemption clause of the Medical Device Amendments of 1976 (“no State . . . may establish . . . with respect to a device intended for human use any requirement which is different from, or in addition to, any requirement applicable under this chapter to the device and which relates to the safety or effectiveness of the device”)
Homer may or may not be right that a pig is a wonderful, magical animal.  But either way the Supreme Court’s decision in Harris is pretty good too.  It underscores once again that broad preemptive language like that contained in the Medical Device Amendments of 1976 is not something to be explained away or rendered meaningless by redefinition and strained parsing.  It means what it says, and Harris provides further rock-solid Supreme Court precedent that it should be applied that way.

Monday, January 23, 2012

After Further (Careful) Review

In football the referees will occasionally change bad calls. Maybe it takes a videotape with unambiguous ocular evidence, but errors can get fixed. By contrast, it’s beastly hard to get judges to change their minds. We recall one instance so clearly because it stands out in our experience. When we were clerking on the U.S. Court of Appeals one of our jobs was to review petitions for reconsideration. They seldom detained us very long. The petitions merely rehashed losing arguments and supplied no real reason to revisit the court’s ruling. But one time one of the judges took an interest, convened a conference call of all three judges plus their clerks, and announced that “we’ve blown it.” The court ended up changing its mind. That judge, by the way, is now on the U.S. Supreme Court, and it is more than a little comforting to know that at least one of the Justices is so devoid of ego and dogma and is truly open-minded and conscientious.

That sort of thing is agonizingly rare.

We’ve been keeping a Mensing scorecard, watching what lower courts have done with generic plaintiffs’ efforts to circumvent preemption. One of the early cases we covered was Fisher v. Pelstring, C.A. No. 4:09-cv-00252-TLW (D.S.C. Sept. 30, 2011). The district court declined to dismiss the complaint, holding Mensing preemption inapplicable because the plaintiff argued that the generic defendant did not timely incorporate in its metoclopramide label certain FDA-approved warnings that were added to the brand label. We blogged about Fisher here. Subsequently, the plaintiff filed an amended complaint. Defendant, PLIVA USA, then filed a motion to dismiss the First Amended Complaint and, in the alternative, requested the court to reconsider its September 30, 2011 order. Dear reader, we have some involvement in metoclopramide litigation, so we must confine ourselves to reporting what happened. We will do so with clenched teeth and pounded keyboard. A copy of the Fisher court's new order can be found here.

First, the good news. The court did change its mind on one point and dismissed the claim for manufacturing defect. In its earlier ruling refusing to dismiss that cause of action, the court had “reasoned that the evidence of record supported a finding there was an issue of fact as to whether an error in the manufacturing process caused the 2003 or 2004 changes to the Reglan labeling to not be included on PLIVA’s metoclopramide labels.” Slip op. at 13. That was then and this is now. In its new motion, PLIVA observed that “the plaintiffs’ allegations in the First Amended Complaint focus on the product, not the product labeling. For their manufacturing defect cause of action, the plaintiffs allege that ‘defects in the products were caused by the way the products were manufactured.’” Id. (emphasis in original). That point seems unanswerable. And, indeed, the plaintiffs did not respond to it. Additionally, “the plaintiffs provided no evidence showing that the metoclopramide Mr. Fisher ingested deviated in some way from its design specifications or that it was rendered unsafe by an error in the manufacturing process.” Id. at 14. It is not clear why that was not perfectly obvious back in September. Oh well -- better late than never.

On all the remaining arguments, the Fisher court stood pat. The defendant argued that the claims for breach of implied warranties were preempted by Mensing. Not so, said the court:

After careful consideration, the Court finds that the plaintiffs’ claims
for breach of the implied warranty of merchantability remains viable after Mensing. Unlike an express warranty, the implied warranty of
merchantability is not created by labeling content but rather is implied in a
sales contract, unless excluded or modified, where the seller is a merchant of
goods of the kind sold. See S.C. Code Ann. Section 36-2-313; id. 36-2-314.
Without relying on PLIVA’s labeling content, the plaintiffs could plausibly
demonstrate that long-term use is an ordinary purpose for which metoclopramide
is used or that the metoclopramide PLIVA manufactured is objectionable in the
trade under the contract description.

Slip op. at 5. Did you notice the word "careful"? You'll see it again. And again.

The defendant also sought dismissal of the negligence claims. The court refused on the ground that PLIVA did not incorporate “into its generic metoclopramide labeling certain FDA-approved warnings added to the brand-name labeling for Reglan in 2003 and July 2004.” Slip op. at 6. Those warnings pertained to geriatric patients being “at greater risk for tardive dyskinesia” and that “Therapy should not exceed 12 weeks in duration.” Id. at 6-7. The defendant contended that the negligence cause of action was ineluctably based “on statements in PLIVA’s labeling regarding the risk of developing extrapyramidal symptoms and therefore this claim is preempted.” Id. But the court did “not view the plaintiffs’ pleadings so narrowly” because the First Amended Complaint included allegations that PLIVA “encouraged the long term use of these drugs,” that PLIVA failed to investigate the accuracy of its metoclopramide label,” that PLIVA “concealed the fact that long-term treatment was unsafe, and that “PLIVA breached its “duty to exercise the care of an expert in all aspects of the formulation, manufacture, compounding, testing, inspection, packaging, labeling, distribution, marketing, and sale of Reglan/metoclopramide to insure the safety of its drug and to insure that the consuming public…obtained accurate information and instructions for the safe use or non-use of this drug.” Id. (emphasis in original).

PLIVA asserted that even if the plaintiffs included an allegation that PLIVA failed to conform its generic metoclopramide labeling to the brand-name labeling, the claim would still be preempted because “the FDCA provides that only the federal government may bring an action to enforce the FDCA’s provisions.” Id. at 7. But the court concluded “after careful consideration of the authority cited by PLIVA, a sufficient basis has not been presented for this Court to conclude that a negligence action in which the standard of care is defined by statute is the equivalent of private enforcement of the FDCA.” Id. at 8. PLIVA also argued “that a state law claim must be premised on a duty that would exist in the absence of the FDCA, meaning the plaintiffs must show a state common law duty existed for a generic drug manufacturer to ensure its labeling always conformed to that of the brand-name drug.” Id. at 9. The court was unimpressed, because “PLIVA provides no authority in support of this assertion, and assuming PLIVA’s argument is accurate, this Court does not conclude that the duty which must exist in the absence of the FDCA should be defined as narrowly as PLIVA asserts.” Id.

Our teeth are still clenched and now the keyboard has been pounded to smithereens.

In its September 30, 2011 Order, the court had concluded “that PLIVA may have had avenues available to communicate with physicians about the 2003 and 2004 label changes without seeking FDA approval first.” Id. at 9-10. It seems that it would be hard to square that holding with the Mensing Court’s acceptance of the FDA’s interpretation that generic drug manufacturers may not use “Dear Doctor” letters to send additional warnings to prescribing physicians because such letters are labeling and “must be ‘consistent with and not contrary to [the drug’s] approved…labeling.’” Mensing, 131 S. Ct. at 2576 (quoting 21 C.F.R. § 201.100(d)(1)). Here’s how to do it, according to the Fisher court: “If PLIVA had made alterations to its labeling consistent with the 2003 and 2004 changes to the Reglan labeling, a letter alerting physicians to these changes would arguably not be inconsistent with the drug’s approved labeling. This Court finds that the plaintiffs, in their First Amended Complaint, sufficiently plead a theory of recovery based on an argument PLIVA should have done more when the 2003 and 2004 labeling changes occurred, such as issue a “Dear Doctor” letter. “ Id. at 10. Got that?

The fraud claim also lives to vex another day: “After reviewing the First Amended Complaint in its entirety and particularly paragraph 188, the Court concluded that the plaintiffs sufficiently plead a claim for fraud by concealment based on PLIVA’s alleged non-inclusion of the 2003 and 2004 warnings. Therefore, after careful consideration of this argument and PLIVA’s other arguments in support of dismissing this claim, including its citation to Jimenez v. Daimler Chrysler Corp. 269 F.3d 439 (4th Cir. 2001), PLIVA’s motion to dismiss the plaintiffs’ fraud by concealment claim is DENIED.” Id. at 10.

The court also rejected PLIVA’s arguments that the causes of action for violation of the South Carolina Unfair Trade Practices Act and for intentional infliction of emotional distress claim are preempted under Mensing. Again, failure timely to include the new warnings seems key. According to the court, “That therapy should not exceed twelve weeks is part of the risk the plaintiffs may have wished to measure in deciding whether to continue taking metoclopramide.” Id. at 12. Note the word “plaintiffs.” Note the word “may.”

PLIVA also challenged the claim for punitive damages. After quoting the usual standard of “willful, wanton, or in reckless disregard of the plaintiff’s rights,” the court supplied this helpful analysis: “After careful review of the first Amended Complaint, the Court finds the plaintiffs plead sufficient facts to support an award of punitive damages.” Id. at 14. Okay, then. Similarly, the court rejected a statute of limitation defense “[a]fter careful consideration,” and after listening politely to the defendant’s argument that the plaintiff’s filing was untimely, the court “after a careful re-examination of the evidence cited by the parties and the applicable law … declines to alter its previous ruling.” Id. at 17.

The defendant wheeled out what appears to be a pretty strong warning causation argument. Did the plaintiff meet its burden of showing that the allegedly deficient warning made any difference? The defendant cited case law, which the court distinguished because the “possible alternative warnings in this case – the 2003 and 2004 warnings added to the brand-name Reglan label – are not nearly as ‘apocalyptic’” as in the case cited by PLIVA. Id. at 20. The court also held that “Dr. Pelstring’s knowledge of the risks for which the plaintiffs allege proper warnings were not given does not demonstrate as clear an understanding of those risk as the record” in the cited case. Id. “For example, testimony has not been cited showing Dr. Pelstring knew in 2004 that therapy with metoclopramide should not exceed twelve weeks.” Id. The court’s opinion does not disclose the evidence showing that Dr. Pelsing would have acted any differently had he been warned about the twelve weeks limitation. But the court keeps telling us how "careful" it was, so perhaps that evidence is in there somewhere.

Friday, January 20, 2012

Distribute This!

Because it applied implied preemption, the decision in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) is powerful.  We’ve previously mentioned how we think Mensing’s principles might be invoked in some claims against non-PMA medical devices, where express preemption is precluded by Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).

We haven’t seen anybody take us up on that idea (yet), but we’re not letting that stop us.  We’ve come across a case that’s given us more reason to think about how the implied preemption principle in Mensing may be gainfully employed on behalf of defendants who aren’t generic drug manufacturers.

First of all, the Mensing preemption principle – because it’s important to keep exactly what we’re talking about firmly in mind:

[W]hen a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.
Mensing, 131 S. Ct. at 1281 (emphasis added).

Because Mensing involved implied preemption, this principle applies outside the specific context of Hatch-Waxman, ANDAs, and generic drugs.  Any interposing federal requirement that deprives the defendant of the ability to satisfy state tort duties “independently” should have the same preemptive effect under Mensing.

Now to the case.  As our continually updated post-Mensing generic preemption scorecard reflects, there’s already been a favorable generic preemption ruling in the Fosamax MDL.  See In re Fosamax Litigation, 2011 WL 5903623 (D.N.J. Nov. 21, 2011) (“Generic Fosamax I”).  Well, there’s just been a follow-up.  In In re Fosamax Products Liability Litigation, 2012 U.S. Dist. Lexis 5817 (D.N.J. Jan. 17, 2012) (“Generic Fosamax II”), the court had to deal with a generic straggler.  All the other generic manufacturers had been dismissed in Generic Fosamax I, but one of them (Watson) was alleged in one case (Welch) to have been more than simply a generic Fosamax manufacturer.

In this Welch case, the plaintiff also alleged:

Defendant Watson was what is known as the authorized distributor of branded Fosamax.  Upon information and belief, under the agreement between [the branded manufacturer] and Watson, [it] manufactured and supplied alendronate and Watson marketed and sold the drug under branded name Fosamax.
Generic Fosamax II, 2012 U.S. Dist. Lexis 5817, at *21 (quoting complaint).

On the basis of that one allegation (supported only by “information and belief” pleading), the Fosamax MDL plaintiffs tried to keep one peripheral defendant in one case.

The court said “no,” and that “no” has implications way beyond this one case.

Mensing implied preemption applies even where the defendant is a distributor of the branded product, as alleged in the Welch complaint.  Under the Mensing implied preemption principle, a mere distributor is no more able than a generic manufacturer to make unilateral changes in drug labeling:

[E]ven if the Plaintiffs in [other] cases made the allegation found in Welch – that Watson was an authorized distributor of Fosamax – Watson would still be entitled to judgment on the pleadings and dismissal from the MDL.  As a distributor of Fosamax, Watson has no power to change Fosamax labeling.  That power lies with the applicant who filed the New Drug Application (NDA) seeking approval to market Fosamax.  See 21 U.S.C. 355(b); 21 C.F.R. 314.70 (describing the Changes Being Effected or “CBE” regulation, which requires that “the applicant must notify FDA about each change in each condition established in an approved application.”) (emphasis added).  In this case, [the branded manufacturer] is the NDA applicant with the corresponding authority to change labeling.  Additionally, if FDA had “become aware of new safety information” in connection with Fosamax use that “it believe[d] should be included in the labeling,” FDA must notify the holder of the NDA to initiate the changes.  21 U.S.C. 355(o)(4)(A).  Neither of these procedures involves a distributor.

As a result of the scheme set forth by the FDCA, Watson has no authority to initiate a labeling change of Fosamax.  That authority lies with the FDA and/or with [the branded manufacturer].  Even taking the allegation in Welch as true, a contractual relationship between Watson and [the branded manufacturer] cannot change the fact that Watson is not the NDA holder.  Consequently, Watson has no power to unilaterally change Fosamax labeling.  Because Watson could not “independently do under federal law what state law requires of it,” the state law claims brought against it are preempted.

Generic Fosamax II, 2012 U.S. Dist. Lexis 5817, at *27-28 (most emphasis added).

Thus, under Mensing’s implied preemption principle, any distributor of any FDA-regulated prescription drug – branded or generic – has a preemption defense to warning claims based on the simple fact that non-manufacturing distributors aren’t manufacturers and thus aren’t “independently” able to change drug labeling through the CBE (or any other) process.  At most, distributors could pass information along to the branded manufacturer – but Mensing also held preempted pass-along claims that “depend[] on the actions of . . . the brand-name manufacturer.”  131 S. Ct. at 2578.

What Generic Fosamax II means is that anybody representing a non-manufacturing distributor of prescription drugs sued as an intermediate seller on a warning-related claim should give a serious look at Mensing impossibility preemption as a defense.  Similar arguments might be made on behalf of other non-manufacturing defendants – hospitals, pharmacists, sales reps, component part sellers, the list could be long – as long as their basis for liability is some deficiency in the FDA-approved label, as opposed to conduct specific to that defendant.

Since distributors are often joined as subterfuges to destroy diversity of citizenship, we note (but do not further discuss) the possible effects of the preemption theory in Generic Fosamax II on subject matter jurisdiction issues.

This is what we like to do best on this blog – pass along ideas for defending our clients that our readers might not have considered – so this is a good day for us.

Wednesday, January 18, 2012

Another Court Throws Generic Plaintiffs a Lifeline

            As evidenced by our generic preemption scorecard the post-Mensing scales have been heavily tipped in favor of the generic manufacturers who have racked up dismissals across the country.  But not every court is willing to jump on the “complete dismissal” side of the seesaw.  We reported  on the Fisher v. Pelstring case from the District of South Carolina back in October and now that court’s neighbor to the north has decided to follow suit – focusing on factual uncertainties regarding timeliness to deny the generic defendants’ motion to dismiss.  Couick v. Wyeth, Inc., 2012 U.S. Dist. Lexis 3699 (W.D.N.C. Jan. 11, 2012) (brand manufacturers previously dismissed). 

            The Couick court divided plaintiffs’ claims into three general categories:  product liability claims under the North Carolina Product Liability Act; express and implied warranty claims; and other claims – which in this case were negligent failure to test or surveil and breach of a special duty to abide by FDA requirements.  Id. at *5-6.  Let’s get rid of the “others” first.  North Carolina doesn’t recognize a cause of action for failure to test or surveil.  Id. at *20.  Claims for private enforcement of FDA requirements are preempted under Buckman.  Id. at *21.  Both of those claims were dismissed, but as to the rest of plaintiffs’ claims, the court found factual issues existed that challenged whether in fact it was impossible for the generic defendants to comply with both state and federal law. 

            For instance, on the failure to warn claim, the court found that the defendants had not “provided any proof . . . that their package inserts matched [the brand’s] throughout the period that Plaintiff alleges she took [the drug].”  Id. at *9.  Because there were conflicting allegations regarding when the plaintiff was prescribed the drug and when defendants adopted certain labeling changes, the court was unwilling to find the claims preempted on the pleadings: 

But if Defendants' PIs did not match the brand, there are at least some changes to their PIs that federal law would allow, or even require, Defendants to make. A state law claim for failure to include such warnings would not be preempted by federal law where the FDA would have permitted, or even required, such changes.

Id.  at *14.
            Similarly on the breach of express warranty claim, defendants argued that the alleged express warranty language was required by federal law to be included in their labeling.  Id. at *18.  However, “[t]he Court [could not] find impossibility on the record before it. Without proof of what Defendants' and [brand’s] PIs stated, Defendants cannot show that this language was required.”  Id. at *17-18.  So, on these claims the court decided that it would need to look beyond the four corners of the complaint and examine facts that were not before it on a motion to dismiss. 

            In denying defendant’s motion on breach of implied warranties, the Couick court found the claims weren’t preempted by Mensing because they “are not dependent on the content of Defendants’ PIs.”  Id. at 18. 

While Defendant's labeling and warnings may play a role in establishing their products' intended purpose or their customers' reliance, Plaintiff's claim is not that Defendants failed to adequately warn about the risks. These claims are not preempted by federal warning label requirements under Mensing.

Id. at *19.  To our knowledge, this is a novel ruling, contrary to the other precedent in our generic preemption scorecard.  And, one we hope won’t hold up under further scrutiny.

Tuesday, January 17, 2012

Motions In Limine In Pa. Case

Motions in limine were decided (or not) recently in Wolfe v. McNeil-PPC, Inc., 2012 U.S. Dist. Lexis 2160 (E.D. Pa. Jan. 9, 2012).  The defendant did pretty well, so here’s a brief listing of the highlights (this isn’t everything, as some were case specific, not decided, moot, or simply boring).

  • Adverse events – These probably aren’t admissible as they are double hearsay. Some earlier ones might be admissible as to notice, assuming that’s disputed.  Experts can rely upon them, but not exclusively, and that doesn’t mean they get to talk about them to the jury (which will be decided at trial).  Id. at *6-12.
  • FDA citizen’s petition – Excluded.  The petition was argumentative and didn’t show notice.  The defendant also can’t use its outcome to argue that the FDA rejected the requested warnings.  Id. at *14-16.  A different (older) FDA petition could show notice, assuming that’s disputed.  Id. at *17-19.
  • Voluntary recalls unrelated to the plaintiff’s condition – Excluded as unduly prejudicial.  Id. at *19-21.
  • Foreign labeling – Generally excluded subject to plaintiff making specific arguments that a particular foreign label is somehow relevant, and not hearsay.  Id. at *21-22.
  • Various FDA documents – Generally excluded subject to plaintiff making specific arguments that a particular FDA document is somehow relevant, and not hearsay.  Id. at *22.
  • Marketing material/information not seen by plaintiff (this is an OTC case) – Generally excluded as prejudicial and irrelevant following dismissal of negligent marketing claim.  Plaintiff may seek reconsideration as to specific items.  Id. at *22-23.
  • Other lawsuits/claims, etc. – Generally excluded as irrelevant. Plaintiff may argue at trial that specific items are relevant to notice.  Id. at *24-25.
  • Plaintiff continuing to use product after injury – Admissible.  That the plaintiff continues to use the product with specific knowledge of its potential risk is relevant to whether any inadequate warning could have been causal.  Id. at *31-32.
  • Other drugs taken in close proximity – Admissible, as tending to prove alternative causes of the claimed injuries.  Id. at *34-35.

One general comment on motions in limine.  The court in Wolfe criticized both sides on a number of occasions for making overbroad and unsupported arguments.  That’s a good thing to keep in mind when drafting or responding to motions in limine.  We believe that anything worth doing is worth doing well.  If counsel is serious about filing motions in limine, such motions should be both focused and supported with everything a court would need to rule.  It’s not only a waste of time to file vague and generic motions in limine/responses, but such filings run the risk of losing credibility with the court.

Monday, January 16, 2012

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.

Friday, January 13, 2012

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'Neilslip 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.

Thursday, January 12, 2012

That's A Spicy (Specious?) Footnote!

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Other cases applying comment k equally to medical devices:

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

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