Kentucky –sure, it gets pretty sticky in the summer, and the bluegrass isn’t really blue, and Wildcats fans – well, they’re a breed of their own. But give us the bourbon, the chicken, and the Derby and we’ll be singing “My Old Kentucky Home” and “Coal Miner’s Daughter” with the rest of the Kentucky natives.

DeMoss v. Eli Lilly & Co., 2017 U.S. Dist. LEXIS 19142 (W.D. Ken. Feb. 10, 2017) is a bit like the commonwealth it’s from — we like some pieces and others we could certainly do without. The case involves an anti-clotting drug which plaintiff alleges led to her husband’s fatal internal bleeding. Plaintiff asserted claims for design, manufacturing, and failure to warn defects under both strict liability and negligence; breach of implied warranties; negligent misrepresentation; and violation of the Kentucky Consumer Protection Act. Id. at *5. On the defendant’s motion to dismiss, all claims except design defect and failure to warn were dismissed without prejudice.

On strict liability, Kentucky has adopted comment k’s exception for unavoidably unsafe products such as prescription drugs and devices, but has not adopted it across the board. Rather, applicability of comment k is determined on a case-by-case basis using a risk-utility test. Id. at *6-7. So, at the pleadings stage, the court was unwilling to toss out plaintiff’s strict liability claim as a matter of law finding the inquiry too fact dependent. Id. at *8. This approach kicks a comment k analysis to the summary judgment stage.

Defendant also argued that plaintiff’s pleading of strict liability design defect was insufficient under TwIqbal. The court disagreed finding that plaintiff’s allegation that the drug carried “an unreasonably high bleeding risk without any reversal agent” and that plaintiff’s husband died as a result of that injury, was more than just regurgitating the basic elements of a design defect claim. Id. at *9. And on the issue of pleading an alternative design, the court allows a different drug to serve as the alternative design. Id. There isn’t much discussion of this and so we hope it’s something that can be more fully explored later in the case – after all, a different drug is a different drug, not an alternative design for the drug at issue. The court similarly found that plaintiff had pleaded enough for her failure to warn claim to survive. Id. at *12. In addition to alleging a failure to adequately warn about the increased risk of bleeding, plaintiff also alleged a failure to adequately test which the court found was not an independent cause of action, but was subsumed in the failure to warn claim. Id. at *15. Based on very similar reasoning, the court allowed both negligent design defect and negligent failure to warn to stand as well. Id. at *13-14.

Strict liability and negligent manufacturing defect claims, however, were both dismissed. Unlike with design defect and failure to warn, plaintiff’s manufacturing defect claims were nothing more than a recitation of the elements of the claim with no specificity or factual support. Id. at *10-11. The complaint fails to allege how the drug taken by plaintiff’s husband deviated from the defendant’s specifications or standard processes or how any such failure caused her husband’s injury. Id. at *11; *13-14 (negligent manufacturing claim dismissed).

Next the court dismissed plaintiff’s breach of implied warranty claim for lack of privity. Id. at *15-16. The same lack of privity was the downfall for plaintiff’s claim for violation of the Kentucky Consumer Protection Act (“KCPA”). Id. at *21. The KCPA, however, has a privity exception when a plaintiff alleges express representations were made. Plaintiff here tried to claim her failure to warn allegations demonstrated express representations that would allow her to fall within the exception. But those allegations did not rise to the level of being “affirmations of fact or promise” that qualify as express representations, so the claim was dismissed. Id. at *23.

On negligent misrepresentation, while plaintiff attempted to argue that she had made out the who, what, where, when and why to satisfy even the heightened pleading standards of Federal Rule 9(b), all of those allegations were about concealing or omitting facts. Under Kentucky law, a claim for negligent misrepresentation “requires an affirmative false statement; a mere omission will not do.” Id. at *20. Essentially, plaintiff wasn’t allowed to re-package her failure to warn claim as an additional negligent misrepresentation claim.

While it’s not a slam dunk (something Wildcats fans are seeing a lot of recently), it’s a much smaller complaint that advances to the next round. Not perfect, but good enough for now.

 

One of us was asked a question the other day that we couldn’t answer immediately.  “Does the learned intermediary rule apply to a physician’s assistant?”  We didn’t remember any cases actually deciding that issue.  So we did what we usually do in that situation and looked at Bexis’ book.  The book has a section (§2.03[2]) titled “Who Is the Learned Intermediary,” which looked like it would cover this subject.  It did, but while it had cases discussing nurses:

Yes: Ellis v. C.R. Bard, Inc., 311 F.3d 1272, 1281 (11th Cir. 2002) (applying Georgia law); Walker v. Merck & Co., 648 F. Supp. 931, 934 (M.D. Ga. 1986), aff’d without op., 831 F.2d 1069 (11th Cir. 1987); Wyeth-Ayerst Laboratories Co. v. Medrano, 28 S.W.3d 87, 93 (Tex. App. 2000); Holley v. Burroughs Wellcome Co., 330 S.E.2d 228, 235-36 (N.C. App. 1985), aff’d, 348 S.E.2d 772 (N.C. 1986); Singleton v. Airco, Inc., 314 S.E.2d 680, 682 (Ga. App. 1984); In re NuvaRing Litigation, 2013 WL 1874321, at *28 (N.J. Super. L.D. April 18, 2013) (applying California law).  No: Mazur v. Merck & Co., 964 F.2d 1348, 1357 (3d Cir. 1992) (a nurse “not authorized to prescribe drugs”) (applying Pennsylvania law); Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1277 (5th Cir. 1974) (applying Texas law).

Cases discussing optometrists:

No: Prager v. Allergan, Inc., 1990 WL 70875, at *4 (N.D. Ill. May 2, 1990); Bukowski v. CooperVision Inc., 592 N.Y.S.2d 807, 809 (N.Y.A.D. 1993);

Cases discussing pharmacists:

No: Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1387 (Pa. 1991); Makripodis v. Merrell-Dow Pharmaceuticals, Inc., 523 A.2d 374, 378 (Pa. Super. 1987);

A case discussing veterinarians:

Yes: Haste v. American Home Products Corp., 577 F.2d 1122, 1124 (10th Cir. 1978) (applying Wyoming law);

A case discussing physical therapists:

Yes: Seifried v. The Hygenic Corp., 410 S.W.3d 427, 433 (Tex. App. 2013); and

A case discussing medical societies:

No: Davis v. Wyeth Laboratories, 399 F.2d 121, 130 (9th Cir. 1968) (applying Montana law) . . . .

There were no cases specifically addressing P.A. prescriptions and the learned intermediary rule in Bexis’ book.

As an aside, we note that, while the weird case we discussed last week from Washington State, Taylor v. Intuitive Surgical, Inc., ___ P.3d ___, 2017 WL 532497 (Wash. Feb. 9, 2017), wasn’t phrased in such terms, it is effectively a ruling that a hospital can be a learned intermediary.

The only specific mention of physician’s assistants in Bexis’ book was quoting dictum in Perez v. Wyeth Laboratories, Inc., 713 A.2d 520 (N.J. Super. A.D. 1998), that although limited to “physicians” by statute, the learned intermediary rule might also apply to “dentists, optometrists, podiatrists, nurse practitioners, home health care service firms, physician’s assistants, or others similarly permitted to prescribe or administer drugs on a limited basis.” Id. at 522-23 (statutory citations omitted).  That decision was, of course, famously reversed in Perez v. Wyeth Laboratories Inc., 734 A.2d 1245 (N.J. 1999), another weird decision that created a “direct to consumer” exception to the learned intermediary rule (since rejected by every other state to consider it), and thus never had to reach the “who is” question.

The next thing we did was to run a ridiculously broad Westlaw search – looking for “learned intermediary” anywhere in the same case as “physician’s assistant”?

Not too bad, this time. Less than 25 cases, including the two Perez decisions.

The most significant case on P.A.s and the learned intermediary rule is Stevens v. Novartis Pharmaceuticals Corp., 247 P.3d 244 (Mont. 2010).  As we discussed here and here, while Stevens is not overall a favorable decision for defendants, it did reaffirm the learned intermediary rule and extend it to a P.A.-prescribed drug.  Stevens first mentioned the Third Restatement’s version of the learned intermediary rule, Restatement (Third) of Torts, Products Liability §6(d)(1), which describes the rule in terms of warnings “provided to . . . prescribing and other health-care providers.”  247 P.3d at 492 (emphasis added).  The court then discussed the “evolution” of the rule “away from limiting the doctrine’s applicability to the prescribing physician alone.” Id. A P.A. could thus be a “learned intermediary” when fulfilling the “traditional” role of a physician:

The modern healthcare system, however, places far less emphasis on these traditional relationships, and patients today often receive the majority of their care from nurses, nurse practitioners, physicians’ assistants, and physicians other than the prescribing physician.  Appropriately, in situations where the underlying rationale of the doctrine − the traditional doctor-patient relationship − is no longer present, the doctrine has adapted to fit the realities of the situation.

*          *          *          *

[T]he evolution of the doctrine [has been] through an expansion of the possible class of learned intermediaries. This development, likewise spurred by the fact that the medical professionals with whom patients most commonly interact are often no longer primary physicians, has led courts and secondary sources such as the Restatement to suggest that a variety of different healthcare providers may be considered learned intermediaries, depending on the unique facts of the patients’ treatment scenario.

*          *          *          *

We concur with authorities who consider the learned intermediary to be the healthcare professional actually responsible for making decisions related to the patient’s care. . . . [Plaintiff] received much of her treatment from nurses, treating physicians, and nurse practitioners.

Stevens, 247 P.3d at 492-95 (footnote citing many of the cases in Bexis’ book omitted).

Another case applying the learned intermediary rule to a physician’s assistant is Luke v. Family Care & Urgent Medical Clinics, 246 F. Appx. 421 (9th Cir. 2007) (applying Washington law).  The drug in question in Luke was prescribed by a P.A., id. at 423, and but the learned intermediary rule still applied:

[T]he district court properly decided that the [risk at issue] was not material and that the physician’s assistant had no duty to warn [plaintiff] of the danger.  Under Washington law, it would be contradictory to require a pharmacist to warn of the same danger when the “learned intermediary” had no duty to warn.

Id. at 425.

The learned intermediary rule also applied to a physician’s assistant in Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015) (applying Ohio law) – a case we usually cite for its preemption holdings.  In Yates the prescriber (“Smith”) was a P.A.  Id. at 288.  Without a lot of discussion of Smith’s P.A. status, Yates found the learned intermediary rule applicable:

Smith testified that it is her custom to use her independent medical judgment when prescribing birth control products to patients, and she specifically testified that she discussed the risks and benefits of several different forms of birth control with [plaintiff].  The mere fact that Smith gave [plaintiff] options and a voice in determining which method of birth control would best fit her needs and lifestyle does not remove Smith from her status as a learned intermediary.

Id. at 293.  Without any separate discussion of P.A. status, Czimmer v. Janssen Pharmaceuticals, Inc., 122 A.3d 1043, 1056-58 (Pa. Super. 2015), treated a prescribing P.A. as a learned intermediary.  See also Canady v. Ortho McNeil Pharmaceutical, Inc., 2014 WL 1653349, at *4 (N.D. Ohio April 24, 2014) (applying learned intermediary rule in negligence action over drug prescribed by a P.A.; not applying learned intermediary rule to strict liability, due to peculiar Oregon statute); Woodhouse v. Sanofi-Aventis U.S. LLC, 2011 WL 3666595, at *2-3 (W.D. Tex. June 23, 2011) (applying learned intermediary rule to prescribing P.A. without regard to P.A. status).

As Stevens in particular demonstrates, expanding the learned intermediary rule to non-physicians such as P.A.s is something of a double-edged sword.  On one hand, recognizing non-physicians who prescribe drugs or devices as learned intermediaries precludes plaintiffs from arguing for direct-to-patient warnings.  On the other hand, the rule requires that adequate warnings be given to the learned intermediary – whoever that might be.  Thus, expanding the categories of medical practitioners who qualify as “learned intermediaries” also expands the scope of a defendant’s warning obligations to such practitioners, although not to plaintiffs themselves.  Given the choice between a plaintiff coached to say whatever is necessary to obtain recovery, and a P.A. who usually won’t be in the plaintiff’s back pocket, we’ll take our chances with the P.A.

Regular blog readers may recall that, every year, we eagerly await a Monday and Tuesday right around February 14th.  This has nothing to do with Valentine’s Day (though we like a dozen roses and a box of chocolates as much as the next person.)  No, at this time every year (for the past eighteen or so) we cross our fingers that there is no blizzard, beg everyone in our work life to cover any emergencies, and head to New York for the Westminster Kennel Club Dog Show.  This year was the 141st annual show, and, as always, it was a mecca for all things dog.  As we ate breakfast in our hotel, we were visited by Mobius, a red Doberman so tall he had to lean down to attempt to taste our complimentary make-it-ourselves waffle.  To board the shuttle from the Hotel Pennsylvania (worthy of its own post) to Piers 92 and 94 for the daytime breed judging, we had to step over “Sky,” a 140-pound Greater Swiss Mountain Dog sprawled in the aisle of the bus, calmly oblivious to accidental bumps and kicks and happily kissing anyone who asked.  We live for this stuff, even if our chosen favorite almost never wins.

For the atmosphere is rarified. A few years ago, the show stopped being “champions only” and admitted “class dogs” – dogs still working their way through point-earning breed classes to achieve their championships – for the first time.  But, save for the infrequent upset, the group competition (the televised portion, in which the single winner of each breed competes against the winners from the other breeds in its “group” – sporting, herding, toy, etc.) is dominated by the very top-winning show dogs in the country.  Last year, we fell in love with a gorgeous German Shepherd Dog named Rumor.  She was a heavy favorite to win it all (“Best in Show”), but was upset by C.J. the German Shorthaired Pointer and settled for Reserve Best – second place.  And she retired, to raise beautiful puppies and live the life of a cherished house pet.

But, alas, said puppies did not get made on the first attempt. And, come January, Rumor’s owner/handler decided to give her one more shot at the big one.  So she “came back out,” showed at ten shows in January, and took one more run at the Garden.  And, this time, after upsetting the favorite, Preston the Puli, to take the Herding Group, she won it all.  It was very, very cool to witness.  And we already can’t wait ‘til next year.

And there was a blog-worthy lesson to be gleaned from it all (at least if you stretch a little): if you haven’t achieved everything you want, think about taking another shot.  And H.R. 985, a bill that passed the House Judiciary Committee this week, would pick up where CAFA left off (and then some) to correct still-rampant abuse of the system by class action and MDL plaintiff lawyers, to the detriment of our clients, the judicial system as a whole, and all too often, to the plaintiffs the lawyers ostensibly represent.

Under “Purposes,” the bill states: “The purposes of this act are to – (1) assure fair and prompt recoveries for class members and multidistrict litigation plaintiffs with legitimate claims; (2) diminish abuses in class action and mass tort litigation that are undermining the integrity of the U.S. legal system; and (3) restore the intent of the framers of the United States Constitution by ensuring Federal court consideration of interstate controversies of national importance consistent with diversity jurisdiction principles.”  Worthy goals all, if a trifle ambitious. The bill’s key points read like a set of nesting boxes – just when you think you’ve opened the last, there is another present inside.  Here are some highlights:

Class Actions

  • Injury allegations: this provision requires a court to deny certification unless “the party seeking to maintain such a class action affirmatively demonstrates that each proposed class member suffered the same type and scope of injury as the named class representative.” This is ascertainability something for which we’ve advocated, and also something that our side tried unsuccessfully to get fixed through the Federal Rules Committee. Thus, the judiciary had its chance to fix this. Nothing happened, so now Congress is poised to step in. About time.
  • Conflicts of interest: this provision requires class counsel to state, in the body of the complaint, “whether any proposed class representative or named plaintiff in the complaint is a relative of, is a present or former employee of, is a present or former client of (other than with respect to the class action) or has any contractual relationship with . . . class counsel” and shall “describe the circumstances under which each class representative or named plaintiff agreed to be included in the complaint and shall identify any other class action in which any proposed class representative or named plaintiff has a similar role.”
  • Attorneys’ fees: “[N]o attorneys’ fees may be . . . paid . . . until the distribution of any monetary recovery to class members has been completed,” and “[u]nless otherwise specified by Federal statute, . . . the portion of any attorneys’ fee award to class counsel . . . shall be limited to a reasonable percentage of any payments directly distributed to and received by class members [and in] no event shall the attorneys’ fee award exceed the total amount of money distributed to and received by all class members.” We particularly like this because it would effectively put an end to cy pres, against which we’ve railed for years. By limiting the denominator for fee awards to “payments directly distributed to and received by class members” it prevents cy pres sums from being used to inflate fee awards.

There are other provisions, requiring stringent accounting provisions for settlement funds forbidding certification of issue classes unless all relevant Rule 23 prerequisites are satisfied (another thing our side tried first to fix through a change to Rule 23), and most significantly providing for severance of misjoined plaintiffs for purposes of jurisdictional determinations. This legislative elimination of fraudulent misjoinder is a key point, since it addresses the multi-plaintiff complaints we love to hate.

We note that since the “effective date” of this act provides for its application to all “pending” civil actions, cases currently in state court can be removed (or removed again) under the provision negating misjoinder as a means of preventing diversity-based removal to federal court.

Finally, in an issue close to our hearts as we daily encounter plaintiffs unwittingly victimized by so-called “litigation funders,” the bill provides, “In any class action, class counsel shall promptly disclose in writing to the court and all other parties the identity of any person or entity, other than a class member or class counsel of record, who has a contingent right to receive compensation from any settlement, judgment, or other relief obtained in the action.” A sunshine law for third-party funding is something else for which we’ve advocated.

Multidistrict Litigation:

  • Proof of exposure and injury: We were thrilled to see a “Lone Pine”-esque provision build into the MDL portion of the bill. It provides, in pertinent part, “In any coordinated or consolidated pretrial proceedings . . . , counsel for a plaintiff asserting a claim seeking redress for personal injury [in the MDL] shall make a submission sufficient to demonstrate that there is evidentiary support (including but not limited to medical records) for the factual contentions in the plaintiff’s complaint regarding the alleged injury, the exposure to the risk that allegedly caused the injury, and the alleged cause of the injury . . . within 45 days after the civil action is transferred to or directly filed in the proceedings. That deadline shall not be extended. Within 30 days after the submission deadline, the judge . . . shall [determine] whether the submission is sufficient and shall dismiss the action without prejudice if the submission is found to be insufficient.” Thirty days later, in the continued absence of a satisfactory submission, the action is to be dismissed with prejudice. Not long ago, we advocated for amending the MDL statute to require early factual disclosure, with dismissal as the sanction for not disclosing enough to satisfy Rule 8. This is the functional equivalent.
  • Trial Prohibition (“waiving Lexecon”): MDL judges “may not conduct any trial in any civil action transferred to or directly filed in the proceedings unless all parties to the civil action consent to trail of the specific case sought to be tried.” This provision would remove the threat of MDL trials as a tool to force defendants to settle. It is something else for which we have advocated.
  • Ensuring Proper Recovery for Plaintiffs: MDL plaintiffs “shall receive not less than 80 percent of any monetary recovery obtained in that action by settlement, judgment or otherwise.”

While most of the press coverage seems to focus on class actions, to us the removal and MDL provisions are at least as important. The vast bulk of our professional life is spent in the mass tort space – mostly MDLs these days, with the occasional class action thrown in. We have become accustomed (but never inured) to plaintiffs without injuries herded by counsel who are their friends or bosses into mass actions in which they don’t belong. On the other end of the spectrum, we encounter severely injured plaintiffs who will recover next to nothing because lawyers and litigation funders own most or all of the plaintiffs’ stakes in the inevitable settlements. And, at every turn, we sit across the table from tanned and affluent plaintiff attorneys who are the only ones apparently immune to the vagaries of the system and who are the sole beneficiaries of its inequities. H.R. 985, as drafted, attempts to address many of these issues. We do have questions. Who defines “the same type and scope of injury,” for example? And we have doubts: can a bill possibly survive the powerful plaintiff attorney lobby when it attempts to resurrect the integrity of mass litigation by hitting those attorneys squarely in their pocketbooks? But we heartily and excitedly support this bill, and we know that some of its provisions are way, way better than none. We will keep you posted.

We’re serious – we’re not planning to give a flip answer like “an extortion racket.”  No, it’s more like law school, where a first-year contracts professor began with the question “What is Chicken?”  (Hint – that’s discussed in Frigaliment Importing Co., Ltd. v. BNS International Sales Corp., 190 F. Supp. 116 (S.D.N.Y. 1960)).  The question of “what is product liability” is of interest to us primarily, but not exclusively, because of 21 U.S.C. §379r(e), which creates an exception for “product liability law” to what is otherwise a rather broad preemption provision governing over-the-counter (also called “monograph”) drugs.

We wrote a post in the early days of the blog – 2008 – about that particular provision, entitled “Preemption Without a Prescription,” where we discussed cases that, up to that time, had addressed the scope of §379r(e)’s saving clause.  That boundary of that clause, as we explained it then, was that “suits for purely economic loss – primarily, but not exclusively, brought under state consumer protection statutes – are not ‘product liability’ actions.”

That’s still true.

We’re not repeating the 2008 post, but we will update it.  Here is a list of cases not discussed in that post, which likewise hold that preemption defeats OTC drug litigation that does not involve personal injury claims:  Wiltz v. Chattem, Inc., 2015 WL 3862368, at *1-2 (C.D. Cal. May 8, 2015); Bowling v. Johnson & Johnson, 65 F. Supp.3d 371, 376-77 (S.D.N.Y. 2014); Gisvold v. Merck & Co., 62 F. Supp.3d 1198, 1202-03 (S.D. Cal. 2014); Crozier v. Johnson & Johnson Consumer Cos., 901 F. Supp.2d 494, 503-05 (D.N.J. 2012) (discussing scope of §379r(e)); Delarosa v. Boiron, Inc., 818 F. Supp.2d 1177, 1188 n.7 (C.D. Cal. 2011) (discussing scope of §379r(e)); Eckler v. Neutrogena Corp., 189 Cal. Rptr.3d 339, 357-61 (Cal. App. 2015) (discussing scope of §379r(e)).

Thanks to this recent blogpost, however, we’ve become aware of another way that the definition of “product liability” is important.  Down in Texas, they have a unique indemnification statute, Tex. Civ. Prac. & Rem. C. §82.002(a) that provides:

A manufacturer shall indemnify and hold harmless a seller against loss arising out of a products liability action, except for any loss caused by the seller’s negligence, intentional misconduct, or other act or omission. . . .

We’d vaguely heard of this statute before, in connection with a case, Hadley v. Wyeth Laboratories, Inc., 287 S.W.3d 847, 849 (Tex. App. 2009), which we liked because it held that prescribing physicians weren’t “sellers” of the drugs they prescribed, which means they can’t be sued for strict liability.

But §82.002(a) also means that, in Texas, the ability of an intermediate seller to recover indemnity (including counsel fees) requires that the underlying action to be one for “products liability.”  That’s where the blogpost comes in.  It discussed a recent case, vRide, Inc. v. Ford Motor Co., 2017 WL 462348 (Tex. App. Feb. 2, 2017), that also addressed the definition of “product liability.” vRide involved an indemnity claim brought by a lessor of a motor vehicle from the defendant, which manufactured the vehicle.  The underlying claim had not been for strict liability, but rather for misrepresentation – that the vehicle did not have the attributes that the original defendant (the lessor) claimed that it did.

The court in vRide held that a misrepresentation claim did not fall within the meaning of “product liability”:

The [plaintiffs’ complaint] did not allege that the [product] was unreasonably dangerous, was defective by manufacture or design, was rendered defective because it lacked certain safety features, or was otherwise defective. Instead, the petition alleged that [defendant] represented [that the product] had certain safety features when in actuality [they] did not have those safety features. . . .  In short, the [complaint] did not contain allegations that the damages arose out of personal injury, death, or property damage allegedly caused by a defective product.

2017 WL 462348, at *7. We can imagine situations in which this definition could come in useful in litigation involving OTC preemption, since it excludes from “product liability” even some actions involving (as did vRide) personal injury.

The most significant hypothetical involves a situation where the plaintiff’s injuries were caused by a generic OTC drug. In that situation, given the broad scope of preemption available in generic drug cases, one could expect plaintiffs to attempt to assert innovator liability against the branded drug manufacturer.  But innovator liability is based (like vRide) on the (we believe phony) proposition that “misrepresentation” is not “product liability” and thus can extend to non-manufacturers.  But if misrepresentation is not “product liability,” then the savings clause in §379r(e) would not apply, and innovator liability claims would be expressly preempted whether or not they involved personal injury. vRide would thus be precedent in favor of preemption.

That would be a good thing.  And so is cross-fertilization – where a definition in a completely unrelated statute can be utilized in support of preemption.

A hospital? What is it? It’s a big building with patients, but that’s not important right now. Airplane, 1980. It’s also a big building filled with doctors and that is important right now. Those doctors are learned intermediaries between prescription drug and device manufacturers and the patients. A manufacturer’s duty to warn runs to the doctor and it then becomes the doctor’s responsibility to use his/her medical expertise to counsel his/her patient and advise the patient of the risks of the recommended treatment, therapy, drug, device, etc. This is drug and device products liability law 101.

Well, now in Washington, device manufacturers (not sure how this will impact prescription drugs) have another duty to warn – the duty to warn the hospital that purchased the device. See Taylor v. Intuitive Surgical, Inc., 2017 Wash. LEXIS 200 (Wash. S.Ct. Feb. 9, 2017). In a bizarre decision, the Washington Supreme Court creates what we believe is a unique, separate duty by device manufacturers to provide warnings to a hospital. Nowhere in the opinion does the court cite any precedent for this alternative warning claim, because there isn’t any. They also hold that the learned intermediary doctrine does not apply to this unprecedented duty. And then the court also refused to apply a negligence standard to plaintiff’s traditional failure to warn claim under comment k. Surely you can’t be serious. I am serious . . . and don’t call me Shirley.

The device at issue in Taylor was a robotic surgical device used for laparoscopic surgeries, including prostatectomies such as the one performed on plaintiff. Id. at *3. It is a complex medical device for which the manufacturer requires surgeons undergo training, including performing at least two proctored surgeries before being credentialed to use the system and recommends surgeons choose “simple cases” for their initial unproctored procedures. Id. at *4-5. The manufacturer also specifically warned surgeons not to use the device for prostatectomies on obese patients or on patients who had undergone prior lower abdominal surgeries and advised that the patient should be in a steep head down position during the procedure. Plaintiff Taylor was the first unproctored procedure for his surgeon and his surgeon opted to use the device despite plaintiff being obese and having had prior abdominal surgery. The surgeon also did not place plaintiff in the downward position due to his weight. Id. at *5-6. Plaintiff’s surgeon conceded plaintiff was not an optimal candidate for using the device. Id. at *6.

Plaintiff brought suit against the surgeon, the hospital, and the manufacturer, then settled with the surgeon and hospital before trial. At trial against the manufacturer, the jury found the manufacturer was not negligent in providing warnings to the surgeon. Id. at *7-8. As noted above, the warnings seem detailed and clear. On appeal, plaintiff argued that the trial court erred in not instructing the jury that the manufacturer had a duty to warn the purchasing hospital and erred in applying a negligence standard to the failure to warn claim.

Continue Reading Washington State Creates Device Manufacturer Duty to Warn Hospitals

Last week three of our posts dealt with Daubert issues.  That was not intentional.  Chalk it up to coincidence.  Or was it?  We are not especially superstitious, but maybe the passing last week of the great “Professor” Irwin Corey had something to do with the Daubert eruption.  Corey was a comedian who pretended to be “the world’s foremost authority”.  As if to parody the parade of plaintiff experts in mass tort cases, Prof. Corey would enter the stage wearing an academic robe, awkwardly look around at the crowd and down at his sneakers, begin with the word “However,” and then proceed to spout gibberish and vague Big Ideas that made no sense.  (This is not the first time in this blog that we have cited the wisdom of Prof. Corey.)  Corey was 102 years old.  He was doing comedy into his 90s, and consistently made more sense than most plaintiff regulatory or causation expert witnesses.  Catch his act on Youtube.  You will find it more enlightening than any plaintiff expert, or even most court opinions discussing the Daubert test.

As if to trumpet one final honor to Prof. Corey, we have a wonderful, clear, compelling Daubert opinion.  This one, Nease v. Ford Motor Co., No. 15-1950 (4th Cir. Feb. 1, 2017), has nothing to do with drugs or devices.  However, [we normally hate starting a sentence with that word, but if it was good enough for Prof. Corey, who are we to stand on ceremony?], the Nease case contains reasoning and language you might want to cite against the next plaintiff exercise in pretentious hokum. That the opinion comes out of the Fourth Circuit is both important and, for the most part, expected.  There are a couple of mass torts in the Fourth Circuit, and the effect of the Nease opinion can only be beneficent.  The Fourth Circuit has long had a reputation for having smart judges who follow the law.  (That being said, we nearly wept over the poor reasoning in the Fourth Circuit’s Cisson decision.)  In this season of judicial nominations by a new administration, we will hear a lot about how judges should decide, rather than create, the law.  The Fourth Circuit has not had a lot of judges posing as philosopher kings.  They actually tend to follow precedent.  We have it on good authority that when the DOJ had an internal debate about where to bring the 9/11 prosecutions – whether S.D.N.Y. (World Trade Center) or E.D.Va. (Pentagon) would be better for the government – the winning argument for E.D.Va. was based not on the pluses or minuses of the district court (or jury pool), but on whether the government would rather face the inevitable appeal in the Second Circuit or the Fourth Circuit.  There was a perception that the Second Circuit was more capable of activism, lenience, and surprise, none of which was particularly welcome under such circumstances.

If you like to see the law interpreted and applied, rather than created, the Fourth Circuit is usually a good forum.  That was certainly true in Nease.   The plaintiff in Nease claimed serious injuries from an accident allegedly caused by a defect in the speed control system of the plaintiff’s pickup truck.  The plaintiff offered the testimony of an electrical engineering expert who maintained that the speed control cable in the truck was susceptible to getting stuck while the throttle was in the open position, thus preventing the driver from being able to slow the vehicle down.  The defendant filed a Daubert motion, challenging the plaintiff expert’s methodology. The district court (S.D.W.Va.) denied the Daubert motion, waved the expert’s testimony along to the jury, and the jury returned a verdict for the plaintiff on strict liability and awarded more than three million dollars.

Continue Reading Fourth Circuit Vigorously Applies Daubert

We’ve been defending the ability of physicians to engage in off-label use ever since the Bone Screw litigation of the 1990s. Buckman Co. v. Plaintiffs Legal Committee, where the United States Supreme Court affirmed that “off-label use is generally accepted” and that under the law, “[p]hysicians may prescribe drugs and devices for off-label uses,” 531 U.S. 341, 351 & n.5 (2001), was one of our Bone Screw cases.  Thus, we follow medical malpractice decisions, like Doctors Co. v. Plummer, ___ So.3d___, 2017 WL 242577 (Fla. App. Jan. 20, 2017), which we discussed recently, for what they have to say about off-label use.  In malpractice cases, the dark side often attempts to equate “intended uses” listed in FDA-approved drug/device labeling with the medical standard of care.  As we mentioned in that post, arguments that FDA-approved product labeling equals the medical standard of care are really  attempts to turn off-label use itself into a tort.

The Doctors Co. decision prompted us to look back over our 9+ years of blogging output for where we addressed this issue previously.  Surprisingly, there was only one, a 2007 Bexis piece that (even more surprisingly) didn’t cite any caselaw.  We also found a 2009 law review article by our erstwhile co-founder, Mark Herrmann, which might have been prompted by the earlier blogpost.  But nothing was on the blog itself that could qualify as useful research.

We rectify that today.

Continue Reading FDA-Approved Labeling ≠ Medical Standard Of Care

A case from Douglas County, Nebraska, caught our eye this week for a couple of reasons. It’s a great Daubert order in an Accutane case in Nebraska state court.  In addition to that, this blogger’s mother grew up on a farm in Douglas County, Nebraska.  It was a lovely 80-acre parcel terraced into a gentle slope leading down to the Platte River.  The Platte River is a shallow meandering river—a mile wide at the mouth and six inches deep, as some Nebraskans like to say—and it flows from west to east, eventually emptying into the Missouri River, and then on to the great Mississippi.  It forms the western boundary of Douglas County.

The Platte River is no use as a commercial waterway, but because of the gradual slope of the Platte River Valley, it has been a highway into the Rocky Mountains for hundreds of years. Traders established trails through the Valley, followed by wagon trains carrying settlors and ultimately surveyors for the Trans-Continental Railroad.  When the Trans-Continental Railroad was built, the government’s policy toward public lands was one of disposition.  The government therefore divided parcels along the railroad’s route into 160-acre tracts and gave every other parcel to the railroad companies, with the government keeping the rest for sale to other private landowners.  This checkerboard land ownership pattern persists to this day.  We have not done the research, but we would wager a bushel of corn that some grantee around the turn of the twentieth century split his 160-acre grant in half and sold it to our great grandfather—resulting in our lovely 80-acre farm in Douglas County.

The Douglas County judge who decided Freeman v. Hoffman La Roche, Inc., No. CI 10-9312802, 2017 WL 385440 (Dist. Ct. Neb. Jan. 23, 2017), may or may not live within view of the Platte River, but she produced an extraordinarily exacting Daubert order that came to the correct result—the exclusion of causation opinion because the expert had not applied a reliable methodology.  The plaintiff alleged that her Accutane use resulted in Crohn’s disease, which the defendants contested.

The battle came down to experts, and it is clear that this case is not the first rodeo for these experts or the lawyers. The plaintiff’s causation expert was Dr. David Sachar, who has been a plaintiffs’ expert for 15 years.  He offered the opinion that Accutane caused the plaintiff’s Crohn’s disease, but he did not follow any accepted scientific method.  Instead, he purported to rely on “lines of evidence” to draw his conclusions.

What are “lines of evidence”? Well, it’s not all that clear to us, but the expert identified nine categories of information:  (1) Animal studies; (2) class effect; (3) biological plausibility; (4) dose relationship; (5) clinical studies; (6) adverse event and challenge/de-challenge/re-challenge reports; (7) the defendants’ internal documents; (8) published medical literature; and (9) epidemiological studies. Id. at *8.  This list looks good on its face, but it does not disclose a scientific method, let alone application of a scientific method to draw a valid conclusion. Put another way, this expert was probably able to produce a nice long report—assuming that expert reports are required and/or permitted under Nebraska procedure.  But a long-winded report is not necessarily good science.

Continue Reading Nebraska Daubert Order Finds Expert a Mile Wide at the Mouth, But Only Six Inches Deep

We have posted several times in the last few years (like here, here, here, and here) about cases alleging birth defects from maternal SSRI use during pregnancy.  Perhaps because of the inherent sympathy for the plaintiff (offspring), it seems that plaintiffs in birth defect cases get extra chances to prove that have enough science to support their claims.  Science in this area is undoubtedly complicated.  For one thing, while ontogeny does not always recapitulate phylogeny, fetal development of placental mammals (of which humans are a relatively recently evolved species) varies, so extrapolation from animal studies on teratogenic effects is even harder than with studies of direct effects on animals.  For another, ethical considerations generally preclude prospective clinical trials designed to study teratogenic effects.  FDA’s treatment of drug labeling on the risks of teratogenic effects has reflected some of this dynamic.

Litigations pursuing birth defect claims seem to follow their own dynamic.  Despite the oft-cited caution from Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 319 (7th Cir. 1996), that “the courtroom is not the place for scientific guesswork, even of the inspired sort.  Law lags science; it does not lead it,” it often seems like cases are pursued before there is science to support them, particularly if specificity of drug, dosage, and injury is going to be required.  This may be due to the impact of statutes of limitations.  It may also be because some courts are lenient on admissibility of causation evidence and there can be years from filing a case a case until Daubert (or equivalent) motions are decided.  Another dynamic seems to be that the only proof as to whether the plaintiff’s mother took the drug during the relevant time can be her word, unless the plaintiff’s expert can argue that the birth defect can itself count as proof of exposure.  We also sometimes see that general causation can be a harder concept for courts to understand than it should be.

Looking through our particular lens, we see all of this in K.E. v. Glaxosmithkline LLC, No. 3:14-cv-1294(VAB), 2017 U.S. Dist. LEXIS 13705 (D. Conn. Feb. 1, 2017), a case that came to the correct result—causation opinions excluded—but took an overly charitable route in arriving there.  The case alleged that maternal use of the defendant’s SSRI during the first trimester of her pregnancy with plaintiff in 2001 caused him to develop a bicuspid aortic valve and accompanying regurgitation.  The plaintiff was diagnosed with a bicuspid aortic valve in September 2010 (after evaluation following his father’s diagnosis with his own heart condition), by which time the drug’s label had been revised to reflect the pregnancy category D—“adverse reaction data from investigational or marketing experience or studies [of the drug] in humans”—and the manufacturer had sent a dear healthcare provider letter describing the basis for the change. Id. at **16-18.  The purported prescribing physician testified that he would not have prescribed the drug to a patient whom he suspected was pregnant or recommended it for a pregnant woman based on the label as it was in 2001. Id. at **16-17.  We say “purported prescribing physician” because he denied prescribing the drug to plaintiff’s mother until after the plaintiff was born, which is what his records and pharmacy records—but not plaintiff’s mother’s testimony—showed. Id. at **9-12.  More on that later.  After the bicuspid valve diagnosis, plaintiff’s records suggested that his mother had used the drug during pregnancy and his mother—plaintiff was still a minor—thought that there was a relationship.  This was reinforced by a lawyer advertisement on television trolling for plaintiffs and she contracted and signed up with a law firm to pursue a lawsuit over plaintiff’s bicuspid aortic valve by September 2011. Id. at **18-19.  Even though the statute of limitations in Connecticut for claims like this was two years, plaintiff waited until late July 2014—close to four years after the diagnosis—to sue.  Within a year—pretty fast for such cases—the manufacturer moved to exclude plaintiff’s sole causation expert and for summary judgment on statute of limitations, lack of causation, and other problems with plaintiff’s proof.  The decision we are discussing followed more than eighteen months later.

Continue Reading Unreliable Expert Causation Evidence Ends Birth Defect Case

We can’t stand “cy pres” distributions of class action settlement funds to non-litigants.  We’ve blogged about this benighted doctrine many times.  We fought against cy pres at in the ALI, and we’ve been fighting against it through Lawyers for Civil Justice in the context of federal rules amendments.

Sure, cy pres can be useful in resolving this or that class action once our clients are unfortunate enough to have become embroiled.  But we firmly believe in the “build it and they will come” theory – that making class actions easier to settle make them easier to bring, because 99% of all class actions (at least those seeking $$$) are brought as strike suits to settle, rather than to litigate.  A cy pres award is a sure-fire indicator of litigation that should never have been brought – because even after settlement, without any opposition from the defendant(s), a cy pres request is an admission that the plaintiffs still can’t prove damages and causation with respect to the absent class members.  They can’t even win a walkover.  Outside the class action area, that would mean “case dismissed” (and maybe sanctions).  As a class action, it means “write a check.”

There is no basis for cy pres in substantive law (outside of a couple oddball statutes), and there’s nothing more “substantive” than taking money supposedly owed to absent class members and giving it to non-litigant charities. Since it’s substantive, there’s also no possible basis for it in Fed. R. Civ. P. 23, since court rules can’t change substantive law.  Cy pres a racket – designed primarily to inflate attorney fee awards − and while the charities might do good work, call us the Grinch, because we don’t think the litigation industry should be funding charities with other people’s money extorted through litigation threats.

Here’s the latest example of cy pres abuse occurring in the context of bogus litigation that should never have been brought, Koby v. ARS National Services, Inc., ___ F.3d ___, 2017 WL 359670 (9th Cir. Jan. 25, 2017).  This isn’t a drug/device case.  Thankfully, between the FDCA no private right of action rule (which, regrettably has a food loophole) and the rejection of personal injury class actions, we don’t encounter all that many of them anymore against drug/device clients.  Instead, Koby is a Fair Debt Collection Practices (“FDCP”) action, and as you might expect from the introduction, a bottom-feeding FDCP action at that.

Supposedly the defendant violated the FDCP at some point a decade or so ago when its employees left messages that did not fully identify themselves. This issue was later fixed, but the class action supposedly includes “some four million people nationwide.”  Koby, 2017 WL 359670, at *1.  Predictably, nobody in the class was actually harmed by what appears to have been a technical FDCP violation (quickly fixed), so only statutory damages were sought.  Theoretically that could have been a lot (4M x $1000), but because ARS was a small company, the 1% of net worth statutory cap limited recovery to $35,000. Id. at *1-2.

You do the math.

Continue Reading More Cy Pres Abuse in California Class Action Litigation