This guest post is by Reed Smith associate Lora Spencer, who (as you might suspect) calls Texas her home.  In her first rodeo on the blog, she discusses a recent MDL decision that she thinks is a few pickles short of a barrel, and hopes it’s not a harbinger of things to come.  Not exactly a conniption fit, but close.  As always our guest posters deserve 100% of the credit (and any blame) for what they write.

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“Everything is bigger in Texas”—or is it? The plaintiffs in Aron v. Bristol-Myers Squibb, 2018 U.S. Dist. LEXIS 39146 (S.D.N.Y. Mar. 9, 2018), would have y’all believe that pharmaceutical manufacturer tort liability, at least, is bigger in Texas.  But, first, before getting to this “Texas Expansion,” here are some interesting “reported” facts about Texas.  Pay attention, there may be a pop quiz, if not now, perhaps at your next networking event.  Knowing such factoids will surely make your “lone star” shine brightly.

Texas is a really BIG state. Texas is ranked 2nd in the country in population and size.  Texas’s total area is twice the size of Germany (albeit half the size of Alaska).  Of 45 United States presidents – three of them hail from Texas—all of them since 1963, hence the slogan “read my lips, no new Texans.”  King Ranch, located in south Texas, is considered “the birthplace of Texas ranching” and is larger than Rhode Island.  Texas also has the most rattlesnakes of any state.  And the weight of the catfish consumed by Texans each year exceeds that of the Paris Eiffel Tower (at least the one in Texas).  “Texas is just too big,” said no Texan ever.  Apparently Aron takes the same view.

Aron purported to apply Texas law in what appears to be the first reported opinion from the Farxiga MDL.  Maybe future opinions will be better.  Aron denied the defendants’ motion to dismiss plaintiffs’ amended complaints under Rule 12(b)(6).  Id. at *9.  Farxiga has only one labeled indication—lowering blood glucose in adults with type 2 diabetes.  Id.  Because everything is bigger in Texas, so is the complaint, which included three Texas plaintiffs with no business being joined in the same complaint.  Getting a free pass on misjoinder, these three plaintiffs brought “causes of action claims, under Texas law, based on the defendants’ failure to warn of [drug] risks …, negligent testing, and gross negligence.” Id. *16.

Failure to Warn

The most important thing about Texas product liability law is that most of it is now statutory.  Under Texas law, in a products liability suit, a statutory presumption precludes a defendant drug manufacturer from being liable for failure to warn claims if its warnings were approved by the Food and Drug Administration (FDA).  Texas Civ. Prac. & Rem. Code Ann. § 82.007.  However, a plaintiff may rebut this presumption by establishing one or more of five statutory exceptions.  Id. at (b)(1-5).

In Aron, the relevant exceptions were § 82.007 (b)(1) and (3).  2018 U.S. Dist. LEXIS 39146, at *17.  Section (b)(1) allows a plaintiff to rebut the presumption by proving fraud on the FDA—that “the defendant, before or after pre-market approval … withheld from or misrepresented to the [FDA] required information that was material and relevant to the performance of the product and causally related to the claimant’s injury.”  Civ. Prac. & Rem. § 82.007(b)(1).  Section (b)(3) avoids the presumption if the plaintiff can show off-label promotion – that “the defendant recommended, promoted, or advertised the pharmaceutical product for an indication not approved by the [FDA], the product was used as recommended, promoted or advertised; and the claimant’s injury was causally related to the recommended, promoted, or advertised use of the product.”  Id. at (b)(3).

As regular blog readers know, a claim predicated on fraud on the FDA should be preempted. Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  Unsurprisingly, the defendants argued the FDA fraud exception is preempted by federal law. Aron, 2018 U.S. Dist. LEXIS 39146, at *20.  The court noted conflicting Fifth and Second Circuit decisions concerning § 82.007(b)(1) and a similar Michigan statute. Compare Lofton v. McNeil Consumer & Specialty Pharms., 672 F.3d 372 (5th Cir. 2012) (applying Texas law) (discussed here), with Desiano v. Warner Lambert & Co., 467 F.3d 85, 95 (2d Cir. 2006) (applying Michigan law), aff’d by equally divided court, 552 U.S. 440 (2008).  However, because the plaintiffs did not plead the fraud exception with “sufficient particularity,” Aron did not decide the preemption issue.  Id. at *21.  Given the other rulings in Aron, its punting on preemption is probably just as well.  In true Texas fashion, Hi-Yo Silver away!  The plaintiffs failed to rebut the presumption using §82.007 (b)(1). Id.

However, fraud on the FDA is only one of § 82.007’s five exceptions.  Properly raising any one of them will get a plaintiff past a presumption-based motion to dismiss.  Id. at *17.  Plaintiffs got away with pleading the “off-label” marketing exception, under § 82.007 (b)(3). Id. at *20.  Plaintiffs alleged:  (i) defendants promoted Farxiga to prescribing physicians for off-label uses, specifically obesity and hypertension, (ii) such off-label promotion caused the physician to prescribe Farxiga for off-label use, (iii) plaintiffs used Farxiga for off-label purposes, and (iv) off-label use caused the plaintiffs injuries.  Id. at *20-22.  Plaintiffs cited press releases, advertisements, and clinical trial protocols to support their claim that off-label marketing occurred.  Id.  However, Aron failed to discuss the pleading of causation  Not one of the various off-label statements was linked to any particular prescriber, let alone to a prescription that caused these plaintiffs’ injuries.  Never mind that physicians may, and often do, prescribe drugs for unapproved uses as part of their practice of medicine.  Aron let the plaintiffs slide on causation.  All hat and no cattle.

Negligent Testing

Aron also allowed the plaintiffs’ negligent failure to test claim to stand.  2018 U.S. Dist. LEXIS 39146, at *22.  The plaintiffs alleged the defendants negligently failed to test Farxiga thoroughly before releasing the drug into the market, failed to analyze pre-market test results, and failed to conduct sufficient post market testing and surveillance.”  Id. at *23.  Defendants argued the plaintiffs’ negligent testing claim is “inextricably intertwined” with the plaintiffs’ failure to warn claim and is inadequately pleaded. Id. The Fifth Circuit, applying Texas law, has so held—twice.  “[A] negligent testing claim is, as a matter of Texas law, a variation of an action for failure to warn.” Dow Agrosciences LLC v. Bates, 332 F.3d 323, 333 (5th Cir. 2003) (applying Texas law), reversed on other grounds, 544 U.S. 431 (2005) (preemption).  Plaintiff’s “negligence claims, such as the alleged failure to adequately test [the product], are subsumed within” a failure to warn claim. Skotak v. Tenneco Resins, Inc., 953 F.2d 909, 912 n.5 (5th Cir. 1992) (applying Texas law).

Even though Fifth Circuit law should have controlled on this point of state law, Aron chose to follow cases that it asserted recognized “an independent cause of action based on negligent failure to test.”  Id. at *22-23.  The most significant of the three, Am. Tobacco Co. v. Grinnell, 951 S.W. 2d 420 (Tex. 1997), certainly did not.  Rather, the Texas Supreme Court’s holding was quite the opposite:

[Plaintiff’s] negligent testing claim is predicated on [defendants’] duty to test and ascertain the dangers inherent in its products about which it must warn consumers.  Because the negligent testing claim is inextricably intertwined with the [plaintiffs’] negligent failure to warn claim, we hold that summary judgment was also proper on this claim.

Id. at 437.  “Inextricably intertwined” is about as far from “an independent cause of action” as you can get.  Of the other two cases, Murthy v. Abbott Laboratories, 847 F. Supp.2d 958 (S.D. Texas 2012), is notorious for improperly construing Texas law.  The other, Romero v. Wyeth Pharmaceuticals, Inc., 2012 WL 12547449, at *4 (E.D. Tex. Aug. 31, 2012), essentially followed Murthy. Aron is another instance of improper federal court judicial activism attempting to push state (Texas) law where no state court has ever gone.

Gross Negligence

Apparently, in Texas, it is not enough just to plead negligent testing. The plaintiffs also pled gross negligence.  2018 U.S. Dist. LEXIS 39146, at *24.  The defendants argued that “[i]t is merely a restatement of plaintiff’s deficient negligence count.” Id.  However, Aron looked to the elements of gross negligence, and held the plaintiffs sufficiently pled facts to support an inference of gross negligence.  Id. at *25.  Those facts oddly included a September 2013 “post market” study.  Id. at *26.  Supposedly, the defendants “terminated” that study in “2013 without posting any results.”  Id. at *9.  However, the FDA did not approve Farxiga until January 8, 2014. Id. at *9.  That does not sound like gross negligence, but rather a preempted fraud on the FDA claim.  Whether or not anything was “posted,” the alleged study termination occurred before the FDA’s approval of this product, so the only reporting duty was imposed by federal law—not Texas law—and it ran to the FDA.  Any public “posting” of product-related information before FDA approval would illegally promote an unapproved product, which almost certainly explains lack of any such post.

With Aron, the Farxiga MDL is not exactly off to a good start.  Will this be another instance of MDL abuse in the making?  Saddle up, and get ready for a wild ride, the prominent phrase “Everything is BIGGER in Texas” is unfortunately reflected in Aron’s approach to product liability.

In searching for cases for this blog, we sometimes feel like its Groundhog Day.  Another preemption win in a PMA medical device case.  Another food labeling decision from California.  Another failure to plead fraud with particularity dismissal.  Another “Okay, campers, rise and shine, and don’t forget your booties ’cause it’s cooooold out there today.”  Well, that last one really only applies to Phil Connors, but you get the idea.

Faced with routine rulings, it can be difficult to be creative, to find the new hook or twist.  So, sometimes the answer is simply to not – be creative that is.  Sometimes, a decision is just what it looks like it is on its face.  Another good ruling in an already good body of law.  But that doesn’t mean it should be disregarded either.  We just need to pluck out the good sound bites and add them to top of the pile.

For instance, if faced with a claim for negligent failure to test in Pennsylvania, you can now add Houtz v. Encore Medical Corp., 2014 U.S. Dist. LEXIS 170481 (M.D. Pa. Dec. 10, 2014) to your motion to dismiss on the ground that “Pennsylvania courts have explicitly stated that negligent failure to test is not a viable cause of action.”  Id. at *7.

Continue Reading Pennsylvania Sound Bites

Back in September we gave you the end of the year holiday season countdown. With Halloween behind us, we are down to Hanukkah (15 days away (Mensch on a Bench is already sold out for 2013)), Thanksgiving (16 days away) and Christmas (42 days to go).  If someone would make a scarecrow holding a turkey and wearing a Santa hat – it sure would save a lot of decorating time.  Especially since each of these holidays seems to start before the last one is over.  If you look around just about anywhere, you’re likely to wonder if you slept through November altogether.  Christmas music started playing in shopping malls across the country November 1st.  Pumpkins were packed away and replaced with stockings, candy corn was traded in for candy canes, and witches were shoved aside to make room for reindeer seemingly overnight.

But despite all the marketing hoopla, there is still one thing that toy stores and advertisers can’t control that really drives home the spirit of the holidays – the first snow of the season.  And for those of us in the Philadelphia, New Jersey, New York area, we got it today.  It wasn’t much.  It didn’t stick to the ground.  It was mostly over before rush hour was.  But it was snow nonetheless.  And a snow that doesn’t cause traffic jams and require shoveling is even better. So, for this area of the North East at least, we feel the holidays are truly upon us.  Let the bustling, the caroling, the baking, and the egg-nogging begin.

And while you ponder sugar plums, mulled cider, and crackling fires, we’ll update you on a recent federal decision that refused to recognize an expansion of state products liability law – Baird v. Bayer Healthcare Pharmaceuticals, Inc., 2013 U.S. Dist. LEXIS 156667 (Oct. 31, 2013).  Plaintiff alleged she sustained injuries as a result of her intrauterine device (“IUD”) and filed a complaint alleging thirteen causes of action:  negligence, strict liability (design defect, manufacturing defect, failure to warn, non-conformance with representations, and failure to adequately test), breach of express and implied warranties, fraudulent and negligent misrepresentation, fraudulent concealment, fraud and deceit, and punitive damages.  Id. at *2-3.  We call that throw-it-against-the-wall-and-see-if-something-sticks pleading.  Defendant filed a motion to dismiss the warranty, negligent misrepresentation, duty to test, and punitive damages claims.  Applying Kentucky law, the court granted defendant’s motion in its entirety and with prejudice.

The court dismissed the warranty claims because plaintiff failed to plead privity.  Id. at *7-8.  As for negligent misrepresentation, duty to test, and punitive damages – the court dismissed them because they aren’t recognized by Kentucky law.  The court tossed out the punitive claim because punitive damages are a remedy, not a separate cause of action.  Id. at *10.  But because punitive damages were alleged in the prayer for relief, the dismissal doesn’t have any substantive bearing on the case.

The other two dismissals however are significant and are grounded in the court’s adherence to the doctrine of Erie v. Tompkins that federal courts sitting in diversity jurisdiction should not usurp the function of state appellate courts and predict expansions of state tort law.  So, because “Kentucky courts have not spoken on this issue, [the Eastern District of Kentucky] will not read into Kentucky products liability law a failure-to-test claim.”  Id. at *6.  Like so many other courts, this one found failure to test subsumed under failure to warn.  Likewise, under Kentucky law, negligent misrepresentation claims are limited to “instances where a party is in the business of supplying false information for the guidance of others in their business transactions.”  Id. at *9.  The court found no Kentucky products liability negligent misrepresentation claims and noted that the Sixth Circuit has predicted that Kentucky would not adopt such a claim.  Therefore, allowing plaintiff Baird’s “negligent misrepresentation claim to proceed . . . would improperly expand the cause of action.”  Id. at *10.

Now, back to the holidays.  Have you heard that Robo Fish are this year’s Hexbugs?  (if you understand this, you are the parent of an elementary school child).

There are several reasons we recommend taking a look at last week’s decision in Ball v. Takeda Pharmaceuticals America, Inc., 2013 WL 4040395 (E.D. Va. Aug. 8, 2013).  One is that the case involves Stevens Johnson Syndrome, a rare but devastating idiosyncratic reaction which has become something of a litigation flavor du jour, with plaintiffs claiming that a great number of drugs cause this condition.  After showing considerable patience (plaintiff filed 5 motions to amend), the court ruled that plaintiff finally struck out.

Most significantly, Ball was super in dismissing the plaintiff’s warning claim.  The court held that the defendant’s warning about SJS/TENS was adequate as a matter of law – and dismissed the case:

The [relevant] label clearly identifies Stevens-Johnsons syndrome as a potential “adverse reaction” that could result from use of the prescription drug.  Under Virginia law, a manufacturer is obligated to give a reasonable warning, not the best possible one.  Courts have routinely held warnings adequate as a matter of law when they alert a party to the very injury for which the plaintiff seeks relief.  [Defendant] disclosed Stevens-Johnson syndrome as a possible adverse reaction to [the drug] prior to plaintiff’s ingesting the drug. . . .  The failure to disclose this risk is the sine qua non of the plaintiff’s negligence and negligence per se claims to the extent they seek to hold [defendant] responsible for plaintiff’s Stevens-Johnson syndrome.  Those claims are dismissed, with prejudice.

Ball, 2013 WL 4040395, at *5 (citations omitted).  A finding of adequacy as a matter of law is powerful, since warning claims are at the heart of prescription drug litigation.  That this determination was made at the motion to dismiss stage, with the court taking notice of the label, is obviously even better. “A manufacturer does not insure its product’s safety, and need not supply an accident-proof product,”  Id. at *6 (citation and quotation marks omitted).

Continue Reading On The Ball In The Old Dominion

Because of Reed Smith’s involvement in this litigation, this post is from the Dechert side of the blog only.

We love to bring you the slam dunks, the grand slams, the holes in one – well, at least the ones that go in defendants’ favor. And, while we dislike having to deal with the air balls, the strike outs, and the shanks into the rough, we do it. Usually with less gusto but then we’ve always been honest that this is a defense oriented blog.  We examine the rulings that go against us to be forewarned, to develop new strategy, and we hope in some small way to contribute to changing the law.  But, as practitioners we know that more often the course of a lawsuit is filled with small victories and minor defeats as the game inches toward completion – whether trial, settlement or dismissal.

That brings us to today’s case – mostly sweet, with a hint of a sour after taste.  Cisson v. C.R. Bard, Inc., 2013 WL 3821280 (S.D. W. Va. Jul. 23, 2013) is another decision out of the Pelvic Mesh MDL and it applies Georgia law.  The decision is actually clarifying the court’s earlier evidentiary ruling regarding evidence of defendant’s alleged failure to test.

First, the court makes clear that under Georgia law, there is no separate cause of action for failure to test.  Id. at *4 (“there is no claim for failure to test under Georgia law”). That’s no shocker; the list of courts reaching the same conclusion is quite lengthy.   But this wasn’t a motion to dismiss, rather a motion in limine.  And, because the “duty to test is subsumed within the plaintiffs’ design defect and failure to warn claims,” id. at *5, the court was called upon to determine what testing evidence would be admissible at trial.

Continue Reading No Duty to Test Claim Doesn’t Keep Out Failure to Test Evidence Entirely

A lot of things happened last week – so much that our usual wrap-up search last Friday took over three hours, which is more than twice as long as normal.  Since there were too many cases of interest to blog about separately, we’re doing the next best thing, which is to give our readers a rundown of what’s left on the agenda.

Although the word “preemption” was never uttered in the opinion, the decision in Bennett v. Hoffmann-LaRoche Inc., 2013 WL 1191899 (E.D.N.C. March 22, 2013), occurred entirely within preemption’s shadow.  The issue was product identification – specifically whether the drug that the decedent took was branded (unpreempted) or generic (preempted).  Use of the drug took place in a military context:  everyone in the decedent’s unit took an antimalarial drug before shipping to Afghanistan.  The decedent then “committed suicide with his service-issued sidearm.”  Id. at *3.  Since the anti-malarial drug was detected by the autopsy, id., of course it must have caused the suicide.

But the service distributed both branded and generic, did so on a FIFO (first in, first out) basis, and didn’t keep records of who got what.  Id. at *2, *4.  Here’s what the plaintiff came up with to avoid preemption:

[Plaintiffs] . . . visited [decedent] at [his base].  While in [decedent’s] barracks room, he opened his closet and all sorts of stuff fell out, including an object with “silver foil” [not original packaging] and a small white rectangular box [consistent with either branded or generic]. . . .  Beyond observing that the white box was about the same size as the silver object, [plaintiff mother] does not recall whether the box had been opened or any markings on the box.[Plaintiff mother] asked [decedent] about the silver object that had fallen out.  In response, he picked up the object, handed it to [plaintiff mother], and said, “It’s Lariam”. . . .  Before [plaintiff mother] responded to [decedent] handing her the blister pack, he also handed her a package insert. . . . To [plaintiff mother], who worked as a nurse, the paper appeared consistent with the type that normally comes in medication packs. . . .  She unfolded the insert and noticed the word “Lariam,” as well as the hexagon logo for Roche.  [Plaintiff mother] estimated that the entire sequence of events . . . occurred in a matter of seconds.

Bennett, 2013 WL 1191899, at *2 (deposition citations and quotation marks omitted).  This testimony was, of course, rank hearsay – out-of-court events being admitted for the truth of the matter.

How convenient.  We’ve blogged before about asbestos-style causation techniques finding their way into drug/device litigation where drugs are dispensed generically.  Bennett – the prescription drug version of “I saw the defendant’s name/logo on the box” − is another example of how questionable litigation tactics spawned in asbestos actions are now trickling into our sandbox.  Bennett let the plaintiffs skate, holding that this testimony, since it took place in “seconds,” was a “present sense impression.”  2013 WL 1191899, at *5.  We think that abuses the exception, since it’s not intended for particular purposes such as product identification:

A declarant who deliberates . . . or provides statements for a particular reason creates the possibility that the statements are not contemporaneous, and, more likely, are calculated interpretations of events.

Schindler v. Seiler, 474 F.3d 1008, 1011 (7th Cir. 2007).  Product identification seems like a classic “particular reason” for rejecting use of the present sense impression.  The abusive potential is obvious.

The “logo-on-the-box”-style identification was supposedly not hearsay at all.  “[S]tatements that identify an object based on words or symbols that appear on the object are not hearsay merely because the means of identification is written.”  Id.  To that, we can only shake our heads.  An unproduced writing is a classic out-of-court statement.  The words – the supposed identification of the product – were useless if not admitted for their truth.  There’s also a “best evidence rule” argument, but we’re not quarreling with that.  What we quarrel with is admitting asbestos-style rank hearsay for product identification purposes.

In a busy week, one can expect pain pump litigation to contribute its share, and it did.  One decision, coincidentally also having to do with North Carolina (or at least what passes for North Carolina law in the District of Minnesota – those in the know can guess the judge), was really painful to read.  In Block v. Woo Young Medical Co., 2013 U.S. Dist. Lexis 44106 (D. Minn. March 28, 2013), just about everything went wrong for the good guys – even though this defendant, unlike other pain pump cases, was never turned down for any FDA clearance (which shouldn’t make a difference anyway, but we digress).

Id. at *3.

First, even though there’s next to no evidence that the prescriber had any contact with any “promotion” (on or off-label) by the defendant (he learned from colleagues, couldn’t remember brand of product, gave no defendant-specific testimony of sales rep contact, made no reliance on labeling, Id. at *3-5), Block nonetheless denied summary judgment on warning causation grounds, adopting instead a weird, totally speculative causation-by-osmosis theory.  Id. at *12-13 (“if [defendant] had warned individuals in the medical community about the orthopedic use of its pain pumps, [the prescriber] would have been likely to learn about the risks”).

Second, as for promotion, there’s no evidence that the defendant did anything, save signing a distribution contract with a third party.  But that was enough (without any discussion of agency) to hold the defendant liable for everything the other party to the contract actually did.  Id. at *10-11.

Third, to supply the otherwise missing element of “foreseeability,” Block – relying on Minnesota, rather than North Carolina law – invented a purported “duty to test” never before seen in North Carolina, see Couick v. Wyeth, Inc., 2012 WL 79670, at *7 (W.D.N.C. Jan. 11, 2012) (rejecting duty to test under NC law) − and actually beyond anything recognized in Minnesota, where testing is not an independent claim, but merely an element of a strict liability (which North Carolina bans by statute) duty to warn.  Solo v. Trus Joist MacMillan, 2004 WL 524898, at *13 n.26 (D. Minn. March 15, 2004) (“duty to test . . . is not a
separate cause of action under Minnesota law”); Kociemba v. G.D. Searle & Co., 707 F. Supp. 1517, 1527-28 (D. Minn. Feb. 16, 1989) (granting judgment n.o.v. against independent duty to test claim).  Under Erie, federal courts are not supposed to invent new liability under their own state’s law; Block is even worse, inventing liability under the unfamiliar law of a different state.

Fourth, and finally, adding insult to injury, Block denied all of the defendant’s Daubert motions.  We can’t tell from Block whether there was more to some of those motions than meets the eye, but letting an expert testify in direct contradiction to his own prior peer-reviewed scholarship, 2013 U.S. Dist. Lexis 44106, at *36-38, borders on bizarre.  So much for the Supreme Court requiring that experts should be held to the same standards inside the courtroom as
outside.  Worst of all Block let the ubiquitous Dr. Parisian testify – even as to what the defendant “should have known” about the medical risk in question (chondrolysis), as to which she has no pretentions to expertise, either as a doctor or as a purported FDA expert.  Id. at *42.  Parisian’s infamous narrative testimony is permitted.  Id. at *47-48.  About the only good thing about Block is its refusal to allow Parisian to testify directly that the defendant violated the FDCA, that being both an improper legal opinion and barred by Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  2013 U.S. Dist. Lexis 44106, at *45.  Even that was partially nullified by allowing equivalent opinions under an industry standards rationale.  Id. at *45-46.

But we don’t want just to discuss yucky cases, so we’re bookending Block with another pain pump decision, Prather v. Abbott Laboratories, C.A. No. 3:09-CV-00573-H, slip op. (W.D. Ky. April 2, 2013), that granted summary judgment and dismissed the entire action.  Prather comes courtesy of Lauren Tulli at Cozen, who won the case.  Unlike North Carolina law in Block, Kentucky law recognizes strict liability.  Slip op. at 5.  In strict liability cases, Kentucky follows Restatement §402A, comment k – and applies it to medical devices.  Slip op. at 6-7.  Unlike Block the court in Prather found no foreseeability of injury as a matter of law – rejecting the same articles and the same expert (Dr. Parisian, once again), that snuck through in Block:

The Court concludes that these articles do not support the conclusion that in 2001, Defendant should have known of the risk of cartilage damage due to the intra-articular infusion of an anesthetic. . . .  The additional articles [offered by plaintiff] suffer from the same deficiencies. . . .  Specifically, these articles document the effects of exposure to solutions that are fundamentally different than the anesthetic medication used in the [plaintiff’s product].  The Court finds that the entirety of the articles presented by [plaintiff] are insufficient to create a factual issue of whether Defendant should have known of the risk of cartilage damage.

Prather, slip op. at 13 (footnotes omitted).  So much for strict liability.  Prather turned to negligence (the only claim at issue in Block). Predictably, plaintiff raised failure to test as a way to avoid the state of knowledge at the time.  The question was the same as in Block – does Kentucky recognize an independent duty to test?  Again unlike BlockPrather refused to invent a new legal theory of liability:

Though [plaintiff’s] expert Dr. Parisian suggests Defendant could have done additional testing, it is unclear whether such testing would have revealed a risk of chondrolysis.  Defendant certainly had an obligation to conduct some amount of testing, defined by what risks the medical community identified or suspected the product to have, in order to ensure the general safety of the product.  However, Defendant did not have an obligation to spearhead medical research by testing for every conceivable risks posed by use of the [device].  Imposing such an extraordinary, heightened duty of care would be inefficient; in most cases, additional testing would likely result in products that are marginally more safe, but unnecessarily more expensive.

Prather, slip op. at 17-18.

Plaintiff Prather also made a quasi-fraud on the FDA argument that “Defendant breached its duty of care by failing to submit sufficient information to the FDA.”  Id. at 18.  It didn’t work.  First, the defendant was a contract manufacturer, not the application holder.  Another company (now dissolved) was. So plaintiff had no evidence that this defendant was (or should have been) involved in the regulatory process.  Id.  Also, since the FDA cleared the device, and the device was used in the “precise way” it was cleared, plaintiff could not prevail in negligence.  Id.

Warning causation also failed as a matter of law.  None of that goofy causation-by-osmosis in Prather:

Here, the evidence indicates that [the prescriber’s] use and placement of the [device] were decisions entirely of his own. . . .  [The prescriber], with his colleagues, adapted the [device] for use in the shoulder. . . .  At no time did Defendant promote any particular use or placement of the [device].  In fact, the record strongly suggests that Defendant’s conduct did not have a meaningful effect on any of [the prescriber’s] medical decisions.

Slip op. at 19-20 (footnotes omitted).  Finally, Prather briefly addressed (and threw out) warranty and fraud.  Id. at 20-22.

When there’s a lot of activity, another likely source is Aredia/Zometa, and that was also true last week.  We know of four new decisions.  First, there’s a lengthy and well-reasoned decision evaluating choice of law, punitive damages, and preemption of the New Jersey fraud on the FDA exception.  Guenther v. Novartis Pharmaceutical Corp., 2013 WL 1225391 (M.D. Fla. March 27, 2013).  You know the drill by now.  Guenther held:  (1) choice of law principles for punitive damages point to the manufacturer’s principal place of business, which in A/Z is New Jersey; (2) New Jersey prohibits punitive damages against FDA-approved products unless there’s fraud on the FDA; and (3) fraud on the FDA is preempted by Buckman.  2013 WL 1225391, at *2-4.

Contrast Guenther to the cruddy little one-paragraph order (there’s a second paragraph dealing with procedure) of another court in the same district that goes the other way (on preemption, at least).  See Chiles v. Novartis Pharmaceuticals Corp., No. 3:06-cv-96-J-25 JBT, slip op. (M.D. Fla. Feb. 25, 2013).  Unfortunately, since punitive damages have since been rejected by the jury at trial in Chiles it’s doubtful whether there’s anything left to appeal on that issue.

There’s also a Parisian motion in Guenther.  Most of it is standard, governed by MDL rulings, and/or stipulated, but there’s one significant issue – so-called “regulatory causation.”  We’ve posted before about plaintiffs’ attempts (we called them sub rosa preemption) to try substitute the FDA’s regulatory labeling standard (“reasonable evidence of a causal association . . . a causal relationship need not have been definitely established”) for the common-law causation standard (but for causation/substantial factor in the result).  Well, Dr. Parisian was up to that trick in Guenther, but the court didn’t allow it:

The Defendant argues that allowing Parisian to testify regarding [defendant’s] compliance with that regulation is effectively the same as allowing her to testify regarding medical causation. . . .  Plaintiffs’ counsel responds that “causal association” is an FDA term, rather than a medical term, and that Parisian as an FDA compliance expert should be permitted to testify in regard to that term.  Aside from its origin, however, Plaintiffs’ counsel offers nothing to meaningfully distinguish “causal association” from medical causation. . . .  Parisian will not be permitted to offer opinions regarding any alleged “causal association” between ONJ and Zometa.

Guenther v. Novartis Pharmaceuticals Corp., 2013 WL 1278089, at *3 (M.D. Fla. March 28, 2013).  The FDA “causal association” standard, is just as Guenther stated – an “end run” around “medical causation.”  Id.

Saving the best for last, the fourth A/Z decision is McKay v. Novartis Pharmaceuticals Corp., ___ F. Supp.2d ___, 2013 WL 1278025 (W.D. Tex. March 28, 2013), granting complete summary judgment.  It’s a Texas case, so the Texas presumption of adequacy (Tex. C.P.&R.C. §82.007) was in play – and had been in the MDL.  Interestingly, McKay agreed that all of the plaintiff’s claims were, at bottom, predicated on warnings – no matter what the plaintiff called them.  No exception to §82.007 applied.  In particular, the exception for off-label promotion required not only promotion, but causation:

Plaintiffs must provide evidence that recommendations, promotions, or advertisements to use Aredia or Zometa for off-label purposes reached and were relied on by the prescribing physician. . . .  Although Plaintiffs do provide evidence that [another doctor] “marketed” Aredia to [the prescriber] for an off-label use, they do not provide any evidence that [the other doctor] is a [defendant] agent or a key opinion leader who drove off-label marketing efforts for [defendant].  Accordingly, Plaintiffs have provided insufficient evidence to establish that any off-label promotion of Aredia or Zometa, by [defendant], actually reached and influenced . . . the prescribing physician.

McKay, 2013 WL 1278025, at *5-6.  Always remember causation in this situation.  The same prescriber non-reliance evidence that often wins learned intermediary cases on causation grounds should likewise win them under the off-label promotion exception to §82.007.  McKay also rejected other, more technical, attempts to avoid §82.007.  It held, first, that the effective date of the statute was the only date that mattered, not when the plaintiff used the product; and second, that the preempted part of the statute was severable.  2013 WL 1278025, at *6-7.

As to other supposed causes of action, the court made the following rulings:  (1) Restatement §402A, comment k applies across the board in Texas, barring separate claims for design defect.  2013 WL 1278025, at *8-9; (2) the duty is to warn the prescriber, not every (unknowable to the manufacturer) doctor that might ever have seen a plaintiff, id. at *8; (3) there’s no direct-to-consumer exception to the learned intermediary rule, id. at *9; and (4) to the extent that plaintiff’s warranty claim otherwise survived, plaintiff failed to provide statutorily required notice.  Id. at *10-11.

Guenther and McKay came to us by way of Hollingsworth, whom we also assume successfully sought F.Supp. publication of McKay (we’ve made similar requests many times, whether we won a decision or not).  Other people sent us stuff this week as well:

Brendan Kenny of Blackwell Burke, who wrote the guest post some weeks ago about the Illinois Supreme Court’s in Fennell v. Illinois Central Railroad Co., ___ N.E.2d ___, 2012 WL 6725822 (Ill. Dec. 28, 2012), on forum non conveniens, has passed along a new decision (unfortunately unpublished) by the First District Appellate Court of Illinois, affirming transfer of a multi-plaintiff action out of Cook County under Fennell.

A source that wishes to remain anonymous sent me Flores v. Ethicon, Inc., C.A. No. 2:12-cv-01804, slip op. (S.D.W. Va. April 4, 2013), which is a favorable fraudulent joinder case from the transvaginal mesh MDL.  First the court resolved an interesting procedural question of which law applied (the case had originally been filed in California district court), holding that on federal matters such as jurisdiction, the MDL/transferee court applied the law of its own circuit.  Slip op. at 5.  As a matter of substantive California law, the court held that the doctors and hospitals were fraudulently joined because:  (1) no possibility of a strict liability or warranty cause of action existed against them from their use/supply of a medical device since they provided services, id. at 11-12, and (2) no negligent conduct of any kind was alleged.  Id. at 8-11.

Finally, a plaintiff’s lawyer (whom we don’t know if he wants to be “outed” as a reader) sent along this certification order concerning the learned intermediary rule that a federal district court in a Humira case recently directed to the Tennessee Supreme Court.  As of now, it hasn’t been accepted.

There.

Now you’re as up to date as we are.

Today’s post is of the “this and that” variety − dealing with things we’ve come across that we haven’t yet blogged about this week.

Medical Device Preemption − The Greatest

As defense counsel appreciate, PMA preemption post-Riegel floats like a butterfly and stings like a bee.  Anybody representing PMA medical device clients will want to read (and cite) Ali v. Allergan USA, Inc., 2012 WL 3692396 (E.D. Va. Aug. 23, 2012).  Ali involved a “lap band” − a PMA device that restricts the ability of the stomach to expand, used as a last-ditch weight control measure in cases of morbid obesity.

Ali involves several preemption issues, and is also good on TwIqbal and the Virginia Consumer Protection Act.  On preemption, as usual the battleground was the so-called “parallel claim” exception.  2012 WL 3692396, at *7.  Plaintiffs offered only “a series of conclusory allegations that that [defendant] violated federal law.”  Id.  Not surprisingly, that didn’t cut it. Thus, everything having to do with warnings was dismissed (albeit without prejudice).  Id.

Plaintiffs contended that they based their negligence and implied warranty claims in a manufacturing defect.  Again they faced TwIqbal.  “[T]the plaintiff must allege sufficient facts to support both the inference that the defendant manufactured the device in a way that violated federal regulations and the inference that this violation resulted in the defect that caused the plaintiff’s injuries.”  Id. at *8.  The manufacturing defect claim required:  (1) that “the plaintiff identif[y] what went wrong in the manufacturing process and cite[] the relevant FDA manufacturing standards that were allegedly violated,” id., and (2) “sufficient facts to support the inference that the defendant’s federal violations resulted in the defect that caused the plaintiff’s injuries.”  Id. at *9 (citations and quotation marks omitted).  The Ali complaint didn’t come close, containing only “information and belief” allegations as to violations and nothing at all about causation.  Id. at *10.  As to what was violated, alleging “any regulations promulgated pursuant to the Act” somehow didn’t impress the court.  Id.  Nor do allegations that are nothing more than “simple recitations of regulatory language” enough.  Id. at *11.  Plaintiff can’t get away with copying sections of the Code of Federal Regulations.  That the plaintiff was injured does not mean that an FDCA violation occurred:

[T]he allegation that the [product] eroded does not, by itself, suggest that [defendant] violated federal requirements in manufacturing this device. At the time the [product] obtained PMA, the FDA was aware of [a] risk of erosion and [that it] could cause serious complications. . . .  Ultimately, the FDA determined that [this risk] was a rare occurrence and that serious complication resulting from [it] was an even rarer occurrence, and approved the device despite these risks.

2012 WL 3692396, at *11 (citations omitted).

The plaintiff threw in allegations that the defendant’s first try at PMA had been unsuccessful.  The court essentially held “so what?”  Even if PMA had at first failed, the defendant “obtained PMA more than eight years before it was first implanted in [plaintiff’s] body.  Id. at *12.  That there had been various recalls of similar models didn’t matter since none of them had involved the device in question or the risk in question.  Id.

To get around TwIqbal, the plaintiffs in Ali trotted out Hofts v. Howmedica Osteonics Corp., 597 F. Supp.2d 830 (S.D. Ind. 2009), the case we love to hate. The judge in Ali hated Hofts almost as much as we do:

This Court respectfully disagrees with the Hofts court’s application of the Rule 8 pleading standard. . . .  This Court finds the Hofts court unusually lax in its application of the standard.  In assessing the sufficiency of pleadings, district courts should not take conclusory allegations as true but must require factual support for any legal conclusions offered in pleadings.  Requiring such factual enhancement does not constitute a heightened pleading standard; it is the basic pleading standard established in Rule 8 as interpreted in [TwIqbal].  Without factual allegations supporting inferences of the defendant’s liability and the plaintiff’s right to relief, pleadings fail to provide adequate notice of the grounds upon which the plaintiff’s claim rests.  In Hofts, the district court relaxed the facial plausibility standard out of existence with respect to the plaintiff’s allegations that the defendant violated federal requirements.  This Court declines to adopt that approach in the context of this case.

This Court also respectfully disagrees with the Hofts court’s approach to the breach of implied warranty claim, where the court placed the burden on the defendant to show that the claim imposed standards different from applicable federal requirements.  Rule 8 places the burden of pleading a plausible claim for relief and the grounds for this claim on the claimant. . . .  This Court agrees with the majority of federal courts in holding, post-Riegel, that the facial plausibility standard applies to the pleading of a federal violation in this context and requires facts indicating noncompliance with federal requirements on the manufacture of the device.

2012 WL 3692396, at *13

The plaintiffs in Ali made a premature demand for discovery before meeting their Rule 8 pleading requirements.  The court had none of it, finding that request to be “precisely the sort of fishing expedition the Supreme Court [in TwIqbal] sought to avoid in requiring the plaintiff to plead facts demonstrating their entitlement to relief and the defendant’s liability.”  Id. at *14.

Ali also followed the majority rule on preemption of express warranty claims.  If they impose duties on the purported warrantor that differ from or add to federal requirements, if they challenge the safety and effectiveness of the PMA device, or if they challenge the manufacturer’s FDA-approved labeling, express warranty claims are preempted.  Id. at *15.  The only way am express warranty claim survives is when there are allegations “based on representations made by the manufacturer about the device that was not approved by the FDA.”  Id. at *16.  The plaintiff didn’t plead anything of the sort, so the express warranty claims were also dismissed.  Id.

We’ve also collected cases holding that consumer fraud claims involving drugs and medical devices fail under “regulated activity” safe harbor provisions in the relevant state statutes.  Ali is another such case:

By its own terms, however, the VCPA does not apply to “[a]ny aspect of a consumer transaction which aspect is authorized under laws or regulations of this Commonwealth or the United States, or the formal advisory opinions of any regulatory body or official of this Commonwealth or the United States.” Va. Code Ann. §59.1-199(A).

Plaintiffs’ VCPA claim fails because it challenges conduct that is expressly excluded from the scope of the VCPA.  Plaintiffs base their VCPA cause of action on representations made by [defendant] . . . in advertisements and other marketing materials concerning the safety and effectiveness of the device.  Representations about the [PMA-approved device] in marketing materials for the device are authorized and regulated by the FDA under federal law.  The VCPA, therefore, does not apply to it and therefore no action challenging [defendant’s] marketing practices . . . may be brought under the VCPA.

2012 WL 3692396, at *19.  Gotta love it.  Ali is the greatest.

Prescription Drugs in Texas − You Can’t Get There from Here

We’re somewhat less enamored with Romero v. Wyeth, C.A. No. 1:03-cv-13467, slip op. (E.D. Tex. Aug. 31, 2012), sent to us by Janelle Davis of Thompson & Knight, although we must admit Romero does have its moments.

Romero evaluates a variety of claims purportedly arising under Texas law, in the wake of the big win in Centocor, Inc. v. Hamilton, ___ S.W.3d ___, 2012 WL 2052783 (Tex. June 8, 2012).  On the good side of the ledger, the court throws out all of the usual bread & butter claims in prescription drug product liability litigation − those involving failure to warn (specifically misrepresentation, fraud, negligence, misrepresentation, gross negligence, and consumer fraud).  The Texas statutory presumption of adequacy of FDA-approved warnings controlled, no matter what form the defendant’s information took:

“[I]f a claim is based upon a product’s labeling, its omissions, or inaccuracies, it falls under this purview of the [statutory presumption]. . . .  [Plaintiff] seeks to distinguish failure to warn claims based upon a drug manufacturer’s statements in a warning label from those premised on other representations contained, for example, in promotional and marketing materials. . . .  Because [plaintiff] cites no other authority [besides the lower court decision reversed in Centocor] for the proposition that [the statute’s] provisions should be so strictly applied, the court declines to make such a determination here.  Accordingly, whether [plaintiff’s] failure to warn claims are based on statements made in [defendant’s] labeling or promotional materials, they fall within the purview of [the statutory presumption of adequacy].

Romero, slip op. at 5.

That’s the good part of Romero. The parts responsible for our “you can’t get there from here” comment then follow.  For one thing the court allows a naked failure to test claim to continue.  Abundant precedent, including controlling precedent under Texas law, holds that “failure to test” isn’t a free-standing cause of action.  The Texas Supreme Court dealt with such a claim in American Tobacco Co., Inc. v. Grinnell, 951 S.W.2d 420 (Tex. 1997), twice holding “failure to test” to be “inextricably intertwined” with failure to warn, and rising or falling with it:

The [plaintiffs’] negligent testing claim is predicated on [defendant’s] duty to test and ascertain the dangers inherent in its products about which it must warn consumers. Because the negligent testing claim is inextricably intertwined with the [plaintiffs’] negligent failure to warn claim, we hold that summary judgment was also proper on this claim.

Id. at 437.

The [plaintiffs’] negligent testing claim is also preempted. . . . [Their] negligent testing claim is inextricably intertwined with advertising and promotional materials because the [plaintiffs] allege only that [defendant] should have tested its products to determine the dangerous characteristics about which [defendant] should have warned consumers.

Id. at 439.  Then there’s the Fifth Circuit.  In Dow Agrosciences LLC v. Bates, 332 F.3d 323, (5th Cir. 2003), reversed on other grounds, 544 U.S. 431 (2005) (preemption), the court held that, “a negligent testing claim is, as a matter of Texas law, a variation of an action for failure to warn.”  Id. at 333.  And again, in Skotak v. Tenneco Resins, Inc., 953 F.2d 909 (5th Cir. 1992):

[N]egligence claims, such as the alleged failure to adequately test [the product], are subsumed within this two-part standard. . . .  [Plaintiffs] were required to prove that an inadequate warning was given and that the inadequate warning was the cause of the injury.  [Plaintiffs] do not argue otherwise, nor do they assert here an independent, or separate, negligence claim.

Id. at 912 n.5 (affirming summary judgment).

Oh well, so much for appellate precedent.  Citing general “reasonable care” negligence cases and an old asbestos case involving failure to warn, Romero concocts some sort of “independent negligence cause of action based upon [defendant’s] failure to test” that no Texas court has ever allowed.  Slip op. at 7-8.  It may be our favorite legal proposition, and it sure applies here – a federal court sitting in diversity is not supposed to invent new, expansive state-law causes of action.

“[I]n hazarding an Erie guess, our task is to attempt to predict state law, not to create or modify it. The practical effect of adopting an exception like the one [plaintiffs] propose is the creation of a previously nonexistent state law cause of action.  Therefore, [plaintiffs] carry a heavy burden to assure us that we would not be making law.

Memorial Hermann Healthcare System Inc. v. Eurocopter Deutschland, GmbH, 524 F.3d 676, 678 (5th Cir. 2008) (applying Texas law).  We’re sure there’s plenty more where that comes from.

Romero also allows a design defect claim, holding that Restatement (Second) of Torts §402A, comment k should be applied on a case by case basis.  Slip op. at 11-12.  It gets to that result by characterizing comment k as an “affirmative defense” even though no Texas law says so (we reiterate the Erie federalism point) and in Centocor the Texas Supreme Court unanimously and emphatically rejected a similar argument about the learned intermediary rule:

The learned-intermediary doctrine is not an affirmative defense. . . .  While the learned intermediary doctrine shifts the manufacturer’s duty to warn the end user to the intermediary, it does not shift the plaintiff’s basic burden of proof.  Doing so would create an anomalous situation where, once the defendant prescription-drug manufacturer invokes the learned intermediary doctrine, the plaintiff would be relieved of proving a key burden in any product warning case – that the product warning was inadequate.

___ S.W.3d ___, 2012 WL 2052783, at *20.  With comment k, the analysis is the same, only it involves design rather than warning claims.  Several federal courts under Texas law cases have applied comment k to all prescription medical products, not requiring the individualized sort of product by product analysis demanded in RomeroReyes v. Wyeth Laboratories, 498 F.2d 1264, 1273 (5th Cir. 1974) (vaccine); Woodhouse v. Sanofi-Aventis United States LLC, 2011 WL 3666595, at *3-4 (W.D. Tex. June 23, 2011); Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *3 (N.D. Tex. Nov. 15, 2007); Carter v. Tap Pharmaceuticals, Inc., 2004 WL 2550593, at *2 (W.D. Tex. Nov. 2, 2004); Hackett v. G.D. Searle & Co., 246 F. Supp.2d 591, 595 (W.D. Tex. 2002) (applying Texas law). Tellingly, Romero does not cite a single Texas prescription medical product case for its contrary proposition.

There’s more we could discuss but for now, suffice it to say that with respect to the non-warning claims, we don’t think Romero can get there from here under what Texas law really is rather than what plaintiffs might want it to be.

We Think That’s About Right

Finally, from our home turf here in Pennsylvania, we offer the decision in Boeynaems v. LA Fitness International, LLC, ___ F. Supp.2d ___, 2012 WL 3536306 (E.D. Pa. Aug. 16, 2012), which we received internally today.  This is not a drug case, but it is a class action in which the plaintiffs were harassing the defendants with massive pre-certification discovery requests.  The defendant asked the judge to require the plaintiffs to pay for that discovery themselves, and the court agreed, holding:

[T]he Court mandates cost allocation as fair and appropriate.  The Court concludes that where (1) class certification is pending, and (2) the plaintiffs have asked for very extensive discovery, compliance with which will be very expensive, that absent compelling equitable circumstances to the contrary, the plaintiffs should pay for the discovery they seek.

Id. at *11.  The court essentially told the plaintiffs that they had to put up or shut up − no more one-way discovery, at least pre-certification in class actions:

If the plaintiffs have confidence in their contention that the Court should certify the class, then the plaintiffs should have no objection to making an investment.  Where the burden of discovery expense is almost entirely on the defendant, principally because the plaintiffs seek class certification, then the plaintiffs should share the costs.

Id.

We think that’s just about right.  If the class isn’t certified because the claims are bogus, the defendant isn’t going to be able to recoup this sort of massive expense from the class plaintiffs, and the attorneys will try to walk away from the case.  If the case is good, then the common fund doctrine will plaintiffs’ counsel recoup their expense.  So as Ron Weasley might say, “put your Galleons where your gob is.”

As anyone following the Pain Pump litigation knows, the state-of-the-art issue – whether it was possible for the defendant to know of the alleged risk of its products given the state of scientific knowledge at the time of a plaintiff’s surgery – is critical.  Well, today the first court of appeals to consider that question has affirmed summary judgment.  Rodriguez v. Stryker Co., No. 11-5335, slip op. (6th Cir. May 21, 2012) (applying Tennessee law).

The court in Rodriguez examined some 13 articles published over the course of seven decades that the plaintiffs claimed that established a jury question on the state of the art (that is, that the risk was knowable).  It concluded (as had the district court) that these articles proved nothing about this particular device at the time in question:

When all is said and done, not one of [plaintiff’s] thirteen articles shows that medical experts understood in 2004 that infusing a joint with [the drug] for two days could cause irreversible cartilage damage.  [Defendant] had no duty to understand what the relevant medical literature did not.

Rodriguez likewise found that the plaintiff’s expert couldn’t make anything more out of the same 13 articles than the articles themselves:

[Plaintiff’s] theory requires two speculative leaps.  It requires the inference that evidence of harm resulting from other solutions meant that anesthetics would cause the same harm.  And it requires the inference that evidence of transient harm to joints meant that irreversible cartilage damage was likely.  Both are far too conjectural and too many steps removed from the problem that developed.

The court went on to demolish plaintiff’s regulatory theory – that because the FDA had denied §510k clearance to the device, that that somehow put the manufacturer on notice of unknowable risks.

The FDA’s action means only that no other device on the market carried that indication for use.  It does not mean that the pump was (or might potentially be) dangerous to use in the joint space.  The 510(k) process does not comment on safety.

Slip op. at 8.  Ironically, the defendants won because of the adverse preemption decision in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).  Plaintiffs were thus prevented from having their cake and eating it, too.  That is, plaintiffs who deny preemption because a §510k clearance doesn’t address safety, can’t play fast and loose by turning around and claiming that lack of §510k clearance has safety connotations.

Continue Reading Breaking News – Pain Pump State Of The Art Affirmed

To us, sometimes plaintiffs’ lawyers sound like Cary Grant.  You know, “Duty, Duty, Duty.”  (By the way, “Judy, Judy, Judy” is a famous misquote.  Cary Grant never once said it in a movie.  But he did say it here – at the 0:50 and 1:30 marks.)  Plaintiffs’ lawyers are often looking for new duties and how companies failed to satisfy them.  When a traditional duty, such as failure to warn of a risk, doesn’t work, new alleged duties seem to crop up.  Susan Burnett of Bowman & Brooke kindly sent us a recent pain pump decision that’s a good example of this – Todd v. Stryker Corp., 2012 U.S. Dist. LEXIS 60953 (E.D. Cal. May 1, 2012).  And the court was having none of it.
In Todd, the traditional claim that the defendant company failed to warn of a risk of which it knew or should have known didn’t work.  The state of the science at the time that the pain pump was used in the plaintiff didn’t support the risk.  There had only been a tiny number of adverse events, a discussion of them at a medical conference, and a fairly weak set of medical literature.  Id. at *13-15 & *20-12.  And, worse for plaintiff, the company seemed to react responsibly to that information, conducting investigations of its files and the medical literature, reporting events to the FDA and seeking advice from outside experts.  Id. at *15-16.
So what’s a plaintiff to do?  Well . . . create a new duty.  While the FDA had cleared the pain pump’s 510(k) application and thereby allowed it to be marketed, it had denied another 510(k) application (apparently more than once) that sought to market it for the particular indication for which the pain pump was used in plaintiff.  Aha!  While maybe there was insufficient scientific evidence of an actual risk, the company should have warned doctors about this regulatory history.  Then maybe doctors would have some basis to speculate about a risk.
This is just what it sounds like: an attempt to sidestep the science.  But in a failure to warn case the science is not something to be worked around.  It defines the very duty that the defendant is supposed to satisfy.  Regulatory history adds nothing.  There’s a reason that labels include sections for indications, warnings, precautions, and adverse events, and not for regulatory history.  As the Todd court put it, regulatory history is simply not a risk about which a warning should be given:
There is no duty to warn the patient’s physician of a prescription product’s regulatory history, because the history is not a “dangerous propensity” about which an adequate warning must be given . . . . .
Id. at *9-10. 
That makes sense.  As we all know, the FDA denies clearance of 510(k) applications for many reasons.  Maybe the FDA decided that there was no substantially equivalent predicate device on the market, or that additional information was needed to clear the new indication. 
Putting regulatory history in a label would simply invite doctors to speculate on what it means.  That’s the opposite of what labels are for.  Doctors are experts in medicine, not regulation.  And, so, labels are places for scientific and medical information, not regulatory dockets.  (For this reason, the rule in informed-consent cases is that doctors need only inform patients of a drug’s benefits and risks, not regulatory status.  See our post on this here.)  If the particular regulatory history in which plaintiff was interested was the result of science that supported the presence of a risk (which apparently was not the case), the science, not the regulatory history, should have been put in the label.  The court properly rejected this new duty. 
Plaintiff didn’t abandon regulatory history so easily, though.  She also argued that the mere fact that the FDA denied clearance for the indication signaled the need to warn of a risk.  But this thinking has the same deficiency as plaintiff’s “regulatory history” argument.  The FDA denies clearance for many reasons.  The denial isn’t what matters.  It’s the science.  And, the science didn’t support the risk. 
Undaunted, the plaintiff tried yet another new duty, one that we’ve seen tried before: the duty to test.  We already deconstructed here plaintiffs’ past attempts to create a claim out of the amorphous and open-ended concept of duty to test.  We even created a cheat sheet of plaintiffs’ many failed attempts.  Suffice it to say that the Todd court wasn’t buying it either.  It found, as have many other courts, that there is no such thing as an independent tort for failure to test:
When the warnings accompanying a prescription product adequately inform the prescribing physician of dangers inherent in its use, the manufacturer’s alleged failure to test that product cannot, by itself, either cause injury or be a source of liability for the manufacturer.
Id. at *10.

Now, the Todd plaintiff’s claims had other, more ordinary deficiencies, including a proximate cause problem because the treating doctor decided to use the pain pump and medication on the basis of his own training and judgment, not any alleged influence by the company.  Todd, 2012 U.S. Dist. LEXIS 60953, at *23-25.  But what makes Todd most interesting, at least to us, was the court’s treatment of plaintiff’s less ordinary claims – the new duties, duties, duties.  The court wasn’t having any of it.

Once a mass tort becomes widely publicized, sometimes based on a combination of a bad study, a verdict or two for plaintiffs, internet sites, and late night television ads, lots of plaintiffs come out of the woodwork, including plaintiffs with weak, late, or marginal claims. Those plaintiffs and the clever lawyers who assist them believe that if they just get past the obstacles the law throws in their way – pesky things like the statute of limitations, product identification, causation, and the like – then they will be given the keys to the kingdom, or at least to the defendant’s vault. As a result, in the life cycle of a popular mass tort, courts often see and resolve almost every kind of claim and issue, including issues that have not been litigated in the jurisdiction for a while.

The pain pump litigation is a good example. It has generated tons of opinions, perhaps because it is not an MDL. The latest is Pavelko v. Breg, Inc., No. 09-cf-01461 (D. Colo. Feb. 28, 2011).

Plaintiff Pavelko had shoulder surgery in 2003 and had a Breg pain pump to alleviate post-surgical pain. Thirty-three months later, in March 2006, she went to a doctor complaining of shoulder pain, and he diagnosed her as having chondrolysis. She brought strict liability and negligence claims in 2009, alleging that defendant Breg was liable because it should have known and warned that pain pumps caused chondrolysis.

After discovery, Breg moved for summary judgment based primarily on the undisputed fact that no one reported any potential connection between shoulder pain pumps and chondrolysis until 2006, three years after plaintiff’s surgery. In other words, the state-of-the-art defense, although the court did not use that term. Plaintiff responded with the alleged duty to test. Plaintiff argued that Breg had a duty to disclose risks that would have been disclosed by reasonable testing and submitted a bunch of medical articles supposedly suggesting further tests.

The court smacked down this argument because plaintiff did not submit expert testimony supporting her argument that these articles put a reasonably prudent manufacturer on notice about the need for further testing, and the court’s own review of the articles found nothing to put the manufacturer on notice. Slip op. at 11-12. The court also bounced for lack of supporting expert evidence plaintiff’s claim that Breg’s general testing of the device was inadequate.

Plaintiff tried to get around these problems by arguing that Breg marketed its device for a purpose not cleared by the FDA, based on that popular notion among plaintiffs that allegations of off-label marketing cure all ills. The court disagreed, finding both that plaintiff failed to submit expert testimony supporting this claim (an unsworn report by the ubiquitous Suzanne Parisian about other manufacturers didn’t do it) and the evidence showed that use of the pain pump in the joint space was considered to be an approved use. Id. at 14-15.

All that stuff is good for our side. But the court put a blemish on this little gem by considering and denying summary judgment based on Colorado’s two-year statute of limitations. There was a factual dispute about whether plaintiff was told in 2006 that the pain pump could have caused her chondrolysis, and therefore summary judgment based on actual knowledge was denied. Fair enough. But Breg argued that plaintiff had a duty to ask her doctor about the potential cause of her chondrolysis in 2006. Her doctor testified that, if asked in 2006, he would have told her that the pain pump may have been the cause. The court, however, found that the plaintiff did not have knowledge of facts that would have put her on notice that her chondrolysis was caused by the wrongful conduct of another and therefore denied summary judgment on this ground.

Given that the court granted summary judgment based on the state-of-the-art defense, the court’s statute of limitations discussion was 100% unnecessary to its decision and therefore dicta. Despite the dicta, Pavelko is a good win for the defense based on the established legal principles that one bad apple don’t spoil the whole bunch and two out of three ain’t bad.