Product Identification

In drug and device litigation, product identification can be a significant issue. Many of us have poured over medical records and worked through question modules at depositions to determine whether the plaintiff actually used our client’s drug or device. Undermining product identification can be one of the quickest ways to end a lawsuit. But it doesn’t get much quicker than it happened in Weddle v. Smith & Nephew, Inc., 2016 U.S. Dist. 48512 (N.D. Ill. Apr. 11, 2016). There, the plaintiff couldn’t (at least so far) get passed the pleadings.

In a variant of the old “when in doubt, pick C” approach to standardized tests, in Weddle, plaintiff went with, “when in doubt, pick them all.” Plaintiff had a Trident Hindfoot Fusion Nail system (“Trident), manufactured by Smith & Nephew, Inc., implanted in her foot. Id. at * 1-2. But other products, including nails and cement manufactured by Howmedica Osteonics Corp. and screws manufactured by DePuy Synthes Sales, Inc., were also implanted. After pain and other problems that required several more surgeries, plaintiff sued everybody. Id. at * 2. She alleged that Smith’s Trident, and/or Howmedica’s nails and cement, and/or DePuy’s screws caused her problems. Id. at * 8. In other words, she picked everybody. But, much like using your #2 pencil to fill in all the circles on a standardized test answer sheet, it didn’t work. The Court dismissed her complaint for failure to state a plausible claim. Id. at *20.

Continue Reading Court Dismisses Medical Device Claims That Named Many Defendants But Picked None Of Them

Today is National Grammar Day. Before anyone of our posts goes online, it dashes thorough a gauntlet of reviewers.  Those reviewers collectively possess just the right amount of neurotic fastidiousness to ensure that what emerges is mostly correct and at least intermittently coherent.  Some of us pretend to actually know Strunk & White by heart.  Still, errors occasionally evade the dragnet of dorks. In honor of National Grammar Day, we have festooned today’s post with enough errors to keep all of you grammar cops busy.  We do this as a matter of principal.

But there are no errors in the case under review.  We have a rare favorable medical device decision out of the Seventh Circuit. The case is called Kallal v. Ciba Vision Corporation Inc., 2015 U.S. App. LEXIS 2987 (7th Cir. Feb. 24, 2015).  Mind you, the Seventh Circuit is one court we think the world of. Any court that is home to legal luminaries like Posner, Easterbrook, Wood, et al. must be fairy formidable.  But the Seventh Circuit is also home to the hideous Bausch precedent.  Perhaps you remember Bausch.  Its hard to forget.  The Seventh Circuit permitted a plaintiff to vaguely state a parallel claim which lacked substance under both federal and state law.  TwIqbal pleading requirements impacted the case not at all.  Irregardless of the Supreme Court’s instruction that lame cases should be dismissed before subjecting defendants’ to expensive discovery, the Bausch court elevated the plaintiff’s desire for discovery into something sacramental.

But Kallal is much better than that is. The plaintiff claimed that defective contact lenses had hurt his eyes.  The plaintiff did not have alot of evidence. The company had recalled some of it’s contact lenses.  Courageously (after Bausch) the district court held that the plaintiff’s claims were preempted nonetheless, and that the parallel claim could not save the case.  The plaintiff argued that his suite fit inside of the Riegel exception because the company failed to list ion permeability as a “material characteristic” in its premarket approval list.  The company responded that the FDA did not require them to meet any ion permeability threshold.  The plaintiff did not offer any evidence to the contrary.  In any jurisdiction but Bausch-land, that argument would win the preemption day for the defendant.  And mirabile dictum, it managed to win for the defendant in Kallal.  At least at the lower court’s level.

Continue Reading An Error-free Seventh Circuit Medical Device Case

Today’s post is really three different posts on three unrelated subjects.  None of them very long (at least by DDLaw Blog standards), but we think that each will be of interest to at least some our readers.

On Generic Plaintiffs’ Preemption “Win” in New Jersey

This piece is from the non-Dechert side of the blog.

Plaintiffs alleging failure to warn of the risks of a generic drug scored a “win” of sorts in In re Reglan Litigation, 2014 WL 5840281 (N.J. Super. App. Div. Nov. 12, 2014).  The court held, in an unpublished decision, that “failure-to-update” claims survived the otherwise comprehensive impossibility preemption that applies to generic drugs:

[T]he trial court correctly determined that plaintiffs’ claims based on the Generic Defendants’ failure to update their warnings to conform to changes made to the brand-name warnings are not preempted by federal law.  The court correctly found that allowing plaintiffs to assert these claims would not frustrate any of the purposes or objectives that Congress sought to achieve . . . .  Moreover, plaintiffs are not pursuing state-law claims based on an alleged violation of federal law.

Id. at *4. As the Appellate Division points out, non-preemption of “duty to update” is the majority view.

We may not like it, but we’re not losing much sleep about it.

Why?

Continue Reading Short Subjects

A recent decision in the propoxyphene litigation – Schiller v. Eli Lilly & Co., No. 2:12-247-DCR (E.D. Ky. Apr. 7, 2014) – confirms a now basic premise of product liability law: if you claim to have been injured by a drug that you don’t identify, you will lose.

The plaintiff in Schiller, a resident of Ohio, claimed to have been injured by generic propoxyphene, which she claimed to have taken for almost seven years.  She didn’t – or couldn’t – identify the particular drug or its manufacturer, so she instead named as defendants a number of companies that manufactured the drug. Discovery didn’t help her. She still couldn’t identify the drug or its manufacturer.  She had a serious product identification problem:

It is well-settled that a threshold requirement of any products-liability claim is that the plaintiff assert that the defendant’s product caused the injury. . . . There is no theory of product liability under which a defendant can be held liable for an injury caused by a product that it did not sell, manufacture, or otherwise supply to the plaintiff.

Slip op. at 3.

Unable to identify the product, the plaintiff had no claim.  And so, when one of the defendants moved for summary judgment, the court granted it.

It was of some interest to us, though, that the court relied on two decisions that rejected market-share liability in the DES litigation.  Id. at 3-4 (citing Sutowski v. Eli Lilly & Co., 696 N.E.2d 187 (Ohio 1998); Kurczi v. Eli Lilly & Co., 113 F.3d 1426, 1431-32 (6th Cir. 1997) (applying Ohio law)).  For those who don’t recall, market-share liability was an attempt by DES plaintiffs who couldn’t identify which DES drug allegedly injured them to hold all DES manufacturers liable to the extent of their share of the overall DES market. That’s not too different from what the Schiller plaintiff tried to do, or from what some plaintiffs have tried to do in generic drug litigation. Ohio was one of the states to reject market-share liability in the DES litigation.  As we put it a few years ago, “[m]arket share liability is so not happening in Ohio.”

Nor is it in many other states.  Let’s see whether in the future we see more references to the DES market-share/product identification decisions in generic drug cases brought against multiple defendants by plaintiffs with product identification problems.

Today is when we hightail our way out of work early to grab the last pumpkin pie and bottle of plonk from the shelves.  We are required to bring something to our Thanksgiving host, and apparently an appetite and ugly sweater will not suffice.  We shall certainly bring thanks to the dinner.

We have heaps for which to be thankful.   We are thankful that both Drug and Device Law heirs are in college.  We are thankful that they are close enough to visit when the mood strikes us (call us crazy, but dorm-room squalor makes us nostalgic), though far enough away to make a laundry shuttle unwieldy.  We are thankful that the Drug and Device Law Daughter tells us much about daily college doings.  We are thankful that the Drug and Device Law Son does not.   We are thankful for the opportunity to stick our snout in a trough of lumpy, buttery mashed potatoes.  We are thankful that between the football games our crowd is more likely to click the remote onto the Twilight Zone marathon or a Hallmark Hall of Fame weepfest, rather than anything that will help us keep up with the Kardashians.

Some of our thanks come from  the job.  We are thankful that 2013 has not seen us consolidated for ‘efficiency’ or sanctioned for producing ‘only’ 20 million documents.  We are thankful that Bartlett was decided the way it was.  We are thankful that we work with such brilliant, generous, creative colleagues.  We are thankful that most of the plaintiff lawyers we contend with have a sense of humor.  We are thankful for the readers of this blog, who are not the least bit shy about offering ideas and (mostly) constructive criticism.

Moreover, we are thankful that a little blow against litigation idiocy was struck in the recent case of Whitener v. Pliva, Inc., 2013 U.S. Dist. LEXIS 164364 (E.D. La. Nov. 19, 2013).  The plaintiffs in that case claimed injuries from metoclopramide and sued every manufacturer in sight – including manufacturers who never made anything that plaintiffs ingested.  The pharmacy records proved as much.  One of those manufacturers, Teva, filed a motion for summary judgment.  But the plaintiffs still intended to conduct lengthy discovery “in a futile attempt to prove their unsupported allegations.”  2013 U.S. Dist. LEXIS 164364 at *5.  (That was how the court construed the defendant’s argument, but we suspect the court agreed with it.  We know that we do.)  Teva, already aggrieved at being sued for having nothing whatsoever to do with the plaintiffs, sought a protective order from the court staying all of its discovery obligations pending the resolution of its summary judgment motion.

Naturally, the plaintiff was outraged that it might be denied the opportunity to drag a hapless defendant through expensive discovery.
Naturally, we think it is reprehensible that defendants who have not been found liable for anything are forced to incur astronomical discovery costs.  Discovery is the brussels sprouts of litigation.  ESI discovery is like brussels sprouts drizzled in vegemite.  Usually, plaintiffs argue that discovery should be available because, well, something might surface.  Just as usually, courts roll over and permit discovery because … who knows?  In the Whitener case, the plaintiffs threw an extra-long hail Mary pass to try to salvage their discovery plan.  They argued that various metoclopramide defendants, including Teva, merged in late 2008, perhaps opening the possibility that the plaintiffs ingested medication manufactured by Teva.

Thanks for playing.  (We don’t really mean that.) The pharmacy history sheet showed that plaintiffs ingested metoclopramide manufactured by defendant PLIVA, and not Teva, during the month of July, 2008. The merger did not take place until December, 2008.  Therefore, the date plaintiffs “ingested Pliva’s product predates the merger of Barr, Pliva, Inc’s subsidiary and Teva.  As such, the Court finds that the metoclopramide Plaintiff ingested during July 2008 was likely, as identified in the pharmaceutical records of Plaintiff, a Pliva and not Teva, product.  The Court finds that Teva has presented sufficient good cause to warrant a temporary stay in discovery as continued discovery will not likely product facts necessary to withstand judgment as a matter of law.”  Id. at **11-12.  Crank up the discovery machine for no reason?  No thanks.

Thank you, E.D. Louisiana.  For your common sense and fairness, we’ll save you an extra helping of cranberry sauce.  We’ll reach deep into the cabinet and pull out the good scotch for you. We’ll let you select the dinner music (but no Perry Como, Kanye West, or Mannheim Steamroller, please).  We’ll let you plop into the comfy chair for the after dinner snooze.  When you finally get up to go, we’ll tell you how much we enjoyed seeing you again, and how much we want to see you again soon.  And we’ll mean it.

 

This post is from the Reed Smith side of the blog only – the
Dechert lawyers were not involved. 
The Iowa Court of Appeals has affirmed summary judgment
entered in favor of both branded and generic manufacturers of metoclopramide,
looking at Mensing’s effect on both
in the process.  In Huck v. Trimark Physicians Group, 2013 Iowa App. LEXIS 435 (April
24, 2013), the Plaintiff sued manufacturers of brand-name and generic
metoclopramide after she developed tardive dyskinesia while taking the
drug.  While her doctor relied upon the
branded product’s labeling as published in the Physician’s Desk Reference –
which warned about the risk of tardive dyskinesia – the Plaintiff took only the
generic form of the drug.  Id. at *2.  Plaintiff relied on the fact that after she had
taken the drug for about five months, the FDA approved a label change for the
branded product to include a warning that the drug should not be used for more
than 12 weeks; the branded product’s label was updated accordingly, but the
generic’s was not.  Id. at *3-4.
The lower court granted summary judgment in favor of the
brand-name manufacturers on straightforward product identification principles:  Plaintiff hadn’t taken their drug, and
therefore, under Iowa law, they could not be liable to her.  Id.
at *4-5.  Plaintiff apparently agreed, as
she didn’t oppose the branded manufacturers’ summary judgment motion.  Id.
at *5.  After the Supreme Court issued
its opinion in Mensing, the generic
manufacturer in Huck moved for
summary judgment, arguing that each of Plaintiff’s claims were preempted.  Id.
at *5.  The lower court agreed, and
Plaintiff appealed.  Id
Noting that the Plaintiff had gone to “great lengths in her
brief to distinguish Mensing,” the Huck appellate court, like the lower
court before it, found the facts “indistinguishable.”  Id.
at *7.  The appellate court first reiterated
the conundrum recognized in Mensing:  that if the generic manufacturer had
independently changed its label in an effort to comply with a purported state
law duty, it would have violated federal law, which requires that the generic’s
label be the same as the branded product’s label.  Id.
at *7-8.  The Huck court also “appreciate[d]” what it called a “harsh result” for
Plaintiff Huck – because she took only the generic form of metoclopramide, and
her claims were preempted against that manufacturer were preempted, she was
left with no means of recovery.  Id. at *8-9.  (We don’t mean to be, well, harsh, but isn’t
this just the correct result, based on the law?  Would the court have expressed a similar
sentiment if things in the lower court had gone differently, and Plaintiff had ultimately
been permitted to recover against the generic manufacturer because she had
suffered a harm that was warned about in the label?  But we digress . . . .)
The appellate court also rejected Plaintiff’s other attempts
to get around Mensing
preemption.  First, it noted that even if
the generic’s label didn’t comply with the requirement that it must be the same
as the branded drug, this didn’t help Plaintiff, given the fact that there’s no
private right of action for such a claim under the FDCA.  Id.
at *9.  The court also rejected Plaintiff’s
argument that the generic manufacturer should have disseminated warnings via
other means – presumably, things like Dear Doctor letters.  Id.
at *10.  Plaintiff conceded that these
additional warnings would have to be consistent with what was in the approved
labeling.  Id.  The court not only
rejected this argument on Mensing
grounds, it noted that at the heart of Plaintiff’s claims was the argument that
the approved labeling was inadequate, and that “Iowa law does not provide a
cause of action for failing to disseminate allegedly inadequate warnings.”  Id. 
That wasn’t the end of the opinion, though.  While Plaintiff had not appealed the grant of
summary judgment in favor of the brand-name manufacturer (or even opposed their
summary judgment motion, remember), after Mensing
was decided, she eventually got around to asking the lower court to revisit the
ruling in favor of the brand-name manufacturer under its “inherent power to
correct interlocutory errors.”  Id. at *12.  To support that request, she claimed that Mensing had overturned prior precedent
that the lower court had relied upon, which held that “generic manufacturers
had the ability to change their labels.” 
Id. at *12.  The reason for Plaintiff’s procedural maneuvering
to get the claims against the brand-name manufacturer in front of the appellate
court seems pretty clear:  under Mensing, this was her only shot at a
non-preempted claim. The appellate court didn’t take the bait, though. 
On appeal, Plaintiff argued that the brand-name manufacturer
had “designed” metoclopramide, and that as such, her negligence,
misrepresentation and fraud claims didn’t require product identification.  Id.
at *13.  However, the appeals court observed
that the only issue explicitly decided by the lower court was that of the
branded manufacturer’s duty to this Plaintiff, and that her “design” claims had
not been preserved for appellate review. 
Id.  There seems to be a question as to whether
these claims were even made in the lower court in the first place – the
brand-name manufacturer seemed to think they weren’t, and the appellate court
rather tepidly referred to them as only “minimally presented.”  Id.  The court held that the only claims that were
properly
before it were whether Mensing
changed Iowa’s law with regard to claims against branded manufacturers (no),
and whether Iowa’s law on product identification would allow the Plaintiff’s
claims against the branded manufacturer to go forward (again, no).  
We’ll be sure to add this case to our preemption scorecard(s). 

 

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.

What follows is a “guest post” by Melissa Wojtylak of Reed Smith.  We place the term in quotes because Melissa has expressed an interest in becoming a member of our crew of merry blogsters.  We’re inclined to say yes (anything that reduces our own workloads is great), so expect to reading more of her work.

We (or at least Bexis) also has to say that Melissa, in addition to her other accomplishments, is also a very nice person.  We (or at least Bexis) were inclined to be quite a bit more sarcastic about the subject of this article.
As always, Melissa deserves all the credit and assumes all the blame for what follows.
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In our line of work, when you read anything that starts with the statement “[p]harmaceutical adverse effects are a leading cause of death and injury in America,” you know you’re at an away game.  This is precisely how a recent Comment in the George Mason Law Review begins.  As we noted in yesterday’s post, in the Comment, which is titled Picking Up the Tab for Your Competitors: Innovator Liability After Pliva, Inc. v. Mensing, the author waves the now-tattered banner of Conte v. Wyeth, Inc., 85 Cal. Rptr. 3d (Cal. App. 2009), and sets out his argument for why, in a post-Mensing world, brand-name manufacturers should be held liable for failure-to-warn claims brought by users of generic drugs – in essence, the holding in Conte – a holding that’s been rejected more times than a telemarketer calling during an American Idol finale.
Regular readers of this blog know how we feel about Conte.  It’s safe to say that the George Mason Law Review Comment has not changed our minds, although it has made us wonder what they’re teaching these days in torts classes at the George Mason Law School.  In any event, from our perspective, the Comment offers no compelling argument – much less legal justification – that supports a rejection of decades of established law, well-supported by practical considerations such as linking liability with responsibility, which holds that manufacturers cannot be liable for injuries to users of products that they did not sell.
As another work-week starts, we thought we’d talk about beginnings – in particular, beginnings to adversarial contests.  They almost always begin after the adversaries and the stakes have been identified.  In the NHL, for instance, the New Jersey Devils learned this weekend that they will play the Rangers in the next playoff round.  The teams have been identified and we know what they’re playing for – a spot in the Stanley Cup Finals.  So now their series begins (tonight).  In the world of reality TV, America’s Got Talent begins tonight.  The contestants have been identified and we know what’s at issue . . . . whether America will accept Howard Stern on prime-time TV!

But unfortunately product liability lawsuits don’t always begin this way.  Sometimes plaintiffs will sue and name particular defendants without even knowing what product may have hurt them or who manufactured it. 

In Parker v. Howmedica Osteonics Corp., 2012 U.S Dist. LEXIS 62477, at *4-5 (May 3, 2012), for instance, the plaintiff brought product liability claims against three manufacturers of knee replacement hardware, claiming that hardware used during her knee surgery was defective and injured her.  Her allegations against the three defendants were in the alternative.  Id.  In other words, she didn’t know which defendant manufactured the hardware.  In fact, she didn’t seem to know whether any of the defendants manufactured the hardware.  So she also sued four fictitious corporations and individuals.  Id. at *5 n.1. 
That hardly seems like a fair way for three defendants to begin a lawsuit.  Now, maybe, one could envision a scenario in which such a scattershot beginning to a lawsuit might be proper.  But the facts in Parker sure don’t seem to indicate that it is such a case.  The plaintiff didn’t even review all of her own medical records before suing the three defendants:
The present record suggest that [the plaintiff] has not yet obtained a copy of all of her medical records, which may include a more precise description of the knee replacement product that was implanted during [the plaintiff’s] surgery.

Id. at *7.  That sure seems like something the plaintiff should have done before beginning her lawsuit.  Even if the medical records didn’t offer an answer, the plaintiff had other options.  She could have, for instance, asked her doctors or the hospital to identify the hardware implanted in her knee. 
In any event, and not surprisingly, the defendants moved to dismiss.  There’s mostly good news in the court’s decision but there’s also some not-so-good news.  The good news is that the court found plaintiff’s complaint “deficient because it fails to identify the product that allegedly caused her injuries.”  Id. at *8.  That is certainly good news.  A plaintiff shouldn’t be allowed to roll forward into full-blown discovery based on guesstimates of who the defendants are.  In fact, the court had already stayed discovery in this and a related case.  Id. at *11-12.  That’s more good news. 
The not-so-good news is that the court “decline[d] to dismiss [plaintiff’s] complaint.”  Id. at 8.  The court instead granted a motion under FRCP 12(e) for a more definite statement of plaintiff’s complaint.  Id.  The court gave plaintiff 30 days to review her medical records and amend her complaint to name the right product.  Id. at *8-9.  We would have preferred a dismissal, even if it was without prejudice.  With that, in the least, the statute of limitations may have run further while the plaintiff conducted the review that she seemingly should have conducted before filing suit.
The court also held that, if plaintiff still cannot identify the product after reviewing her own medical records, she could file a motion with the court describing limited discovery that she believes is necessary for her to identify the product and its manufacturer.  Id. at *9.  During this time, the stay on general discovery would remain in effect.  Id. at *12.  This part of the opinion doesn’t thrill us either.  We aren’t enamored of the notion that a plaintiff can begin a lawsuit unsure of whether she is suing the right defendants, yet still somehow get discovery from those defendants – limited or not. 
That said, the court did give the defendants the opportunity to respond/object to any motion by plaintiff for discovery on the identity of the product.  That opportunity should include the chance to argue that the plaintiff is entitled to no discovery whatsoever.  The plaintiff should not be allowed discovery unless she can show that she conducted a proper review of her medical records and exhausted other avenues available to her to identify the product – something that seemingly should have happened before she began the lawsuit. 

It will be interesting to see how the case proceeds, and we may know more after plaintiff’s 30 days are up.  And by that time we may also know how prime-time America and Howard Stern mix.

Someone (we don’t remember who) once said that the mark of a cultured person is the ability to discuss the work of Marcel Proust without ever having read a word of it. Okay, here goes.

Proust wrote A la Recherche du Temps Perdu, which properly translates into In Search of Lost Time, though it traditionally has been called Remembrance of Things Past. Proust offered a theory of voluntary and involuntary memory. (Proust’s father, by the way, was an epidemiologist). A voluntary memory is retrieved via conscious effort. Quick: who was your third-grade teacher? By contrast, an involuntary memory hits us unexpectedly. The most famous example of the latter is Proust’s recollection of childhood after sniffing some fresh-baked Madeleines. That reminds us of our Evidence professor who said you could refresh a witness’s recollection with anything, including a plate of spaghetti.

As we get older, we are getting way worse at voluntary memory, and way more susceptible to involuntary memory.

The other day we saw a very short opinion out of New York called Gianvito v. Premo Laboratories, (N.Y. App. Div., 1st Dept. March 20, 2012). The plaintiffs “allege that they suffered injury due to in utero exposure to the estrogen drug Diethylstilbestrol (DES), and they urge application of the ‘market share’ theory of liability.” In about a page and a half, the Gianvito court decided that New Jersey law applies, that “New Jersey has not formally adopted a market share theory of liability in DES or similar cases,” that “such a theory cannot be found based on dicta” from New Jersey cases, and that “to the extent New Jersey law is unsettled on this issue, we decline to expand the law therein to allow plaintiffs to allege a market share theory.” It is the right result.

It also brought back memories of our Torts class in law school. These are not necessarily happy memories. Suspicion is provoked when we hear somebody look back with fondness at first year in law school. Still, we learned a couple of things that are worth holding onto besides the lyrics to “Rock the Casbah”. For instance, we will always remember how the case of Sindell v. Abbott Laboratories, 26 Cal. 3d 588 (1980), introduced us to the fact that the law, especially in California, could be utterly crazy. It was not quite a loss of innocence, but it helped prepare us for a couple of decades of batty rulings.

The plaintiff in Sindell was a woman who had developed cancer as a result of her mother’s use of DES during pregnancy. Because approximately 200 different companies had manufactured DES, and because so much time had passed, the plaintiff could not identify the manufacturer of the particular DES her mother had taken. She sued the five biggest DES manufacturers, which sold 90% of the DES during the relevant time. What to do? In a 4-3 opinion authored by Justice Mosk, the California Supreme Court held that the plaintiff could proceed on a market share theory of liability. The rule was that if all the defendants are potential tortfeasors, the product is fungible, the plaintiff is legitimately unable to identify the product that harmed her, and a substantial share of the manufacturers who produced the product during the relevant time period are named as defendants, then a rebuttable presumption arises in favor of the plaintiff and she can collect from each defendant a percentage of her damages equal to that defendant’s market share at the time the product was used. A manufacturer may rebut the presumption by showing that its product could not possibly have injured the plaintiff.

The Sindell opinion was considered a Very Big Deal in the 1980s. It continued a trend in California law of treating the tort system as a form of social insurance. The plaintiff was absolutely innocent, whereas the defendants had made and sold a dangerous drug. The manufacturers were in a better position than the plaintiff to bear the costs and guard against future harm. Arguably, deterrence would be undermined if all manufacturers of a dangerous product eluded liability. Sindell was judicial policy-making plain and simple. You could debate whether it was good or bad policy, but you could not pretend it was not policy.

Sindell was also a pretty long walk down the road of collective responsibility. Sure, there have been other cases involving joint tortfeasors where it was hard to discern the specific culprit, such as a pair of quail hunters negligently discharging their shotguns toward a fellow hunter (Summers v. Tice, 33 Cal. 2d 80 (1948)) or one member of a hospital operating room screwing up (Ybarra v. Spangard, 25 Cal. 2d 486 (1944)), but the Sindell opinion puts a defendant on the hook merely for being in the marketplace. The opinion repeatedly cites a Fordham Law Review article, and in an oral memoir Justice Mosk stated that the article is what gave him the idea. Let that serve as proof of the pernicious influence of law review articles. Surely, we cannot be the only practitioner who regards law review articles as being somewhat useful to the extent they collect and categorize cases, but invariably useless when they go on to propose some new ‘solution’.

The question back in the 1980s was whether Sindell was blazing a new trail or whether it was an aberration, a dead-end. We think it was mostly the latter. Gianvito is the latest example of a court refusing to buy the Sindell burden-and-cost-shifting theory. And courts have usually refused to extend Sindell beyond DES. True, the resolution of asbestos and Agent Orange litigation had some Sindell-stink. But they are isolated, regrettable exceptions. Most products are not perfectly fungible. Not all manufacturers act in the same way. Thus, in Skipworth v. Lead Industries Ass’n, 690 A.2d 169 (Pa. 1997), the court declined to apply market share liability to manufacturers of lead-based paint. Lead-based paint is not fungible. Plus, the house in question had been around for a century.

We are not comfortable with collective responsibility. We want evidence that a particular defendant did something wrong and harmed this particular plaintiff. If we remember correctly, in A Civil Action (the book, not the movie) there is a discussion of a hypothetical involving a plaintiff who was hit by a school bus. The plaintiff could not identify the particular school bus. There were two school bus companies in town — call them A and B. Assume that A has 80 percent of the buses in town, and 80 percent of the business. Is that 80 percent share enough to prove by a preponderance of the evidence that A was liable? Or should the plaintiff recover 80 percent of her damages from A and 20 percent from B? Don’t these approaches, while making sense on some sort of macro-epidemiological-social-insurance level, offend one’s sense of justice?

On the whole, it seems to us that the judiciary has retreated from activism. Most judges are content to interpret law rather than engage in social engineering. Judicial activism is perilous. If you are going to act like a policy maker, then you will be treated like one. That is why SCOTUS confirmation hearings turned so ugly. If judges will make policy, they need to answer questions about their policy predilections. So the logic goes, anyway. Mind you, we write this hot on the heels of the Affordable Care Act oral arguments. It’s heady stuff when we are thrust back on thoughts of Wickard and Lochner.

This is not to say that we are completely out of the woods. Sindell has mostly been relegated to the ash-heap of legal history. But its notion of assigning liability to defendants that did not manufacture the product in question has not completely vanished. Not surprisingly, it was a California court that issued the execrable Conte opinion, permitting a brand manufacturer to be held liable to a plaintiff who took the generic product. As we explained here, Conte is even worse than Sindell because the allegedly limiting factors in Sindell were absent in Conte. In Conte, the manufacturer of the product at issue was known, and there was no long-delayed injury. We look forward to the day when the Conte doctrine is only a bad memory.