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

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

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

Continue Reading Unreliable Expert Causation Evidence Ends Birth Defect Case

Last week’s Westlaw search (that’s one way we find the cases we discuss in the Blog) brought a blast from the past – a case almost three years old showed up discussing – and rejecting – expert testimony about so-called “regulatory causation.”  Since we’d only touched upon this type of expert opinion once, we thought we’d take a more in-depth look at this concept.

The first thing we discovered is that “regulatory causation” apparently was invented by the ubiquitous Suzanne Parisian, largely for use in the now-mostly-concluded Aredia/Zometa litigation.  That theory was an attempt to dumb down the usual common-law requirements for both causation (ordinarily “more likely than not”) and expert certainty (a “reasonable degree of medical” either “certainty” or “probability” depending on the jurisdiction).

As we described in more detail, here, the FDA, being a regulatory agency, is able to intervene prophylactically, before actual harm takes place, in order to prevent such harm.  Thus, the FDA is not bound by common-law causation or expert standards in deciding when a warning should appear on the label for a drug or device.  And the Agency doesn’t.  Instead, its regulations governing label changes state the new warnings should be added “as soon as there is reasonable evidence of a causal association [of a risk] with a drug; a causal relationship need not have been definitely established.”  21 C.F.R. §201.57(c)(6)(i).  That’s for drugs approved after mid-2001.  For some older drugs (without an update since 2001), the standard is similar, although the words vary:  “as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved.”  Id. §201.80(e).  See In re Incretin-Based Therapies Products Liability Litigation, 142 F. Supp.3d 1108, 1120 (S.D. Cal. 2015) (describing how these regulations work).  For medical devices, the equivalent standard is harder to locate, since the FDA’s “labeling” regulations for devices does not address when to change a label.  For PMA devices a standard of sorts – “reasonable evidence of a causal association” – in the CBE provisions applicable to such devices.  21 C.F.R. §814.39(d)(2)(i).

Continue Reading “Regulatory Causation” Roundup

For those of us who spend large chunks of our professional lives in mass tort MDLs, expressions like “settlement inventory” are ubiquitous. It is too easy to lose sight of the fact that these expressions put the rabbit in the hat, assuming that resourceful plaintiff lawyers will necessarily queue up for settlement payments at the end of the day and disregarding the fact that plaintiffs are supposed to be able to prove injury and causation before money changes hands.  And so we were especially pleased to read last week’s decisions in the Lipitor MDL, in which the  cautious and relentlessly thorough MDL  judge granted defendant Pfizer’s omnibus summary judgment motion, dismissing all but a single newly-filed case, because the plaintiffs could not meet their burden of proving that Lipitor caused their diabetes.  (There are two decisions relating to different dosages of Lipitor.  You can read them here and here.)

The Lipitor MDL, created in February 2014, centralized cases in which female plaintiffs alleged that Lipitor – prescribed in dosages of 10 mg., 20 mg., 40 mg., and 80 mg. – caused them to develop Type 2 diabetes.  In March and April of 2015, as trials of two bellwether cases approached, the plaintiffs served common expert disclosures of general causation experts, followed, in May and June, 2015, by specific causation expert disclosure in the two bellwether cases.  After full expert discovery, Pfizer moved to exclude all of these experts.  Ultimately, the court excluded the plaintiffs’ expert testimony on general causation with respect to Lipitor dosages of 10, 20, and 40 mg.  The court  also excluded the testimony of the bellwether plaintiffs’ specific causation experts, finding that the experts failed to rule out other possible causes of diabetes and relied impermissibly on temporal relationships, and granted summary judgment  for Pfizer on the claims of both bellwether plaintiffs.  (You can read our posts on these Daubert decisions here and here.)

However, the court left one general causation “window” open, based on one study finding that it was more likely than not that patients with certain characteristics who took 80 mg of Lipitor would not have developed diabetes in the absence of Lipitor. Thus, though neither of the bellwether plaintiffs had the requisite characteristics, it was possible that a plaintiff existed who took Lipitor at the 80 mg dosage and who could proffer a specific causation opinion that would survive Daubert.

Continue Reading Lipitor MDL Court Grants Pfizer’s Omnibus Summary Judgment Motion: No Evidence of Causation

This is a guest post from Michael Salimbene, an associate at Reed Smith.  It’s about learned intermediary causation, and the need for prescriber testimony.  Not infrequently, in mass torts with lots of solicited plaintiffs, the other side puts off doing anything, including preserving prescriber testimony, for as long as possible.  If the prescriber dies or disappears, plaintiffs don’t have any causation testimony, and since they bear the burden of proof, that’s a problem for them.  The guest post describes the latest example.  As always our guest poster deserves 100% of the credit (it’s not our work), and any blame, for what follows.

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This guest blogger lives just outside of Philadelphia. In this neck of the woods, the post-holiday, pre-Spring window is perhaps the most universally loathed time of year.  It’s filled with grey skies and frigid winds.  Partner in-office attendance, which tends to wane during the summer months and late December, hits its yearly high.  The all-important billable hour “clock” resets to 0.  Street corner sales of unlicensed Carson Wentz tee shirts have stalled, and playoff football will feature two of Philadelphia’s most hated rivals, the Giants and the Cowboys.  Your children, if anything like this guest blogger’s, will ignore the Frozen-themed electric car that “Santa” left (but took you 4 hours to assemble) in favor of a $6 pair of pink bunny slippers.  So for today’s post, in search of some good news, we travel to the Middle District of Georgia where the temperature hovers just above 60 degrees.  In a few short months, Northeasterners will also be enjoying warm skies and Georgia’s finest offering, The Masters.  Until then, we’ll have to make due with favorable warning-causation decisions like this one.

Today’s case comes to us from the Mentor Corp. Obtape Transobturator Sling Products Liability Litigation MDL in the Middle District of Georgia. In re Mentor Corp. ObTape Transobdurator Sling Prods. Liab. Litig., No. 4:13-cv-229, 2016 WL 4611572 (M.D. Ga. Sept. 2, 2016).  We’ve blogged about this MDL quite a bit (recently here, here, and here).  As were most plaintiffs in the ObTape litigation, this plaintiff’s prescribing surgeon treated her for a form of incontinence with the relevant device.  If you’ve watched daytime TV in the past 5 years, you’ll be familiar with the typical list of complaints that undergird vaginal mesh lawsuits:  mesh “erosion” or “extrusion” (movement of the mesh material into surrounding tissue); “dyspareunia” (painful intercourse); and the need to have additional surgery to correct mesh-related complications, to name a few.  Plaintiff never had her mesh removed, but alleged, among other things, that the product caused her to suffer from chronic pain.  So what makes this case different from the thousands of other mesh cases pending across the nation?  Plaintiff’s implanting physician died before he could testify in her case.

Continue Reading Guest Post – Failure to Warn Claim Dead on Arrival Without Testimony from Prescribing Physician

What follows is a guest post about a recent favorable decision in Canadian drug/device litigation.  Unlike in the USA, product liability class actions cases are often certified in Canada.  Thus, any pro-defense decision is good news indeed.  Robin Linley and Jessica Lam of Blake, Cassels & Graydon LLP in Toronto have been good enough to provide us what they call a “brief and selective summary” of Wise v. Abbott Laboratories Limited, No. CV-16-550747CP, 2016 ONSC 7275 slip op. (Ont. Super. Nov. 23, 2016), which in typical Canadian fashion, takes 85 pages to reach a result that our clients will like.  As always, our guest posters are 100% responsible for their content, and thus entitled to 100% of the credit or blame, as it may be, for what appears below.

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In a recent product liability class action decision, Wise v. Abbott Laboratories Limited, No. CV-16-550747CP, 2016 ONSC 7275 slip op. (Ont. Super. Nov. 23, 2016) (“Wise“), the Ontario Superior Court of Justice (“Court”) granted the defendants’ motion for summary judgment in advance of the certification motion, concluding that there was no genuine issue requiring a trial because there was insufficient evidence of general causation.  The decision highlights the potential for defendants to use summary judgment to resolve a class action before certification in appropriate cases.

The representative plaintiff brought a proposed class action against Abbott alleging that its testosterone replacement product, for the treatment of hypogonadism (testosterone deficiency) in men, caused serious cardiovascular (CV) events.  The plaintiff further alleged that the drug had no therapeutic benefit and that class members should be compensated for their economic losses incurred in purchasing the product. The plaintiffs also sought recovery from the defendant based on allegations of failure to warn and the novel claim of “waiver of tort”.

Abbott submitted that the plaintiff’s claims should be dismissed on the grounds that they could not prove general causation, which was a constituent element in all of the plaintiff’s product liability claims, and that ultimately, there was insufficient evidence of a “genuine issue requiring a trial”.

Continue Reading Guest Post – Ontario Court Decision Highlights Summary Judgment as a Potential Tool in Class Proceedings North of the Border

It is always nice to win a case, whether by motion or trial. But just in terms of pure exhilaration, it is hard to beat hearing the jury foreperson announce that, after a hard-fought trial, you win. But note that term “hard-fought.” Most trials really are hard. They really are expensive. They really are stressful. The road to even the most resoundingly wonderful verdict probably had a couple of nasty potholes. That was the case with Horrillo v. Cook Inc., 2016 U.S. App. LEXIS 21026 (11th Cir. Nov. 23, 2016). Prior to trial, there was at least one Daubert ruling that couldn’t have pleased the defense. Also, as reported by our friends in the Abnormal Use blog, there was a learned intermediary ruling that we do not like one bit. But all’s well that ends well, right?

In Horrillo, the plaintiff brought a product liability action on behalf of his deceased mother, who had undergone a surgery to clear her renal artery. The surgery went terribly wrong, as the patient sustained a stroke. The opinion also does not tell us whether the plaintiff ever sued the doctor. The surgeon used a stent manufactured by the defendant. That stent was designed for use in bile ducts, but the surgeon used it off-label in this case. That off-label use was apparently not all that uncommon. The plaintiff’s legal theories included negligence and negligent failure to warn, strict products liability and strict failure to warn, and breach of warranty. After a nearly four-week trial, the jury returned a verdict in favor of the defendant. The plaintiff then moved for a judgment notwithstanding the verdict, or, in the alternative, a new trial. The trial court denied those motions, and the plaintiff appealed to the 11th Circuit. Applying the appropriate standards of review, the 11th Circuit affirmed the trial court’s rulings and the defense verdict.

Continue Reading 11th Circuit Upholds Stent Defense Verdict

Bexis, who took some lumps in probably the worst Wisconsin product liability decision ever (he filed PLAC’s amicus brief in Thomas v. Mallett, 701 N.W.2d 523 (Wis. 2005)), just read what we believe is the best Wisconsin law decision ever – at least in the drug/medical device sandbox that we inhabit. The decision is In re Zimmer Nexgen Knee Implant Products Liability Litigation, 2016 WL 6135685 (N.D. Ill. Oct. 21, 2016) (since the caption is a mouthful, we’ll call it “ZNKI“).

Here’s why ZNKI is favorable on Wisconsin legal issues.

First, as our longstanding 50-state survey on the learned intermediary rule points out, Wisconsin is one of nine states in which only federal courts predicting state law have had occasion to adopt the learned intermediary rule.  Looking more closely at these nine, Wisconsin is one of only two states (South Dakota being the other) where only federal district courts have reached this holding.  What isn’t there, but is discussed in ZNKI, is that some courts have (without much reasoning) refused to predict Wisconsin’s adherence to the rule.  Refusing to dodge the issue, ZNKI forthrightly examines both Wisconsin precedent and the general state of the law and concludes that Wisconsin would join the nationwide learned intermediary consensus:

[F]ederal courts applying Wisconsin law have reached different conclusions about the doctrine’s applicability.  The vast majority of states, however, do employ some version of the doctrine.  In addition, this court’s research suggests that those courts that have declined to apply the doctrine under Wisconsin law have done so in cases involving prescription drugs, not medical devices, and those courts offer no reason to believe that the Wisconsin Supreme Court would not adopt this majority rule if presented with the issue.

In the context of . . . surgery, a patient must rely on the experience and judgment of his or her surgeon, who selects the appropriate implant and educates the patient about the particular risks − based on the patient’s particular circumstances and physiology. . . .  Given that context, and given the widespread acceptance of the doctrine throughout the country, the court believes it is likely that the Wisconsin Supreme Court would apply the learned intermediary doctrine in this case.

ZNKI, 2016 WL 6135685, at *19-20 (numerous citations omitted).  As we’ve pointed out recently, the learned intermediary rule is, if anything, enjoying a renaissance, with thirteen straight state high court adoptions since the infamous Karl case (since overruled by statute) was the only supreme court to go the other way.

Continue Reading Probably the Best Wisconsin Law Decision We’ve Ever Seen

Over the last couple of years, the Accutane mass tort in New Jersey state court has become the gift that keeps on giving.  The latest installment is a two-fer: In re Accutane Litigation, 2016 WL 5958374 (New Jersey Super. Law. Div. Oct. 12, 2016), and In re Accutane Litigation, 2016 WL 5958375 (New Jersey Super. Law. Div. Oct. 12, 2016).  Between these two orders, practically every permutation of causation under the learned intermediary rule is addressed, and the end result is the grant of summary judgment against an impressive 160 of 162 plaintiffs.

For obvious reasons, we’ll call the first (#374) “Accutane I” and the second (#375) “Accutane II” to tell them apart.

Eighty-six plaintiffs’ cases failed in Accutane I because they couldn’t even begin to satisfy their usual burden of proof.  That was because, by the time they got around to bringing their lawsuits, their prescribing physicians had either died (44 plaintiffs) or else simply could not be located (42 plaintiffs).  2016 WL 5958374, at *1-2.  As we’ve discussed before, in one of our “little lists” posts, there’s now quite a bit of law enforcing the burden of proof in dead/missing prescriber cases.  We even feel somewhat paternal feelings in this area, because several of your merry bloggers (Eric A, Steve M, and Bexis), litigated this issue extensively a decade ago in Diet Drug cases at a time when there was practically no directly on-point precedent.  In doing so, we increased the number of favorable decisions from one to seven.

Accutane I represents another giant step forward. The court held that, under the law of no fewer than 35 jurisdictions, a plaintiff who could not obtain any prescriber testimony at all could not meet his/her burden under the learned intermediary rule (now the law, as we’ve pointed out, of all fifty states) of establishing that the absent prescriber would have changed the relevant prescription had s/he received a supposedly “adequate” warning.  The defendant’s causation argument was rather basic:

Defendants argue that without the testimony of the deceased or missing physicians, Plaintiffs cannot establish that [the drug] would not have been prescribed given a different warning and thus they cannot satisfy proximate cause. Absent physicians’ testimony, Defendants argue that the causal link to injury is broken.  Even if the proximate cause standard were as Plaintiffs claim – that their prescriber might hypothetically have altered their risk discussion somehow if only [the manufacturer] had warned differently – Defendants assert that physician testimony is still needed.

2016 WL 5958374, at *3 (citation omitted). Plaintiffs fell back on that old canard, the “heeding presumption.” Id. at *4.  The court, however, was having none of it.

[T]he Court is persuaded by Defendants’ arguments that the heeding presumption within a learned intermediary context does not equate with a decision by the physician to not prescribe the drug.  If it did, medications would never be prescribed when accompanied by warnings because of the various risks associated with their use.

. . .Plaintiffs concede that their physicians are deceased or otherwise unavailable, and they have offered nothing by way of individual opposition papers. . . . Accordingly, the case-specific facts presented by Defendants are undisputed.

Plaintiffs’ reasoning is flawed, especially when one considers the slew of risks associated with and heeded by [prescription drug] users and prescribing physicians. Notably, application of the heeding presumption in the context of a pharmaceutical learned intermediary case where a manufacturer provided a warning and its adequacy remains in issue is not reflected within any of the cited case law.

Id. at 10-11 (citation omitted) (emphasis added).  Regardless of any presumption, all plaintiffs “still have the burden of proof for every element of their claim.”

Continue Reading Warning Causation Potpourri in New Jersey Mass Tort

Sometimes we take routine things for granted. We don’t appreciate the taste of our morning coffee, it’s just always there. We don’t appreciate the softness of our favorite college sweatshirt, it’s just always been that way. We don’t appreciate that while watching an episode of The Walking Dead and seeing a familiar face we can IMDB and find out we recognize the actor from a 3-episode storyline on Law & Order from the late 1990s. That last one hasn’t always been available, but it’s getting harder to recall what it was like to not have that answer until it woke you from a sound sleep at three in the morning.

In the legal world we take things for granted too. We talk about things like breach, duty, causation, and on this blog, preemption, so routinely, we do start to gloss over them a bit. TwIqbal, Daubert, Buckman. Routine, routine, routine. And for sure, learned intermediary fits into this category of things we know about, we like, but maybe take a bit for granted. For many of us, it’s been part of drug and device law our whole careers given that the term was first coined in 1966 by the Eighth Circuit in Sterling Drug Inc. v. Cornish, 370 F.2d 82, 85 (8th Cir. 1966). So sometimes, it’s good to be reminded just how important it is.

That is what today’s case is all about. In Bock v. Novartis Pharmaceuticals Corp., 2016 U.S. App. LEXIS 18042 at *1 (3d Cir. Oct. 5, 2016), decedent’s family alleged that the defendant failed to adequately warn decedent’s doctors that its drugs Aredia and Zometa contribute to the risk of developing osteonecrosis of the jaw (“ONJ”), which decedent developed following multiple tooth extractions and other dental procedures. The court’s decision starts out with a recitation of the warnings that accompanied the drugs as well as additional warnings distributed by the defendant via “Dear Doctor” letters. Those warnings, which pre-dated decedent’s prescription and use of the drugs, included information such as that ONJ had been reported in patients using the drugs, mostly associated with dental procedures like tooth extractions and that invasive dental procedures should be avoided. Id. at *2-3. We know we come at this from the skewed perspective of drug and device defense counsel, but the warning seems fairly clear to us.

Continue Reading Aredia/Zometa Plaintiff Can’t Avoid Learned Intermediaries

This past weekend, we paid a return visit to Cleveland, the home of our best law school friend, who braved the (figurative) waters of New Haven with us so many years ago.  In deference to the Drug and Device Law Traveling Companion, we visited the Pro Football Hall of Fame.  In contrast to the stunning rotunda of our beloved Country Music Hall of Fame, the Football Hall stacks all of the inductees’ busts against a single wall – sort of a warehouse of disembodied heads.  We felt like we were in the parts department of Dr. Frankenstein’s laboratory.  But we enjoyed the visit and paid fond homage to the bust of Tommy McDonald.  We also visited the Rock and Roll Hall of Fame, which we had seen before and which we continue to find both impressive and tons of fun.  This time, we lingered at the “One-Hit Wonders” display, commemorating so many recording artists who disappeared after just a bit of noise, never to be heard from again.

The plaintiff in today’s case followed the same trajectory, albeit after his apparently meritless case languished on an MDL docket for eight years.  In Wilhelm v. Pfizer, Inc. 2016 U.S. Dist. LEXIS 127269 (D. Nev. Sept. 19, 2016), the complaint was originally filed in 2006 in the District of Nevada by fourteen plaintiffs alleging that the defendant’s product caused suicidal ideations.  The JPML transferred the case to the Neurontin MDL after it was filed, and remanded it back to the transferor court in July 2013 with three plaintiffs remaining.   One month later, the court permitted counsel for these plaintiffs to withdraw.  Two of the plaintiffs dropped out, leaving a single plaintiff, proceeding pro se. In February 2014, the defendant moved for summary judgment, arguing that the plaintiff could not produce any expert evidence proving that the defendant’s product caused his injuries.  The plaintiff filed for Chapter 7 bankruptcy in June 2014.  He never disclosed his product liability lawsuit in the course of his bankruptcy proceedings.

Continue Reading The End of the Road for Pro Se Neurontin Plaintiff with No Evidence of Causation