We loved La La Land.   We were enchanted by the colors and the music and the dancing.  We were transported by the dreams-come-true and saddened by the could-have-beens.  We disappeared into the characters’ world for two hours and were not ready when the lights came up.   For us, it was the epitome of a movie experience, and we were thrilled – momentarily – when it was announced as Best Picture.  But, as all who witnessed Oscargate (and anyone who didn’t spend the last week in a submarine) can attest, simply saying it didn’t make it so.

Last week, in Bowersock, et al. v. Davol, Inc. and C.R. Bard, Inc., 2017 WL 711849 (S.D. Ind. Feb. 23, 2017) the United States District Court for the Southern District of Indiana reached the same conclusion, excluding the plaintiffs’ experts in a hernia mesh case.  The plaintiffs claimed that a component of the defendants’ hernia mesh patch – a polyethylene terephthalate ring – perforated the intestines of the plaintiffs’ decedent, ultimately resulting in sepsis and death.

An autopsy was performed and concluded that the decedent’s small bowel and colon were intact, without perforation. But the hernia mesh patch was not retrieved from the decedent’s body before she was buried, so, seven years later (!!!), the plaintiffs had the body exhumed so the patch could be retrieved and analyzed, after which they submitted the reports of two causation experts – a surgeon and a biomedical engineer – to opine that components of the mesh patch caused the decedent’s injuries.

The Surgeon

The plaintiffs’ first expert, a general and gastrointestinal surgeon who used the defendants’ patch in his own practice, reviewed the patch explanted from the decedent’s exhumed body. He opined that the ring, though not broken, had buckled, creating a sharp edge that rubbed against the decedent’s bowel and perforated it.

Continue Reading Southern District of Indiana Excludes Plaintiffs’ Experts in Hernia Mesh Case

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

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

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

Continue Reading Fourth Circuit Vigorously Applies Daubert

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

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

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

Continue Reading Unreliable Expert Causation Evidence Ends Birth Defect Case

We have long suspected that the reason some judges are hostile to Daubert is because application of the doctrine involves so much work. Rather than merely count whether there are enough other experts out there who seem to be saying something similar to what the proffered expert would say, judges under Daubert must act as gatekeepers who scrutinize the reliability of the expert’s methods. Such an effort burns up pages, time, and calories. Is it any wonder that judicial opinions that simply wave junk science along to the jury, with the usual suggestion that cross-examination and juror common sense will separate the wheat from the chaff, are pretty short, whereas those judicial opinions that really test experts under Daubert and find them wanting can be as long as a Victor Hugo novel?

Recently, Judge Hopkins of the Northern District of Alabama issued a 119-page opinion throwing out a lot of plaintiff expert opinions in Jones v. Novartis Pharmaceuticals Corp., 2017 WL 372246 (N.D. Ala. Jan. 26, 2017). We read all 119 pages, so you don’t have to, though the opinion is clear and pleasant enough. It is definitely no Les Miserables. Indeed, any sense of misery vanished when we saw a heading early on in the opinion entitled “General Requirements – Judge as Gatekeeper.”

The plaintiff in the Jones case alleged that she experienced an atypical femur fracture (“AFF”) as a result of her treatment with a prescription osteoporosis medication, Reclast. The plaintiff proffered a variety of expert opinions. The ubiquitous Dr. Suzanne Parisian submitted the usual magnum opus about how the drug had a “causal association”with the AFFs, how the defendant was on notice of that fact, and how the defendant violated much of the Federal Register and slapped on an inadequate label, There were also two retained and two nonretained medical experts who would opine on medical causation.

The Jones court began by observing that, like Caesar’s Gaul, a Daubert analysis is divided into three parts: (1) whether the expert is qualified, (2) whether the expert’s methodology is reliable, and (3) whether the expert’s opinion would help the jury in determining scientific or technical issues. The Jones court also emphasized that the proponent of the expert bears the burden of satisfying this test. The existence of that burden should, by itself, prevent courts from issuing perfunctory blessings of junk science. But, too often, it does not.

Continue Reading Reclast Plaintiff Experts Hobbled by Daubert

Remember Frye v. United States, the case from 1922 that created the “general acceptance” standard for expert testimony?  In the federal system it’s been replaced by Daubert and Federal Rules of Evidence 702 and 703.  But Frye was technically a decision under DC law (1922 was before Erie v. Tompkins). So, while the rest of the federal courts have been applying Daubert for the last 23 years, DC has remained a Frye jurisdiction. Until now.

In Motorola v. Murray, No. CAB-8479-01 (D.C. App. Ct. Oct. 20, 2016), the District of Columbia Court of Appeals (successor to the DC Cir. as DC’s highest court) inters Frye for good.

Following extensive expert evidentiary hearings, the trial court found that certain of the expert testimony would be admissible under Frye but that most would be inadmissible under Daubert. So, the trial court certified for interlocutory appeal the question of “whether the District of Columbia should adopt Federal Rule of Evidence 702 (or a revised Frye standard) for admissibility of expert evidence. Motorola, slip op. at 3.

The appellate court first examined both evidentiary standards. Under Frye, the entire inquiry is limited to whether “there is general acceptance of a particular scientific methodology.” Id. at 6. The Frye standard equated general acceptance with reliability and looked no further. Id. The standard announced in Daubert viewed general acceptance as one possible factor for the court to consider in its role as a gatekeeper for the admission of expert testimony. Under Daubert, the trial court must “perform a preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue.” Id. at 7-8.

As subsequent courts refined Daubert, it also became clear that “conclusions and methodology are not entirely distinct from one another.” Id. at 10, citing General Electric Co. v. Joiner, 522 U.S. 136, 146 (1997). This was yet another step away from the rigid Frye focus on methodology only. After Joiner, as part of the gatekeeping function, a court could “conclude that there is simply too great an analytical gap between the data and the opinion proffered.” Id. Application of a particular methodology was something else for courts to consider in determining if the expert testimony was both relevant and reliable.

The Motorola decision includes a quote from the trial court’s own examination of the competing standards that we think fairly clearly demonstrates the superiority of Daubert:

[A]t the risk of over-simplification[,] if a reliable, but not yet generally accepted, methodology produces good science, Daubert will let it in, and if an accepted methodology produces bad science, Daubert will keep it out; conversely under Frye, as applied in this jurisdiction, even if a new methodology produces good science, it will usually be excluded, but if an accepted methodology produced bad science, it is likely to be admitted.

Id. at 14.

Most recently in the history of expert evidence admissibility, Rule 702 was amended to reflect Daubert and its progeny. Id. at 12-13. It is Rule 702 that the DC Court of Appeals decides to adopt over Frye. Rule 702(c) admits expert testimony if it “is the product of reliable principles and methods” – similar to the Frye general acceptance standard. Id. at 15. But, Rule 702 (d) further provides that to be admissible the expert must also have “reliably applied the principles and methods to the facts of the case.”

We conclude that Rule 702, with its expanded focus on whether reliable principles and methods have been reliably applied, states a rule that is preferable to the [Frye] test. The ability to focus on the reliability of principles and methods, and their application, is a decided advantage that will lead to better decision-making by juries and trial judges alike.

Id.

The remainder of the opinion is focused on providing guidance to the DC courts which now must switch to applying Rule 702 and Daubert and become expert evidence gatekeepers. Id. at 16-19. The Court of Appeals specifically admonishes DC trial courts not to “reflexively admit expert testimony because it has become accustomed to doing so under the [Frye] test.” Id. at 18-19. A concurring opinion reiterates this warning and provides some additional resources and guidance for courts faced with applying Daubert for the first time. Id. at 20-23.

Frye is dead; long live Daubert.

Today we have a guest post from Reed Smith‘s Jaclyn Setili, about one of our pet peeves – MDL plaintiffs (and their counsel) who think they don’t have to do any work at all on their cases, and simply show up come settlement time with their hands out.  In this instance, they received a much deserved comeuppance.  As is the case with all our guest posts, Jaclyn deserves all the credit for what follows, as well as any blame.

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At last, friends, it’s that time of year again. Time to dust off the sweater vest, memorize your favorite college football team’s schedule (Go Blue), and indulge in the ubiquitous pumpkin-spice-flavored everything.  In fact, just the other day as we were jogging along the Schuylkill River Trail, after an oppressively hot and humid summer, we glimpsed the first few yellow leaves of the year as they gently, and gracefully, made their journey to the asphalt, and our heart leapt with joy and relief.

Unlike spring, however, autumn is not a time for fresh hope or new beginnings.  Rather, the season reminds us of the inescapable promise that another year is nearing its eventual terminus.  A recent opinion from the Southern District of Florida, In re Denture Cream Products Liability Litigation, — F. Supp.2d —-, 2016 WL 4582185 (S.D. Fla. Aug. 31, 2016), encapsulates that idea:  the fundamental truth that every summer—like every lawsuit—must come to an end.  Winter, friends, is always coming.

In re Denture Cream is another order from the denture cream MDL, which we have covered on several prior occasions, i.e. here and here.  To remind you, the JPML consolidated multiple cases in MDL 2051 on September 12, 2011, finding that they all shared common questions of fact concerning allegations that the level of zinc found in certain brands of denture cream may cause copper deficiencies and neurological injuries.  The opinion we discuss today, however, involves a frequent bane of MDL defendants – the plaintiffs who try to lie back, hide in the weeds, do as little as possible, and share in an eventual settlement.  This time, it didn’t work out so well for those plaintiffs.

Continue Reading Guest Post – With No General Causation Experts, Denture Cream Plaintiffs Drop Like Leaves In Autumn

We here at the DDL Blog try to stay on top of the goings on at the FDA. We’ve learned that on September 14, 2016, the FDA will hold an advisory committee meeting to review the results of a recently completed, randomized, placebo-controlled clinical trial (Evaluating Adverse Events in a Global Smoking Cessation Study or “EAGLES”), as well as findings from other studies that have assessed the neuropsychiatric effects of Chantix (varenicline).  See September 14, 2016: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.  The committee will consider whether data from these studies supports changing the Chantix product labeling, including potentially removing the boxed warning regarding serious neuropsychiatric events.  The meeting comes approximately three years after Pfizer agreed to pay nearly $300 million to settle thousands of lawsuits filed by plaintiffs alleging that they experienced adverse neuropsychiatric effects while taking Chantix.  See Pfizer 2012 Financial Report, at 107.

This chain of events seems to be a clear cut example of litigation marching ahead of the science, and at that cost, we thought we’d probe the situation a little deeper. Chantix was approved by FDA in May 2006.  It was the first new smoking cessation medication to come to market in more than a decade, and was recognized at the time to be one of the most effective treatments available to help smokers break their addiction to nicotine.  The following, year, however, a highly publicized incident involving a Texas musician named Carter Albrecht raised concerns about potential adverse neuropsychiatric effects of the medication.  The musician, who was taking Chantix and was heavily intoxicated at the time, was shot and killed by a neighbor who thought that Mr. Albrecht was burglarizing his home.  Mr. Albrecht’s girlfriend publicly blamed Mr. Albrecht’s behavior on his use of Chantix.  See Girlfriend Believes Chantix Contributed to Texas Musician’s Death.  The incident sparked national media attention, which led to an increasing number of anecdotal reports of patients experiencing neuropsychiatric events while taking Chantix.

Based largely on these anecdotal reports, the FDA instructed Pfizer to include warnings about potential neuropsychiatric effects in the Chantix product labeling, and, in July 2009, mandated the addition of a boxed warning.  The boxed warning advised that patients being treated with Chantix should be monitored for neuropsychiatric symptoms “including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide” and recommended stopping Chantix if any of these symptoms are observed.   To further evaluate this issue, FDA also asked Pfizer to conduct a clinical trial—the recently completed EAGLES study—to assess the neuropsychiatric safety of Chantix.

Continue Reading Chantix: A Lesson in Why Litigation Should Not Be Allowed to Get Ahead of Science

In his poem “To Summer,” Blake begs the season to “curb thy fierce steeds, allay the heat/That flames from their large nostrils!”  That is typical Blake; he takes our favorite time of the year and turns it into a satanic beast.  We’d prefer to consider the delightful aromas that Summer brings to our nostrils: beach, fresh cut grass, BBQ, citronella, funnel cakes, empty courtrooms, etc.  Plus, if we believe the Seals and Crofts song “Summer Breeze,” the scent of jasmine is out there.  Summer is redolent of youth and hope.

Sometimes we get the sense that the sense of smell does not get its due.  We are taught that seeing is believing.  McCartney sang, “Listen, do you want to know a secret?”  Morrison insisted, “C’mon, c’mon, c’mon and touch me, babe.”  It took us a moment to think of any olfactory songs, but there are more than you might suspect.  Primus inter pares, of course, is Nirvana’s “Smells Like Teen Spirit.”  A mellow Mac Davis asked his fans to “Stop and Smell the Roses.”  Lynyrd Skynyrd rocked out to “That Smell.”  Todd Rundgren might have been floating in that ocean of cash he got from producing Bat Out of Hell when he wrote “The Smell of Money.”  And what was the reason for the great guitarist Buddy Guy’s fixation on all things nosey?  His huge catalog of classics includes “I Smell Trouble,” “I Smell a Rat,” and “Smell the Funk.”  Does all that Chicago blues stinkiness have anything to do with the fact that the name “Chicago” comes from an Indian word for a malodorous onion?   [Meanwhile, expect the Abnormal Use blog to issue a challenge about which roster of legal geeks can come up with more smelly songs.  Hey, Dedman, we’re waiting.]

A lawyer friend of ours who was born without a sense of smell reports that she considers it a blessing.  She reasons that when people mention smells, they (like Buddy Guy) are usually not happy about it.  There is more fetor than perfume in the air.  But, clearly, not everyone agrees with this opinion.

Today’s case, Bunin v. Matrixx Initiatives, Inc., 2016 WL 3090777 (Fla. 4th DCA June 1, 2016),  was brought by a plaintiff who alleged that she had lost her sense of smell from using a nasal spray. Loss of the sense of smell is called anosmia.  She brought her case in Florida state court in 2009, and brought in an expert to testify that the nasal spray was what caused the plaintiff’s anosmia.  The issue was whether that expert’s opinions would be tested by Florida’s old expert standard, which existed when the case was filed, or the new test, patterned after the federal Daubert test, which had been enacted by the Florida legislature in section 90.702 of the Florida statutes in 2012 — after the case had been filed.  In other words, the issue was whether Florida’s adoption of the Daubert test would have retroactive effect.   Retroactivity mattered in this case, because the trial court held that the plaintiff expert’s opinions would have been admissible under the old test (the court referred to a “pure opinion” rule, which sounds loosey-goosey), but not under the new Daubert test.

The appellate court held that the test for retroactivity is “well-settled.” Procedural or remedial statutes are to be applied retrospectively and are to be applied to pending cases.  More specifically, a statute “that merely ‘relates to the admission of evidence’ is generally considered procedural.”  Applying this rule, “Section 90.702 of the Florida Evidence Code indisputably applies retrospectively.”  That makes sense.  After all, no matter what the expert test is under any state law, if the case is in federal court, the Daubert test (and Fed. R. Evid. 702) will apply.  That is because the standard for admitting expert evidence is procedural.  If it were substantive, we’d be talking about Erie.

Once the appellate court decided that Florida’s version of Daubert applied, it wasted little time in affirming the trial court’s exclusion of the plaintiff expert.  There was no abuse of discretion.  Without the expert causation opinion, the case was not viable.  Accordingly, it was dismissed.

We’d say that the Florida Bunin opinion passes the smell test.

Last week, we (along with many of you, we assume) attended the DRI Drug and Medical Device conference in Chicago. We re-connected with friends dating to the beginning of our lengthy career (literally – ran into the head of our decades-ago summer associate program), met lots of new people, and attended great parties.  (Perhaps we are biased, but we thought the reception Reed Smith co-sponsored was particularly fabulous – stunning venue, fantastic food, great company and ambiance.)

Squeezed in among the parties was a whole seminar program, covering all manner of hot topics in the mass tort space in which we practice. We were (as we always are) awed by the sheer intellectual firepower the speakers brought to bear and by the depth of their knowledge and the thoroughness of their preparation.  We also enjoyed observing the diversity of presenters’ styles.  Some were earnest and academic, some deceptively casual and colloquial, still others politician-impassioned.  As wordsmiths, we always delight in this, and we count it among the reasons we like today’s case, which follows a mostly serious and measured (albeit dismissive) majority opinion with a snarky and stylized dissent.  (Guess which one was more fun to read.)

Milward v. Rust-Oleum Corp., 2016 U.S. App. LEXIS 7470 (1st Cir. Apr. 25, 2016), is not a drug or device case. It is the First Circuit’s review of the District of Massachusetts’s exclusion of the plaintiffs’ specific causation expert in a benzene-exposure toxic tort case, but the issues are identical to Daubert issues we face in our cases.

Continue Reading First Circuit: Plaintiffs’ Specific Causation Expert Fails to Pass Muster in Benzene Case

One of the greatest spectacles on earth is the annual migration of wildebeest, zebras, and antelope in a loop around the Serengeti.  The Blog will have its own migration shortly, which we hope will be a one-time event without dangerous river crossings or, well, loads of crap for either us or our readers.  Next week, the Drug and Device Law Blog will be moving to an upgraded platform via LexBlog.  All the old posts will be available and going to the old site should redirect you to the new site.  That’s the easy part.  The comparatively difficult part should take you about 30 seconds, less time than it usually takes to google one of McConnell’s obscure movie references.  Click HERE to fill out the new e-mail sign-up form.  (Personal information will not be used for holiday cards from Bexis or any other nefarious purpose.)  After you complete the form, you will receive a confirmation e-mail and you will have to click to confirm your subscription.  Then you will get posts by email once we have completed the not-so-great migration.  As an added bonus (?) from the migration, we will not be posting on May 23 or May 24.  If your DDL addiction is too strong for that much of a break, then feel free to peruse old posts.  Checklists and surveys might do the trick.  If you need a stronger fix, then try searching for obscure or inflammatory words used in past posts.  Hours of fun.

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In the mythical days of product liability yore, a big drug litigation was spurred by a notable event—like a study describing a new risk appearing in a major journal, a significant labeling change because of new or greater risk, or the withdrawal of the drug—and was built on identifiable and otherwise uncommon injuries in patients who took the drug.  Because there was a notable event and there were identifiable injuries, the manufacturer could generally expect when lawsuits about those injuries would need to be filed and that it could figure out if a plaintiff was suing over an injury that fit the larger liability issues.  In the purportedly distinct modern era of drug litigation, the only notable events sometimes are the start of plaintiff lawyer conferences and advertising on the drug and the injuries claimed may not be particularly identifiable or otherwise uncommon.  The cases brought probably include non-product liability claims for economic harm and product liability claims loosely tied to the risk of the injury actually sustained by the individual plaintiffs.  Even if there is no good science backing up the plaintiffs’ claims, it can take quite a bit of time and effort for the manufacturer to get the rulings needed to show the claims and evidence offered in support of them to be bogus.

This seems to be what is going on in litigation involving the drug Lipitor, which has been one of the most widely prescribed drugs over the last twenty years (although generic entry had an effect a few years ago).  Along the way, the manufacturer has faced litigation over liver injuries and rhabdomyolysis (like the other statins), antitrust claims, and some other issues.  Meanwhile, the drug continued to be recommended as first line therapy for an expanding range of indications related to improving lipids and reducing cardiovascular risk.  From what we can tell, without anything terribly dramatic, the drug was also one of several in the class associated with a possible small increase in the risk of developing Type 2 diabetes.  If you have been paying attention over the last few decades, then you probably know that the rates of Type 2 diabetes have climbed dramatically, basically hand-in-hand with increases in the rates of obesity, hypertension, unhealthy eating, inactivity, and some other bad habits that call to mind the scooter-bound humans of the future in “WALL-E.”  You might also know that the risks of heart attacks and strokes go up when you add a bad lipid profile to the mix and go down when the lipid profile improves.  That is why doctors and patients care about LDL, HDL, and triglycerides in trying to prevent first or second heart attacks, for instance, just as they try to monitor and control obesity, hypertension, diabetes, sleep apnea, etc.  In this context, it makes sense that doctors might continue to prescribe Lipitor or any of the other statins pretty much as they did before the labels warned of a possible increase in blood sugar levels and the rate of diabetes.  That might make you think plaintiffs suing over a risk of diabetes might have hard time establishing either medical causation or proximate cause for failure to warn of diabetes.  But the plaintiff lawyers filed enough cases that an MDL was established, so they must have mustered some good theories and evidence to support their claims, right?

Continue Reading Trimming Some Fat From Statin Litigation With Daubert and Preemption