By now, the learned intermediary rule is so well established that new opinions addressing core learned intermediary issues, as opposed to applying the rule to specific fact patterns, are relatively uncommon. The last one of those we covered was the Seventh Circuit’s prediction that Wisconsin would adopt the learned intermediary rule, almost a year ago in In re Zimmer, NexGen Knee Implant Products Liability Litigation, 884 F.3d 746 (7th Cir. 2018).

We’ve got another.

In Ideus v. Teva Pharmaceuticals USA, Inc., ___ F. Supp.3d ___, 2019 WL 912121 (D. Neb. Feb. 19, 2019), the court, applying Nebraska law, held that the learned intermediary rule applied to a copper intra-uterine device (“IUD”).  The foundational learned intermediary question in Nebraska was decided in Freeman v. Hoffman-La Roche, Inc., 618 N.W.2d 827, 841 (Neb. 2000), adopting the rule as enunciated in Restatement (Third) of Torts, Products Liability §6(d) (1998), but the plaintiff in Ideus invoked purported “exceptions” in an attempt to avoid the rule.  The most on-point of those exceptions was “for prescription contraceptives.”  2019 WL 912121, at *2.

Ideus thoroughly trashed that supposed exception, pointing out that the Eighth Circuit got it wrong thirty years ago in Hill v. Searle Laboratories, 884 F.2d 1064, 1070 (8th Cir. 1989), when it predicted that Arkansas would adopt such an exception.  But in West v. Searle Co., 806 S.W.2d 608, 614 (Ark. 1991), the Arkansas Supreme Court rejected the West prediction and the purported contraceptive exception.  2019 WL 912121, at *3.  This discussion reminds us of what recently happened in Arizona, with the en banc Ninth Circuit getting “Spalding” embossed in its collective forehead from the Arizona Supreme Court’s forceful (and unanimous) rejection of its mythical tort “duty to report” to the FDA.

So, with West both non-binding (being a different state’s law) and discredited even in that state, Ideus followed the clear majority rule, and overwhelming recent trend, and rejected the idea of a “contraceptive exception” to the learned intermediary rule. First, “determining what contraceptive fits [a patient’s] particular criteria necessarily requires the knowledge and advice of a physician.” 2019 WL 912121, at *4. Therefore, there was “no reason to distinguish between a patient’s final choice to use a particular contraceptive and a patient’s final decision relating to any other course if treatment.” Id.

[T]he fact that the patient makes the final choice among suggested contraceptives (or decides not to use any at all) does not constitute a distinction which makes the [learned intermediary] rule inapplicable.  [The Court] can readily conceive of situations in which a physician gives the patient a choice of courses to follow.  There is, for example, a patient’s choice between continuing to endure a physical ailment or submitting to surgery or some other course of treatment; an obese person’s choice among diets suggested by the doctor; and a surgery patient’s choice of anesthesia. . . .

In any such situation which may come to mind, the patient is expected to look to the physician for guidance and not to the manufacturer of the products which he may use or prescribe in the course of treatment.

Id. (quoting Terhune v. A.H. Robins Co., 577 P.2d 975, 978 (Wash. 1978)).  Nothing inherent in contraceptives justified singling them out for an exception to the learned intermediary rule:

[W]hatever differences there may be between contraceptives and “typical” prescription drugs, they have one important thing in common:  both are always prescribed by a physician or through the services of a physician.  And when a patient relies on the skill and knowledge of a physician in any particular method of treatment, the learned intermediary doctrine ought to apply.  This is no less true for prescription contraceptives as for any other prescription medication.

Id. (citation omitted).

Finally, Ideus relied upon Nebraska’s adoption of the Third Restatement §6(d)’s version of the learned intermediary rule, which did not recognize any exception for contraceptives.

[T]hat section of the Restatement acknowledges circumstances under which the doctrine might not be applicable. . . .  [N]othing in the record or the parties’ arguments . . . suggest[s] with respect to contraceptives in general . . . that a health care provider is not in a position to reduce the risk of any foreseeable harm to the patient.  In other words, the Nebraska Supreme Court did acknowledge the possibility of exceptions to the learned intermediary doctrine, when it expressly adopted § 6(d) of the Restatement − but nothing suggests that such an exception should be recognized here.

2019 WL 912121, at *5 (citations and quotation marks omitted).

Thus, Ideus predicted that “the Nebraska Supreme Court would following the overwhelming majority of decisions that have applied the learned intermediary doctrine to cases involving contraceptives.”  Id.  The court followed with an impressive string citation to well over a dozen cases applying the learned intermediary rule to contraceptives of various types.  Id.  This being the DDLaw Blog, however, we will provide our own, even more extensive, list of such cases:

State Supreme Court Cases:

Martin v. Ortho Pharmaceutical Corp., 661 N.E.2d 352, 356-57 (Ill. 1996); Shanks v. Upjohn Co., 835 P.2d 1189, 1200 (Alaska 1992); West v. Searle & Co., 806 S.W.2d 608, 613-14 (Ark. 1991); Humes v. Clinton, 792 P.2d 1032, 1039-41 (Kan. 1990); Lacy v. G.D. Searle & Co., 567 A.2d 398, 400-01 (Del. 1989); Tetuan v. A.H. Robins Co., 738 P.2d 1210, 1228 (Kan. 1987); Wooderson v. Ortho Pharmaceutical Corp., 681 P.2d 1038, 1052 (Kan. 1984), McKee v. Moore, 648 P.2d 21, 25 (Okla. 1982); Seley v. G.D. Searle & Co., 423 N.E.2d 831, 839-40 (Ohio 1981); Terhune, 577 P.2d at 978; Vaughn v. G.D. Searle & Co., 536 P.2d 1247, 1248 (Or. 1975); McEwen v. Ortho Pharmaceutical Corp., 528 P.2d 522, 528 (Or. 1974).

Other State Cases:

Wyeth-Ayerst Laboratories Co. v. Medrano, 28 S.W.3d 87, 91 (Tex. App. 2000); Plenger v. Alza Corp., 13 Cal. Rptr.2d 811, 819 n.6 (Cal. App. 1992); Taurino v. Ellen, 579 A.2d 925, 928 (Pa. Super. 1990); Brecher v. Cutler, 578 A.2d 481, 485 (Pa. Super. 1990); Rhoto v. Ribando, 504 So.2d 1119, 1123 (La. App. 1987); Eiser v. Feldman, 507 N.Y.S.2d 386, 387-88 (N.Y. App. Div. 1986); Taylor v. Wyeth Laboratories, Inc., 362 N.W.2d 293, 297 & n.11 (Mich. App. 1984); Cobb v. Syntex Laboratories, 444 So.2d 203, 205 (La. App. 1983); Reeder v. Hammond, 336 N.W.2d 3, 5 (Mich. App. 1983); Ortho Pharmaceutical Corp. v. Chapman, 388 N.E.2d 541, 548-49, 553, 557 (Ind. App. 1979); Hamilton v. Hardy, 549 P.2d 1099, 1110 (Colo. App. 1976), overruled on other grounds, State Board of Medical Examiners v. McCroskey, 880 P.2d 1188 (Colo. 1994); Leibowitz v. Ortho Pharmaceutical Corp., 307 A.2d 449, 457 (Pa. Super. 1973); Carmichael v. Reitz, 95 Cal. Rptr. 381, 400-01 (Cal. App. 1971) (contraceptive prescribed for other purpose); Hayes-Jones v. Ortho-McNeil Pharmaceutical, 2012 WL 3164558 (N.J. Super. Law Div. Aug. 3, 2012) (applying Virginia law).

Federal Courts of Appeals:

Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281, 292-93 (6th Cir. 2015) (applying New York law); In re Norplant Contraceptive Products Litigation, 165 F.3d 374, 379 (5th Cir. 1999) (applying Texas law); Odom v. G.D. Searle & Co., 979 F.2d 1001, 1003-04 (4th Cir. 1992) (applying South Carolina law); Beyette v. Ortho Pharmaceutical Corp., 823 F.2d 990, 992-93 (6th Cir. 1987) (applying Michigan law); Brochu v. Ortho Pharmaceutical Corp., 642 F.2d 652, 656 (1st Cir. 1981) (applying New Hampshire law); Lindsay v. Ortho Pharmaceutical Corp., 637 F.2d 87, 91 (2d Cir. 1980) (applying New York law).

Federal District Courts:

Lussan v. Merck Sharp & Dohme Corp., 2017 WL 2377504, at *3 (E.D. La. June 1, 2017); Gonzalez v. Bayer Healthcare Pharmaceuticals, Inc., 930 F. Supp.2d 808, 813 (S.D. Tex. 2013); Hanhan v. Johnson & Johnson, 2013 WL 5939720, at *3 (N.D. Ohio Nov. 5, 2013) (applying California law); James v. Ortho-McNeil Pharmaceutical, Inc., 2011 WL 3566844, at *3 (N.D. Ohio Aug, 12, 2011) (applying Louisiana law); In Re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation, 692 F. Supp.2d 1025, 1033-34 (S.D. Ill. 2010), aff’d, 643 F.3d 994 (7th Cir. 2011); Mendez Montes De Oca v. Aventis Pharma, 579 F. Supp.2d 222, 228 (D.P.R. 2008); In re Norplant Contraceptive Products Liability Litigation, 215 F. Supp.2d 795, 809-10 (E.D. Tex. 2002) (applying law of all fifty states); Nelson v. Dalkon Shield Claimants Trust, 1994 WL 255392, at *4 (D.N.H. June 8, 1994); MacPherson v. Searle & Co., 775 F. Supp. 417, 424-25 (D.D.C. 1991); Reaves v. Ortho Pharmaceutical Corp., 765 F. Supp. 1287, 1291 (E.D. Mich. 1991); Zanzuri v. G.D. Searle & Co., 748 F. Supp. 1511, 1514-15 (S.D. Fla. 1990); Amore v. G.D. Searle & Co., 748 F. Supp. 845, 849-50 (S.D. Fla. 1990); Allen v. G.D. Searle & Co., 708 F. Supp. 1142, 1147-48 (D. Or. 1989); Spychala v. G.D. Searle & Co., 705 F. Supp. 1024, 1032 (D.N.J. 1988); Kociemba v. G.D. Searle & Co., 680 F. Supp. 1293, 1305-06 (D. Minn. 1988); Dupre v. G.D. Searle & Co., 1987 WL 158107, at *4 (D.N.H. April 28, 1987); Skill v. Martinez, 91 F.R.D. 498, 507 (D.N.J. 1981), aff’d per curiam, 677 F.2d 368 (3d Cir. 1982); Steinmetz v. A.H. Robins Co., 1981 U.S. Dist. Lexis 14314, at *3-5 (D. Or. Aug. 27, 1981); Goodson v. Searle Laboratories, 471 F. Supp. 546, 548 (D. Conn. 1978); Dunkin v. Syntex Labs, Inc., 443 F. Supp. 121, 123 (W.D. Tenn. 1977); Chambers v. G. D. Searle & Co., 441 F. Supp. 377, 381 (D. Md. 1975), aff’d per curiam, 567 F.2d 269 (4th Cir. 1977) (applying District of Columbia law).

Secondarily, the plaintiff in Ideus tried to assert the so-called “direct to consumer” advertising exception to the learned intermediary rule.  The decision disposed of that contention in a footnote:

For the same reason, to the extent that [plaintiff] claims the direct consumer marketing exception to the learned intermediary doctrine applies, that argument has no merit.  If anything, it further supports the Court’s conclusion the contraceptives and other prescription drugs are not actually distinguishable.

Ideus, 2019 WL 912121, at *4 n.3 (citations omitted).  We don’t have to provide a list of cases here, because we’ve thoroughly addressed the almost universal rejection of the direct-to-consumer exception before.  That post was in January, 2011. However, for the sake of completeness, here are more recent cases also rejecting any direct to consumer exception:

Watts v. Medicis Pharmaceutical Corp., 365 P.3d 944, 950-51 (Ariz. 2016); Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 159-64 (Tex. 2012) (reversing lower court adoption); Shah v. Forest Laboratories, Inc., 2015 WL 3396813, at *6 (N.D. Ill. May 26, 2015); Thomas v. Abbott Laboratories, 2014 WL 4197494, at *6 (C.D. Cal. July 29, 2014); McKay v. Novartis Pharmaceuticals Corp., 934 F. Supp.2d 898, 910 (W.D. Tex. 2013), aff’d, 751 F.3d 694 (5th Cir. 2014); In re Avandia Marketing, Sales Practices & Products Liability Litigation, 2013 WL 3486907, at *2 (E.D. Pa. July 10, 2013); Calisi v Abbott Laboratories, 2013 WL 5462274, at *3 (D. Mass. Feb. 25, 2013); DiBartolo v. Abbott Laboratories, 914 F. Supp.2d 601, 614-15 (S.D.N.Y. 2012); Swoverland v. GlaxoSmithKline, 2011 WL 6001864, at *2 (D. Conn. Oct. 5, 2011); James, 2011 WL 3566844, at *3.

Why the plaintiff in Ideus was desperate to avoid the learned intermediary rule was obvious from the rest of the opinion – the defendant’s warning was adequate as a matter of law because it warned physicians of exactly the risk that plaintiff blamed for her injuries.  Her only hope was to require a manufacturer warning directly to her (which wasn’t given):

[Plaintiff] has not even named the physician who prescribed and placed her IUD − much less demonstrated that had that physician been given the proper warning, she would not have placed [the device]. . . .  [T]he package insert expressly warned about the possibility of breakage, embedment, and the difficulties of removing [device], making the warning adequate as a matter of law.  A warning is adequate if it accurately and unambiguously coveys the scope and nature of the risk to the prescribing physician.

2019 WL 912121, at *6 (citations omitted).

Astute readers will note that many of the cases in our (and Ideus’) string cites are pretty old – more from the 1970s to 1990s than afterwards.  It’s a stroll down memory lane, and we hope it will stay that way.  As Bexis’ book points out, concerning this erstwhile exception to the learned intermediary rule, “The trend of judicial decisions has shown little acceptance of this exception . . ., and several of the decisions that initially recognized it are now of questionable validity.”  Beck & Vale, “Drug and Medical Device Product Liability Deskbook” §2.03[3][e], at 2.03-70 (2018).  Indeed, subtracting the “questionable” jurisdictions, leaves only one – Massachusetts – definitely still following it.  So it’s no more widely accepted nowadays than the direct to consumer exception peculiar to New Jersey.

The Nebraska Supreme Court issued a gem of a Daubert opinion in an Accutane case last week, Freeman v. Hoffman-La Roche, Inc., No. S-17-800, 2018 WL 2296772, at *2 (Neb. May 18, 2018).  We don’t write much about Nebraska, but the last time we waxed on about the beauty of the Platte River Valley, we actually received a few emails.  That was when we wrote last year about the Daubert order that the Nebraska Supreme Court has now affirmed, in an opinion that is as correct and straight-headed as the order it was reviewing.  Indeed, the current opinion might actually be the end of this case, which has been kicking around in the Nebraska state courts amazingly since the late 1990s.

Nebraska keeps a low profile. Growing up in California, we were told that Nebraska is in the Midwest.  But then we went to college in New England and learned that Nebraska is just plain “West,” unqualified by any prefix.  Sandwiched in between Colorado and Iowa, we suppose that either moniker could justifiably apply.  Nebraska has the country’s largest railyard, including a tall public viewing tower from which you feel as if you are looking down on a sprawling model train set.  We know because we have been there.  We had a few hours to kill in North Platte one day (don’t ask why) and we Googled “things to do in North Platte.”

There is a city in Nebraska named Kearney and a street in San Francisco named Kearny. They are spelled differently and pronounced differently (Nebraskans say Car-nee,” while Californians say “Ker-nee.”).  But they are named after the same guy.  Go figure.

Legalwise, Nebraska is the only state with a unicameral legislature—i.e., one chamber, with no separate house and senate.  The Nebraska state motto is “Equality Before The Law.”  We like that motto a lot, and we were even more impressed when we learned that it predates the Fourteenth Amendment by one year.  We begrudgingly admit that we prefer “Equality Before The Law” over our home state’s motto, “Eureka!”  The former echoes a bedrock principle of our post-Civil War legal tradition and is both declaratory and aspirational.  California’s motto celebrates sudden wealth.  Must have been sponsored by plaintiffs’ lawyers.

We like the Nebraska Supreme Court’s opinion in Freeman v. Hoffman-La Roche a lot, too.  The plaintiff was prescribed Accutane for chronic acne and allegedly experienced Crohn’s disease in her colon and rectum as a result.  2018 WL 2296772, at *2.  There is, however, no reliable scientific evidence showing a causal relationship between Accutane and this particular condition, so when it came time to produce the expert opinions necessary to prove her claims, the plaintiff could not come through.

She banked on a single expert, whom the trial court found to have applied an unreliable methodology and who “unabashedly cherry-picked supporting studies from an overwhelming contrary body of literature.” Id. The trial court’s 42-page order is among the more thorough orders on expert opinion that you will see, and you can review our take on it here.  It’s a strong order showing that the trial court understood who this expert was and what he was offering.

The Nebraska Supreme Court agreed, and it affirmed the exclusion of the expert’s opinions and the trial court’s order granting summary judgment. The Nebraska Supreme Court must have been as impressed with the trial court’s order as we were, because it affirmed the result in just a few pages.  Under Nebraska’s standard—known as the Daubert/Schafersman framework—the court must determine whether an expert’s methodology is reliable and whether the expert applied the methodology properly to the facts. Id. at *3.

This expert employed a “weight of the evidence” methodology, under which he purported to form an opinion based on a variety of disparate data—animal tests, case reports, epidemiological studies, etc. Id. at *4.  That methodology, according to the Nebraska Supreme Court, is generally accepted.  But the problem was and remains that the expert did not apply the methodology in a reliable fashion. Id. He recognized that there was no study determining that Accutane use was a risk factor for Crohn’s disease, but theorized that it would be a risk factor for a particular type of Crohn’s disease—Crohn’s disease of the colon.

Where did he get that? Well, essentially from nowhere.  He disregarded all but one of the epidemiological studies finding no significant relation between Accutane use and irritable bowel syndrome, which is a disease of the colon.  He also found studies reporting no association between Accutane use and Crohn’s disease a “waste of time” because they did not account for the “different manifestations” of Crohn’s disease.  He admitted, though, that the scientific community does not agree that “different manifestations” of Crohn’s disease make any real difference.  He also admitted that Crohn’s disease has a different clinical presentation and different causes than ulcerative colitis, but then he still relied on one study on ulcerative colitis to support his causation opinion. Id. at *4.  So Crohn’s disease is different, except when it isn’t.

Most tellingly, the expert rejected epidemiological studies on Crohn’s disease that showed no association because they did not focus narrowly on Crohn’s disease of the colon.  But then he relied on anecdotal case reports of Crohn’s disease in Accutane patients whether they reported disease of the colon or not.  So the location of the disease was critical when it helped him, but was immaterial when it did not.  As we said before, this is called talking out of both sides of your mouth, and it is neither good nor scientific.

Taking its cue from the trial court, the Nebraska Supreme Court thus concluded:

The objective of the trial court’s gatekeeping responsibility is to make certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field. Clearly, cherrypicking studies from an overwhelming contrary body of literature without valid, supporting reasons for why the other studies were disregarded does not meet the standard of intellectual rigor required of expert witnesses.

Id. at *5.  Without admissible expert opinion, the plaintiff tried to fill the gap with “internal documents,” but that fell short, too.  To the extent the documents were in the record, they did not show a causal relationship.  Id.  Summary judgment affirmed.  This expert’s opinion was shallower than the Platte River itself—a mile wide at its mouth and six inches deep, as some Nebraskans like to say.  We got that saying, by the way, from Bexis.

This post is from the non-Reed Smith side of the blog.

When we say Nebraska, what comes to mind? Cornhusker football? Warren Buffet, the Wizard of Omaha? Buffalo Bill’s Wild West Show? Mutual of Omaha’s Wild Kingdom? An amazingly haunting album by Bruce Springsteen? As the Jersey Girl blogger on this site, it should be no surprise that those ten songs go right to the top of the list. And, if you too are a true fan you’ll already know that Nebraska is actually mostly demos that Springsteen recorded as an experiment on a four-track cassette recorder. When the songs were tried later with the full power of the E Street Band behind them – most of them didn’t work. Born in the USA, Downbound Train, Pink Cadillac, and Working on the Highway found a home on later albums. But for songs like Atlantic City, Highway Patrolman, and My Father’s House – a guitar and a harmonic sold those songs more than a heavy back beat. Nebraska isn’t Springsteen’s only stripped-down album (The Ghost of Tom Joad and Devils & Dust), but for this Jersey Girl, it’s the one with the power. And it was recorded in a New Jersey bedroom one day in January 1982.

Nowhere in any of that did we connect Nebraska to preemption. That is until now. Until Ideus v. Teva Pharmaceuticals USA, Inc., 2017 WL 6389630 (D. Neb. Dec. 12, 2017). Based on our review, and please correct us if we’ve missed something, this is the first case to find a complaint was deficient for failure to plead any facts to establish why the warning claim involved “newly acquired evidence” that would allow it to escape preemption under Wyeth v. Levine, 555 U.S. 555 (2009).

Plaintiff alleged that defendant failed to warn about the risks of an intrauterine device. While the device was being removed, a piece of it broke off and embedded in plaintiff’s uterus. The broken piece later had to be surgically removed. Ideus, at *1. To support her claim, plaintiff alleged that the device’s brochure and package insert, lacked any warning that the device “could break during removal, or that smaller pieces of the device (as opposed to the device as a whole) could separate and become embedded.” Id. A quick aside. This distinction between the device as a whole and a piece of the device made us look at the device’s label. As a disclaimer, we simply looked at the available label on line, but it appears that product contains a warning that the device can become embedded and require surgery to remove. So, in essence, plaintiff’s claim is that while the manufacturer did warn of embedding and surgery as to the whole device, it didn’t warn about those things with a piece of the device. And plaintiff’s other claim is that the manufacturer didn’t warn the device could break. From our perspective, that’s a claim for something that was warned about and something that is a general risk of every product in the world. We don’t think much of plaintiff’s claims.

But we told you this was about preemption, so let’s get back to that. Defendant challenged plaintiff’s claims on the grounds of preemption. The warnings were FDA approved and therefore, plaintiff’s claims don’t survive conflict preemption. Id. As non-surprising as a Jersey Girl loving Springsteen, is a plaintiff raising the FDA’s Changes Being Effected (“CBE”) regulations in response to a failure to warn preemption challenge. Because CBE regulations allow a manufacturer to change the device’s warning without prior FDA approval, per Wyeth, it is possible for a manufacturer to change its warning and not run afoul of federal law. Hence, no preemption. But, what the court said in Ideus is that CBE isn’t a “magic” word that gets plaintiff around preemption even at the pleadings stage. More is required.

A CBE is only allowed based upon “newly acquired information,” not previously submitted to the FDA. “In the absence of such information, the [manufacturer] cannot alter its product’s labeling, and any state regulation or law requiring it to do so is necessarily preempted.” Id. at *2. The court in Ideus, therefore concluded that because “newly acquired information” is a pre-requisite for a valid CBE, facts to support the existence of such new information must be affirmatively pleaded in the complaint. The court cites three cases in support of its finding. We’ve discussed all three on this blog here, here, and here. The difference between those cases and Ideus is that in the prior cases the plaintiff had alleged some facts regarding “new” evidence. The courts were able to examine those allegations and reach conclusions regarding whether they demonstrated new information sufficient to support a CBE. They did not address the specific question of “whether the plaintiff must affirmatively plead the existence of “newly acquired information” to state a cognizable claim for relief.” Id. The closest earlier case was Utts v. BMS, 251 F.Supp.3d 644, 661 (S.D.N.Y 2017) which said:

In sum, if the plaintiff can point to the existence of “newly acquired information” to support a labeling change under the CBE regulation, the burden then shifts to the manufacturer to show by “clear evidence” that the FDA would not have approved the labeling change made on the basis of this newly acquired information.

Sounds like a pleading requirement to us.  Even construing the allegations in a light most favorable to plaintiff, “dismissal is nonetheless appropriate . . . if the facts alleged in the complaint do not plausibly give rise to a claim that is not preempted.” Ideus, at *3 (citations omitted). Because “some indication of newly acquired information [is required] to trigger the applicability of the CBE regulation,” those allegations are required to be in the complaint. Id.

And, of course, they must then meet the requirements of TwIqbal. So, while plaintiff is being given an opportunity to amend her complaint, she “must plead with specificity any newly acquired evidence which may have warranted a change” in the device’s warning after the device was approved but before it was implanted in plaintiff.” Id.  Given our earlier aside about the substance of the claims, we wonder if there was nothing in plaintiff’s complaint because there is nothing. We’ll wait and see, but in the meantime Nebraska, in addition to lending its name to a classic rock album, has given us a significant ruling in our preemption arsenal.

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

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

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

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

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

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