As we roll out of bed on the day after Thanksgiving, we are often confronted with contradictory thoughts. For instance, “why did I have that third plate at dinner?” might be followed by “How can I eat some leftovers for breakfast?”  Leftovers are as much of an American tradition on this day as watching videos of altercations during frenzied early holiday shopping. Both celebrate wretched excess in their own way. Some leftovers, however, can be combined to create something tasty and worthwhile. Other leftover uses should not be attempted. We would put sandwiches of turkey, stuffing (dressing down South), and cranberry goop in the former category and Brussels sprouts omelets in the latter.

A while back, for a few years, we chronicled a real turkey of a case called Howard. The saga is recounted here, where the plaintiff’s expert was finally kicked for the unreliability of his defect opinion about the PMA device at issue in the case. Along the way, the case generated two notably foul (fowl?) opinions. Deciding on preemption in the context of a theoretical claim, the Sixth Circuit held that a negligence per se claim could be a parallel claim and avoid express preemption.  Years later, on a referred question, the Oklahoma Supreme Court okayed a negligence per se claim under Oklahoma law based on violations of the FDCA.  That gobbler took home the ribbon for third worst of 2013.  Our well-documented view that there can be no negligence per se claims based on violations of the FDCA notwithstanding, Oklahoma now has a claim that came from a case that was soon to be plucked and exposed as lacking merit.

A few years later, the plaintiffs in Cantwell v. De La Garza, No. CIV-18-272-D, 2018 WL 5929638 (W.D. Okla. Nov. 13, 2018), sued an implanting orthopedic surgeon, non-profit health care system, and medical device manufacturer for alleged injuries from the alleged off-label use of a PMA medical device in a spinal surgery. The manufacturer moved to dismiss. We do not have many details of the underlying facts or allegations, but we are focusing on the negligence per se claim—the leftover from the Howard turkey, in case you missed our less-than-subtle theme. A few weeks before the Oklahoma Supreme Court’s decision in Howard, the Western District of Oklahoma rejected the purported parallel claims in Caplinger. After a motion to reconsider was denied, the Tenth Circuit affirmed in Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015), one of our favorite preemption decisions and a 2015 winner.  In part because that decision was authored by future Justice Gorsuch, we have drilled down on Caplinger a few times and tracked its impact.

The Cantwell plaintiffs claimed that the manufacturer had promoted the device to be used off-label—it was approved for use in the thoracolumbar spine, but was used in the cervical spine—and that violated apparently unspecified provisions of the FDCA and its regulations. Under the Oklahoma Supreme Court’s decision in Howard, “To establish negligence per se, the plaintiff must demonstrate the claimed injury was caused by the violation [of a statute], and was of the type intended to be prevented by the statute . . . [and] the injured party [was] one of the class intended to be protected by the statute.” Pretty much the hornbook definition, along with the requirement that the plaintiff prove breach, causation, and damage. In the context of pleadings and the Howard decision, the court went back to basics. Plaintiffs did not plead a particular statute or regulation that had been allegedly violated, let alone that could be tied to the injuries attributed to the device at issue. Howard did not lower the pleadings bar: “The court said nothing to suggest, however, that a plaintiff wishing to bring such a claim could proceed without identifying the statute or regulation allegedly violated, and thus the duty allegedly breached by the defendant’s conduct.” Looking to Caplinger and the unaddressed but obvious issue of preemption, the court noted that “such identification is particularly important in the area of medical devices, where a state-law negligence claim must survive the FDCA’s provision of a federal preemption device.” So, no identified allegedly violated federal statute or regulation meant no properly pleaded claim for negligence per se. Citing to the FDCA in general or invoking the loaded term “off-label” was not enough to get past a motion to dismiss. Predictably, though, the dismissal was without prejudice, so we expect plaintiffs will try again. If they do, then we would not be surprised if Justice Gorsuch’s former colleagues on the Tenth Circuit get another chance to weigh in on express preemption with a re-heated version of Howard.

Since Conte in 2008, we have not made a secret of our view that innovator liability is a bad idea, contrary to traditional tort law principles and to sound public policy.  We, especially Bexis, may even be accused of being somewhat obsessed with chronicling the decisions, big and small, on this issue over close to a decade.  We have kept a scorecard of the decisions and commemorated the one-hundredth decision.  We tracked when the Alabama legislature got sick of the turbulent expansion by the courts and kept product liability limited to the product designed, manufactured, or sold/leased by the defendant.  We have peppered our top and bottom ten lists with these decisions and we expect they will find places on our august enumerations for the eleventh year in a row this December.

The decision in In re Zofran (Ondansetron) Prods. Liab. Litig., MDL No. 1:15-md-2657-FDS, 2018 WL 2317525 (D. Mass. May 21, 2018), has familiar ring to it.  Among the claims presented in this MDL are those against the branded manufacturer from the offspring of women who received generic versions of a prescription antiemetic.  These plaintiffs sought to impose innovator liability on the theory that the branded manufacturer had made misrepresentations to unspecified doctors that somehow encouraged the off-label prescription to pregnant women for morning sickness without disclosing a purported risk of birth defects.  (As an aside, while not in the decision, this is considered an essential medication by WHO and the current labeling suggests that FDA rejects that any birth defect risk has been established.)  Last year, the court ruled on a motion to dismiss this version of innovator liability under Georgia, Indiana, Kentucky, Massachusetts, New York, and Oklahoma law.  We discussed it here  and it took on honorable mention on last year’s top ten list.  Other plaintiffs persisted with these claims and the branded manufacturer defendant filed a motion for judgment on the pleadings.  After some voluntary dismissals, the court considered the issue under the law of Oklahoma (again), Connecticut, and New Jersey.

Why is this worth a post instead of just an update to our scorecard? Well, there have been two really big, bad decisions on innovator liability since the court’s prior decision and we like to make sure the majority position continues to hold after such dreck.  The first innovator abomination was T.H. v. Novartis Pharm. Co., which we railed about here and took over the spot of worst case of 2017 in a rare supplemental shuffling of the list.  We have said quite a bit about why this decision, and the Court of Appeals decision before it, were especially bad, extending innovator liability into perpetual liability under the guise of foreseeability.  A few months later, the Massachusetts Supreme Judicial Court a mile away from the Zofran MDL issued its own stinker in Rafferty v. Merck & Co., Inc., reversing a lower court rejection of innovator liability.   Even with the “limitation” that innovator liability would only for “reckless” conduct in failing to update the branded drug’s label, there is a good chance that this will find a place on the list of 2018’s worst come December.  There was also a good decision a few weeks ago from the West Virginia Supreme Court soundly rejecting innovator liability in McNair v. Johnson & Johnson, which may end up with a place on 2018’s best list.  More important than our lists—breathe, Bexis, breathe—is that the Zofran court reviewed and considered these decisions before addressing the merits.

The Oklahoma plaintiff’s claim was easy, given the court’s evaluation of Oklahoma law less than a year ago. “While it is true that the minority view has gained ground in the last year with the California and Massachusetts opinions, that is not sufficient under the circumstances to tip the balance.”  2018 WL 2317525, *4.

The court had not previously considered Connecticut law and the Connecticut state courts had not previously considered the issue. The Sixth Circuit had, though.  Connecticut was one of the 22 states at issue in In re Darvocet, which we lauded here before giving it the top spot in our 2014 list.  The Darvocet analysis was that the Connecticut Product Liability Act provided the sole remedy for misrepresentation claims asserted and it required the product at issue to be the defendant’s to impose liability.  While not binding, “In re Darvocet is a 2014 decision by a federal appellate court that addresses the issue in comprehensive terms, and there appears to be no Connecticut authority suggesting a contrary result.” Id. at *5.

Predictably, In re Darvocet (in the district court) had addressed New Jersey law and New Jersey lower courts have addressed the issue a few times, even if the New Jersey Supreme Court has not.  They all came out against innovator liability, with pre-Conte cases followed post-Conte.  (See here and the New Jersey part of this.)  The New Jersey PLA also limits liability to the manufacturer or seller of the product that allegedly hurt the plaintiff and misrepresentation claims like the plaintiffs assert against the branded manufacturer are subsumed by the NJPLA. Id. Thus, there is no innovator liability under New Jersey law.

Despite our retrospective here, we do not see this decision making this year’s top ten list. However, the First Circuit could certainly take high honors by affirming this or the prior Zofran MDL decision.  Just saying.

We can be inundated with news.  Old news.  New news.  Fake news.  Breaking news.  News that makes you want to break something.  News that makes you want to go back to bed.  In trying to be discerning consumers of the news, it is useful to do not just a reality check but a date check.  Stories on a social media stream come with a presumption of newness, but the date of the release of the story—once you find it—may make you stop reading because it is not news any more.  You may even have read the old news when it was new and just got suckered back by the misimpression of novelty.  A story about a new species of dinosaur, or even beetle, being discovered?  We are clicking.  Einstein’s prediction of gravitational waves verified?  Click—wait, we saw that way back in early 2016, and a Nobel Prize was awarded for that last month.

Generic drug preemption may not be as clickworthy as a “new” ankylosaur, but these decisions do still catch our attention.  After Mensing, Bartlett and scores of published decisions preempting the vast majority of conceivable claims—or holding that state law does not recognize the claim the plaintiff would need to sidestep preemption—you might think that plaintiffs would stop pursuing these claims.  Well, the nonsense that is innovator liability has not provided a viable alternative—although the plaintiffs keep trying (like here and here)—and courts have not yet resorted to Rule 11 for pursuing obviously preempted claims, so the plaintiffs keep trying.  When Kious v. Teva Pharmaceuticals USA, Inc., No. 16-990-R, 2016 WL 9559038 (W.D. Okla. Dec. 8, 2016), popped up in our searches, we thought it might be new and newsworthy.  It really was old news made to seem new because it had taken eleven months to get on Westlaw.  The generic manufacturer defendant secured dismissal of the claims against it on preemption, but was there anything new, different or interesting about it?  We think it is pretty much old hat, but that may be the point.

Kious involves a plaintiff who claims to have developed Stevens-Johnson Syndrome as the result of the use of a generic antibiotic, the label for which apparently matched that of the reference drug.  The plaintiff sued the generic manufacturer, asserting standard state law claims, and a motion to dismiss the amended complaint followed.  (He also sued the branded manufacturer, but that is not discussed in the opinion.)  The court walked through each asserted claim, starting with design defect.  Preemption of such claims is not really a question post-Bartlett, but the Tenth Circuit’s decision in Schrock, discussed here, left no doubt that strict liability and negligence design claims fail.  Id. at *2.  Next up was the claim for manufacturing defect, which was really just a re-packaged claim for design defect.  Plaintiff claimed “that every dose of azithromycin was defective because of its design and/or lack of adequate warnings,” so he did not plead a manufacturing defect claim under Oklahoma law (and the design claim under a different label was still preempted). Id.

Next up were the warnings claims.  Plaintiff did not allege a failure to update the generic label to mirror the reference drug’s label, so Mensing’s application should have been straightforward.  Not so, claimed the plaintiff, because Mensing involved prescriptions written before the Food and Drug Administration Amendments Act of 2007, which established a procedure under which FDA could ask for a new label from a generic manufacturer if the reference drug was no marketed and there is new safety information.  Even this argument, however, was not new, as courts like the Seventh Circuit had already rejected it.  The Wagner decision (a lofty fifth place on last’s year’s best list) made clear that the FDAAA did not remove the prohibition against a generic drug manufacturer changing its label unilaterally.  2016 WL 9559038, *4. Kious went a step further—and we think this was actually novel—and noted that the FDA’s proposed rule from 2013 to allow generic manufacturers to change their labels unilaterally in some situations supports preemption.  “The proposed rule would be unnecessary if, as Plaintiff urges, the 2007 Amendments permitted unilateral labeling changes by generic manufacturer.” Id. No news is good news, at least here, so warnings claims are still preempted.

The remaining claims were also dismissed.  Express warranty claims are really preempted warnings claims and implied warranty claims were really preempted design claims or preempted warnings claims, depending on how construed.  Again, the Schrock decision, also under Oklahoma law, determined the result. Id. at *5.  For the claims of fraud, negligent misrepresentation, and negligent concealment, the court looked to the Eleventh Circuit’s decision in Guarino for clear authority that these were simply another version of preempted warnings claims. Id. at **5-6.  That was it for every claim plaintiff offered and, plaintiff did not get to amend again.  Judgment for the defendant after only two strikes.  Could it be that sanctions for asserting frivolous claims are next in such suits?  That would be news, no matter when it happens.

Our learned intermediary rule “head count” lists Oklahoma as solidly in support of the doctrine:

Oklahoma: Edwards v. Basel Pharmaceuticals, 933 P.2d 298, 300-01 (Okla. 1997); Tansy v. Dacomed Corp., 890 P.2d 881, 886 (Okla. 1994); McKee v. Moore, 648 P.2d 21, 24 (Okla. 1982); Cunningham v. Charles Pfizer & Co., 532 P.2d 1377, 1381 (Okla. 1974).

The “head count” lists every state supreme court decision to follow the learned intermediary rule, and the Oklahoma Supreme Court’s four decisions applying the doctrine are exceeded only by Ohio’s six (plus a statute) and Kansas’ five opinions.

Oklahoma courts had never applied the rule to pharmacists, however. As we’ve discussed before, the learned intermediary rule helps pharmacy defendants by precluding claims that pharmacies, as intermediate sellers of prescription drugs, should have some sort of independent duty to warn patients. Just as the rule recognizes physicians as learned intermediaries in passing along relevant warnings from prescription medical product manufacturers to their patients, learned intermediary principles also preserve the physician-patient relationship by precluding imposition of independent warning duties on other possible interlopers – such as pharmacies – who otherwise might be legally required to confuse patients by providing information that conflicts with what prescribing physicians tell their patients. Back in 2011, on occasion of the Arkansas decision Kowalski v. Rose Drugs, Inc., 378 S.W.3d 109 (Ark. 2011), we did a 50-state survey post on this issue, and Oklahoma was missing in action.

Not any longer. In Carista v. Valuck, ___ P.3d ___, 2016 WL 6237855 (Okla. App. Oct. 20, 2016), the court applied the learned intermediary rule to pharmacy-related claims in essentially the same fashion as the previous cases in our survey post. Carista involved a plaintiff (or more precisely, a plaintiff’s decedent) who took too many painkillers – it appears, from the opinion, illegally − overdosed, and then attempted to blame someone else, in this case the pharmacy where the prescriptions were allegedly filled. The case was dismissed, and the plaintiff appealed. Recognizing the issue as one of first impression, the court followed what it concluded, rightly, was the majority rule:

Many other states appear, however, to have adopted the [learned intermediary] doctrine, with limited exceptions, to shield pharmacists from being required to “second guess” a physician’s medical decisions embodied in an otherwise authorized and legally made prescription.

Continue Reading Oklahoma Becomes the Latest State To Apply Learned Intermediary Principles To Pharmacies

Here’s another guest post, by Richard Dean and Peter Reed of Tucker Ellis.  They describe a successful combination (what we might call a “one-two punch” if that phrase were not already taken) of lack of personal jurisdiction under Bauman (also called Daimler) with removal, once the non-diverse (and fraudulently misjoined) plaintiffs lost their defendants.  We mentioned the state court ruling a while ago, here, but this post puts it in greater perspective. As always all credit and blame go to our guest posters.

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Plaintiffs like to use multi-plaintiff filings to defeat federal diversity jurisdiction and keep cases in state court in contravention of the spirit, if not the technical language, of the Class Action Fairness Act (“CAFA”).  That’s why a recent set of decisions from the Oklahoma state and federal courts is so heartening.  First, an Oklahoma state court properly recognized that the bright-line jurisdiction rule of Daimler AG v. Bauman, 124 S. Ct. 746 (2014), precluded the non-forum plaintiffs from obtaining jurisdiction over non-forum defendants, resulting in the dismissal of their suits.  Second, those non-forum plaintiffs were the only non-diverse parties, so dismissal of their suits presented a second opportunity for defendants to remove the remaining cases to federal court.  Third, a federal court held that the subsequent removal was not barred by the infamous voluntary-involuntary dismissal rule, which is often used to send “other paper” removals back to state court.  See Kathleen Teague v. Johnson & Johnson, et al., No. Civ-14-702-L, slip op. (W.D. Okla. Oct. 14, 2014).

This saga began with 11 filings with under 100 plaintiffs each (approximately 650 total) in a single-judge state county court in Oklahoma.  In each of the 11 cases, only one or two plaintiffs were from Oklahoma and all the other plaintiffs were from out of state (including one or two jurisdictional spoilers).  Defendants removed under principles of fraudulent misjoinder and CAFA.  They lost.  The District Court remanded the case, see Halliburton v. Johnson & Johnson, 983 F. Supp.2d 1355 (W.D. Okla. 2013), and the Tenth Circuit affirmed that decision, see Parson v. Johnson & Johnson, 749 F.3d 879 (10th Cir. 2014).  Defendants argued that filing several hundred cases before a single state court judge constituted an implicit proposal for a joint trial under CAFA, but the Tenth Circuit held that the statute’s technical language required a more express statement of any such request from plaintiffs.

Continue Reading Guest Post – Daimler (Bauman) As a Removal Tool in Multi-Plaintiff Cases

Over the past week, we received two new decisions from our readers.  This post is about the first of them (there’s an internal hang-up with the other, that we hope will clear up shortly).

The first case sent to us is In re Plavix Related Cases, 2014 WL 3928240 (Ill. Cir. Cook Co. Aug. 11, 2014), concerning post-Bauman personal jurisdiction, and specifically the impending demise of litigation tourism.  This Plavix decision is a welcome counterpoint to the absurd and abusive California decision – also about Plavix litigation tourism – that we blogged about last week in our “Hotel California” post.  Unlike the California court, the Illinois decision didn’t go along with the plaintiffs’ effort to reassemble pre-Bauman “continuous and substantial” precedent under the guise of “minimum contacts” jurisdiction.

The Illinois Plavix decision arose from coordinated proceedings involving 502 Plavix plaintiffs in Cook County (Chicago), Illinois – 486 of which were non-Illinois litigation tourists.  By “litigation tourist” we mean non-resident plaintiffs whose claims also had nothing to do with the state in which they sued.  At this point, some of you may be asking, “what about CAFA?” Well, we don’t know either, but we have to assume that plaintiffs were intelligent enough:  (1) to file complaints with fewer than 100 plaintiffs, and (2) not to do anything that smacked of seeking consolidation for trial.

Back to the main story.  The only fact that the non-Illinois plaintiffs offered was that the defendants sold a lot of Plavix ($1.7 billion worth) to persons, unlike them, who actually resided in Illinois.  2014 WL 3928240, at *1.  Other than that, none of the defendants was either incorporated of had a principal place of business in Illinois.  Whatever other contacts the defendants had with Illinois (branch offices with a few employees) had nothing to do with these plaintiffs’ claims.  Id.

In short, Plavix presented the same sort of situation as Bauman – a large company being sued in-state solely because of a volume of business commensurate with the overall size of the enterprise.  That’s not enough according to the Supreme Court, as we discussed here.

The Cook County mass torts judge agreed.  First, there was no waiver of the personal jurisdiction issue. Plavix, 2014 WL 3928240, at *6. Timing can be a big deal, because challenges to personal jurisdiction are easily waived if not brought early in litigation.

Second, there could be no general jurisdiction under Bauman. “International relations” was not a basis for distinguishing Bauman (which it refers to as “Daimler”):

Daimler is binding precedent from the United States Supreme Court which this Court is bound to follow. . . .  [T]he Court in Daimler made clear that the general jurisdiction rule in set forth in Goodyear applied to foreign corporation from “sister state[s].”  Accordingly, the Court will apply the holding of Daimler to the present case.

Plavix, 2014 WL 3928240, at *6 (emphasis added).  Under Bauman, “jurisdictional formulations” that would “permit[] general jurisdiction over [a corporation] in every other State in which [its] sales are sizable” are “unacceptably grasping.”  Id. (Bauman cites and quotation marks omitted).

The only exception to Bauman’s state of incorporation/principal place of business rule is for “exceptional” situations similar to Perkins v. Benguet Consol Mining Co., 342 U.S. 437 (1952), in which a corporation “was essentially headquartered in [a different place] on an interim basis.”  Plavix, 2014 WL 3928240, at *7.  There is no analogy between Perkins and today’s litigation tourism:

In the present case, by contrast, Plaintiffs claim that Defendants should be subject to general jurisdiction in Illinois because Defendants have retained an Illinois agent for service of process, occupied buildings in Illinois, and employed Illinois residents.  Defendants’ Illinois contacts are far from exceptional. To the contrary, these are contacts which would be typical of a corporation doing business in any state.  Plaintiffs’ suggestion that Defendants’ substantial Illinois sales revenue justifies imposing general jurisdiction on Defendants warrants special attention because a similar argument was raised and rejected in Daimler. . . .  Plaintiffs’ jurisdictional framework, taken to its logical conclusion, would produce exactly that forbidden result: national general jurisdiction in every state in which Defendants are doing business and generating sales revenue.  Daimler makes clear that such an approach to general jurisdiction does not comport with due process.

Id. (emphasis added).

Third, there wasn’t any specific jurisdiction in Plavix either.  The court considered the “Hotel California” decision and specifically rejected it as “unpersuasive” – finding it based on a “substantial connection test” that did not exist in Illinois.  Plavix, 2014 WL 3928240, at *8.  The Plavix court was being nice – personal jurisdiction is a constitutional question, so the California quirk cited was a fig leaf. The California court simply got it wrong:

[T]o satisfy the second factor of the specific jurisdiction analysis, the plaintiff’s claim must directly arise out of the contacts between the defendant and the forum. . . .  [T]he [necessary] relationship between the plaintiff’s claim and the defendant’s forum contacts exists where (1) the plaintiff’s claim would not have occurred but for the defendant’s forum activities and (2) the defendant’s forum conduct gave birth to the cause of action.

Id. (citations and quotation marks omitted).  With respect to litigation tourists, with no domiciliary or injury-related ties to Illinois, the court instead found the specific jurisdictional analysis in Glater v. Eli Lilly & Co., 744 F.2d 213, 216 (1st Cir. 1984), more appropriate.  Plavix, 2014 WL 3928240, at *9:

Plaintiffs in the present case are individuals who (1) ingested a drug in one state; (2) were allegedly harmed by the drug in that state, and (3) then filed suit for injuries caused by the drug in a different state where the drug is also distributed. . . .  [T]he injuries suffered by Plaintiffs’ in the present case do not arise from Defendants’ Illinois contacts.  The non-Illinois Plaintiffs claim they were injured when they ingested Plavix in their home states.  Likewise, Plaintiffs’ claims do not relate to Defendants’ Illinois contacts.  While Defendants established a large business network to facilitate the distribution of Plavix in Illinois, Plaintiffs have failed to establish any causal or logical link between their claims and Defendants’ Illinois operations.  Accordingly, Plaintiffs have failed to satisfy the second factor of the specific jurisdiction analysis. This failure is fatal to Plaintiffs’ jurisdictional argument.

Id. Because neither of the first two prongs of specific jurisdiction were met, whether exercising jurisdiction was otherwise “reasonable” never came into play.  Id.

Plavix also refused to retain “pendent” personal jurisdiction under the ruse of a “common fact scheme.”  Such jurisdiction was neither procedurally proper nor would it further “judicial economy, avoidance of piecemeal litigation, and overall convenience of the parties.”  Id.

The bottom line on personal jurisdiction in Plavix was that “All non-Illinois Plaintiffs’ cases are hereby DISMISSED” – 486 out of 502.  That’s good news.  If Bauman can clear out the litigation tourists in Cook County, it can do so elsewhere.

While we’re on the question of personal jurisdiction, it’s probably a good idea to add the transcript of the personal jurisdiction hearing in Halliburton v. Johnson & Johnson, Inc., CJ-13-299, Transcript (Ok. Cir. Pottawatomie Co. June 17?, 2014), which we’ve had kicking around here for some time.  Facing some 700 litigation tourists, the Oklahoma Court came to essentially the same conclusion  as Plavix – that personal jurisdiction was precluded by Bauman:

[T]he Court is unconvinced at this particular time that the specific jurisdiction for the non-Oklahoma plaintiffs has been shown sufficiently for the Court to grant personal jurisdiction of those persons and be the order of the Court . . . that the motion . . . to dismiss the non-Oklahoma plaintiffs for lack of personal jurisdiction is granted.

Transcript at 23-24. This is the same case the the Washington Legal Foundation blogged about here, and you can learn the case’s backstory on the WLF site. What we’re adding is the actual transcript of the hearing at which the litigation tourists were dismissed.

We hope to be in a position to tell you about the other case tomorrow (it’s also a favorable result).  In any event, keep those defense wins coming!

Here’s another guest post, this time by Vani Singhal and Jason McVicker of McAfee Taft.  It’s about tort reform, Sooner style.  As always, our guest correspondents get all the credit (or blame, as the case may be).

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Oklahoma has enacted a new law relating to evidence in product liability cases.  It is effective on November 1, 2014 (for new cases, its application to existing cases will probably be litigated).  The short version is as follows: In a formulation/labeling/design case, if a manufacturer or seller can prove compliance with federal safety standards, it triggers a rebuttable presumption the manufacturer or seller is not liable for injury arising out of the formulation/labeling/design.  The presumption can be rebutted only if the plaintiff demonstrates the federal regulations were inadequate or the manufacturer withheld or misrepresented facts relevant to the federal determination.

Alternatively, if a manufacturer or seller can prove “by a preponderance of the evidence” that the product was subject to premarket licensing or approval by the federal government, that it complied with the licensing or approval process, and that it was licensed or approved, it triggers a rebuttable presumption that the manufacturer or seller is not liable for any injury to a claimant arising out of the formulation/labeling/design.  The presumption can be rebutted only if the plaintiff demonstrates the standards were inadequate or that the manufacturer withheld or misrepresented facts relevant to the process if causally related to the plaintiff’s injuries.

Continue Reading Guest Post – Oklahoma’s Latest Tort Reform

As one of our other bloggers have recently revealed, Bexis recently went on vacation for two weeks.  He was diligent, however, and pre-wrote two posts (not time sensitive) that appeared in his absence.  As for the co-blogger’s quip about Bexis’ “active, muscular vacations” well, in this instance that’s probably right.  For most of Bexis’ two-week absence, he was rafting through the Grand Canyon.

With Bexis otherwise occupied, the blog’s other denizens did an admirable job of keeping up with current developments in case law, but nonetheless items piled up in Bexis’ inbox awaiting his return.  Most of them weren’t even judicial opinions.  It’s time to empty that inbox.

Perhaps the most important development was the approval, on May 29, by the full Federal Judicial Conference’s Standing Committee on Rules of Practice and Procedure, of the discovery-related rules changes that we’ve been covering on the blog.  Bexis has been heavily involved in this effort through the Lawyers for Civil Justice (“LCJ”), and LCJ sent him notice of the approval. We’d pass it along, except it includes internal LCJ business as well.  So we’ll just hit the highlights.

First, there were no changes to the language of the proposed amendments themselves, which we have previously discussed.  The only changes from the version published in the subcommittee’s agenda book were:  (1) a new sentence in Note for Rule 26(b)(1) encouraging computer search technology (that is to say, predictive coding), and (2) modifying the Note for Rule 37(e) concerning the role of prejudice in subsection (e)(2).  Thus, the main benefits of the amendments from our perspective remain:

  • enshrinement of proportionality in Rule 26(b)(1);
  • curtailment of the capacious “reasonably calculated” standard for the scope of discovery in the same subsection;
  • Explicit rejection of the negligence-based standard for ediscovery sanctions in Residential Funding Corp. v. DeGeorge Financial Corp., 306 F.3d 99 (2d Cir. 2002), and thus by necessary implication of other precedent in that circuit following that standard (this means you, Zubulake); and
  • Requiring a finding of specific “intent to deprive another party of the information’s use in the litigation,” under Rule 37(e)(2) before any federal jury can be instructed on evidentiary presumptions from loss of electronic information.

Continue Reading Bexis’ Inbox 2014

Howard v. Zimmer is an old case. It was filed in the Northern District of Oklahoma in 2002 and got transferred to the Northern District of Ohio for the Sulzer Hip and Knee MDL. In 2010, after not participating in a class action settlement in 2003 and having plaintiff’s claims carved up on summary judgment in 2006, Howard went up the Sixth Circuit, which held in 2010 that a claim for negligence per se—if Oklahoma law recognized it—would not be preempted.

Then the case was remanded back the original Oklahoma federal court, which referred to the Oklahoma Supreme Court the question of whether Oklahoma recognized negligence per se based on an alleged violation of the FDCA. The resulting “yes” to that question in March 2013 made #3 on our list of the worst decisions of 2013.  At that point, the case went back the Northern District of Oklahoma to see if plaintiff could actually offer admissible evidence to prove his remaining claim for negligence per se based on a violation of the FDCA. Howard surfaced again last week with Daubert challenge to a fair amount of plaintiff’s expert evidence. Somewhere in the interim, plaintiff had focused his negligence per se claim on the allegation that the Defendant’s manufacturing process allowed for some residue to remain on some portion of the particular knee implant used in plaintiff’s knee replacement surgery back in 2000. Howard v. Zimmer, Inc., No. 02-CV-0564-CVE-FHM, 2014 U.S. Dist. LEXIS 28758, ** 1-2 (N.D. Okla. Mar. 6, 2014). This claim sounds an awfully lot like manufacturing defect or negligent manufacturing and not really at like negligence per se based on a violation of the FDCA, but maybe a plaintiff in a case old enough to be reserving space for its bar mitzvah party should finally be showing whether he has any admissible evidence to support any claim linked to his injury.

Compared to what we have posted on in this case before, the Daubert decision was sound and not results-driven. The weakness of plaintiff’s experts could be viewed either as a shame given the judicial resources spent on the case or as a product of the particular non-preempted claim that plaintiff was left trying to prove. Either way, with plaintiff’s experts hamstrung, we expect Howard is nearing its end, especially if Defendant gets another shot at summary judgment.

The major part of the decision focused on the reliability of gas chromatography/mass spectrometry testing of the explanted device conducted by plaintiff’s expert to show residue—basically oil—was on the device when it was implanted. We know that our readers would appreciate an explanation of how gas chromatography and mass spectrometry work. Luckily, the internet is really cool, so we are not providing the explanation ourselves. Because the challenge here was to how the testing here was performed, as opposed to whether properly performed testing can ever be a reliable basis for expert opinions, the science behind the tests does not matter too much. Id. at **7-8. Also, the alleged methodologic failures were fairly basic when cast in laymen’s terms.

First, chain of custody for the implant was only established starting when the expert’s outfit got it, leaving open questions of what might have happened to it before then, innocently or otherwise. If what got tested was not what got explanted, then the testing can hardly be said to be useful to a jury. Second, part of the testing may have involved pouring a solvent into a plastic container, which itself could have produced some or all of the chemicals (hydrocarbons) that allegedly indicated possible residue oil from manufacturing the device. It was fairly obvious that some additional testing of the container should have been done to rule it out as a source of the chemicals. Third, although plaintiff contended only one part of the device had some post-manufacturing residue on it—and instructed the expert to only test it—the testing was done on the whole device together, including a plastic part that arguably could have produced the chemicals at issue when put in contact with the solvent. Following steps to avoid false results is fairly typical of good science. Fourth, the plaintiff’s expert never tested for the specific lubricants used in manufacturing the device, but only tested some generic mineral oil, which may or may not have the same mix of hydrocarbons.

Rather than resolving these questions or determining that success on any one challenge would have been sufficient to knock out the testing, the court held that “it is clear that the combination of the four errors is sufficient” to find the testing unreliable. Id. at ** 13-14. We might have preferred if the court had stated this as a failure of plaintiff to establish the reliability of the testing, as it was clearly plaintiff’s burden to do. The court had indirectly quoted Paoli for “any step that renders the analysis unreliable . . . renders the expert’s testimony inadmissible. This is true whether the step completely changes a reliable methodology or merely misapplies that methodology.” Id. at * 13 (quoting Mitchell v. Gencorp Inc., 165 F.3d 778, 783 (10th Cir. 1999)). Then the court found it “unclear” if the hydrocarbons found in the testing could have come from the lubricants used to manufacture the part at issue, as opposed to from the container, another part, or some post-explant contamination. Id. at * 14. So, this really does sound like the plaintiff not carrying his burden and we are content.

We were also pleased that all opinions based on the unreliable testing were excluded without any particular analysis. The tidy decision to exclude regulatory opinions from the expert who did the testing was also good. He denied expertise in FDA’s regulation of medical devices, but got a “general idea of what needs to be done” from internet research. Not enough. Id. at ** 16-17. Just like conducting the internet research we advocated above would not confer expertise in gas chromatography. Unfortunately, this expert did offer some opinions based neither on the testing or his non-existent regulatory expertise, so he was not excluded entirely.

That was not the case for Dr. Fred Hetzel, whom we have mentioned before. In addition to opinions based on the unreliable testing, he tried to offer legal conclusions about the meaning of FDA regulations on Good Manufacturing Practice regulations and speculation that metallic residue also could have been on the device when it was implanted. As to the first part, it was apparently “law of the case” from way back when the case was back in the MDL that Hetzel was “not competent to testify to legal conclusions about what the GMPs require.” Id. at * 18. This is an interesting limit to have in a case where the plaintiff was trying to proceed on the theory that the violation of those regulations constituted negligence per se. As to the second part, Hetzel basically admitted that he had no evidence of any metallic residue on plaintiff’s device, in part because relevant evaluating and testing was not performed. Id. at ** 18-19. This made it easy for the court to find opinions on metallic particulates unreliable—and obviously irrelevant.

The last part of the decision concerned the attempt of a treating opinion to ascribe the failure of plaintiff’s knee replacement surgery to an issue with the manufacture of the device based on his experience that he saw a similar course with another patient with the same device. Opinions based on “clinical experience” often get offered by plaintiff and defense experts, particularly surgeons, and it can be hard to sort out when an opinion is simply based on what amounts to a comparison to the expert’s own unpublished case report or on something more substantial. The court’s analysis was direct and logical, so we will just insert it:

There is no evidence that any further scientific inquiry was conducted to determine the extent of the similarities between [plaintiff’s] experiences and those of the other patient. The sole basis for Dr. Robertson[‘s] opinion appears to be that both [plaintiff] and the other patient had aseptic loosening and that both patients’ implants were easier to remove than anticipated. Plaintiffs have failed to establish that this comparison is reliable. Plaintiffs have not provided evidence that this comparison has been subject to peer review and publication, that there is an established rate of error for this comparison, or that this comparison has general acceptance. See Bitler v. A.O. Smith Corp., 400 F.3d 1227, 1233 (10th Cir. 2005). Dr. Robertson’s methodology for reaching the conclusion that [plaintiff] and his other patient’s experiences were substantially identical is insufficiently rigorous, and, as a result, his opinion should be excluded. See Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137 (1999) (“[The objective of Daubert’s gatekeeping requirement] 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.

Id. at * 22-23 (record cite omitted). That is dead on and even introduced the burden issue we harped about above. As its parting shot, the court dismissed the argument that cases providing for the admissibility of prior accidents (or ADEs or MDRs for our typical cases) do not support an expert’s reliance on a single prior patient for a causation opinion. Id. at ** 23-24.

We hope that we are nearing the end of Howard, as it seems to have been a long and expensive exposition of a principle we find self-evident: not every failed surgery with a medical device gives rise to a viable cause of action against the device’s manufacturer. With close to twelve years of litigating, including a bad preemption decision by the Sixth Circuit and a really bad negligence per se decision by the Oklahoma Supreme Court, it may be that the case was an exercise in futility from the start, because there was never anything wrong with the device. (And, much like Howards End, movies where Antony Hopkins does not play a psychopath can run a little long.)

About a year ago, we discussed precedent establishing that off-label use can be, and often is, the medical standard of care.  Conversely, that means that it could be considered medical malpractice not to prescribe certain off-label therapies.  All of a sudden, that issue has popped up again, with two cases in the last week, both dealing with the off-label use of drugs in the abortion context.

We stay away from politics on this blog – whether it’s the merits of Obamacare or the merits of  legal restrictions on medical abortion. But where legal questions associated with this sort of controversial issue impact matters relevant to drug/device defense, we will cautiously venture into such territory, as we did here (ACA could render medical monitoring cause of action unnecessary) and here (FDCA preemption in abortion litigation context).  This time, it’s off-label use.
We’ll polish off the lesser of the two off-label use decisions quickly.  In Planned Parenthood of Greater Texas Surgical Health Services v. Abbott, ___ F. Supp.2d ___, 2013 WL 5781583 (W.D. Tex. Oct. 28, 2013) (“Abbott”), stay granted in part on other grounds, ___ F.3d ___, 2013 WL 5857853 (5th Cir. Oct.  31, 2013), an “off-label protocol” for terminating pregnancy using drugs rather than surgery was, as with the other off-label uses we discussed in our earlier post, determined to be the medical standard of care, and conversely, the FDA-approved intended use of the same key drug (mifepristone, also known as RU-486) was obsolete.  As the court stated:

Abortion-performing physicians have since developed a medication-abortion protocol using mifepristone that, although varying significantly from the FDA protocol, has become the de facto standard of care in Texas.  This protocol, or one substantially identical, accounts for the vast majority of medication abortions performed nationwide since 2007.  The new protocol [is] endorsed by the American College of Obstetricians and Gynecologists.

Id. at *7 (footnote omitted).  We omitted a footnote.  We now add it back in, because it is more relevant to our product liability defense-related concerns than most of the opinion:

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