The Pope came to Philadelphia this past weekend.  That’s not the first time this has happened (JPII stopped by in 1979), but the level of paranoia this time around led to four days of street shutdowns, parking prohibitions, and all-around dystopian security that closed roads all the way from Conshohocken to City Line Avenue to the Ben Franklin Bridge.  Commercial strangulation by the unprecedented security caused Bexis’ firm shut down its Philly office for two days.

Bexis, not being a Catholic, decided that the better part of valor was simply to get out of Dodge.  So he went to New York where instead he could follow the Devil’s Path instead.  It was good, very good – some parts considerably more perpendicular than horizontal.  The Devil’s Path and nearby areas beat the literal “hell” out of anything in Pennsylvania.  The only downside is the New York State Thruway, which in its southerly direction is prone to traffic jams for no discernable reason (of course, so is the Schuylkill Expressway in Philly, except when closed entirely for Papal visits).

While walking the Devil’s Path has its benefits, so does walking the path of compliance.  In an early blogpost on the subject of punitive damages, we collected all of the caselaw we could find where compliance with government regulatory standards precluded punitive damages.  Of all the cases we found, only a couple were from state supreme courts.  Now we have another one.  While the Pope was visiting Washington, DC, the Kentucky Supreme Court reversed a multi-million dollar punitive damages award in Nissan Motor Co., Ltd v. Maddox, ___ S.W.3d ___, 2015 WL 5626432 (Ky. Sept. 24, 2015), holding that the defendant’s undisputed compliance with (and in some ways exceeding) federal regulatory standards for automobiles precluded a finding of “gross negligence” or “reckless disregard,” which is the Kentucky standard, id. at *2, to support punitive damages.  That compliance precluded punitive damages as a matter of law even under a “slight care”/gross negligence standard is particularly notable, since many states set the bar higher for punitive damages than merely gross negligence.


Continue Reading Walking the Regulatory Compliance Path Defeats Punitive Damages

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

Do you remember way back yesterday when we posted on Daubert rulings from an OTC pediatric ibuprofen SJS case?  The rulings were in March but just popped up on Lexis last week.  We led in with a discussion of video games as a clever segue to the games some experts play. Really, no glimmer of recognition?  Well, the same case had summary judgment rulings that have now been “published,” so we are giving you a double dose.  See Newman v. McNeil Consumer Healthcare, No. 10 C 1541, 2013 U.S. Dist. LEXIS 113440 (N.D. Ill. Mar. 29, 2013).  As with the expert rulings, there is a mix of good and bad, but the bad gets stuck in our throat.  Dispensing with the lame medication jokes, on to the rulings, the good ones first.

Plaintiffs asserted a claim under the Illinois Consumer Fraud Act premised on “standby statements” from 2003 and 2005 concerning separate reports of SJS/TEN in children using defendants’ ibuprofen products.  This claim failed both because the statements were not deceptive—an obvious element of the claim—and because the defendants established the applicability of the Act’s regulatory compliance defense.  (The Act did not require that the plaintiff rely on the deceptive statement, only that the defendants intended that there be reliance, or there would have been another obvious basis where plaintiffs and their parents surely never saw the statements before using the product.)  As anyone who has ever participated in drafting any statements on adverse events knows, the line between saying something that will later be called an admission of causation and saying something that will later be called minimizing is a fine one.  The statements at issue described the particular cases as “allegedly associated” with the defendants’ product and noted that SJS and/or TEN, in general, “are associated” or “reported to be associated” with ibuprofen and other medications.  The FDA-approved label from 2009, when the plaintiffs used the product, included the warning that “[i]buprofen may cause a severe allergic reaction . . . .”  Under these circumstances, the statements were held consistent with the label and not “so misleading or deceptive in the context that federal law itself might not regard [it] as adequate.”  Id. at *19 (quoting Bober v. Glaxo Wellcome PLC, 246 F.ed 934, 941 (7th Cir. 2001)).  It was very sensible to not read “associated with” as deceptive simply because the label later said “may cause.”

The sensible approach continued in the evaluation of the evidence offered on the regulatory compliance defense—an unnecessary analysis given the lack of an otherwise actionable deceptive statement.  Without rehashing the discussion, which overlaps with the Daubert analysis at issue in yesterday’s post, the part that interested us was the use of statements from FDA in light of the inevitable allegations that defendants had underreported adverse events and generally kept FDA in the dark about the SJS risk of ibuprofen.  Defendants here were able to rely both on a 2006 denial of a citizen’s petition call for withdrawal of all OTC ibuprofen products—for once, not made by Public Citizen, at least openly—and deposition testimony of an FDA official.  The denial included the statement that “we have no evidence that there is additional undisclosed safety information that was withheld by ibuprofen manufacturers” and the FDA official did not suggest that defendants failed to perform any required analysis of adverse events.  Id. at **23-26.  With this back drop, the plaintiffs’ “slight, at best,” evidence of noncompliance could not be assumed to have “affected . . . FDA’s decision making.”  Id. at **26-27.  Placing the burden on plaintiffs to come forward with evidence that alleged noncompliance with regulatory requirements somehow invalidated FDA’s authorization of defendants’ statements was predictably fatal to plaintiff’s claim.


Continue Reading Recurring Intermittent Headache

A couple of weeks ago we posted about the recently enacted Wisconsin tort reform statute, which, among a bunch of other things, included a “rebuttable” presumption that a product compliant with federal or state standards isn’t defective. Specifically, the statute provides:

Evidence that the product, at the time of sale, complied in material respects with relevant

When you see a reference to West Virginia in this blog, it’s usually followed by biting criticism, regret, and a citation to the latest Judicial Hellhole listing. But not everything out of the Wild and Wonderful state makes us grimace. Heck, we’re huge fans of Chuck Yeager, Jerry West, and Don Knotts. John Denver sang a pretty nice song about the place — sort of. (The Shenandoah River and Blue Ridge Mountains are associated more with Virginia.)

And, mirabile dictu, last week saw a nice West Virginia opinion on state safe harbor law. Arnett v. Mylan, Inc., 2010 U.S. Dist. LEXIS 50460 (S.D. W. Va. May 20, 2010). It’s not exactly preemption, but it’s kind of a kissing cousin to it (we are resisting the usual West Virginia jokes, honest), and it’ll do.

The case was a wrongful death action, claiming plaintiff’s decedent died from wearing a fentanyl pain patch. The decedent was an Oklahoma resident, and the defendants are corporate residents of West Virginia. Because West Virginia uses the lex loci delicti (place of the injury) test, Oklahoma law applied to the case. That in itself is a good ruling. Then the court discusses the Twombly standard. By this point, we’re practically shooting off fireworks, and it’s not just because of the Holiday. (More on that later.)

Count Three of the Complaint asserts a claim under the Oklahoma Consumer Protection Act (OCPA). The OCPA provides a safe harbor for defendants by providing that nothing in the act applies to “[a]ctions or transactions regulated under laws administered by … any … regulatory body or officer acting under statutory authority of this state or the United States.” 15 Okla. Stat. section 754(2). The pain patch was subject to the Food Drug and Cosmetic Act, so the OCPA action is history, right? Yes. Yes it is. But not without a fight.


Continue Reading A Safe Harbor Opinion that is Almost Heaven

Not too long ago, one of our plaintiff-side readers (who probably wishes to remain nameless) sent us an opinion he had won in the Aredia/Zometa mass tort.  We put it on ice for a bit, because being defense lawyers, we weren’t going to publicize a plaintiff win of any sort unless it first

Many states have enacted statutes creating a defense to some or all damages if a drug manufacturer complies with requirements imposed by the FDA.

This is already a big issue; it is about to become a bigger one.

As readers of this blog know, the preemption defense is percolating through the courts. Colacicco is first

We’re big fans of the preemption defense in prescription drug cases.

It’s the FDA’s job to assess the safety and efficacy of new drugs. The FDA can surely do that job more dispassionately than jurors, who are not scientific experts and who are, by definition, judging the safety of a product, after the fact, in

We’ve already posted a number of items about Philip Morris USA v. Williams, 127 S.Ct. 1057 (2007), but like a kids in a candy store, we’re still looking at the case to try to figure out all the things that defendants might be able to do with it. We closed our last post on