The federal Advisory Committee on Rules of Civil Procedure released its latest Civil Rules Agenda Book on November 7, 2017. A copy of it is available here.  A couple of items on the agenda should be of interest to blog readers.

The first topic has to do with proposed changes Fed. R. Civ. P. 30(b)(6), dealing with corporate witness designations (see tab 5 beginning on page 171). The following changes are under consideration:

  • Inclusion of specific reference to Rule 30(b)(6) among the topics for discussion at the Rule 26(f) conference, and in the report to the court under Rule 16.
  • Amending Rule 30(b)(6) to clarify that testimony at a Rule 30(b)(6) deposition is not a judicial admission.
  • Requiring and/or permitting supplementation of Rule 30(b)(6) testimony.
  • Forbidding contention questions in Rule 30(b)(6) depositions.
  • Adding a provision for objections at Rule 30(b)(6) depositions.
  • Amending Rule 30(b)(6) to address the application of limits on the duration and number of depositions.

The second topic has to do with requiring disclosure of third-party litigation funding arrangements (see tab 7B beginning on page 345). The proposed rules change would amend Fed. R. Civ. P. 26(a)(1)(A) to add a new subsection (v) to the items subject to mandatory initial disclosure:

(v) for inspection and copying as under Rule 34, any agreement under which any 5 person, other than an attorney permitted to charge a contingent fee representing a party, has a right to receive compensation that is contingent on, and sourced from, any proceeds of the civil action, by settlement, judgment or otherwise.

The committee notes several areas of “disagreement” that would have to be resolved before a rules change could be adopted. These are:

  • Definition of what types of third-party litigation funding agreements are covered.
  • Whether a new disclosure rule for third-party litigation funding should be parallel to the existing requirement for disclosure of a defendant’s insurance policies.
  • Extent to which third-party litigation funders control or impact the conduct of the litigation at issue.
  • Extent to which third-party litigation funders control or impact settlement of the litigation at issue.
  • Possible impact of disclosure of third-party litigation funding on the parties’ strategic behavior.
  • Potential for conflicts of interests created by third-party litigation funding.
  • Whether disclosure of third-party litigation funding is important to judicial recusal.
  • Whether disclosure of third-party litigation funding would be a threat to attorney/client privilege or work product protection.
  • How proportionality affects disclosure of third-party litigation funding.
  • Whether third-party litigation funding increases frivolous litigation.
  • Possible conflict between disclosure of third-party litigation funding and state regulation of professional responsibility.

It appears uncertain whether the committee will seriously consider this proposal or continue to defer action as it did in 2014.  A possible motivating factor, not present in 2014, is the threat of congressional action to amend the rules.

Readers who are interested in either of these two issues can comment on them here.

We remember how, shortly after the atrocious decision in Johnson & Johnson v. Karl, 647 S.E.2d 899 (W. Va. 2007), rejecting altogether the learned intermediary rule, litigation tourists visiting West Virginia argued that Karl represented that state’s “public policy” and therefore the learned intermediary rule could not apply even to their out-of-state cases under the “public policy” exception to the ordinary rules for sorting out choice of law issues.  This was also back in the halcyon days (for the other side) of essentially unlimited plaintiff forum shopping pre-Bauman, so the specter existed that, if this argument succeeded, plaintiffs from all over the country, or even the world, would flock to West Virginia, and by the mere fact of their litigation tourism, thereby rid themselves of one of our side’s most significant arguments.

A couple of West Virginia federal courts were sufficiently pro-plaintiff to buy that “public policy” choice-of-law analysis.  Woodcock v. Mylan, Inc., 661 F. Supp.2d 602, 609 (S.D.W. Va. 2009) (“[b]ecause West Virginia has rejected the learned-intermediary doctrine on public-policy grounds and applying Alabama law to the marketing defect claim would violate that public policy, West Virginia law applies to that claim”); Vitatoe v. Mylan Pharmaceuticals, Inc., 696 F. Supp.2d 599, 610 (N.D.W. Va. 2010) (“it is impossible to apply the substantive law of Louisiana to [plaintiff’s] inadequate warning claim without violating West Virginia public policy”; following “Woodcock’s helpful public policy analysis”).  For doing this, we trolled Woodcock with eighth place on our 2009 bottom ten decisions list:

This decision invoked “forum public policy” to apply West Virginia’s rejection of the learned intermediary rule to a forum shopping plaintiff from Alabama – a staunch learned intermediary state.  That can’t be right.  Practically all major tort law doctrines are grounded in a court’s sense of “public policy.”  Thus the “forum public policy” exception (previously limited to legislatively set policy) becomes another constitutionally suspect means of applying forum law to cases with no significant ties to the state in question.  Any other forum shopper can presumably make the same argument. We’re sure we haven’t seen the last of this.  We blogged about Woodcock here.

Fortunately, the West Virginia legislature stepped in and did the right thing, making its own declaration of West Virginia public policy in 2011:

Choice of Law in Pharmaceutical Product Liability Actions.

It is public policy of this state that, in determining the law applicable to a product liability claim brought by a nonresident of this state against the manufacturer or distributor of a prescription drug for failure to warn, the duty to warn shall be governed solely by the product liability law of the place of injury (“lex loci delicti”).

W. Va. Code §55-8-16(a).  We cheered that development here.

Of course, the entire Karl learned intermediary brouhaha became moot (or so we thought) several years later when the legislature did themselves one better and directly overruled Karl on the merits.  See W. Va. Code 55-7-30 (restoring the learned intermediary rule).  Even more vigorously, we cheered on that development – after the fact, of course, since we made sure not to breathe a word about this before it was a done deal (we know the other side reads our blog, so there are some things we do keep quiet about).

Given this background, it is with no small degree of schadenfreude that we bring to you M.M. v. Pfizer, Inc., ___ S.E.2d ___, 2017 WL 5077106 (W. Va. Nov. 1, 2017).  M.M. involved the West Virginia sojourn of other litigation tourists, this time from Michigan.  Id. at *2.  Michigan, as anyone involved in the defense of prescription medical product liability litigation knows, has a statute that provides the strongest FDA compliance defense in the country (although Texas is close):

In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved . . . by the [FDA], and the drug and its labeling were in compliance with the [FDA’s] approval at the time the drug left the control of the manufacturer or seller. . . .

Mich. Comp. Laws Ann. §600.2946(5).  As we’ve mentioned before, that statute has produced a “diaspora” of Michigan plaintiffs all running away from the policy judgment made by the legislature of their chosen state of residence.  Those prior plaintiffs didn’t have much luck, and as it turns out, neither did this one.

This time, even if West Virginia courts might have been inclined to cut the Michigan plaintiffs a break, they ran headlong into the West Virginia choice-of-law statute mentioned above.  Even though it was passed to overturn half-baked Karl-based “public policy” determinations, the statute’s literal terms establish West Virginia choice of law “public policy” as to all prescription drug warning cases.  Thus, the M.M. plaintiff – despite having nothing to do with Karl – was entirely out of luck.  “Here, there is no dispute that the injuries alleged by [plaintiffs] all occurred in the State of Michigan.  Thus, [the] failure to warn claim is governed by Michigan law, which forecloses such a claim if the drug was approved by the FDA and the manufacturer complied with the FDA’s labeling requirements.”  2017 WL 5077106, at *3 (also discussing why fraud-on-the-FDA exception to statute doesn’t apply).  Thus, “Michigan law forecloses [plaintiffs’] failure to warn claim.” Id. Interestingly, the court added:

To recognize such a claim under West Virginia law where the same already is foreclosed in the same case by the law of another jurisdiction, however, would contradict the full faith and credit due our sister jurisdictions.

Id. (citations omitted).  “Full faith and credit”?   We confess we haven’t seen that much, indeed ever, before in prescription medical product liability litigation, but anything that keeps a plaintiff from relitigating something they’ve already lost finds favor here.

Unfortunately for these plaintiffs, they were also entirely unable to come up with any defect claim that wasn’t really a statutorily covered warning claim.  “[B]oth the strict liability and negligence claims allege that [defendant] improperly failed to include . . . warnings on its labeling, which, again, constitute allegations that [defendant] failed to warn.”  Id. at *4.  Even if West Virginia law could apply, the choice-of-law statute meant that West Virginia law kicked things back to Michigan, and was “foreclosed thereby.”  Id.  Both their strict liability and negligence claims, although making boilerplate allegations, were “merely a restatement of [plaintiffs’] failure to warn claim,” id. (strict liability), or “merely a reiteration of [plaintiffs’] failure to warn claim.”  Id. at *5 (negligence).  Any way one looked at the case, plaintiffs alleged only a failure to warn, and failure to warn claims had to be determined by Michigan law, where plaintiffs lost.

[B]ecause [plaintiffs’] failure to warn claim is governed by Michigan law, and the governing Michigan statutes provide that a manufacturer cannot be held liable where it has complied with the FDA reporting, disclosure, and labeling requirements, there exists no duty that could have been breached so as to establish a claim for negligence.

Id. at *5.

Now that BMS has pulled the welcome mat away from litigation tourists, we don’t expect much more of a Michigan diaspora, but even if there were, the West Virginia choice-of-law statute, enacted for an entirely different purpose, will preclude any of them from relying on more favorable West Virginia law.  See Id. at *3 n.2 (noting that §55-8-16(a) has since been expanded so that it applies to “all liability claims at issue,” not just warnings).

For the second time in three years the Pennsylvania legislature has proven itself entirely unable to carry out its most basic function, which is to pass a budget – any budget – which is balanced and otherwise meets constitutional requirements.  Instead, it seems bent on distracting the public from its abject failures with empty gestures.

Thus, we saw in Law 360 the other day that the legislature has passed, and the governor has agreed to sign, “right to try” legislation.  As we’ve discussed before, right to try legislation purports to make it easier for terminally ill patients to obtain access to drugs (and other FDA-regulated products) that have not completed the FDA’s long and arduous approval process.  In fact, we have seen no evidence that such legislation has ever actually helped anyone.  State right to try legislation has been ineffective chiefly for three reasons:  (1) it is federally preempted by the FDA’s compassionate use program, (2) manufacturers are unlikely to opt into these purely voluntary programs because any adverse events involving what would be a very sick patient population would have to be reported to the FDA and thus could jeopardize eventual approval, and (3) the legislation does not adequately protect manufacturers from potential liability for allowing the use of unapproved drugs.  Why do we care?  Because we worry about terminally ill patients suing manufacturers to force them to provide investigational drugs, which has been unsuccessfully tried in the past, and might be tried again in the future.

Obviously, no state legislation can do anything about problems #1 or 2, because those are matters governed by federal law that would require a federal statute.  As for problem #3, states have immunized manufacturers from state-law liability to a greater or lesser extent, so what about Pennsylvania?

Here’s a link to the text (as amended) of the current bill, HB45.

While there’s a section devoted to “health care provider immunity” (§5(a)), the potential liability of the entities that actually manufacture the investigational drugs (and other products) in question is only addressed in the section (§6) involving “construction” of the statute. That section provides – with unnecessary verbosity removed for clarity:

Nothing in this act may be construed as creating a private cause of action against a manufacturer of an investigational drug, biological product or medical device . . . for any injury suffered by the eligible patient resulting from the investigational drug, biological product or medical device, as long as the manufacturer . . . acted in accordance with this act, except when the injury results from a failure to exercise reasonable care.

(Emphasis added).

Pathetic. Probably worse than nothing. This section says zilch about liability under existing common-law theories – only about “creating” a new “private cause of action.”  Nor does it even preclude a new, private statutory cause of action.  To the contrary, it allows one, only it must be based on negligence (“failure to exercise reasonable care”).  As we’ve pointed out before, negligence is already the existing basis for Pennsylvania product liability for prescription medical products. See, e.g., Hahn v. Richter, 673 A.2d 888, 889 (Pa. 1996) (another case Bexis worked on way back when).  Thus, the Pennsylvania Right To Try legislation provides no additional protection to participating manufacturers at all – even those who complied with the statute – instead it appears to allow an additional, redundant negligence-based private statutory cause of action.

That being the case, there is no incentive whatsoever for any FDA regulated manufacturer to participate in the putative Pennsylvania Right To Try program, and every reason for them to refrain from doing so.  Rather, it’s an empty gesture – intended to distract the public from the legislature’s inability to perform its most basic constitutional duties.

We’ve generally been skeptical of state “Right To Try” statutes, for several reasons.  First, to the extent that they try to circumvent the FDCA, they’re likely to be preempted.  Second, drugmakers aren’t likely to distribute experimental drugs due to liability concerns, and these statutes don’t go far enough in removing that threat.  Third, such statutes interfere with drug development because they involve the inclusion of people who don’t meet study criteria – often because they are too sick – which is likely to increase the number of adverse results, all of which must be reported to FDA.

Apparently the number of states with Right To Try statutes is up to 37 – but we have yet to learn of a single individual that has successfully utilized any of them.  For the reasons we’ve stated before, we’re not surprised.

But earlier this month, the United States Senate just passed (apparently by voice ) a reworked version of the “Trickett Wendler Right to Try Act” (S. 4788) that we discussed in our prior post.  A federal act would, of course, obviate the preemption problem, or at least replace it with issues of reconciling two federal statutes – which would be a somewhat less daunting a challenge.

Because of that senate action, we’re taking another look at the proposed legislation, a link to which is here.  First, it applies to anyone “with a life-threatening disease or condition” “who has exhausted approved treatment options and is unable to participate in a clinical trial.”  §561B(a)(1)(A-B).  Eligibility must be “certified” by a treating physician who “will not be compensated directly by the manufacturer for so certifying.”  Id. §561B(a)(1)(B).

The “investigational drugs” that the legislation would make available must have completed a preliminary “Phase 1 clinical trial” and must be under active “investigation in a clinical trial that is intended to form the primary basis of a claim of effectiveness in support of approval or licensure.” Id. §561B(a)(1)(C).  Essentially S.4789 seeks to open up to terminal patients access to any unapproved drugs under current investigation, provided they have passed the relatively basic threshold Phase I determinations that they aren’t acutely toxic to humans and might have some plausible benefit.  Phase I investigations:

are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.  During Phase 1, sufficient information about the drug’s pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies.

21 C.F.R. §312.21(a).  Phase 1 studies are small, with between “20 to 80” study participants. Id.

Getting down to litigation-related brass tacks, S.4789 contains a subsection, §561B(something) (b) – we’re frankly not sure of the numbering – entitled “no liability,” that would provide as follows:

(1) ALLEGED ACTS OR OMISSIONS.—With respect to any alleged act or omission with respect to an eligible investigational drug provided to an eligible patient pursuant to section 561B of the Federal Food, Drug, and Cosmetic Act and in compliance with such section, no liability in a cause of action shall lie against—

(A) a sponsor or manufacturer; or

(B) a prescriber, dispenser, or other individual entity (other than a sponsor or manufacturer),

unless the relevant conduct constitutes reckless or willful misconduct, gross negligence, or an intentional tort under any applicable State law.

(2) DETERMINATION NOT TO PROVIDE DRUG.—No liability shall lie against a sponsor manufacturer, prescriber, dispenser or other individual entity for its determination not to provide access to an eligible investigational drug under section 561B of the Federal Food, Drug, and Cosmetic Act.

(3) LIMITATION.—Except as set forth in paragraphs (1) and (2), nothing in this section shall be construed to modify or otherwise affect the right of any person to bring a private action under any State or Federal product liability, tort, consumer protection, or warranty law.

Meh. We’re not impressed.

We consider this language a significant step backwards from the non-liability language of the 2016 version (S.2912) of this legislation that we reviewed here.  That language would have provided that compliance with the act allowed “no liability” “[n]otwithstanding any other provision of law.”  The current language of S.4789 would allow liability – despite “compliance” – as long as a plaintiff could allege “reckless or willful misconduct, gross negligence, or an intentional tort.”  That’s not much protection at all, given how readily the other side throws around such allegations, and how infrequently judges throw them out.  In subsection 1, “Reckless/willful” is a standard for punitive damages, which routinely survive dismissal in MDLs and other actions around the country.  “Gross negligence” is a standard even less than that – merely an aggravated form of negligence that doesn’t require any finding of intent at all.  Intentional torts include fraud, which is currently included in just about any product liability complaint.  Battery, which encompasses informed consent in many states, is also an intentional tort.

In short, the heading “no liability” is itself misleading.  Manufacturers complying with S.4789 would be risking plenty of potential liability in today’s litigation-addicted society.  Underscoring the lack of protection that this section provides to participating parties, subsection 3 further specifies that, outside of subsections 1 and 2, no protection at all from civil liability is created by this bill.

Subsection 2 is a lot more absolute: “No liability” lies against anybody for a “determination not to provide access.”  In light of the wholly inadequate immunity language in Part 1 of the “no liability” section of S.4789, it becomes difficult to recommend to a nervous client anything other than the conduct that would bring the absolute non-liability of subsection 2 into play.  Manufacturers stand to gain nothing by participating in this postulated federal Right To Try program – it’s not even clear if they can charge anybody for the cost of the investigational drugs in question – so don’t expect them to them to gravitate to something with the potential to open up new liability for the provision of untried, incompletely tested, investigational drugs.  The Swiss-cheese liability shield of S.4789, by itself, is an invitation to failure.

The legislation’s approach to the reporting of adverse events to the FDA is better, but nevertheless still comes with a significant caveat:

Notwithstanding any other provision of . . . Federal law, the Secretary may not use a clinical outcome associated with the use of an eligible investigational drug pursuant to this section to delay or adversely affect the review or approval of such drug . . . unless—

(A) the Secretary makes a determination, in accordance with paragraph (2), that use of such clinical outcome is critical to determining the safety of the eligible investigational drug; or

(B) the sponsor requests use of such outcomes.

§561B(c)(1).

Think that the “unless” won’t happen?  We’re hardly sanguine.  Remember, the FDA was once run by the likes of current-plaintiff-expert David Kessler.  Consider the gyrations that the FDA has gone through, first to create and for the last couple of decades to justify, its ban on truthful speech regarding off-label uses.  If there has ever been an agency more likely than the FDA to use its discretionary authority to “hide elephants in mouseholes,” Gonzales v. Oregon, 546 U.S. 243, 267 (2006) (citing, inter alia, FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 160 (2000)), we haven’t encountered it.  The bill contains no definition of “critical”; its only limit on the “unless” exception is that be in writing and made “part of the administrative record” by the FDA commissioner.  §561B(c)(2).

All in all, we are disappointed with the current version of the federal Right To Try statute.  For all the aspersions that the other side likes to heap on this Congress as being “pro-business,” this version of Trickett Wendler is less pro-business, and more plaintiff friendly, than the 2016 version that was written by a Senate controlled by Democrats.  If passed, we doubt that it would be any more effective than the current hodge-podge of state Right To Try statutes in saving the lives of terminally ill patients.

 

One of the issues that the federal Civil Rules Committee’s discovery subcommittee considered, but that eventually fell by the wayside, on the way to the 2015 discovery rules amendments, were proposals to convert to a “requestor pays” discovery system.  That would be a very significant change, and one of the criticisms that the other side leveled at such a system was that only rich people (or at least only rich plaintiff lawyers) could afford to bring suit, given the prospect of having to pay for expensive discovery that current system now gives plaintiffs for free.

Well, not for free.  Nothing is free.  The current “producer pays” discovery system gives plaintiffs a windfall by allowing them to demand production of millions of dollars’ worth of documents – and as importantly, electronically stored information (“ESI”) − and to impose those costs almost entirely on defendants.  As any economist will tell you, any system that provides access to something for free or at greatly below-market cost, be it health care, “dumped” imports, or discovery, creates greater demand for whatever the below-cost item is than would exist otherwise.

It’s worse in the legal system, because the other side’s heightened demand for “free” discovery has the concomitant effect of increasing the nuisance (that is to say, settlement) value of all litigation in which such demands are made – since one’s opponent is stuck with the bill.

All our side got out of the 2015 rules amendments cycle on requestor pays is a provision more clearly recognizing the authority of courts to shift discovery requests.  See Fed. R. Civ. P. 26(c)(1)(B).  As we’ve mentioned, a couple of courts have done this during prescription drug/device MDL litigation.  See In re Bard IVC Filters Products Liability Litigation, 317 F.R.D. 562 (D. Ariz. 2016); In re Benicar (Olmesartan) Products Liability Litigation, 2016 WL 5817262 (D.N.J. Oct. 4, 2016).  Both of those cases involved what the courts viewed as excessive and unnecessary MDL discovery targeted at the defendants’ overseas activities.

Now we’ve found a third case – it took a little longer because it didn’t involve prescription medical products – that also invoked the new cost-shifting provisions in a very familiar (and frustrating) situation.  McClurg v. Mallinckrodt, Inc., 2016 WL 7178745 (E.D. Mo. Dec. 9, 2016), wasn’t an MDL, but it could have been, except for a limited geographic scope.  Many hundreds of plaintiffs were all seeking recovery for alleged radiation-induced injuries from the same two defendants.

A situation depressingly familiar to any defense counsel in mass tort litigation developed.  Although plaintiffs are nominally responsible under the rules for collecting (and paying for the collection of) their own medical and related records in response to discovery requests, they botched the job so badly that the defendants – in whose interests it was to have these records – had to step in and do it themselves on their own dime.  Plaintiffs did produce “a list of known health care providers and a signed authorization for the release of medical records.”  Id. at *1.  “Because Plaintiffs did not timely and fully produce all of their records, Defendants contracted with a third-party vendor . . . to collect records directly from Plaintiffs’ health care providers and employers.”  Id.  Also, “the parties in this matter could not agree to a reasonable scope of record collection and allocation of costs.”  Id. at *4.

So things stood until bellwether plaintiffs were selected (interestingly, by random selection, id. at *2).  All of a sudden the plaintiffs became very interested in the additional records that the defendants had been collecting at their own expense.  So they served discovery requests seeking those records – only for the bellwether plaintiffs – for free.  Id. (“Plaintiffs served document requests seeking ‘all documents and records’ that Defendants had collected regarding each of the 16 Bellwether Plaintiffs”).  Somewhat ironically, they also claimed that the defendants had engaged in excessive records gathering, and therefore also demanded access to the defendant’s records database (also set up at defendants’ sole cost) so they could select which records they wanted.  Id. (“Plaintiffs assert that they, too, wish to access [defendants’] secure portal free of charge, in order to decide which records they want”).

The two McClurg defendants’ response was “hell, no; not without you sharing the cost equally – that is shouldering one-third of the expense along with the defendants each sharing a third.  Id. (subject to a credit for whatever records plaintiffs had actually collected and turned over).

The McClurg court shifted costs, not 33% but 18%, to plaintiffs under Rule 26(c)(1)(B).  2016 WL 7178745, at *3.  Cost-shifting was necessary so that the plaintiffs did not become free riders:

The Court finds . . . that good cause exists to order some amount of cost-sharing before Plaintiffs may obtain the records collected by Defendants here.  Plaintiffs would ordinarily have been, and pursuant to the Court’s order were, responsible for gathering and producing their own records.  But while Plaintiffs appear to have produced some records as new complaints were filed, they did not do so in a complete and timely manner.  Indeed, Plaintiffs apparently produced records for a few of the Bellwether Plaintiffs just one or two days before their scheduled depositions.

Id.  That “Plaintiffs [were] seek[ing] access to the portal establish and maintained at Defendants’ expense” further justified a cost allocation order.  Id.

Although it was “unfortunate” that the parties never sought court intervention after failing to reach a records production protocol, id. at *4, giving plaintiffs free access to records collected and maintained at the defendants’ expense was unfair.  Id. (“it would be unfair to allow Plaintiffs to gain the benefit of Defendants’ early record collection and creation of the portal, which helped move the case forward, without contributing a fair share of the overall costs of such collection”).  Crediting plaintiffs’ complaints about excessive collection, McClurg reduced the percentage to 18%.  Id. (eliminating records collected concerning plaintiffs that the defendants knew could not be in the bellwether pool).  Plaintiffs also received a credit for the comparatively small amount of timely produced records they had collected.  Id.

Since the same failure by plaintiffs to collect their own records competently is endemic to prescription medical product MDLs, the cost-shifting in McClurg is of significant interest to us.

In fact, the results in all three of these cases – Bard IVC, Benicar, and McClurg – are also of interest to us because they provide pointers to where the requestor pays debate might reasonably go.  We certainly don’t agree with the other side’s largely bogus argument that across-the-board requestor pays discovery might shut the courthouse doors on the “poor” plaintiffs in the litigation-funded, advertising-driven mass tort industry.  In such litigation, there “does not appear to be a significant financial disparity in the parties’ ability to finance these putative litigations.  Thus, what this Court and other courts similarly situated are faced with is ‘Goliath versus Goliath.’”  Arch v. American Tobacco Co., 175 F.R.D. 469, 496 (E.D. Pa. 1997).

However, since the federal rules are supposed to be transubstantive, we will accept for the sake of argument that some deserving plaintiffs in some types of litigation might be excluded by a blanket requestor pays regime.  As an alternative, we think that the rules should include a presumption that the requestor pays for certain types of unduly burdensome, or otherwise unfair, discovery.  While such discovery might nonetheless be “proportionate,” were it to uncover something significant, these types of discovery are expensive and not particularly likely to produce evidence usable at trial.

Here are some examples of discovery that we have encountered that we think deserve to be presumptively discoverable only at the requestor’s expense – there are undoubtedly more:

  • Discovery into a defendant’s overseas activities, particularly if the documents are not in English (Bard IVC and Benicar both involved this kind of discovery);
  • Discovery into information independently gathered by the defendant for purposes of the litigation, excepting witness statements, and other items specified by the rules as peculiarly relevant (that’s McClurg);
  • Discovery into products manufactured by defendants other than those used by plaintiffs;
  • Discovery into product risks other than those suffered by plaintiffs;
  • Discovery into information in the possession of third parties, including government agencies;
  • Discovery into time periods where recovery is barred by relevant statutes of limitations;
  • Discovery into post-litigation information, after the alleged conduct has ceased;
  • Subjects of Rule 30(b)(6) depositions where the entity faced with deposition has no available percipient witnesses, and any witness would only have reviewed the same documents available to the deposing party;
  • ESI discovery into information located on inactive legacy/obsolete computer systems; and
  • Other similarly burdensome discovery, not of a type likely to produce significant evidentiary benefit, as determined by research commissioned by the Federal Judicial Center.

None of this kind of information is ordinarily essential to the hypothetical impecunious plaintiffs who would otherwise be shut out of court by having to pay for what are almost always expensive wild goose chases.

And if one of these categories turns out to be of particular importance in a given lawsuit, the requestor pays directive is only presumptive.  The party requesting the discovery would be able to go to the judge – either before or after the discovery takes place − and explain why a category of discovery, presumptively disfavored under the new regime, should be exempted from the requestor pays rule on the facts of the case in question.  Likewise, if the requestor is able to overcome the presumption beforehand, and the supposedly important discovery turns out to be a wild goose chase anyway, then the producer should be entitled to file a motion to shift those costs back to the requestor.

Implementing across-the-board requestor pays is a long shot right now, and such a dramatic change in the system could well have unintended and unforeseeable litigation consequences.  We think our proposal is not only a way to discourage types of discovery that are peculiarly prone to abuse, but might also be a way of trying out requestor pays on a smaller scale to see whether it is indeed a desirable change to the system generally.

If anybody out there is interested in this idea, have at it. Unlike discovery, our blogging is free to all readers.

Regular blog readers may recall that, every year, we eagerly await a Monday and Tuesday right around February 14th.  This has nothing to do with Valentine’s Day (though we like a dozen roses and a box of chocolates as much as the next person.)  No, at this time every year (for the past eighteen or so) we cross our fingers that there is no blizzard, beg everyone in our work life to cover any emergencies, and head to New York for the Westminster Kennel Club Dog Show.  This year was the 141st annual show, and, as always, it was a mecca for all things dog.  As we ate breakfast in our hotel, we were visited by Mobius, a red Doberman so tall he had to lean down to attempt to taste our complimentary make-it-ourselves waffle.  To board the shuttle from the Hotel Pennsylvania (worthy of its own post) to Piers 92 and 94 for the daytime breed judging, we had to step over “Sky,” a 140-pound Greater Swiss Mountain Dog sprawled in the aisle of the bus, calmly oblivious to accidental bumps and kicks and happily kissing anyone who asked.  We live for this stuff, even if our chosen favorite almost never wins.

For the atmosphere is rarified. A few years ago, the show stopped being “champions only” and admitted “class dogs” – dogs still working their way through point-earning breed classes to achieve their championships – for the first time.  But, save for the infrequent upset, the group competition (the televised portion, in which the single winner of each breed competes against the winners from the other breeds in its “group” – sporting, herding, toy, etc.) is dominated by the very top-winning show dogs in the country.  Last year, we fell in love with a gorgeous German Shepherd Dog named Rumor.  She was a heavy favorite to win it all (“Best in Show”), but was upset by C.J. the German Shorthaired Pointer and settled for Reserve Best – second place.  And she retired, to raise beautiful puppies and live the life of a cherished house pet.

But, alas, said puppies did not get made on the first attempt. And, come January, Rumor’s owner/handler decided to give her one more shot at the big one.  So she “came back out,” showed at ten shows in January, and took one more run at the Garden.  And, this time, after upsetting the favorite, Preston the Puli, to take the Herding Group, she won it all.  It was very, very cool to witness.  And we already can’t wait ‘til next year.

And there was a blog-worthy lesson to be gleaned from it all (at least if you stretch a little): if you haven’t achieved everything you want, think about taking another shot.  And H.R. 985, a bill that passed the House Judiciary Committee this week, would pick up where CAFA left off (and then some) to correct still-rampant abuse of the system by class action and MDL plaintiff lawyers, to the detriment of our clients, the judicial system as a whole, and all too often, to the plaintiffs the lawyers ostensibly represent.

Under “Purposes,” the bill states: “The purposes of this act are to – (1) assure fair and prompt recoveries for class members and multidistrict litigation plaintiffs with legitimate claims; (2) diminish abuses in class action and mass tort litigation that are undermining the integrity of the U.S. legal system; and (3) restore the intent of the framers of the United States Constitution by ensuring Federal court consideration of interstate controversies of national importance consistent with diversity jurisdiction principles.”  Worthy goals all, if a trifle ambitious. The bill’s key points read like a set of nesting boxes – just when you think you’ve opened the last, there is another present inside.  Here are some highlights:

Class Actions

  • Injury allegations: this provision requires a court to deny certification unless “the party seeking to maintain such a class action affirmatively demonstrates that each proposed class member suffered the same type and scope of injury as the named class representative.” This is ascertainability something for which we’ve advocated, and also something that our side tried unsuccessfully to get fixed through the Federal Rules Committee. Thus, the judiciary had its chance to fix this. Nothing happened, so now Congress is poised to step in. About time.
  • Conflicts of interest: this provision requires class counsel to state, in the body of the complaint, “whether any proposed class representative or named plaintiff in the complaint is a relative of, is a present or former employee of, is a present or former client of (other than with respect to the class action) or has any contractual relationship with . . . class counsel” and shall “describe the circumstances under which each class representative or named plaintiff agreed to be included in the complaint and shall identify any other class action in which any proposed class representative or named plaintiff has a similar role.”
  • Attorneys’ fees: “[N]o attorneys’ fees may be . . . paid . . . until the distribution of any monetary recovery to class members has been completed,” and “[u]nless otherwise specified by Federal statute, . . . the portion of any attorneys’ fee award to class counsel . . . shall be limited to a reasonable percentage of any payments directly distributed to and received by class members [and in] no event shall the attorneys’ fee award exceed the total amount of money distributed to and received by all class members.” We particularly like this because it would effectively put an end to cy pres, against which we’ve railed for years. By limiting the denominator for fee awards to “payments directly distributed to and received by class members” it prevents cy pres sums from being used to inflate fee awards.

There are other provisions, requiring stringent accounting provisions for settlement funds forbidding certification of issue classes unless all relevant Rule 23 prerequisites are satisfied (another thing our side tried first to fix through a change to Rule 23), and most significantly providing for severance of misjoined plaintiffs for purposes of jurisdictional determinations. This legislative elimination of fraudulent misjoinder is a key point, since it addresses the multi-plaintiff complaints we love to hate.

We note that since the “effective date” of this act provides for its application to all “pending” civil actions, cases currently in state court can be removed (or removed again) under the provision negating misjoinder as a means of preventing diversity-based removal to federal court.

Finally, in an issue close to our hearts as we daily encounter plaintiffs unwittingly victimized by so-called “litigation funders,” the bill provides, “In any class action, class counsel shall promptly disclose in writing to the court and all other parties the identity of any person or entity, other than a class member or class counsel of record, who has a contingent right to receive compensation from any settlement, judgment, or other relief obtained in the action.” A sunshine law for third-party funding is something else for which we’ve advocated.

Multidistrict Litigation:

  • Proof of exposure and injury: We were thrilled to see a “Lone Pine”-esque provision build into the MDL portion of the bill. It provides, in pertinent part, “In any coordinated or consolidated pretrial proceedings . . . , counsel for a plaintiff asserting” a claim seeking redress for personal injury [in the MDL] shall make a submission sufficient to demonstrate that there is evidentiary support (including but not limited to medical records) for the factual contentions in the plaintiff’s complaint regarding the alleged injury, the exposure to the risk that allegedly caused the injury, and the alleged cause of the injury . . . within 45 days after the civil action is transferred to or directly filed in the proceedings. That deadline shall not be extended. Within 30 days after the submission deadline, the judge . . . shall [determine] whether the submission is sufficient and shall dismiss the action without prejudice if the submission is found to be insufficient.” Thirty days later, in the continued absence of a satisfactory submission, the action is to be dismissed with prejudice. Not long ago, we advocated for amending the MDL statute to require early factual disclosure, with dismissal as the sanction for not disclosing enough to satisfy Rule 8. This is the functional equivalent.
  • Trial Prohibition (“waiving Lexecon”): MDL judges “may not conduct any trial in any civil action transferred to or directly filed in the proceedings unless all parties to the civil action consent to trail of the specific case sought to be tried.” This provision would remove the threat of MDL trials as a tool to force defendants to settle. It is something else for which we have advocated.
  • Ensuring Proper Recovery for Plaintiffs: MDL plaintiffs “shall receive not less than 80 percent of any monetary recovery obtained in that action by settlement, judgment or otherwise.”

While most of the press coverage seems to focus on class actions, to us the removal and MDL provisions are at least as important. The vast bulk of our professional life is spent in the mass tort space – mostly MDLs these days, with the occasional class action thrown in. We have become accustomed (but never inured) to plaintiffs without injuries herded by counsel who are their friends or bosses into mass actions in which they don’t belong. On the other end of the spectrum, we encounter severely injured plaintiffs who will recover next to nothing because lawyers and litigation funders own most or all of the plaintiffs’ stakes in the inevitable settlements. And, at every turn, we sit across the table from tanned and affluent plaintiff attorneys who are the only ones apparently immune to the vagaries of the system and who are the sole beneficiaries of its inequities. H.R. 985, as drafted, attempts to address many of these issues. We do have questions. Who defines “the same type and scope of injury,” for example? And we have doubts: can a bill possibly survive the powerful plaintiff attorney lobby when it attempts to resurrect the integrity of mass litigation by hitting those attorneys squarely in their pocketbooks? But we heartily and excitedly support this bill, and we know that some of its provisions are way, way better than none. We will keep you posted.

We’ve addressed many times Texas Civil Practice & Remedies Code §82.007, a tort reform statute that, essentially, creates a presumption in drugs cases that a drug’s warning is adequate if the FDA approved it. See §82.007(a)(1). The statute gives plaintiffs with five ways to rebut that presumption, one of which is to show that the defendant withheld information from, or misrepresented information to, the FDA. §82.007(b)(1). That means of rebuttal, however, was held to be preempted by the Fifth Circuit under Buckman because it requires a plaintiff to prove fraud on the FDA. Lofton v. McNeil Consumer & Specialty Pharma., 672 F.3d 372 (5th Cir. 2012).

We recently uncovered a case in which a plaintiff actually tried to expand the Fifth Circuit’s ruling as a way around §82.007’s presumption of warning adequacy. See T.R.M. v. GlaxoSmithKline LLC, 2015 U.S. Dist. LEXIS 183272, (S.D. Tex. Aug. 21, 2015). In particular, the plaintiff argued that, if Buckman preemption applies at all, it must invalidate all of §82.007, not just its fraud-on-the-FDA based rebuttal. In short, even though the statute created a presumption of adequacy and five ways to rebut it, the plaintiff asked the court to scrap the entire presumption regime because one means of rebuttal was preempted.

Uh, no.

Rules of statutory construction require courts to give effect to as much of a statute as possible while maintaining its original purpose, severing only as little as necessary. Preempting only the fraud-on-the-FDA rebuttal provision of §82.007 accomplishes that. Plaintiffs still have the potential options of four other means of rebuttal and, in fact, might even be able to use the fraud-on-the-FDA rebuttal if the FDA itself made such a finding.

Continue Reading Texas Federal Court Rejects Attempt to Misapply Buckman to Invalidate Statutory Rebuttable Presumption of Warning Adequacy

It’s hard to believe that, with over half of all cases pending in the federal courts now docketed in multi-district litigations (“MDLs”), the statutory basis for all this litigation is but one section of the United States Code:

(a) When civil actions involving one or more common questions of fact are pending in different districts, such actions may be transferred to any district for coordinated or consolidated pretrial proceedings. Such transfers shall be made by the judicial panel on multidistrict litigation authorized by this section upon its determination that transfers for such proceedings will be for the convenience of parties and witnesses and will promote the just and efficient conduct of such actions.  Each action so transferred shall be remanded by the panel at or before the conclusion of such pretrial proceedings to the district from which it was transferred unless it shall have been previously terminated:  Provided, however, That the panel may separate any claim, cross-claim, counter-claim, or third-party claim and remand any of such claims before the remainder of the action is remanded.

(b) Such coordinated or consolidated pretrial proceedings shall be conducted by a judge or judges to whom such actions are assigned by the judicial panel on multidistrict litigation. For this purpose, upon request of the panel, a circuit judge or a district judge may be designated and assigned temporarily for service in the transferee district  . . .  The judge or judges to whom such actions are assigned, the members of the judicial panel on multidistrict litigation, and other circuit and district judges designated when needed by the panel may exercise the powers of a district judge in any district for the purpose of conducting pretrial depositions in such coordinated or consolidated pretrial proceedings.

(c) Proceedings for the transfer of an action under this section may be initiated by −

(i) the judicial panel on multidistrict litigation upon its own initiative, or

(ii) motion filed with the panel by a party in any action in which transfer for coordinated or consolidated pretrial proceedings under this section may be appropriate. A copy of such motion shall be filed in the district court in which the moving party’s action is pending.

[Procedures for the JPML deliberations on creating MDLs, notice, and filing of transfer orders]

(d) [Composition of JPML]

(e) [Restrictions on appealability of JPML orders]

(f) The panel may prescribe rules for the conduct of its business not inconsistent with Acts of Congress and the Federal Rules of Civil Procedure.

(g) [Peculiar to antitrust]

(h) [Peculiar to antitrust]

28 U.S.C.A. §1407.

That’s it. There are as many subsections of the MDL statute (2) peculiar to antitrust as there are governing the substance of what MDLs are intended to accomplish.

Continue Reading The Multi-District Litigation Statute Needs Rewriting

We blogged about possibly interesting nuggets in the 21st Century Cures Act (“21CCA”) back in February, 2015 – when it was only 400 pages long.  In true congressional fashion, it’s now twice as long and loaded up with enough goodies (mostly of the $$$ variety) that it just passed the House of Representatives by a 392 to 26 margin.  It thus seems poised to become law.  Given the prospects for imminent passage, we decided to revisit this monster and see if there’s anything more of interest to product liability defendants.  We aren’t interested in the spending-related aspects of this bill, which are what’s really greasing its skids.

So here goes.

Preemption

The first thing we wanted to see is if there is any preemption of civil lawsuits, so we searched the text of the bill for the word “state.” More than 100 matches.

Continue Reading Anything Worthwhile For Product Liability Defendants In The 21st Century Cures Act?

Even after having read it through twice, we find the result in Barron v. Abbott Laboratories, Inc., ___ S.W.3d ___, 2016 WL 6596091 (Mo. App. Nov. 8, 2016), hard to fathom, and even harder to stomach.  For several years after starting the blog, one of our aphorisms was “nothing good ever comes out of Missouri.”  Then legal developments caused us to retire that slogan.  Now we may have to bring it back – maybe.

Barron affirmed a $48 million verdict – concerning birth defects – against the maker of a drug that had a black box warning – about birth defects

[THE DRUG] CAN PRODUCE TERATOGENIC EFFECTS SUCH AS NEURAL TUBE DEFECTS (E.G., SPINA BIFIDA). ACCORDINGLY, THE USE OF [THE DRUG] IN WOMEN OF CHILDBEARING POTENTIAL REQUIRES THAT THE BENEFITS OF ITS USE BE WEIGHED AGAINST THE RISK OF INJURY TO THE FETUS.

Barron, 2016 WL 6596091, at *1.

Astonishingly, this boxed warning, which only the FDA can mandate, was a sufficiently inadequate advisory that the drug could cause birth defects that a St. Louis (City) jury awarded $23 million in punitive damages to the plaintiff, who was from Minnesota.

And those two places – St. Louis City and Minnesota – are as much the problem as the “Show-Me-The-Money State” verdict itself. Barron is a poster child for venue and joinder run amok.  First, the underlying action was filed by 24 plaintiffs from all over the country (13 different states), with nothing in common save claiming somewhat similar injuries to different persons from the same drug.  Id. at *4.  Of course, a couple of plaintiffs were from Missouri (and another presumably from the home state of a defendant), in order to defeat diversity.  Id. at *2.

Continue Reading Awful Missouri Venue/Joinder Ruling Offers Way Out – Take It!