Today’s post is on a short decision from the Court of Appeals of Florida, but it is important. In drug and device litigation, defendants are almost always required to produce the adverse event reports related to the product at issue based on the argument that they go to notice. Beyond notice we take strong issue with their admissibility. Take a look at our AER cheat sheet.  And with so many courts excluding them from evidence, extensive discovery of adverse events is something defendants should push back on. As part of that push back, defendants should never overlook raising the burden of redacting from any adverse event report any information that identifies either the voluntary reporter (physicians, consumers) or the person who used the drug or device (if not one and the same). If you’ve made that argument, you may have had a court question whether redaction is really necessary. The answer is an unequivocal yes.

The FDA requires manufacturers to maintain the confidentiality of this information.

The names and any information that would identify the voluntary reporter or any other person associated with an adverse event involving a human drug, biologic, or medical device product shall not be disclosed by the Food and Drug Administration or by a manufacturer in possession of such reports in response to a request, demand, or order. Information that would identify the voluntary reporter or persons identified in the report includes, but is not limited to, the name, address, institution, or any other information that would lead to the identities of the reporter or persons identified in a report.

21 C.F.R. §20.63(f) (emphasis added). So, whether plaintiffs request them or the court orders their production, the manufacturer is obligated to redact adverse event reports before producing them. So, from a practical standpoint, time must be built into any schedule to allow for this redaction to take place. Further, if plaintiffs’ adverse event request is overly broad, you might have grounds to ask for cost-shifting or at least cost-sharing. May help to refocus plaintiffs on what they really want/need.

Continue Reading Protecting Foreign Adverse Events

Is the lesson learned by at least one plaintiff’s counsel in the In re Yasmin & Yaz Mktg. Sales Practices & Prod. Liab. Litig. We already know mass tort MDLs are a breeding ground for lax plaintiff-side representation. A handful of plaintiffs’ attorneys lead the charge, while the rest file their cases, and then lie in the weeds waiting for settlement. And in a system designed not to pay much attention to the individual cases, at least until the litigation is significantly advanced, missing due dates in an individual case also doesn’t garner much attention. That is until it does.

Today’s case isn’t about preemption, or expert opinions, or off-label use, or even about pleadings standards. What it is about is an individual plaintiff’s counsel being held accountable for not paying attention to MDL orders and for simply doing nothing. We’re just going to tell this one like it is, because we couldn’t even make up facts this absurd.

The individual case is Dzik v. Bayer Corp., 2017 U.S. App. LEXIS 684 (7th Cir. Jan. 13, 2017). Plaintiff filed her suit alleging that she suffered a blood clot from her use of Yasmin, a birth control pill. Id. at *2. Discovery, however, revealed that plaintiff had not filled a Yasmin prescription for 10 months before her alleged injury. Plaintiff’s counsel suggested that plaintiff had been given samples shortly before her injury. In May 2014, defense counsel requested plaintiff produced additional medical records or even an affidavit from the prescribing doctor to substantiate use at the time of injury. Id. That requested was ignored for 15 months.

During those many months, defendant began settling the pending cases. As for non-settling plaintiffs the court entered an order (sometime in the summer of 2015) splitting them into two groups – those likely to settle and those likely not to. Pursuant to the order, if a plaintiff thought her case was likely to settle with a little more negotiation, plaintiff should so notify defendant and if defendant agreed, the case was stayed for 60-90 days to facilitate settlement. Id. at *3. For all other cases, defendant had to notify plaintiff that her case was in the non-settling group and if plaintiff didn’t timely object to that classification, plaintiff had 120 days to serve a Plaintiff Fact Sheet and certain pharmacy and medical records, and a report from an expert on causation. Id. If a plaintiff failed to comply, defendant could move for dismissal and dismissal with prejudice was automatic for any plaintiff who did not respond to the motion to dismiss within 14 days.

Continue Reading You Can Hide But You Can’t Run

This is the time of year for Best and Worst lists.  Our own lists of the best and worst drug and device law decisions of 2016 will be coming out soon.  Meanwhile, we have no doubt that the worst moments in our own day-to-day practice consist in litigating about litigation.  That is, whether on offense or defense, it is mind-numbing to fight over, not the merits of the case, but whether some party is complying with the rules of civil procedure.

We said “offense or defense,” but who are we kidding?  Discovery in our cases is wildly asymmetrical.  Plaintiffs grudgingly sign health record authorizations, while our clients are forced to disgorge millions of documents, at an expense many times over what most defendants in other civil litigations who have already been found liable (of course, our clients have thus far not been found liable for anything) end up paying in total. Producing electronically stored information (ESI) is virtually impossible to get fully right, but plaintiffs ask for, and all too frequently get, a requirement that corporate defendants furnish certificates of completion.  Such certificates are not required by any rules.  Somehow, overreaching plaintiffs have managed to persuade some courts to take something as silly and unrealistic as the discovery rules and make them even worse.   Pretty soon, court hearings devolve into plaintiff lawyers ruefully marching to the lectern to complain about alleged gaps in discovery and demand sanctions.  Forget about the fact that this litany of carping is on behalf of an inventory of plaintiffs whose mostly meritless claims go gleefully untested until the defendant waves a white flag and submits to a fairy tale otherwise known as a settlement grid.  Apropos of the season, we say humbug.

It is a pleasant surprise when a court calls an end to the discovery gotcha game.  That happened last week in Small v. Amgen, Inc., No. 2:12-cv-476-FtM-PAM-MRM (Dec. 14,  2016).  We have written on the Small case before.  See here, for example.  The issue teed up most recently in the Small case was the plaintiffs’ motion for sanctions under Federal Rule of Civil Procedure 37 for an alleged failure to comply with the court’s omnibus discovery order.  The Small court held that “[f]or all its sound and fury … Plaintiffs’ Motion fails – utterly – to identify any actual violation” of the court’s prior orders.   That magisterial “utterly” conveys a sense of weariness and frustration.  Yes, we know the feeling.

Continue Reading Good Things Come in Small Packages: M.D. Fla. Rejects Plaintiff’s Discovery Gotcha Gamesmanship

Many years ago, we represented a client in a quandary.  (We know, we know: that’s pretty much always the case.)  The product had been sold for many decades, the early history was important in marshalling a defense, and there were no employees around who were percipient witnesses.  What was the solution?  We made an employee an expert on the history of the product.  Voila!  The good part of that approach is that the witness would be free to talk about product issues predating his involvement (or, indeed, his birth).  The bad part was that much of the preparation work with the now-expert might no longer be shielded by the attorney-client privilege.

Federal Rule of Civil Procedure 26(a)(2) addresses that odd creature of the expert witness who was not retained or specially employed to provide expert testimony.  Think of, as in the instance mentioned above, a company employee whose job is mostly not devoted to rendering expert testimony.  Or think of treating physicians.  Rule 26(a)(2)(B) provides that an expert witness must provide an expert report “if the witness is one retained or specially employed to provide expert testimony in the case or one whose duties as the party’s employee regularly involve giving expert testimony.”  By contrast, Rule 26(a)(2)(C) provides that for witnesses who are not required to provide a written report – i.e., those not included in Rule 26(a)(2)(B) – the proffering party need only disclose the subject matter of testimony and “a summary of the facts and opinions to which the witness is expected to testify.”  We all know that treating physicians do not need to provide expert reports.  We couldn’t make them do it.  We probably could make employee/experts do a report, but under Rule 26(a)(2)(B), we don’t need to do that.  But to what extent does the attorney-client privilege shield our prep work with that employee/expert under that rule?

Continue Reading Attorney-Client Privilege Held Not to Apply to Nonreporting Employee/Expert

People supplement a lot of things. You can supplement your diet with a multivitamin. You can supplement your income with a part-time side job. On the DDL Blog, we are always supplementing our scorecards and cheat sheets. Generally speaking, supplement is a pretty common word and has a fairly universally accepted definition. A supplement is an add-on. Something you do to make something more complete. Does the food you eat contain vitamins and minerals? Sure. But that multivitamin adds to it. It’s a boost.

In litigation too, we do a lot of supplementing. In fact, we are required to do so. Federal Rule 26(e) requires a party to supplement its discovery responses if it “learns that in some material respect the disclosure or response is incomplete or incorrect.” This duty to supplement extends to expert reports as well. Fed.R.Civ.P. 26(e)(2). But what does it mean to “supplement” an expert report? And when does supplementing to make a correction or completion go too far?

Plaintiffs got the answer to that question in U.S. ex. rel. Brown v. Celgene Corp., 2016 U.S. Dist. LEXIS 156826 (C.D. Cal. Aug. 23, 2016). Plaintiff-Relators brought a False Claims Act and Medicare Anti-Kickback Statute case against defendant alleging it illegally marketed Thalomid and Revlimid off-label and paid kick-backs to physicians for prescribing off-label. Id. at *6. The court set a deadline for the expert reports and relators timely served a report from their damages expert. Shortly thereafter, however, relators sought leave to supplement that expert report based on late produced Medicare data. Id. at *6-8. Relators wanted to time to analyze the data and supplement the report with that analysis. Relators also represented that while the supplement would be based on new data, the opinions were not expected to differ significantly. Id. at *8. The court granted the leave requested. Defendant was likewise given an opportunity to amend its expert reports in rebuttal and relators’ expert was deposed after his supplemental report was served. Id. at *11.

Continue Reading Plaintiffs Learn Supplementing Isn’t a Second Bite at the Apple

A lot of companies rely on retired and otherwise former employees for information in litigation – including product liability litigation. Particularly where a product (such as a drug that’s now gone generic) has a long history, they are often the best source of knowledge about what happened years ago.  In dealing with ex-employees, however, defendants must keep in mind that, for purposes of the attorney/client privilege, discussions with ex-employees are subject to being treated much differently (and less protectively) than corporate communications with current employees.

The recent case, Newman v. Highland School District No. 203, 381 P.3d 1188 (Wash. 2016), although not involving prescription medical products, or even product liability, is a cautionary tale.  The defendant in Newman was a governmental entity, a school district.  The plaintiff alleged that he suffered a brain injury playing high school football, and that the injury occurred because the plaintiff was allegedly allowed to play in a game the day after suffering a concussion in practice.

The plaintiff in Newman didn’t sue until some three years after the injury. Id. at 1189-90.  By then, most of the coaching staff had turned over, and the individuals with the best knowledge of what had happened were employed elsewhere.  The school district’s litigation counsel contacted the ex-coaches and when they were deposed, claimed to represent them.  Id. at 1190.  Plaintiff challenged that representation as a conflict of interest and “sought discovery concerning communications between [the defendant] and the former coaches.”  Id.  The defendant resisted discovery with a claim of attorney/client privilege, and plaintiff opposed.  The defendant lost, and appealed denial of its motion for a protective order.  Id.

Continue Reading A Reminder To Be Careful With Ex-Employees And Confidential Information

Bexis recently attended the “Emerging Issues in Mass-Tort MDLs Conference” sponsored by Duke Law School (those of us from Philly remember Duke as part of “Black Saturday” back in 1979).  Several panels discussed various issues relating to MDLs including using early, issue-specific fact sheets, which Bexis advocated be considered amended pleadings subject to Rule 8 and TwIqbal, as a winnowing tool against the hordes of meritless plaintiffs that persist for years in MDLs involving prescription medical products.  Another discussion, about Lone Pine orders, produced (among other things) a great deal of disagreement as to what exactly a “Lone Pine order” actually requires.

By the end of it all, Bexis was moved to make a modest proposal. A lot of the problem – both with the use of plaintiff questionnaires/fact sheets and with Lone Pine orders – is definitional.  There is no set standard for either of these supplemental discovery procedures.  What’s really needed is the type of clarity that can only be brought about by an actual rule of civil procedure.  Thus, Bexis proposed (and proposes here) creation of a new Federal Rule of Civil Procedure governing “optional discovery methods” that allow judges to use defined procedures for party questionnaires/fact sheets (not necessarily plaintiffs in all cases) and Lone Pine orders would set standards, as well as several other discovery techniques that we think should be defined and allowed by a formal rule.

The other techniques Bexis would include in a new rule are: (1) authorizations for release and production of medical and other relevant records in the hands of third-parties; (2) informal interviews with treating physicians; (3) predictive coding in ediscovery; and (4) provision of blood or tissue sampling for genetic testing.  The first two are traditional discovery techniques that suffer (like Lone Pine and questionnaires) from wildly divergent standards and could benefit from the uniformity imposed by a rule – as well as a leveling of the plaintiff/defendant playing field.  The latter two are innovative discovery techniques that are driven by technological advances.  Predictive coding (as we discussed in the links above) could both cheapen and sharpen electronic discovery.  Genetic testing, reliant on DNA and other molecular sequencing techniques that have become dramatically cheaper and more accurate over the past decade, will become more and more necessary in toxic exposure cases of all kinds as causation of more and more medical conditions, such as mesothelioma and other cancers, is determined to vary by individualized genetic differences (also discussed in our prior link).

As illustrious as the attendees of the (invitation only) Duke Conference are, that is not the forum for actually amending the Federal Rules of Civil Procedure. That honor goes to Discovery Subcommittee of the Federal Judicial Conference’s Standing Committee on Rules of Practice and Procedure.  Having successfully completed its project on scope and sanctions that resulted in the amendments that became final in December, 2015, that Subcommittee might be looking for something else to do.  Maybe it could see fit to take up some or all of Bexis’ modest proposal.

For the second time within a month, an MDL court has rejected wide-ranging and potentially abusive discovery on the basis that the requests were out of proportion to the needs of the case. This is a welcome development.  We have written multiple times about the 2015 amendments to the Federal Rules of Civil Procedure, including the amendments elevating proportionality to a marquee spot in Rule 26(b) and placing the “reasonably calculated to lead to discovery of admissible evidence” standard on the ashbin of history (at least in federal court).  We have lamented (particularly here) that multiple district courts continue to apply that now-obsolete standard, relying on case authority that predates the amended Rule 26(b) by nearly 30 years.

We particularly appreciated the recent order in the Bard IVC Filter MDL, where the MDL judge also happens to chair the Advisory Committee on the Federal Rules.  That court thus took the opportunity to remind his colleagues about the applicable rules and also to emphasize that discovery requests must be proportional to their burden, even when there are hundreds or thousands of plaintiffs. See In re Bard IVC Filters Products Liability Litigation, ___ F.R.D. ___, 2016 WL 4943393 (D. Ariz. Sept. 16, 2016).

Last week, the district judge in the Benicar MDL demonstrated that he too knows the rules. In that proceeding, the plaintiffs moved to compel the depositions of employees of the defendant drug manufacturer’s European affiliate and to compel production of documents from Europe. See In re Benicar (Olmesartan) Prods. Liab. Litig., No. 15-2606, 2016 U.S. Dist. LEXIS 137839, at **196-97 (D.N.J. October 4, 2016).  The court denied both motions, and before the court explained why, it observed that “it is helpful to summarize the discovery to date.” Id. at *198.

Continue Reading Another Champion for Proportionality in Discovery

We’ve blogged several times over the past couple years about the 2015 amendments to the federal rules as they pertain to discovery, including electronic discovery.  Earlier this year, after the amendments had been in effect for a few months, we complained about how some courts were evading the new rules by citing a Supreme Court case, Oppenheimer Fund, Inc. v. Sanders, 437 U.S. 340, 351 (1978).  Oppenheimer was dependent upon language in the prior Rule 26 − “reasonably calculated to lead to discovery of admissible evidence” − that the 2015 amendments intentionally deleted.  We supported our point with empirical research showing that, of 73 citations to Oppenheimer following the amendments’ effective date, more than 70% of them, 53 cases, cited to the headnote for the obsolete language.

Well, it seems that we aren’t alone in recognizing a pattern of disregard for the 2015 amendments in recent discovery decisions. The MDL judge in In re Bard IVC Filters Products Liability Litigation, 2016 WL 4943393 (D. Ariz. Sept. 16, 2016), pointed out the same kind of ongoing judicial disregard for the rules that we spotted earlier.  IVC Filters held that – yes, even in an MDL – discovery requests must be proportional to their compliance costs.  It just so happens that this judge, Hon. David G. Campbell, is also chair of the Advisory Committee on the Federal Rules.  So he knows of what he speaks.

You’re probably thinking that the discovery request in question in IVC Filters had to be pretty absurd, and you’re right.  Despite not a single overseas plaintiff in the MDL, plaintiffs sought all communications with foreign regulators from foreign affiliated companies of the defendant.  2016 WL 4943393, at *3-4.  Specifically, plaintiffs sought to force the defendant to rummage through electronic communications of affiliates in “Canada, Korea, Australia, India, Singapore, Malaysia, Italy, Ireland, the United Kingdom, Denmark, the Netherlands, Sweden, Norway, Finland, Mexico, Chile, Brazil, and China . . . for the last 13 years.”  Id. at *4.  You can imagine how expensive and time consuming it would be to sort through that many overseas computer systems.  Adding to the expense would be obsolete formats, some over a decade old, in multiple languages.  The objective would be hypothetical communications concerning other countries’ regulatory schemes not at issue in the litigation.  As we’ve discussed before, foreign regulatory actions, as such, are neither relevant nor admissible in American product liability litigation.

That’s where the 2015 rules changes came in. “The new rule defines the scope of permissible discovery as . . . non-privileged matter that is relevant to any party’s claim or defense and proportional to the needs of the case.”  Id. at *1.  The language before the amendments was broader.  “Before the 2015 amendments . . . inadmissible evidence was discoverable if it ‘appears reasonably calculated to lead to the discovery of admissible evidence.’”  Id.  IVC Filters pointed out that deletion of the “reasonably calculated” language specifically intended to curtail discovery that had gotten out of hand:

The former provision for discovery of relevant but inadmissible information that appears “reasonably calculated to lead to the discovery of admissible evidence” is also deleted.  The phrase has been used by some, incorrectly, to define the scope of discovery.  As the Committee Note to the 2000 amendments observed, use of the “reasonably calculated” phrase to define the scope of discovery “might swallow any other limitation on the scope of discovery.”  . . . The “reasonably calculated” phrase has continued to create problems, however, and is removed by these amendments.

Id. at *2 (quoting Advisory Committee Notes for 2015 Amendments, 305 F.R.D. 457, 555 (2015)).

Continue Reading Rules Amendments Mean That Proportionality Limits Even MDL Discovery

There used to be a TV show called “That Was the Week That Was.”  It was a satirical look at the news of the prior week, but perhaps it’s most lasting accomplishment was to launch David Frost’s career.  Without an ounce of satire, however, we have to say that the business week of August 15 through 19, 2016 was a heck of a week for implied preemption utilizing Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  We’ve already blogged about the Ninth Circuit’s decision in DeBons v. Globus Medical, Inc., ___ F. Appx. ___, 2016 WL 4363171 (9th Cir. Aug. 16, 2016), which invoked Buckman preemption to affirm dismissal of a consumer protection class action that was seeking to recover based on allegations that a medical device wasn’t properly “approved” (but rather cleared under §510(k)) by the FDA.

But DeBons was only one part of that week’s Buckman hat trick.

On the same day, the Fifth Circuit got into the act, affirming a preemption-based dismissal of another medical device product liability suit in Estes v. Lanx, Inc., ___ F. Appx. ___, 2016 WL 4375644 (5th Cir. Aug. 16, 2016).  We’ve already blogged about favorable district court results in the Estes case three times.  The Fifth Circuit affirmed all of them.  Estes involved a spinal fixation system anchored with bone screws, some of which broke under the intense pressures of holding the human body upright.  The screws were explanted and replaced, but “neither the hospital nor [defendant]  retained” them. Id. at *1.

Plaintiff first screamed “spoliation” – he lost.  Id. (“we find no basis for disturbing the district court’s finding of no bad faith”).

Continue Reading A Banner Week For Buckman Preemption