A couple of weeks ago, we reported that, under pressure from the Drug and Device Law Rock Climber, we were headed to New York to see the Broadway production of Orwell’s 1984. Publicity surrounding this spectacle focused on audience members fleeing, fainting, and/or vomiting during the torture scene. Incautiously well-fed (Vietnamese/Thai food from a singularly
The cases we typically write about focus on events after medical products have made their way through the applicable regulatory process and been marketed in the United States. The marketed product is used, people claim to have been injured by it, and they sue the manufacturer under various product liability theories. Often, in the course…
We all know how important a prescriber’s testimony is in a drug or device case. In many jurisdictions, the testimony of the prescriber is a mandatory requirement if a plaintiff is going to meet his/her burden of proof on a failure to warn claim. That’s because under an ordinary burden of proof, warning claims are…
This is our quasi-annual update to our cheat sheet about ediscovery for defendants. Essentially that means using discovery to obtain access to what plaintiffs have said about themselves, and their supposed injuries, on social media. Such material can be critical to defeating a plaintiff’s case. See Zamudio-Soto v. Bayer Healthcare Pharmaceuticals, Inc., 2017 WL…
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…
Charges of discovery abuse get thrown around frequently in product liability litigation. We have not done a scientific survey, but we guess that such charges are levied against the manufacturer defendants more often than against individual plaintiffs. For one thing, seeking burdensome discovery, and then discovery on discovery, has been in the product liability plaintiff…
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.
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.
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.
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?