Most recently, the Archives of Internal Medicine got a black eye when it published an article, a “critical reappraisal” of a statin trial, here, in which several authors questioned the methodology and motives of a trial that showed that statin therapy prevented major cardiac events – a good thing – when used in people who might not have been conventionally indicated to take statin. In other words, the study suggested that more people could benefit from statin therapy than had previously been thought. So if authors disagree with the clinical trial, its conduct or outcome, all is fair in scientific debate. But the Archives published the challenge without noting that some of its authors belong to a group that questions the wisdom of statins The International Network of Cholesterol Skeptics – and indeed, whether high cholesterol is even something that should be treated. Clearly, these folks represent a very small minority view in the medical profession. So when the Archives prints their article without any disclosure regarding this membership, it belies the claim that the expansive financial disclosures are truly meant to contextualize journal articles rather than to demonize researchers for working with drug and device companies. [hat tip to Pharmalot for its coverage of the issue]

druganddevicelaw.blogspot.com

We praised Weiss, because while we support informal interviews, we support a level playing field even more. Defense counsel are content to live by whatever rules that courts set – as long as the rules are the same for both sides. If they’re not, we’ll live by the rules, but we’ll certainly not be content.

For similar reasons, we’re also reasonably happy with the recent decision in In Re: Ortho Evra Products Liability Litigation, MDL No. 1742, slip op. (N.D. Ohio Jan. 20, 2010). Even though Ortho Evra does it by a wholly different route, it’s a step towardsthe same ultimate outcome as Weiss – a level playing field (or at least close to it) for informal contact with treating physicians.

But the playing field is set up rather differently.

The defendants in Ortho-Evra were concerned about the same sorry litany of prejudicial plaintiff conduct that we’ve already chronicled in our Weisspost. Thus they sought “to prevent an unfair advantage by Plaintiffs lobbying their theories of liability and causation upon the treating physicians during the ex parte contact.” Id. at 1.

Predictably the plaintiffs (or their lawyers, who benefit from being able to threaten and cajole treaters in private) blew their tops and raised a bunch of objections. We won’t go into those because the court rejected them all. Instead, the court let plaintiffs know that “woodshedding or gaining an unfair advantage by ambush when engaged in ex parte contact with treating physicians. . .will not be tolerated. Slip op. at 3.

“Based upon [the court’s] experience with lead counsel in this litigation,” id., the court added some specific guidelines to make sure that treating physicians would not be lobbied or pressured about liability issues:
[The court] allow[s] Plaintiffs’ counsel to have ex parte contact with treating physicians with the following limitations. Specifically, Plaintiffs’ counsel may meet ex parte to discuss the physicians’ records, course of treatment and related matters, but not as to liability issues or theories, product warnings, Defendant research documents or related materials. Violations of this approach, as stated above, will result in sanctions.Slip op. at 3 (emphasis added). We hope that “liability theories” is construed broadly enough to preclude the familiar tactic of threatening to sue treaters for malpractice if they give unfavorable testimony in product liability litigation.

The court cited two cases as precedent. In one of these, In re Nuvaring Products Liability Litigation, 2009 WL 775442, at *2 (E.D. Mo. March 20, 2009), the plaintiffs’ counsel were a bit more reasonable than the crew running Ortho-Evra and agreed that it “would be appropriate” for all informal “interview[s] should be limited to the particular plaintiff’s medical condition at issue in the current litigation.” Id.

A second decision, from New Jersey state court in Gaus v. Novartis Pharmaceuticals Corp., No. MID-L-007014-07-MT, slip op. (N.J. Super. L.D. Oct. 29, 2009) (Zometa-Aredia), forbade both sides from all informal contact with treaters “in the interests of fairness”:

[N]o party – Plaintiffs nor Defendants – shall engage in ex parte contacts with Plaintiffs’ treating physicians or influence the deposition or trial testimony of Plaintiffs’ treating physicians. To hold otherwise would facilitate the potential for either counsel to influence Plaintiffs’ treating physicians. To ensure that all parties have the same right of access to all nonparty fact witnesses, this court shall prohibit the parties from engaging in ex parte contacts with Plaintiffs’ treating physicians.
Gaus,slip op. at 18. Gaus is another way to level the informal interview playing field.

As we said, we like informal interviews and we like a level playing field. That’s why of the various approaches we still prefer Weiss. As a practical matter, we think things work best when both sides can talk to treaters. There is value in such interviews, which is why both sides like to do them. As defense counsel, it lets us know early on if the case is a really bad one that we should advise the client to settle. It can also help zone out treaters that didn’t really have much to do with the condition in question and prevent unnecessary depositions.

As for important treaters, however, informal interviews simply aren’t going to eliminate formal discovery. In mass torts, those doctors have to be deposed, if for no other reason than to preserve their testimony during prolonged litigation. Anybody could get hit by a bus tomorrow, so it’s in neither side’s interest to do nothing between an informal interview and a subpoena for testimony at trial.

If we can’t get Weiss, then we suppose we’d rather have Gaus. A total prohibition of informal interviews is less efficient than allowing them, but it’s still a level playing field. Like we said, we can live with any form of level playing field.

Ortho-Evra, while only our third choice, is definitely better than nothing. Like the court in that case, we’ve had our “experience” – treating physician’s depositions in several mass torts have brought to light all sorts of interesting things, from the aforementioned malpractice threats to invitations for treaters to “consult” with a plaintiff’s expert on the case. Thus, limiting the subject matter of informal plaintiffs’ counsel interviews to the facts of the plaintiff’s medical condition and treatment is a big step in the right direction.

The specific threat of “sanctions” made in the Ortho-Evra order is another important aspect. But to be effective, the sanctions cannot simply be a $500 slap on the wrist. A sanction must remediate the effects of any improper conduct to work properly. So, beyond fines, a court needs to be ready to enforce an order of this sort with preclusions and adverse inferences if violative conduct has exerted undue influence upon a treater’s testimony that cannot otherwise be cured.

So we give three cheers to Weiss, two cheers to Gaus, and one cheer for Ortho-Evra.

Finally, as a service to our readers, we’d like to remind them of the resources available on the blog that concern the informal interview issue.

First, we have our 50-state survey of state law on whether or not defendants can conduct informal interviews with treating physicians, here. Let us know if we’ve missed anything.

Second, we have a detailed discussion of how the filing of a personal injury lawsuit works a waiver of the physician-patient privilege in our Weiss post, here. That post also discusses whether state-law restrictions are applicable in federal court in diversity actions, and contains a collection of cases that discuss why informal interviews are a good idea as a matter of policy.

Third, we have a lengthy post on why HIPAA does not preempt state law concerning informal physician interviews in the litigation context, here. HIPPA contains a litigation exception. This free stuff about HIPAA preemption is especially valuable to attorneys handling smaller cases, since the other side has been known to spring the bogus HIPAA preemption argument in those sorts of cases in hope of sneaking one by unprepared counsel.

druganddevicelaw.blogspot.com