Thursday, May 23, 2013
Latest A-Z Motion In Limine Rulings Are Anything But Boring
We occasionally blog about motion in limine rulings, but not nearly as often as we read this type of decision. Let’s face it, as blogging material (as opposed to their impact on a particular case) decisions on motions in limine can be pretty boring. You can talk about this; you can’t talk about that. In modern prescription medical product mass tort litigation, the plaintiff usually has about fifteen stock motions, whereas the defendant probably has between 35 and 50. Motion in limine decisions are usually a matter of checking off this or that from a long list. We read them – well at least Bexis does, because he has to update the evidentiary chapter for his book – but usually there’s not enough there there for a blogpost
Not so with Hill v Novartis Pharmaceuticals Corp., ___ F. Supp.2d ___, 2013 WL 1953753 (E.D. Cal. May 10, 2013), which decided a number of very interesting issues (including preemption) in the context of motions in limine filed in an Aredia/Zometa case. In fact, Hill is so interesting that West has decided to publish it, a rarity with motion in limine rulings.
Here’s a rundown of the more important rulings.
(1) A batch of emails were excluded. Normally this kind of thing is extremely case specific, and thus not of general interest. These emails, however, were between "members of a panel of physicians and oral surgeons" who were editing a document about the drug. Hill, 2013 WL 1953753, at *1. These doctors were on an outside "advisory panel" to the defendant manufacturer, but none were employees or otherwise formally affiliated with the defendant. The emails were excluded as hearsay. Id. at *1. The plaintiffs argued that doctors on a "advisory panel" were "agents" of the company, and thus the emails were admissions by a "party opponent." That’s an important issue, since many drug and device company have outside physician advisory groups. The court rejected the agency argument:
Rule 801(d)(2)(D) requires . . . agency. An agency relationship arises when both the principal and the agent must manifest assent to the principal’s right to control the agent. Here, there is, at present, simply no evidence that would permit the Court to conclude that [panel physicians] were agents (or employees) of [defendant], let alone evidence to show that the emails related to matters within the scope of their purported agency. . . . [W]hile it is true . . . that persons serving as "advisors" and "consultants" have sometimes been held to be agents, in none of these cases was it the fact of being an advisor or consultant that alone created the agency relationship. . . . Where an advisor or a consultant is not subject to the control of the party opponent with respect to consultation he or she is hired to give, the consultant cannot be deemed an agent.
2013 WL 1953753, at *3 (citations and quotation marks omitted). Here, the emails themselves refuted agency, as they "criticized" what was being drafted (precisely why plaintiff wanted to use the emails). Id. That the physician advisors "could criticize the [document] and propose changes to it suggests that their role was to provide an independent assessment and that [defendant] did not have the right to control them." Id. at *4.
Thus, if fighting claims that your client’s physician-advisors have somehow become "agents" of your client, Hill is definitely a decision of interest.
(2) The court threw out allegations of "ghostwriting." This seems to be one of the other side's flavors du jour, as we see it asserted here, there, and everywhere. We say, "big whoop" – as if it should surprise anybody that initial drafts of articles (or lawyers’ briefs) weren’t actually written by the ultimate author. Lawyers do this all the time, as do other busy professionals. As long as the information that’s presented is correct, we don’t see a problem. It’s irrelevant to the merits of anything . . . and that’s more or less what the court found:
[T]he Court was concerned that Parisian’s [ghostwriting] opinion lacked a proper foundation. [Plaintiff] also represented to the Court . . . that Parisian would not be questioned about this issue. [Since] the only expert who offered an opinion . . . about ghostwriting and company-funded publications was Parisian, this prong of [defendant’s] omnibus motion is granted.
(3) The court allowed plaintiffs to argue that the duty to warn was not limited to the prescribing physician. Before the A-Z litigation started, we’d thought, and Bexis had even written in his book, that limiting the duty to warn in this way was a loser. But the defense has done a lot better than we thought on this issue, and has won it outright in several cases. Not in Hill, however – although the ruling is phrased in a rather odd way:
[Plaintiff] would not be precluded under the learned intermediary doctrine from introducing such [inadequacy of warning] evidence and from arguing that [defendant’s] duty to warn ran to individuals other than her prescribing physicians. While [defendant] would then be entitled to a jury instruction directing the jury not to consider such a duty where the jury found that the warnings to the physician were inadequate, it could not preclude [plaintiff’s] counsel from introducing evidence and argument to the contrary.
Hill, 2013 WL 1953753, at *7. That’s not bad for a denial. Instead of simply holding that non-prescribing treaters (usually dentists in A-Z) must be provided with adequate warnings, and leaving it at that, the court found that those physicians were part of the population against which the adequacy of warnings is to be judged. Still the defendant was entitled to a jury instruction "not to consider such a duty" with respect to inadequate warnings, id., so it’s hardly a total loss.
(4) Several of the evidentiary rulings were grounded in preemption. A-Z involves prescription drugs, so after Wyeth v. Levine, 555 U.S. 555 (2009), preemption arguments are swimming upstream. The first motion concerned "black box" warnings, where (as we discussed here) a very good preemption argument exists because the FDA reserves to itself the decision whether to include boxed warnings and what they say. As is often the case with such allegations, the plaintiff backed down. Hill, 2013 WL 1953753, at *7 (plaintiff "represents she will not offer argument or evidence on black box warnings"). Too bad; that one’s a winner.
One that wasn’t a winner was defendant’s attempt to extend Mensing preemption to prescription drugs. Not that PLIVA v. Mensing, 131 S. Ct. 2567 (2011), an implied preemption case, shouldn’t apply across the board, but because this particular aspect of the plaintiff’s warning claim – involving "a different dosing regimen" – unfortunately appears to fall on the bad side of the "changes being effected" ("CBE") divide that marks the boundary between the domains of Levine and Mensing:
Among other things, this "changes being effected" (CBE) regulation provides that if a manufacturer is changing a label to add or strengthen a contraindication, warning, precaution, or adverse reaction or to add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product, it may make the label change upon filing its supplemental application with the FDA; it need not wait for FDA approval.
Hill, 2013 WL 1953753, at *9 (citations and quotation marks omitted) (emphasis added). With "dosage" within the general scope of the CBE reg, the court wasn’t about to find preemption.
Not so, however, with respect to that aspect of a warning claim alleging that the defendant "should have formatted the [drug] labeling differently." Id. at *10. The formatting of drug labels is minutely governed by the FDA’s regulations, and is not governed by CBE standards. In what may be a ruling of first impression, Hill held that warning claims attacking how the warnings were formatted were preempted:
FDA regulations for prescription drug labeling extend not only to content but to formatting. While the case law is clear that manufacturers may modify the contents of a brand-name drug label without FDA approval by adding to or strengthening the warnings, [plaintiff] has provided no authority − and the Court’s research reveals no authority − to suggest manufacturers may do the same with the label’s formatting. Accordingly, [defendant’s] motion is hereby granted to the extent it seeks to preclude [defendant] from arguing that the [drug] labeling should have been formatted differently.
2013 WL 1953753, at *11. While the formatting claim is only a minor part of the A-Z litigation, we’ve seen warning claims based on allegations in other cases that this or that risk was insufficiently highlighted to make it stand out. Preemption of formatting claims would kill off such claims. To us, the finding of what we’ll call "formatting preemption" from here on out may well be the most important of all the Hill rulings. Defense counsel – make a note of it.
(5) Also of general interest is the ruling in Hill precluding the plaintiff from pursuing a "lost chance" case. "Lost chance" is a medical malpractice concept arising from failure-to-diagnose situations where a pre-existing disease (usually cancer) gets worse in the interim. The theory seeks to recover for the "increased risk" that the plaintiff will die of the belatedly diagnosed condition, and utilizes negligent services sections of the Restatement (Restatement (Second) §§321 & 323) that excuse plaintiffs from having to prove "but for" causation. In short, it’s not a product liability theory – since in product liability the product is alleged to be the cause of whatever injury is asserted
We’ve opposed plaintiffs trying to infiltrate "lost chance"/"increased risk" theories into product liability litigation in Pennsylvania:
The doctrine of increased risk of harm is inapplicable absent the undertaking of a service either gratuitously or for consideration. Appellants’ allegations of negligence did not assert that [defendant] undertook to "render services" to [plaintiff], therefore a charge on increased risk of harm was not appropriate. Additionally, the doctrine presupposes an outside injury or source of negligence not concurrent with any alleged negligence by a defendant.
Ettinger v. Triangle-Pacific Corp., 799 A.2d 95, 107-08 (Pa. Super. 2002). Accord Steamfitters Local Union No. 420 Welfare Fund v. Philip Morris, Inc., 171 F.3d 912, 936 (3d Cir. 1999) ("Converting a company’s marketing into a special undertaking . . . would subject every manufacturer that advertises its products to liability for a ‘special duty’ created by such marketing. . . . We are unwilling to so dramatically extend the scope of liability for a state-law cause of action"); Lempke v. Osmose Utilities Services, 2012 WL 94497, at *4 (W.D. Pa. Jan. 11, 2012) (courts "have invoked Section 323 in a variety of factual settings, but never in the context of a negligence-based products liability case"); Lobianco v. Eckerd Corp., 2004 WL 3009005, at *4 n.23 (E.D. Pa. Dec. 29, 2004) (increased risk "theory is limited to medical malpractice cases [and] is inapplicable to this [product liability] case").
Thankfully, the court in Hill also rejected this misplaced theory:
[T]he lost chance doctrine, even when recognized, has been limited to medical malpractice cases. . . . [Plaintiff] has provided no authority − and the Court's research reveals no authority − to suggest that the doctrine could conceivably apply in a products liability case where, as here, the plaintiff alleges that a pharmaceutical manufacturer’s failure to warn of risks associated with a prescription drug caused the plaintiff to develop a condition she would not otherwise have developed had she not taken the drug.
2013 WL 1953753, at *13. Thus, while ostensibly deciding a motion in limine, the ruling in Hill is a significant substantive legal decision with respect to the "lost chance"/"increased risk" issue.
(6) The defendant in Hill also sought to have everything that happened after the plaintiff last used the drug excluded, mostly as subsequent remedial measures. The defendant lost – but won. The most significant subsequent events – label changes – were excluded:
Evidence that a manufacturer changed a product’s warning label after a plaintiff was allegedly injured by the product is not admissible in a failure-to-warn case because such evidence could lead a jury to infer the manufacturer added the warning because it believed the product was unsafe without it. This is precisely the type of inference that Rule 407 [pertaining to subsequent remedial measures] forecloses in order to avoid discouraging the taking of remedial measures. [Plaintiff] argues that the changes [defendant] made to the [drug’s] label . . . involved nothing more than the inclusion of intentionally misleading [information] . . . and were therefore not subsequent remedial measures. . . . [A] manufacturers motive for making the change is irrelevant.
2013 WL 1953753, at *14 (citations and quotation marks omitted). As to everything else, the court in Hill was unwilling to enter a "blanket" exclusion order against evidence based on one point in time. Id. at *14-15. Defendant will have to "offer individualized objections to the introduction of [such] evidence at trial." Id. at *15. Again, for a loss, that’s not bad – not bad at all.
(7) Finally, the defense came away with a win with respect to "evidence of medical expenses that were not actually paid" – that is, nominal charges for medical costs that far exceeded what the plaintiff (or her insurer) actually paid for the services. This is another recurring issue, as so-called "chargemaster" prices for medical services bear no resemblance to reality, and are routinely reduced to pennies on the dollar by insurers (and the government). We’ve seen this in Pennsylvania as well, where the rule is that the reasonable value of medical services cannot exceed the sum that a plaintiff's medical care providers accepted as payment in full. Moorhead v. Crozer Chester Medical Center, 765 A.2d 786, 789-90 (Pa. 2001).
That’s the majority rule, and Hill followed it:
The Court concludes that because evidence of any amounts billed above the amounts paid are not of consequence in determining plaintiff’s damages claim . . ., and because such evidence would be of only modest probative value for other purposes, such evidence would have extremely limited relevance under Rule 401 and its introduction would likely confuse and mislead the jury into considering collateral payments within their damages calculation if introduced at trial. Consequently, the prejudice of introducing such evidence substantially outweighs its probative value.
2013 WL 1953753, at *17.
There are a number of other rulings in Hill – some that the defense won and others that it lost – but these are the ones that aren’t so fact-bound as to be of little interest outside of the A-Z litigation. With preemption, lost chance, agency, post-sale warning changes, actually-paid medical costs, and ghostwriting on the table, this was an extraordinarily meaty set of in limine rulings.