Thursday, August 30, 2007

An MDL Irrelevancy

Here’s today’s question: What the heck is the difference between a “notice of related case” and a “tag-along notice” filed with the MDL Panel?

We’re MDL jocks, and, until recently, we had no idea. We routinely see notices filed with both titles, seemingly interchangeably.

But one of our colleagues recently asked the Clerk of the Panel, and now we know the answer. Or at least we know the answer the Clerk gave last week.

According to the MDL Panel Clerk, parties should file a “notice of related case” to identify new federal cases filed before the MDL Panel issues a transfer order. That is, when a new case is filed early, before the MDL Panel has coordinated the cases, the case should be identified in a “notice of related case.”

On the other hand, after the MDL Panel has entered an order of coordination, later-filed cases should be identified in “tag-along notices.”

Deep in our hearts, we suspect this makes no difference at all. We’re fairly confident that that the Clerk of the MDL Panel would deem a “notice of related action” to be a “tag-along notice” or vice versa, to assure that no party was prejudiced by a truly trivial mistake.

On the other hand, folks who practice regularly before the MDL Panel, and who view themselves as MDL jocks, should store away this juicy tidbit of information. It may not have any practical effect, but think of how you can impress (well, okay, bore to tears) your colleagues.

Tuesday, August 28, 2007

Abigail Alliance: Tempest In A Teapot?

We’re thinking about the recent Abigail Alliance case again. As readers of this blog know, the en banc D.C. Circuit held on August 7 that terminally ill patients do not have a constitutional right to take unapproved drugs in the hope of a cure.

We did a short post on that topic, which the Volokh Conspiracy picked up, which prompted our rejoinder, which led to yet more commentary at Volokh. (And all that in just two days. Is the web cool, or what?)

Here’s where we settled.

Our concern was that terminally ill patients who are permitted to take unapproved drugs must get the drugs from somewhere. The only place to get the drugs is from the people who have them – the pharmaceutical companies. Terminally ill patients will thus predictably turn handstands to try to force pharmaceutical companies to provide those drugs. And the emotional appeal of lawsuits filed to obtain access to those drugs will be truly compelling. Plaintiffs will be telling judges that they are terminally ill and have no hope for survival unless they are permitted to take an experimental drug. In that context, shouldn’t the drug manufacturer provide the drug, so the patient can have a chance to live?

The scholars at Volokh criticized our thinking in two ways. First, they insist that drug companies are not “state actors,” so no court would ever find that the fundamental constitutional right alleged in Abigail Alliance applies to them. As we said in our previous post, we’re far less sanguine about that than the academics are. The FDA regulates drug companies awfully closely, and judges will bend over backwards to find in favor of plaintiffs in the emotionally-charged situation we’ve just described. In that situation, we would not be surprised to find a judge (wrongly) ordering a company to provide an experimental drug.

But assume the scholars are right. If so, then drug companies are not state actors, and drug companies would never be subject to a constitutional obligation to provide drugs.

Here’s our question: If drug companies are not going to provide drugs to the patients, who the heck is?

The drug companies themselves would be crazy to provide these drugs. The companies would presumably have to provide the drugs free of charge. There’s no (economic) upside to providing the drugs. But there is a downside. The companies are forbidden to speak about the risks of unapproved drugs, so the companies could not protect themselves against “failure to warn” tort claims if they provided the drugs to patients.

Moreover, if terminally ill patients were permitted to ingest investigational drugs, the FDA would surely force manufacturers to track how those patients fared. The logistics and cost of that process would deter drug companies from providing drugs. And the results of those experiments – with most patients dying – might wrongly be used to delay approval of drugs or as purported ammunition for plaintiffs in later litigation.

One alternative would be for the drug companies not to produce the drugs themselves, but instead to license the drugs to other companies that could then sell them for experimental use.

But why? And to whom? Why would a licensee care to manufacture and sell drugs in a situation where it, too, would have no defense to resulting product liability lawsuits? And why would the licensee want to manufacture a drug either to give away free or sell for what would surely be no profit? There’s no incentive for licensees to act.

Moreover, the innovator drug company also has little incentive to grant the license. Just as plaintiffs sometimes join innovators in product liability lawsuits resulting from having ingested a generic version of a drug, a plaintiff who ingested an Abigail Alliance drug manufactured by a licensee might also choose to join the innovator as a defendant.

In the end, we just don’t get it. (No surprise there, right?) Assume the Abigail Alliance plaintiffs prevail and establish a constitutional right to ingest experimental drugs. Unless we’re missing something, almost no one would manufacture or sell those drugs, so the plaintiffs would have established the right to ingest drugs that will not be available anyway.

We have an awful lot of sympathy for the plaintiffs in Abigail Alliance and, as we’ve said before, we pass no judgment on the constitutional issues involved. But it does seem to us that, if you focus on the practicalities of the situation, the entire litigation is a tempest in a teapot. The plaintiffs may be fighting for a right that will ultimately have no practical effect at all.

Monday, August 27, 2007

An MDL Conundrum

There’s an issue that we face repeatedly when we are opposing motions filed with the Judicial Panel on Multidistrict Litigation to coordinate cases. Sadly, we don’t have an answer; just an issue.

The issue arises when product liability plaintiffs file a motion seeking to coordinate. The defendant believes that its strategic interest is best served by dividing and conquering the enemy. The defendant will therefore file a brief opposing coordination.

But the plaintiffs have not simply requested coordination. They have also identified a specific proposed transferee district, and they have suggested transfer to a specific judge. What’s a defendant to do? If the defendant simply opposes coordination, it has not denied the propriety of the transferee district and judge. If the defendant loses the threshold issue of coordination, it may find that the cases have not simply been coordinated, but coordinated in a district and before a judge the plaintiffs view as being favorable.

This is high-stakes poker. The choice of transferee district makes a difference. For issues of federal law, the law of the transferee circuit will likely govern the coordinated proceedings. If Seventh Circuit law favors the defendant, but Ninth Circuit law favors the plaintiff, an awful lot rides on whether the cases are centralized in Chicago or Los Angeles.

The choice of transferee judge matters, too. We’re practicing lawyers, so we don’t write nasty things about judges in this blog. So we’ll simply repeat: even within a specific transferee district, choice of judge can matter.

The defendant could, of course, file a brief that both opposes coordination and adopts a fall-back position: If the cases are coordinated (which they should not be), then they should be sent to a certain district and assigned to a certain judge the defendant prefers. That puts the defendant’s preference of jurisdiction and judge on the table. Unfortunately, the fall-back position may give away the game. When the Panel sees that the defendant is advocating in favor of a particular transferee district, the Panel may decide that the defendant is not so violently opposed to coordination after all.

This is a tough nut to crack. How can the defendant effectively oppose coordination while at the same time suggesting its preferred transferee court?

Let us count the ways.

It won’t take long.

Frankly, we stop at two.

One alternative is to file a brief with the MDL Panel that only opposes coordination. This makes clear to the Panel that your client really does oppose coordination. During oral argument, however, you could present the step-back position that, if coordination is ordered, the defendant prefers a particular district court or judge.

Defendants often choose that tack, but it has its pitfalls. If the Panel has, before argument, tentatively decided to coordinate the cases and begun to make inquiries about who could serve as a transferee judge, the defendant’s input comes too late.

The other alternative is to file a brief that both opposes coordination and suggests a transferee district and judge. But, as we said, that weakens the argument opposing coordination.

We don’t like either solution, but we can’t come up with anything better.

What prompted this post was the brief that GlaxoSmithKline recently filed with the MDL Panel in the Avandia litigation. Here’s a link to that opposition brief. There, GSK’s brief devoted just one page to opposing coordination, one page to explaining why the plaintiffs’ choice of transferee district was illogical, and two pages to explaining why the Eastern District of Pennsylvania was, in fact, a preferred forum.

That’s not a bad strategic choice, although it suffers the problems that we discussed above. By making only a short argument against coordination, the MDL Panel may read this brief as not strongly opposing the need for coordination.

These days, the choice that GSK made in its Avandia brief may be the logical one. As has been explained elsewhere, the MDL Panel has, in recent years, increasingly chosen to coordinate product liability cases. See Mark Herrmann & Pearson N. Bownas, “Making Book on the MDL Panel: Will It Centralize Your Product Liability Cases?” BNA Class Action Litigation Report (Feb. 9, 2007). In the Avandia situation, although only six federal actions had been filed as of the date that GSK filed its brief, many more cases will probably have been filed by the time the MDL Panel hears argument on the motion. In that situation, GSK may have decided that coordination was essentially inevitable, and the more important issue was to express its preference of transferee court.

Unfortunately, we have no answers to this MDL conundrum; we can do no more than pose the question. When defendants are faced with this situation, they must chose the best of two bad alternatives, and they must then live with the result.

Friday, August 24, 2007

Wyoming Does It Right

We pointed out recently that 32 states had recognized the learned intermediary rule either by statute, decision of the highest court, or both. We're pleased to announce that this number has increased to 33 with the addition of Wyoming. In Rohde v. Smiths Medical, ___ P.3d ___, 2007 WL 2376613 (Wyo. Aug. 22, 2007), the court cites learned intermediary principles in two different places in holding that the defendant's warning to the plaintiff's treater about device fracture was inadequate. The plaintiff's only evidence - that the doctor had not warned him - was not enough.

Warnings, however, were not the main focus of the Rohde appeal. The majority of the opinion consists of a cogent discussion of why simply pointing to a broken implant doesn't establish either a design or manufacturing defect.

Thursday, August 23, 2007

Dealing With Plaintiffs Who Use Prescription Drugs Illegally

It’s an unfortunate fact of life that there are a lot of prescription drugs out there that people can also use to get high. We’re not just talking about cocaine, barbiturates, and methamphetamines, or even the long lists of drugs found at 21 U.S.C.A. §812. The truth of the matter is that just about any painkilling drug, and most drugs sold indicated for the treatment of psychosocial conditions such as depression, can be abused.

We’re product liability lawyers, not prosecutors. Our interest in this topic comes from those situations – and there’ve been more of these than we care to think about – where discovery leads us to suspect that the injuries a plaintiff is suing over were in fact caused by recreational, rather than therapeutic use of the product.

While stoner plaintiffs often like to think that they’re being slick, in reality they’re usually not as smart as their doctors – nor are they much of a match for determined discovery. Docs are pretty smart. Unless they’re actually in cahoots with the plaintiff (unfortunately we’ve run into a few of those, too) they tend to note such things as “drug seeking behavior” or excessive consumption in their records. Most docs don’t hesitate to cut off prescriptions to suspected abusers. Also, with the increasing computerization of prescription records, it’s easier than ever to compile evidence of overuse and other abuse even where a plaintiff tries to cover his or her tracks by getting prescriptions from multiple sources and filling them at multiple pharmacies.

So, you’ve got a plaintiff that you’re convinced is responsible for his or her own injuries due to excessive (or other illegal) use of the drug. This plaintiff has violated the prescriber’s usage limitations – not to mention anything and everything that your client says in its package insert. What can you do to blow this doper out of court?

Well, in addition to the usual causation and adequacy as a matter of law defenses, there’s a special legal doctrine that’s been crafted to deal with precisely this situation. It’s called the “wrongful conduct rule” or the “in pari delicto” doctrine, and it invokes public policy to preclude anyone who injures him or herself in the course of criminal activity from recovering in tort for those injuries. It’s tailor made for the addict plaintiff – and more than that, its invocation can cause a lot of lawyers on the other side to reconsider their involvement in any given case.

So what is this doctrine? It’s a variant of the longstanding general rule that intervening criminal conduct cuts off liability, but it’s more than that, because it has a moral aspect to it as well. It’s discussed in Restatement (Second) of Torts §889, comment b (1979), which states “if the injured person has violated a statute designed to prevent a certain type of risk, he is barred from recovery for harm caused by violation of the statute if, but only if, the harm resulted from a risk of the type against which the statute was intended to give protection.” The Restatement also uses as an illustration an accident where the plaintiff was driving illegally at night without lights. Id. at Illustration 5.

The wrongful conduct rule has been applied in prescription drug product liability litigation. In Orzel v. Scott Drug Co., 537 N.W.2d 208 (Mich. 1995), the plaintiff had gotten multiple prescriptions from different doctors for the defendant’s drug, and had also been buying it on the street. The court invoked the wrongful conduct rule to throw the plaintiff out of court:

[T]he wrongful-conduct rule [is] rooted in the public policy that courts should not end their aid to a plaintiff who founded his cause of action on his own illegal conduct. If courts chose to regularly give their aid under such circumstances, several unacceptable consequences would result. First, by making relief potentially available for wrongdoers, courts in effect would condone and encourage illegal conduct. Second, some wrongdoers would be able to receive a profit or compensation as a result of their illegal acts. Third, and related to the two previously mentioned results, the public would view the legal system as a mockery of justice.
Id. at 213. See also Ortolano v. BDI Marketing, 930 So.2d 192, 196 (La. App. 2006) (affirming summary judgment against plaintiff who abused OTC athsma by taking excessive quantities “to lose weight and gain energy”); Pappas v. Clark, 494 N.W.2d 245, 246-48 (Iowa App.1992) (drug addict could not recover on claim that the defendant pharmacy should have warned other pharmacies that the plaintiff was attempting to procure prescription drugs by using fraudulent prescriptions).

We’ve seen the wrongful conduct rule cited most recently in cases involving Oxycontin, a narcotic pain reliever designed to release its active ingredient slowly over time. Lots of Oxy-C plaintiffs, however, are addicts who thwart the time release function by chewing on or otherwise breaking the time release units so that they get the entire narcotic effect at one time – of course, in violation of the law and the defendant’s instructions. That’s quite rightly gotten them thrown out of court. In Price v. Purdue Pharma Co., the plaintiff used the multiple prescription ruse to obtain illegal quantities of the drug, and the supreme court affirmed dismissal as a matter of law:

No court will lend its aid to a man who founds his cause of action upon an immoral or an illegal act. . . . If a plaintiff cannot open his case without showing that he has broken the law, a court will not aid him. It has been said that the objection may often sound very ill in the mouth of the defendant, but it is not for his sake the objection is allowed; it is founded on general principles of policy which he shall have the advantage of, contrary to the real justice between the parties. The principle of public policy is that no court will lend its aid to a party who grounds his action upon an immoral or illegal act.
920 So.2d 479, 484 (Miss. 2006). Seven Kentucky plaintiffs – all persons who abused Oxy-C “for their mind-altering characteristics” – suffered the same fate:

Kentucky. . .public policy. . .den[ies] recovery for illegal acts, [so] the seven plaintiffs that procured and used OxyContin illegally may not recover in this action. . . . Because they must inevitably rely on their illegal actions to establish their claims, their claims should be denied in the first instance.
Foister v. Purdue Pharma, L.P., 295 F.Supp.2d 693, 705 (E.D. Ky. 2003).

The rule arose in a slightly different context - but to the same result - in Sorrentino v. Barr Laboratories, Inc., 397 F. Supp.2d 418 (W.D.N.Y. 2005), aff’d, 218 Fed. Appx. 7 (2d Cir. 2007). There the plaintiff had murdered his wife and attempted to blame his conduct on the defendant’s product. Again, the ruling was that the plaintiff could not recover for the consequences of his own illegal act:

[P]laintiff is barred from seeking damages stemming from his wife’s death, under New York’s public policy against allowing individuals to profit from their own wrongdoing. Plaintiff states that. . .“there were two victims that night of the murder, (my wife and myself). That may be his sincere belief, but a criminal jury found otherwise. Under New York public policy, therefore, this action must be dismissed.
Id. at 422-23. Compare Patten v. Raddatz, 895 P.2d 633, 637-38 (Mont. 1995) (plaintiff’s knowing receipt and ingestion of illegally prescribed tranquilizers barred any claim for injury arising from her illegal drug use).

As these cases indicate, while the wrongful conduct rule applies to abuse of prescription drugs, this is only a specialized indication of a much broader rule. Thus defense counsel who are not litigating in one of the states where there is directly on point drug precedent should not hesitate to put the drug abusing plaintiff where he or she belongs – out of court. As a public service, to help purge the courts of cases brought by criminal plaintiffs, here’s a list of general wrongful conduct rule precedent.
  • Alabama: Ex parte W.D.J., 785 So.2d 390, 393 (Ala. 2000); Oden v. Pepsi Cola Bottling Co., 621 So.2d 953, 954 (Ala. 1993).
  • Alaska: Lord v. Fogcutter Bar, 813 P.2d 660, 663-664 (Alaska 1991); Adkinson v. Rossi Arms Co., 659 P.2d 1236, 1240 (Alaska 1983).
  • California: Kashani v. Tsann Kuen China Enterprise Co., 13 Cal. Rptr.3d 174, 194-95 (Cal. App. 2004); Goldstein v. Enoch, 57 Cal. Rptr. 19, 23 (Cal. App. 1967); Goodwin v. Anheuser-Busch Cos., 2005 WL 280330, at *4 (Cal. Super. Jan. 28, 2005).
  • Colorado: Sender v. Kidder Peabody & Co., 952 P.2d 779, 782 (Colo. App. 1997).
  • Florida: Leo’s Gulf Liquors v. Lakhani, 802 So.2d 337, 342-43 (Fla. App. 2001); Cabrerizo v. Fortune International Realty, 760 So.2d 228, 230 (Fla. App. 2000).
  • Illinois: Vine Street Clinic v. HealthLink, Inc., 856 N.E.2d 422, 436-37 (Ill. 2006).
  • Indiana: Rimert v. Mortell, 680 N.E.2d 867, 876 (Ind. App. 1997).
  • Kansas: Parker v. Mid-Century Insurance Co., 962 P.2d 1114, 1116 (Kan. App. 1998).
  • Massachusetts: Nisselson v. Lernout, 469 F.3d 143, 151-52 (1st Cir. 2006); Choquette v. Isacoff, 836 N.E.2d 329, 334 (Mass. App. 2005).
  • Minnesota: Christians v. Grant Thornton, LLP, 733 N.W.2d 803, 814-15 (Minn. App. 2007).
  • Missouri: Dobbs v. Dobbs Tire & Auto Centers, Inc., 969 S.W.2d 894, 897-98 (Mo. App. 1998); Clouse v. Myers, 753 S.W.2d 316, 319 (Mo. App. 1988).
  • New Jersey: Tryanowski v. Lodi Board of Education, 643 A.2d 1057, 1062 (N.J. Super. Law Div. 1994); Amato v. United States, 549 F. Supp. 863, 867 (D.N.J. 1982), aff’d without opinion, 729 F.2d 1445 (3rd Cir. 1984).
  • New York: Alami v. Volkswagen of America, Inc., 766 N.E.2d 574, 576-77 (N.Y. 2002); Barker v. Kallash, 468 N.E.2d 39, 42 (N.Y. 1984).
  • North Carolina: Carver v. Carver, 314 S.E.2d 739, 744-45 (N.C. 1984).
  • Oklahoma: Tillman v. Shofner, 90 P.3d 582, 584-85 (Okla. Civ. App. 2004).
  • Pennsylvania: Minnesota Fire & Casualty Co. v. Greenfield, 855 A.2d 854, 868-69 (Pa. 2004); Holt v. Navarro, ___ A.2d ___, 2007 WL 2326870, at *7 (Pa. Super. Aug. 16, 2007).
  • South Carolina: Myatt v. RHBT Financial Corp., 635 S.E.2d 545, 548 (S.C. App. 2006).
  • South Dakota: Quick v. Samp, 697 N.W.2d 741, 747 (S.D. 2005).
  • Tennessee: Nashville Ford Tractor, Inc. v. Great American Insurance Co., 194 S.W.3d 415, 428 (Tenn. App. 2005); Moss v. Mid-South Hospital, 1989 WL 134666, at *2 (Tenn. App. Nov. 7, 1989).
  • Texas: Sharpe v. Turley, 191 S.W.3d 362, 369 (Tex. App. 2006); Jones v. Hyman, 107 S.W.3d 830, 831-32 (Tex. App. 2003).
  • Virginia: Martin v. Ziherl, 607 S.E.2d 367, 371 (Va. 2005); Lee v. Nationwide Mutual Insurance Co., 497 S.E.2d 328, 329-30 (Va. 1998).
  • West Virginia: Gray v. Fraley, 1992 WL 564130, at *3 (S.D.W. Va. Oct. 26, 1992).
  • Wyoming: Feltner v. Casey Family Program, 902 P.2d 206, 208-09 (Wyo. 1995).

Monday, August 20, 2007

Third Circuit Finds Preemption Of Consumer Fraud Claims Challenging FDA-Approved Labeling

In our prior posts on “Preemption Lite” and “Then There Were Seven,” we discussed the impact of certain “safe harbor” provisions under state consumer fraud acts where the violations being claimed involved FDA-regulated activities.

We’re pleased to report that one of those cases, Pennsylvania Employee Benefit Trust Fund v. Zeneca, Inc., 2005 WL 2993937, at *4 (D. Del. Nov. 8, 2005), has just been affirmed by the Third Circuit. Here’s a link to the affirmance and another to the Third Circuit’s website, where the Zeneca opinion is number one on the list as we write this. It will undoubtedly appear on the services soon, but hasn’t yet.

One unusual aspect is that we’re pleased (notoriously picky that we are) even though the Third Circuit actually reversed on the ground for which our posts cited the district court opinion. The court found that the particular consumer fraud statute in question (Delaware’s) contained a safe harbor written in terms of conduct regulated by the “Federal Trade Commission.” It then held that the FDA’s approval process for advertisements was too attenuated a link to anything that the FTC had approved to fall within the state statute’s safe harbor.

So why are we pleased at being back down to six safe harbor opinions? What's the title of this post? The Third Circuit went on to affirm the district court’s result on an even better and more generally applicable ground – implied conflict preemption. We’ll trade a state-specific ruling for a generally applicable decision under federal law any day. Especially if it’s by the same court that will eventually hear the Colaccio appeal, previously mentioned here and here.

So what’s the Zeneca case about? It’s a claim that direct-to-consumer (“DTC”) advertisements about a FDA-approved prescription drug (Nexium) violated state consumer fraud laws of, initially, all 50 states by making certain statements that were consistent with the drug’s FDA-approved advertising. As usual, in such actions, nobody got hurt – it’s one of what we call “strike suits” by persons seeking only economic losses for allegedly misleading advertisements that allegedly induced purchases of drugs that were safe and effective for the prescribed indication. In this particular instance, the plaintiffs were third parties who reimbursed the cost of the prescriptions.

According to the Zeneca opinion, one of the studies upon which the FDA approved the drug showed a “statistically significant healing rate,” over a competing product. Slip op. at 5. The FDA approved the doses that had been studied. Id. The allegedly misleading DTC campaign was also based upon this study. Id. The other drug became considerably cheaper, as its status changed to over-the-counter.

The Delaware statute that the class action eventually boiled down to contains a “safe harbor” for “any advertisement or merchandising practice which is subject to and complies with the rules and regulations, of and the statutes administered by, the Federal Trade Commission.” Slip op. at 8, quoting 6 Del. Code §2513(b)(2). That presented a problem, as the relevant regulatory actions were by the FDA rather than the FTC. The court goes through an interesting analysis of the history of FDA/FTC interactions in the prescription drug field, and the difference between “labeling” and “advertising.” Slip op. at 9-18. The net result is that the FDA’s authority over “labeling” is too far removed from the FTC’s authority over “advertising” for to be encompassed by a safe harbor stated solely in terms of FTC-compliant activities. Id. at 18-19 (citing requirement to “liberally” construe the Delaware statute).

Thus the Third Circuit turned to preemption to affirm dismissal of the action - and did so with a vengence. The court found that the district court had properly applied “implied conflict preemption.” Slip op. at 19. The question, as the Third Circuit put it, was “whether state consumer fraud laws pose an obstacle to the FDA’s congressionally-mandated regulation of prescription drug advertising.” Id. at 20.

The court found the FDA’s regulation of drug “safety” to be “critical” to its analysis. Id. That safety regulation included review and analysis of clinical trials:

During the approval process, the Secretary may determine, “based on relevant science, that data from one adequate and well-controlled clinical investigation and confirmatory evidence (obtained prior to or after such investigation) are sufficient to establish effectiveness....” Id. (emphasis added). Such data and evidence constitute “substantial evidence” under 21 U.S.C. §355.
Slip op. at 21.

The court then points out that that the FDCA, in 21 U.S.C. §352(n), specifically exempts compliant advertisements from the false advertising provisions of the Federal Trade Commission Act. Slip op. at 21-22. Then the court discusses a number of other relevant FDA regulatory requirements: the information that prescription drug advertising must include; the FDA’s definition of a “true statement” is in such advertising; the many reasons why the FDA can find advertising to be false; and the FDA’s sanctions for a false advertisement. Id. at 21-24.
The court characterizes the FDA’s supervision of prescription drug advertising as “ongoing and extensive”:

The degree of discretion inherent in the regulations demonstrates that the FDA envisioned itself occupying an ongoing and extensive role in the supervision of prescription drug advertising. However, neither the language of the FDCA nor the regulations explicitly preempt state consumer fraud law.

Id. at 24 (citing various regulatory materials).

Thus any preemption had to be implied from the conflict between the particular claims and the FDA’s regulatory scheme. In a footnote, the court disposed of the presumption against preemption:

The prevention of consumer fraud has traditionally been within the purview of the states. This historical preference does not foreclose the possibility of preemption, where applicable. While the protection of consumers from unfair practices is a traditional state police power function, federal laws and administrative regulations may operate in tandem with – or even preempt – state law under the Supremacy Clause.

Id. at 25-26 n. 11 (citation and quotation marks omitted).

The court next explains that federal regulations are as preemptive as congressional statutes. Id. at 25-27. Interestingly, during this discussion the court incorporates the FDA’s interpretation of preemption in the medical device context as occurring when there are “specific counterpart regulations or. . .other specific requirements.” Id. at 26 (quoting 21 C.F.R. § 808.1(d)).

Then the court analyzes Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), the major FDA-related conflict preemption supreme court opinion. The court emphasized Buckman’s reliance upon the FDA’s enforcement powers:

[Buckman] explained that “[t]he conflict stems from the fact that the federal statutory scheme amply empowers the FDA to punish and deter fraud against the Administration, and that this authority is used by the Administration to achieve a somewhat delicate balance of statutory objectives.” In so holding, the Court emphasized the flexibility inherent in the statutory and regulatory framework, and noted that such flexibility was necessary for the FDA to pursue “difficult (and often competing) objectives.”

Zeneca, slip op. at 28 (Buckman citations omitted). The court conceded that, unlike Buckman the FDA’s regulations were not as “critical,” slip op. at 28, but found that allowing consumer fraud action based upon advertising the FDA had permitted would “frustrate” the purposes of the administrative scheme:

[A]llowing these claims to proceed would unnecessarily frustrate the FDCA’s
purpose and FDA regulations, as the extent of agency involvement in regulating
prescription drug advertising is extensive and specific
.

Id. at 28-29 (emphasis added). We like that - it deserves a “wow”. It’s as broad a description of preemption as we’ve seen since the FDA’s Final Rule reignited the entire preemption issue.

The Third Circuit doesn’t rest its decision solely on general frustration. Rather, it goes on to examine the particular nature of state-law consumer fraud claims and their impact on federally regulated activities:

An even stronger case for preemption occurs when FDA approved labeling is the basis for allegedly fraudulent representations made in prescription drug advertising. The essential affinity between advertising and labeling is clear in the composition of the FDCA and its associated regulations. [numerous regulatory citations omitted] Although labeling is often directed at medical practitioners, the rules that govern labeling form the basis for the advertising regulations. [more regulatory citations omitted] Accordingly, the purpose of protecting prescription drug users in the FDCA would be frustrated if states were allowed to interpose consumer fraud laws that permitted plaintiffs to question the veracity of statements approved by the FDA.

Slip op. at 29-30 (emphasis added). In other words, where the FDA says “yes” to statements in labeling, the states cannot say “no” to the manufacturer’s use of those same statements in its advertising.

The court then solidifies its holding by finding the FDA’s advertising requirements to be “specific” and that under the FDCA only the government has authority to pursue supposed regulatory violations. Application of “general” state consumer protection statutes would be “irreconcilable” with the federal scheme:

Implied conflict preemption of state consumer fraud laws is required in this setting because both the FDCA and FDA regulations provide specific requirements for prescription drug advertising. Congress specifically determined that all proceedings for the enforcement, or to restrain violations, of the FDCA] shall be by and in the name of the United States. The high level of specificity in federal law and regulations with respect to prescription drug advertising is irreconcilable with general state laws that purport to govern all types of advertising. Accordingly, the plaintiffs’ state consumer fraud claims are preempted.

Slip op. at 30 (citation and quotation marks omitted) (emphasis added). This is another very broad “wow” ruling, one potentially applicable to state-law claims other than those based upon consumer fraud statutes.

Then the court cleans up a few odds and ends. The preemption ruling was equally applicable to state-law claims for “unjust enrichment.” Id. at 31 n.12. It was improper to dismiss the action based upon the FDA’s primary jurisdiction without giving plaintiffs the opportunity to brief that issue. Id. Given the preempted nature of plaintiffs’ claims, any amendment would be futile. Id. at 32-33.

In closing, the court ended summed up its preemption ruling:

By specifically excluding advertisements covered by 21 U.S.C. § 352(n) and the regulations promulgated thereunder from the scope of 15 U.S.C. §52 [the FTCA], Congress signaled its intent to give the FDA exclusive authority to regulate prescription drug advertising. The FDA has established specific regulations regarding such advertising. To allow generalized state consumer fraud laws to dictate the parameters of false and misleading advertising in the prescription drug context would pose an undue obstacle to both Congress’s and the FDA’s objectives in protecting the nation’s prescription drug users. Accordingly, the state consumer fraud laws are preempted by the extensive federal legislative and regulatory framework.

Slip op. at 34.

We like this – a lot. It is very broad and if followed elsewhere has the potential to kill off most, if not all, state-law consumer fraud claims involving prescription drug advertising. This result warrants big time congratulations to Mark Haddad and the rest of the Sidley & Austin folks who represented Zeneca.

In closing, we would be remiss in not pointing out that there is a dissent. Slip op. at 34-51. The dissent: (1) relies upon the presumption against preemption (id. at 36); (2) discounts the specificity of the FDA regulatory scheme (id. at 37-38); (3) compares the ruling to field preemption (id. at 38); (4) does not find as much “affinity” between labeling and advertising as the majority (id. at 39-40); (5) disputes any specific FDA “approval” of the advertisements at issue (id. at 41-42); (6) declines to analogize the exemption from the FTCA to state consumer fraud claims (id. at 44); (7) reads Buckman more narrowly; and (8) would not find that state-law parameters for false advertising necessarily conflict with the FDA’s authority to make the same determinations about advertisements for regulated products – finding them “parallel” instead. Id. at 46-49. To us, the primary significance of a dissent is that it increases the chance that the plaintiffs might seek en banc reconsideration.

Given the Third Circuit's previous preemption ruling in Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir. 2004), and the favorable preemption rulings in the Eastern District of Pennsylvania, we'd have to say that there’s probably no court before which we’d rather be litigating a FDA-related preemption case at the moment.

Friday, August 17, 2007

C.B. Fleet's Turn

One by one, we watch people get radicalized.

When they start, they are innocent. These people simply manufacture a product that is meant to improve the public health. They are uninvolved in efforts at tort reform or to improve the judicial system.

Then, there's a glitch: A television show; an FDA announcement; an adverse jury verdict; something.

Then, the deluge: Lawsuits by the mailbag full.

Then, there's the radicalization: "How can the plaintiffs' bar do this to us? It's an outrage!" And only then, too late, do they become involved in efforts at reform.

(This scenario is actually more typical of device companies than drug companies. Most pharmaceutical companies are all too keenly aware of the litigation environment that they inhabit.)

Here's today's victim: C.B. Fleet of Lynchberg, Virginia.

The FDA issued a Patient Information Sheet about a rare side effect of ingesting an oral phosphate product used for cleansing bowels before patients undergo colonoscopies. (This link takes you to the C.B. Fleet website, which in turn links to the FDA's announcement.)

The plaintiffs' bar started trolling for clients.

And now the press has picked up the story. Here's a link to an article from yesterday's Arizona Republic. Apparently, there are more than 50 lawsuits already on file, and this press coverage won't help any.

We're terribly sorry to welcome the folks at C.B. Fleet to the club. We regret only that, like the others, they will have become radicalized too late.

We're reminded of the words of Martin Niemöller:

"When the Nazis came for the communists, I remained silent; I was not a communist.

When they locked up the social democrats, I remained silent; I was not a social democrat.

When they came for the trade unionists, I did not speak out; I was not a trade unionist.

When they came for me, there was no one left to speak out."

Another Accutane "Causality" Win

The Accutane guys are on a roll.

We posted last month about the defense win on Daubert in the Accutane MDL, and before that about the order excluding "relatedness assessments" as proof of causation in the inflammatory bowel disease cases.

The new news just arrived on Wednesday, August 15. It involves the "psychiatric-track cases."
In those cases, plaintiffs allege that Accutane causes patients to develop suicidal thinking (or to attempt suicide, or actually to commit suicide).

As readers of this blog know, when investigators report adverse events in clinical trials (such as, for example, where a patient ingesting Accutane develops suicidal thinking), investigators must then provide their best guess of whether the adverse event is "related" to the patient's ingestion of the drug. The relatedness assessment is not a complete wild guess; the investigator uses his or her clinical judgment to assess relatedness. On the other hand, the relatedness assessment is hardly proof of anything, either. For example, investigators routinely say that an adverse event is "related" to drug use only to learn, when the patient in the clinical trial is unblinded, that the patient was actually taking a placebo, not the drug.

In his newest decision, In re Accutane Prods. Liab. Litig., MDL No. 1626, slip op. (M.D. Fla. Aug. 15, 2007) (here's a link to the three-page order), Judge Moody grants Hoffman-La Roche's motion to exclude evidence regarding "causality assessments" in the psychiatric-track cases. (We don't even like the phrase "causality assessments," because that confuses the medical term "relatedness" with the legal concept of "proximate cause." But we didn't write this order; we're just reporting about it.) Judge Moody notes that neither a drug manufacturer nor the FDA draws conclusions about causality from relatedness assessments. Id., slip op at 2. He says that the relatedness assessments are not needed to prove notice, because the underlying report of the adverse event -- not the relatedness assessment -- provides any notice to the defendant. Id. And Judge Moody says that the case reports are available to plaintiffs as well as defendants, so the plaintiffs could investigate them if they cared to. Id.

Finally, and helpfully in other cases, Judge Moody notes that "the danger of the causality assessments is that the wording used in them is subject to being mischaracterized as an admission of causation when they are not. In that way, they are highly prejudicial and excludable under [Federal Rule of Evidence] 403." Id., slip op. at 2-3.

That last point is indisputably true. Plaintiff's counsel always say, before trial, that they want the relatedness assessments admitted only to show that the defendant was on notice of the adverse event. As soon as a jury is empaneled, however, counsel trumpet assessments that an adverse event was related to drug use as absolute proof of causation. To illustrate the point, Judge Moody points to what happened at trial in an Accutane case in New Jersey state court. (The opinion itself does not recite the examples, but the defendants' brief does. Here's a link to that brief, so you can see what happened.)

Defense lawyers should note a wise tactical choice that defense counsel Mike Imbroscio and Paul Schmidt (of Covington & Burling) made in this case: They did not move to exclude the entire case reports, which include the relatedness assessments. That motion would bite off more than it needs to chew -- the underlying case reports may (in some circumstances) be relevant to notice, and the case reports are not the information that is unduly prejudicial. Imbroscio and Schmidt moved only to exclude one piece of the case reports -- the relatedness assessments. By focusing on that narrow point, they achieved the right (and helpful) result: The relatedness assessments are excluded; the underlying case reports can be addressed separately.

Nice work, guys. Keep those defense victories coming.

Thursday, August 16, 2007

Informal Interviews - Docs For The Goose, Docs For The Gander

In our cases, we like to talk to the prescribing doctors whenever we can. Given the learned intermediary rule , the prescriber is almost always the most important witness in the case. While we almost always have questions relating to the plaintiff’s treatment, usually what we’re even more interested in is what the prescriber thinks of the drug itself.
  • Was s/he already aware of the claimed risk?
  • If the risk were controversial, had s/he been following the controversy?
  • Did s/he take the risk into account in deciding to prescribe and prescribe anyway?
  • Would the claimed risk materially alter his/her risk benefit analysis in this particular case? In any case?
  • Did s/he read the package insert (or the Physician’s Desk Reference, which is the same thing), or did s/he rely on other sources?
  • Where relevant, did s/he pay attention to the company’s sales representatives or ignore them?
Those are the kinds of information we really like to know from prescribers – how they judge the science; how they judge the drug; and how they judge the company. Favorable answers lead to summary judgment. Unfavorable answers point towards settlement.

Plaintiffs’ counsel like to talk to prescribers too. We’re sure they cover many of the same subjects, but we know from experience that a lot of them cover other topics as well:

  • Like how the statute of limitations on a malpractice claim might be allowed to expire if the perscriber were to testify to being “duped” by the drug company.
  • Like how the prescriber should read a sheaf of carefully selected derogatory material about the product.
  • Like how the prescriber should sign a peculiarly worded affidavit about what s/he knew and when (that somehow seems to fall apart under cross-examination).
  • Like how “irrelevant” information should be purged from the plaintiff’s file - things like drug-seeking, prior litigation, non-compliance with treatment, and psychotic episodes that “have nothing to do with this case.”
  • Like how much would the prescriber charge to be the plaintiff’s expert witness.
Because, by definition, there’s a physician/patient relationship between the plaintiff and his or her prescriber, the plaintiff’s lawyer can have all of these conversations with these critical fact witness in secret, and never has to let our side know that such talks have been going on.

We think we should have the same right. Whatever rules the plaintiffs get to play by should apply to us as well. What’s sauce for the goose should be sauce for the gander.

For as long as we’ve been practicing, however, plaintiffs’ counsel have done everything they can to thwart equal defense access to prescribing physicians under the same rules (or lack of rules) applicable to both sides. Unfortunately, they’ve gotten away with all sorts of discriminatory practices in far too many cases.

That’s why we were pleased last week when we first came across Weiss v. Astellas Pharma, US., Inc., 2007 WL 2137782 (E.D. Ky. June 25, 2007), in which the court leveled the playing field. Weiss involved the usual situation – plaintiff went merrily on his way, having all the private meetings with the prescribing physicians that counsel wanted, while claiming the right to prevent the prescriber (whom, we assume, was willing) from meeting with defense counsel under similar circumstances.

The defendant finally had enough and moved to compel the plaintiff to execute releases that would ensure that the prescriber couldn’t be sued if he met with defense counsel in the same informal way that he had been meeting with plaintiff’s counsel. Alternatively, the court (well, technically a magistrate) was asked to prohibit plaintiff’s informal – so-called “ex parte” visits by plaintiff’s counsel. Id. at *1.

The defendants argued that the relevant state, Kentucky, didn’t recognize a legal privilege applying to the physician/patient relationship, and even if it did, any privilege had been waived when the plaintiff filed suit and thus placed his medical condition at issue. Id.

That first question – about whether a privilege exists – is one on which the states are all over the lot, and it’s impossible to generalize. Some states recognize common-law privileges, others have statutes of widely different breadth, while still others haven’t recognized any privilege. According to the Weiss opinion, Kentucky falls into the third category. Id. at *2. It’s a particularly important issue because the Federal Rules require federal courts to adhere to state law with respect to privileges. Fed. R. Evid 501.

On the second question, however, there is general consensus that filing a personal injury lawsuit waives any physician/patient privilege to the extent that it involves a medical issue relevant to the case. The highest courts of many states have held precisely that. Alcon v. Spicer, 113 P.3d 735, 740 (Colo. 2005) (plaintiff “waive[s] the physician-patient privilege with respect to the injuries claimed in her lawsuit”); Henricksen v. State, 84 P.3d 38, 48-49 (Mont. 2004) (plaintiff “waived any physician-patient privilege as to a mental or physical condition in controversy”); Willoya v. State Dept. of Corrections, 53 P.3d 1115, 1124 n.38 (Alaska 2002) (“the filing of a personal injury action waives the physician-patient privilege as to all information concerning the health and medical history relevant to the matters which the plaintiff has put in issue”); Laznovsky v. Laznovsky, 745 A.2d 1054, 1067 (Md. 2000) (parent placing fitness at issue “did waive any physician-patient privilege”); Doe v. Orangeburg County School District No. 2, 518 S.E.2d 259, 261 n.7 (S.C. 1999) (“[b]y placing one's mental or physical condition in issue, a party has done an act which is so incompatible with an invocation of the physician-patient privilege that the privilege is deemed waived”); Rodriguez v. Suzuki Motor Corp., 996 S.W.2d 47, 63 (Mo. 1999) (“most common” waiver of physician-patient privilege “involve[s] plaintiffs who voluntarily place their medical condition in issue by . . . alleging that they suffered physical or mental injuries”); Marsh v. Wenzel, 732 So. 2d 985, 990 (Ala. 1998) (“commencement of the action made the information that had passed between physician and patient subject to discovery and, therefore, caused a waiver”); Donovan v. Bowling, 706 A.2d 937, 940 (R.I. 1998) (after commencing litigation, plaintiff “was no longer entitled to the benefits of the patient-physician privilege”); Maynard v. Hereen, 563 N.W.2d 830, 837 (S.D. 1997) (“waiver of privilege in this case under [statutory physician-patient privilege] is absolute as to an opposing party”); Steinberg v. Jensen, 534 N.W.2d 361, 368 (Wis. 1995) (“the physician-patient privilege did not protect communications relevant to or within the scope of discovery”); Stigliano v. Connaught Laboratories, Inc., 658 A2d 715, 718 (N.J. 1995) (“[b]y bringing suit against . . . plaintiffs have waived the physician-patient privilege”); Nelson v. United States, 649 A.2d 301, 308 (D.C. 1994) (“a patient waives the privilege as to relevant evidence by filing a lawsuit which places in issue the patient's medical condition”); Carson v. Fine, 867 P.2d 610, 618 (Wash. 1994) (once suit is filed “a patient . . . cannot insist on continued confidentiality from her physicians regarding the condition at issue based on the fiduciary nature of their relationship”); Vredeveld v. Clark, 504 N.W.2d 292, 300 (Neb. 1993) (“filing a personal injury claim waives the physician-patient privilege as to all the information concerning the health and medical history relevant to the matters which plaintiff has put at issue”); Pearce v. Ollie, 826 P.2d 888, 903 (Idaho 1992) (“plaintiff has waived any physician-patient privilege relating to her mental and physical condition in controversy”); Owen v. Owen, 563 N.E.2d 605, 608 (Ind. 1990) (“[w]hen a party-patient places a condition in issue by way of a claim, counterclaim, or affirmative defense, she waives the physician-patient privilege”); State v. Valley, 571 A.2d 579, 586 (Vt. 1989) (“by bringing an action for damages arising from the injuries the plaintiff claims to have suffered, the physician-patient privilege is waived”); Dillenbeck v. Hess, 536 N.E.2d 1126, 1135 (N.Y. 1989) (“a plaintiff waives the physician-patient privilege by commencing an action which puts plaintiff's own physical condition in issue”); Nelson v. Lewis, 534 A.2d 720, 722 (N.H. 1987) (patient waives physician-patient privilege to relevant information by putting medical condition at issue); State v. Berry, 324 So. 2d 822, 827 (La. 1976) (“by bringing the action, [a plaintiff] waives his right to claim the privilege as to any physicians who have prescribed for or treated him for such injuries”); State v. Campbell, 500 P.2d 21, 33-34 (Kan. 1972) (“there is no privilege. . . in an action in which the condition of the patient is an element or factor of the claim or defense of the patient”); City & County of San Francisco v. Superior Court, 231 P.2d 26, 28 (Cal. 1951) (“if there had been a physician patient relationship, the privilege would be waived. . . by [plaintiff's] bringing the action for personal injuries”).

The Weiss court determined that, since neither the state legislature nor the state courts had seen fit to create a physician/patient privilege, it was not the job of a federal court, sitting in diversity, to change state law. 2007 WL 2137782, at *2 (“declin[ing] to recognize a privilege where it has not been expressed in the general laws of evidence existing in the state or in legislative enactment”). Once the court (magistrate) had made that determination, the question whether to permit informal interviews with treating physicians was purely procedural – unless there is a prohibition grounded in a state-law privilege, federal courts are free to decide discovery issues under the Federal Rules of Civil Procedure. Id. at *3-4.

Once again, that’s a point for which there’s lots of law. In Williams v. Rene, 72 F.3d 1096 (3d Cir. 1995), for example, the court held the federal courts were not bound by a purely procedural local rule that restricted informal interviews with treating physicians and instead followed “time-honored and decision-honored principles, namely, that counsel for all parties have a right to interview an adverse party’s witnesses (the witness willing) in private, without the presence or consent of opposing counsel and without a transcript being made.” Id. at 1103. See also Patton v. Novartis Consumer Health, Inc., 2005 WL 1799509, at *3 (S.D. Ind. July 25, 2005); Eve v. Sandoz Pharmaceuticals Corp., 2002 WL 32153352, at *2 (S.D. Ind. May 16, 2002); Shots v. CSX Transportation, Inc., 887 F. Supp. 206, 208 (S.D. Ind. 1995); Evertson v. Dalkon Shield Claimants Trust, 1993 WL 245972, at *1 (D. Kan. June 2, 1993); Filz v. Mayo Foundation, 136 F.R.D. 165, 170 (D. Minn. 1991); In re Orthopedic Bone Screw Products Liability Litigation, 1996 WL 530107, at *2 (E.D. Pa. Sept. 16, 1996).

The question in Weiss thus became, whther under the guiding principles of the Federal Rules of Civil Procedure, was this type of “informal” discovery of prescribing physicians a good thing? The court held that it was:

[T]reating physicians are important fact witnesses, and absent a privilege, no party is entitled to restrict an opponent's access to a witness, however partial or important to him. Treating physicians are percipient fact witnesses, and as such, the information and opinions they possess should be freely accessible to both parties as would be the case with any other ordinary fact witness.
2007 WL 2137782, at *5 (various internal citations and quotation marks omitted). That's the position we like to see, and lots of courts have taken it.

“[A] party’s right to interview witnesses is a valuable right. Witness interviews are one of the primary investigative techniques.” Wharton v. Calderon, 127 F.3d 1201, 1204 (9th Cir. 1997). “Once a patient places his care and treatment at issue in a civil proceeding, there no longer remains any restraint upon a doctor in the release of medical information concerning the patient within the parameters of the complaint.” Orr v. Sievert, 292 S.E.2d 548, 550 (Ga. App. 1982). Informal interviews are:

less costly and less likely to entail logistical or scheduling problems; it is conducive to spontaneity and candor in a way depositions can never be; and it is a cost-efficient means of eliminating non-essential witnesses from the list completely.
Romine v. Medicenters, Inc., 476 So. 2d 51, 55 (Ala. 1985). Restricting informal physician depositions “hinders settlement negotiations and trial preparation by restricting the gathering of relevant evidence in an informal fashion, thus requiring the more expensive and time-consuming procedures of a formal deposition.” Williams, 72 F.3d at 1103.

“May one cry secrecy! secrecy! professional confidence! when there is no secrecy and no professional confidence? . . . To hold so leaves a travesty on justice at the whimsical beck and call of a litigant.” Brandt v. Pelican, 856 S.W.2d 667, 672 (Mo. 1993). Rather, the physician-patient privilege “was never intended to be used as a trial tactic by which a party entitled to invoke it may control to his advantage the timing and circumstances of the release of information he must inevitably see revealed at some time.” Street v. Hedgepath, 607 A.2d 1238, 1247 (D.C. 1992).


Counsel are entitled and expected to look for witnesses and to interview them. Their interviews constitute the paradigm attorney work product. . . . An informal interview may provide the best available substitute for [] a deposition to prepare for trial. . . . [T]he right to conduct [informal witness] interviews is taken for granted as a matter of federal procedure.
****
[Judicial] discretion does not support a ruling. . .that allows one side unfettered and unsupervised access to important witnesses, yet prohibits such contact for the other side. None of these witnesses are represented by plaintiff’s counsel. None of them have been retained as testifying or non-testifying experts. . . . This is a matter of fairness and symmetry. Neither side owns these witnesses. Each side is free to contact them and to talk with them privately. The witnesses are free to make their own decisions about whether they will meet with anyone, and if so on what conditions.

Patton, 2005 WL 1799509, at *4-5.

Many other jurisdictions likewise recognize the benefits of informal interviews. See, e.g., Samms v. District Court, 908 P.2d 520, 525-26 (Colo. 1995) (“Informal methods of discovery not only effectuate the goals of the discovery process but tend to reduce the litigation costs and simplify the flow of information”); Steinberg, 534 N.W.2d at 371-72 (allowing informal interviews with treating physicians to afford a wide latitude of cost-efficient discovery); Heller v. Norcal Mutual Insurance Co., 876 P.2d 999, 1005 (Cal. 1994) (“disapprov[ing]” cases that “could be read to prohibit all ex parte contacts between a physician and. . .attorneys or insurers”); Lewis v. Roderick, 617 A.2d 119, 122 (R.I. 1992) (informal interviews are beneficial by reducing trial preparation time and expense of litigation); Domako v. Rowe, 475 N.W.2d 30, 33 (Mich. 1991) (encouraging open discovery to which both parties have a right); Morris v. Thomsen, 937 P.2d 1212, 1217-18 (Idaho 1987) (if plaintiff has not retained the treating physician as an expert witness, discovery rules. . .do not limit defense counsel’s access); Trans-World Investments v. Drobny, 554 P.2d 1148, 1152 (Alaska 1976) (“informal methods are to be encouraged, for they facilitate early evaluation and settlement of cases, with a resulting decrease in litigation costs, and represent further the wise application of judicial resources”); Butler-Tulio v. Scroggins, 774 A.2d 1209, 1216-17, (Md. App.) (refusing to create extra-statutory prohibition against informal interviews of treating physicians where patients have placed their medical conditions in issue); Hogue v. Kroger Store No. 107, 875 S.W.2d 477, 481 (Tex. App. 1994) (the “conclusion that [the treating physician] did not act improperly when he met privately with [defense] counsel was reasonable” since filing suit waived physician-patient privilege); Green v. Bloodsworth, 501 A.2d 1257, 1258-59 (Del. Super. 1985) (“This Court will not condone the use of the formal discovery rules as a shield against defense counsel’s informal access to a witness when these rules were intended to simplify trials by expediting the flow of litigation and to encourage the production of evidence.”); Eve, 2002 WL 32153352, at *2 (“[t]o require that the parties redepose each physician because the defendant wishes to clarify information as they prepare for trial would add an extra layer of costs to the trial preparation portion of this case, which is unwarranted”); Orthopedic Bone Screw, 1996 WL 530107, at *2 (allowing informal physician interviews in mass tort litigation “[b]ecause many states grant defendants the right to conduct informal discovery”); Bryant v. Hilst, 136 F.R.D. 487, 491 (D. Kan. 1991) (a patient who places his or her medical condition at issue forgoes right to preclude treating physicians from disclosing relevant information; interested parties should not be given complete control over categories of fact witnesses); Filz, 136 F.R.D. at 169-74 (informal interviews with treaters are a valuable component of discovery); Doe v. Eli Lilly Co., 99 F.R.D. 126, 128 (D.D.C. 1983) (“there are entirely respectable reasons for conducting discovery by interview vice deposition: it is less costly and less likely to entail logistical or scheduling problems; it is conducive to spontaneity and candor in a way depositions can never be; and it is a cost-efficient means of eliminating non-essential witnesses from the list completely”).

For all of these reasons, “to disallow a viable, efficient, cost effective method of ascertaining the truth because of the mere possibility of abuse, smacks too much of throwing out the baby with the bath water.” Langdon v. Champion, 745 P.2d 1371, 1374 (Alaska 1987). Likewise, in Stempler v. Speidell, 495 A.2d 857 (N.J. 1985), the New Jersey Supreme Court recognized that personal interviews are “an accepted, informal method of assembling facts and documents in preparation for trial” and that “[t]heir use should be encouraged…[to] reduce the cost and time of trial preparation.” Id. at 864. Plainly, allowance of informal interviews of treating physicians reflects a balanced approach founded in sound and widely-recognized policy concerns. “[P]olicy considerations which support giving plaintiffs inordinate control over a witness’s disclosures and allowing plaintiffs to monitor the work of defendants in preparing their case, act in favor of an unfair discovery process and are not persuasive.” Stewart v. Women in Community Service, Inc., 1998 WL 777997, at *4 (D. Nev. Oct. 7, 1998).

One argument that Weiss didn’t need to address – we assume because it was not strongly pushed – is what we consider the bogus claim that the Health Insurance Portability & Accountability Act of 1996 (“HIPAA”) somehow precludes litigants from informally interviewing physicians who are also potential witnesses. We’ve already exploded that argument at great length in a previous post, so we’ll not repeat ourselves here. Weiss did require HIPAA-compliant authorizations, 2007 WL 2137782, at *6, but we’ve found that’s preferable these days, since it’s what the people we want to talk to are increasingly accustomed to seeing.

Of the alternatives, we like the informal interview process the best – which should be obvious to anyone who’s read this far. But nobody always gets what s/he wants all the time. Thus, we’ve done this drill in different ways in different cases. You won’t hear us complaining (much) about this or that procedural hoop to jump through as long as one fundamental principle is recognized. Both sides have to play by the same set of rules. If that happens, we’ll be, if not content, than at least accepting, even if the ground rules are restrictive.

But if the plaintiffs get to do whatever they want, while the defendants are stuck having to play solely by the rules of formal discovery – as we’ve seen in all too many situations – don’t expect us to roll over and play dead about it. Where plaintiffs are allowed to claim some sort of proprietary type of right over access to prescribing physicians, they shouldn’t be surprised that we’re going to do what we can to challenge such one-sided litigation practices.

In Pennsylvania, for example, Bexis has to put up with a very one-sided state-court rule prohibiting informal physician interviews that was adopted in the dead of night without any public comment. He reports that defendants have had some success arguing that, because plaintiffs now have superior access to these witnesses, plaintiffs who don’t call prescribing physicians should be subject to an adverse “missing witness” inference. Bowman v. Plumbarama, 53 Pa. D. & C.4th 434, 437-38 (C.P. Philadelphia Co. 2001), aff’d, 797 A.2d 367, 2001 WL 34394456, at *2 (Pa. Super. 2001); Clark v. Frankford Hospital, 30 Pa. D. & C.4th 1, 14-15 (Pa. CP. Philadelphia Co. 1996), aff’d mem., 695 A.2d 433 (Pa. Super. 1997). That’s the kind of creative response to unfair rules we like to see. Even when forced to comply with unfair discovery procedures, the defense needs to do what it can to fight back.

Tuesday, August 14, 2007

Untitled (As In "Untitled Letters")

You know what ticks us off?

(Regular readers of this blog know that that's a rhetorical question: Plainly, everything ticks us off.)

Well, what's ticking us off today, then?

First, there's a news report that the FDA sent a nastygram to a drug company -- a letter raising an issue about the company's promotional materials. Here's a link to CNN's coverage of a letter the FDA sent to Pfizer last month, but just posted on the FDA website yesterday. The FDA's letter criticizes materials used to promote the schizophrenia drug Geodon. And the headline, of course, screams that "FDA Accuses Pfizer of False Advertising."

Others pick up the story. All of a sudden, the FDA has sent a "Warning Letter," which sounds like it's a big deal.

And, as sure as we're sitting here, if Pfizer is ever sued in a product liability case about an alleged side effect of Geodon, plaintiff will offer this letter into evidence as supposed proof that Pfizer did something wrong.

Slow down.

This communication from the FDA is not a "Warning Letter." It's an "Untitled Letter." An untitled letter is "initial correspondence . . . that cites violations that do not meet the threshold" for issuing a more serious "warning letter." FDA Regulatory Procedures Manual, Ch. 4, Advisory Actions 4-27 (2006) (available on-line here). An untitled letter does not "demand" that the manufacturer stop using the questioned material; it only "requests" a response. An untitled letter typically does not ask a manufacturer to take "corrective action" by publishing new ads to offset the effect of the old, supposedly misleading ones. And an untitled letter is far from proof that the manufacturer did anything wrong; it is simply the lowest-level communication from the FDA suggesting that someone at the FDA thinks the manufacturer may have dome something wrong.

If the FDA were ever to run that allegation up its internal flagpole -- to elevate the accusation even to a "Warning Letter," let alone to some type of enforcement action, others within the agency might choose not to proceed. And, even if the FDA chose to proceed, a court could hold that the FDA was wrong, and the promotional materials were entirely proper.

These issues rarely go to court, of course, because a manufacturer would be nuts to pick this type of fight with the FDA. But courts should be sensitive to two things: (1) the regulatory insignificance of "Untitled Letters," and (2) the undue weight a lay jury might accord an untitled letter if it were admitted into evidence.

"Untitled Letters" should almost never be admitted into evidence. If relevant to any issue at all, their prejudicial effect surely outweight their probative value.

We hope that both defense counsel and courts will keep that point in mind.

Sunday, August 12, 2007

(b)(2) Becomes (b)(3): Buynie v. Airco

Medical monitoring claims are an odd thing.

We almost never see them in individual lawsuits. Plaintiffs are happy to recover money damages; they don't need an injunction to obtain medical monitoring relief.

Somehow, in the class action context, those very same plaintiffs need different relief: The class members say they need injunctions to guarantee that they receive necessary medical check-ups.
Why? Why do people need medical attention when they sue as a class that they do not need when the very same people sue individually?

Oddly enough, we don't think the answer lies in medical science. We don't think that people need different medical treatment when they sue collectively than they need when they sue individually. Rather, we think that counsel choose to pursue different relief for putative class members because that is counsel's only hope for obtaining class certification, which is where the payoff lies.

Historically, when class counsel sought to recover money damages to pay for medical check-ups for class members, courts refused to certify those classes. Classwide claims for money damages had to be pursued under Federal Rule of Civil Procedure 23(b)(3), and the plaintiffs' conditions varied too widely to permit class certification under that rule.

So plaintiffs' counsel changed their tack. Instead of seeking money damages to pay for check-ups, counsel began seeking injunctions to compel defendants to create medical monitoring programs to benefit the class. Since these complaints supposedly sought "injunctive" relief, the classes did not have to satisfy the stringent requirements of Rule 23(b)(3) and could supposedly be certified under the supposedly less restrictive Rule 23(b)(2). A few courts fell for this ruse, certifying (b)(2) medical monitoring classes, and the floodgates opened. Product liability class action complaints routinely sought money damages under (b)(3) and also sought injunctive relief in the form of medical monitoring programs under (b)(2).

Needless to say, this sleight-of-hand did nothing to improve the logic of the law. Courts were being asked to certify under one subsection of Rule 23 classes that did no more than plead thinly disguised versions of claims that coud not be certified under another section. The law has now adjusted to this legal legerdemain, but the adjustment hasn't been pretty.

The New Jersey appellate decision of Buynie v. Airco, No. A-3193-05T1, 2007 WL 2275013 (N.J. Super. Aug. 10, 2007), is the most recent example of what's happened. Here's a link, too, in case you don't have Westlaw handy.

In Buynie, plaintiffs were employed at a Pantasote plant in New Jersey that manufactured poly vinyl chloride. One of the constituents of poly vinyl chloride is vinyl chloride monomer ("VCM"), a colorless gas that has been classified by the EPA as a Group A human carcinogen. Plaintiffs pleaded claims on behalf of a putative class of all employees at the plant seeking an injunction under the New Jersey equivalent of Federal Rule 23(b)(2) to compel the defendants to establish a medical monitoring program.

How do defendants oppose class certification in this context? They know they can defeat a motion for class certification under Rule 23(b)(3) -- and properly so: The individual plaintiffs' exposure to VCM varied in amount and duration, as did the plaintiffs' lifestyle and other factors that predisposed them to cancer. So the defendants must graft the (b)(3) factors into the (b)(2) analysis to defeat the plaintiffs' claim for relief under a different name.

Under (b)(3), defendants would defeat class certification because classwide issues do not "predominate." Defendants therefore explain that, although (b)(2) does not have a "predominance" requirement, (b)(2) does require that the class's claims be "cohesive." And what does "cohesiveness" mean? Exactly the same thing as predominance.

Don't take our word for it. Look at what the court did in Buynie. Certification under (b)(2) "requires that the class be cohesive. In fact, the need for cohesiveness is enhanced for a (b)(2) [class] because individual class members have no ability to opt out of the class." Id., slip op. at 14. And what precedents did the court rely upon to determine whether a class is cohesive under (b)(2)? None other than the U.S. Supreme Court decision in AmChem, a (b)(3) case. The AmChem class could not be certified under (b)(3) because the plaintiffs had been exposed to different products in different ways and different amounts over different periods of time. The consequences of exposure differed for each plaintiff, and plaintiffs differed in their medical histories and treatment needs.

The Third Circuit, in Barnes v. American Tobacco Co., 161 F.3d 127 (3d Cir. 1998), applied those same types of factors to decertify a (b)(2) class that sought medical monitoring relief. And the Buynie court followed that precedent to use the same (b)(3) factors to affirm the trial court order denying class certification because the proposed class lacked the cohesiveness required by Rule 23(b)(2). Voila -- (b)(2) becomes (b)(3)!

We're not criticizing the Buynie court here. We like this result; we agree with this result; we think this is a perfectly good way to get there.

But we're disturbed as lawyers about the convergence of Rules 23(b)(2) and 23(b)(3). A few decades ago, those rules were reasonably distinct: (b)(2) classes sought, for example, injunctions prohibiting discrimination, while (b)(3) classes sought money damages. Over time, the plaintiffs' bar merged these two provisions by seeking "injunctions" that would really do no more than award money damages in disguise. To defeat class certification in those cases, defendants (properly) imported (b)(3) analysis to defeat certification of what were, in reality, (b)(3) claims. The courts accepted that analysis, and -- presto! -- courts now analyze (b)(2) classes under standards that were developed for (b)(3).

Although this may achieve the right result in the (b)(2) medical monitoring cases, the analysis distorts the fabric of the law. Over time, the analysis of (b)(2) and (b)(3) classes will merge, and courts and litigants will struggle to remember that those provisions were created to address very different legal issues that, in many instances, require very different legal analysis.

Friday, August 10, 2007

Abigail Alliance and the Volokh Conspiracy

We're taking it on the chin in the "comments" over at the Volokh Conspiracy. Jonathan Adler linked to our post yesterday about the Abigail Alliance case, and the scholars are lining up to say that pharmaceutical companies are not "state actors" and so would never be compelled to provide experimental drugs to terminally ill patients. We really hope they're right -- but we're still glad that it appears we'll never have to find out.

C'mon, guys. First, the doctrine of "state action" is hardly a bright-line rule that gives a potential defendant any real solace. A private entity's actions may become "state action" if the private entity (1) acts as an agent of government in performing a particular task delegated to it by government, (2) performs a function that is generally considered the responsibility of government, or (3) obtains substantial resources, prestige, or encouragement from its involvement with government.

When drug companies are conducting clinical trials -- or selling drugs, or speaking about drugs, or maybe even thinking about drugs -- the FDA is all over them like a cheap suit. Take a look at Title 21 of the Code of Federal Regulations. Why, the regs for clinical trials, Part 3.12, alone come to 37 pages of itty-bitty type. That's a lot more intensive regulation than over, say, some poor schmoe who stupidly files a lawsuit to enforce a racially restrictive covenant.

We realize that no court has yet found a drug company to be a state actor in this context, but, until now, no one had created an environment in which scores of intelligent, motivated plaintiffs' counsel would be pursuing multiple theories to try to achieve that result. As our full post (not just the excerpt posted on Volokh) discussed, even without the constitutional right there's already been litigation -- so far unsuccessful, to be sure -- seeking to force drug companies to provide experimental drugs when they've decided to terminate clinical trials. This isn't some paranoid fantasy, as some of the Volokh commentators suggest.

If a court were to create a constitutional right for terminally ill patients to ingest experimental drugs, cases asserting that right will (quite properly) hold immense emotional appeal for the plaintiffs. Lawyers will line up left and right to take those cases, and judges will bend over backwards to find a remedy. We're litigators, that's something we know.

And the judges who are doing the bending are not Jonathan Adler or Eugene Volokh or any of the other scholarly superstars over at the Volokh Conspiracy analyzing constitutional issues pitched right into their power alleys. They're just plain judges, doing their best to wrestle with obscure constitutional issues that they haven't studied since law school. (We're reminded of the time a trial judge in state court in Philadelphia peered over the bench at one of us and asked, incredulously: "Is that a constitutional argument, counsel? We don't do that stuff here.")

We appreciate the constitutional subtleties involved in all of this, but, frankly, the companies put at the center of the fray -- those who invent and manufacture the drugs -- will spend years litigating their way out of this trap, if courts choose to create it. And even when they win, they lose, both in terms of $$$ spent on yet another way of keeping lawyers busy billing time, and in terms of bad publicity.

As we said before, let's not create new constitutional rights to be defined through amorphous litigation. Instead, let's have Congress pass a law that lays out rules -- and rights, and protections -- and thus create a legal environment that has some appropriate boundaries.

More on Milberg

We can't resist.

We posted last week about the private class action litigation filed against Milberg Weiss seeking to recoup the hundreds of millions of dollars of legal fees the firm recovered in cases in which the government now says Milberg improperly paid shareholders to act as named plaintiffs.

It turns out that the firm that filed the new case against Milberg Weiss -- Beatie & Osborn -- has a longstanding grudge against Milberg Weiss. Milberg Weiss often aced out Beatie & Osborn in securing the lucrative role as lead counsel in securities fraud class actions.

For those who are interested in the case -- or who simply can't resist the lure of a good cat fight -- here's the link to Fortune's "Legal Pad."

We don't know about you, but we're waiting on tenterhooks hooks here. What the heck might a Milberg Weiss counterclaim -- or third party claim against Beatie & Osborn -- plead?

Thursday, August 09, 2007

No Constitutional Right To Compassionate Use Of Unapproved Drugs

Nobody who reads our blog can have any doubt that we’re four-square in favor of allowing drug and device manufacturers (our clients) to engage in the truthful promotion of off label uses. It’s not just that we think the restrictions are unconstitutional (although we do); it’s that we think that off-label use saves lives and alleviates suffering.

That’s why we we’ve been profoundly conflicted about the ongoing litigation seeking to establish a constitutional right for terminally ill patients to have access to entirely unapproved drugs that might save their lives. On the one hand, it bears some resemblance to off-label use. On the other hand, we’re old enough to remember Laetrile – a supposed “miracle cure” for cancer that had people flocking to Mexico back in the 1970s. Laetrile turned out to be entirely useless, dangerous (if not prepared properly, it could contain cyanide), and oversold by those with a financial interest in it. The FDA quite rightly put its foot down over Laetrile, and was rewarded with landmark precedent supporting deference to administrative agency (the FDA, of course) decisions regarding statutory interpretation. United States v. Rutherford, 442 U.S. 544 (1979).

But as we’ve said repeatedly, we’re lawyers representing FDA-regulated manufacturers. So when Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, ___ F.3d ___, 2007 WL 2238914 (D.C. Cir. Aug. 7, 2007), was decided earlier this week, and rejected any constitutional right of access to totally FDA-unapproved drugs, we were mostly relieved. Our clients dodged another bullet.

There’s already been a lot of comment about Abigail Alliance in the blogosphere. The Law Professors quite predictably have an excellent thumbnail sketch of the decision. Our favorite FDA specialists quite understandably dive into the implications of the decision on the Agency’s pending initiatives. Other drug law gurus had a field day with the court’s really long regulatory history discussion. Volokh also has a lot to say, especially about the nature of the constitutional right that the plaintiffs asserted. The interesting ideological split and, of course, prospects for further appeal, are on the menu at Scotusblog. The appellate mavens over at How Appealing even found an appellate procedure twist.

We’ll leave the constitutional and administrative implications of the decisions to the professors and other scholars who specialize in that sort of stuff. We’re tort lawyers. We’re not even sure we can count as high as the Tenth Amendment. Our perspective is different and, not surprisingly, practical. We'd like to pose the question, if the decision had gone the other way, just what our clients would have been expected to do?

In Abigail Alliance terminally ill people were suing the FDA. They were represented, interestingly enough, by the Washington Legal Foundation, folks that we ordinarily think of as friends of the pharmaceutical and medical device industries. But that’s really more of an alliance of convenience. Those guys are ideologically in favor of less government. We’re not ideological about much of anything. We just want government (especially the FDA) to do right by our clients. “Cough … preemption … cough.” When it doesn’t, the WLF is a great bunch to work with. Our biggest problem with this sort of suit over access to experimental drugs is that, if the FDA had lost, our industry clients probably would have been the next defendants.

Essentially, the plaintiffs in Abigail Alliance sought to overturn the FDA’s ability to prohibit access to new drugs before they had been approved for anything. The FDA’s clinical trial process is nothing if not fiendishly complicated, but in a nutshell, it requires manufacturers who wish to test a new drug (or device, but this controversy is almost solely about drugs) to contract with a group of doctors (“investigators”) and hospitals (“institutions”), and restrict availability of the drug under study to those enrolled in research studies conducted under elaborate, FDA-approved written protocols. If a patient doesn’t qualify for the study, that patient cannot get the drug – not legally, anyway.

The new drug must then run the gauntlet of several phases of study, from animal testing all the way to (if the drug continues to show promise) double-blinded experiments involving hundreds or thousands of research subjects. The Abigail Alliance opinion describes this laborious process in detail. 2007 WL 2238914, at *1-2.

One overwhelming, unfortunate fact: most potential drugs don’t make the cut, and for those that do, the entire process can take quite a few years. The Abigail Alliance decision says the average is seven years. Id. at *1. We believe it.

The FDA already has an exception for terminally ill patients, involving so-called “compassionate use.” 21 C.F.R. §312.34(a-b). That program is rather limited, though, because: (1) there can’t be any alternative, approved therapy; (2) research into the drug must be sufficiently advanced for there to be ongoing clinical trials, and (3) the would-be manufacturer must be “actively pursuing” FDA approval. Nor is compassionate use particularly attractive to our clients, since they’re not allowed to make any profit at all from such use. 21 C.F.R. §312.7(d)(3).

So the plaintiffs in Abigail Alliance sought a broad constitutional right, unfettered by FDA red tape, for access to possibly life-saving unapproved drugs at just about any stage in the research and approval process. Their argument was very simple and powerful. It’s our lives at stake. We can make the choice to assume the risk that the drugs won’t work or might cause other injuries. 2007 WL 2238914, at *4, 10-11. To this assertion of personal autonomy, they added an argument by analogy – the constitution extends protection to private matters like education, travel, abortion, and consensual sex. If the constitution affords people the right to refuse lifesaving therapy, how can it not extend its protection to people seeking to save their own lives? Id. at *11 n.19, *14 (dissenting opinion).

The en banc Court of Appeals for the District of Columbia Circuit said “no” anyway. The plaintiffs’ notion of some “legal tradition” in favor of free access to drugs failed when the long history of regulation of drug safety was considered:

[Plaintiff’s] effort to focus on efficacy regulation ignores one simple fact: it is unlawful for [anyone] to procure experimental drugs not only because they have not been proven effective, but because they have not been proven safe. Although [plaintiff] contends that it only wants drugs that “are safe and promising enough for substantial human testing,” i.e., drugs that have passed Phase I testing, current law bans access to an experimental drug on safety grounds until it has successfully completed all phases of testing.
2007 WL 2238914, at *6.

OK, we suppose that’s right, but just exactly how relevant is it in this context? We’re the first to admit that drug safety is of paramount importance, but this case is about people who are going to die anyway – unless some miracle happens. It sort of reminds us of Heckler v. Chaney, 470 U.S. 821 (1985), in which a bunch of death row inmates sued because the use of drugs for lethal injections wasn’t a use that the FDA had been approved as “safe and effective.” Needless to say, they lost.

If a terminal cancer patient has six weeks to live, does it really matter if a potentially lifesaving drug might increase the risk of heart attack or diabetes? We think there are just some extreme situations in which drug safety doesn’t count for all that much. This is one of them.

Like we say, we’re conflicted. We like the result, but some of the reasoning the court employs to get there is rather hard to defend.

The court next went into excruciating detail concerning the history of governmental control over the safety of drugs going all the way back to 1447. Id. at *6-8. The net result of all this history is that the court finds plenty of legal basis for the FDA’s role in regulating experimental drugs.

However, once again the rhetoric gets a little over the top. The court finds no tort-based justification for “a constitutional right to override the collective judgment of the scientific and medical communities expressed through the FDA’s clinical testing process.” Id. at *9. While we agree with the sentiment about tort law – strip away the constitutional overlay and the court gave a pretty good description of conflict preemption – the notion of FDA approval as expressing “collective” medical and scientific judgment is questionable when a very large percentage of all prescriptions written in this country are for off-label uses. E.g., David C. Radley, et al., Off-Label Prescribing Among Office-Based Physicians, 166 Arch. Internal Med. 1021, 1023 (2006) (over 20% of all prescriptions off-label; 46% of cardio-vascular prescriptions off-label); Shane M. Ward, WLF & the Two-Click Rule: The First Amendment Inequity of the Food & Drug Administration’s Regulation of Off-Label Drug Use Information on the Internet, 56 Food & Drug L.J. 41, 45-46 (2001) (off-label use over 30% for cancer, 40% for AIDS, 80% for children, and 90% for patients with rare diseases). While the FDA certainly has a big role to play, the importance of that role can be exaggerated, and we think the DC Circuit did so here. This is another reason for our conflicted attitude towards the Abigail Alliance litigation.

In the end, however, it was the Supreme Court precedent upholding the FDCA against similar, but sometimes non-constitutional, challenges that proved dispositive. In Gonzales v. Raich, 545 U.S. 1, 28 (2005), and United States v. Oakland Cannabis Buyers’ Co-op., 532 U.S. 483, 490 (2001), the Court considered a variety of arguments and rejected claimed constitutional and non-constitutional grounds for allowing the medicinal use of marijuana. In Rutherford, 442 U.S. at 552, the Court had refused to resort to "statutory interpretation" to create an implied “medical necessity” exception that would have permitted access to supposedly curative drugs by the terminally ill.

That was enough to kill the notion of terminally ill patients’ right as a protected constitutional right. The Abigail Alliance court then went through the motions of applying the “rational basis” test (otherwise known as the “plaintiff always loses” test), to the FDA’s restrictions upon the use of unapproved drugs. Not surprisingly, those restrictions passed that test with flying colors:

Although terminally ill patients desperately need curative treatments, as Rutherford holds, their deaths can certainly be hastened by the use of a potentially toxic drug with no proven therapeutic benefit. Thus, we must conclude that, prior to distribution of a drug outside of controlled studies, the Government has a rational basis for ensuring that there is a scientifically and medically acceptable level of knowledge about the risks and benefits of such a drug.
2007 WL 2238914, at *12.

So back to the beginning: Why, oh great defenders of off-label use, is this not analogous to the therapeutic use of drugs for unapproved uses? It is, sort of, but then it isn’t. The main differences are:
  • Off-label use involves a drug that’s had its basic safety thoroughly reviewed and found sufficient for at least some human use. Completely unapproved drugs have had little if any safety screening.
  • Drugs used off-label are manufactured in this country (or at least up to prevailing FDA standards), in accordance with accepted good manufacturing practices. (We’re assuming legality here.) Totally unapproved drugs, the sale of which is illegal, could come from anywhere, be manufactured in somebody’s basement, and have handwritten labeling.
  • Unlike off-label use, there’s no procedure for reporting and categorizing adverse reactions to drugs lacking any FDA approval whatsoever.
  • Drugs used off-label are nevertheless dependably on the market for their approved uses. Most unapproved drugs are at best in the process of being investigated. Such investigations might fail, or the owner of the drug might decide not to proceed for any number of reasons, some of which might be economic in nature.

For these reasons, when push comes to shove, we have to agree with the FDA on the basic point. If the FDA can’t at least require that a drug be approved as safe and effective for some purpose before it can be sold, then there wouldn’t be much left of the FDA’s regulatory authority. Add to that the practical problems in dealing with drugs that aren’t necessarily being made by anyone we’d feel comfortable buying them from, and we don’t find the off-label use analogy all that compelling.

But as lawyers representing clients, we can’t pretend that there isn’t more at work here (well, we could, but that wouldn’t be very persuasive, and you’d stop reading our blog). If the Abigail Alliance plaintiffs had succeeded against the FDA today, they’d be suing our clients tomorrow.

Why?

Well, who’s got the drugs that those plaintiffs want?

Our clients, the drug manufacturers, that’s who.

Even without a constitutional right to give them momentum, some desperate, terminally ill participants in FDA-approved clinical trials have sued manufacturers demanding that they continue supplying them with experimental drugs after the manufacturer has made the decision not to continue with trial. See Abney v. Amgen, Inc., 443 F.3d 540 (6th Cir. 2006). The Sixth Circuit described the claims in Abney thusly:

The plaintiffs in this case are eight individuals involved in a clinical drug trial sponsored by [defendant]. When the study was terminated, the plaintiffs sued claiming that [defendant] was legally required to continue providing them with the drug.

Id. at 542.

The study-subject plaintiffs in Abney lost, because nothing in the informed consent forms they signed or in the study materials they received amounted to a contractual promise to keep giving them the medication after the manufacturer decided not to continue with the study. Id. at 548-49. The court also determined that the manufacturer had done nothing that amounted to a promissory estoppel (a fancy legal term for a promise not meeting the standards for a contract, but that the court decides to enforce anyway), id. at 549-50, and had not formed a fiduciary relationship with any of the study subjects. Id. at 550-51.

Chillingly, while the claims against the manufacturer failed in Abney, the court suggested that the plaintiffs might have been on firmer ground suing the hospital at which the study was being conducted. Id. at 551. In making that suggestion, the court forgot one little detail – the suit was for a preliminary injunction to continue supplying certain medications. If enjoined, the hospital would have had to get the medication from somewhere. We repeat, who’s got the drugs that those plaintiffs want? The manufacturer, of course. The plaintiffs in Abney weren’t dumb, they went right to the source.

Abney is just the tip of the iceberg. A nifty little biotech blog we just discovered lists five examples of similar litigation that haven’t yet matured into any published opinions. We can just imagine how Abney and similar cases might turn out if, instead of having to argue contracts and estoppels, the plaintiffs are able to point to a newly-minted “fundamental” constitutional right as the basis for seeking an injunction. That’s why we’re more relieved than anything else at the result in Abigail Alliance.

Think about it, just what would our clients be required to do if there were a constitutional right of access to unapproved and experimental drugs? What warnings would our clients have to put on the totally unapproved drugs that they’d be required to supply? There are no standards – by definition there can’t be. From our perspective as tort lawyers we’d probably advise our clients to give the ultimate warning:

WARNING: This drug ain’t approved for nuthin. If you take it, there’s a good chance it’ll kill you – but we don’t know how. Don’t expect it to work either. We really don’t know what this stuff’ll do, and we ain’t gonna try to find out. Take this entirely at your own risk.

Trouble is, if a manufacturer did put a warning like that on an unapproved drug, it would go to jail. If a manufacturer put any warning at all on an unapproved drug, it would go to jail. The FDA simply doesn’t let manufacturers from making any statements at all about unapproved uses, let alone entirely unapproved drugs. It’s called “promotion,” and it’s illegal.

The recognition of a constitutional right of access to entirely unapproved drugs would create a Catch-22 legal environment where, on the one hand a company definitely should provide warnings – if only to protect itself from liability – but the law absolutely forbids giving them.

Plainly, in addressing the claim of a broad, vague new constitutional right, neither side in Abigail Alliance gave much thought to the practicalities of the situation. In order to satisfy that right, would the manufacturer of an experimental drug be forever locked into providing it, even after it had decided not to proceed with commercialization? FDA good manufacturing practices are pretty strict. Unless manufacturing is turned over to some fly-by-night foreign operation (which nobody advocates), to keep a production process going for a minuscule population claiming constitutional entitlement is not a cheap proposition. So from a purely monetary standpoint, we’re pleased that no new constitutional right is going to interfere with our clients’ ability to allocate their limited resources available for research in favor of those drugs in the pipeline that appear to have the most promise.

Isn’t that putting the crass commercial interests of drug companies ahead of the needs of desperately ill people? Well, if it is, then we’re in good company – eight of ten DC circuit court judges agree with us. Not bad for a couple of tort lawyers whose only real familiarity with constitutional law is limited to preemption and the First Amendment.

Further, we don’t think so, for two reasons: (1) forcing an uneconomic reallocation of research dollars will ultimately result in fewer FDA approvable “safe and effective” drugs being discovered, something that would wind up hurting many more people than a few unapproved drugs could possibly help; and (2) creating an uncertain, litigation-charged environment around experimental drugs that might cure fatal diseases would have any number of unintended consequences – from making enrollment in clinical trials more difficult, to driving the conduct of such trials out of the country altogether.

Nor does it hurt that we’re defense lawyers, and this kind of pejorative rhetoric is something we’ve had thrown at us in practically every case we have to defend.

All of this is why, in the end, we think that notwithstanding some questionable reasoning, the court got it right. These plaintiffs, like so many others, have fallen prey to judicial triumphalism – the notion that litigation and court decisions are the best way to solve any and all societal problems. The solution isn’t for courts to create another undefined constitutional right enforceable through amorphous litigation. Rather, Congress should legislate, and the FDA should regulate to create an environment in which experimental drugs can be available for terminally ill patients under rational and economically sensible criteria, and in which drug companies can provide such drugs without the risk of being sued or being subject to administrative sanction.

That’s precisely what the majority said towards the end of their opinion:

The [plaintiffs’] arguments about morality, quality of life, and acceptable levels of medical risk are certainly ones that can be aired in the democratic branches, without injecting the courts into unknown questions of science and medicine. Our Nation’s history and traditions have consistently demonstrated that the democratic branches are better suited to decide the proper balance between the uncertain risks and benefits of medical technology, and are entitled to deference in doing so. . . . [O]ur holding today ensures that this debate among the Alliance, the FDA, the scientific and medical communities, and the public may continue through the democratic process.

2007 WL 2238914, at *12-13 (emphasis added). That’s something with which we agree whole-heartedly.