Supreme Court Denies Cert in Case Excluding Treater Opinions

Readers may recall our post about Simmons v. Novartis Pharmaceutical Corp., a case in which the Sixth Circuit affirmed the exclusion of plaintiff's expert testimony seeking to link osteonecrosis of the jaw to plaintiff's use of two cancer medications. The issue was specific causation, and the court helpfully noted that a treating physician’s testimony is subject to Daubert; that an expert's statement that he found “a very close association” between ONJ and the class of drugs is not enough; and that while a treater may be qualified to diagnose a patient, a diagnosis is merely a hypothesis, which does not by itself satisfy Daubert and Rule 702.

The Supreme Court earlier this month denied the plaintiff's cert petition. See Simmons v. Novartis Pharmaceutical Corp., U.S., No. 12-283, cert. denied 11/5/12).

Plaintiff had argued that when a case involves medication that has not been widely studied, and thus published about, a different standard should apply.  She also argued that the opinions would have been admissible under the law of Maryland which, she said, requires only that expert opinions be expressed “to within a reasonable degree of medical/dental probability.”

Novartis has had a number of victories in similar cases, challenging treating physicians who seek to offer expert causation opinions. 

Learned Intermediary Adopted in Texas

We cannot comment, but commend to your study the recent decision by the Texas Supreme Court on the applicability of the learned intermediary doctrine under state law. See Centocor Inc. v. Hamilton et al., No. 10-0223 (6/8/12, Texas).

In the context of prescription medication, the learned intermediary doctrine holds that a drug manufacturer satisfies its duty to warn when it informs a prescribing physician about the drug's potential risks. Most but not all jurisdictions have adopted the doctrine. 

Congratulations to my colleagues at Shook, Hardy & Bacon, including Gene Williams. and Manuel Lopez

Court of Appeals Rejects RICO Claim in Drug Case

One of the things we like to do here at MassTortDefense is keep an eye on the non-traditional claims plaintiffs concoct -- to evade the requirements of traditional torts, or to expand the group of "injured" plaintiffs.  Earlier this month the Third Circuit knocked down just such an attempt. See In Re: Schering Plough Corp. Intron/Temodar Consumer Class Action, Nos. 10-3046 and 10-3047 (3d Cir. May 16, 2012).

The issue here was an attempt by two groups of plaintiffs to hold a drug manufacturer liable for violating the federal Racketeer Influenced and Corrupt Organizations Act (RICO) by allegedly marketing drugs for off-label uses. The court of appeals affirmed that neither had standing to maintain this cause of action, primarily for failure to allege a plausible nexus between the assailed marketing campaign and the physicians‘ decisions to prescribe certain drugs for off-label use.

While off-label marketing is prohibited, prescription drugs frequently have therapeutic uses other than their FDA-approved indications. The FDCAct does not regulate the practice of medicine, and so physicians may lawfully prescribe drugs for off-label uses. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001) (recognizing off-label usage as an accepted and necessary corollary of the FDA‘s mission to regulate in this area without directly interfering with the practice of medicine); Wash. Legal Found. v. Henney, 202 F.3d 331, 333 (D.C. Cir. 2000) (physician may prescribe a legal drug to serve any purpose that he or she deems appropriate, regardless of whether the drug has been approved for that use by the FDA).

Plaintiffs' claims, as is so common, attempted to piggy-back off of prior government investigations. They alleged that Schering‘s marketing practices caused physicians to prescribe the drugs for off-label uses instead of equally effective alternative treatments that were approved for the prescribed uses or no medication at all. They assert that these marketing techniques led to a significant increase in prescriptions of the drugs for off-label uses, and contend that this caused the plaintiffs an "ascertainable loss" (key concept) because they supposedly paid millions of dollars for the drugs that they otherwise would not have paid.

The district court granted a motion to dismiss, and the plaintiffs appealed.

A motion to dismiss for lack of standing implicates Rule 12(b)(1) because standing is a jurisdictional matter, and 12(b)(6) with the Twombly/Iqbal guidance.  While the plausibility standard of those cases does not impose a probability requirement, it does demand more than a sheer possibility that a defendant has acted unlawfully. The plausibility determination is a context-specific task that requires the reviewing court to draw on its judicial experience and common sense; and some claims require more factual explication than others to state a plausible claim for relief.

The Constitution imposes a requirement that there be an actual case or controversy. Federal courts have developed several justiceability doctrines to enforce the case-or-controversy requirement, and perhaps the most important of these doctrines is the requirement that a litigant have standing to invoke the power of a federal court. The standing question is whether the plaintiff has alleged such a personal stake in the outcome of the controversy as to warrant his invocation of federal-court jurisdiction and to justify exercise of the court's remedial powers on his behalf. The plaintiff bears the burden of meeting the irreducible constitutional minimum of Article III standing by establishing three elements: First, the plaintiff must have suffered an injury in fact—an invasion of a legally protected interest which is (a) concrete and particularized and (b) actual or imminent, not conjectural or hypothetical. Second, there must be a causal connection between the injury and the conduct complained of—the injury has to be fairly traceable to the challenged action of the defendant, and not the result of the independent action of some third party not before the court. Third, it must be likely, as opposed to merely speculative, that the injury will be redressed by a favorable decision.

In addition to meeting the constitutional standing requirements, plaintiffs seeking recovery under RICO must satisfy additional standing criterion set forth in section 1964(c) of the statute: that the plaintiff suffered an injury to business or property; and that the plaintiff‘s injury was proximately caused by the defendant‘s violation.

The Union plaintiff on behalf of a proposed class of third-party payors alleged economic loss based on paying for ineffective drugs. Accordingly, to establish standing, it must allege facts showing a causal relationship between the alleged injury—payments for a specific drug that was ineffective or unsafe for the use for which it was prescribed—and Schering‘s alleged wrongful conduct. However, there were no averments that came close to satisfying this standard. It was pure conjecture to conclude that because Schering‘s misconduct supposedly caused other doctors to write prescriptions for ineffective off-label uses for other products, the Union ended up paying for prescriptions for a different drug due to the same kind of alleged misconduct. (Again, attempted piggy-backing on government allegations.)

The court of appeals spent considerable effort reviewing claims of a proposed class of plaintiff consumers, who tried to prove standing by incorporating materials from the government investigation and concocting a series of purported links between drug trials, marketing activities and prescribing doctors' behavior.  The district court rejected this, and plaintiffs' focus on appeal on the pleading standards for each of these claims was secondary to the threshold issue that the consumers did not adequately allege an injury fairly traceable to Schering‘s alleged misconduct. Although the complaint was replete with factual allegations and indeed asserted them with somewhat greater specificity than the third-party payor complaint, they do not present a plausible allegation actually linking the injuries to any type of miscommunication or false claim about the drugs that were actually prescribed.

No standing. Dismissal affirmed. 

MDL Court Addresses Ex Parte Communication With Treating Physicians

A recent federal court  decision explores a seemingly small but potentially crucial issue involving a product liability plaintiff's treating physicians.  In Re: Ortho Evra Products Liability Litigation, No. 1:06-40000, MDL Docket No. 1742 (N.D. Ohio).

Many product liability suits turn on a battle of the experts on issues of injury and causation.  In many cases, a key set of witnesses, therefore, are the plaintiffs' treating physicians. When the views of the treater are on the side of one party, that party will typically emphasize the "neutral" status of the witness and the fact that the treater has had more and closer contacts with the plaintiff.  Whichever side disagrees with the treater will try to emphasize that the doctor is not the "world class" expert on the relevant scientific issues, and that his or her real function was to treat the injury/illness, not figure out whether a particular product caused it.  Accordingly, the deposition of treating physicians -- and the preparation for those depositions -- can be a critical stage of products liability litigation.

In this MDL, defendants moved to regulate ex parte contacts with plaintiffs’ treating physicians. Defendants sought to prevent what many see as an unfair advantage by plaintiffs lobbying their theories of liability and causation upon the treating physicians during such ex parte contact -- often on the eve of deposition. 

Defendants asserted that this issue had been taken up by the New Jersey court in the Zometa/Aredia Litigation litigation.  In that New Jersey litigation, Gaus v. Novartis Pharmaceuticals Corp., No. MID-L-007014-07-MT (New Jersey, Oct. 29, 2009), the court emphasized the “unique set of practical concerns presented in mass tort cases” as well as the number of plaintiffs in determining that the court’s resources would be impaired by a flood of discovery disputes regarding each treating physician. To ensure the same right of access and promote an efficient discovery process, the court there ordered all parties to proceed by way of formal deposition of plaintiffs’ treating physicians. See also In re NuvaRing Products Liability Litigation, 2009 WL 775442 (E.D. Mo., 2009).

Here, the MDL court allowed plaintiffs’ counsel to have ex parte contact with treating physicians with an important limitation. Specifically, plaintiffs’ counsel can meet ex parte to discuss the physicians’
records, course of treatment and related matters, but not as to liability issues or theories, product warnings, defendant's research documents, or related materials. Violations of this approach, the court said, will result in sanctions.