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. 

Proof of General Causation in Drug Case Not Automatic

A West Virginia federal court has granted summary judgment against a plaintiff alleging that the heartburn drug metoclopramide caused her tardive dyskinesia.  Meade v. Parsley, et al., 2010 WL 4909435 (S.D.W.Va.,  11/24/10).

Since its approval by the Food and Drug Administration in 1980, metoclopramide has been widely used to treat gastroesophageal reflux disease (“GRD”), nausea, and gastroparesis.  Plaintiff's treater, Dr. Deidre Parsley, prescribed metoclopramide to Mrs. Meade in order to treat her
GRD, nausea, and loss of appetite. Plaintiff  never read any written materials accompanying her metoclopramide prescriptions, which included a statement that therapy longer than 12 weeks has not been evaluated and cannot be recommended.  Dr. Parsley likewise did not read the metoclopramide package insert or any other written materials produced by PLIVA before prescribing the drug to Mrs. Meade. After the drug usage, the FDA added a black box warning about tardive dyskinesia.  But, save for the placement of the warning in a black box, the previous warning seemed not too different.

Plaintiffs contended that the warnings were inadequate in that they misleadingly invited long term use that has never been approved by the FDA, despite the fact that the warning did state that therapy longer than 12 weeks has not been evaluated and cannot be recommended. In addition,
plaintiffs claim that the warnings downplayed the seriousness and potential irreversibility of the risk of tardive dyskinesia in long term use, but the warning did state that the risk is highest among the elderly, especially elderly women (like this plaintiff), and that the likelihood of irreversibility is believed to increase with the duration of treatment and the total cumulative dose. 

Defendant moved for summary judgment, contending that there were no genuine issues of material fact inasmuch as (1) plaintiffs could not establish causation; (2) Dr. Parsley was aware of the risks of using metoclopramide when she prescribed the drug to Mrs. Meade; (3) PLIVA satisfied any alleged duty to warn by providing a package insert explaining potential side effects of
metoclopramide.  The court never had to reach the third argument.

In a pharmaceutical products liability action, a plaintiff must initially establish both general and specific causation for his injuries. Bourne ex rel. Bourne v. E.I. Dupont de Nemours & Co., 189 F. Supp. 2d 482, 485 (S.D. W. Va. 2002).  General causation is whether a substance is capable of causing a particular injury or condition in the general population, while specific causation is whether a substance caused a particular individual's injury. In re Rezulin Prods. Liab. Litig., 369 F.
Supp. 2d 398, 402 (S.D.N.Y. 2005); In re Hanford Nuclear Reservation Litig., 292 F.3d 1124, 1129 (9th Cir. 2002). General causation is established by demonstrating, often through a review of scientific and medical literature, that exposure to a substance can cause a particular disease.

In addition to general and specific causation, plaintiffs must establish proximate causation.To
show proximate causation in a failure-to-warn case based on an allegedly inadequate drug label, a plaintiff must show that a different label or warning would have avoided the plaintiff’s injuries. The court noted that the West Virginia Supreme Court has not had occasion to clarify whether a drug manufacturer must warn both the patient and the physician, or just the patient.  But it did not need to resolve this issue in evaluating proximate causation, however, because the undisputed evidence shows that an adequate warning would not have changed either Mrs. Meade’s or Dr. Parsley’s behavior in a manner which would have avoided Mrs. Meade’s injury.  Rather than merely showing that “adequate warnings would have changed behavior,”  as plaintiff argued, plaintiffs must
establish that an adequate warning would have changed behavior in a manner which would have avoided the plaintiff’s injury.  Mrs. Meade testified that she never read the package insert or any other documents accompanying her metoclopramide prescription.  Dr. Parsley likewise testified that she did not read the metoclopramide warning. And while Dr. Parsley did read the PDR for
the brand name version of the drug, it is undisputed that the defendant did not create that PDR.

The more interesting part of the opinion for our readers is the treatment of the issue of general causation.  It seems that none of plaintiffs’ retained experts offered any opinions regarding general
causation. So plaintiffs were left to argue that several of Mrs. Meade’s treating physicians (whom plaintiffs began referring to as “non-retained experts”) testified regarding the causal link between metoclopramide and tardive dyskinesia. None of these non-retained experts provided written
reports, and in deposition none of these physicians testified directly as to general causation. They assumed causation as a prelude to a specific causation opinion, but this mere assumption does not establish general causation. The law is clear that a mere possibility of causation and, more
specifically, indeterminate expert testimony on causation that is based solely on possibility is not sufficient to allow a reasonable juror to find causation. 

As an alternative basis for general causation, plaintiffs tried to rely on the fact that defendant's own package inserts and brand name warnings refer to a "causal link” between metoclopramide and tardive dyskinesia. Plaintiffs could cite no authority for the proposition that a plaintiff in a pharmaceutical products liability case can satisfy his or her burden of proving general causation by relying on the defendant manufacturer’s drug label warnings. Moreover, this contention was undermined by the general principle that causation evidence in toxic tort cases must be in the form of expert scientific testimony.  PLIVA’s drug label, which merely warns of metoclopramide’s potential side-effects without explaining the scientific basis for the warning, was no substitute for expert testimony that establishes causation in terms of reasonable probability.

Third, plaintiffs also tried to cite, as evidence of general causation, the subsequent FDA directive requiring drug manufacturers to insert a black box warning on metoclopramide labels to convey a
greater risk of tardive dyskinesia. The court, as have several other courts have, however, rejected reliance on agency determinations as a basis for general causation. Inasmuch as the cost-benefit balancing employed by the FDA differs from the threshold standard for establishing causation in tort actions, this court likewise concluded that the FDA-mandated tardive dyskinesia warning cannot establish general causation.

 Summary judgment granted.

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.

 

 

 

 

Defense Use Of Plaintiffs' Treaters As Experts In MDL Disallowed

The Magistrate Judge in the Kugel Mesh Hernia Repair Patch MDL has refused to allow defendants to retain as experts any physicians who have treated any of the plaintiffs. See In re: Kugel Mesh Hernia Repair Patch Litigation, MDL Docket No. 07-1842ML (Order 9/19/08).

The Court had previously ordered that defendants were precluded from engaging in substantive ex parte communications with plaintiffs’ treating physicians. Defendants proposed, however, to have the ability to retain a plaintiff’s treating physician as a consulting or testifying expert as long as they do not call the expert in his/her patient’s case and refrained from discussing with him/her the medical history of that patient/plaintiff.

The Court saw the motion as requiring it to balance the trust and confidentiality embodied
in the physician-patient relationship against a litigant’s right to reasonably assemble and present a defense.

The reality of some mass torts is that:

-the sheer number of plaintiffs may preclude defendants from retaining any consultants who are not also treating physicians of some plaintiffs;

-this is especially true in the case of medical devices in which the experts in the devices are experts mainly because they treat people using those devices;

-in mass torts, with thousands of cases in multiple venues, defendants need multiple experts;

-allowing defendants access to treaters -- who are not automatically experts for the plaintiff, but who possess knowledge needed by both sides – may accelerate the discovery process.

The Court here, however, adopted the balancing performed by the Rhode Island Superior Court, which currently sees more than 1000 of these cases. See In re: All Individual Kugel Mesh Cases, 2008 R.I. Super. LEXIS 101 (R.I. Super. August 26, 2008). The state court concluded that any “potential inconvenience” to defendants in engaging experts was “significantly outweighed” by plaintiffs’ right to confidentiality in their medical matters. Id. at *9.

The Court may have given insufficient weight to the protection available from the fact that the treater, if consulted by the defense on plaintiff X, is under an independent ethical duty not to disclose confidential information about patient Y. And the doctor is always available to be deposed about whether he or she was even asked any questions about a patient.

The Court criticized the defendants for not specifically identifying the “small group of hernia repair specialists” who were inevitable, likely treaters of one or more plaintiffs. (“The fact that only one surgeon to date has fallen into the consultant/treating physician category belies Defendants’ claims of prejudice.”) However, generally, and without any knowledge of this specific MDL, MassTortDefense would assert that the issue was not whether defendants had already identified many potential experts who were also treaters. The prejudice comes when defendants cannot find qualified experts who are not treaters and thus must turn to the treater pool –even if they haven’t already done so and thus cannot identify the specific overlapping people. Defendant has no easy way, absent revealing substantial confidential work product, of showing that it cannot find adequate and sufficient experts without resort to the treater pool. Courts, particularly MDL courts, may need to seek a deeper understanding of the reality of expert retention.