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. 

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. 

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.

State Supreme Court Upholds Verdict For Device Maker

The Connecticut Supreme Court recently took a second look at a case offering guidance on the application of the learned intermediary defense, and affirming a judgment for pacemaker manufacturer Medtronic Inc. See Hurley v. Heart Physicians PC, 298 Conn. 371, 2010 WL 3488962 (9/14/10).

The plaintiff was born with a congenital complete heart block condition that interfered with her heart's capacity to produce a safe heart rhythm. When she was seven days old, her physicians implanted a cardiac pacemaker manufactured by the defendant. Every few years, plaintiff received a new pacemaker manufactured by the defendant, allowing her to grow and live a normal life. When the plaintiff was fourteen years old, her pacemaker's elective replacement indicator signaled that the pacemaker battery was nearing the end of its life cycle and was wearing down. The plaintiff's cardiologist asked a representative of the defendant, to attend an examination of the plaintiff and to test the battery in her pacemaker. In so doing, in part because of issues about replacing the entire unit, the rep allegedly presented to the doctor the option of lowering the rate. He explained that, by taking the rate from sixty to forty paces per minute, it would give them more time before a device would hit the "end point," and thus more time to work on the "replacement situation."

The approach was taken, but a few weeks later the plaintiff went into cardiac arrest while at school, and allegedly suffered permanent brain damage.  Plaintiff sued, and the trial court granted summary judgment in favor of the device company on the failure to warn claim, based on the learned intermediary doctrine. The state supreme court reversed this judgment with respect to the plaintiff's product liability claim, finding that an issue of material fact existed as to whether the rep's words and actions were in derogation of the pacemaker's technical manual --whether he undercut the warning that was given. After remand, a jury trial was held, and the jury returned a verdict in favor of the defendant. The trial court rendered judgment in accordance with the verdict, and this (second) appeal followed.

The plaintiff's claim before the trial court (both times) was based on the assertion that the defendant's representative had made statements to plaintiff's treating physician, and had engaged in conduct (recommending that the pacemaker's function level be reduced), which nullified the warnings regarding battery replacement that were contained in the pacemaker's technical manual.  The plaintiff claimed that, because the statements and conduct nullified the pacemaker's adequate published warnings about the risks inherent in setting the pacemaker at a reduced level, the defendant had, net, failed to properly warn her of the potential risks associated with reducing the pacemaker's function in lieu of replacing the battery.  Defendant contended that the plaintiff's physician was a learned intermediary and stood in the best position to evaluate and to warn the plaintiff of any risks associated with reducing the pacemaker's function and, as a result, it was not their obligation to warn the plaintiff.

Concerning the trial after remand, plaintiff claimed that the trial court improperly required her to prove that the rep's advice and conduct “actually contradicted,” and therefore “vitiated” and “nullified” the warnings in the manual. She contended that she should have been required to prove only that his actions were “inconsistent” with the manual, which she contended was a less onerous requirement than the one applied by the trial court.

On appeal again, the state supreme court found that the trial court properly reviewed its mandate within the context of the entire opinion and proceeded properly with a jury trial in order to secure a factual finding by the jury as to whether the advice and conduct were in accordance with the pacemaker's manual. The trial court based the relevant jury charge and the jury interrogatory on the factual issue that it had determined could not be resolved as a matter of law. Indeed, the trial court carefully tracked the language used in the first appeal.  The relevant interrogatory asked the jury to determine whether “the [p]laintiff [has] proven by a fair preponderance of the evidence that [rep], by his oral communications to [doctor] that turning down the pacemaker was an option, accompanied by his physical adjustment of the pacemaker to forty paces per minute, actually contradicted the technical manual thereby vitiating and nullifying the manual's warnings....” 

The court disagreed with the plaintiff that the trial court imposed a heightened burden of proof because, first, the trial court directly cited what the supreme court had determined to be the remaining triable factual issue, and, second, the words “contradict” (used by the trial court)and “inconsistent”  (used by the supreme court) are interchangeable.  In this context, the words are synonymous, said the court.  No error in the instruction, so no reversal of the jury verdict.

 

Court of Appeals Vacates Jury Verdict for Plaintiff in Welding Case

The Sixth Circuit last week vacated one of the rare plaintiff verdicts in the welding rod litigation.  Tamraz  v. Lincoln Electric Co., et al., 2010 WL  3489002 (6th Cir. 9/8/10).  The key issue in the appeal was the trial court's decision to allow a causation expert, Dr. Walter Carlini, to testify on behalf of the plaintiff Jeff Tamraz over defendants' Daubert challenge.

From roughly 1979 to 2004, Jeff Tamraz worked as an independent-contracting welder in California, on bridges and buildings.  Plaintiffs contended that Mr. Tamraz suffers from manganese-induced Parkinsonism as a result of exposure to manganese-containing welding fumes on these jobs.

The case went to trial in 2007, and the jury in the Northern District of Ohio (plaintiffs are from Oregon) returned a plaintiff verdict, awarding $17.5 million to Jeff Tamraz in compensatory damages and $3 million to his wife, Terry Tamraz, for loss of consortium.

Defendants, including Lincoln Electric, Hobart Brothers Co. and ESAB Group Inc., appealed on various grounds, including the trial court's decision to permit the testimony of Dr. Carlini on causation issues despite the Daubert challenge.

The opinion offers a number of useful observations for toxic tort litigation, especially on the almost-always central issue of causation.

It begins with a nice overview of the science on the spectrum of movement disorders often termed "parkinsonism" that have different causes and different but overlapping symptoms.  No one disputed that plaintiff here suffered from parkinsonism; the questions were what kind and from what cause. Apparently, every doctor to examine Tamraz reached a different conclusion about one or both of those issues.  Plaintiff's expert concluded that Tamraz suffers from “manganese-induced parkinsonism,” but not in the sense of a manifestation of the disease "manganism," as that phrase is sometimes used in these welding cases. Rather, he believed that manganese exposure caused something closely akin to traditional Parkinson's Disease in Tamraz.  Dr. Carlini hypothesized that Tamraz might have a genetic predisposition to Parkinson's Disease, and that manganese in lower levels than necessary to cause true manganism might nevertheless “trigger” the symptoms of Parkinson's Disease, like “the straw that broke the camel's back.” He did not believe that Tamraz has Parkinson's Disease in the strict medical sense, but manganese caused a disease that he believed to be otherwise similar to Parkinson's Disease. 

Defendants disputed this conclusion that manganese exposure caused the illness; that is, they challenged Dr. Carlini's etiology (what caused the disorder diagnosed?), not the methodology to arrive at his general spectrum diagnosis (what disorder caused the set of symptoms observed?).  And the Sixth Circuit agreed there were serious issues here. The problem here was that, when Dr. Carlini testified that manganese exposure caused Tamraz's condition, he went beyond the boundaries of allowable testimony under Rule 702.

The opinion was at most a working hypothesis, not admissible scientific “knowledge.” Fed.R.Evid. 702. His theory was a "plausible hypothesis. It may even be right. But it is no more than a hypothesis."  For example, the expert admitted that the literature hypothesizing a link between environmental toxins and latent genetic Parkinson's Disease was “all theoretical.”  He also conceded there were no studies finding a link between manganese and true Parkinson's Disease.  He further he conceded that he was speculating that Tamraz had an underlying predisposition to Parkinson's Disease, even though Tamraz had no family history of Parkinson's Disease. 

And finally, even if manganese could cause Parkinson's Disease in someone like Tamraz, that did not show that manganese did cause Tamraz's Parkinson's Disease. Parkinson's Disease occurs commonly in the general population and usually without any known cause. Any given case of Parkinson's Disease thus might have occurred regardless of the manganese exposure, making it hard to attribute one case to manganese exposure over all of the other possible causes.

Plaintiffs stressed on appeal that Dr. Carlini opined “with a reasonable degree of medical certainty,” but the court of appeals correctly noted that the phrase --the conclusion by itself-- does not make a causation opinion admissible. The “ipse dixit of the expert” alone is not sufficient to permit the admission of an opinion. General Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997). Minus that one phrase, nothing in this testimony took the opinion beyond speculation, theory, hypothesis. 

Plaintiffs, understandably, also tried to bolster the opinion by emphasizing areas of agreement among experts on the general diagnosis of some parkinsonism disorder.  But in conflating “manganese-induced parkinsonism” with manganism, plaintiff conflated diagnosis with etiology, erasing the distinction between Tamraz's disease and what caused it. Diagnosis and etiology, however, both were in play in this case. Because Dr. Carlini diagnosed Tamraz with something akin to Parkinson's Disease, not manganism, and because Parkinson's Disease unlike manganism has no standard etiology and lots of idiopathic cases, Dr. Carlini's etiology opinion had to rise or fall on its own.

Plaintiffs also trotted out the standard "differential diagnosis" argument, the tent that supposedly (and too often does) covers all kinds of unreliable causation opinions from medical experts.  The court here made some very useful observations about this issue. 

1) Most treating physicians have more training in and experience with diagnosis than etiology. See D. Faigman, Judges as “Amateur Scientists”, 86 B . U. L.Rev. 1207, 1221-22 (2006); E. Imwinkelried, The Admissibility and Legal Sufficiency of Testimony About Differential Diagnosis (Etiology), 56 Baylor L.Rev. 391, 405 (2004); M. Henefin, Reference Guide on Medical Testimony, in Reference Manual on Scientific Evidence 439, 471-72 (2d ed.2000). 

2) When physicians think about etiology in a clinical setting, moreover, they may think about it in a different way from the way judges and juries think about it in a courtroom. 

3) Getting the diagnosis right matters greatly to a treating physician, as a bungled diagnosis can lead to unnecessary procedures at best and death at worst. See Bowers v. Norfolk S. Corp., 537 F.Supp.2d 1343, 1361 (M.D.Ga.2007). But with etiology, the same physician may often follow a precautionary principle: If a particular factor might cause a disease, and the factor is readily avoidable, why not advise the patient to avoid it? Such advice  --telling a worker, say, to use a respirator-- can do little harm, think the doctors, and might do some good. See J. Hollingsworth & E. Lasker, The Case Against Differential Diagnosis: Daubert, Medical Causation Testimony, and the Scientific Method, 37 J. Health L. 85, 98 (2004). A lower threshold for making a causation decision serves well in the clinic but not in the courtroom, said the court. 

Of course, some courts permit the physician to testify as to etiology using this methodology, e.g., Hardyman v. Norfolk & W. Ry. Co., 243 F.3d 255, 260-67 (6th Cir.2001), but even these courts must apply the Daubert principles carefully in considering it. The ability to diagnose medical conditions is not remotely the same as the ability to deduce, in a scientifically reliable manner, the causes of those medical conditions. Gass v. Marriott Hotel Servs., Inc., 501 F.Supp.2d 1011, 1019 (W.D.Mich.2007), rev'd on other grounds, 558 F.3d 419 (6th Cir.2009). Doctors thus may testify to both, at least in the Sixth Circuit, but the reliability of one does not guarantee the reliability of the other. 

Thus, whether plaintiffs described Dr. Carlini's causation methodology as “differential etiology” or “differential diagnosis,” that label does not make it reliable. Using the differential diagnosis method is not some "incantation that opens the Daubert gate.”  The issues remain, did the expert make an accurate diagnosis of the nature of the disease? Did the expert reliably rule in the possible causes of it? Did the expert reliably rule out the rejected causes? If the court answers “no” to any of these questions, the court must exclude the ultimate conclusion reached. See Best v. Lowe's Home Ctrs., Inc., 563 F.3d 171, 179 (6th Cir .2009).

Here, Dr. Carlini's opinion failed the last two prongs because his efforts to “rule in” manganese exposure as a possible cause, or to “rule out” other possible causes, turned on speculation and theory and hypothesis, not a valid methodology. 

While expressing sympathy for the plaintiffs, the court observed that ignoring Rule 702 — allowing the law to "get ahead of science" — would be just as unfair. Such an approach eventually would destroy jobs and stifle innovation unnecessarily, because it would impose liability on business based on speculation, not science.

Case remanded for new trial, with different evidence obviously. 

(The dissent would have found the challenge going to the weight, not admissibility of the testimony, and the trial court's decision not an abuse of discretion.)

Lone Pine Ruling Affirmed in Vioxx

The Sergeant Joe Friday character on Dragnet was created and played by actor Jack Webb.  Like so many famous lines, the immortal words, "Just the facts, ma'am," were apparently never uttered by the character.  What Friday actually said in early episodes is "All we want are the facts, ma'am."  

Either way, that's our motto when we post about litigation the firm has been involved in.  But with that limitation, a noteworthy decision is In re Vioxx Products Liab. Litig., 2010 WL 2802352 (5th Cir. July 16, 2010).

After a tentative settlement was reached in the Vioxx litigation, the MDL court entered several pre-trial orders with respect to the claims of those plaintiffs who could not or chose not to participate in the Master Settlement Agreement (MSA).  PTO 28 required non-settling plaintiffs to notify their healthcare providers that they must preserve evidence pertaining to the plaintiffs' use of Vioxx. Plaintiffs were also required to produce pharmacy records and medical authorizations, answers to interrogatories, and a Rule 26(a)(2) report from a medical expert attesting that the plaintiff sustained an injury caused by Vioxx and that the injury occurred within a specified time period. Failure to comply could result in dismissal of the plaintiffs' claims with prejudice.

PTO 28 is characterized as a Lone Pine order, named for Lore v. Lone Pine Corp., No. L-33606-85, 1986 WL 637507 (N.J.Super. Ct. Law Div. Nov. 18, 1986). Lone Pine orders are designed to handle the complex issues and potential burdens on the aprties and the court in mass tort litigation. Acuna v. Brown & Root Inc., 200 F.3d 335, 340 (5th Cir.2000).

The trial court extended deadlines, but eventually defendant Merck moved for an Order to Show Cause as to sixty-one plaintiffs for alleged failure to provide a case-specific expert report as required by PTO 28. The plaintiffs filed responses, arguing that they were in substantial compliance with PTO 28 and that state substantive law only required general forms of causation proof. In April 2009, the district court dismissed these plaintiffs' complaints with prejudice for failure to comply with PTO 28.

A district court's adoption of a Lone Pine order and decision to dismiss a case for failing to comply with a Lone Pine order are reviewed for abuse of discretion. Acuna, 200 F.3d at 340-41. The district court stated that “it is not too much to ask a plaintiff to provide some kind of evidence to support their claim that Vioxx caused them personal injury.”

The court of appeals had previously held that such orders are issued under the wide discretion afforded district judges over the management of discovery under Federal Rule 16. The court had held that the Lone Pine orders essentially required information which plaintiffs should have had before filing their claims pursuant to Rule 11.  Each plaintiff should have at least some information regarding the nature of his injuries, the circumstances under which he could have been exposed to harmful substances, and the basis for believing that the named defendants were responsible for his injuries.

The Fifth Circuit reaffirmed its view that it is within a trial court's discretion to take steps to manage the complex and potentially very burdensome discovery that these mass tort cases would require. The court of appeals thus affirmed the judgment of the district court.
 

Maryland Court Resists Imposing "Duty To The World" On Pharmaceutical Maker

Maryland's top court recently affirmed summary judgment for defendant Eli Lilly & Co., in a case brought by a widow whose husband was killed in an auto accident. His car was allegedly hit by a diabetic who blacked out while under treatment with two insulin medications. Gourdine v. Crews, No. 134 (Md. Ct. App. 9/4/08).

Background
Ellen Crews, a Type I diabetic who was taking a combination of insulin medications from Lilly, while operating her car, allegedly suffered some kind of debilitating episode and struck a vehicle driven by Isaac Gourdine, resulting in his death. The issue for the Court was whether Lilly owed a duty to Mr. Gourdine, the third-party who did not ingest the drugs. Plaintiff, the wife of Mr. Gourdine, argued that it was somehow foreseeable to Lilly that Ms. Crews, might allegedly suffer an adverse reaction to the medications, which in turn would cause injury and death to third persons while she was operating a motor vehicle. If she had not been adequately warned about the dangers that allegedly were associated with the specified medications, that would supposedly impact a duty owed to Mr. Gourdine.

Specifically, Ms. Crews took a combination of Humalog, a quick-acting form of insulin taken with meals, and Humulin N, a medication designed to supply a constant source of insulin to the body. Ms. Gourdine contended that, at the time of the accident, Ms. Crews suffered a hypoglycemic reaction and experienced a “blackout” causing her to lose control of her vehicle. Defendant Lilly, plaintiff alleged, owed a duty to protect users of the highway from drivers suffering from hypoglycemia induced by the allegedly misbranded drug.

Lilly sought and obtained summary judgment below on the basis it owed no duty to decedent Gourdine, a nonuser of the drug, to warn about alleged risks associated with the medications. Plaintiff appealed, and the Maryland Court of Special Appeals affirmed; the case then went up again.

Reasoning
The Court began with a discussion of the elements of plaintiff’s causes of action, noting that duty is an essential element of both negligence and strict liability causes of action for failure to warn. In contrast to the reasoning of the lower courts, however, the Court stated that the duty issue should not be analyzed in the context of the learned intermediary rule – which holds that the manufacturer’s duty to warn is to the prescriber – but as an issue of the common law of torts.

At its core, the determination of whether a duty exists represents a policy question whether the specific plaintiff is entitled to protection from the acts of the defendant; ultimately, the determination of whether a duty should be imposed is made by weighing the various policy considerations and reaching a conclusion that the plaintiff's interests are, or are not, entitled to legal protection against the conduct of the defendant. The foreseeability test relied on by plaintiff  “is simply intended to reflect current societal standards with respect to an acceptable nexus between the negligent act and the ensuing harm.”  While foreseeability is often considered among the most important of the relevant factors, its existence alone does not suffice to establish a duty under Maryland law.

In this case, there was no direct connection between Lilly’s warnings, or the alleged lack thereof, and Mr. Gourdine’s in jury. In fact, there was no contact between Lilly and Mr. Gourdine whatsoever. To impose the requested duty from Lilly to Mr. Gourdine would expand traditional tort concepts beyond manageable bounds, because such duty could apply to all individuals who could have been affected by Mr. Crews after her ingestion of the drugs. Essentially, Lilly would owe a duty to the world, an indeterminate class of people, for which the Court has “resisted the establishment of duties of care.”

Gourdine attempted to draw support from cases in other jurisdictions, in which she asserted that a doctor's duty to warn his or her patient of the risks associated with medication extends to nonpatients who are foreseeably at risk. The Court responded that it has not historically embraced the belief that duty should be defined mainly with regard to foreseeability, without regard to the size of the group to which the duty would be owed, which the courts in Alabama, Hawaii, and Washington, according to plaintiff, have.

On the other hand, numerous jurisdiction had rejected this kind of universal duty, the Court noted. See Kirk v. Michael Reese Hospital & Medical Center, 513 N.E.2d 387 (Ill. 1987); Gilhuly v. Dockery, 615 S.E.2d 237, 239 (Ga. Ct. App. 2005) (patient who was involved in a car accident in which sons were injured filed suit on their behalf based on physician’s alleged failure to warn patient not to drive after taking certain medications; the Court of Appeals of Georgia rejected the claims on behalf of the sons because “[t]o expand a doctor’s duty to his patient to generally include members of the public at large in a case such as this one would be contrary to Georgia public policy”); Lester ex rel. Mavrogenis v . Hall, 970 P.2d 590, 597 (N.M. 1998) (holding that physician owed no duty non-patient injured in automobile accident with patient because the “consequences of placing a legal duty on physicians to warn may subject them to substantial liability even though their warnings may not be effective to eliminate the risk in many cases”); Rebollal v. Payne, 145 A.D.2d 617, 618 (N.Y. App. Div. 1988) (“There is no duty on the part of the operator of a methadone clinic to control the travel activities of a methadone patient giving rise to liability for accidents to a third party such as plaintiff’s decedent.”); Praesel v. Johnson, 967 S.W.2d 391, 398 (Tex. 1998) (stating that treating physicians do not owe a duty to third parties to warn epileptic patients not to drive, for purposes of negligence claims against physicians for failure to warn if patient has accident and injures third party during seizure; “Balancing both the need for and the effectiveness of a warning to a patient who already knows that he or she suffers from seizures against the burden of liability to third parties, we conclude that the benefit of warning an epileptic not to drive is incremental but that the consequences of imposing a duty are great.”).

Gourdine also argued that the Federal Food, Drug, and Cosmetic Act, which prohibits drug manufacturers from placing a misbranded product into interstate commerce, conferred a duty on Lilly. This statute and its regulations, however, are framed to protect the public in general, and, a statutory obligation which “runs to everyone in general and no one in particular” cannot impose a duty between two parties.