DES Plaintiff's Reach for Market Share Liability Rejected Again

If asbestos is the grandfather of mass torts, the DES litigation may be the grandmother, with claims continuing today for harm allegedly caused by in utero exposure to diethylstilbestrol decades ago. DES is a drug once prescribed during pregnancy to prevent miscarriages or premature deliveries. In the U.S. an estimated 5 to 10 million persons were exposed to DES from 1938 to 1971, including pregnant women prescribed DES and their children. So we are 40 years out now, with some litigation remaining.

Recently, a federal court in New York held that a DES plaintiff could not meet the product identification requirement under applicable Texas law.  See Bezuidenhout v. Abbott Laboratories,  No. 10-CV-1011(E.D.N.Y., 1/17/13).

Readers may recall that what is often termed "product identification" is part of the cause in fact requirement of every tort claim.  A plaintiff must show that he or she has been injured not just by a type of product but by a product actually made or sold by the defendant.  In the context of DES, product identification may be especially challenging because the plaintiff's exposure may be in utero and the manifestation of the injury may not come for many years after the exposure.  A tiny minority of jurisdictions have flirted with weakening the traditional cause in fact requirement by adopting some form of the "market share" doctrine, under which defendants may be held proportionately liable to a plaintiff who cannot show which manufacturer sold the product that caused the injury, based on that defendant's sales of the product in the "relevant market."  Flawed and unfair, the concept did not gain wide acceptance.

Bezuidenhout was born in 1957 in Texas. While pregnant, her mother allegedly took DES, which was prescribed to her in Texas, according to the amended complaint. Decades later, plaintiff alleged various personal injury and increased risk of future injuries.  Defendants moved for summary judgment, asserting that plaintiff could not identify which manufacturer made the DES her mother took, as required under Texas law.

Plaintiff argued that Texas law was unsettled, that Texas courts had not clearly rejected the market share theory.  The court said it  need not wade too deeply into Bezuidenhout's "pool of hypotheticals", since it rested upon a false premise—that Texas law, as to proof of causation, is unsettled..."It is not.”  Indeed, the court opined that one of the goals of this case was to unsettle it. Texas does not permit recovery under a collective liability or market share theory. The courts in In re Fibreboard Corp., 893 F.2d 706 (5th Cir. 1990), and Cimino v. Raymark Indust., Inc., 151 F.3d 297, 312 (5th Cir. 1998), held that in Texas, it is a fundamental principle of traditional products liability law that the plaintiff must prove that the defendants supplied the product which caused the injury. Plaintiff tried to bootstrap to an "alternate reality," said the court. The Texas Supreme Court has never chosen to adopt market share liability.  

With the market share approach rejected, plaintiff had not proffered sufficient evidence to identify the defendant as a manufacturer of her mother's DES. Her mother's affidavit contradicted her prior sworn deposition testimony about whose product she might have used.  And, at best, a log from the pharmacist indicated that defendant's DES was among the many medications available at the pharmacy, but did not show which DES her mother took. The court thus found plaintiff failed to raise a genuine issue of material fact regarding the identity of the DES manufacturer.

Consumer Fraud Class Claim Over Dietary Supplements Dismissed

A federal court in Illinois recently ruled that a plaintiff in a putative class action failed to state a claim in his suit challenging the marketing of two dietary supplements. See Padilla v. Costco Wholesale Corp., No. 11-C-7686 (N.D. Ill.,  1/16/13).

Plaintiff  alleged a violation of the Illinois Consumer Fraud and Deceptive Business Practices Act (“ICFA”), 815 ILCS 505/2. He alleged that defendant distributed and marketed the Kirkland Signature™ line of dietary supplements in stores and on-line. These products included  Glucosamine with MSM products, and the Glucosamine/Chondroitin line of products.  Plaintiff asserted he purchased a bottle of Glucosamine with MSM.  And he alleged that that there was no competent and reliable scientific evidence that taking glucosamine either with chondroitin sulfate, or with MSM, results in the body metabolizing it into something that builds or nourishes cartilage or provides joint mobility or joint cushioning.  He asserted that clinical studies have found that glucosamine, chondroitin sulfate, and MSM are not effective.  Thus, he was allegedly deceived by defendant's representations regarding the products, and he would not have purchased Glucosamine with MSM had he known the truth.

Defendant moved to dismiss the (latest) complaint..  The court noted that a complaint must allege enough facts to state a claim to relief that is plausible on its face to survive a motion to dismiss. Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 547 (2007).  For a claim to have facial plausibility, a plaintiff must plead factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged. Ashcroft v. Iqbal, 129 S.Ct. 1937, 1949 (2009). Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice. Typically, the amount of factual allegations required to state a plausible claim for relief depends on the complexity of the legal theory alleged. See Limestone Dev. Corp. v. Vill. of Lemont, 520 F.3d 797, 803 (7th Cir. 2008).

The court concluded the Padilla failed to state an ICFA claim as to Glucosamine Chondroitin because Padilla did not actually purchase Glucosamine Chondroitin. Plaintiff proposed to pursue claims on behalf of himself and putative class members who purchased either Glucosamine with MSM and/or Glucosamine with Chondroitin.  To bring an ICFA claim, a plaintiff must either allege it was a consumer of the defendant or allege a close nexus with Illinois consumers. Padilla purchased a bottle of Glucosamine with MSM, according to the complaint, but never alleged he purchased of the Glucosamine/Chondroitin. Because Padilla did not purchase Glucosamine Chondroitin, Padilla had not sustained any actual damage from alleged representations about it.

As to Padilla’s ICFA claim based on Glucosamine with MSM, the clinical studies cited by plaintiff were insufficient to state a claim that the product representations were false or misleading. Although Padilla cited to clinical studies supposedly showing the dietary supplements were ineffective for the treatment of osteoarthritis, he failed to make a connection between the studies and the actual representations on the label.  The Glucosamine with MSM product label did not claim to be effective for the treatment of osteoarthritis. Thus, clinical studies regarding the ineffectiveness of glucosamine or chondroitin in the treatment of osteoarthritis did not have any bearing on the truthfulness of the actual representations made.  

The court thus dismissed with prejudice the claims over the Glucosamine/Chondroitin supplement, and the MSM claim were dismissed with leave to amend. 



 

State Supreme Court Clarifies Causation Standard in Asbestos Case

The unique and overwhelming features of the grandfather of all mass torts, asbestos, has created bad law in many jurisdictions, procedurally and substantively.  One important example is the issue of causation, and the questions that arise from an injury possibly associated with multiple  exposures to multiple products over many years.  Last year, we posted about a Pennsylvania decision that rejected the plaintiff position that an expert can opine that any level of exposure to a toxic substance is a substantial contributing factor to a disease that is governed by a dose-response relationship.

Recently, the Virginia Supreme Court adopted a new “multiple sufficient causes” analysis as the standard for Virginia mesothelioma cases involving multiple asbestos exposures. See Ford Motor Co. v. Boomer, No. 120283 (Va. 1/10/13).

Plaintiff was diagnosed with mesothelioma, a malignant cancer of the pleura of the lungs.  He asserted that his job duties required that he observe vehicle inspections wherein mechanics used compressed air to blow out brake debris (dust) to allow for a visual inspection of the vehicle's  brakes. He testified that he observed vehicle inspections in approximately 70 garages a month, for five to six hours a day, ten days each month. He testified that his rotations included supervising inspections at a Ford dealership. He said he also specifically remembered Oldsmobile dealers on his rotation. Plaintiff could not identify the type of brake linings being inspected, but presented some circumstantial evidence as to the likely manufacturer of the brake linings being Bendix.

Plaintiff's experts opined that the exposure to dust from Bendix brakes and brakes in Ford cars were both substantial contributing factors in his mesothelioma. And they opined that the current medical evidence suggests that there is no safe level of chrysotile asbestos exposure above background levels in the ambient air. However, plaintiff also testified that he worked as a pipefitter at the Norfolk Naval Shipyard in the early 1940s. His own work and the work of those immediately around him involved packing sand into pipes so that the pipes could be bent to fit the ships. Defense experts opined that his profile was more consistent with a person who had exposure to amosite asbestos at a shipyard sixty years ago than a person exposed to chrysotile brake products.

The jury found in favor of the plaintiff; the trial court denied Bendix' and Ford's motions to strike the expert testimony and their motions to set aside the verdict or for a new trial. Bendix and Ford timely appealed, including on the issue that the court had instructed the jury to determine whether Ford's or Bendix' negligence was a "substantial contributing factor" to plaintiff's mesothelioma. Defendants challenged the use of the substantial contributing factor language as contrary to prevailing Virginia law as to causation.

The court reviewed the traditional Virginia law of causation, which in most instances requires proof that but for the defendant's actions the plaintiff would not have been injured.The 'but for' test is a useful rule of exclusion in all but one situation, said the court: where two causes concur to bring about an event and either alone would have been sufficient to bring about an identical result.  Thus, state law has long provided a means of holding a defendant liable if his or her negligence is one of multiple concurrent causes which proximately caused an injury, when any of the multiple causes would have each have been a sufficient cause.

Causation in a mesothelioma case, however, observed the court, presents a challenge beyond even that standard concurring negligence instruction. Mesothelioma is virtually a signature disease: it was uncontroverted at trial that in most situations the cause of mesothelioma is exposure to asbestos at some point during an individual's lifetime. The long latency period of the disease, however, makes it exceedingly difficult to pinpoint when the harmful asbestos exposure occurred and, in the presence of multiple exposures, equally difficult to distinguish the causative exposures. Further complicating the issue, said the court, although numerous individuals were exposed to varying levels of asbestos during its widespread industrial use before safety measures became standard, not all persons so exposed developed mesothelioma.  It is not currently known why some are more susceptible than others to developing mesothelioma, or why even comparatively lower levels of exposure may cause mesothelioma in some individuals while others exposed to higher dosages never develop the disease. Thus, in the context of a lifetime of various potential asbestos exposures, designating particular exposures as causative presents courts with a unique  challenge.

Certainly, said the court, if the traditional but-for definition of proximate cause was invoked, the injured party would virtually never be able to recover for damages arising from mesothelioma in the context of multiple exposures, because injured parties would face the difficult if not impossible task of proving that any one single source of exposure, in light of other exposures, was the sole but-for cause of the disease. The lower court thus used a "substantial factor" test.  In the last several decades, with the rise of asbestos-based lawsuits, the "substantial contributing factor" instruction has become prominent in some other jurisdictions. See, e.g., Lohrmann v. Pittsburgh Corning Corp., 782 F.2d 1156, 1162-63 (4th Cir. 1986) (upholding Maryland's substantial contributing factor standard in an asbestosis case); Rutherford v. Owens-Illinois, Inc., 941 P.2d 1203, 1219 (Cal. 1997).

Here, the court rejected the “substantial contributing factor” analysis used by these several other jurisdictions.  The Court did not believe that substantial contributing factor has a single, common-sense meaning, and concluded that a reasonable juror could be confused as to the quantum of evidence required to prove causation in the face of both a substantial contributing factor and a proximate cause instruction. In sum, some jurors might construe the term to lower the threshold of proof required for causation while others might interpret it to mean the opposite. The court also agreed with the explicit rejection of substantial contributing factor language in the recent Restatement (Third) of Torts: Liability for Physical and Emotional Harm (2010).  The substantial-factor rubric, says the commentary, tends to obscure, rather than to assist, explanation and clarification of the basis of causation decisions. The latest Restatement provides a rule for finding each of two acts that are elements of sufficient competing causal sets to be factual causes without employing the substantial-factor language of the prior Torts Restatements. There is no question of degree in the new version.  It holds that if multiple acts occur, each of which alone would have been a factual cause of the physical harm at the same time in the absence of the other act(s), each can be regarded as a factual cause of the harm.

The court found this model, as explicated in the comments, quite consistent with its prior rulings regarding concurring causation. A defendant whose tortious act was fully capable of causing the plaintiff's harm should not escape liability merely because of the fortuity of another sufficient cause. So the but-for standard is a helpful method for identifying causes, but it is not the exclusive means for determining a factual cause. Multiple sufficient causes may also be factual causes.  The acts themselves do not have to be concurrent, so long as they are operating and sufficient to cause the harm contemporaneously. As to mesothelioma, said the court, the "harm" occurs not at the time of exposure but at the time when competent medical evidence indicates that the cancer first exists and  thus causes injury. 

 The court said that the separate comment under Restatement § 27, entitled "Toxic substances and disease," should not be applied here.  That approach allows for a finding of causation when multiple exposures combine to reach the threshold necessary to cause a disease, allowing parties who were responsible for some portion of that threshold to be held liable. While it may be the case that this dose-related approach to causation is indeed appropriate for some cancers or diseases, the court did not find it to be necessarily appropriate for mesothelioma from asbestos.

Based on this rule, plaintiff must show that it is more likely than not that his alleged exposure to dust from defendant's brakes occurred prior to the development of cancer and was sufficient to cause his mesothelioma. Given that this approach differs from that taken in the circuit court, the court did not find it appropriate to rule on the sufficiency of the evidence at trial at this time, and instead remanded. On remand, the experts must opine as to what level of exposure is sufficient to cause mesothelioma, and whether the levels of exposure at issue in this case were sufficient.

Follow-up to Fennell

Recently, we posted about the decision of the Illinois Supreme Court interpreting (and putting more teeth in) the forum non conveniens doctrine.  See Fennell v. Illinois Central.

A  tip of the hat to faithful reader Brendan Kenny at Blackwell Burke for noting that the decision is already having important effects.  Here, and here, are three recent Illinois appellate decisions overturning lower court denials of defendants’ forum non conveniens motions.


 

Accolade for the Firm

If our readers will forgive a little bragging, we are pleased to share that  Shook Hardy & Bacon LLP has earned a place on Law360’s list of Product Liability Practice Groups of the Year.

The article announcing the award cited the role of the firm's 270+ product liability attorneys in pharmaceutical litigation, tobacco litigation such as the Engle progeny litigation,and other national matters such as the hot fuel litigation.  The article cited a number of defense verdicts garnered in tough jurisdictions.

The article also pointed out how the firm's product liability practitioners make an effort to innovate for clients, including extensive use of alternative fee arrangements. 

Last, but not least, the article notes the opening of the new in Philadelphia, where your humble blogger is based. 

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Another "Natural" Food Claim Falls to Common Sense

A  federal district court recently dismissed a putative class action alleging the defendant food company mislabeled its Florida's Natural products as 100% orange juice despite the alleged addition of compounds to mask the taste caused by pasteurization. See Veal v. Citrus World Inc., No. 2:12-cv-00801 (N.D. Ala. 1/8/13).

The plaintiff asserted that because the label did not mention that flavoring and aroma are added, consumers desirous of 100% pure and fresh squeezed orange juice had been deceived into purchasing Florida’s Natural.  The plaintiff did not aver that he personally ever consumed Florida’s Natural orange juice or that he suffered any ill health effects from consumption of the same, but rather alleged only that he purchased it, repeatedly, over the six years preceding the first complaint.  The essence of his claim concerned the question of how much processing is permissible in a product labeled as “fresh” “100%” or “pure.”

Despite plaintiff’s numerous allegations as to the general conduct of the orange juice industry, the court found the plaintiff had failed to state an actual, concrete injury. He stated he did not know store-bought orange juice was not fresh squeezed, but nowhere alleged any harm from its purchase or consumption. He did not even claim that upon learning packaged orange juice was not truly “fresh”, he had to resort to squeezing his own oranges. In other words, despite plaintiff’s protestations that he did not receive the product he believed he was purchasing, he made no allegation that he had stopped purchasing what he considered to be an inferior product in favor of
purchasing what he actually sought, which is apparently unpasteurized fresh squeezed orange juice.

In an attempt to save his claim and demonstrate an injury worthy of finding standing, the plaintiff argued that he did not receive the “benefit of the bargain” of what he believed he was actually purchasing. He professed to compare the cost of defendant’s orange juice to an orange juice concentrate, and alleged the difference between them is proof of his loss. This theory did not rise to the level of a “concrete and particularized” injury as opposed to a “conjectural or hypothetical” one. Plaintiff did not allege what the “higher value charged” was or what the orange juice supposedly “would have been worth” if it was “as warranted.” He did not show what products he actually bought, when he bought them, or where he bought them, much less what he paid.

From a legal standpoint, many courts have held that “benefit of the bargain” theories of injury like plaintiff’s, where a plaintiff claims to have paid more for a product than the plaintiff would have paid had the plaintiff been fully informed (or that the plaintiff would not have purchased the product at all), do not confer standing. See In re Fruit Juice Products Marketing and Sales Practices
Litigation, 831 F.Supp.2d 507 (D. Mass. 2011); see also Birdsong v. Apple, Inc., 590 F.3d 955, 961-62 (9th Cir. 2009) (noting potential for hearing loss from improper iPod use was not sufficient to state an injury for standing); cf. Rivera v. Wyeth-Ayerst Labs., 283 F.3d 315, 319-21 (5th Cir. 2002); McKinnis v. Kellogg USA, 2007 WL 4766060, *4 (C.D.Cal.2007); Sugawara v. Pepsico, Inc., 2009 WL 1439115 (E.D.Cal.2009). Young v. Johnson & Johnson, 2012 WL 1372286 (D.N.J.2012).

The plaintiff also complained that even though the FDA does require that defendant label its product as “pasteurized orange juice,” all of defendant’s other alleged representations were voluntary, and thus not within the protection of the FDA. Because the court found the plaintiff lacked standing to pursue his claims, the court did not have to rely on the impact of the extensive FDA regulations governing orange juice,  Nevertheless, the court noted, defendant labeled its orange juice in accordance with FDA regulations. The plaintiff could not dispute that the defendant’s product is “squeezed from our Florida oranges” or “100% orange juice.” Rather, his focus was that the squeezing and pasteurization is performed on a massive scale, and that the pasteurization process destroyed the flavor, causing ingredients already present in orange juice to be replaced in the marketed juice.

However, said the court, the fact that the plaintiff may have believed defendant hired individuals to hand squeeze fresh oranges one by one into juice cartons, then boxed up and delivered the same all over the country does not translate into a concrete injury to plaintiff upon his learning that beliefs about commercially grown and produced orange juice were incorrect.  By its very definition under FDA guidelines, pasteurized orange juice is orange juice (1) that has been processed and treated with heat, (2) in which the “pulp and orange oil may [have] been adjusted in accordance with good manufacturing practice,” and (3) which may have been “adjusted” by the addition of concentrated orange juice ingredients or sweeteners. Clearly, the defendant was selling pasteurized orange juice while labeling it “pasteurized orange juice.” Although the plaintiff objected to such labeling, in the light most favorable to the plaintiff, he purchased a product labeled as pasteurized orange juice and then complained that it was pasteurized.

 No standing, complaint dismissed with no leave to amend yet again.

Class Denied for Failure to Show Common Injury

A federal court recently denied class certification in the MDL coordinating claims over an alleged defect in hybrid vehicles’ braking systems.  See IN RE: TOYOTA MOTOR CORP. HYBRID BRAKE MARKETING, SALES PRACTICES and PRODUCTS LIABILITY LITIGATION, No.: SAML 10-2172-CJC (C.D. Cal., 1/09/13). The basis of the ruling, that a substantial majority of class members never suffered an actual injury caused by the defect, will be of interest to our readers.

Plaintiffs alleged that a defect in the anti-lock brake system of their vehicles causes the ABS to improperly engage when it is not needed, resulting in increased stopping time and distance.  In February 2010, Toyota voluntarily recalled the vehicles and offered to install a software update to remedy the braking defect. Toyota asserted the software update accomplished its intended purpose, and remedied the defect, but plaintiffs claimed that the braking defect was not cured.

Plaintiffs brought five separate class actions in February 2010, later consolidated into an MDL, alleging Toyota had fraudulently induced them to purchase their hybrids by concealing the alleged defect in the braking system. Plaintiffs then moved to certify a class based on Federal Rule of Civil Procedure 23(b)(3), consisting of individuals who purchased or leased the Class Vehicles in California or Texas prior to February 8, 2010. Toyota opposed certification of any class, contending, among other things, that Plaintiffs cannot satisfy the predominance requirement of Rule 23(b)(3).
The court concluded Toyota was correct.

Although there were serious questions as to whether plaintiffs could satisfy the commonality, typicality, and adequacy requirements of Rule 23(a), the court concluded it need not  address those questions because plaintiffs clearly could not satisfy the predominance requirement of Rule 23(b)(3). It is beyond dispute that the critical issue involved in this case was whether there was a manifest defect in the ABS that caused an actual injury to each member of the proposed class. Unless plaintiffs could demonstrate such a manifest defect resulting in actual injury, they could not succeed on any of their five product liability claims. The resolution of this crucial issue, however, could not be accomplished through common or generalized proof as is required to maintain a class action. It must be done by an individualized and particularized inquiry for each member of the proposed class.

Most problematic for plaintiffs, said the court, was that they sought to certify a class in which the
substantial majority of class members never suffered an actual injury that was caused by a manifest defect in the ABS. Toyota presented substantial evidence that the updated software installed in the Class Vehicles as part of the national recall rectified any actual or perceived problem with the braking performance of the ABS. Plaintiffs presented no evidence to contradict Toyota’s evidence in this regard.  Indeed, plaintiffs did not even retain an expert to render an opinion on the safety and performance of the ABS postrecall. Plaintiffs instead argued that they suffered an actual injury because they would not have paid that same purchase price for each of their vehicles had they known of the problem with the ABS. Plaintiffs’ benefit-of-the-bargain argument was insufficient as a matter of law. Merely offering a creative damages theory does not establish the actual injury that is required to prevail on their product liability claims. And in this case, the class reps and, apparently, the majority of the purported class they seek to represent, received exactly what they paid for — that is a vehicle with a safe and operable ABS. After the updated software was installed in their vehicles, the class reps admitted they had no problem with
the braking performance of their vehicles. They were able to apply their brakes and stop their vehicles without incident. They never sold their vehicles. They never incurred any expense as a result of any problem with the ABS in their vehicles. Simply stated, the majority of the class members suffered no actual injury, let alone a common one resulting from the same manifest defect.

Moreover, since the number of members of the proposed class that allegedly suffered an injury was tiny, the proposal to certify a class of thousands of owners of the Class Vehicles, then determine which few suffered an actual injury that resulted from a manifest defect in the ABS, would render the class action device nothing more than a façade for conducting a small number of highly individualized, fact-intensive cases. In re Cannon Cameras, 237 F.R.D. 357, 360 (S.D.N.Y. 2006). Such a class action is certainly not a superior, fair, and efficient method for resolving the parties’ controversy.

Solomon Court Issues Wise Decision in Drug Case

The federal court in New Jersey recently granted summary judgment to a drug manufacturer in a failure to warn claim under Texas law.  See Solomon v. Bristol-Myers Squibb Co., No. 07-1102 (D.N.J., 1/3/12).  The opinion offers a number of useful observations.

The case involved Plavix, a drug that inhibits blood platelets from forming clots. The drug is often used in patients with recent heart attack, stroke, or diagnosed peripheral vascular disease, to prevent dangerous clots.Taking Plavix, like any medicine, is not without risk. Because it functions by inhibiting the formation of blood clots, Plavix increases the risk of bleeding. The manufacturer warned of this risk extensively on the label. 

In November 2002, Plaintiff suffered a heart attack, and his doctors placed two metal stents in his arteries to maintain blood flow to his heart. At that time, one of his doctors prescribed Plavix with aspirin in order “to prevent clots.” Subsequently, Plaintiff’s treating cardiologist continued this prescription. In July 2005, Plaintiff began suffering gastrointestinal bleeding, which led him to sue Defendants asserting product liability related causes of action, under Texas state law, for defective design, manufacturing defect, failure to warn, and negligence.  All these  claims essentially turned on whether Defendants adequately warned that Plavix carried a risk of bleeding complications.

Defendants moved for summary judgment, relying in large measure on the learned intermediary doctrine. Readers will recall that within the prescription drug context, where a plaintiff sues the manufacturer of a prescription drug for failing to adequately warn of the drug’s effects, Texas courts employ the learned intermediary doctrine. As the Texas Supreme Court has explained, the underlying premise for the learned intermediary doctrine is that prescription drugs are complex and vary in effect, depending on the unique circumstances of an individual user, and for this reason, patients can obtain them only through a prescribing physician. Indeed, a patient’s doctor, who stands between the patient and the drug manufacturer, is in the best position to professionally evaluate the patient's needs, assess the risks and benefits of available drugs, prescribe one, and supervise its use. Hence, if the doctor is properly warned of the possibility of a side effect and is advised of the symptoms normally accompanying the side effect, it is anticipated that injury to the patient will often be avoided. Recognizing the doctor-patient relationship, the doctrine excuses a drug manufacturer from warning each patient who receives the product when the manufacturer properly warns the prescribing physician of the product’s dangers.

In arguing the warning claim, Plaintiff contended that he was entitled to a heeding presumption that proper warnings would have a made a difference and that this presumption excused him from proving causation. However, Texas law creates no such presumption. The Fifth Circuit has noted that neither Texas nor federal courts applying Texas law have applied the read-and-heed
presumption to pharmaceutical cases involving learned intermediaries. Indeed, Texas has explicitly rejected the Restatement (SECOND) Of Torts § 402A, Comment j's read-and-heed presumption for policy reasons and, said the court, because it has been superseded by Restatement (THIRD) Of Torts::Products Liability § 2.

On the factual assertions of failure to warn, the court found that although Plaintiff presented various studies and articles challenging the efficacy of Plavix in certain types of patients, none of those studies were  relevant to Plaintiff’s medical situation. For example, the studies upon which Plaintiff tried to rely regarding Plavix’s alleged ineffectiveness for patients 75 years or older had no relevance since Plaintiff was well under 75 years old when he stopped taking the drug. More fundamentally, many of Plaintiff's arguments seemed to center on an alleged lack of efficacy; Plaintiff’s efficacy arguments were not relevant in the context of a failure-to-warn analysis. Plaintiff’s claim was essentially premised on the fact that he suffered substantial bleeding, while his response to the motion argued Plavix did not work. A proper warning should adequately alert any danger or harm that may result from ingesting the drug; efficacyis a separate issue. Permitting Plaintiff to pursue his failure-to-warn claim on an efficacy theory would, as has been found in other jurisdictions with similar laws, impermissibly expand liability under Texas law on the adequacy of pharmaceutical warning labels.

Focusing on the alleged inadequacy of the warning, Texas law is clear that when a warning appropriately and specifically mentions the circumstances complained of, the warning is adequate as a matter of law. First and foremost, said the court, the warning label here clearly cautioned users that PLAVIX use with aspirin was associated with an increase in bleeding. Plaintiff failed to provide any evidence to show that the risk levels published on the Plavix warning label were inaccurate, insofar as the warnings concerned the risk of bleeding.

Another ground for summary judgment. In addition to proving inaccuracy, Plaintiff had to show that
the allegedly defective warning label was the producing cause of Plaintiff’s injury. Thus, it was Plaintiff’s burden to demonstrate that the treating physician would not have used or prescribed the product but for the inadequate warning. However, the cardiologist insisted that despite the risks, it was important that these drugs were prescribed to Plaintiff to prevent a life-threatening problem.  The doctor acknowledged that the therapy could cause serious risk of bleeding in patients.   Nevertheless, the cardiologist insisted that despite the risks, it was important to prescribe the drug.  Furthermore, throughout the prescribing doctor's deposition, he  consistently testified that he did not rely on Plavix warning labels.  Texas law is clear on causation: when the prescribing physician is aware of the product’s risks and decides to use it anyway, any inadequacy of the product’s warning, as a matter of law, is not the producing cause of the patient’s injuries.  It was clear that  the doctors were aware of the serious risks of bleeding when placing Plaintiff on the medicine. 

Plaintiff’s failure-to-warn claim failed for the additional  reason that, under Texas law, Defendants are presumed not liable because the Plavix warning labels were approved by the FDA. In Texas, where prescription drug manufacturers comply with the FDA regulations, Texas law creates a rebuttable presumption of non-liability in prescription drug suits. See Tex. Civ. Prac. & Rem.
Code. Ann. § 82.007.

Summary judgment granted.

FDA Issues Proposed Food Safety Rules

The FDA last week issued two highly anticipated proposed rules relating to food process safety, with a stated goal of preventing foodborne illnesses. Readers will recall our posts on the litigation that can arise from food safety issues. FDA has now released for public comment a proposed rule on Preventive Controls for Human Food and a proposed rule on Standards for Produce Safety.

These rules are two of the proposed rules that FDA says are key to the preventive food safety approach established by the 2011 FDA Food Safety Modernization Act. The proposed rules build on existing voluntary industry guidelines for food safety, which many producers, growers and others currently follow. FDA expects to soon issue its proposed rule on importer foreign supplier verification; future proposed rules will address preventive controls for animal food, and accreditation of third-party auditors.

The FDA will accept comments on the proposals for 120 days. While the effective date for the rules would be 60 days from publication of the final rule, the general compliance date would be two years after the effective date. For small businesses, the compliance date would be three years after the effective date, and for very small businesses four years after the effective date.

The proposed rule on preventive controls for human food would apply to facilities that manufacture, process, pack or hold human food. In general, with some exceptions, the new preventive control provisions would apply to facilities that are required to register with FDA under FDA’s current food facility registration regulations. The rule proposes firms have written plans in place to identify potential hazards, put in place steps to address them, verify that the steps are working, and outline how to correct any problems that arise. FDA says the proposed hazard analysis rules are similar to the "HACCP” (Hazard Analysis and Critical Control Points) regulations that govern the production of certain seafoods and meats. The proposed produce rule covers all fruits and vegetables except those rarely consumed raw, produced for personal consumption, or destined for commercial processing that will reduce microorganisms of public health concern.

FDA estimates that the total annual compliance costs for the two regulations will exceed $1 billion.  million, depending on the scope of the exemption for “very small businesses.” The draft appears not to offer an estimate of the benefits that might result from the new rules.

No Duty on Manufacturer to Design A Product that Cannot be Misused

Duty, foreseeability, and causation.  A recent decision by the Fourth Circuit involves these important tort concepts. See Durkee v. Geologic Solutions Inc., No. 12-1360 (4th Cir., 1/3/13).  Plaintiffs injured in a motor vehicle accident sued, trying to hold the maker of an in-vehicle texting system liable for their harm.

The product liability claims arose from a motor vehicle accident in North Carolina in which a fully loaded tractor-trailer ran into vehicles that were slowed or stopped in front. Appellants alleged that the truck driver became distracted by the presence of a texting system located in the cab of his truck. The texting system had been manufactured by defendant and appellants contended that the defendant owed them a legal duty of care because injuries to the traveling public were reasonably foreseeable based on the texting system’s design.  Specifically they pointed to the facts that the system (1) required the driver to divert his eyes from the road to view an incoming text from the dispatcher, and (2) permitted the receipt of texts while the vehicle was moving.

The district court granted the motions to dismiss, concluding that the accident was caused by the driver’s inattention, not the texting device itself, and that manufacturers are not required to design a product incapable of distracting a driver.

On appeal, appellants challenge the district court’s conclusion that defendant owed them no duty of care. The court of appeals concluded that the district court properly dismissed appellants’ claims, relying on the state tort law, see Kientz v. Carlton, 96 S.E.2d 14, 18 (N.C. 1957), holding that the duty owed by product manufacturer does not require him to guard against hazards apparent to the casual observer or to protect against injuries resulting from the user’s own patently careless and improvident conduct.

The district court correctly concluded that the accident was caused by the driver's inattention, not the texting device itself. "Misuse” in the sense of improper or careless use of the system by the driver, rather than a use that was unintended by the manufacturer. The fact that injuries to the traveling public were reasonably foreseeable based on the system's design does not create a duty.

Score one for personal responsibility.  

Drug Maker Defeats AG Motion to Dismiss Action Challenging Private Contingency Counsel

We have warned readers before about the dangerous and growing practice of governmental agencies delegating state police powers to private (plaintiff) attorneys on a contingency fee basis.  The latest round in this nationwide battle comes from Kentucky, where the court recently ruled that Merck can continue its suit alleging violation of its due process rights after the state hired such outside counsel.  See Merck Sharp & Dohme Corp. v. Conway, No. 3:11-cv-51 (E.D. Ky., 12/19/12).

The matter underlying this action arose from Merck’s marketing and distribution of the prescription medication Vioxx. The AG filed suit against Merck in the Franklin County Circuit Court in 2009, alleging a violation of the Kentucky Consumer Protection Act (“KCPA”). Merck removed the case to federal court, and the action was then transferred to the Eastern District of Louisiana on April 15, 2010, as part of the multidistrict litigation, In re Vioxx Product Liability Litigation, MDL No. 1657.  But on January 3, 2012, the District Court for the Eastern District of Louisiana granted the AG’s motion to remand, concluding that the case was improperly removed from state court. In re Vioxx Prods. Liab. Litig., MDL No. 1657, 2012 WL 10552, at *14 (E.D. La. Jan. 3, 2012).

Now, approximately one year into the proceeding, the AG had retained outside counsel to take over the Vioxx KCPA litigation.  Under the contract executed, private counsel agreed to be compensated by a contingency fee “to be withheld from any settlement award resulting from the litigation.” Merck filed suit against the AG in federal court in August, 2011, seeking a declaratory judgment and injunctive relief. In its complaint,  Merck alleged that the AG had “delegated his coercive powers to private lawyers having a clear, direct and substantial financial stake in the outcome...."  The case was "a punitive enforcement action that must be prosecuted in the public interest or not at all.”  As a result, Merck asserted, its “right to due process under the Fourteenth Amendment had been infringed.” 

The AG moved to dismiss, and the issue in this decision focused on the abstention doctrine announced in Younger v. Harris, 401 U.S. 37 (1971); it provides that when a state proceeding is pending, principles of federalism dictate that any federal constitutional claims should be raised and decided in state court without interference by the federal courts. See Pennzoil Co. v. Texaco, Inc., 481 U.S. 1, 17 (1987).  If a federal district court concludes that its resolution of the case before it would directly interfere with ongoing state proceedings, then it must determine whether to abstain from hearing the case altogether, under the following: (1) there must be an ongoing state
judicial proceeding; (2) the proceeding must implicate important state interests; and (3) there
must be an adequate opportunity in the state proceeding to raise constitutional challenges.

Merck argued that the AG’s active litigation in federal court — through the filing of answers, motions to dismiss, and motions for summary judgment — was sufficient to establish that proceedings of substance had taken place before the remand, i.e., before an action had been pending in state court.  The court agreed that the abstention doctrine did not require a strict view of the federal action timeline nor a formalistic approach to the abstention analysis. Using a "common sense approach," several factors weighed in favor of a conclusion that proceedings of substance had taken place: (1) the federal action had been pending for over seven months when the state court proceeding was remanded on March 20, 2012; (2) on the date of the remand, there were two important motions that were fully briefed and ripe for adjudication; and (3) the court had held a scheduling conference during which the parties advised the court about their positions on those two motions. Based on these facts, the court concluded that the federal action was well beyond an “embryonic stage.” Because the state proceeding was not “ongoing” in a meaningful sense, abstention was not appropriate under the principles of Younger.

Your humble blogger notes that the legal policy of many states strongly favors open, competitive bidding for contracts involving state funds. Such requirements, included in some state Constitutions and various statutes, are designed to prevent fraud, eliminate bias and favoritism, and thus protect vital public interests. Those same goals of open and good government reside in the requirement that state officials give their undivided loyalty to the people of a state. Many of the contingent fee contracts used by state officials to bring mass tort actions violate the core principle that attorneys pursuing actions on behalf of the state represent a sovereign whose obligation to govern impartially is essential to its right to govern. Government attorneys must exercise independent judgment as a ministers of justice and not act simply as advocates. The impartiality required of government lawyers cannot be met where the private pecuniary interest inherent in the contingent fee is the primary motive force behind the bringing of the action. By turning over sovereign prosecutorial-like power to contingency counsel, a state effectively creates a new branch of government – motivated by the prospect of private gain rather than the pursuit of justice or the public welfare. This subversion of neutrality does more than implicate the due process rights of those confronting such tainted prosecutions. Direction of state prosecutions by financially interested surrogates also damages the very public interest that such litigation is supposed to advance. 
 

State Supreme Court Issues Forum Non Conveniens Decision

A tip of the hat to faithful reader Brendan Kenny at Blackwell Burke for noting the recent decision by the Illinois Supreme Court in Fennell v. Illinois Central Railroad.

The issue is forum non conveniens. Brendan notes that the Illinois Supreme Court ruled that the trial court abused its discretion when it denied defendant Illinois Central's forum non conveniens motion. The state Supreme Court reversed the appellate court judgment affirming the trial court's denial, and remanded the case to the trial court with instructions to dismiss. Per Brendan, this 5-1 decision will be helpful to defendants as it emphasizes that Illinois trial courts must grant a defendant's forum non conveniens motion if the plaintiff has no significant connection to the forum and there is an alternative forum that is more convenient. This decision likely strengthens defendants' challenges to asbestos plaintiffs forum shopping in plaintiff-friendly forums like Madison County. This will allow defendants to move asbestos cases to more appropriate forums. 

Brendan notes that Fennell involved plaintiff's 37-year exposure to asbestos-containing products while working for Illinois Central. Fennell lived and sometimes worked in Mississippi, but he also worked across the country for the railroad, and he alleged that he was exposed to asbestos-containing products wherever he worked. In 2002, Fennell and a group of 80 other plaintiffs sued Illinois Central in Mississippi state court. In 2006, Illinois Central filed a motion to dismiss, and the Mississippi court dismissed the case without prejudice.

In 2009, rather than re-file the case in Mississippi, Fennell filed an action against Illinois Central in Saint Clair County, Illinois. He alleged that he was exposed to asbestos and other toxic substances while working for Illinois Central, but he did not allege an injury in Saint Clair County. In May 2010, Illinois Central filed a forum non conveniens motion. Brendan observes that the trial court denied the motion because: (1) Illinois Central's lawyers had significant evidence in Saint Clair County, (2) two of Fennell's important witnesses would testify in Illinois but not in Mississippi, (3) Saint Clair County is closer for Fennell's Chicago-based expert witness than Mississippi, (4) Saint Clair citizens have an interest in "traveling asbestos and other harmful substances"; and (5) Saint Clair County's dockets are uncongested.

Illinois Central appealed, and a divided appellate-court panel affirmed. Illinois Central appealed to the Illinois Supreme Court, and several amici filed briefs.

A trial court's denial of a forum non conveniens motion is reviewed for abuse of discretion. Under the forum non conveniens doctrine, a trial court may decline jurisdiction if it appears that another forum can better serve the parties' convenience and the ends of justice. When ruling on the motion, trial court must consider what forum the totality of public and private-interest factors favor.

Brendan notes that private-interest factors include the parties convenience, access to evidence, ability to compel witnesses to appear for trial, cost of presenting willing witnesses at trial, possibility of viewing the premises at issue, and any other factors that make a trial "easy, expeditious, and inexpensive." Trial courts should also consider that courts have never favored forum shopping, and that a plaintiff's interest in selecting a forum is less if the plaintiff is foreign to the forum and the action arose outside the forum. Public-interest factors include the congestion of the forum's courts, the unfairness of imposing jury duty on residents in a community unconnected to the litigation, and the interests of local communities in deciding local issues.

The Supreme Court held that the trial court abused its discretion because it failed to properly apply the public and private-interest factors. Brendan points out that Fennell was from Mississippi and his cause of action arose outside Illinois. The Supreme Court noted that trial court ignored that Fennell initially filed in Mississippi and re-filed in Illinois. It emphasized that Fennell lives less than 25 miles from the Mississippi courthouse, but 530 miles away from the Saint Clair courthouse, and that almost no one connected with Fennell's case lives in Illinois. Nothing suggested that having the case in Mississippi would unduly hamper the parties' discovery. And it held that Fennell's Chicago-based expert's convenience was entitled to little weight because he is compensated for his travel, and factoring the convenience of plaintiffs' expert would make forum shopping even easier.

The Illinois Supreme Court also rejected the trial court's conclusion that two of Fennell's important witnesses would not testify in court in Mississippi; these witnesses were Illinois Central employeees and this makes it unlikely that Fennell would have difficulty compelling them to testify in Mississippi. In contrast, the Mississippi-based witnesses could not be compelled to testify in Saint Clair County, and bringing the willing witnesses there would cost more.

The Illinois Supreme Court was not persuaded, Brendan notes, that the office of Illinois Central's counsel in Saint Clair County was significant. Assuming that the law firm had many Illinois Central documents relevant to the case there, the Illinois Supreme Court noted that modern technology allows litigants to copy and transport the documents long distance easily and cheaply. 

The Supreme Court found that Saint Clair County had a strong interest in avoiding subjecting its citizens to jury duty in a case unrelated to their community. And even assuming that Saint Clair County citizens had some interest in "traveling asbestos and other harmful substances," they have a greater interest in not being burdened with litigation they have no connection to. 

 

Practice Group of the Year Award

I am very excited to start the New Year postings with the announcement that my firm Shook Hardy & Bacon's product liability group has been named by Law360 as a winner of this year’s Practice Groups of the Year award.

The editors of Law360 reviewed more than 550 entries from almost 100 law firms. Winners were selected based on the significance of the litigation wins; the size and complexity of the litigation wins; and the number of significant, large or complex lawsuits the group won between Nov. 1, 2011, and Nov. 1, 2012.

SHB is very pleased to be one of the product liability winners.  And thanks to all our clients who entrust us with some of their most challenging and complex matters.

 

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