Supreme Court Issues Important Preemption Ruling

The Supreme Court last week reversed the First Circuit decision in Mutual Pharmaceutical Co. v. Bartlett, No. 12-142 (U.S., 6/24/13).

Readers will recall that in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), the Supreme Court held that state tort law claims against generic drug manufacturers based on the alleged inadequacy of the drug labeling are preempted; under the Hatch-Waxman Amendments to the Food, Drug and Cosmetic Act, generic drug labeling must be the same as the labeling of the reference-listed drug. Because generic drug manufacturers cannot independently change the labeling, state law failure to warn claims are preempted.

Plaintiffs proceeded to hunt for exceptions, ways around the ruling.  One of the strategies was to resurrect design defect theories, which traditionally were not a major aspect of most drug plaintiff claims. This case was tried on a design defect theory of liability after the plaintiff’s failure to warn claims were dismissed prior to trial and the district court rejected the generic manufacturer’s preemption defense on the design claim.  The jury found for plaintiff, and defendant appealed, arguing that just as the manufacturer cannot alter the label, once a drug—whether generic or brand-name—is approved, the manufacturer is prohibited from making any major changes to the qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved new drug application.  In Bartlett, the First Circuit held that the plaintiff’s state law theory of liability could nevertheless be reconciled with federal law because, although the generic manufacturer could change neither the design nor the labeling, it could avoid liability if it stopped selling the drug entirely within the state.

The Supreme Court reversed.

New Hampshire imposes design defect liability where the design of the product created a defective condition unreasonably dangerous to the user. To determine whether a product is “unreasonably dangerous,” the New Hampshire Supreme Court employs a risk/utility approach under which a product is defective as designed if the magnitude of the danger outweighs the utility of the product. The New Hampshire Supreme Court has repeatedly identified three factors as germane to the risk-utility inquiry: the usefulness and desirability of the product to the public as a whole, whether the risk of danger could have been reduced without significantly affecting either the product’s effectiveness or manufacturing cost, and the presence and efficacy of a warning to avoid an unreasonable risk of harm from hidden dangers or from foreseeable uses.  

In the drug context, either increasing the “usefulness” of a product or reducing its “risk of danger” would require redesigning the drug: a drug’s usefulness and its risk of danger are both direct results of its chemical design and, most saliently, its active ingredients. Here, said the Supreme Court, redesign was not possible, as the FDCA requires a generic drug to have the same active ingredients, route of administration, dosage form, strength, as the brand-name drug on which it is based. Given the impossibility of redesigning the drug, the only way for the defendant to ameliorate the drug’s “risk-utility” profile—and thus to escape liability—was to strengthen the presence and efficacy of the warning in such a way that the warning avoided an unreasonable risk of harm from hidden dangers or from foreseeable uses.

That was, of course, preempted.  When federal law forbids an action that state law requires, the state law is “without effect.” Because it is impossible for generic manufacturers to comply with both state and federal law, New Hampshire’s warning-infused design defect cause of action was pre-empted with respect to FDA-approved drugs sold in interstate commerce.

The Supreme Court rejected the argument that a defendant could satisfy both laws by paying tort judgments or refraining from selling its product in that particular state. And rejected the “stop-selling” rationale as incompatible with its pre-emption jurisprudence. The Court's pre-emption cases presume that an actor seeking to satisfy both his federal and state law obligations is not required to cease acting altogether in order to avoid liability. Indeed, if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be all but meaningless. The incoherence of the stop-selling theory becomes plain when viewed through the lens of the previous cases. In every instance in which the Court has found impossibility pre-emption, the direct conflict between federal and state law duties could easily have been avoided if the regulated actor had simply ceased acting.

Interestingly, there is nothing in the Court's rejection of “stop-selling” limiting it to generic drugs; the rejection seems applicable to all federally regulated products because it's not based on the FDCA but is an argument “incompatible with our pre-emption jurisprudence.”

 

State Supreme Court Takes Controversial Asbestos Case

The California Supreme Court agreed last week to review an asbestos case involving an important failure to warn theory. See Webb v. Special Electric Co. Inc., No. S209927 (Cal., 2013).

Plaintiff Webb was diagnosed with mesothelioma, which he attributed to his exposure to asbestos products, including Transite pipe allegedly manufactured by Johns-Manville at its plant in Long Beach,
California, which allegedly contained asbestos supplied to it by Special Electric.  Transite pipe was four inches in diameter, and came in five-foot and sometimes ten-foot lengths. It was typically used for water-heater venting. Webb alleged he used no gloves or respiratory protection when handling the pipe. 

After trial, the lower court decided it would hear Special Electric's motions for nonsuit and directed verdict, both of which argued, inter alia, that Special Electric had no duty to warn Johns-Manville of the dangers of asbestos, either because Johns-Manville had been warned of those dangers, or because the dangers were obvious and known to Johns-Manville, a sophisticated user of asbestos. Special Electric argued also that it had no duty to take measures to warn allegedly unsophisticated downstream users of products containing its asbestos, such as Webb, because Special Electric could rely on Johns-Manville to provide those warnings. The trial court agreed, concluding that "telling Johns-Manville about asbestos is like telling the Pope about Catholicism." In so doing, the trial court relied on the well-settled rule that sophisticated users of dangerous products need not be warned about dangers of which they are already aware, derived from Restatement Second, Torts, section 388.

Plaintiff appealed, and the court of appeals reversed. Much of the discussion was on procedural issues (timing and notice, etc.) but our focus is on the alternative ruling on the merits.  The court of appeals agreed that Johns-Manville was a sophisticated user of asbestos, one which needed no warning about its dangers. But, nevertheless, reversed, finding that whether all the asbestos shipped to Johns-Manville had warnings, whether the warnings were adequate, and whether reasonable efforts to warn downstream
users could have been undertaken by Special Electric, were issues of fact. The jury found that Webb had
been exposed to asbestos sold or supplied by Special Electric; that the risks of its asbestos products were known or knowable to Special Electric; and that the risks of Special Electric‘s asbestos products presented a substantial danger to consumers, that ordinary consumers would not recognize. Special Electric‘s duty to warn foreseeable potential users such as Webb, said the court, arose as a matter of law, as seen from the jury‘s fully supported findings.  Because Special Electric‘s duty existed as a matter of law, the jury was entitled to—and did—find from the evidence that Special Electric breached that duty and that its breach was a substantial factor in causing Webb‘s harm, whether some other factors (such as superseding cause) terminated Special Electric‘s share of liability, and the appropriate apportionment of liability between the various actors.

The state Supreme Court will consider the issues now, and tell us what happened to the sophisticated user doctrine.  The concern is that the court of appeals appears to be saying that it can be a tort to fail to tell a customer something they already know, and that it can also be a tort to fail to impose on a direct customer a contractual duty to do something with their customer they already have a tort duty to do. On causation, the dissent offered a cogent analogy: if a defendant in an automobile collision breached the duty of care by driving a car with nonfunctioning headlights, then the plaintiff cannot prove causation merely by demonstrating that the defendant’s car caused the plaintiff‘s injuries when they collided. Rather, the plaintiff must show that the defendant’s driving with nonfunctioning headlights caused the plaintiff’s injuries (because, for example, the accident happened in the dark of night rather than in broad daylight). The case arguably can be limited to unique facts, procedural posture, and some strange jury instructions, but perhaps the high court will clarify that the California courts cannot ignore the sophisticated user doctrine and its impact on duty to warn. 

 

Supreme Court Declines to Review Defense Win in Drug Case

The Supreme Court declined earlier this month to review a decision by the Second Circuit affirming a defense verdict in the Fosamax litigation.  See Secrest v. Merck, Sharp & Dohme Corp., U.S., No. 12-1318, cert. petition denied 6/3/13).  The case explicates an interesting and somewhat rare evidentiary issue.

Readers may recall that a jury in the Southern District of New York handed down a defense verdict for Merck in October, 2011. One of the key evidentiary issues was the trial court's decision to exclude one of the expert witnesses for plaintiff under the so-called “sham issue of fact” doctrine. Dr. Epstein initially was designated a fact witness, and deposed as such.  After Merck moved for summary judgment, Dr. Epstein was designated as an expert, and he was re-deposed, and changed his testimony.  The second time around the witness testified that plaintiff took Fosamax in 2004 and 2005, but earlier had said he did not know about her alleged usage.

Because the physician’s expert testimony contained contradictions that were unequivocal and inescapable, unexplained, arose after the motion for summary judgment was filed, and were central to Secrest’s failure-to-warn claim, the Second Circuit held that the District Court did not err in determining that there was no genuine dispute of material fact raised by the later testimony.  The Supreme Court refused to entertain plaintiff's appeal.

Specifically, the District Court was entitled to disregard Dr. Epstein’s new testimony relating to his knowledge based on the “sham issue of fact” doctrine, which prohibits a party from defeating summary judgment simply by submitting an affidavit that contradicts the party’s previous sworn testimony. See Perma Research & Dev. Co. v. Singer Co., 410 F.2d 572, 578 (2d Cir. 1969). Although courts more typically apply the sham issue of fact doctrine where a party submits an affidavit that contradicts the party’s own prior statements, it may also apply when a party attempts to use evidence from an expert witness to defeat summary judgment.


Here, said the Second Circuit, the doctrine applied to stop Secrest from manufacturing a factual dispute by submitting testimony from an expert whom she tendered, where the relevant contradictions between the first and second depositions were unequivocal and inescapable, unexplained, arose after the motion for summary judgment was filed, and were central to the claim at issue.  See Rivera v. Rochester Genesee Reg’l Transp. Auth., No. 11-762-cv, 2012 WL 6633938, at *7 (2d Cir. Dec. 21, 2012) (concluding that summary judgment was inappropriate because the inconsistencies in the plaintiff’s testimony were not “real, unequivocal, and inescapable contradiction[s]”).  Here, Dr. Epstein’s February 2011 expert deposition testimony inescapably and unequivocally contradicted the testimony he gave in August, 2008.

Also, the relevant contradiction was not only unequivocal but was left unexplained – indeed, was inexplicable – so the trial court could properly determine that plaintiff had manufactured a sham issue of fact. See Rojas, 660 F.3d at 105-06; AEP Energy, 626 F.3d at 735-36. Finally, the sham issue of fact doctrine applied here, continued the Second Circuit, because the relevant contradictions in Dr. Epstein’s testimony were central to Secrest’s failure-to-warn claim. Applicable Florida law required Secrest to show that her treating physician would have recommended that she cease taking the drug if a different, adequate warning had been provided. Here, no reasonable juror could find that Dr. Epstein would have recommended that Secrest cease taking Fosamax if he did not even know she was taking it at the relevant time. 

The Supreme Court then denied plaintiff's cert petition. 

 

 

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.

Successor Liability Rejected in Aircraft Case

One of the interesting types of projects your humble blogger gets to work on from time to time concerns product liability and mass tort issues that arise from the M&A context, including due diligence going into a deal and successor liability issues coming out of a deal.  Recently a federal court held that the successor to the assets of an aircraft manufacturer was not liable for injuries arsing from the crash of an airplane built before the acquisition. See Thornton v. M7 Aerospace LP, No. 12 C 329, (N.D. Ill., 10/23/12).

The aircraft was a Fairchild Aircraft SA227-DC Metro 23, with tail number VH-TFU.  On approach to Lockhart River Airport, Australia, the aircraft crashed, resulting in the deaths of the passengers and crew. The incident was one of the worst civil aviation accidents in Australian history.  The plane was designed, manufactured, assembled, tested, and sold by Fairchild Aircraft, Inc. Fairchild went bankrupt in 2002 and as a result, Fairchild and defendant executed an Asset Purchase Agreement.  The agreement stated that the buyer/defendant assumed no ”liability for personal injury or property damage arising at any time out of or in connection with goods manufactured, produced, distributed or sold by the Sellers prior to the Closing Date, including but not limited to any Product Liability claims." 

In 2007, plaintiffs commenced this negligence and strict products liability action against numerous defendants including defendant M7. In the Second Amended Complaint, plaintiffs asserted claims against M7 in two categories: direct claims and indirect claims. First, plaintiffs’ indirect claims sought to impose vicarious liability on defendant as successor-in-interest to Fairchild. Plaintiffs alleged that defendant “is indirectly liable in strict product liability and negligence for the actions of its predecessor, Fairchild, in its defective and negligent design of the [Subject Aircraft], its failure to warn of the defects and its failure to advise operators to fit the aircraft with an "Enhanced Ground Proximity Warning System.” Second, plaintiffs’ direct claims sought to impose liability on defendant for its independent conduct in allegedly breaching of its own duty to so warn and advise.

The EGPWS claims argued M7 was negligent in failing to advise the owner and operator of the aircraft to install a new system that system was an improvement on the conventional ground proximity warning system because, among other reasons, it allegedly was capable of providing increased warning time to pilots about potential terrain conflicts by incorporating additional functions into the conventional ground proximity warning system.

Defendant moved for summary judgment.  On plaintiff’s claims of successor liability, it argued that
M& had as a matter of law “no liability as the successor corporation to Fairchild.” The Court agreed.
Under applicable Illinois law, a corporation which purchases the assets of another corporation is not generally liable for the debts and liabilities of the transferor in the absence of an agreement providing otherwise. The court explained that this traditional rule of successor corporate non-liability developed as a response to the need to protect bona fide purchasers from unassumed liability and was designed to maximize the fluidity of corporate assets. See Diguilio v. Goss Int’l Corp., 389 Ill. App. 3d 1052, 1059-60, 329 Ill. Dec. 657, 906 N.E.3d 1268 (Ill. App. Ct. 2009).

 A successor corporation can face liability, if one of the following four exceptions applies: (1) if there is an express or implied agreement of assumption; (2) if the transaction between the purchaser and the seller corporation is a consolidation or merger; (3) if the purchaser is a continuation of the seller; or (4) if the transaction is an attempt to escape liability for the seller’s obligations.  Illinois does not recognize the so-called product line exception.

Here, the undisputed evidence showed that the Bankruptcy Court approved the transfer of
Fairchild’s assets “free and clear of any and all liens, claims and encumbrances”, and to a purchaser that was not an insider, affiliate or owner of Fairchild. Plaintiffs argued that defendant ought to have successor liability because it “impliedly assumed Fairchild’s continuing duty to warn.”  But, the court noted, the question is not whether M7 impliedly assumed a duty to warn, but rather whether M7 had an implied agreement with Fairchild whereby M7 agreed to assume Fairchild’s liabilities.  And it did not.

On the direct claim, plaintiffs alleged that defendant owed – and breached – an independent duty to advise owners and operators of the accident aircraft to fit that aircraft with an Enhanced Ground Proximity Warning System. To prevail on their claims of direct (i.e. non-successor) liability, plaintiffs needed to establish that defendant owed an independent duty to warn of the alleged defects in the plane.  Illinois courts have recognized a limited cause of action against the purchaser of a
product line for failing to warn of defects in its predecessor’s products. See Kaleta v. Whittaker Corp., 221 Ill. App. 3d 705, 715, 164 Ill. Dec. 651, 583 N.E.2d 567 (1991).  The critical element required for the imposition of this duty is a continuing relationship between the successor and the
predecessor’s customers benefitting the successor. To determine the presence of a nexus or
relationship effective to create a duty to warn, the following factors are considered: (1) succession to a predecessor’s service contracts; (2) coverage of the particular machine under a service contract; (3) service of that machine by the purchaser corporation; and (4) a purchaser corporation’s knowledge of defects and of the location or owner of that machine.

Here, viewing the evidence in the light most favorable to plaintiffs, there was an insufficient nexus or relationship between defendant and the operator of the aircraft to impose an independent duty to warn upon defendant. Plaintiffs focused their argument on the relationship between defendant and the product line generally, but that is not the legal standard: Illinois law focuses on the relationship between the successor (here, defendant) and the operator of the allegedly defective unit (here, Transair).  It was undisputed that M7 did not assume any of Fairchild’s serve contracts relating
to the plane, and that M7 never serviced, maintained, or repaired the plane. There was no evidence that it worked on or had any contact with the subject aircraft.

Finally, under a voluntary undertaking theory of liability, the duty of care to be imposed upon a defendant is limited to the extent of the undertaking.” Bell v. Hutsell, 2011 IL 110724, 353 Ill. Dec. 288, 293-95, 955 N.E.2d 1099 (2011) (stating that Illinois courts look to the Restatement (Second) of Torts to define the theory). Here, defendant argued that plaintiffs’ voluntarily undertaking theory fails because even if it undertook a duty (which it disputed) regarding warnings and advice to owners and operators, plaintiffs failed to proffer sufficient evidence of reliance. Again, the Court agreed. Illinois law requires proof of reliance; that is, proof that the operator (here, Transair) relied on the defendant’s voluntary undertaking of a duty to warn. See, e.g., Chisolm v. Stephens, 47 Ill. App. 3d 999, 7 Ill. Dec. 795, 365 N.E.2d 80, 86 (Ill. App. Ct. 1977). Plaintiffs offered no such proof.

Summary judgment granted.

Federal Court Offers Cogent Analysis of Warning Causation in Drug Case

A New Jersey federal court granted summary judgment last week to a pharmaceutical defendant in a failure to warn case. See Baker et al. v. APP Pharmaceuticals LLP et al., No. 3:09-cv-05725 (D.N.J.).  The case should be interesting to our readers in part because there really isn't a huge amount of law on warning causation in the busy jurisdiction of New Jersey.

During a hospital stay, plaintiff Baker was administered the commonly prescribed drug heparin. Heparin is an anticoagulant: it prevents blood clots. The opinion noted that the drug is associated  with heparin induced thrombocytopenia (“HIT”), or low blood platelet count. HIT may in a few patients progress to a more serious adverse reaction called heparin induced thrombocytopenia  and thrombosis (“HITT”). Plaintiff received heparin during and after her surgery, and a few days later her  platelet count was down; but according to the opinion it was not known at what point her platelet count reached serious levels because no one measured her platelet level for several days, despite the hospital’s stated protocol to monitor a patient’s platelet count periodically in order to detect possible HIT.

Plaintiff suffered injury to her left foot and leg, and thereafter sued several manufacturers of heparin, asserting they failed to adequately warn of the serious side-effects associated with heparin use. The parties agreed that defendant’s heparin has always contained FDA-approved labeling, including risk disclosures and warnings. In 2001, the heparin label specifically disclosed the risk of HIT and HITT in the “Precautions” section.  In 2005, defendant submitted a supplemental NDA via the “changes being effected” process to include additional HIT and HITT information the “Warnings” section of its heparin labeling. See 21 C.F.R. 314.70. The FDA suggested several alterations, all of which defendant incorporated into the labeling, and the FDA found the updated labeling “acceptable” in June 2007. 

In New Jersey, product liability actions are governed by the New Jersey Products Liability Act (“PLA”). N.J. Stat. Ann. §2A:58C-1, et seq. Under the PLA, in failure to warn cases involving prescription drugs, if the warning or instruction given in connection with a drug has been approved or prescribed by the FDA, there is a rebuttable presumption that the warning is adequate. This is no ordinary rebuttable presumption, remarked the court. Compliance with FDA regulations gives rise to “what can be denominated as a super-presumption.” Kendall v. Hoffman-La Roche, Inc., 36 A.3d 541, 544 (N.J. 2012).  Indeed, the PLA’s presumption that an FDA-approved prescription drug label is adequate “is stronger and of greater evidentiary weight than the customary presumption referenced" in the rules of evidence. Bailey v. Wyeth, Inc., 37 A.3d 549, 571 (N.J. Super. Ct. Law Div. 2008), aff’d sub nom. Deboard v. Wyeth, 28 A.3d 1245 (N.J. Super Ct. App. Div. 2011).

In this case, there is no dispute that the heparin labeling was approved by the FDA. Therefore, defendant was entitled to the statutory presumption that its heparin labeling satisfied its duty to warn. Plaintiff tried to rebut the presumption, first, with allegations of deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects by the pharmaceutical company, and second with allegations of an economically-driven manipulation of the post-market regulatory process. See McDarby v. Merck & Co., Inc., 949 A.2d 223, 256 (N.J. Super. Ct. App. Div. 2008).

However, significantly, all of the information plaintiff accused defendant of withholding was publicly available in published scientific and medical literature.  And defendant did in fact disclose much
of what plaintiff claimed was deliberately concealed or withheld. For example, when submitting its proposed updated label to the FDA in 2005, Baxter included several scientific articles and a number of adverse event reports relating to HIT and HITT.  As to the second rebuttal effort, plaintiff offered no real evidence that Baxter rejected the FDA’s proposed changes to heparin labeling, or asked pharmaceutical representatives to avoid discussing HIT and HITT when speaking to physicians, or manipulated the conclusions of heparin clinical trials, or did anything sufficient to "manipulate" the regulatory process.

The more interesting part of the opinion arises from the fact that even if a plaintiff is able to demonstrate that a prescription drug’s warning is inadequate, that plaintiff still must prove that the inadequate warning proximately caused her injury. See Campos v. Firestone Tire & Rubber Co., 485 A.2d 305, 311 (N.J. 1984). “To satisfy this burden, a plaintiff must show that adequate warnings would have altered her doctors’ decision to prescribe.” Strumph v. Schering Corp., 606 A.2d 1140 (N.J. Super. Ct. App. Div. 1992) (Skillman, J., dissenting), rev’d 626 A.2d 1090 (1993) (adopting Judge Skillman’s dissent).

The court noted that “a heeding presumption may be applicable to claims of failure to warn of the dangers of pharmaceuticals.” McDarby, 949 A.2d at 267. A heeding presumption allows one to presume that the plaintiff’s physician would not have prescribed the drug to the plaintiff if there had been an adequate warning; in other words, the plaintiff’s physician would have heeded the adequate warning. The heeding presumption is rebuttable and can be rebutted if the plaintiff’s physician was aware of the risks of the drug that he prescribed, and having conducted a risk-benefit analysis, nonetheless determined its use to be warranted. Also. a manufacturer who allegedly fails to warn the medical community of a particular risk may nonetheless be relieved of liability under the learned intermediary doctrine if the prescribing physician either did not read the warning at all, or if the physician was aware of the risk from other sources and already considered the risk in prescribing the product. In that context, the physician’s conduct is the superseding, intervening cause that breaks the chain of liability between the manufacturer and the patient.

Here, the doctor stood by his decision to administer heparin to Mrs. Baker. She required heparin by standard medical procedure, and well documented clinical knowledge, at several different  points during her operation and for several different reasons, he opined.  Since he was aware of the risks of the drug that he prescribed and, having conducted a risk-benefit analysis, nonetheless determined its use to be warranted, the presumption was rebutted as a matter of law.

Moreover, the prescriber testified in his deposition that he does not read the label of drugs he frequently prescribes, which includes heparin. Therefore, a different warning would not have made a difference in plaintiff's treatment or outcome because there was no evidence he would have reviewed it.

Finally, there was a third causation problem; the opinion notes that it was undisputed that, despite doctors orders, the Hospital failed to follow its own heparin treatment protocol. Had that monitoring occurred, Mrs. Baker’s physicians would have discovered the onset of HIT sooner. Plaintiff's own expert admitted that her injuries “would have been substantially mitigated” with a “good chance of avoiding" them.   Therefore, plaintiff failed to raise a genuine issue of material fact that it was the heparin labeling, as opposed to the conduct of the hospital, that caused her injury.

 Summary judgment on the warning claim.

Appeals Court Vacates Asbestos Plaintiff Jury Verdict

The Florida court of appeals recently reversed a $6.6 million judgment for the plaintiff in an asbestos case raising interesting issues of the law applicable to design and warning defects. See Union Carbide Corp. v. Aubin,  No. 3D10-1982 (3d DCA 6/20/12).

Plaintiff Aubin worked construction and alleged he routinely handled and was otherwise exposed to joint compounds and ceiling textures that contained asbestos. He contracted mesothelioma and sued.  At trial, plaintiff presented studies purportedly linking defendant's product to a higher degree of danger with respect to the development of asbestosis than other types of asbestos, but he failed to introduce any evidence suggesting it was more dangerous than other asbestos fibers with respect to the contraction of cancer or peritoneal mesothelioma. Also at trial, the parties offered contrasting evidence as to whether Union Carbide adequately informed intermediary manufacturers about the dangers of asbestos. Defense representatives testified that along with an OSHA-mandated warning label, Union Carbide regularly updated its clients regarding the dangers of asbestos as such dangers came to light. Conversely, plaintiff claimed that because there were no warnings on the end product, he was unaware of the dangers associated with the liberation of asbestos fibers into the air, and, therefore, allegedly did not wear any respiratory masks or protective gear while working around the asbestos.

Relying on the component parts doctrine recognized by the Restatement (Third) of Torts: Products Liability § 5 (1997), adopted by the 3d DCA in Kohler Co. v. Marcotte, 907 So. 2d 596, 598-99 (Fla. 3d DCA 2005), defendant moved for a directed verdict on plaintiff's strict liability and negligence claims. That motion was denied. At the charge conference, Union Carbide also requested jury instructions regarding the Third Restatement’s component parts doctrine, The trial court denied Union Carbide’s requests, choosing instead to deliver the special instructions that were requested by plaintiff. The key instruction read: “An asbestos manufacturer, such as Union Carbide Corporation, has a duty to warn end users of an unreasonable danger in the contemplated use of its products.”  The requested context was not provided.

The court of appeals concluded that the trial court erred, first, in determining that Aubin’s claims were governed by the Second Restatement rather than the Third Restatement and, as a result, erred in denying Union Carbide’s motion for a directed verdict with respect to Aubin’s design defect claim. Second, the trial court erred in instructing the jury that Union Carbide had a duty to warn end-users without also instructing the jury that a defendant could have discharged this duty by adequately warning the intermediary manufacturers, and reasonably relying on them to warn end-users. Accordingly, the court remanded for a new trial as to the warning defect claim.

Specifically, the trial court erred as a matter of law in determining that Aubin’s claims were governed by Sections 388 and 402 of the Second Restatement.  In Kohler, the court had adopted the component parts doctrine articulated in Section 5 of the Third Restatement as the governing law for products liability claims arising out of a defendant’s sale of a component part to a manufacturer who then incorporates the component into its own products. Kohler, 907 So. 2d at 598-99. This Appeals Court’s adoption of the Third Restatement was later reaffirmed and extended in Agrofollajes, S.A. v. E.I. Du Pont De Nemours & Co., 48 So. 3d 976, 997 (Fla. 3d DCA 2010), which rejected the Second Restatement’s “consumer expectations” test as an independent basis for finding a design defect, determining instead that, after Kohler, the appropriate standard is the “risk-utility/risk-benefit” test articulated in Section 2 of the Third Restatement.

Regarding the warnings claim instructions, reversible error exists where the trial court delivers an instruction that reasonably might have misled the jury.   Plaintiff Aubin had requested, and the trial court granted, the special instruction: “An asbestos manufacturer, such as Union Carbide Corporation, has a duty to warn end-users of an unreasonable danger in the contemplated use of its products.” While this requested special instruction was "technically accurate," it was, standing alone, misleading because Florida law provides that this duty may be discharged by reasonable reliance on an intermediary. Recognizing that Aubin’s requested instruction was misleading, Union Carbide requested that Aubin’s special instruction be supplemented with an explanation of how the duty to warn could have been discharged by Union Carbide. The trial court rejected Union Carbide’s request, and delivered Aubin’s instruction without further explanation. This was also error.

The court of appeals explained that under both the Third Restatement and the Second Restatement, the determination as to whether a manufacturer like Union Carbide may rely on intermediaries to warn end-users is to be analyzed by the trier of fact, and the standard to be  employed is one of “reasonableness.” The Third Restatement provides several factors to guide the analysis, and these factors are substantially the same as those set forth in the Section 388 of the Second Restatement under comment n.  The trial court, however, did not instruct the jury on any of these factors. 

Because the trial court’s instruction communicated to the jury that Union Carbide had a duty to warn end-users, but did not inform the jury that Union Carbide could have discharged its duty by adequately warning the intermediary manufacturers and reasonably relying on them to warn end-users, the court of appeals concluded that the instruction given was misleading and entitled defendant to a new trial.

Court Again Dismisses Claim Against "Non-Conventional" Alcohol Beverage

We posted last year about the dismissal of a motorcycle passenger's claim against the maker of a caffeinated alcoholic drink, seeking to hold the company liable for her crash-related injuries.See Cook v. MillerCoors LLC, No. 11-1488 (M.D. Fla.).

The operator of the motorcycle in the accident was killed, and the plaintiff Cook, who was a passenger, was injured. Prior to the crash, the driver allegedly had consumed several alcoholic beverages containing caffeine and other stimulants, manufactured by the defendant. Cook argued that such beverages were “uniquely dangerous” because they appeal to younger drinkers and because the addition of caffeine allegedly enables one to drink more alcohol without feeling as intoxicated as one normally would. Thus, she contended, consumers of these beverages are more likely to “engage in dangerous behavior such as driving.” She asserted the driver did not appear impaired, even though toxicology reports from his autopsy revealed that his blood alcohol level was 0.10 at the time of the crash.

The district court found flaws with the duty, breach, and causation elements of the claim. The court found that Cook had not established a duty to warn because “the dangers inherent in alcohol consumption are well known to the public.”  Readers can readily see why the court was reluctant to make an exception to the rule for the so-called "unconventional" beverage. There are hundreds of alcohol-containing products that are arguably not "conventional" in one way or another, by taste, ingredients, color, manufacturing process, advertising... To shift responsibility from the person who over-consumes one of these and then drives impaired is to send the absolutely wrong policy message.

Courts have typically recognized no duty on the beverage maker, regardless of a plaintiff's attempt to differentiate either themselves or the product. See, e.g., Malek v. Miller Brewing Co., 749 S.W.2d 521 (Tex. App. 1988) (finding no duty to warn despite claim that advertising led plaintiff to believe that “Lite” beer was less intoxicating than other beer); Pemberton v. Am. Distilled Spirits Co., 664 S.W.2d 690 (Tenn. 1984); Greif v. Anheuser-Busch Cos., Inc., 114 F. Supp. 2d 100 (D. Conn. 2000)(particular, alleged tolerance of an individual consumer); MaGuire v. Pabst Brewing Co., 387 N.W.2d 565 (Iowa 1986).

Plaintiff attempted to re-plead her claim, again alleging that the addition of stimulants that mask the intoxicating effects of alcohol was a defect, but also focusing on the supposed risks this formulation posed to youth. The court again found the complaint lacking. Alcoholic beverages are not considered unreasonably dangerous as defined by the Restatement (Second) of Torts, because the dangers associated with alcohol are well known.  Cook asserted that the risks are not common knowledge to youthful drinkers having experience only with conventional alcoholic beverages. This court was not convinced that “the special risks posed to youth” made the drink unreasonably dangerous from the perspective of the general public.  More significantly, Cook’s argument overlooked an important point: the alleged “special risks” manifest themselves only if the consumer chooses to drink in excess. The case law recognizes that anyone who drinks alcohol may become impaired and yet may not be able to discern his or her impairment. That does not make alcoholic beverages unreasonably dangerous or absolve the drinker of responsibility.

Moreover, the youth-based allegations did not change Florida law on causation, under which voluntary drinking of alcohol is the proximate cause of such an injury, rather than the manufacture or sale of those intoxicating beverages to that person. As to the plaintiff's warning theory, persons engaging in the consumption of alcoholic beverages may not be able to ascertain precisely when the concentration of alcohol in their blood, breath, or urine reaches the proscribed level, so they should in the exercise of reasonable intelligence, understand what type of conduct places them in jeopardy of violating the law. The degree of intoxication to be expected from any particular brand (or formulation) of alcoholic beverage does not require a special duty to warn, or give rise to a fact question about the warnings here.

The court distinguished Cuevas v. United Brands Co., Inc., 2012 WL 760403 (S.D. Cal. Mar. 8, 2012), as an economic injury claim brought under various consumer protection statutes and warranty theories which focused on the sale of the product allegedly in violation of FDA rules rather than its consumption.


 

Federal Court Upholds "Bare-Metal" Defense

A federal court last week became the latest to refuse to hold a defendant liable for injuries allegedly caused by asbestos-containing parts manufactured by others but used with the defendant's products. See Conner v. Alfa Laval Inc., No. MDL-875 (E.D. Pa.  2/1/12).

The issue arose in the consolidated asbestos products liability multidistrict litigation pending in the U.S. District Court for the Eastern District of Pennsylvania. Defendants moved for summary judgment on the ground that they were not liable for injuries caused by asbestos products, such as insulation, gaskets, and packing, that were incorporated into their products or used as replacement parts, but which they did not manufacture or distribute.

As the asbestos litigation has evolved, and the major manufacturing defendants have declared bankruptcy, the litigation has moved away from the manufacturers of asbestos to new types of defendants, including premises owners, and even those that manufactured so-called “bare-metal” products that contained or were later encapsulated in asbestos made by others. Litigants often refer to the defense raised in this case as the “bare-metal defense,” but it is more properly understood, as the court explained, as a challenge to a plaintiff’s prima facie case to prove duty or causation.

Here, the court considered the availability and scope of the so-called “bare-metal” defense under maritime law.

Plaintiffs alleged they developed mesothelioma as a result of exposure to defendants products while working on vessels operated by the U.S. Navy. One alleged he was exposed to asbestos products used with turbines while he served in the U.S. Navy from 1962 to 1971 aboard the U.S.S. Yorktown. (This was the 2d Yorktown;  under construction as Bon Homme Richard, this new Essex-class carrier was renamed Yorktown in honor of  the carrier sunk at the epic Battle of Midway  in June, 1942. Much of the Academy Award-winning documentary "The Fighting Lady" was filmed aboard the Yorktown.)

Another alleged he was exposed to asbestos aboard the U.S.S. Pollux and U.S.S. Delta, through products like turbines, pumps, boilers, and valves that used and, in some cases, were originally distributed with, asbestos-containing insulation, packing, gaskets, and other products.
The third alleged he was exposed to asbestos used with products while serving as a boiler tender in the U.S. Navy from 1959 to 1976 aboard various naval vessels.

Plaintiffs did not, however, proffer evidence that defendants manufactured or distributed the particular asbestos components or replacement parts to which they were allegedly exposed. Instead, they argued that defendants were liable for all the intended and foreseeable uses of asbestos parts in connection with their original products.

In determining whether defendant manufacturers were liable under maritime law for injuries caused by asbestos parts used with their products, whether in strict liability or negligence, a plaintiff must establish causation with respect to each defendant manufacturer. See Lindstrom v. A-C Prod. Liab. Trust, 424 F.3d 488, 492 (6th Cir. 2005). A plaintiff generally establishes causation under maritime law by showing (1) that the plaintiff was exposed to the defendant’s product and (2) that the product was a substantial factor in causing the plaintiff’s injury, said the court.

Plaintiffs raised two arguments to hold manufacturers liable for harm caused by asbestos products they did not manufacture or distribute. First, plaintiffs argued that under the integrated-products doctrine the “products” at issue were really defendants’ products together with the asbestos-containing components and replacement parts supplied by third parties.  Second, plaintiffs argued that defendants had a duty to warn of the hazards posed by the foreseeable uses of their products.

The court rejected both arguments. The first was not consistent with the law under the component parts doctrine. Even if the court were to accept that defendants were component-part manufacturers, a component-part manufacturer is not liable for injuries caused by the finished product into which the component is incorporated unless the component itself was defective at the time it left the manufacturer.  The defective product here was the asbestos insulation, not the pumps and valves to which it was applied after defendants’ manufacture and delivery.  Also, as a matter of law, defendants did not owe a duty to warn under maritime law of the hazards posed by products they did not manufacture or distribute.

The court cited with approval the view of other courts that the overwhelming case law does not support extending strict liability for failure to warn to those outside the chain of distribution of a product. Products liability has always been premised on harm caused by deficiencies in the defendant’s own product. Moreover, a manufacturer does not have an obligation to warn of the dangers of another manufacturer’s product.  The law does not impose a duty to warn about dangers arising entirely from another manufacturer’s product, even if it is foreseeable that the products will be used together.  Any expansion of the duty of care as urged here would impose an obligation to compensate on those whose products caused the plaintiffs no harm. To do so would exceed the boundaries established over decades of product liability law.  And it would also be unfair to require manufacturers of non-defective products to shoulder a burden of liability when they derived no economic benefit from the sale of the products that injured the plaintiff.

Having held as a matter of law that a manufacturer is not liable for harm caused by the asbestos products that it did not manufacture or distribute, the court concluded that plaintiffs failed to raise a genuine issue of material fact as to whether any of the defendants manufactured or distributed the asbestos products that caused the alleged injuries.

The decision puts the court in the company of others, like O'Neil v. Crane Co., Cal., No. S177401 (Cal. 1/12/12), which have declined to extend liability for asbestos-related injury to makers of products used with asbestos insulation, gaskets, and packing.  

Study Examines Impact of FDA Drug Risk Communications

A recurring topic here at MassTortDefense is the role of hazard communications in product safety, and the related issues of a consumer reading, heeding, or relying on such warnings.  This is particularly true in the area of prescription drug litigation, focused on over at Drug and Device Law.

So, that makes a recent study in Medical Care interesting reading: Dusetzina, et al.,  Impact of FDA Drug Risk Communications on Health Care Utilization and Health Behaviors: A Systematic Review.

The paper reviews the literature of the past 20 years on the impact of FDA drug risk communications on medication utilization, health care services use, and health outcomes.  These 50 or so studies covered roughly 16 therapeutic classes; most used medical or pharmacy claims and a few examined patient-provider communication, decision making, or risk perceptions.

The authors concluded that although some FDA drug risk communications had immediate and strong impacts, many had either delayed or no impact on health care utilization or health behaviors. These data demonstrate the complexity of using risk communication to improve the quality and safety of prescription drug use, and suggest the importance of continued assessments of the effect of future advisories and label changes, according to the authors.

Although not the focus of the article, the findings are relevant to those of us who need to think about the learned intermediary doctrine, preemption, and other legal warning doctrines.

State Supreme Court Reverses Dangerous Expansion of Product Liability

The California Supreme Court held last week that the law does not impose liability on manufacturers of equipment used in conjunction with asbestos-containing parts made by others.  See O'Neil v. Crane Co., Cal., No. S177401 (Cal. 1/12/12).
 
Readers may recall that we posted on this case before. The Restatement of Torts (Third): Products Liability says that in the context of a final, finished product that injures a user and which is made up of components from different manufacturers, if a given component is itself defective and the defect causes the harm, then the supplier of that component is of course liable. In addition, the supplier can be liable even if the component by itself is not defective, but only if the seller substantially participates in the integration of the component into the design of the product (and the defect causes the harm). See Restatement 3d, Section 5. In essence, the doctrine holds that an entity supplying a non-defective raw material or a non-defective component part is not strictly liable for defects in the final product over which it had no control. In this respect, the Third Restatement of Torts simply codified the doctrine of various states’ common law.
 
Nevertheless, a split had existed among the lower courts in California about whether to
extend liability for asbestos-related disease beyond the manufacturers of the asbestos insulation, gaskets, and packing to which many ship workers were exposed (and which makers are now bankrupt) to the makers of the products the asbestos was used with (to find a solvent target).  So the state supreme court confronted the limits of a manufacturer’s duty to prevent foreseeable harm related to its product: When is a product manufacturer liable for injuries caused by adjacent products or replacement parts that were made by others and used in conjunction with the defendant’s product?   It held that a product manufacturer may not be held liable in strict liability or negligence for harm caused by another manufacturer’s product unless the defendant’s own product contributed substantially to the harm, or the defendant participated substantially in creating a harmful combined use of the products.
 
Defendants made valves and pumps used in Navy warships. They were sued here for a wrongful death allegedly caused by asbestos released from external insulation and internal gaskets and packing, all of which were made by third parties and added to the pumps and valves post-sale. It is undisputed that defendants never manufactured or sold any of the asbestos-containing materials to which plaintiffs’ decedent was exposed. That is, no evidence was presented that any of the asbestos-containing dust came from a product made by defendants. Neither company manufactured or sold the external insulation or flange gaskets that the repairmen like plaintiff removed. Although the valves and pumps contained internal asbestos-containing gaskets and packing, these original components had been replaced long before plaintiff encountered them years later. There was no evidence that any of these replacement parts were made by defendants.  The Court of Appeal asserted defendants’ products were defectively designed “because they required asbestos packing and insulation.” But this factual assertion was unsupported by the record. The evidence established that the requirement for asbestos derived from military specifications, not from any inherent aspect of defendants’ pump and valve designs

Nevertheless, plaintiff claimed that defendants should be held strictly liable and found negligent because it was foreseeable that workers would be exposed to and harmed by the asbestos in replacement parts and products used in conjunction with their pumps and valves. The Court of Appeals held that the component parts defense applied only to manufacturers of “multi-use or fungible products” designed to be altered and incorporated into another product. It then concluded defendants’ products did not meet these requirements. The Court of Appeal also rejected defendants’ argument that they could not be found strictly liable because they did not manufacture or supply the asbestos-containing products that caused plaintiffs' disease. The lower court announced a broad definition of strict products liability: a manufacturer is liable in strict liability for the dangerous components of its products, and for dangerous products with which its product will necessarily be used. Even though it was replacement gaskets and packing that allegedly caused disease, the lower appeals court concluded these replacement parts were “no different” from the asbestos-containing components originally included in defendants’ products.
 

Plaintiff's claims would represent an unprecedented expansion of strict products liability, which the supreme court declined to do.  California law, like most states, has long provided that manufacturers, distributors, and retailers have a duty to see to the safety of their products, and will be held strictly liable for injuries caused by a defect in their products. Yet, the state has never held that these responsibilities extend to preventing injuries caused by other products that might foreseeably be used in conjunction with a defendant’s product. Nor has the state's high court ever held that manufacturers must warn about potential hazards in replacement parts made by others when, as here, the dangerous feature of these parts was not integral to the product’s design.  From the outset, strict products liability in California has always been premised on harm caused by deficiencies in the defendant’s own product.  The reach of strict liability is not limitless; strict liability does not extend to harm from entirely distinct products that the consumer can be expected to use with, or in, the defendant’s non-defective product. Instead, the courts require proof that the plaintiff suffered injury caused by a defect in the defendant’s own product.
 
In this case, it was undisputed that plaintiff was exposed to no asbestos from a product made by the defendants. Although he was allegedly exposed to potentially high levels of asbestos dust released from insulation the Navy had applied to the exterior of the pumps and valves, defendants did not manufacture or sell this external insulation. They did not mandate or advise that it be used with their products. It is fundamental that the imposition of liability requires a showing that the plaintiff’s injuries were caused by an act of the defendant or an instrumentality under the defendant’s control.
 
Generally speaking, manufacturers have a duty to warn consumers about the hazards inherent in their products. The requirement’s purpose is to inform consumers about a product’s hazards and faults of which they are unaware, so that they can refrain from using the product altogether or evade the danger by careful use. Typically, under California law, manufacturers are strictly liable for injuries caused by their failure to warn of dangers that were known to the scientific community at the time they manufactured and distributed their product. The supreme court has never held that a manufacturer’s duty to warn extends to hazards arising exclusively from other manufacturers’ products. Plaintiff's alleged exposure to asbestos came from replacement gaskets and packing and external insulation added to defendants’ products long after their installation; there was no dispute that these external and replacement products were made by other manufacturers.
 
So the supreme court reaffirmed that a product manufacturer generally may not be held strictly liable for harm caused by another manufacturer’s product. The only exceptions to this rule arise when the defendant bears some direct responsibility for the harm, either because the defendant’s own product contributed substantially to the harm or because the defendant participated substantially in creating a harmful combined use of the products.   Plaintiffs sought to expand these exceptions to make manufacturers strictly liable when it is foreseeable that their products will be used in conjunction with defective products or even replacement parts made or sold by someone else. However, the mere foreseeability of harm, standing alone, is not a sufficient basis for imposing strict liability on the manufacturer of a non-defective product, or one whose arguably defective product does not actually cause harm.
 
The decision was supported by common sense. A manufacturer cannot be expected to exert pressure on other manufacturers to make their products safe and is not able to share the costs of ensuring product safety with these other manufacturers. It would be unfair to require  manufacturers of non-defective products to shoulder a burden of liability when they derived no economic benefit from the sale of the products that injured the plaintiff.  And a contrary rule would require manufacturers to investigate the potential risks of all other products and replacement parts that might foreseeably be used with their own product and warn about all of these risks. Such a duty would impose an excessive and unrealistic burden on manufacturers. Such an expanded duty could also undermine consumer safety by inundating users with excessive warnings. “To warn of all potential dangers would warn of nothing.”
 
 
 
 

 

State Court Upholds Questionable Bystander Liability Claim

The Montana Supreme Court recently upheld the imposition of liability on a bat manufacturer for allegedly failing to warn about the dangers of aluminum bats. Patch v. Hillerich & Bradsby Co., d/b/a Louisville Slugger, No. DA 10-0051 (Mont. 7/21/11).  Bad facts made bad law here. 

Many people consider "The Natural" to be one of the greatest sports movies of all time, and those that think deep thoughts have asserted that the screenplay  (presumably not the 1952 book too?) was based in part on the story of Sir Percival from the Arthurian myths, with the broken bat "Wonderboy" taking the part of the knight's broken sword.  Had Roy Hobbs used an aluminum bat, that aspect of the story would have been lost. Since their introduction in the early 1970's, aluminum bats have become quite popular in youth and amateur adult baseball and softball markets. The new bats are often touted as having a wider sweet spot, more power, better feel, or higher performance. It is pretty much accepted that balls come off metal bats faster than they do from wood bats, but this aspect of performance has fueled an ongoing metal/wood issue in some circles.

While pitching in an American Legion baseball game on July 25, 2003, the eighteen year-old plaintiff was struck in the head by a batted ball that was hit using H&B’s model CB-13 aluminum bat. Tragically, plaintiff died from his injuries. In 2006, Brandon’s parents sued H&B, claiming H&B’s model CB-13 aluminum bat was in a defective condition because of the alleged enhanced risks associated with its use: It increased the velocity speed of a batted ball when it left the bat, thus decreasing infielders’ reaction times, which allegedly resulted in a greater number of high energy batted balls in the infield.

The matter was tried in October, 2009, and the design defect and failure to warn claims were submitted to the jury, which concluded that the model CB-13 aluminum bat was not designed defectively, but determined the bat was in a defective condition due to H&B’s failure to warn of the enhanced risks associated with its use. They awarded plaintiffs an $850,000 verdict on their failure to warn claim. Defendant appealed.

The key issue was whether a failure to warn claim can be brought by a bystander -- plaintiff was not the consumer nor the user. H&B asserted that only the individual batting (actual user) and the individual who purchased the bat (actual consumer) could assert a failure to warn claim.  The court disagreed, saying this interpretation of the terms user and consumer is somehow contrary to the definition of the terms as contained in the Restatement (Second) of Torts § 402A. This state court’s products liability jurisprudence had recognized that a failure to warn claim may be brought by some persons who are not actual purchasers or users of a product; previous plaintiffs included those who are passively enjoying the benefit of the product, as in the case of passengers in automobiles or airplanes, as well as those who are utilizing it for the purpose of doing work upon it.  "The realities of the game of baseball" supported, said the court, the decision to submit the failure to warn claim to the jury. The bat was deemed an indispensable part of the game. The risk of harm accompanying the bat’s use extends beyond the user, beyond a player who holds the bat in his or her hands. A warning of the bat’s risks to only the batter standing at the plate inadequately communicates the potential risk of harm posed by the bat’s increased exit speed, concluded the court. In this context, all of the players, including plaintiff, were deemed "users or consumers" placed at risk by the increased exit speed caused by H&B’s bat.

Defendant also argued that plaintiff could not establish causation - reading and heeding the warning. The court held that H&B’s argument erroneously assumed that placing a warning directly on the bat is the only method to provide a warning. While placing a warning directly on a product is certainly one method of warning, other methods of warning exist, including, but not limited to, issuing oral warnings and placing warnings in advertisements, posters, and media releases. Davis v. Wyeth Laboratories, Inc., 399 F.2d 121, 131 (9th Cir. 1968) (“[O]ther means of communication such as advertisements, posters, releases to be read and signed . . . or oral warnings . . . could easily have been undertaken . . . .”). Such warnings, if issued by H&B in this case, said the court, could have communicated to all players the potential risk of harm associated with H&B’s bat’s alleged increased exit speed.

What the court here called a "flexible" approach to causation really eviscerates one of the fundamental elements of the claim. The court allowed the jury to infer without any basis in fact that plaintiff would have heeded a warning had one been given-- apparently because he was deceased, and thus real proof of causation was hard to find. There is no basis to allow a jury simply to express sympathy for a tragic accident victim,as here there was not sufficient proof that the plaintiff would have adjusted his behavior after receiving the warning to avoid the injury. The decision puts this court in a tiny minority of states that recognize some kind of bystander failure to warn liability, which most courts agree is unworkable and contrary to the reality of modern commerce.

The concurrence correctly noted that plaintiff did not articulate specifically what a warning should have contained and what message should have been given. Statements to the effect that the bat would hit balls at unusually fast speeds or unusually far distances are the kind of messages accompanying usual product advertising and are not likely to change a player's/plaintiff's behavior. Moreover, they are precisely the qualities in a bat which baseball teams and players seek out. Plaintiff could not articulate specifically how a warning would have changed the result here, in other words, how the failure to warn caused this accident.

H&B also argued that because plaintiff had been hit by batted balls before, he knew he could be hit and, therefore, assumed the risk when he continued playing baseball. The court explained that assumption of the risk defense in this state is inapplicable as a matter of law without evidence the victim actually knew he or she would suffer serious injury or death, and, knowing that, the victim voluntarily exposed himself or herself to the danger. Lutz v. Natl. Crane Corp., 267 Mont. 368, 379-80, 884 P.2d 455, 461-62 (1994). What the victim actually knew is evaluated using a subjective standard in Montana. Here, said the court, there was no evidence that plaintiff actually knew he would be seriously injured or killed when pitching to a batter using one of H&B’s model CB-13 aluminum bats. He knew he could be hit with a screaming line drive, but not that it could injure him seriously?

Plaintiff's apparent theory, as articulated in closing argument, was that H&B should have
advertised that its bat “could kill.” And the inference which plaintiff asked the jury to draw in order to establish causation was that, following the publishing of a warning “that this bat could kill,” the parents would have prohibited Brandon from playing baseball.  That tells you how unworkable the theory is. This was a terrible accident on a baseball field, the kind of accident that has also occurred with wood bats. The bat was not defective. It was made in accordance with the rules approved for play by baseball's organizing and governing bodies. Bad facts again make bad law.
 


 

Court of Appeals Explores Obvious Danger Doctrine

The 5th Circuit last week affirmed a grant of summary judgment to defendants in a case of a plaintiff allegedly injured when he used a gasoline-soaked rag to start a diesel engine while wearing a polyester and cotton uniform. Spears v. Cintas Sales Corp., No. 09-30750 (5th Cir., 2/28/11).

At the time of his accident, Spears was employed as the shop foreman for Apeck Construction, Inc., and was the head mechanic in charge of servicing and repairing equipment used by Apeck in its business. While performing his duties, Spears wore a Cintas uniform that Apeck had purchased for him. The uniform was 65% polyester and 35% cotton.The agreement between Apeck and Cintas specified that the garments were not flame-retardant, and the employer promised to tell its employees that their garments are not designed for use in areas of flammability risk or where contact with hazardous materials is possible.

Spears was injured while attempting to start a dump truck powered by a diesel engine.  Spears used a gasoline-soaked rag, a procedure he had used “thousands of times” to attempt to start an engine.The dump truck backfired, and Spears’s uniform caught on fire. As the uniform burned, it melted and fused to his body.

Spears filed suit in state court under the Louisiana Product Liability Act, alleging that the Cintas
uniform was an unreasonably dangerous product. Cintas moved for summary judgment, arguing that Spears could not present sufficient evidence to prove two elements of his claim: (1) that his damages were proximately caused by a characteristic of the Cintas uniform that rendered it unreasonably dangerous; and (2) that the damage arose from a reasonably anticipated use of the uniform. The district court found that Spears’s use of the uniform was not a reasonably anticipated use and granted summary judgment in favor of Cintas. Plaintiff appealed.

Under the LPLA, a manufacturer of a product shall be liable to a claimant for damage proximately caused by a characteristic of the product that renders the product unreasonably dangerous when such damage arose from a reasonably anticipated use of the product. If a plaintiff’s damages did not arise from a reasonably anticipated use of the product, then the unreasonably dangerous question need not even be reached. Reasonably anticipated use means a use or handling of a product that the product’s manufacturer should reasonably expect of an ordinary person in the same or similar circumstances. The court said  this is an objective inquiry that requires a court to ascertain what uses of its product the manufacturer should have reasonably expected at the time of manufacture.

A plaintiff’s use of a product is not reasonably anticipated in a situation where a manufacturer provides an express warning cautioning against a use of the product for which the product was neither designed nor intended, and where the plaintiff acts in direct contravention of that warning. Even if the warning did not reach the users, if the danger from a particular use of a product is obvious, then it is not a “reasonably anticipated use” under the LPLA. If the plaintiff acts in contravention of an express warning, the plaintiff’s use may still be reasonably anticipated if the plaintiff presents evidence that despite the warnings, the manufacturer should have been aware that users were using the product in contravention of the warnings.

Cintas did not dispute that the warning did not reach Spears. Instead, Cintas argued that Spears’s use was not a reasonably anticipated use because the danger of exposing the uniform to flammability risks was obvious to Spears. The record demonstrated that Spears knew that his uniform was not flame retardant. Furthermore, Spears’s testimony established that Spears knew that his poly-cotton uniform would melt.  Because the danger of exposing the uniform to flammability risks was obvious to Spears, his use of the uniform is not a “reasonably anticipated use” under the LPLA.

Plaintiff spent considerable effort arguing about the foreseeability of the danger involved in starting the engine with a gasoline-soaked rag. But the 5th Circuit said that was the wrong issue; it may be relevant in assessing a plaintiff’s comparative negligence, but it was not relevant to whether Spears’s use of the uniform was a reasonably anticipated use. The correct obvious-danger analysis in this case related to what Spears argues that Cintas should have warned against—that the uniform would melt when exposed to flame -- whatever the source. Furthermore, the court pointed out, Spears’s argument that he did not know the engine would backfire was contradicted by his other argument that Cintas should have reasonably anticipated that he would be exposed to flammability risks while wearing his uniform. If Spears, an expert mechanic, supposedly did not know that there was a risk that the engine would backfire when he attempted to start it, Cintas could not reasonably anticipate that its uniform would be exposed to the backfire of a diesel engine.

 

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.

 

Failure to Warn Even When You Warn? Court Rejects Plaintiff's Theory

One of the fascinating and disturbing things about failure to warn claims is the endless supply of creative, far-fetched, fantastic, implausible, fanciful, incredible, questionable, even bizarre theories that plaintiff lawyers sometimes come up with to support this type of claim.

Last week, a Pennsylvania appeals court rejected just such a theory. Specifically, plaintiff alleged that a failure to warn caused her injury -- nothing strange there.  But the manufacturer DID warn specifically of the condition she developed.  So, what was the plaintiff's failure to warn theory?  That a drug maker may be liable for failure to warn despite warning of the condition plaintiff developed, because a warning about a different medical issue —one that she did not develop— would somehow have caused her doctor to not prescribe the drug.  Cochran v. Wyeth Inc., 2010 WL 2902717 (Pa. Super. Ct., 7/27/10).

Plaintiff ingested the prescription weight-loss drug dexfenfluramine, which was manufactured by Wyeth and sold under the brand name Redux. Wyeth informed the prescriber that Redux may cause primary pulmonary hypertension (“PPH”). The doctor, in turn, warned plaintiff of the risk of PPH prior to prescribing her Redux. At the time of his decision, however, the prescriber claimed he was unaware of the risk that Redux may cause valvular heart disease (“VHD”).  Later, plaintiff was diagnosed with PPH, which she had been warned about.  But she claimed that the doctor would not have prescribed Redux to her had he been warned that Redux could cause VHD.

Proximate cause is an essential element in a failure to warn case.  A proximate, or legal cause, is defined under Pennsylvania law as a substantial contributing factor in bringing about the harm in question. That is, a plaintiff must establish proximate causation by showing that had defendant issued a proper warning to the learned intermediary, he would have altered his behavior and the injury would have been avoided.   Wyeth argued that even if its warnings with regard to VHD were inadequate, its failure to warn of VHD was not the proximate cause of plaintiff's PPH.  To establish proximate causation, plaintiff must prove that the warnings failed to disclose the risk of her particular injury (PPH).

The trial court agreed. On appeal, the court found an absence of clear authority on the issue, but strong guidance in those cases that have addressed a plaintiff's burden of proving proximate causation in the informed consent context.  Finding the torts of informed consent and failure to warn analogous, the superior court was persuaded by those jurisdictions that have concluded a plaintiff cannot establish proximate causation where the non-disclosed risk never materialized into an injury.

Here, the risk of VHD did not develop into the actual injury of VHD. Although the prescriber testified in deposition that he would not have prescribed Redux had he known of the risk of VHD, this does not alter the fact that while Wyeth allegedly failed to disclose the risk of VHD the plaintiff suffered from PPH. In these circumstances, the relationship between the legal wrong (the alleged failure to disclose the risk of VHD) and the injury (PPH) was  "not directly correlative and is too remote" for proximate causation.

Summary judgment for defendant affirmed.

 

Failure to Warn Claim Survives- But Why?

Sometimes, manufacturers have to wonder, what good does a warning do if the courts won't require people to read and heed the warning given?

Harley Davidson is an iconic American product manufacturer. In 1903, William S. Harley and Arthur Davidson made available to the public the first production Harley-Davidson® motorcycle. The bike was built to be a racer, with a 3-1/8 inch bore and 3-1/2 inch stroke. The factory in which they worked was a 10 x 15-foot wooden shed with the words "Harley-Davidson Motor Company" crudely scrawled on the door.

William and Arthur would likely be scratching their heads over a recent ruling denying the company's summary judgment motion on a failure-to-warn claim in a suit filed after a motorcycle crash. Steven Morris v. Harley-Davidson Motor Co., et al., No. 3:09-cv-74 (M.D. Ga.).

Plaintiff alleged that the rear tire of his motorcycle failed, resulting in a crash that killed plaintiff’s wife and left plaintiff seriously injured. Plaintiff contended that the defendants (including the tire company) failed to provide an adequate warning regarding the dangers of overloading the motorcycle. With a full tank of gas weighing 31 pounds, the plaintiff's Ultra Classic’s Gross Vehicle Weight Rating (GVWR) allowed for an additional 420 pounds of weight capacity for the rider, any passenger, cargo, and accessories. Plaintiff, who weighed 250 pounds, was with his wife, who weighed 204 pounds, riding as a rear passenger. Plaintiff was also pulling a trailer.

When plaintiff purchased the Ultra Classic, he was provided with an owner’s manual, which contained warnings and instructions regarding the Ultra Classic. Specifically, the Owner’s Manual warned against exceeding the GVWR; that exceeding these weight ratings can affect stability and handling, which could result in death or serious injury; explaining that GVWR is the sum of the weight of the motorcycle, accessories, and the maximum weight of the rider, passenger and cargo that can be safely carried.  It tells the owner that the GVWR is shown on the information plate located on the frame steering head.

The court found it significant that the weight of the trailer was not listed in the components of the GVWR, but that was because the Owner’s Manual also warned against pulling a trailer, ever: “Do not pull a trailer with a motorcycle. Pulling a trailer can cause tire overload, reduced braking efficiency and adversely affect stability and handling, which could result in death or serious injury.”  That is exactly what happened, according to plaintiff!

Plaintiff admitted he never read the Owner’s Manual. But in addition to the warnings in the Owner’s Manual, there were also warnings on the Ultra Classic. One warning was located inside the storage compartment on the back end of the Ultra Classic, over the rear wheel, and behind the passenger’s seat, and the Ultra Classic also contained an information plate on the steering head, which listed the Ultra Classic’s GVWR, recommended tire pressures, and other information.  Plaintiff testified that he did not see these warnings either.

Harley-Davidson contended that plaintiff’s failure to warn claim failed as a matter of law because he did not read the warnings in the Owner’s Manual or the warnings on the Ultra Classic.  The court construed  the claim as not relating to the substance of the warning, but the procedure, the method by which the information was communicated.  The court concluded that plaintiff contended that he never read the warnings because Harley-Davidson failed to communicate them adequately. Failure to read a warning does not bar recovery when the plaintiff is challenging the adequacy of the efforts of the manufacturer or seller to communicate the dangers of the product to the buyer or user, found the court.

Failure to communicate an adequate warning involves such procedural questions as location and presentation of the warning. The court found that it was a jury question whether or not the manufacturer was negligent in failing to place a warning in such position, color and size print or to use symbols that would adequately convey the information. Thus, based on the present record, said the court, a reasonable fact-finder could conclude that Harley-Davidson failed to place useful load information regarding the Ultra Classic where a user would likely see it.

But, even accepting the substance/procedure distinction, the only evidence the court focused on concerning the alleged inadequacy of the warnings was plaintiff's self-serving testimony. A plaintiff should not be able to create an issue of fact on the procedural aspects of the warning simply by saying, "I didn't see it, so it must have been inadequate." Where was the genuine issue of fact?  Where was the proof that the vehicle's Owner's Manual is not the right place to put a warning about safe operation of the vehicle.    Bottom line - there can be no genuine issue of fact when an admittedly adequate warning is placed in the Owner's Manual and the owner never opens the manual. Where is the genuine dispute about warnings right on the motorcycle itself? Where was the proof of where else the manufacturer was supposed to put a warning?

 

Brand Name Drug Maker Not Liable To Plaintiff Who Used Generics

A federal trial court in Texas has held that a plaintiff who admitted using only generic products cannot maintain failure to warn claims against brand-name drug manufacturers. Finnicum v. Wyeth Inc.,  2010 WL 1718204 (E.D. Tex., 4/28/10). 

Finnicum alleged that her doctor prescribed metoclopramide to treat her heartburn sometime in 2003 and that she regularly ingested a generic form of the drug until at least 2007. Finnicum stipulated, however, that she never ingested any form of metoclopramide manufactured or distributed by defendants Wyeth or Schwarz. In mid-2007, Finnicum alleged she began exhibiting symptoms of tardive dyskinesia, a neurological disorder characterized by involuntary movements, especially of the lower face. Finnicum contended that her long-term ingestion of metoclopramide caused her to develop the disease.

She brought suit, asserting causes of action against Wyeth and Schwarz for negligence, strict products liability, breach of warranty, fraud, and violations of the Texas Deceptive Trade Practices Act.

Although plaintiff never ingested any form of metoclopramide that defendants manufactured or distributed, she alleged that manufacturers of generic metoclopramide are required by federal law to use brand name warnings when selling their products. Finnicum further contended that physicians rely on brand-name warnings when prescribing generic drugs. Finnicum maintained that defendants, as manufacturers of the brand name drug (Reglan), failed to provide adequate warnings of the long-term effects of metoclopramide use. And that impacted the warnings she did get.

The court granted summary judgment to the defendants, joining the majority of courts that have considered this question. Texas law applied. The Texas Supreme Court has stated that a manufacturer generally does not have a duty to warn or instruct about another manufacturer's products, even though a third party might use those products in connection with the manufacturer's own products. Thus, Texas law does not permit a plaintiff who ingested another manufacturer's drug to maintain a failure-to-warn claim against a brand-name manufacturer.  This result is in accord with, for example, the Eighth Circuit in Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir.2009); see also Foster v. American Home Prods. Corp., 29 F.3d 165 (4th Cir. 1994).

The court expressly rejected the California decision, Conte v. Wyeth, Inc., 85 Cal.Rptr.3d 299 (Cal.Ct.App.2008). In Conte, the court extended a brand name drug manufacturer's duty of care regarding product information to patients who were injured by generic brands. This ruling would impose a duty that would stretch the concept of foreseeability too far.

Appeals Court Affirms Summary Judgment Based on Learned Intermediary Rule

A federal appeals court recently affirmed judgment for the maker of an anti-depressant drug, ruling that the plaintiff could not show that an allegedly inadequate warning caused the injury at issue. Dietz v. Smithkline Beecham Corp., 2010 WL 744273 (11th Cir. 2009).

The case reminds readers about the importance of the testimony of the prescriber in a pharmaceutical case. The plaintiff's physician diagnosed him with major depression and offered him hospitalization for psychiatric treatment, which Dietz declined. The doctor then prescribed him Paxil, a selective serotonin reuptake inhibitor (“SSRI”) antidepressant.  Eight days after having filled and begun his Paxil prescription, Dietz apparently committed suicide by throwing himself in front of a train.

Appellant filed a diversity suit. During discovery, the parties deposed Dietz's physician, who testified that he had considered the potential risks and benefits of prescribing Paxil to Dietz when he wrote the prescription in 2002.  He also testified that, even in retrospect, he agreed with his decision to treat Dietz with Paxil and would do so again today under the same circumstances.

Within the context of prescription drugs, Georgia employs the learned intermediary doctrine, which alters the general rule which imposes liability on a manufacturer for failing to warn an end user of the known risks or hazards of its products. According to the doctrine, the manufacturer of a prescription drug does not have a duty to warn the patient of the dangers involved with the product, but instead has a duty to warn the patient's doctor, who acts as a learned intermediary between the patient and the manufacturer. The rationale for the doctrine is that the treating physician is in a better position to warn the patient than the manufacturer, in that the decision to employ prescription medication involves professional assessment of potential medical risks in light of the physician's knowledge of a patient's particular needs.

Here the court affirmed summary judgment for the manufacturer since the appellant could not demonstrate that any alleged failure to warn the treater about increased suicide risks associated with Paxil proximately caused Dietz to commit suicide. The doctor provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings, he still would have prescribed Paxil for Dietz's depression. Pursuant to Georgia's learned intermediary doctrine, this assertion severs any potential chain of causation through which appellant could seek relief. 

Summary Judgment for Drug Company in Pain Pump Case

A federal court has granted defendant summary judgment in a case which alleged that cartilage damage sustained by the plaintiff, a former high school athlete, was caused by the post-surgery use of the drug company’s pain medication in an automated pump device. Jensen Meharg, et al. v. I-Flow Corp., et al., No. 1:08-cv-00184 (S.D. Ind. 3/1/10).

The former high school athlete underwent shoulder surgery, after which a pain pump was utilized. The pain pump in question was manufactured and sold by I-Flow Corporation; the local anesthetic–bupivacaine Hcl – was manufactured and sold by defendant AstraZeneca.  AstraZeneca did not in any way promote the use of bupivacaine with pain pumps, and that use was not mentioned in the instructions and warnings provided with the drug -- an off-label use. Several months later, plaintiff began to experience shoulder pain again. An MRI allegedly revealed that plaintiff had developed chondrolysis in her shoulder, which she alleged was caused by the post-surgery administration of the bupivacaine with the pain pump.

The strict liability claim was for alleged failure to warn; a warning defect claim requires that defendant had a duty to warn.  Duty is generally a legal issue.  In the context of a prescription drug manufacturer, the duty to warn does not arise until the manufacturer knows or should know of the risk.  In cases that involve an off-label use of a prescription drug that is not promoted by the manufacturer, the requisite knowledge of the risk, at a minimum, includes that the manufacturer must know (or be charged with knowledge of) both that the off-label use is occurring and that the off-label use carries with it the risk of the harm at issue – in this case, damage to cartilage.

The court found as a matter of law that the information allegedly possessed by defendant was insufficient to trigger AstraZeneca’s duty to warn of the risk of cartilage damage from continuous infusion of bupivacaine into a patient’s joint. Simply put, the plaintiff failed to point to sufficient evidence that demonstrated that at the time of plaintiff’s surgery AstraZeneca knew of that risk or that it should have known of the risk because experts in the relevant field had such knowledge.

More interesting was plaintiff's other theory. Plaintiff's expert also opined that prior to plaintiff’s surgery the defendant supposedly knew that bupivacaine was being used in pain pumps, and that this knowledge triggered an alleged duty to “investigate the nature of that use, determine whether the drug was being promoted in accordance with approved indications, conduct or sponsor those studies necessary to ensure that the promoted use was safe, and to warn physicians that long-term risks to the joint had not been scientifically established but that the risks should be weighed seriously, given that the anticipated use was for elective post-operative pain therapy for which multiple alternatives existed.”  The court noted that such a  “duty” does not exist under relevant (Indiana) law.  The duty to warn does not arise until the manufacturer knows or should know of the risk.  The alleged far broader duty  – a  duty, in essence, to warn physicians that there might be a risk, although we don’t know yet because neither we or the scientific community at large has studied it yet -- doesn't exist.

Such a duty would cause physicians to be inundated with such pseudo-warnings and quasi-risk information distracting them from heeding real warnings of actual risk; and it would add very little to the fact that physicians already know, i.e., that if a use is omitted from a prescription drug’s label, that use has not been tested sufficiently to demonstrate to the FDA that it is safe and effective.

New Paper On Reduced Legal Oversight of FDA Warning Letters

The WLF has just published a thought piece, co-authored by your humble blogger and colleagues Jim Beck and Vincent Gallo, on how "Reduced Legal Oversight For FDA Warning Letters Amplifies Compliance And Liability Risks."
 

Last summer, the Commissioner of the Food and Drug Administration reversed existing, sound policy that required prior legal review of regulatory letters (Untitled and Warning Letters) by the Agency's Office of Chief Counsel. This reversal -- eliminating review of regulatory letters for legal integrity except in cases of "significant legal issues" -- is one of several changes instituted by the Commissioner to increase enforcement activity and purportedly to limit enforcement delays.

Our paper explores the potential problems with this policy reversal and the risks for industry.