Component Part Seller Liability At Issue In Asbestos Case

California's high court is preparing to address a split among the state's lower courts on what seems to be a straightforward issue of product liability law governing component parts.

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). 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. E.g., TMJ Implants Products Liability Litigation, 872 F. Supp. 1019 (D. Minn. 1995), aff’d, 97 F.3d 1050 (8th Cir. 1996) (applying Minnesota law)); Kealoha v. E.I. Du Pont de Nemours & Co., 844 F. Supp. 590 (D. Hawaii 1994), aff’d, Kealoha v. E.I. Du Pont de Nemours & Co., et al., 82 F.3d 894 (9th Cir. 1996) (applying Hawaii law); Jacobs v. E.I. Du Pont de Nemours & Co., 67 F.3d 1219 (6th Cir. 1995) (applying Ohio law); Apperson v. E.I. Du Pont de Nemours & Co., 41 F.3d 1103 (7th Cir. 1994) (applying Illinois law); Crossfield v. Quality Control Equip. Co., Inc., 1 F.3d 701 (8th Cir. 1993) (applying Missouri law); Childress v. Gresen Mfg. Co., 888 F.2d 45 (6th Cir. 1989) (applying Michigan law); In Re: Silicone Gel Breast Implants Products, 996 F. Supp. 1110 (N.D. Ala. 1997); Travelers Ins. Co. v. Chrysler Corp., 845 F. Supp. 1122 (M.D.N.C. 1994); Sperry v. Bauermeister, 786 F. Supp. 1512 (E.D. Mo.1992); Estate of Carey v. Hy-Temp Mfg., Inc., 702 F. Supp. 666 (N.D. Ill. 1988); Orion Ins. Co., Ltd. v. United Tech. Corp., 502 F. Supp. 173 (E.D. Pa. 1980); Mayberry v. Akron Rubber Machinery Corp., 483 F. Supp. 407 (N.D. Okla. 1979); Artiglio v. General Electric Co., 61 Cal.App.4th 830 (Cal. Ct. App. 1998); Bond v. E.I. Du Pont de Nemours & Co., 868 P.2d 1114 (Colo. Ct. App. 1993); Shaw v. General Motors Corp., 727 P.2d 387 (Colo. Ct. App. 1986); Castaldo v. Pittsburgh-Des Moines Steel Co., Inc., 376 A.2d 88 (Del. 1977); Depre v. Power Climber, Inc., 263 Ill.App.3d 116 (Ill. App. Ct. 1994); Curry v. Louis Allis Co.,
Inc., 100 Ill.App.3d 910 (Ill. App. Ct. 1981); Murray v. Goodrich Eng’g Corp., 30 Mass. App. Ct. 918 (Mass. App. Ct. 1991); Welsh v. Bowling Electric Machinery, Inc., 875 S.W.2d 569 (Mo. Ct. App. 1994); Zaza v. Marquess & Nell, Inc., 144 N.J. 34 (N.J. 1996); Parker v. E.I. Du Pont de Nemours & Co., Inc., 121 N.M. 120 (N.M. Ct. App. 1995); Munger v. Heider Mfg. Corp., 90 A.D.2d 645 (N.Y. App.
Div. 1982); Hoyt v. Vitek, Inc., 134 Ore. App. 271 (Or. Ct. App. 1995); Moor v. Iowa Mfg. Co., 320 N.W.2d 927 (S.D. 1982); Davis v. Dresser Indus., Inc., 800 S.W.2d 369 (Tex. App. 1990); Bennett v. Span Indus., Inc., 628 S.W.2d 470 (Tex. App. 1982); Westphal v. E.I. Du Pont de Nemours & Co., 192 Wis. 2d 347 (Wis. Ct. App. 1995); Noonan v. Texaco, Inc., 713 P.2d 160 (Wyo. 1986).

Sometimes the issue is analyzed as one of no duty on the part of the component seller; other courts view it as an absence if causation.  The policy reasons behind the component parts doctrine are well established. Multi-use component and raw material suppliers should not have to assure the safety of their materials as used in other companies' finished products. That would require suppliers to retain experts in a huge variety of areas in order to determine the possible risks associated with each potential use. And finished product manufacturers know exactly what they intend to do with a component or raw material and therefore are in a better position to guarantee that the component or raw material is suitable for their particular applications.  In the drug and device area, liability is inconsistent with the FDA regulatory scheme because suppliers cannot warn consumers of dangers created by the design of the finished product; the FDA controls who warns and what the warning says.

But when a component manufacturer sufficiently participates in designing a defective and unreasonably dangerous final product, the component manufacturer may be held liable for injuries caused by the final product even though the component itself was not defective or unreasonably  dangerous.  Which raises the question what is ‘‘substantial participation.’’ The Restatement suggests the courts look at whether: (1) the manufacturer or assembler of the integrated product invited the component manufacturer to design a component that would perform specifically as a part of the integrated product;  (2) the component part manufacturer assisted the seller in modifying the design of the integrated product so that it would accept the component part, or (3) the component part manufacturer played a substantial role in deciding which component best serves the requirements of the seller’s integrated product.

A common mass tort battleground for these issues is asbestos.  In O'Neil v. Crane Co., 177 Cal.App.4th 1019, 99 Cal.Rptr.3d 533 (2009)(review granted 12/23/09), the plaintiffs, the widow and children of a naval officer who died of mesothelioma, sued the manufacturers of shipboard pumps and valves, alleging that asbestos insulation used with those components caused the injury.  The trial court dismissed the claims under the component part make doctrine, but last Fall, a panel of the Second Appellate District overturned the trial court's dismissal and said the pump and valve makers could be liable for the officer's death.

The court found that the defendants did not supply a “building block” material, dangerous only when incorporated into a final product over which they had no control. Rather, they sold finished valves and pumps, which needed insulation of some kind. That analysis did not give sufficient attention to the notion that the steam system of the ship ought to be viewed as the finished product, as that term is used in the context of the component parts defense. And it gave insufficient weight to the basic policy underlying the compnent part doctrine.

The panel disagreed with the trial court and with two other appellate decisions going the other way. The state's First Appellate District in Taylor v. Elliott Turbomachinery Co., 171 Cal. App. 4th 564 (2009), found  that pump and valve manufacturers were not liable —as manufacturers of non-defective component parts of a greater whole, and as manufacturers of separate products from those (asbestos) that actually caused the alleged harm. And a different panel of the Second District, Merrill v. Leslie Controls Inc. (Cal. Ct. App., 2d App. Dist., No. B200006, 11/17/09), had also declined to find liability in similar circumstances. See generally Lindstrom v. A-C Product Liability Trust, 424 F.3d 488 (6th Cir.2005)(no liability; causation focus). 

That a component seller knew or should have known that the product maker might use potentially hazardous materials in its design should never be sufficient to impose liability for the design that is the responsibility of the finished product seller.  It makes no sense to have suppliers act as "design police" for every possible item their non-defective part could possibly be combined with in a finished product. 

Under a proper analysis, a warning claim should fare no differently. See Braaten v. Saberhagen Holdings, 198 P.3d 493 (Wash. 2008); Simonetta v. Viad Corp., 197 P.3d 127 (Wash. 2008)(no liability for failure to warn of the hazards of exposure to another manufacturer's asbestos insulation).  The Washington court found the duty to warn under common law negligence was limited to those in the chain of distribution of the hazardous product. Because the defendants did not manufacture, sell, or supply the asbestos insulation, the defendants could not be found liable for breaching a duty to warn. The defendants were not strictly liable because only a product's manufacturer, seller, or marketer is in the position of knowing its dangerous aspects.  To hold a defendant strictly liable for another party's product would be manifestly unfair.

The California Supreme Court has recently agreed to review the issue. O'Neil v. Crane Co., Cal., No. S177401, (petition for review granted 12/23/09).  Here's hoping the doctrine is applied correctly, and this does not become another "asbestos" law exception to common sense rules.

Summary Judgment in Remicade Case

Defendants were granted summary judgment in a case in which the parents of a young woman alleged her death was caused by the infusion treatment Remicade.  Mack v. AmerisourceBergen Drug Corp., 2009 WL 4342513 (D. Md. 11/24/09).  The lesson here for defendants is to put plaintiffs to their proof on every element of a claim.

Crystal Ann Mack was diagnosed with a severe form of Crohn's disease, an inflammatory disease affecting the gastrointestinal tract. In the autumn of 2006, Ms. Mack was hospitalized on two occasions and ultimately diagnosed with anemia, vomiting, weight loss, and various other symptoms. Her treating physician recommended that Ms. Mack undergo Remicade treatments. She received four infusions, in accordance with the medication's dosing instructions. Later, Mack fell unconscious in her home and died. Mack's parents sued three defendants, the drug makers and the distributor, alleging that Mack died of a cardiac arrhythmia that was proximately caused by Remicade.

The defendants sought summary judgment.  Analyzing the product liability claims first, the court concluded that plaintiffs' claims cannot survive summary judgment because they did not establish an issue of fact on whether Remicade is a defective product. Plaintiffs made great efforts to prove specific and general causation, but they made no adequate showing with respect to the issue of defect. Because a showing of defect is an independent prerequisite for a products liability claim, the court didn't even feel the need not address whether plaintiffs satisfied their burden on the issue of causation.

In order to recover on a product defect claim, under the applicable state law, a plaintiff must prove that a defect which renders the product unreasonably dangerous might arise from the design of the product, a deficiency in its manufacture, or from the absence or inadequacy of any instructions or warnings as to its safe and appropriate use. The court noted that the plaintiffs did not assert a failure-to-warn theory.

Under Maryland law, courts may apply both the “risk/utility” test and the “consumer expectation” test when evaluating the efficacy of design defect claims. The “risk/utility” test involves an assessment of “whether the benefits of a product outweigh the dangers of its design.”  Alternatively, a drug could be deemed unreasonably dangerous if it is “dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics. Here, plaintiffs merely cited the legal standards for alleging and proving defect. 

Moreover, plaintiffs failed to present expert testimony on the issue of defect.  The testimony of the doctors largely focused on the issue of causation, and they failed to explain how Remicade was unreasonably dangerous. This shortcoming was especially damaging to plaintiffs' claims, because the issue of defect in this case involved technical medical questions beyond the common knowledge of laypersons.

Nor was there sufficient circumstantial evidence of defect. Plaintiffs' counsel proffered several miscellaneous documents, including internal corporate memoranda and correspondence that referred to the exhibited side effects of Remicade. However, such documents did not militate for the submission of the defect issue to a jury. The fact that a drug may exhibit certain adverse side effects does not, by itself, create an issue of material fact on whether the drug is unreasonably dangerous. The courts have recognized that all drugs involve risks of adverse side effects in those who take them.  In the face of FDA approval, plaintiffs would need to provide a much greater evidentiary showing to establish that the medication's attendant risks outweigh its benefits, the necessary showing under the “risk/utility” test.

 


 

Absence of Causation Evidence Leads to Reversal of Accutane Verdict

An appellate court in Florida last week overturned a verdict in favor of a plaintiff in the Accutane litigation.  Hoffmann-LaRoche Inc. v. Mason, 2009 WL 3430190 (Fla. 1st DCA 10/27/09). The opinion reminds readers of the crucial nature of the causation inquiry during discovery, especially in a warnings context.

Plaintiff developed severe acne while in middle school, which caused him to seek treatment from  a dermatologist. After the acne failed to respond to topical agents and antibiotics, Dr. Fisher prescribed Accutane, which was also later prescribed by plaintiff's family practitioner, Dr. Kenneth Counselman, until November 2000, at which time he was diagnosed with Crohn's Disease, a form of Inflammatory Bowel Disease (for which the epidemiology, BTW, does not show any association with the drug).

Plaintiff filed suit under theories of strict liability and negligent failure to warn alleging that Accutane's warning label was inadequate to warn his physicians about the risk of developing IBD. Specifically, plaintiff presented an expert witness who testified that the warning was insufficient because it allegedly did not adequately describe the relationship between Accutane and IBD. At the close of plaintiff's case, defendant moved for a directed verdict, arguing that plaintiff had failed to establish that his injury was proximately caused by any inadequacies in the warning. The trial court denied the motion after the jury returned its verdict in favor of plaintiff in the amount of $7 million.

The issue on appeal was the adequacy of the warnings testimony, and on particular, the causation issue. 

While plaintiff presented testimony that the warning label was allegedly inadequate to warn physicians that Accutane use could lead to IBD, Dr. Fisher, the prescribing physician, testified that he understood the warning label to mean that there was at least a possibility of a causal relationship between Accutane and IBD. (Dr. Fisher testified that he understood the phrase “temporally associated” to mean that there was a possibility of a causal relationship; virtually all doctors understand that this means an association in time; you take the drug and later you get the effect).  He testified that he would still be willing to prescribe Accutane to his patients even if there was evidence showing that it could cause IBD in rare cases. He also testified that even if the warning label contained all of the additional information suggested by plaintiff's expert, he would still have prescribed the medication. Thus, any alleged inadequacies in Accutane's warning label could not have been the proximate cause of plaintiff's injury because Dr. Fisher understood that there was a possibility that use of the drug could lead to plaintiff developing IBD. And he made an informed decision to prescribe the drug for this patient despite this risk.  Dr. Counselman admitted that he did not consult a prescribing reference manual before prescribing the drug, and thus a different warning would not have mattered to him. 

While a jury somehow found that the alleged failure to provide an adequate warning was a substantial contributing cause of plaintiff's development of IBD, plaintiff actually presented no evidence to establish proximate cause. The trial court erred in denying the motion for a directed verdict. Again, because plaintiff presented no evidence from either prescribing physician that a differently worded warning would have resulted in either physician not prescribing Accutane for his extreme acne, plaintiff failed to establish that the allegedly deficient warning was the proximate cause of his injury; judgment reversed.

 

Sophisticated User/Bulk Supplier Defenses Applied In Chemical Case

In a wrongful death suit brought by the family of a chemical plant employee, the U.S. District Court for the Southern District of West Virginia predicted last week that West Virginia would allow the application of the “sophisticated user” and “bulk supplier” defenses to the plaintiff's product liability claim. Roney, et al. v. Gencorp, et al., No. 3:05-cv-00788 (S.D. W.Va. Sept. 4, 2009).

From 1965 until 1982, Mr. Roney worked at the Pantasote Corporation/Gencorp Inc. Polyvinyl Chloride plant in Point Pleasant, West Virginia. There, he worked extensively with vinyl chloride monomer (“VCM”) – a major raw component of Polyvinyl Chloride (“PVC”). VCM is now associated in some scientific studies with the particular form of liver cancer – angiosarcoma – to which Mr. Roney succumbed. Mr. Roney’s estate filed suit against the defendants for failure to disclose their alleged full knowledge of the danger of VCM and for failing to warn Mr. Roney of its hazardous nature.

Such cases raise, as readers of MassTortDefense know, the related and difficult issues of the duty and ability of a remote supplier of a bulk product to warn downstream users, the customers or employees of their actual customers.  The issue is complicated by the duty of the supplier's immediate customer, in its own right, to warn its customers and to provide a safe workplace for its own workers.  When should that independent or separate duty, imposed on a party who is arguably in a more direct position to pass on effective warnings, cut off the chain of causation flowing up to the remote supplier?  And what about when the employer/intermediate customer is itself an expert in the potential hazards of the product?

Here, in defense of the failure to warn claim, the main product supplier asserted that it had no duty to warn because that duty was obviated by the employer’s own duty to warn its workers. Such a defense, commonly referred to as a “sophisticated user” defense, is available in many states but had not been explicitly adopted or rejected in the state courts of West Virginia. In some jurisdictions the stress is on the bulk supplier aspect and the practicability of warning downstream users; in others the emphasis is in the knowledge of the customer.  Here, the court addressed both aspects.

Section 388 of the Restatement (Second) of Torts addresses a supplier’s potential liability
for a “Chattel Known to Be Dangerous for Intended Use.” Comment n of this section is commonly cited as the basis for the sophisticated user defense: There is necessarily some chance that
information given to the customer will not be communicated by him to those who are to use the
chattel. This chance varies with the circumstances existing at the time the chattel is turned over to the person, including the known or knowable character of the third person and the purpose for which the chattel is given. "Modern life would be intolerable unless one were permitted to rely to a certain extent on others' doing what they normally do, particularly if it is their duty to do so."

Plaintiff relied on the fact that the West Virginia Supreme Court has rejected the learned intermediary doctrine, a defense plaintiff claimed was similar to the sophisticated user defense. See State ex Rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899 (W.Va. 2007). The reasoning of that decision, questionable in its own right, is not applicable to a scenario outside of the prescription pharmaceutical context and the rise of direct-to-consumer advertising. In deciding Karl, the court had recognized that through such DTC advertising pharmaceutical companies had arguably gained direct access to patients, a relationship starkly different than that which had existed when the learned intermediary doctrine was developed – when patients received drug information exclusively through their doctors. And starkly different from the industrial context. Chemical workers would typically have had little opportunity to influence the choice of products to which they would be exposed. Instead, they relied upon their employer to determine the scope of their duties and their role in the production process. They were insulated from the manufacturer of the chemicals they used, much as the patient used to be insulated from the drug manufacturer, observed the court.

The duty to warn, said the federal court, involved an analysis of the reliability of the third party as a conduit of necessary information about the product; the magnitude of the risk involved; and the burdens imposed on the supplier by requiring that it directly warn all users. That, in turn, included the degree to which the danger related to the particular product is clearly known to the  purchaser/employer. Thus, West Virginia would recognize a sophisticated user defense.

As with the sophisticated user defense, the bulk supplier notion is rooted in Restatement § 388
comment n. While the sophisticated user defense focuses on the reasonableness of reliance on the employer, the bulk user defense concerns the burden which would be imposed on the supplier if it were bound to directly warn all downstream users.  The impracticability of the manufacturer getting a warning for a chemical shipped in tank trucks or rail cars to the employees of the customer would also be recognized as a defense in the state, predicted the federal court.

The court rejected the defendant's third assertion that the dangers of vinyl chloride monomer are “open and obvious," as the connection between cancer and VCM is not readily known outside scientific, medical and industrial communities, said the court.

 

FEMA Trailer MDL Decision on Preemption

The federal court overseeing the MDL involving trailers issued by the U.S. government following Hurricane Katrina has dismissed some of the plaintiffs' state law claims against mobile home manufacturer defendants, on the basis of the federal preemption doctrine. In Re: FEMA Trailer Formaldehyde Products Liability Litigation, MDL No. 1873 (E.D. La.)

As readers of MassTort Defense know, Hurricane Katrina impacted much of the Gulf Coast in August 2005, and Hurricane Rita followed in September 2005, causing extensive damage along the Louisiana and Texas coasts. In the wake of the hurricanes, many individuals whose homes were lost or damaged moved into temporary housing provided by FEMA. Plaintiffs allege that these trailers exposed residents to high levels of the chemical formaldehyde, about which they were not warned. The Judicial Panel on Multidistrict Litigation consolidated a number of suits against defendants, including the federal government and several trailer manufacturers, over the alleged formaldehyde exposure in 2007.

Judge Kurt Engelhardt of the U.S. District Court for the Eastern District of Louisiana last week granted the manufacturer defendants' motion to dismiss certain state law claims. The defendants asserted that the construction of these mobile homes was regulated by the Manufactured Home Construction and Safety Standards Act, 42 U.S.C. § 5401 et seq., (“the MHA”) and the regulations promulgated by the United States Department of Housing and Urban Development (“HUD”), pursuant to 24 C.F.R. § 3280 and § 3282 (“the HUD Code”). Pursuant to the MHA, HUD established the Manufactured Home Construction and Safety Standards (“MHCSS”), 24 C.F.R § 3208 et seq., which govern the standards for formaldehyde emissions from materials used in manufactured homes. This regulation expressly and specifically dictates the maximum level of formaldehyde gas that component products in mobile homes can emit. The regulations also specify that a health notice on formaldehyde emissions shall be temporarily displayed in the kitchen of each manufactured home.Accordingly, the defendants asserted that the federal statutes and regulation in the MHA and the HUD Code explicitly and impliedly preempt plaintiffs’ state law claims against them.

As several courts have previously noted, the MHA does not explicitly preempt state causes of action. Turning to implied preemption, the court noted that implied preemption exists when state law regulates conduct in a field Congress intended the Federal Government to occupy exclusively (also referred to as “field preemption”), or when state law actually conflicts with federal law (also referred to as “conflict preemption”). Conflict preemption exists in two scenarios: (1) when compliance with both a state and federal law is impossible, and/or (2) when the state law conflicts with the federal law such that it stands as an obstacle to the achievement of the federal law’s purposes and objectives.

After analyzing the statute and regulations, the MDL court concluded that if plaintiffs in the instant case were allowed to go forward with their state product liability claims raising the ambient air standard, then defendants in the mobile home industry would essentially be required to deviate (in ways variable from state to state) from those federal standards so carefully and thoroughly crafted by HUD. The MHA clearly states that if states want to regulate safety matters that federal law already covers (like formaldehyde emissions), those regulations must be “identical.” 42 U.S.C. § 5403(d). Furthermore, it was noteworthy that the plaintiffs contend that the moving defendants should have adhered to the ambient air standard, which differs from the HUD-accepted component products standard. Thus, cases that present situations where the plaintiffs are not arguing that the defendants should have adhered to a standard higher than, or different from what the MHA imposes, are inapplicable.

The court concluded similarly that any such claims relating to inadequate warnings of exposure
to purportedly high levels of formaldehyde contained in the units, that require more than the federal
label standards, should be dismissed. However, any of plaintiffs’ state law claims that advance non-compliance with federal formaldehyde regulations (to the extent that such claims exist) are considered to be parallel claims, are not preempted and, thus, are not dismissed. See Riegel v. Medtronic, Inc., 128 S.Ct 999, 1011 (2008).

Preemption Decision in Wake of Levine

Much attention has been focused on what aspects of the preemption doctrine were restricted by the U.S. Supreme Court's recent decision in Wyeth v. Levine. A recent decision holds that claims that a drug was “unreasonably dangerous” and that no warning would have been adequate, are preempted. Longs v. Wyeth, 2009 WL 754524 (N.D. Ohio, 3/20/09). Plaintiff sued Wyeth and asserted strict liability and negligence claims concerning the diet drug Redux. Wyeth argued that plaintiff's claim that Redux was an unreasonably dangerous drug, for which no warning would have been adequate, directly conflicts with the FDA's authority to determine which drugs are sufficiently safe and effective to be marketed. The court affirmed its grant of summary judgment, finding that the strict liability and negligence claims related to pre-FDA approval were preempted by federal law, and that the claims that were not preempted failed on their merits.

The Court rejected plaintiff’s claim that Wyeth v. Levine called for reconsideration. In Wyeth, the Court considered the narrow issue of whether the FDA's drug labeling judgments preempt certain state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use. The court noted that the Supreme Court emphasized that it was Congress' intent to have state law complement federal drug regulation because manufacturers may have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge.

The instant case was distinguishable from Wyeth v. Levine because it did not involve a failure to warn claim, and because Levine arose out of the actions of the manufacturer post-FDA approval. A post-FDA approval duty is distinguishable from a manufacturer's duty prior to approval by the FDA, a circumstance that the Supreme Court did not explicitly address. Whatever Wyeth v. Levine may stand for regarding whether post-FDA approval claims are preempted, it does not purport to hold anything for pre-FDA approval claims, held the court.
 

9th Circuit Affirms Summary Judgment In Failure To Warn Case

The Ninth Circuit has affirmed that the trial court did not err in granting summary judgment for defendant Merck under California's learned intermediary doctrine in a failure to warn case. Latiolais v. Merck & Company, Inc., 2008 WL 5157705 (9th Cir. 2008).

Latiolais appealed the district court's grant of summary judgment on her claim that Merck failed to adequately warn, as a result of inadequate testing, of claimed suicide risks associated with the cholesterol-lowering medication Zocor.

Under California's learned intermediary doctrine, a prescription drug manufacturer's duty to warn runs to the physician. A product defect claim based on insufficient warnings cannot survive summary judgment if stronger warnings would not have altered the prescribing physician's conduct. See Motus v. Pfizer, Inc., 358 F.3d 659, 661 (9th Cir.2004).

Here, there was no genuine issue of material fact as to causation made out by the prescriber’s deposition testimony. It indicated that the drug inserts accompanying Zocor did not play a role in his decision to prescribe that medication. Furthermore, Dr. Oppenheim was not equivocal regarding whether he would have prescribed Zocor in light of a supposed warning of suicide risk associated with Zocor. Such a warning was deemed “hypothetical” by the court, and, in any event, could come into play only after one makes several assumptions on issues that include whether Merck was obligated to issue a suicide risk warning for Zocor, whether Dr. Oppenheim would have read or heeded such a warning, and what information Mr. Davis would have disclosed to Dr. Oppenheim with respect to his mental state. Such speculation did not create an issue of fact.

 

Federal Court Grants Summary Judgment To Defense On Accutane Warnings

A federal district court has granted summary judgment to drugmaker defendants Hoffmann-LaRoche Inc. and Roche Laboratories Inc. in an Accutane failure to warn case. Snyder v. Hoffman-LaRoche, Inc., 2008 WL 4790666 (M.D.Fla., October 30, 2008). Plaintiffs alleged their teenage son was prescribed Accutane in 2000 to treat young Snyder's severe acne condition. He had three courses of treatment through April, 2003. On February 28, 2005, Snyder committed suicide.

Prior to prescribing Snyder's first course of Accutane treatment, Dr. Kalb received and reviewed the drug’s 1998 Package Insert, the 1998 Dear Doctor Letter, the 1999 issue of the PDR, the February 25, 1998 FDA Talk Paper, and the Seventh Edition of the Accutane Brochure, all of which discussed the potential suicide risks. Dr. Kalb testified that he discussed the risks and benefits of Accutane with Snyder before prescribing the drug, including specifically the potential risk of depression and suicide. Such discussion was consistent with his regular practice, as was his practice of providing each patient with a copy of the then current Accutane Brochure. Throughout Snyder's courses of treatment, Dr. Kalb continued to monitor him for symptoms of depression.  According to Dr. Kalb, who would know, no symptoms of depression were reported or observed while Snyder was taking Accutane.

Plaintiff's Complaint included claims for negligence, strict products liability, breach of implied warranty, and negligent and fraudulent misrepresentation. Each of these claims was predicated upon defendants' alleged failure to warn that Accutane could cause Snyder to commit suicide. Defendants moved for summary judgment on the issue of the adequacy of the warnings. Snyder resided and was prescribed Accutane in the State of New York. Accordingly, the Court considered whether Defendant's warnings were adequate under New York law.

Under New York law, a prescription drug manufacturer may avoid liability for injuries that would ordinarily render the manufacturer strictly liable by distributing proper directions and warnings with the drug. To avoid liability, a manufacturer must warn of all potential dangers in its prescription drugs that it knew, or, in the exercise of reasonable care, should have known to exist. New York employs the learned intermediary doctrine, under which physicians act as “informed intermediaries” between manufacturers and patients regarding warnings for prescription drugs. Thus, a manufacturer's duty to caution against a drug's side effects is fulfilled by giving adequate warning through the prescribing physician, not directly to the patient.

Because the defendant had issued a warning about this specific risk, plaintiffs were left to try to argue that defendant's warnings were not direct, unequivocal and sufficiently forceful to convey the risk of suicide. Plaintiff argued defendants' warnings equivocated in stating that Accutane “may” cause depression and suicidal ideation, that emotional instability “may” bear no relation to therapy, and that the side effect of suicide is “uncommon” and/or “rarely” occurs. Moreover, Plaintiff argued that the defendants' statement that “no one knows if Accutane caused these suicidal behaviors” further dilutes the warning.

The Court disagreed with plaintiffs. The February 1998 warnings specifically warned that Accutane treatment may cause suicide. MassTortDefense notes that the drug does not always cause suicide, if it ever does (which is unproven), so “may” is perfectly accurate. The statements that Accutane “may” cause suicide, or that such a result “rarely” occurs, do not inappropriately diminish the seriousness of the warning; rather they describe the medical record. The Court properly viewed the extensive warning language as a prescriber would, in full context, not isolating a word or phrase. Taken as a whole, the warnings clearly, accurately, and consistently conveyed to Dr. Kalb that Accutane might cause suicide, with or without prior symptoms of depression. Accordingly, the Court concluded that defendants' warnings were adequate as a matter of law. Defendants were entitled to summary judgment as to plaintiff's failure to warn claims

 

Food Allergies In Kids

According to some media outlets, food allergies in American children are on the rise, now affecting about 3 million kids. The media is citing a recent report by the CDC, a comprehensive federal study of the problem. Branum and Lukacs, NCHS Data Brief No. 10, “Food Allergy Among U.S. Children: Trends in Prevalence and Hospitalizations,” (October 2008). The study reports that about 1 in 26 children had food allergies last year, up from 1 in 30 kids in 1997.


Food allergy is a potentially serious immune response to eating specific foods or food additives. Eight types of food account for over 90% of allergic reactions in affected individuals: milk, eggs, peanuts, tree nuts, fish, shellfish, soy, and wheat. About 1 in 50 are allergic to shellfish and nearly 1 in 100 react to peanuts. Other research suggests that about 1 in 40 Americans will have a milk allergy at some point in their lives, and 1 in 50 percent will be allergic to eggs. Reactions to these foods by an allergic person can range from a tingling sensation around the mouth and lips to hives to death, depending on the severity of the allergy.


The report:
• In 2007, approximately 3 million children under age 18 years (3.9%) were reported to have a food or digestive allergy in the previous 12 months.
• From 1997 to 2007, the prevalence of reported food allergy increased 18% among children under age 18 years.
• Children with food allergy are two to four times more likely to have other related conditions such as asthma and other allergies, compared with children without food allergies.
• From 2004 to 2006, there were approximately 9,500 hospital discharges per year with a diagnosis related to food allergy among children under age 18 years.


While some are quick to blame product manufacturers, nobody knows for sure what's driving the increase. The mechanisms by which a person develops an allergy to specific foods are largely unknown. Food allergy is more prevalent in children than adults, and a majority of affected children will "outgrow” food allergies with age.


A likely big part of the explanation of the new data is a from of reporting bias, as parents are more aware and quicker to have their kids checked out by a doctor these days. Parents and doctors are both more likely to consider food as the trigger for generic symptoms like vomiting, skin rashes and breathing problems. Parents today are quicker to take their kids to specialists to check out the possibility of food allergies. Thus, the findings could be related to increased awareness, reporting, and use of specific medical diagnostic codes for food allergy rather than a real increase in the number children who are experiencing food-allergic reactions.

The fact that a small number of the population is so constituted that they may suffer severe reactions to products which may be harmless or generally beneficial to others poses a dilemma to the legal scholars and courts. Generally speaking, the allergic or unusually susceptible plaintiff has found the road to financial recovery a difficult one, irrespective of the theory of recovery, the manufacturer of a reasonably safe product generally having been held not liable for damages where the basis of the injury was an allergy, hypersensitivity, or unusual susceptibility on the part of the user. See 63 Am. Jur. 2d, Products Liability § 1453. Plaintiffs’ main theory in allergy cases is that the supplier should be liable for damages arising from an allergenic, idiosyncratic reaction to its product where it has failed to give adequate and timely warning. E.g., Livingston v. Marie Callender's, Inc., 85 Cal. Rptr. 2d 528, 533 (Cal. App. 1999) (warning for allergy to MSG); Brown v. McDonald's Corp., 655 N.E.2d 440, 444 (Ohio App. 1995) (warning for allergy to seaweed); Advance Chem. Co. v. Harter, 478 So.2d 444, 448 (Fla. App. 1985) (warning for allergy to ammonia); Gober v. Revlon, Inc., 317 F.2d 47, 50 (4th Cir. 1963) (warning for allergy to nail polish). At times, plaintiffs will also try to add a manufacturing defect claim in the nature of an alleged failure to reduce or minimize the amount of the allergen in the product by washing, for example. This was seen in the latex glove mass tort.