Appeals Court Affirms Summary Judgment for Cart Manufacturer

The Second Circuit affirmed the grant of summary judgment for a golf cart maker who challenged plaintiff's expert opinion in a design defect suit by a teenager injured in a 2007 golf cart accident. See Valente v. Textron, Inc., No. 13-1456 (2d Cir., 3/10/14).

Plaintiffs appealed from an award of summary judgment in favor of defendants on Valente’s strict liability and negligence design defect claims for damages allegedly sustained when Valente was operating a golf car manufactured by defendants. Valente contended that the district court erred in precluding the testimony of his expert (K. Seluga) after a hearing pursuant to Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).

Specifically, the district court excluded Seluga’s testimony that yaw instability—resulting from a design defect in the use of a two-wheel rear braking system as opposed to a four-wheel braking system—was responsible for Valente’s accident. In fact, the court of appeals concluded, the district court’s thoughtful and thorough explanation for excluding Seluga’s testimony convincingly demonstrated that it acted well within its discretion.

There is no dispute that the coefficient of friction term in the relevant calculations was the determining factor in the expert's opinion that yaw instability was responsible for Valente’s accident. But the coefficient of friction used by Seluga, based on flat surface testing, was approximately 40% lower than the coefficient measured by Seluga and defendants' expert on the actual path of the accident, as well as that used by the expert in a published peer reviewed article on the topic.

 

Even assuming the reliability of the coefficient, Seluga testified that his simulation would predict a
rollover due to yaw instability somewhere between 25% and 50% of the time.  The purpose for which Valente sought to offer Seluga’s testimony, however, was not that under certain circumstances there was a 25% chance that the accident could have occurred as a result of the defect in the golf car, but rather that the design defect actually caused the accident “to a reasonable degree of engineering certainty.” Where, as here, data is simply inadequate to support the conclusions reached, Daubert and Rule 702 mandate the exclusion of that unreliable opinion
testimony.

 

With Seluga’s testimony properly excluded, the record was devoid of any evidence supporting Valente’s theory that the golf car had a design defect or that such a design defect likely caused his accident.

Affirmed.

 

State Supreme Court Reaffirms Death of Single Fiber Theory

The Pennsylvania Supreme Court recently reaffirmed several important principles in toxic tort exposure, specifically asbestos, cases. See Howard, et al. v. A.W. Chesterton Co., et al., Nos. 48 EAP 2012, 49 EAP 2012 and 50 EAP 2012 (Pa. Sept. 26,2013).

Plaintiff alleged personal injury from exposure to dust from defendant's asbestos-containing products. The common pleas court awarded summary judgment in favor of defendants/appellants, reasoning that plaintiff's deposition testimony failed to establish that he breathed asbestos-containing dust from the products manufactured or distributed by appellants, and the court also found expert affidavits submitted by plaintiffs represented insufficient proof of actual exposure.  On appeal, the Superior Court reversed on the basis that dust may have been invisible to the naked eye, and the expert affidavits were sufficient to establish exposure to dust which was a substantial causal factor in plaintiff's injury.

The Supreme Court reversed the intermediate appeals court, and in so doing reaffirmed several key principles of state law:

--The theory that each and every exposure, no matter how small, is substantially causative of disease may not be relied upon as a basis to establish substantial-factor causation for diseases that are dose-responsive. See Betz v. Pneumo Abex, LLC, 44 A.3d 27, 55-58 (Pa. 2012). 

-- Relatedly, in cases involving dose-responsive diseases, expert witnesses may not ignore or refuse to consider dose as a factor in their opinions. See id.

-- Bare proof of some de minimus exposure to a defendant’s product is insufficient to establish substantial-factor causation for dose-responsive diseases. See Gregg v. V-J Auto Parts, Inc., 943 A.2d 216, 225-26 (Pa. 2007).

-- Relative to the testimony of an expert witness addressing substantial-factor causation in a dose-responsive disease case, some reasoned, individualized assessment of a plaintiff’s or decedent’s exposure history is necessary. See Betz, 44 A.3d at 55-58.

-- Summary judgment is an available vehicle to address cases in which only bare de minimus exposure can be demonstrated and where the basis for the experts testimony concerning substantial-factor causation is the any-exposure theory. See Betz, 44 A.3d at 55-58; Gregg, 943 A.2d at 227.

In an interesting procedural twist, during arguments before the Supreme Court, plaintiff conceded that the Superior Court had erred in its ruling -- an apparent attempt to have the Supreme Court not reiterate the points that some lower courts in the state inexplicably continued to not apply.  Nevertheless, in light of the intensely protracted nature of asbestos litigation, the Court decided to provide at least some limited guidance.  Indeed, as explained in detail in the unanimous decision in Betz, the any-exposure opinion is simply unsupportable both as a matter law and science.

 

(Note that my colleague Mark Behrens was involved in the amicus briefing on behalf of the Coalition for Litigation Justice.)

Summary Judgment Granted on Product Identification

Sometimes simpler is better.  In product liability litigation nothing is more basic, perhaps, than proof the plaintiff used defendant's product.  Last week, a federal judge granted summary judgment against two plaintiffs' making claims in multi-district litigation over injuries allegedly related to the painkillers Darvocet and Darvon. See In Re: Darvocet, Darvon and Propoxyphene Products Liability Litigation, No. 2:11-md-02226 (E.D. Ky.). The issue was this basic cause in fact element.

Summary judgment is appropriate when “the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a); see Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986).

Defendant argued that it was entitled to summary judgment because neither plaintiff demonstrated the ingestion of a propoxyphene product manufactured, sold, or distributed by the defendant. In their Amended Complaint, both plaintiffs allege that they ingested propoxyphene products manufactured by Lilly. It is indeed a general principle of products liability law in Texas and Georgia (the applicable rules under choice of law in an MDL) that a plaintiff must allege sufficient facts to allow the reasonable inference that the injury-causing product was sold, manufactured, or distributed by the defendant. Plaintiffs could not dispute that they failed to establish the ingestion of a Lilly  product.

Instead, Lilly presented evidence demonstrating that plaintiffs represented that they intended to pursue only claims that relate to generic drugs; that is, they would seek to hold Lilly liable for
the injuries allegedly arising out of their taking of generic drugs made by someone else.

Such arguments were already rejected by the Court in this MDL.  The Court had previously found unpersuasive the plaintiffs’ argument that a brand-name manufacturer may be held liable under a misrepresentation theory of liability to a plaintiff who ingested generic propoxyphene. The prevailing rule regarding misrepresentation claims against brand-name manufacturers has its origins, noted the Court, in Foster v. American Home Products Corp., 29 F.3d 165 (4th Cir. 1994), which rejected “the contention that a name brand manufacturer’s statements regarding its drug can serve as the basis for liability for injuries caused by another manufacturer’s drug.” Id. at 170.

The majority of courts that have addressed similar claims have followed the Fourth Circuit’s lead. Notably, federal district courts in Texas have repeatedly found that “the Texas Supreme Court would conclude that a brand-name manufacturer does not owe a duty to warn users of the risks related to another manufacturer’s product.” Finnicum v. Wyeth, Inc., 708 F. Supp. 2d 616, 621 (E.D. Tex. 2010); see also Burke v. Wyeth, Inc., No. G-09-82, 2009 WL 3698480, at *2-3 (S.D. Tex. Oct. 29,
2009).  And, similarly, there can be no recovery under Georgia law, “[u]nless the manufacturer’s defective product can be shown to be the proximate cause of the injuries . . .” Hoffman v. AC&S, Inc., 548 S.E.2d 379, 382 (Ga. Ct. App. 2001) (“To survive summary judgment, [the plaintiff] clearly
needed to present evidence that she was exposed to defendants’ products.”).

Defendant thus sufficiently established that there was no genuine dispute concerning the only
material fact that determined the viability of these plaintiffs’ misrepresentation claims: the identity
of the propoxyphene product ingested.  Therefore, the plaintiffs’ claims failed as a matter of law.

 

 

 

Failure of General Causation Proof Leads to Summary Judgment in Chemical Case

The Ohio appeals court ruled recently that a plaintiff could not pursue her chemical exposure toxic tort suit since her sole general causation expert's testimony was properly deemed unreliable by the lower court.  See Cooper v. BASF Inc., No. 26324 (Ohio Ct. App. 6/28/13).

The plaintiffs alleged they contacted a defendant Pest Control Company due to a termite infestation in various parts of their home, and the company applied Termidor SC, which contains the chemical fipronil, inside an open wall in the Coopers' bedroom, underneath a bathroom drain which is accessed through an opening under a sink cabinet, and around the perimeter of the house. A few months later, Mrs. Cooper was hospitalized complaining of various symptoms and was diagnosed with hypothyroidism and related encephalopathy, of unknown etiology. The plaintiffs claimed that the symptoms were caused by alleged exposure to pesticides.  The Coopers filed a complaint alleging: (1) negligence against the chemical manufacturer and the Pest Control Company; (2) strict products liability claims; and (3) fraud against the Pest Control Company.

The trial court ordered the Coopers to identify one or more expert witnesses who would support their theory of general and specific causation in this matter, and to make a submission that the expert was prepared to testify that  the chemical generally is capable of causing the medical conditions about which plaintiff complained and that in this specific instance there was a good faith basis for believing that her conditions were caused by her exposure to this chemical.  The Coopers identified Richard L. Lipsey, Ph.D., as their general causation expert.  Defendants moved to exclude the expert and for summary judgment.

The trial court granted the motions, finding that the expert had not based his opinion regarding general medical causation on reliable scientific, technical, or other specialized information. None of the articles or studies he reviewed showed a causal connection between Fipronil exposure and plaintiff's disease. The key epidemiological study of 103 workers exposed to Fipronil in the factory manufacturing flea collars found that symptoms associated with Fipronil exposure were temporary, and workers' conditions improved when no longer exposed. The animal studies cited by Dr. Lipsey failed to establish any correlation across species, and the expert had to admit that the animals used were not appropriate models for humans.

The court of appeals affirmed.  Ohio follows the Daubert test. And here the expert reached this conclusion without adequate scientific proof of a causal link between fipronil and hypothyroidism in humans. The record contained no evidence of any generally accepted methodology that has been adopted by the scientific community to establish a causal link between fipronil and hypothyroidism in humans. The court also noted, beyond the factors stressed by the lower court, that the expert testified that: (1) he had never written any peer-reviewed articles concerning the effects of pesticides on the human thyroid, (2) he had not done a dose reconstruction as to the amount of fipronil Mrs. Cooper was allegedly exposed to, and (3) there was no biological sampling done on Mrs. Cooper's blood or fatty tissue to prove that she had been exposed to a significant level of the chemical.

Without an expert opinion, summary judgment was appropriate as plaintiff could not prove the causation element of each cause of action.

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. 

 

 

Federal Court Reaffirms Summary Judgment in NORM Case

A federal court recently reaffirmed its prior ruling that a plaintiff's expert failed to establish causation in a suit alleging increased risk of cancer from radioactive scale deposited inside pipes.  See Hill v. Exxon Mobil Corp., No. 11-2786 (E.D. La. 4/30/13).

Plaintiff worked at Tuboscope Vetco International. He alleged he was exposed to radioactive scale
(naturally occuring radioactive materials or "NORM") when he cleaned pipes at work. Hill sued Shell Oil
Co. and Chevron U.S.A. Inc. alleging that these companies sent used pipes containing radioactive scale to Tuboscope to be processed and that he was exposed to the radioactive scale in these pipes.

Earlier this year, the court granted defendants' motion for summary judgment on the grounds that Hill could not prove that he was exposed to radiation attributable to Shell or Chevron.  A fundamental cause in fact issue. His evidence only supported general inferences about radiation at Tuboscope but nothing that showed (1) he actually cleaned used pipe containing scale with NORM or (2) that these pipes were attributable to Shell or Chevron. Hill's evidence required an impermissible chain of speculation to find that he was exposed to radiation in these defendants' pipes.

Plaintiff then moved to alter and amend the summary judgment arguing that the court should amend or reconsider its judgment because of new evidence. The court concluded that the new evidence, largely depositions taken after the motion was pending but before it was ruled on, was not grounds for altering the court's judgment. 
 
Defendants argued that these depositions were not the proper basis for a Rule 59(e) motion to amend because the evidence was available before the judgment issued. See Rosenzweig v. Azurix Corp., 332 F.3d 854, 863-864 (5th Cir. 2003).  Hill deposed these witnesses before the court issued its judgment, and he apparently made no attempt to supplement the record. Accordingly, this evidence was not "newly discovered." See Russ v. Int'l Paper Co., 943 F.2d 589, 593 (5th Cir. 1991).

Even if this evidence was considered, however, the court noted that plaintiff's motion still would fail.  For example, one expert testimony did not establish that Hill was exposed to radioactive scale attributable to Shell and Chevron. No party disputed that new pipe does not have scale, and not all used pipe has scale. Further, not all used pipe with scale contains NORM.  The later expert's calculation of the average radiation dose of pipes that do have scale containing NORM does not provide any proof that Hill was actually exposed to (1) used pipes that have scale containing NORM or (2) that these pipes were attributable to defendants. Accordingly, this kind of "new" testimony was irrelevant to proving Hill's exposure to NORM attributable to Shell and Chevron. The evidence did not show that Hill handled defendants' NORM-containing pipes and did not create an issue of material fact. Motion denied.


 

Summary Judgment for Defendant in Heater Case

A federal court granted defendant summary judgment in a products case alleging that a  propane heater that exploded was responsible for plaintiff's husband's death.  See Ayala v. Gabriel Building Supply, No. 2:12-cv-00577 (E.D. La., 4/26/13).

Plaintiff filed a wrongful death and survival action in state court. Defendants removed the matter and the federal court dismissed plaintiff's claims for negligence, strict liability, and manufacture of an ultra hazardous project, holding that plaintiff's theories of recovery are limited to the Louisiana Products and Liability Act ("LPLA").  Under Louisiana law, the LPLA provides the exclusive remedy against manufacturers in a products liability action. Demahy v. Schwarz Pharma, Inc., 702 F.3d 177, 182 (5th Cir. 2012). To maintain a successful action under the LPLA, a plaintiff must prove: "(1) that the defendant is a manufacturer of the product; (2) that the claimant's damage was proximately caused by a characteristic of the product; (3) that this characteristic made the product 'unreasonably dangerous'; and (4) that the claimant's damage arose from a reasonably anticipated use of the product . . . . " Stahl v. Novartis Pharms. Corp., 283 F.3d 254, 261 (5th Cir. 2002). 

Defendants then moved for summary judgment on the basis that the subject heater was not "unreasonably dangerous" under the LPLA. A product can be "unreasonably dangerous" in four ways: (i) in construction or composition; (ii) in design; (iii) for failure to provide an adequate warning; and (iv) for failure to conform to an express warranty.

One of plaintiff's claims was design defect.  A product is unreasonably dangerous in design if, at the time the product left the manufacturer's control:
(1) There existed an alternative design for the product that was capable of preventing the claimant's damage; and
(2) The likelihood that the product's design would cause the claimant's damage and the gravity of that damage outweighed the burden on the manufacturer of adopting such alternative design and the adverse effect, if any, of such alternative design on the utility of the product La. Rev. Stat. § 9:2800.56.

Plaintiff failed to present any credible evidence that an alternative design existed that could have prevented plaintiff's injuries. And there was no evidence regarding the burden of adopting the design and
any adverse effect on the utility of the heater. Given the foregoing, plaintiff could not prove that the
subject heater was unreasonably dangerous in design.

To prevail under the manufacturing defect (construction or composition theory), Louisiana courts require the plaintiff to (i) set forth the manufacturer's specifications for the product and (ii) demonstrate how
the product materially deviated from those standards so as to render it unreasonably dangerous. Roman v. W. Mfg, Inc., 691 F.3d 686, 698 (5th Cir. 2012). Plaintiff's expert opined that the most probable cause of the fire and the injuries was a propane leak in the subject heater. However, since all non‐ferrous components of the subject heater melted in the fire, he based his opinion on an examination of another heater.  He conceded that there was no evidence to suggest the subject heater itself was defective. In fact, the expert admitted that he could not conclusively rule out other potential sources of a propane leak, such as a faulty propane tank or plaintiff's failure to properly secure the fitting.  That didn't meet the burden.

To maintain a failure‐to‐warn claim, a plaintiff must demonstrate that the product possessed a characteristic that may cause damage and the manufacturer failed to use reasonable care to provide an adequate warning of such characteristic and its danger to users of the product. Stahl, 283 F.3d at 261. In all cases, however, a manufacture is liable for inadequate warning only if such defect was a proximate cause of the plaintiff's injury. Peart v. Dorel Juvenile Grp., Inc., No. 09–7463, 2011 WL 1336563, at *3 (E.D. La. Apr. 7, 2011).  In addition to proving causation in fact, a plaintiff must also demonstrate that the inadequate warning was the most probable cause of his injury. See Wheat v. Pfizer, Inc., 31 F.3d 340, 342 (5th Cir. 1994). Here, Plaintiff failed to meet this burden of establishing causation. Indeed, Plaintiff's expert failed to adequately support a defect, as above, and offered nothing credible to establish a causal connection between the alleged failure to provide an adequate warning and plaintiff's injury.

 

 

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.

Court of Appeals Affirms Exclusion of Plaintiff Expert Testimony

The Sixth Circuit earlier this month affirmed the exclusion of plaintiff expert testimony seeking to link osteonecrosis of the jaw to plaintiff's use of two cancer medications. See Simmons v. Novartis Pharmaceuticals Corp., No. 11-5053 (6th Cir., 6/5/12).

Simmons developed osteonecrosis of the jaw (ONJ), a bone disease affecting the jaw, allegedly as a result of using the prescription medications Zometa and Aredia. He sued and the Judicial Panel on Multidistrict Litigation transferred the action under 28 U.S.C. § 1407 to the United States District Court for the Middle District of Tennessee and assigned it to Chief Judge Todd Campbell.

To prove specific causation, plaintiff offered two experts. Plaintiff offered Dr. Obeid, a board-certified oral and maxillofacial surgeon who saw the plaintiff, and Dr. Edward Gutman an experienced oral surgeon. Defendant moved to exclude, inter alia, the testimony of Drs. Obeid and Gutman, on the issue of causation. The MDL court granted the motion to exclude any testimony by Dr. Obeid as
to the cause of Simmons’s injury, and by a separate order the district court granted defendant’s motion to exclude Dr. Gutman’s causation testimony. The court then granted defendant’s motion for summary judgment on all of plaintiff’s claims because plaintiff no longer had proof of an essential element of a product-liability claim under Maryland law, i.e., specific causation. Plaintiff appealed.

The court of appeals noted that a treating physician’s testimony is subject to Daubert. See Gass v. Marriott Hotel Servs., Inc., 558 F.3d 419, 426 (6th Cir. 2009). Plaintiff was therefore required to demonstrate that Dr. Obeid’s reasoning or methodology was scientifically valid and that he properly applied that reasoning or methodology to the facts at issue. Plaintiff relied on Dr. Obeid’s statement that he found “a very close association” between ONJ and the class of drugs. However, Dr. Obeid also specifically acknowledged that he “didn’t establish causation” in evaluating Simmons’s ONJ.  Readers know that association is not causation.  Furthermore, Dr. Obeid agreed that the current level of evidence did not support a cause-and-effect relationship between bisphosphonate exposure and ONJ. While there were references to the medication in Dr. Obeid’s medical records, even if this was a "diagnosis," a diagnosis is merely a hypothesis, which does not satisfy Daubert and Rule 702. Moreover, nowhere in his testimony did Dr. Obeid rule out other conditions as the sole cause of Simmons' ONJ.

As to Dr. Gutman, the court noted that he had no knowledge of the etiologies of ONJ prior to meeting Simmons, and then gained only a limited familiarity based on literature supplied to him by plaintiff’s counsel. He had never treated any patients who were taking Aredia or Zometa or any other bisphosphonate, had never diagnosed a patient with ONJ, or determined a cause of
a patient’s ONJ.  Dr. Gutman admitted that he was not an expert on Zometa, Aredia, bisphosphonates, or ONJ, except as to Simmons’s case. He had no independent expertise from any other source other than six medical articles plaintiff’s counsel gave him; other than these
articles, there was no other "methodology" supporting his opinion.

The district court also did not abuse its discretion in excluding Dr. Gutman’s specific causation
opinion as unreliable because it was not derived from scientifically valid principles but
rather relied exclusively on the scientific literature provided by counsel. Dr. Gutman
made no attempt to verify this information, such as by doing his own research for other articles, and then drawing an independent conclusion. Courts view with special caution expert testimony prepared solely for purposes of litigation, rather than flowing from an expert’s line of scientific or technical work.  

Exclusions upheld; summary judgment affirmed.

Fracking Toxic Tort Case Dismissed Per Lone Pine Order

Readers will recall our earlier postings on "fracking"; natural gas from shale rock promises to provide cleaner, abundant energy for the U.S.  New drilling methods allow companies to tap into huge quantities of gas from shale rock. New estimates show that we have enough of this natural gas to last 100 years at current consumption rates.

The second biggest natural gas field in the world -- the Marcellus -- runs through your humble blogger's home state of Pennsylvania. The energy, jobs, taxes, and independence that tapping into this domestic resource will bring has spurred much interest and anticipation. The method to extract the gas from the rock is called hydraulic fracturing, or fracking, which like any technology, carries potential risks.

However, the potential drilling into the Marcellus Shale has caught the attention of the plaintiffs' bar, including personal injury and environmental class action lawyers. Plaintiffs lawyers are openly speculating about everything from gas leaks and fires, to environmental groundwater impacts, to the problems of large tanker trucks on small rural roadways.

We posted before about one such case already filed regarding another deposit, out West. See Strudley v. Antero Resources Corp., No. 2011CV2218 (Colo. Dist. Ct., Denver Cty., 3/24/11). Plaintiffs sued the gas exploration company and drilling equipment contractor, alleging that the hyrdrofracking contaminated their well water.

Earlier this month, the Colorado court dismissed the claim, relying on a  Lone Pine order, 2012 WL 1932470. The case arose from drilling and completing three natural gas wells in Silt, Colorado known as the Diemoz A well, the Fenno Ranch A well, and the Three Siblings A well. Construction of the Wells allegedly began on August 9, 2010. By January 10, 2011, plaintiffs had moved out of their home and away from Silt.

The central issue was whether defendants caused plaintiffs’ alleged injuries, which
plaintiffs vaguely described as “health injuries” from exposure to air and water contaminated by
defendants with “hazardous gases, chemicals and industrial wastes." Plaintiffs also alleged that
defendants had caused loss of use and enjoyment of their property, diminution in value of
property, loss of quality of life, and other damages. 

Cognizant of the significant discovery and cost burdens presented by a case of this nature, the court endeavored to invoke a more efficient procedure than we see in the standard case management order. The court required plaintiffs, before opening full two-way discovery, to make a prima facie showing of exposure and causation, a form of a Lone Pine order. See Lore v. Lone Pine Corp., No. L-33606-85 1986 WL 635707 (N.J. Sup. Ct. Nov. 18, 1986). The court further
determined that the prima facie showing requirement should  not prejudice plaintiffs because
ultimately they would need to come forward with this data and expert opinion on exposure and causation in order to establish their claims anyway.

The court also seemed influenced by the fact that the Colorado Oil and Gas Conservation Commission (“COGCC”) had conducted an investigation of the plaintiffs’ well water and had concluded that the water supply was not affected by oil and gas operations in the vicinity. Defendants also provided evidence to support their contention that the air emission-control
equipment at the Wells and prevailing wind patterns made it unlikely that plaintiffs or their
property were exposed to harmful levels of chemicals from defendants’ activities.

Specifically, the CMO required plaintiffs to identify the identity of each hazardous substance from defendants’ activities to which he or she was exposed and which caused him or
her injury;  evidence whether any and each of these substances can cause the type(s) of disease or illness that plaintiffs claimed (general causation);  the dose or other quantitative measurement of the concentration, timing and duration of his/her exposure to each substance; a medically recognized diagnosis of the specific disease or illness from which each plaintiff allegedly suffers or is at risk for such that medical monitoring is purportedly necessary; and a conclusion that such illness was in fact caused by such exposure (specific causation).

Plaintiffs were given 105 days to comply with the CMO. After that time, all plaintiff's expert could opine was that “sufficient environmental and health information exists to merit further substantive discovery.” Significantly, he offered no opinion as to whether exposure was a contributing factor to plaintiffs’ alleged injuries or illness. And the requested march towards further discovery
without some adequate proof of causation of injury is precisely what the CMO was meant to
curtail. The expert  suggested, at best, a very weak circumstantial causal connection between the Wells and plaintiffs’ injuries. In fact, he merely temporally associated plaintiff’s symptoms with the Wells being brought into production.

While the proffered evidence showed existence of certain low level gases and compounds in both the air and water of plaintiffs’ Silt home, there was neither sufficient data nor expert analysis stating with any level of probability that a causal connection does in fact exist between the alleged injuries and exposure to defendants drilling activities.  This is particularly telling, since Mr. Strudley complained of “nasal sinus congestion, nose bleeds at inconvenient times” and “an aversion to odors,” while he owns a painting business, and was frequently exposed to paint vapors -- offering a ready alternative explanation for his alleged respiratory symptoms.

The expert did not opine on whether any and each of the substances present in the air and water samples (taken after plaintiffs had moved out) can cause the type(s) of disease or illness that plaintiffs claimed (general causation). He did not discuss the dose or other quantitative measurement of the concentration, timing and duration of the alleged exposure to each substance. Finally, and perhaps most significantly,the expert did not even attempt to draw a conclusion that plaintiffs’ alleged injuries or illnesses were in fact caused by such exposure (specific causation).

The case reflects an effective, but also appropriate, use of the Lone Pine order. It may be a useful model for other fracking toxic tort suits, and is important as an illustration of a method to avoid long, expensive, and unnecessary discovery in such cases. 

 

Update BUT SEE Strudley v. Antero, Colo. Ct. App., No. 12CA1251, 7/3/13.

Court Hits Cancel On Bulk of Printer Class Action

A California federal court earlier this month rejected many of the claims in a putative class action against Epson America Inc.  Christopher O'Shea, et al. v. Epson America Inc., et al., 2011 WL 3299936 (C.D. Cal.). What may be of most interest to our readers is the important reminder that a manufacturer is not required under consumer protection laws to denigrate its own product and broadcast that its product may not perform as well as its competition.

Plaintiffs claimed that Epson affirmatively misrepresented and failed to disclose material information regarding the performance and/or value of Epson inkjet printers and ink cartridges. Named plaintiffs claimed to be frustrated with the amount of ink the Epson printer consumed.

In fact, Epson discloses that its printers are tested in accordance with ISO standards, and makes available to consumers detailed information about how ink yields are calculated, including the fact that testing is conducted based on continuous printing; potential consumers, further, are expressly cautioned that since no single yield standard can duplicate a customer's actual printer usage, Epson recommends that customers also consider print yield comparisons from reputable independent sources. In the same vein, Epson discloses on the packaging of its printers that actual cartridge yields may vary considerably for reasons including images printed, print settings, temperature and humidity.  But plaintiffs never let a wealth of information deter them from finding one factoid they allegedly didn't get.

So, in essence, plaintiffs sought to impose a duty on the seller to compare this feature of its printers to competitors' products, as the Complaint referred to yields which were allegedly well below the yields of other manufacturers' printers. 

The California courts have held that for an omission to be actionable for purposes of  the state consumer fraud laws, it must be either (1) contrary to a representation actually made by the defendant, or (2) a fact the defendant was obligated to disclose.  E.g., Daugherty v. Am. Honda Motor Co., Inc., 144 Cal.App.4th 824, 835–36, 51 Cal.Rptr.3d 118, 128 (2006). Here, because there was no allegation that the “omitted” information was contrary to an actual representation, to defeat summary judgment and prevail on an omission-based theory of liability, plaintiffs had to establish that Epson was affirmatively obligated to disclose the information.

Yet, plaintiffs failed to identify—and the Court was unable to find—any case in any jurisdiction in which a court imposed an affirmative legal obligation upon a manufacturer to disclose on its packaging that its products performed less efficiently than similar products from competing manufacturers. To the contrary, as Epson pointed out, courts have unequivocally rejected this proposition. As the federal court explained, in the absence of some special circumstance, any duty to disclose information about a competitor's products would be anathema to a competitive free-market economy.  Imagine a car manufacturer having to tell you in every ad about every other car that got better gas mileage or did better in a crash test. Imagine every food maker having to tell you in its ads of every competitive food or beverage that was lower in calories.

Plaintiffs did not allege that Epson's printers were defective, let alone dangerously defective. Their claim, rather, was that they were unhappy upon discovering that Epson's printers “wasted” more ink than other printers.  California's consumer protection laws, though broad and sometimes scary, do not extend so far as to require a company to denigrate its own products or promote those of its competitors just because consumers might be interested in the comparison. The duty that plaintiffs sought to impose upon Epson was properly served by independent consumer reports.

The court held that Epson was not legally obligated to disclose that actual print yields generated by its printers and ink cartridges are “grossly inefficient” vis à vis “reason-able consumer expectations and the yields of other manufacturers' printers.”  Because Epson was not obligated to disclose the purportedly “omitted” information, plaintiffs' omission-based claims consequently failed as a matter of law.

However, the court denied the motion as to express representations allegedly made concerning the claims on one proposed sub-class which alleged that the defendant deceived customers when it told them that its NX series of printers, which uses individual cartridges for different colors of ink, would allow customers to “replace only the color you need.”  There was an issue of fact regarding whether the consumer is familiar enough with printer technology and operations to know that small amounts of colored ink are used when printing black-and-white documents to keep the print head clear. The plaintiffs have moved for class certification, with the hearing set for later in August.
 

Appeals Court Upholds Summary Judgment Based on Daubert in Benzene Case

The Sixth Circuit last week upheld the dismissal of a plaintiff''s claim that benzene exposure caused her cancer. Pluck v. BP Oil Pipeline Co., No. 09-4572 (6th Cir.,  5/12/11).  The central issue was the exclusion of plaintiff's causation expert's opinion based on a "differential diagnosis" that failed to reliably rule in benzene exposure as a potential cause of plaintiff's cancer, and to rule out some other potential exposures.

This case arose from benzene contamination allegedly caused by gas-pipeline releases allegedly resulting in the seepage of gasoline into the surrounding soil and groundwater. Benzene, a component of gasoline, is a known carcinogen in sufficient doses under certain exposure circumstances, and is also ubiquitous in the ambient air and is a component or constituent of vehicle exhaust and cigarette smoke, said the court. Plaintiffs purchased a home in the area,  and used well water to drink, wash, shower, and irrigate their yard and garden. In October,  1996, plaintiffs say they noticed a gasoline odor in their home and water, and benzene was first detected in the well on their property in the amount of 3.6 parts per billion (“ppb”).  They began drinking bottled water in lieu of tap water, although they claim to have resumed drinking tap water upon the drilling of a new, deeper well. Between 1997 and May 2002, the new well tested negative for benzene twenty-two times.

Mrs. Pluck was diagnosed with Non-Hodgkins lymphoma (“NHL”) in 2002 at age forty-eight. She filed suit, alleging claims of strict liability for hazardous activity, negligence, and loss of consortium. To support their claims, plaintiff and spouse retained Drs. Joseph Landolph and James Dahlgren as experts on causation to demonstrate that benzene is generally capable of causing NHL and specifically caused Mrs. Pluck’s NHL. Defendant filed motions in limine to exclude the testimony of Dahlgren and Landolph on the grounds that their testimony failed to satisfy the standard for reliability set forth in Daubert. In particular, BP argued that Dr. Dahlgren’s testimony on specific causation was unreliable because he formulated a specific causation opinion without evidence of dose, and subsequently performed an unreliable dose reconstruction in an attempt to support his opinion.  Dahlgren then submitted a supplemental declaration in which he evaluated Mrs. Pluck’s illness under a "differential-diagnosis" methodology. The district court granted the motions, and plaintiff appealed.

In a toxic tort case, as here, the plaintiff must establish both general and specific causation through proof that the toxic substance is capable of causing, and did cause, the plaintiff’s alleged injury.  As to specific causation, the plaintiff must show that she was exposed to the toxic substance and that the level of exposure was sufficient to induce the complained-of medical condition (based on a dose-response relationship). Both causation inquiries involve scientific assessments that must be established through the testimony of a medical expert. Without this testimony, a plaintiff’s toxic tort claim will fail.

The Plucks had to concede that the expert Dr. Dahlgren did not establish dose; they instead argued that Dahlgren used differential diagnosis to determine specific causation. Defendant argued that Dr. Dahlgren did not apply differential diagnosis in either his expert opinion or his deposition, but did so only in an untimely supplemental declaration filed five months after the deadline for expert reports. And in any event, his approach was flawed. The Sixth Circuit has recognized differential diagnosis, properly done, as an appropriate method for making a determination of causation for an individual instance of disease. Differential diagnosis -- originally a standard technique for determining what disease caused a patient's symptoms -- has been adapted in some courts as an acceptable scientific technique for identifying the cause of a medical problem by eliminating the likely causes until the most probable one is isolated. A physician who applies differential diagnosis to determine causation considers all ("rules in") relevant potential causes of the symptoms and then eliminates ("rules out") alternative causes based on a physical examination, clinical tests, and a thorough case history.

Even in courts that accept this adapted method, not every opinion that is reached via a differential-diagnosis method will meet the standard of reliability required by Daubert.  Calling something a “differential diagnosis” or “differential etiology” does not by itself answer the reliability question but prompts at least three more:

(1) Did the expert make an accurate diagnosis of the nature of the disease?

(2) Did the expert reliably rule in the possible causes of it?

(3) Did the expert reliably rule out the rejected causes?

If the court answers “no” to any of these questions, the court must exclude the ultimate conclusion reached.

Here the court agreed that Dahlgren could not reliably “rule in” benzene exposure as the cause of Mrs. Pluck’s NHL. In recognition of the fact that benzene poses a health concern at certain levels of exposure, the EPA has stated that the maximum permissible contaminant level for benzene in
drinking water is 5 ppb. 40 C.F.R. § 141.61(a)(2). Dahlgren, however, did not ascertain Mrs. Pluck’s level of benzene exposure, nor did he determine even whether she was exposed to quantities of benzene exceeding the EPA’s safety regulations. The levels of benzene in the Plucks’ wells never exceeded the maximum permissible contaminant level of 5 ppb designated by the EPA.

Dahlgren’s opinion that Mrs. Pluck’s “low-level exposure” to benzene caused her NHL was thus not grounded in “sufficient facts or data,”  nor did it reflect the “reliable principles and methods” required by Rule 702. It was, instead, pure conjecture.  Although the Plucks argued that the district court required too much specificity regarding Mrs. Pluck’s dose, this argument was also without merit. The mere existence of a toxin in the environment is insufficient to establish causation without proof that the level of exposure incurred could cause the plaintiff’s symptoms. See also McClain v. Metabolife Int’l, Inc., 401 F.3d 1233, 1242 (11th Cir. 2005) (causation “requires not simply proof of exposure to the substance, but proof of enough exposure to cause the plaintiff’s specific illness”).

Finally, even if Dr. Dahlgren had properly “ruled in” benzene exposure as the cause plaintiff's NHL, he failed to “rule out” alternative causes of her illness, as is required under the differential-diagnosis methodology. See also Wills v. Amerada Hess Corp., 379 F.3d 32, 50 (2d Cir. 2004) (expert’s opinion suffered from a “fatal flaw” when he acknowledged that cigarettes and alcohol were risk factors for developing squamous-cell carcinoma but failed to account for these variables in concluding that decedent’s cancer was caused by exposure to toxic chemicals such as benzene and PAHs).  In this case, Dahlgren acknowledged in his deposition that Mrs. Pluck was
exposed to other sources of benzene, from her extensive smoking habit and from other organic solvents.  Yet, Dr. Dahlgren neither identified these other solvents nor determined Mrs. Pluck’s potential level of exposure to these other possible sources of benzene.Thus, Dahlgren failed to “rule out” alternative causes of Mrs. Pluck’s NHL.

The court of appeals determined that the district court did not abuse its discretion in concluding that the expert did not perform a reliable differential diagnosis.  And summary judgment properly followed.

 

Appeals Court Applies Sophisticated User Doctrine

A California appeals court earlier this month affirmed a trial court's dismissal of a product liability failure to warn claim, based on the sophisticated user doctrine. Walkowiak v. MP Associates, No. B220494, (Cal. Ct. App., 2d App. Dist., 3/9/11)(not published).

Plaintiff Christopher Walkowiak began working for a special effects company in the movie industry in 1994. His boss had a Class 1 Pyrotechnic Operator license, and Walkowiak received on-the-job training in special effects. He obtained a Class 3 Pyrotechnic Operator license in 1995 and a Class 2 license in 1998. In order to obtain these licenses, Walkowiak had to obtain references from pyrotechnicians and pass a written examination. The written examination was general in nature and did not cover every specific types of explosive device used in productions.

Defendant MP Associates (MP) manufactures pyrotechnic devices. Defendant Roger George Rentals (RGR) rents and sells special effects supplies, including pyrotechnic devices manufactured by MP. Its primary clientele is the entertainment industry. One of the products they sold was a simulated stinger missile (SSM). The SSM consists of a cardboard tube with a red plastic cap on one end and a white plastic cap on the other end. The tube contains pyrotechnic materials near the end with the red plastic cap. Prior to ignition, the white plastic cap is to be removed. Upon ignition, a pellet of pyrotechnic material is propelled out of the end of the tube by gunpowder. It produces bright white light and smoke, and it travels about 200 feet. It simulates the appearance of a missile. Pretty clever, and can fool the camera.

The SSM had a sticker on the side of the cardboard tube which read, “Dangerous. Handle With Care. Keep Fire Away.” This was a standard warning that MP placed on all of the pyrotechnic devices it sold. The SSM also had a piece of tape over the white plastic cap which read, “Remove Before Ignition. This Side Up.” Once the tape was removed, there was nothing on the SSM to indicate which end was to face up. Packaging materials which came with the SSM included a list of “Dos and Don’ts” which applied to pyrotechnic devices in general. The list included the warning not to “use any explosive material unless completely familiar with safe procedures for their use, or under the direction of competent, experienced persons.” However, the packaging materials did not include any specific instructions for use of the SSM.  The manufacturer sold SSMs only to purchasers with a Class 1 or Class 2 Pyrotechnic Operator license. And the company would personally discuss use of the SSM with the purchaser. Since 1998, MP had reportedly sold over 20,000 SSMs. Until the accident in this case, there had been no misfires or injuries resulting from the use of an SSM.

On January 18, 2007, Walkowiak was working on the movie set for “Charlie Wilson’s War.”  His supervisor instructed Walkowiak to test fire an SSM that had been leftover from a previous production, using the same shoulder launcher that had been used in “Over There.” The shoulder launcher consisted of a steel tube bolted to a rifle stock. The steel tube was closed at the end bolted to the rifle stock. The SSM was loaded into the open end of the steel tube. It was fired by means of a battery-operated power switch which was connected to the SSM by wires. Walkowiak’s Class 2 license allowed him to use the SSM fired from a shoulder launcher under the supervision of a Class 1 license holder.

But Walkowiak had not worked on “Over There.” He had never fired an SSM before or seen an SSM loaded into a shoulder launcher. He had not seen any instructions for using the SSM. What he did know was that the SSM was a controlled pyrotechnic device that was potentially dangerous. He knew that he should get questions regarding its use answered before using it. Walkowiak called one of the defendants and asked how to operate the shoulder launcher. Defendant told him how to wire and prepare the launcher. He did not tell Walkowiak how to load the SSM into the launcher, however. Before loading the SSM into the shoulder launcher, Walkowiak saw tape with printing on one end of the SSM. He did not recall seeing the words “Remove Before Ignition” or “This Side Up” on the tape. However, he understood these words to mean that the cap and tape should be removed before discharging the SSM, and “This Side Up” referred to the discharge end of the SSM.

Walkowiak removed the cap and the tape from the SSM. Walkowiak made the decision as to how to load the SSM into the shoulder launcher. Walkowiak loaded the SSM into the shoulder launcher and connected the wires. He believed he was loading the device safely and correctly. He knelt down and pointed the shoulder launcher toward a wall. After a countdown, Walkowiak fired the device. There was an explosion and a bright flash of light. The SSM exploded in the steel tube. The steel tube broke off the rifle stock and hit Walkowiak in the face, causing severe injury. It was determined that he had loaded the SSM in backwards.

Plaintiff sued the various parties in the chain of distribution of the SSM.  The trial court dismissed the claim.  The trial court explained that merely because an accident has occurred, there is no presumption of a defect or negligence.  In this case, Walkowiak had not shown that the device had any physical, manufacturing or design defect. There was no evidence of even a single incident where the device was used properly but caused this kind of injury.  Therefore, the trial court noted, the only potential basis for imposing liability on defendants was the breach of a duty to warn of a danger. The court added, however, that product liability cannot be based on failure to warn of a danger that is known or obvious to a user, under California law. Failure to warn of a danger that is generally known and recognized does not, by itself, render a product dangerous.

Plaintiff appealed. The court of appeals discussed the doctrine of sophisticated user. In explaining the development of the sophisticated user defense, the state Supreme Court had begun with the general principle that manufacturers have a duty to warn consumers about the hazards inherent in their products. This enables consumers to avoid the hazards through careful use of the products or refraining from using the products altogether.  However, the sophisticated user defense exempts manufacturers from their typical obligation to provide product users with warnings about the products’ potential hazards. It provides that sophisticated users need not be warned about dangers of which they are already aware or should be aware. Because these sophisticated users are charged with knowing the particular product’s dangers, the failure to warn about those dangers is not the legal cause of any harm that product may cause. The rationale supporting the defense is that the failure to provide warnings about risks already known to a sophisticated purchaser usually is not a proximate cause of harm resulting from those risks suffered by the buyer’s employees or downstream purchasers. This is because the user’s knowledge of the dangers is the equivalent of prior notice.

In California, a manufacturer is not liable to a sophisticated user of its product for failure to warn of a risk, harm, or danger, if the sophisticated user knew or should have known of that risk, harm, or danger. An objective test applies, because it would be nearly impossible for a manufacturer to predict or determine whether a given user or member of the sophisticated group actually has knowledge of the dangers because of the infinite number of user idiosyncrasies. Hence, even if a user was truly unaware of a product’s hazards, that fact is irrelevant if the danger was objectively obvious to the expert user.  And, the defense applies to both negligence and strict liability causes of action.

Here, Walkowiak’s own deposition testimony supported the finding that he was a sophisticated user of pyrotechnics. He had a Class 2 Pyrotechnic Operator license and years of experience in special effects. He knew that the SSM was a controlled pyrotechnic device and potentially dangerous. He understood the nature of the warnings provided on and with the SSM. He knew to ask for instructions on how to operate the device, and in fact asked for some information. In other words, said the court, Walkowiak knew or should have known of the risk involved in use of the SSM.

That Walkowiak did not have experience using the SSM and could only use it under supervision did not establish that he was unaware of the risks associated with its use. His testimony established that he was aware of the risks: he knew the SSM was dangerous, and he understood the nature of the warnings on the device, “Remove Before Ignition” and “This Side Up.” He simply did not know how to use the SSM with the shoulder launcher. Plaintiff could cite no authority, however, that would require a manufacturer not only to apprise a user of the risks associated with use of its product but also to provide instruction on how to use the product in a device it did not manufacture. 

(The court remanded the design defect claim, under the risk benefit test, as the trial court had jumped the gun on its conclusion that an alternate design would make the SSM unsuitable for other uses.)


 

Snapple Prevails in All Natural Suit

A federal court granted summary judgment to defendant Snapple in a lawsuit accusing
Snapple Beverage Corp. of misleading consumers by labeling drinks as "all natural" even though they are sweetened with high fructose corn syrup. Weiner et al. v. Snapple Beverage Corp., No. 1:07-cv-08742 (S.D.N.Y.).

We have commented on the growing and alarming trend of plaintiffs' lawyers concocting consumer fraud class action claims against products, even when consumers were not injured and got basically what they paid for, because of some alleged ambiguity in the label or old-fashioned puffing.

Snapple Beverage Corporation was founded in New York’s Greenwich Village in 1972. Snapple began selling and marketing its teas and juice drinks in the late 1980s. In marketing its beverages, Snapple focused on, among other things, flavor, innovation, and humor. Snapple became known for its quirky personality and funny advertising, as well as its colorful product labels and beverage names. For instance, Snapple’s television advertisements featured, among other things, Snapple bottles dressed in wigs and hats, singing in a Backstreet-esque “boy-band,” running with the bulls (hamsters with cardboard horns) in Spain, and performing synchronized swimming.

When Snapple entered the beverages market in the late 1980s, it avoided putting preservatives, which were then commonly found in some similar beverages, in its teas and juice drinks. Snapple was able to do so by using a “hot-fill” process, which uses high-temperature heat pasteurization to preserve products immediately before bottling. Snapple also used 16-ounce glass bottles instead of aluminum cans or plastic. Hence the term on their label "All Natural."

From their inception, Snapple’s beverages were sweetened with high fructose corn syrup. HFCS is made from corn ( a natural product last time we checked), and its primary constituents are glucose and fructose, the sugars that comprise table sugar and honey (which also sound pretty natural). It is undisputed that Snapple disclosed the inclusion of HFCS in the ingredient list that appears on the label of every bottle of Snapple that was labeled “All Natural.”

Readers may recall from our previous post, that here plaintiffs sued seeking to represent a nationwide class of consumers who made purchases between 2001 and 2009 in New York of Snapple beverages labeled “all natural” and which contained high fructose corn syrup.  The plaintiffs alleged they paid a premium for the company's drinks as a result of the all natural claim.

Judge Cote denied the plaintiffs' motion for class certification last year, finding that plaintiffs had not proposed a suitable methodology for establishing the critical elements of causation and injury on a class-wide basis. Without a reliable methodology, plaintiffs had not shown that they could prove at trial, using common evidence, that putative class members in fact paid a premium for the beverage. Because individualized inquiries as to causation, injury, and damages for each of the millions of putative class members would predominate over any issues of law or fact common to the class, plaintiffs’ claim could not be certified under Rule 23(b)(3).

Snapple then moved for summary judgment on the two named plaintiffs' individual claims
under New York's consumer protection laws, as well as claims of unjust enrichment and breach of express warranty.

Jurisdiction was predicated on CAFA, so a preliminary issue was whether the court retained jurisdiction after the denial of class certification. The statute does not speak directly to
the issue of whether class certification is a prerequisite to federal jurisdiction, and the Second Circuit has not addressed the issue. The circuits that have considered the issue, however, have uniformly concluded that federal jurisdiction under CAFA does not depend on class certification. See Cunningham Charter Corp. v. Learjet, Inc., 592 F.3d 805, 806 (7th Cir. 2010); United Steel, Paper & Forestry, Rubber, Mfg., Energy, Allied Indus. & Serv. Workers Int’l Union, AFL-CIO, CLC
v. Shell Oil Co., 602 F.3d 1087, 1092 (9th Cir. 2010); Vega v. T-Mobile USA, Inc., 564 F.3d 1256, 1268 n.12 (11th Cir. 2009).

The court granted the motion, finding that the named plaintiffs had failed to show that they were injured as a result of Snapple's labeling.  According to Snapple, because the plaintiffs had not offered evidence showing either the price they paid for Snapple or the prices charged by competitors for comparable beverages, they could not demonstrate that they paid a premium for the “All Natural” Snapple product and thus could not show harm stemming from the allegedly misleading label.  Neither of the plaintiffs had any record of his purchases of Snapple. Their most recent purchases were made in 2005 and 2007, or 3 to 5 years before their deposition testimony was taken. Not surprisingly, they had only vague recollections of the locations, dates, and prices of their purchases of Snapple. Besides being unable to establish the actual price they paid for the Snapple products at issue here, the plaintiffs have offered no other evidence from which to
calculate the premium they paid for Snapple. The court agreed that plaintiffs failed to prove that they paid more for Snapple's products than they would have for comparable beverages.

As for the breach of expressed warranty claim, an injured party is entitled to the benefit of its bargain, measured as the difference between the value of the product as warranted by the manufacturer and its true value at the time of the transaction. Because the plaintiffs
had not demonstrated that they purchased Snapple's drinks in reliance on the “all natural”
label, they could not show any such difference in value. 

Court of Appeals Affirms Exclusion of Plaintiff Causation Experts in Toxic Tort Case

Insecticide manufacturers held on to summary judgment as the Eight Circuit affirmed the lower court's causation ruling under DaubertJunk v. Terminix International Co., No. 08-3811 (8th Cir., 12/9/10).

The plaintiffs'  home had been infested with spiders during the mother's pregnancy, and she contacted Terminix about the problem.  Defendant thereafter sprayed a pesticide inside and outside the Junks' home, approximately 20 times, the last occurring two years after her son's birth. Junk alleged that the child's multiple medical conditions were caused by exposure to ingredients in Dursban, an insecticide manufactured by Dow, distributed by Terminix.

The defendants moved to exclude the causation testimony of plaintiffs' two medical experts, and for summary judgment.  The trial court first excluded the testimony of Dr. Richard Fenske, who had been retained to determine whether the son had been exposed to an unsafe level of the insecticide during his mother's pregnancy and after his birth. Dr. Fenske testified that when making toxic exposure and dosage estimates he usually relied on a "deterministic modeling" method in which he creates an exposure model that accounts for numerous variables. In this case, however, he did not have sufficient data to perform such an analysis. Instead, he compared what he knew about the circumstances of the child's exposure with those in published studies. This comparative analysis led him to conclude that plaintiff had been exposed to an unsafe level. Observing that Dr. Fenske had not followed his own usual methodology and concluding that he had relied on a number of ungrounded assumptions in his comparative approach, the district court excluded his opinion on the ground that his methodology was not sufficiently reliable.

Dr. Cynthia Bearer's testimony was also excluded. She was a neonatologist and board certified pediatrician whom Junk retained to give her opinion on general and specific causation.  Because Dr. Bearer's opinion on specific causation relied on Dr. Fenske's conclusions, after the court excluded Dr. Fenske's testimony, it found Dr. Bearer's opinion on specific causation also lacked a scientific factual basis and declined to admit it.

Plaintiffs appealed.

The court of appeals agreed that Dr. Fenske's comparative analysis depended on various unsupported assumptions. He did not account for differences between conditions in the Junk household and those described in the articles he consulted. In one instance, his only basis for comparison was the fact that the Junk household and those in a particular study were all treated with the Dursban ingredient chlorpyrifos. In another, he relied on a study where the only common variable between the Junks' experience and the homes studied was the total amount of chlorpyrifos applied. Dr. Fenske thus disregarded other important variables such as where and how chlorpyrifos was applied in the household and whether the homes in a comparison study were the same size as the Junks' home.


While Dr. Fenske was not required to produce a mathematically precise table equating levels of exposure with levels of harm, he was required to have a "scientifically valid" method to estimate that plaintiff's exposure exceeded a safe level. The expert's failure to follow his own general practice and his reliance on unfounded assumptions in his comparative method created "too great an analytical gap" between his opinion and the data on which it relied.

Because Dr. Bearer's differential diagnosis depended on Dr. Fenske's opinion on exposure, the district court did not abuse its discretion in excluding it. A differential diagnosis begins with an expert's "ruling in" plausible causes of an injury. See Kudabeck v. Kroger Co., 338 F.3d 856, 860–61 (8th Cir. 2003). Then the expert "rules out" less likely causes until the most likely cause remains. Without a scientific basis for including unsafe chlorpyrifos exposure in her differential, her opinion amounted to speculation.

To succeed in her claims, Junk needed to present expert testimony showing that the chlorpyfiros could have caused the son's injuries and that it did in fact cause those injuries. Junk's  experts did not survive the district court's Daubert analysis. After the court properly excluded Dr. Bearer's
testimony, Junk could not prove specific causation as required under Iowa law. As there was no longer a genuine issue of material fact as to that necessary element, Dow and Terminix were entitled to judgment.

 

 
 

Proof of General Causation in Drug Case Not Automatic

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

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

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

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

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

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

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

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

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

 Summary judgment granted.

MDL Court in Peanut Butter Litigation Grants Multiple Summary Judgments For Defense

The MDL court overseeing the coordinated federal litigation stemming from a 2007 peanut butter recall recently granted summary judgment to the defendant manufacturer ConAgra Foods in multiple cases.  See Southern v. ConAgra Foods Inc., MDL 1845, No. 09-1544  (N.D. Ga. 9/29/10).

Readers may recall that in 2007, ConAgra Foods Inc. recalled jars of Peter Pan and Great Value peanut butter that were made at its Georgia plant, after the CDC and FDA observed a possible association between these products and reports of salmonella poisoning.  As part of the recall, ConAgra instructed consumers to discard the jar but to save the lid, which contained the product code identifying when and where the peanut butter was manufactured.  After the recall, multiple consumers sued ConAgra, alleging they had contracted salmonella after eating either Peter Pan or Great Value peanut butter. The lawsuits were consolidated in an MDL in the Northern District of Georgia.

To prove causation, each plaintiff must show that it is more likely than not that contaminated peanut butter caused his or her illness. The best way to show that peanut butter is contaminated with Salmonella is to test the peanut butter itself, said the court. The fact that the peanut butter was recalled here does not mean that it was contaminated. In fact, most of the recalled peanut butter was completely free of Salmonella contamination. During discovery, accordingly, ConAgra asked the plaintiffs to provide the product code for the peanut butter that allegedly caused their illnesses. It also asked the plaintiffs whether they submitted a blood, urine, or stool sample to a doctor for testing. Because the symptoms of Salmonellosis are similar to those of other common gastrointestinal illnesses, these samples were important in determining causation, said defendant.

Here, the 19 plaintiffs could not establish causation, as a matter of law. First, they could not show that the peanut butter they ate was manufactured by ConAgra at the Sylvester plant during the outbreak.  Plaintiffs did not know the product codes from their peanut butter. Without these numbers, which indicate when the peanut butter was manufactured, it was impossible to know whether the peanut butter was at risk of contamination.

Second, the plaintiffs did not provide enough evidence to show that they contracted Salmonellosis shortly after eating the peanut butter. Symptoms alone are not enough to permit a reliable diagnosis of this disease because the symptoms of Salmonellosis – usually diarrhea, abdominal cramps, and fever – are more commonly associated with viruses, parasites, fungi, other bacteria, toxins, and various chronic diseases. Indeed, the CDC estimates that nearly 300 million cases of diarrhea and related gastrointestinal symptoms occur each year of other causes. A positive blood, urine, or stool sample is the best way to show that Salmonella caused a plaintiff’s illness. A proper differential diagnosis by a physician who examined and treated a plaintiff during his illness may also support a finding of causation in some cases, said the court.  

But none of the plaintiffs here provided evidence of a differential diagnosis or a positive blood, urine, or stool culture. None of the plaintiffs' available medical records indicated that the plaintiffs’ doctors considered and excluded other causes or performed any form of differential diagnosis or diagnostic tests. To the contrary, the records showed that most plaintiffs did not even visit the doctor until several months after eating the allegedly contaminated peanut butter.

Without more, concluded the court, no reasonable jury could find that it was more likely than not that
contaminated peanut butter caused the plaintiffs’ alleged illnesses.

 

 

Game Over for Plaintiffs in Wii Class Action

A federal court last week granted defendant's summary judgment motion in a putative class action alleging Nintendo of America Inc. sold defective wrist straps with its Wii controllers.  Elvig, et al. v. Nintendo of America Inc., No. 08-cv-02616 (D. Colo.)

Readers are familiar with the Wii game system. The Wii employs a motion sensing controller that allows the player to manipulate the on-screen action by performing imitative physical actions, such as swinging the controller like a tennis racquet to control the onscreen action in a tennis game. (Readers may recall the classic product liability issues over various lawn dart games; with Wii you can play them in your family room.) To ensure that controllers do not leave a player’s hand during vigorous physical activity, Nintendo includes a “safety strap” to be worn around the player’s wrist. The strap, in turn, connects to the controller by means of a “string sling.” 

Plaintiff sued, alleging the strap was defective, broke, and caused damage to her television. She alleged violation of the Colorado Consumer Protection Act (“CCPA”), of the Colorado Product Liability Act, and a breach of implied warranty or merchantability and of fitness for a particular purpose. To establish a claim under the CCPA, a plaintiff must show: (i) that the defendant engaged in one of several categories of unfair or deceptive trade practices; (ii) the practice occurred in the course of the defendants business or trade; (iii) the practice significantly impacts the public as actual or potential consumers of the defendant’s goods or services; (iv) the plaintiff suffered an injury; and (v) the challenged practice caused the injury. Nintendo argued that Ms. Elvig could not establish the first and last elements – i.e. a deceptive practice and causation of injury.  The court found that plaintiff's vague reference to “false advertising” that “touts the Wii’s athletic usages while making no mention of the straps’ propensity to break” was inadequate in detail and content to make out such a claim.  Plaintiff lacked specifics about what the advertising actually said.

On the product liability claim, Nintendo contended that it gave players adequate warnings of the need to retain possession of the controller and advised them of the possibility that release of the controller during vigorous motion could result in breakage of the strap and damage to persons or property. The court noted the evidence that Nintendo did advise players, via a safety card included with the Wii system, that “If you use excessive motion and let go of the Wii Remote, the wrist strap may break and you could lose control of the Wii Remote. This could injure people nearby or cause damage to other objects.” This, coupled with repeated instructions on the safety card that advise players “DO NOT LET GO OF THE REMOTE DURING GAME PLAY,” ensure that, if the player follows Nintendo’s instructions and heeds its warnings, the Wii system does not pose an unreasonable danger. Ms. Elvig did not dispute that such instructions were included with the Wii she received. Nintendo thus having given an adequate warning to users, it may “reasonably assume that it will be read and heeded,” and thus, has ensured that the product was not “unreasonably dangerous” under the Second Restatement, § 402A, comment j. An interesting take on the relationship of warning and design issues.

On the implied warranty of merchantability, the court cited the lack of evidence that would indicate what the intended purpose of the strap was. One might plausibly assume, as plaintiff did, that the strap was intended to prevent a controller, inadvertently released by the player during vigorous activity, from hurling towards the player’s television (or towards another player) and causing damage.  But equally, one might assume that the strap was simply intended to keep an
inadvertently released controller in the vicinity of the player so that it could be easily retrieved and was was never intended to withstand the forces of high-speed controller release. To withstand summary judgment, plaintiff needed more than one of alternate plausible assumptions; she needed evidence of the ordinary purpose of the strap and proof that it failed the ordinary purpose.

Finally, the court noted that a “particular purpose” differs from the ordinary purpose for which the goods are to be used; in other words, a buyer obtaining goods for a “particular purpose” is one who, for reasons peculiar to the buyer, is obtaining the goods for use other than that which is customarily made of the goods.  Here, there was no evidence that Ms. Elvig obtained the Wii for a “particular purpose” other than that for which it would customarily be used.  The damages occurred when the plaintiff was allegedly playing the Wii bowling game  (no bowling shoes required)-- in the manner and fashion represented by Nintendo in its marketing and promotion materials. In short, using the Wii for its “ordinary purpose” at the time of the accident, not for some “particular” – e.g. unusual – purpose.

Hence, summary judgment for defendant on all claims.

 

No Second Bite of the Apple for HT Plaintiffs

A federal court granted summary judgment in litigation brought by hormone replacement drug plaintiffs whose suits were previously ruled untimely by a New York court. See Rick v. Wyeth Inc.,  No. 08-1287 (D. Minn., 9/23/10).

Plaintiffs, all citizens of New York, were women, and spouses of women, who allegedly used
hormone therapy drugs manufactured and sold by defendants. Plaintiffs further alleged that they developed breast cancer as a result of the use of HT drugs.  Plaintiffs had previously brought suit individually in New York state court where their claims were consolidated into a single
coordinated proceeding. In the New York proceeding, defendants moved for summary judgment based on the New York statute of limitations. Foreseeing the end of their suits, plaintiffs moved for a discontinuance without prejudice. While the dueling motions in the New York proceeding were pending, plaintiffs commenced another action in federal court in Minnesota (where there is a much longer, highly controversial statute of limitations; none of plaintiffs, nor any of the claims at issue, had any connection to Minnesota. Instead, it seems this case, like hundreds of others involving HT drugs, was brought solely to take advantage of Minnesota’s six-year statute of limitations.)

The New York trial court granted the defendants’ motion for summary judgment and denied the
plaintiffs’ motion for "discontinuance without prejudice." In doing so, the New York trial court reasoned that the defendants would be unfairly prejudiced by allowing the litigation to re-start in another forum after having completed discovery and reached the summary judgment phase in the New York proceeding.

In the federal court proceeding, defendants then moved for summary judgment arguing that the New York judgment was entitled to preclusive effect.  The traditional rule for claim preclusion was that dismissal for untimeliness does not bar a second action in another jurisdiction with a longer, unexpired statute of limitations. Semtek Int’l Inc. v. Lockheed Martin Corp., 531 U.S. 497, 504 (2001). However, the actual test for a federal court determining the preclusive effects of a prior state-court judgment is to ask ask what preclusive effect that state intends other jurisdictions to accord its judgments.  Here, the federal court determined that New York has not definitively answered that question in this context. Therefore, the court had to determine what rule New York would likely apply.

On one hand, the New York Court of Appeals has stated that, in general, New York views statutes of limitations as procedural rather than substantive. However, the New York Court of Appeals has also held that, in the narrow context of claim preclusion, statutes of limitations “in a practical sense may also be said to be substantive.”  Thus, said the federal court, the procedural/substantive distinction that formed the foundation of plaintiffs’ argument here was hardly clear under New York law. Indeed, while the procedural/substantive distinction may be a useful tool in some instances, a clear line between procedure and substance is not always ascertainable.

In interpreting this ambiguous area of New York law, the federal court was also mindful of the overarching principals of claim preclusion. Claim preclusion doctrine values judicial economy, preventing parties from burdening courts with claims already litigated.

Against this backdrop, the federal court found the procedural posture of the case decisive.  In the New York proceeding, the plaintiffs moved for a discontinuance without prejudice. Under New York law, an element of granting such a motion is whether the adverse party will suffer prejudice. The NY trial judge believed that a discontinuance without prejudice would not have preclusive effects in the federal action, and noted that granting the plaintiffs’ motion might thus allow plaintiffs’ Minnesota action to continue. Concluding that defendants would be highly prejudiced if forced to continue litigation in another forum, the trial judge denied the plaintiffs' motion. Implicit in that reasoning was that the grant of summary judgment instead would have preclusive effect in the federal litigation. Indeed, the New York trial court specifically stated that defendants had a right to judgment on the merits.

Thus, at the summary judgment phase, the timeliness issues were “sufficiently close to the
merits” to implicate claim preclusion. Plaintiffs chose to bring their claims in New York and continued litigation up to summary judgment.

 

Federal Court Grants Daubert Motion and Summary Judgment in Toxic Tort Cases

A federal court last week dismissed consolidated toxic tort suits brought against Alcoa Inc. and other defendants brought by employees of Lockheed Martin Corp. who claimed they were exposed to beryllium used in the manufacture of airplanes. Neal Parker et al. v. Brush Wellman Inc. et al., No. 04-cv-606; Timothy Berube et al. v. Brush Wellman Inc. et al., No. 08-cv-2725(N.D. Ga. 9/17/10).

The dozen plaintiffs in the cases were current or former employees of Lockheed Martin Corp.at its Marietta, Georgia plant site; plaintiffs alleged they had a variety of job responsibilities, time periods of employment, and work areas at the Lockheed facility. Lockheed’s Marietta Facility was purchased by the U.S. Government in 1942 and is leased and operated by Lockheed. Since 1952, Lockheed has produced the beryllium-containing C-130 Hercules airlifter, the C-5 Galaxy, the C-141 Starlifter, and the F/A-22 Raptor Air Dominance Fighter at its Marietta location. Each defendant was alleged to have manufactured component parts for Lockheed using copper-beryllium or aluminum-beryllium alloys.  Plaintiffs alleged that defendants failed to provide Lockheed with sufficient and accurate warnings pertaining to the beryllium contained in the manufactured products. Specifically, plaintiffs asserted a failure to warn claim, arguing that the warning materials that the defendants provided did not adequately communicate the health risks associated with the use of beryllium nor did they describe the methods that would reduce such risks.

Defendants filed a Daubert motion to exclude the testimony of Dr. John Martyny, plaintiffs' causation expert, and a companion motion for summary judgment. The Court ordered a Daubert hearing to clarify the evidentiary and factual background for the expert witness’s opinion and an evidentiary hearing regarding the motions to compel and summary judgment.

Since beryllium is generally recognized in the medical community as being able to cause the type of harm plaintiffs alleged –beryllium-related sickness– the Daubert analysis here focused on specific or individual causation to the plaintiffs, the plaintiff-specific questions: was plaintiff exposed to the toxin, was plaintiff exposed to enough of the toxin to cause the alleged injury, and did the toxin in fact cause the injury? The Eleventh Circuit has recognized that in order to carry
this causation burden in a toxic tort case, a plaintiff must demonstrate the levels of exposure that are hazardous to human beings as well as the plaintiff’s actual level of exposure to the defendant’s toxic substances before he or she may recover.

Here, the link between the expert’s opinion and the dose relationship was a key element of the analysis. Indeed, the hallmark of the science of toxic torts is the dose-response  relationship.  Exposure is only the opportunity for contact. Dose is what enters the body. While Dr. Marytny indicated, based on his experience and anecdotal evidence, that plaintiffs may have been exposed to beryllium at the plant, he did not indicate the level, frequency, duration or particle size of this exposure which would indicate the dose from these defendants’ products.  Importantly, Dr. Marytny did not produce any evidence that even a low-dose exposure resulted from defendants’ products. In fact, Dr. Martyny admitted that he could not opine as to the individual product or products that were the source of the alleged exposure.

Secondly, Dr. Martyny’s theory had not been appropriately tested.  The company itself did some sampling, and every air sample indicated that airborne beryllium concentrations were below the analytical reporting limit (<0.001 μg/sample) and thus also less than the OSHA PEL for beryllium.  Theoretically, defendants’ products could have been placed in an environmental chamber and the various machining procedures could have been reenacted to determine the particle production and size. While clearly this would not be as conclusive as personal sampling data for each plaintiff, this evidence would at least minimally indicate that bio-available beryllium from defendants’ products was possible, said the court.  But plaintiffs did no such testing.  Furthermore, no published studies documented levels of beryllium released by workers working with beryllium-aluminum in the aircraft industry.

Without such data, the expert's opinion merely assumed that plaintiffs’ injuries must have been caused by defendants’ products because the defendants produced  beryllium parts which were sold to Lockheed. However, nothing in his opinion linked these products to the alleged exposure of the plaintiffs nor ruled out other manufacturers’ products that were also present at the Marietta facility. 

Thus, the expert's opinion was excluded, and absent a reliable causation opinion, summary judgment was also appropriate.

The court the offered an alternative basis for the summary judgment on the failure to warn claim -- the sophisticated user doctrine. If a sophisticated user’s employees have knowledge that a particular risk of harm exists and yet allow the harm to occur, this knowledge may bar other employees’ claims against the product manufacturer. The supervising employees’ knowledge –the knowledge of the sophisticated user– can bar other employee’s claims against the product manufacturer. And the user’s knowledge does not need to encompass the precise, physical nature of the hazard presented by his use of the product; it is sufficient if he is aware generally that the use being made of the product is dangerous.

Here, Lockheed was a sophisticated user of beryllium alloys. Lockheed, as a part of the beryllium
industry, had as much access to information regarding beryllium safety as anyone else. For more than forty years, Lockheed  used the Department of Defense’s “Handbook for Metallic Materials and Elements for Aerospace Vehicle Structures” which provides guidelines for proper beryllium use. Lockheed issued its own “Safety and Industrial Hygiene Standard" which recognized that beryllium dust and vapors can cause respiratory problems. Lockheed recognized that it should order “medical monitoring” for those within the exposed worker population. The record made clear that the employer was a sophisticated user; summary judgment was appropriate on this basis as well.

Summary Judgment in Ignition Lock Class Action

A federal judge has dismissed a class action against Ford Motor Co. over allegedly defective ignition locks. Richard Smith, et al. v. Ford Motor Co., No. 06-00497 (N.D. Calif. 9/13/10).  The case offers an interesting take on the interplay of express warranties and fraud/failure to disclose claims.

Plaintiffs alleged that Ford unlawfully concealed information concerning the failure rate of the ignition locks in its Focus vehicles. An ignition lock is the vehicle part in which the key is inserted and turned to activate the ignition; its purpose is to start the car. When an ignition lock fails, the driver is prevented from turning the key. Following the launch of the Focus, there was a spike in warranty claims related to the ignition locks. In order to counter the relatively high warranty repair rates, Ford and its ignition lock manufacturer made manufacturing and design changes to the subject ignition locks, which resulted in a substantial decrease in the warranty repair rates. Specifically, from a warranty repair rate of 24.3 % for its 2000 model year Focus vehicles, Ford saw the rate drop to 6.9% for its 2001model year vehicles, then drop again to 3.1% for its 2002 model year vehicles.

In their complaint, plaintiffs asserted state law claims against Ford for, inter alia, Unfair and
Deceptive Acts and Practices in Violation of California’s Consumer Legal Remedies Act (“CLRA”), Cal. Civ. Code § 1750 et. seq.; and Unfair, Fraudulent, and Unlawful Practices under the Unfair Competition Law (“UCL”), Cal. Bus. & Prof. Code sections 17200-17209.

Ford moved for summary judgment, arguing that it had no legal duty to disclose the risk that the subject ignition locks would fail, and could stand on its standard three-year, 36,000 mile warranty.

The district court agreed, granting summary judgment.  The court noted first that  under California law, a manufacturer cannot be found liable under the CLRA for failure to disclose a defect that manifests itself after expiration of the warranty period unless such omission (1) is contrary to an express representation actually made by the defendant, or (2) pertains to a fact the defendant was obligated to disclose.  Plaintiffs argued there was an obligation to disclose "material" risks.  But where, as here, a plaintiff’s claim is predicated on a manufacturer’s failure to inform its customers of a product’s likelihood of failing outside the warranty period, the risk posed by such asserted defect cannot be “merely” the cost of the item's repair.  Rather, for the omission to be material, the failure must pose “safety concerns.”  In other words, under California law, a manufacturer’s duty to consumers is limited to its warranty obligations absent either an affirmative misrepresentation or a safety issue. 

Accordingly, because plaintiffs’ CLRA claim here was not based on any misrepresentation made by Ford, but rather was based on an allegation that Ford had a duty to disclose the risk its ignition locks would fail, plaintiffs’ claim, absent evidence of a safety concern, could not succeed. Plaintiffs argued that the ignition lock issue was a substantial "safety concern" because such locks can (1) prevent drivers from starting their vehicles, and (2) prevent drivers from shutting off their vehicles’ engines -- despite the fact that there were no reports that anyone has ever been injured by the failure of an ignition lock.  Plaintiffs hypothesized drivers getting stranded in unsafe locales. Ford argued that the dangers described by plaintiffs were too speculative to amount to a safety issue giving rise to a duty of disclosure.

The court agreed with Ford, noting “security” concerns are distinguishable from “safety” concerns. The dangers envisioned by plaintiffs were speculative in nature, deriving in each instance from the particular location at which the driver initially had parked the vehicle and/or the driver’s individual circumstances. Plaintiffs offered no evidence that the ignition-lock defect causes engines to shut off unexpectedly or causes individuals to stop their vehicles under dangerous conditions.

Similarly, to the extent plaintiffs’ fraudulent concealment claim was based on Ford’s alleged duty to disclose the risk of failure of the subject ignition locks, Ford was entitled to summary judgment on that claim also as there was no duty to disclose a failure rate, post-warranty, for a non-safety issue.  Again, as plaintiffs have failed to show an affirmative duty to disclose the risk of post-warranty failure of the ignition locks, plaintiffs also had not shown that a reasonable customer could have been deceived; as a matter of law, the only reasonable expectation customers could have had about the subject ignition locks was that they would function for the length of Ford’s express warranty. 

Third Circuit Rejects Medical Monitoring in Device Case

The Third Circuit has properly recognized that a claim for medical monitoring claim does not lie against the manufacturer of a medical device product. See M.G. v. A.I. DuPont Hospital for Children, No. 09-1426 (3d Cir., 8/24/10).

Readers may recall the post about this appeal last year.  Doctors at the A.I. duPont Hospital for Children in Wilmington, Delaware, had implanted a Cheatham Platinum stent (“CP stent”) in plaintiffs, who alleged that they had been injured or were at risk of injury from the use of the CP stent. After discovery, the trial court granted summary judgment to defendants on a number of the claims, but summary judgment was denied on Count VI, the medical monitoring claim. The trial court predicted that the Delaware Supreme Court would recognize a medical monitoring cause of action if presented with the facts of these cases.

The trial court recognized that there were substantial grounds for disagreement over whether Delaware will actually recognize a cause of action for medical monitoring. Even if the Delaware Supreme Court were to recognize a medical monitoring claim, there were substantial grounds for disagreement over whether plaintiffs here could state a claim. Plaintiffs' specific theory that medical devices can be the basis for a medical monitoring claim is novel, at best (and has been rejected in many states: Drugs and devices do not present the same policy issues as involuntary exposure to environmental toxins). The trial court was satisfied that plaintiff's novel theory here was one in which certification of an interlocutory order for appeal was appropriate.

The Third Circuit noted that plaintiff’s claim entitled “Medical Monitoring” contended that “[a]s a direct result of defendants’ acts, omissions, and conduct, plaintiffs . . . who have received NuMED CP stent have been exposed to a hazardous procedure and product, and suffered a significantly increased risk of the side effects caused by this device. This increased risk makes periodic diagnostic and medical examinations reasonable and necessary.”

While the district court predicted that the Delaware Supreme Court would recognize a medical monitoring cause of action, the appeals court didn't have to reach that broader question because it concluded that plaintiffs were unable to establish the elements necessary to state a claim for medical monitoring.

Defendants contended on appeal  that the trial court erred in extending Delaware law beyond the bounds of the recognized medical monitoring claim (in those minority of states that accept it) in which a plaintiff alleges long-term involuntary exposure to a proven toxic substance with known tendencies to produce serious future medical injuries. The Third Circuit agreed, finding no persuasive cases anywhere in which a free-standing medical monitoring claim has been allowed to proceed although the plaintiff has not demonstrated significant exposure to a toxic (poisonous) or proven hazardous substance. The lower court’s prediction that the Delaware Supreme Court would permit a claim for medical monitoring on this record thus requires several “leaps” from the current state of the law, generally, let alone Delaware law.

Specifically, here, there was no toxic or hazardous substance, as such. While unapproved devices are termed “adulterated”, they are not necessarily harmful, and certainly not toxic. Moreover, the risk here is not a risk of  “contracting a serious latent disease.” Rather, it is a risk of the need for further care. Further examinations are not to “monitor” the risk of disease, but to perform routine
oversight of the device. Thus, even if the Delaware Supreme Court would recognize a “standard” medical monitoring claim --one which requires a plaintiff to demonstrate that a defendant’s
negligence caused the plaintiff to be exposed to a proven hazardous substance that resulted in a significantly increased risk of contracting a serious latent disease -- the plaintiff here could not demonstrate that she had been exposed to a proven hazardous substance, nor could she prove that such exposure resulted in a significantly increased risk of contracting a serious latent disease.

Accordingly, the court found that plaintiff was unable to establish the elements necessary to make out a claim for medical monitoring.  Summary judgment should have been granted.

On a personal note, also on the winning brief was my former partner, the late R. Nicholas Gimbel, Esq., an outstanding advocate, in one of his last cases.  On the amicus brief for PLAC was my colleague James M. Beck, Esq.
 

Ninth Circuit "Strikes" a Blow for Proper Motion Procedure

Phillies' slugger Ryan Howard was ejected from a game this week in extra innings, leaving his team (which had no more position players) to insert ace pitcher Roy Oswalt into the outfield and to use him at the plate. First time the Phils used a pitcher in the field in decades. Howard argued a mistakenly called third strike on a check swing.

Today's post relates to a different kind of mistaken strike. The Ninth Circuit has explained that trial courts cannot strike a claim for damages on the ground that the damages are precluded as a matter of law.  Whittlestone Inc. v. Handi-Craft Co., No. 09-16353 (9th Cir. Aug. 17, 2010).  Specifically, Rule 12(f) of the Federal Rules of Civil Procedure does not authorize the court to strike the claim for damages on the basis that such damages are legally not recoverable.

Here, the defendant field a Rule 12 motion to strike the paragraphs of the complaint that sought the recovery of lost profits and consequential damages, in alleged violation of the plain language of the parties' contract.  The trial court granted the motion, and plaintiff appealed.

Rule 12(f) states that a district court “may strike from a pleading an insufficient defense or any redundant, immaterial, impertinent, or scandalous matter.” The function of a 12(f) motion
to strike is to avoid the expenditure of time and money that would arise from litigating spurious issues by dispensing with those issues prior to trial.  While the motion here seemed to fit the purpose of the rule, it didn't fit the language. The court found that the damages allegations met none of those listed categories. 

Handi-Craft argued that Whittlestone’s claim for lost profits and consequential damages should be stricken from the complaint, because such damages were precluded as a matter of law.  But that meant that Handi-Craft’s 12(f) motion was really an attempt to have certain portions of  Whittlestone’s complaint dismissed or to obtain summary judgment against Whittlestone as to those portions of the suit, which attempt was better suited for a Rule 12(b)(6) motion or a Rule 56
motion, not a Rule 12(f) motion. 

And this was not harmless error, said the 9th, because the standard for review of the different motions is not the same, and there was some question whether a 12(b)(6) motion would be granted, had it been filed.

The court concluded that Rule 12(f) of the Federal Rules of Civil Procedure does not authorize a district court to dismiss a claim for damages on the basis it is precluded as a matter of
law.


 

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?

 

Causation Expert Opinions Excluded in Toxic Tort Case

A federal judge has issued an opinion explaining her Daubert and summary judgment rulings in a case brought by a consumer who alleged he contracted lung disease from the fumes of microwave popcorn. Newkirk et al. v. ConAgra Foods Inc., No. 2:08-cv-00273 (E.D. Wash. 7/2/2010).

Readers of MassTortDefense may be familiar with the so-called "popcorn lung" litigation in which plaintiffs have alleged they contracted a series of diseases, including Bronchiolitis obliterans, from inhaling the chemical diacetyl which had been used in the artificial butter on microwave popcorn.  Most of the claims have been made by workers with alleged industrial-level exposures on a daily basis in popcorn factories several years ago.  There are, however, a handful of cases by consumers claiming they somehow had sufficient exposure in their homes to have the same respiratory injuries.  These latter cases raise significant issues of general and specific causation, arising from the central tenet of toxicology: the dose makes the poison.  The studies relied on by plaintiffs noted that the cumulative exposure to diacetyl was correlated with chronic effects on lung function in plant workers.

Plaintiff Newkirk claimed that the natural and artificial butter flavoring in ConAgra's Act II Butter and Act II Butter Lovers popcorn products caused him severe and progressive damage to the respiratory system, extreme shortness of breath, and reduced life expectancy.  He claimed that he ate between five and seven bags of ConAgra's popcorn every day for more than a decade.

The motions centered around plaintiff's burden to prove causation. Plaintiffs in toxic tort cases must establish both general and specific causation. Golden v. CH2M Hill Hanford Group, Inc., 528 F.3d 681, 683 (9th Cir.2008). Evidence supporting general causation addresses “whether the substance at issue had the capacity to cause the harm alleged.” In re Hanford Nuclear Reservation Litigation, 292 F.3d 1124, 1133 (9th Cir.2002). Specific causation, by contrast, concerns whether a particular individual suffers from a particular ailment as a result of exposure to the substance. Defendants challenged plaintiff's proof of both under Daubert.

Plaintiffs retained Dr. Egilman to offer an opinion on general causation, as well as to examine Mr. Newkirk, diagnose him, and offer an opinion regarding the specific cause of his condition. The expert opinion testimony of Dr. Egilman was the plaintiffs’ primary evidence supporting general causation. (All of the Newkirks’ other causation expert witnesses assumed that general causation already has been established.)  He opined that,  “There is no known safe level of diacetyl exposure. Existing scientific studies also suggest that levels of diacetyl exposure below and around 1 ppm can cause BO and other respiratory illnesses.”


The court found, however, that Dr. Egilman's attempt to analogize kitchen to industrial exposures failed. He offered no sufficient basis or methodology for support for the conclusion that there is no important (medically relevant) qualitative difference between the vapor from butter flavoring slurry in a mixing vat in a popcorn plant and the vapor from butter flavoring that is emitted from microwave popcorn in the home. There was nothing to support Dr. Egilman’s conclusions that were at the heart of this case: that the vapors emitted from a microwave popcorn bag contain the same proportion of chemicals or in sufficient doses or that all of the substances in the two instances are identical. In other parts of his reports and testimony, the court found, Dr. Egilman relied on some existing data, mostly in the form of published studies, but drew conclusions far beyond what the study authors concluded.

Or, Dr. Egilman manipulated the data from those studies to reach misleading conclusions of his own. Slip opin. at 25. For example, he relied on statements by a Dr. Cecile Rose, on a patient (and another consumer plaintiff), Mr. Watson, who allegedly contracted disease from popcorn fumes. But this was in the nature of a single case report, and in it even Dr. Rose did not assert that her conclusions could be extrapolated to other consumers in the absence of publication or peer review; Dr. Egilman acknowledged that Dr. Rose did not publish the exposure levels measured in Mr. Watson’s home -- so no such comparison was possible.  Dr. Rose herself qualified her conclusions: “It is difficult to make a causal connection based on a single case report. We cannot be sure that this patient’s exposure to butter flavored microwave popcorn from daily heavy preparation has caused his lung disease.” 
 

The expert also relied on testing conducted by Dr. John Martyny in a kitchen (not of a consumer), despite that doctor's own reflections that the methodology underlying the work could not support extrapolating to general causation for a broader group of consumers.  The expert also relied on animal studies. Expert opinion relying on animal studies to reach an opinion on causation in humans is usually admissible only when the expert explains how and why the results of the animal toxicological study can reliably be extrapolated to humans. General Electric Co. v. Joiner, 522 U.S. 136, 143-45 (1997).  Dr. Egilman offered no such analytical bridge between the animal studies finding harm from high levels of diacetyl exposure to lab rats and his conclusion that those studies demonstrate that diacetyl exposure causes decreased lung function in humans. He offered no sufficient explanation for how and why the results of those studies could be extrapolated to humans, let alone low-dose consumer contexts.

Without Dr. Egilman's testimony to support causation, the plaintiffs' other expert witnesses couldn't establish this element either.

Note also that the court excluded Dr. Egilman's "legal conclusions" from his expert report and affidavits, since the witness was no more capable than the fact-finder to draw such a conclusion. See Nationwide Transp. Fin. v. Cass Info. Sys., 523 F.3d 1051, 1059-60 (9th Cir.2008) (expert witness cannot give an opinion as to her legal conclusion, i.e., an opinion on an ultimate issue of law). For example, Dr. Egilman tried to opine that about what the defendant "knew" and "failed to warn" consumers. This is another useful precedent against plaintiffs' mis-use of the conduct "expert" who provides mere legal conclusions and invades the province of the jury.

(Your humble blogger is involved in the diacetyl litigation, but not this case.)

General Causation Opinion Excluded by Eleventh Circuit in Autism Case

The Eleventh Circuit recently  affirmed a judgment for defendant Evenflo Co. in a suit by a plaintiff who had alleged that the car seat manufacturer was responsible for her son's autism. Hendrix v. Evenflo Co., 2010 WL 2490760 (11th Cir., 6/22/10).

Plaintiff alleged that her son sustained traumatic brain injuries when a child restraint system manufactured by Evenflo allegedly malfunctioned during a minor traffic accident. Hendrix further alleged that those brain injuries caused the son to develop autism spectrum disorder (“ASD”). The district court excluded testimony from two of Hendrix's expert witnesses that the accident caused the ASD, concluding that the methods used by Hendrix's experts were not sufficiently reliable under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). See Hendrix v. Evenflo Co., Inc., 255 F.R.D. 568 (N.D.Fla. 2009). The lower court then granted partial summary judgment to Evenflo on Hendrix's ASD claim, determining that without the excluded testimony there was no reliable evidence to support Hendrix's theory that the accident caused the ASD. Hendrix voluntarily dismissed, with prejudice, her remaining damages claims and filed a notice of appeal.

Hendrix's experts relied primarily on the controversial differential etiology method to link the child's traumatic brain injury to his ASD diagnosis. Differential etiology, said the court, is a medical process of elimination whereby the possible causes of a condition are considered and ruled out one-by-one, leaving only one cause remaining. It is a questionable extension of the method by which doctors diagnose a disease into the area of what caused the disease.

The Eleventh Circuit has previously held that, when applied under certain circumstances that it thinks will ensure reliability, the differential etiology method can provide a valid basis for medical causation opinions. The reliability of the method must be judged by considering the reasonableness of applying the differential etiology approach to the facts of this case and the validity of the experts' particular method of analyzing the data and drawing conclusions therefrom. According to the court, a reliable differential etiology analysis is performed in two steps. First, the expert must compile a comprehensive list of hypotheses that might explain the set of salient clinical findings under consideration; the issue at this point in the process is which of the competing causes are generally capable of causing the patient's symptoms. See Clausen v. M/V New Carissa, 339 F.3d 1049, 1057-58 (9th Cir.2003). Second, the expert must eliminate all causes but one.

With regard to the first step, the district court must ensure that, for each possible cause the expert “rules in” at the first stage of the analysis, the expert's opinion on general causation is derived from scientifically valid methodology.  Hollander v. Sandoz Pharm. Corp., 289 F.3d 1193, 1211 (10th Cir.2002); Siharath v. Sandoz Pharms. Corp., 131 F.Supp.2d 1347, 1362-63 (N.D.Ga.2001). This is because a fundamental assumption underlying differential etiology is that the final, suspected cause must actually be capable of causing the injury. Thus, here, the experts' purported use of the differential etiology method will not overcome a fundamental failure to lay the scientific groundwork for the theory that traumatic brain injury can, in general, cause autism.

The Eleventh Circuit has distinguished cases in which the medical community generally recognizes that a certain chemical or product can cause the injury the plaintiff alleges from those in which the medical community has not reached such a consensus. In the second category of cases, the district court must apply the Daubert analysis not only to the expert's methodology for figuring out whether the agent caused the plaintiff's specific injury, but also to the question of whether the drug or chemical or product can, in general, cause the harm plaintiff alleges. Thus, the district court must assess the reliability of the expert's opinion on general, as well as specific, causation.  In this regard, the court (like most) rejects the “post hoc ergo propter hoc fallacy" which assumes causality from temporal sequence; a mere temporal relationship between an event and a patient's disease or symptoms does not allow an expert to place that event on a list of possible causes of the disease or symptoms. Case studies and clinical experience, used alone and not merely to bolster other evidence, are also insufficient to show general causation.

Here, none of the medical textbooks and epidemiological studies submitted by the expert came close to providing useful evidence of a definitive causal link between traumatic head injuries and autistic disorders, and none provided even marginal support for plaintiff's theory of a relationship between abnormal cerebral spinal fluid pressure and problems with cerebellum pressure, leading to autism. For example, the text chapter listing the known etiological factors involved in ASD does not mention acquired trauma in the perinatal brain.

Plaintiff also attempted to sidestep the deficiencies in the medical literature by focusing on the expert's experience and training. Merely demonstrating that an expert has experience, however, does not automatically render every opinion and statement by that expert reliable. The witness must explain how that experience leads to the conclusion reached, why that experience is a sufficient basis for the opinion, and how that experience is reliably applied to the facts. The trial court's gatekeeping function requires more than simply “taking the expert's word for it.”

Judgment for defendant affirmed.

Welding Fume MDL Court Releases "Trial Template"

The Judge overseeing the Welding Fume Products Liability MDL Litigation has issued a “Trial Template” to assist transferor courts in handling the 3,900 remaining cases in the future.  In re: Welding Fume Products Liability Litigation, MDL No. 1535 (N.D. Ohio).

The document outlines the proceedings that have occurred in this MDL since its 2003 inception,
and summarizes the court’s pretrial rulings applicable to every MDL case. (All of this MDL court's written Orders cited in the document are available through the MDL court’s site.)  The stated purpose of the document is to assist trial judges in transferor courts who may preside over the trial of an individual welding fume case, after the Judicial Panel on Multi-District Litigation remands the
case from the MDL court back to the transferor court.

(Another good source on this mass tort for the interested reader is Jowers v. Lincoln Elec. Co., 608 F.Supp.2d 724 (S.D. Miss. 2009), in which the court reviewed all of the parties’ evidence in the context of resolving defendants’ post-judgment motions, filed after the jury reached a rare plaintiff’s verdict in the fourth MDL bellwether trial.)

Key points: since the MDL was created in the U.S. District Court for the Northern District of Ohio in June 2003, more than 9,800 cases have been transferred from other courts, and 2,700 have been removed to or directly filed with the court. Voluntary dismissals, remands and other events have reduced the number of pending cases to approximately 3,900. The gravamen of the complaint in each of these cases is that manganese contained in the fumes given off by welding rods has caused the plaintiff to suffer neurological injury, and the defendant manufacturers of these welding rods failed to warn of this hazard. At trial, defendants typically interpose some or all of the following fact-based defenses: (1) the warning language defendants used was adequate; (2) the plaintiff did not prove he used a particular defendant’s welding rods; (3) the plaintiff did not prove he saw a particular defendant’s warnings; (4) the plaintiff did not prove his neurological condition was caused by exposure to welding fumes; (5) the plaintiff’s neurological condition is not manganese-induced "Parkinsonism," it is something else (e.g., psychogenic movement disorder); (6) the defendants are immune pursuant to their role as government contractors; (7) the defendants are not liable because the plaintiff’s employer was a learned intermediary; (8) the defendants are not liable because the plaintiff was a sophisticated user; (9) the plaintiff did not prove that a better warning would have made any difference; (10) the plaintiff is, to some degree, responsible for his own injuries under the theories of contributory negligence, comparative negligence, or assumption of the risk; and (11) punitive damages are not available because the plaintiff did not present clear and convincing evidence of gross negligence.

The MDL court presided over six bellwether trials and is now in the process of suggesting remand to transferor courts of cases that have become close to trial-ready, the judge said. The court has so far applied the laws of five states in MDL bellwether trials: Mississippi, Texas, South Carolina, California, and Iowa. The parties sometimes, but not always, have agreed on which state’s law applies. In cases of disagreement, the choice-of-law analysis a transferor court will have to apply is likely to be fact-specific.

The court has granted summary judgment to certain defendants (MetLife & Caterpillar) in all welding fume cases. Further, the Court entered a “Peripheral Defendant Dismissal Order,” dismissing without prejudice all defendants in every case except those against whom a given plaintiff is most likely to proceed at trial. Still remaining as defendants in virtually every case are five of the biggest welding rod manufacturers: (1) Lincoln Electric Company, (2) BOC Group (formerly known as Airco) (3) ESAB Group, (4) TDY Industries (formerly known as Teledyne Industries and Teledyne McKay), and (5) Hobart Brothers Company. Defendant-specific discovery in each case may lead to dismissal of some of these five defendants, and possibly to renaming of some previously-dismissed defendants, the court observed. 

Regarding discovery, the parties have engaged in huge amounts of generic discovery directed at
information potentially relevant to every case. This includes, for example, the defendants’ alleged historical knowledge of the hazards posed by welding fumes, the warnings defendants provided to welders over time, and the state of medical and scientific knowledge regarding neurotoxicity of manganese in welding fumes. For the most part, the parties have completed all general discovery. To prepare for trial in a specific welding fume case, the parties must engage in substantial case-specific discovery directed at information relevant to the individual plaintiff’s particular claims and circumstances. This discovery typically will address the plaintiff’s employment history, medical history, and welding experiences. The court observed that at least some of this plaintiff-specific discovery may not occur until after the MDL court has remanded the case to the transferor court. Accordingly, a transferor court may need to oversee some aspects of case-specific discovery.

As to plaintiffs, about ten years ago, the national plaintiffs’ bar engaged in a concerted effort to notify welders that, if they suffered from a movement disorder, their neurological injury might be caused by exposure to welding fumes. The MDL court then imposed several obligations on plaintiffs’ counsel to ensure they intend to actually try the cases they filed. These additional obligations include the filing of: (1) a “Notice of Diagnosis” of neurological injury, signed by a medical doctor; and (2) a “Certification of Intent to Try the Case,” to be submitted by plaintiff’s counsel following initial medical records discovery. These obligations have winnowed the plaintiffs’ cases substantially, so the MDL court believes that there is some likelihood that a case remanded to a transferor court will go to trial.

On the expert front, the parties sought to introduce at trial testimony from a plethora of experts in a number of fields, including neurology, neuro-pathology, neuro-psychology, neuro-radiology, epidemiology, bio-statistics, industrial hygiene, industrial engineering, chemistry, materials science, toxicology, warnings, corporate ethics, military specification and procurement, economics, government lobbying, and ancient corporate documents. Early in this MDL, the court held a multi-day Daubert hearing to determine the admissibility of opinions offered by these experts. Further, the court engaged in additional analyses of the admissibility of expert testimony prior to each MDL
bellwether trial.

Before each MDL bellwether trial, the parties filed numerous motions in limine addressing the admissibility of various pieces of evidence, ranging from critical documents to relatively short comments made by witnesses. The court reviews each of those rulings in this latest document.  Similarly, the court had ruled on a number of motions for summary judgment as a matter of state and federal law. These motions are also described in the document.  For example, to prevail on his product liability claims against a particular manufacturing defendant, a welding fume plaintiff must show he actually used that manufacturer’s products. Because many plaintiffs worked as welders for a variety of employers in different locations over many years, and because welding rods are somewhat fungible, the discovery of product identification evidence can be difficult, and the results less than clear, said the court. Whether a given defendant is entitled to judgment as a matter of law based on lack of product identification is a highly fact-specific question, and the answer as to certain defendants in certain cases may not become clear even until after trial.

Finally, the court provides a number of useful appendices and charts, including MDL Bellwether Trial Result Summary and MDL Bellwether Trial Witness Chart.

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.

Claim Against Classic Coke Down the Drain

The Coca-Cola Co. has successfully obtained summary judgment in a case alleging that the company unfairly marketed its Coca-Cola Classic soft drink as “original formula” despite allegedly having substituted high-fructose corn syrup for the ordinary table sugar it used when the drink was introduced. Judge Patrick Murphy issued an order last week in the U.S. District Court for the Southern District of Illinois.

Plaintiffs Amanda Kremers and Jason McCann, sued on behalf of themselves and a proposed class of Illinois citizens, alleging that Coca-Cola’s conduct in labeling cans and bottles of “Classic” Coke with the terms “Original Formula” constitutes a deceptive and unfair trade practice. This is because, plaintiffs contended, the “Original Formula” of Coke, which was invented in 1886, called for Coke to be sweetened using sucrose (ordinary table sugar, in essence), whereas “Classic” Coke currently is sweetened using high fructose corn syrup (“HFCS”). They alleged violation of the Illinois Consumer Fraud and Deceptive Business Practices Act (“ICFA”), and unjust enrichment.

Proposed class rep Kremers conceded at her deposition that she has known since the 1990's that “Classic” Coke contained HFCS and that “Classic” Coke is marketed as the “Original Formula” of Coke.  Kremers admitted also that she read the words “Original Formula” on a container of “Classic” Coke in the 1990s.  That was sufficient to put her on notice to inquire about her alleged claims, and that she knew or reasonably should have known of her so-called injury. Thus, her claim was barred by the statute of limitations, even with the discovery rule.

Turning to the merits of the case, the state statutory cause of action requires: (1) a deceptive act or practice by the defendant, (2) the defendant’s intent that the plaintiff rely on the deception, (3) the occurrence of the deception in the course of conduct involving trade or commerce, and (4) actual damage to the plaintiff (5) proximately caused by the deception.  To prove that element of proximate causation in a private cause of action brought under the ICFA, a plaintiff must allege that he was, in some manner, actually deceived. 

McCann’s testimony at his deposition was that he wasn't actually deceived.  He never read the key language until after he was approached by counsel for plaintiffs in this case about serving as the representative of the proposed class. Hence, he could not prove proximate causation for purposes of a claim for deceptive trade practices under the ICFA.

To establish a prima facie case of unfair trade practices under the ICFA, a plaintiff must prove that a defendant intentionally engaged in an unfair practice in the course of conduct involving trade or commerce, and that this practice proximately caused harm to the plaintiff. The court found that as a matter of law, the sales here were not unfair trade practices. The trade practices in dispute in this case were not deceptive acts (as above). No public policy of Illinois proscribed the use of HFCS as a sweetening agent in beverages and foodstuffs. The facts concerning plaintiffs' use hardly suggested they had been oppressed by Coca-Cola’s trade practices, or had been afforded the lack of meaningful choice necessary to establish unfairness.

Perhaps most importantly, McCann could not show the necessary substantial harm for an unfair trade practice, given the small amount of the product he purchased, the fact that he continued to purchase "Classic” Coke after the commencement of this suit and despite knowledge that the product contains HFCS, and because the alleged injury was one any consumer of “Classic” Coke quite easily could have avoided, by, for example, simply drinking a different soft drink or other beverage.

Although fraud is not an element of a claim for unjust enrichment under Illinois law, the Seventh Circuit nevertheless has made clear that where the plaintiff’s claim of unjust enrichment is predicated on the same allegations of fraudulent conduct that support an independent claim of fraud, resolution of the fraud claim against the plaintiff is dispositive of the unjust enrichment claim as well.

Class motion dismissed as moot.

 

Appeals Court Upholds Summary Judgment on Negligence Per Se Claim

Last week, the Ninth Circuit upheld summary judgment for the maker of an artificial disc on a claim that the company's alleged off-label promotion of the device constituted negligence per se. See Carson v. DePuy Spine Inc.,  No. 08-56698 (9th Cir., 2/16/10)(unpublished).

Readers know that alleged violations of state or federal regulations can be used by plaintiffs in a number of ways, including the allegation that the violation constitutes negligence per se under state law.  The artificial disc involved in this action was a class III medical device that had received pre-market approval from the FDA in 2004. All devices approved by the agency carry labels that describe the uses and patient conditions for which they may be used. Any use by a physician that differs from the label is considered an off-label use.  Here, plaintiff argued that the defendant was negligent in allegedly promoting off-label use for its product. 

The court noted that he FDCAct expressly protects off-label use: “Nothing in this chapter shall be
construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.” 21U.S.C. § 396. In addition, the Supreme Court has emphasized that off-label use by medical professionals is not only legitimate but important in the practice of medicine. Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001). And a manufacturer is not liable merely because it sells a device with knowledge that the prescribing doctor intends an off-label use.
 

Plaintiffs argued  that the FDA has adopted regulations that limit a drug or device manufacturer’s
ability to promote a drug or device for off-label use. Therefore, while doctors may use a drug or device off-label, the marketing and promotion of a Class III device for an unapproved use violates Section 331 of the FDCA, 21 U.S.C. § 331, claimed plaintiff.  Thus, plaintiff asserted a state law negligence per se theory predicated on violation of federal law.   

In California, negligence per se is not a separate cause of action but is the application of an evidentiary presumption. Quiroz v. Seventh Avenue Center, 140 Cal. App. 4th 1256, 1285-86 (Cal. 2006). In California, there are four elements required to establish a viable negligence per se theory: (1) the defendant violated a statute or regulation; (2) the violation caused the plaintiff's injury; (3) the injury resulted from the kind of occurrence the statute or regulation was designed to prevent; and (4) the plaintiff was a member of the class of persons the statute or regulation was intended to protect. See Alejo v. City of Alhambra, 75 Cal.App.4th 1180, 1184-1185 (Cal.App. 1999).

The court of appeals found that the district court had correctly concluded that Carson had failed to present sufficient evidence to create a genuine issue as to two of the elements: violation of
federal law and causation. There was no evidence in the record to support the claim that defendant illegally promoted an off-label use of the products, that the physician was influenced by such promotion, or that the off-label use of the disk caused the injury. Indeed, there was uncontroverted testimony that plaintiff developed a spinal condition that put undue stress on the device, and that the surgeon broke the disc himself during revision surgery.

Summary judgment affirmed.

Summary Judgment In ABS Case on Causation: Try, Try Again Doesn't Work

A federal court has dismissed a case against Ford Motor Co. brought on behalf of a minor who was severely hurt when she was struck by a Ford pickup truck while riding her bike.  The court concluded that plaintiff offered insufficient evidence that the alleged defect in the truck (absence of front-wheel anti-lock brakes) caused the accident and thus the ensuing injuries. BancFirst v. Ford Motor Co., 2009 WL 5168342 (W.D.Okla. 12/21/09). 

A seven-year-old rode her bicycle into the path of an oncoming Ford F150 pickup truck driven by Brandon Moore. Although he took evasive action, Moore was unable to avoid hitting the child, who was severely injured as a result of the impact. Plaintiff alleged that the truck wheels locked and the truck began to rotate in a counter-clockwise direction. The truck slid on wet pavement through the intersection, and the child was hit by the right rear corner of the truck as it passed through the inside lane.  Plaintiff brought an action against the manufacturer of the truck, Ford Motor Company, alleging that the truck was unreasonably dangerous because it lacked front-wheel anti-lock brakes (“ABS”).  Ford moved for summary judgment.

Under either a strict liability or negligence theory, plaintiff must show that the lack of front-wheel anti-lock brakes on the F-150 truck caused the accident. In support of its contention that the failure to equip Moore’s truck with ABS on all four wheels caused the accident, plaintiff offered the opinion of William Medcalf, a registered professional engineer. During his deposition, plaintiff’s expert conceded that he could not testify to a reasonable degree of engineering certainty that the alleged defect – lack of all-wheel ABS – caused the accident in this case. Expert testimony in this regard was crucial to plaintiff’s case as the efficacy and functionality of anti-lock braking systems are not within the understanding of ordinary jurors.

So far, so good. A basic failure of an expert to perform at deposition the way the plaintiff probably hoped he would.  But its what happened next that makes the case more useful.

The plaintiff offered a later affidavit from the same expert, but it was ignored because it was based on the same data he had when he gave his first opinion.  Readers of MassTortDefense may be interested in the discussion of another tactic, as the expert attempted to change his previous testimony to avoid summary judgment, through an errata sheet to his deposition, the court said. While Rule 30(e) of the Federal Rules of Civil Procedure permits "corrections" to deposition transcripts, it does not permit wholesale changes to sworn testimony. Coleman v. Southern Pac. Transp. Co., 997 F.Supp. 1197, 1205 (D. Ariz.1998) (discrediting deposition testimony directly contradicted by errata sheet); S.E.C. v. Parkersburg Wireless, L.L. C., 156 F.R.D. 529, 535 (D.D.C. 1994) (noting trend in which courts do not allow a party “to make any substantive change she so desires” in deposition testimony); Rios v. Bigler, 847 F.Supp. 1538, 1546-47 (D. Kan.1994) (court will consider only those changes which clarify the deposition, and not those which materially alter it); Greenway v. International Paper Co., 144 F.R.D. 322, 325 (W.D. La. 1992) (suppressing deponent's attempt to rewrite material answers given in deposition); Barlow v.. Esselte Pendaflex Corp., 111 F.R.D. 404, 406 (M.D.N.C. 1986) (refusing to consider changes to deposition that were made in bad faith).

The changes here were not a clarification; they were substantive changes diametrically opposed to the answers given during the deposition, said the court. Moreover, although Medcalf stated that his new answers were just clarifications to the record, there was no indication that he was confused during the deposition. That the expert treated the deposition like a "take home examination" was clear to the court not only from his proposed changes, but also from the timing of the errata sheet, which appeared only after Ford moved for summary judgment.

Plaintiff had no competent evidence that the accident would not have occurred had Moore’s truck been equipped with four-wheel ABS. It thus had no evidence that the alleged defect caused the accident and the subsequent injuries to plaintiff.  And the last minute attempts to fix that problem were of no avail. Defendant was therefore entitled to summary judgment in its favor. 

 

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.

 


 

Summary Judgment in Proposed Medical Monitoring Class Action

A federal court has granted defendant CSX Transportation, Inc.’s Motion for Summary Judgment in a medical monitoring case arising from a train accident. See Mann v. CSX Transportation, et al., NO. 1:07-cv-3512 (N.D. Ohio Nov. 10, 2009).

The case arises from the derailment of 31 rail cars, nine of which contained hazardous materials, and the subsequent fire that burned for around sixty hours. Ohio emergency personnel oversaw an
evacuation of a one half mile radius. The next day, plaintiffs filed a putative class action complaint in state court, which was removed to the Northern District of Ohio. Plaintiffs’ complaint, under
theories of strict liability and negligence, primarily sought the establishment of a judicially administered medical monitoring program.

After discovery had been completed, defendant filed its motion for summary judgment. The court began by noting that Ohio law recognizes medical monitoring as a form of remedy for an underlying tort. See Wilson v. Brush Wellman, 817 N.E.2d 59, 63 (Ohio 2004). (Readers will note some states consider it a separate cause of action.) Therefore, medical monitoring is only granted if a plaintiff is able to prove all the elements of the underlying tort and the elements of medical monitoring. On the first part, in order to avoid summary judgment, plaintiffs thus must make a showing of a genuine issue of material fact as to the elements of a negligence claim under Ohio law: (1) defendant had a duty to plaintiffs, (2) defendant breached that duty, and (3) plaintiffs suffered damages directly and proximately caused by defendant’s breach. See, e.g., Menifee v. Ohio Welding Products, 15 Ohio St. 3d 75, 77 (Ohio 1984).

The first two issues were not contested for purposes of the motion. On injury and causation, the court noted the overlap with typical medical monitoring requirements, such that to meet this aspect of their negligence claim plaintiffs must demonstrate a genuine issue of material fact that: (1) the chemicals (dioxins) released into the air by the fire are known causes of human disease; and (2) that the plaintiffs were exposed to the dioxins in an amount sufficient to cause a significantly increased risk of disease such that a reasonable physician would order medical monitoring.

Plaintiff experts relied on classifications of the chemicals as carcinogens as their only evidence that dioxins cause the various endpoint diseases for which they seek medical monitoring.  Plaintiffs’ experts also failed to provide an independent assessment of the causal link between dioxins and disease.  Instead they "parroted" the conclusions of other experts and cited to EPA, IARC and NTP documents labeling dioxins as known carcinogens. This was an insufficient showing, said the court.

But even if plaintiffs could demonstrate a causal relationship between dioxins and cancer, plaintiffs had failed to establish that they were exposed to dioxins in an amount warranting a reasonable physician to order medical monitoring. See Day v. NLO, 851 F.Supp.869, 881 (S.D. Ohio 1994).

Plaintiffs’ theory was that they were at an increased risk of disease because they lived for eighteen months with alleged contamination from the fire inside and around their homes. However, none of the named plaintiffs presented evidence that a physician has examined them or their medical records and opined that they are at an increased risk of disease. Similarly, plaintiffs’ experts had not conducted any measurement of dioxin inside or outside of the homes of five of the seven named plaintiffs. At least three of the seven had not even lived in their air dispersion modeling expert's "impact zone" long enough to qualify for his proposed medical monitoring program. Even for those that did, mere residence in the so-called impact zone is insufficient evidence of sufficient contamination and increased risk because it ignores any individual variables, including other sources, and most notably, at what level each of the named plaintiffs was actually exposed to dioxins. The Sixth Circuit has stated “generalized proofs will not suffice to prove individual damages.”  Sterling v. Velsicol Chem. Corp., 855 F.2d 1188, 1200 (6th Cir. 1988).

Again, even if plaintiffs had presented sufficient evidence of the amount of named plaintiffs’ dioxin exposure, plaintiffs did not demonstrate that a reasonable physician would order medical monitoring based on this exposure. Plaintiffs attempted to rely upon the EPA soil cleanup level after the accident as a basis for justifying medical monitoring. The court found two fatal defects in using this EPA soil cleanup level. First, demonstrating why regulatory guidelines are often not useful in the tort litigation context, see Rowe v. E.I. DuPont de Nemours & Co., 2008 WL 5412912 (D.N.J. Dec. 23, 2008); Redland Soccer Club, Inc. v. Dep’t of the Army, 55 F.3d 827 (3d Cir. 1995), the EPA soil cleanup level represented a threshold for the cleanup of contaminated soil, not a danger point
above which individuals would require medical monitoring. And even if government regulations were relevant to showing increased risk, a conservative soil cleanup level should not be used in place of a medically based risk assessment or evidence of the actual dose level at which dioxin truly causes cancer – the danger point critical to a medical monitoring determination.  Second, the EPA’s threshold soil cleanup level represents an increase in the risk of developing cancer from the baseline level for the general population of one in a million. Thus, even assuming there were a million members in this class who had been exposed to this level of dioxin over their entire lives, and assuming causation, only one of them would develop cancer because of the exposure. Plaintiffs thus sought to commence medical monitoring based on this one-in-a-million risk, but this risk and indeed risks higher, have been found insignificant as a matter of law.  Medical monitoring typically requires a significantly increased risk. Plaintiffs' expert opinion to the contrary was a legal conclusion, and thus it did not create a genuine issue of material fact.

In sum, the court concluded that the plaintiffs had not presented a genuine issue of material fact that the circumstances would warrant a reasonable physician to order medical monitoring. Medical monitoring in Ohio is a form of relief which should only be granted "with prudence."  Interestingly, the court concluded that plaintiffs’ proposed program would likely be extremely expensive, said the court, and inconvenience thousands of people for many years in the future. (Note to readers, the potential down-sides of medical monitoring must be explored in each case.) Plaintiffs had not presented enough evidence for a reasonable jury to conclude that such a burdensome program is warranted.

 

 

Partial Summary Judgment Granted in Genetically Modified Rice MDL

The judge overseeing the federal MDL involving genetically modified rice has granted partial summary judgment to the defendants, dismissing several claims, including a public nuisance allegation. In re: Genetically Modified Rice Litigation, No.4-md-1811 (E.D. Mo. 10/9/2009). 

This multi-district litigation relates to the claims of U.S. long-grain rice producers, and others in the rice business, who allege that certain defendants contaminated the U.S. rice supply with non-approved genetically modified strains of rice. The first of a series of bellwether trials will begin in November; this first trial involves Missouri farmer plaintiffs, and the court's Order rules on only the portions of the motions directed to the claims of the Missouri plaintiffs.

The Missouri plaintiffs are seeking damages under a variety of theories, including negligence,  public and private nuisance, negligence per se, and the North Carolina Unfair Trade Practices Act. The plaintiffs are suing to recover allegedly lost income they claim resulted from the drop in market price for rice; following the announcement of the contamination in 2006, some rice companies around the world banned the importation of U.S. rice, which allegedly caused a dramatic drop in the U.S. market price for rice.

Judge Catherine Perry of the U.S. District Court for the Eastern District of Missouri issued an opinion on a host of summary judgment  issues, most notably granting defendants’ motion for summary judgment on plaintiffs’ claims under the North Carolina Unfair Trade Practices Act and on plaintiffs’ claims for public nuisance and negligence per se.

Defendants asserted first that the economic loss doctrine bars all the common-law claims.  The economic loss doctrine bars recovery of purely pecuniary losses in certain tort cases if there is no personal injury or physical damage to property other than the property at issue in the case – usually an allegedly defective product in a products liability case. A plaintiff suing over damage to a product he contracted for is limited to his contract remedies. Many states have adopted the economic loss doctrine for products liability cases, and some states have applied the doctrine to other torts
as well. Here, however, the court found that the alleged damages were not to any property that was the subject of a contract, and the plaintiffs were not claiming damage to any property that is alleged to be defective. Rather, they claim market losses and damage to other property, including equipment, land, and rice. Because they alleged damage to other property, the doctrine does not
apply, concluded the MDL court.

Defendants fared better with plaintiffs' attempt to rely on the more pro-plaintiff North Carolina statute.  The court noted that plaintiffs are not suing based on contracts with Bayer, and although some of Bayer’s decision-making occurred in North Carolina, the claims of plaintiffs cannot be said to arise mainly from those North Carolina activities.  Although there was some conflicting authority, the court concluded that the better reasoned cases require an in-state injury to a plaintiff’s in-state business operations. In other words, the North Carolina Unfair and Deceptive Trade Practices Act is intended to protect the North Carolina consumer.  Plaintiffs had not shown that their claims here had a sufficient effect on North Carolina business for them to benefit from this act intended to protect North Carolina commerce.

Third, in Missouri, a public nuisance is an offense against the public order and economy of the state that violates the public’s right to life, health, and the use of property, while, at the same time annoys, injures, endangers, renders insecure, interferes with, or obstructs the rights or property of the whole community, or neighborhood, or of any considerable number of persons. Bayer was able to show that, as matter of law, plaintiffs cannot recover for public nuisance. There is no evidence in the record showing the sort of public harm or negative effect on the entire community that public nuisance law was developed to remedy.

A private nuisance, on the other hand, is the unreasonable, unusual, or unnatural use of one’s property so that it substantially impairs the right of another to peacefully enjoy his property.  Plaintiffs’ private nuisance claim survived summary judgment because factual disputes remain regarding whether contamination of plaintiffs’ crops may interfere with their enjoyment of their land. The focus of a private nuisance claim, said the MDL court,  is on defendant’s unreasonable interference with the use and enjoyment of plaintiff’s land.  A genuine issue of fact remains regarding whether plaintiffs can prove a private nuisance.

Defendants were entitled to summary judgment on plaintiffs’ negligence per se claim, to the extent it relied on a violation of federal Animal and Plant Health Inspection Service regulations. This is because they are more in the nature of performance standards that do not provide a standard of
care.  So, for example, if a building code says a stair riser must be six inches tall, that is a precise directive that a builder can follow, and if someone is injured because the riser is taller or shorter, negligence per se might apply.  A building code that says the stair riser should be of a sufficient height not to be dangerous or so that a person will not fall could not provide a basis for a negligence per se claim because the question of what is reasonable was not answered by the building code regulations.

We will keep an eye on the first bellwether case for our readers.