New England Journal of Medicine Speaks Out Against Preemption. “Drug and device companies have chosen an inauspicious moment to attack the right of patients to seek redress. A series of pivotal reports on patient safety from the Institute of Medicine, as well as numerous articles in scholarly journals, has put the issue of patient safety in the national spotlight. Although frivolous lawsuits should not be condoned, product-liability litigation has unquestionably helped to remove unsafe products from the market and to prevent others from entering it. Through the process of legal discovery, litigation may also uncover information about drug toxicity that would otherwise not be known. Preemption will thus result in drugs and devices that are less safe and will thereby undermine a national effort to improve patient safety. Owing in part to a lack of resources, approval of a new drug by the FDA is not a guarantee of its safety. As the Institute of Medicine has reported, FDA approval is usuall based on short-term efficacy studies, not long-term safety studies. Despite the diligent attention of the FDA, serious safety issues often come to light only after a drug has entered the market. The FDA, which – unlike most other federal agencies – has no subpoena power, knows only what manufacturers reveal. Why should doctors be concerned about preemption? In stripping patients of their right to seek redress through due process of law, preemption of common-law tort actions is not only unjust but will also result in the reduced safety of drugs and medical evices for the American people. Preemption will undermine the confidence that doctors and patients have in the safety of drug and devices.” See Curfman, et al, “Why Doctors Should be Worried About Preemption” New England Journal of Medicine (July 3, 2008).

U.S. Supreme Court Rejects Claims of Preemption Under Clean Water Act in Exxon Valdez Case. Although reversing, in part, the punitive damage award under the general maritime law, the U.S. Supreme Court rejected Exxon's argument that a common law award of punitive damages was preempted by the Clean Water Act. See Exxon Shipping Co v. Baker, No.07-219, 2008 WL 2511219 (June 25, 2008).

Louisiana First Circuit Rejects Cause of Action by User of Generic Drug Against Brand Name Drug Manufacturer. Plaintiff was prescribed Cordarone, a drug manufactured by Wyeth, for a non-life-threatening heart condition. The pharmacist filled the prescription with the generic version of amiodarone, made by Sandoz. The plaintiff took the medication as prescribed, developed severe liver complications, allegedly a side-effect from the drug, underwent two liver transplants, and ultimately died. The plaintiff’s family filed suit against Wyeth alleging liability for: (a) failing to warn of the dangers associated with amiodarone; (b) understating the drug’s nature and adverse effects; (c) actively promoting the drug for off-label uses including atrial fibrillation; (d) misleading physicians and pharmacists regarding the risks of amiodarone, and downplaying the severity and duration of side effects; and (e) marketing, promoting and pushing amiodarone as a drug suitable to treat non-life-threatening heart conditions. The court found that Wyeth owed the plaintiff no legal duty, regardless of the theory of recovery asserted. “Mrs. Stanley did not use Wyeth’s product, so the plaintiffs cannot proceed with a products liability claim. Neither did they show that Wyeth owed them a duty of care, nor that they relied on representations made by Wyeth.” See Stanley v. Wyeth, Inc., 2007-2080 (La. App. 1st Cir. 5/2/08), 2008 WL 1930154.

Judge Wilson Delivers Pithy Admonition Against Federal Preemption as an Assault on Trial by Jury. In a Supplement to the Court’s April 10, 2008 Order, Judge Wilson took pause to consider the broad implications of preemption: “The thought underlying expansive preemption (‘backdoor federalization’) is that bureaucratic experts are better at determining what is reasonable, what is too dangerous, etc., than are juries. Over the past several years I believe that all three branches of government have become more and more distrustful of juries. They seem to forget that juries are a cross-section of citizens who elected them to office (or elected those who appointed them). In political campaigns these citizens are paragons of virtue; but when they are called for jury service, they somehow become incapable of making important decisions. The language in the decisions favoring preemption is high flown; but, at bottom, it reflects distrust of the randomly selected citizens who sit on juries. Perhaps our public officials, including judges, have read too much Plato and too little Alexis de Tocqueville. Trial by jury is the essence of government reposed by the people. We should trust this institution in fact, not just in word.” See in re Pempro Products Liability Lit., MDL No. 1507 (E.D.Ark. April 16, 2008).

Divided Supreme Court Allows the Kent Decison to Stand. In Desiano v. Warner-Lambert, (discussed below), the U.S. Second Circuit Court of Appeals refused to apply Federal Preemption under Buckman with respect to product liability claims under Michigan Law, which provides that a pharmaceutical manufacturer can escape liability where the drug is approved by the FDA, unless the defendant withheld or misrepresented material information that would have prevented approval. In a one-sentence per curiam, the U.S. Supreme Court said: "The judgment is affirmed by an equally divided Court." Chief Justice Roberts took no part in the decision. See Warner-Lambert v. Kent, No.06-1498, 2008 WL 552875 (March 3, 2008).

U.S. Supreme Court Holds that Claims for Defective Medical Devices Are Preempted Where Device Undergoes Pre-Market Approval Process. The plaintiff filed suit under New York law against the manufacturer of Class III device (balloon catheter) which received pre-market approval from the FDA in 1994. As contrasted with the “substantially equivalent” device at issue in Lohr, pre-market approval imposes “requirements” under the MDA. “Unlike general labeling duties, premarket approval is specific to individual devices. And it is in no sense an exemption from federal safety review - it is federal safety review. Thus, the attributes that Lohr found lacking in §510(k) review are present here. While §510(k) is ‘focused on equivalence, not safety,’ premarket approval is focused on safety, not equivalence.” The Court noted that: “State requirements are pre-empted under the MDA only to the extent that they are ‘different from, or in addition to’ the requirements imposed by federal law. Thus, §360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case ‘parallel,’ rather than add to, federal requirements.” However, in this particular case, the district court interpreted the claims to assert that the device violated state tort law notwithstanding compliance with the relevant federal requirements. See Riegl v. Medtronic, No.06-179, 2008 WL 440744 (Feb. 20, 2008).

U.S. Supreme Court Grants Cert in Third FDA Preemption Case. The U.S. Supreme Court granted certiorari to review the Vermont Supreme Court's decision in Levine v. Wyeth, No. 2004-384, 2006 WL 3041078 (Vt. Oct. 27, 2006), [discussed below], cert granted, No.06-1249 (Jan. 18, 2008).

U.S. House of Representatives Unanimously Rejects Preemption under Consumer Product Safety Act. By a vote of 407 to 0, the House reauthorized the Consumer Product Safety Commission and included statutory language specifically prohibiting the CPSC from issuing any rule or regulation that expands the scope of preemption. The Committee Report language disapproves the Commission's effort to preempt state law in preambles to proposed or final rules. The Report identifies the importance of “tort actions based on negligence” which the Committee notes “are predicated on procedures and standards developed over hundreds of years of American and English jurisprudence.” Hence: “The preemption provisions of the statutes under the jurisdiction of the CPSC are clear, and State common law actions and standards are not preempted.”

Preemption Argued to U.S. Supreme Court in Medical Device Case. The Federal Government, appearing in support of Medtronic, told the U.S. Supreme Court that medical devices approved by the FDA are broadly shielded from product-liability lawsuits, even if a company continues selling a device that it discovers may be improperly labeled. The U.S. and Medtronic argued that Federal Law only allows product liability lawsuits when a company fails to report problems with a device and someone is injured or killed because of the flaw. Otherwise, Congress meant to shield companies from lawsuits.
"Every time there is an accident or something bad happens the lawyers assert a design claim and gear up discovery," Justice Stephen Breyer said, adding he wonders if "Congress could have intended that kind of thing" when it was trying to create a uniform Federal approval process for medical devices. Several justices, including Justice Kennedy, posed several questions aimed at testing the limits of FDA authority over medical devices. For example, Kennedy asked if a company can be sued if it sells a device while simultaneously seeking "serious" labeling changes for it at the FDA. The case is: Riegel v. Medtronic, No.06-179 (argued Dec. 4, 2007).

The U.S. Government Files Amicus in Desiano in Support of Warner-Lambert and Preemption. The Solicitor General took the position that the Michigan statute at issue in Desiano/Kent (discussed infra) is preempted under the Buckman decision. See Brief of the United States as Amicus in Support of Petitions, Warner-Lambert v. Kent, No.06-1498 (filed Nov. 2007).

FDA Panel Acknowledges Serious Scientific Deficiencies and Inability to Respond to Current or Emerging Demands. A special subcommittee of the Food and Drug Administration concluded that "the scientific demands on the Agency far exceeds its capacity to respond. This imbalance is imposing a significant risk to the integrity of the food, drug, cosmetic and device regulatory system, and hence the safety of the public. FDA Science and Mission at Risk (Nov. 2007).

Fifth Circuit Finds No Preemption under Federal Motor Vehicle Safety Standard 205 in Rollover Case. The plaintiff was partially ejected from the passenger side window of a Tahoe during a low-speed quarter-rollover accident, and sued GM in Texas state court alleging that GM's use of tempered glass in the side windows was unreasonably dangerous and that the use of advanced glazing would have decreased the likelihood of passenger ejection. The U.S. Fifth Circuit found that FMVSS 205 is, on its face, a "materials standard that sets a safety 'floor' to ensure that the glazing materials used by manufacturers meet certain basic requirements." As to the frustration of some Federal policy, the Court found that the NHTSA Final Rule Commentary on FMVSS 205 is very different from the commentary on FMVSS 208 analyzed in Geier. "There is no language in the Glazing Materials Final Rule commentary indicating that NHTSA intended to 'preserve the option' of using tempered glass in side windows, or that preserving this option would serve the safety goals of FMVSS 205." Hence, the plaintiffs' common law claims were not preempted. See O'Hara v. General Motors, No.06-10498, 2007 WL 4105758 (5th Cir. Nov. 20, 2007).

Fifth Circuit Addresses "Superceding Cause" and Claims for "Negligence" in Upholding Jury Verdict under LPLA. Plaintiff, a production supervisor for Lockheed, was injured when the scaffolding on which he was standing partially collapsed. Visioneering designed and manufactured the scaffolding, referred to as the Unit 5 intertank platform, in accordance with a Statement of Work (SOW) that Lockheed provided to Visioneering. At trial, the jury found Visioneering 30% at fault and Lockheed 70% at fault. On appeal, Visioneering argued that the jury's finding of a "superceding or intervening cause" (namely the failure to perform point-load testing on the Unit 5 intertank platform) conflicts with the finding that Visioneering was 30% at fault. "A manufacturer of an unreasonably dangerous product will be relieved of liability" noted the U.S. Fifth Circuit Court of Appeals, in affirming the judgment, "only if an intervening cause superseded the original negligence and alone produced the injury. Foreseeable intervening forces are within the scope of the original risk and, therefore, will not relieve the manufacturer of liability. Visioneering's duty under the LPLA to provide intertank platforms without any unreasonably dangerous characteristics in design included the foreseeable risk that Lockheed would subsequently fail to perform the necessary point-load test, and that failure would lead to Paul Mazant's injury. As Visioneering contends, its failure to perform the point-load test may have been predicated on 'negligence,' but this 'negligence' occurred in the design phase, creating an unreasonably dangerous product under the LPLA. Therefore, the plaintiffs did not prevail based on a separate claim of negligence, apart from the LPLA, but instead under the LPLA by proving that the point-load test should have been performed as part of the design of the Unit 5 intertank platform." See Mazant v. Visioneering, Inc., No.06-30758, 2007 WL 2908082 (5th Cir. Oct. 4, 2007).

U.S. Supreme Court Grants Cert. in FDA Preemption Case. In Desiano, the U.S. Second Circuit Court of Appeals refused to apply Federal Preemption under Buckman with respect to product liability claims under Michigan Law against the makers of Rezulin. Under Michigan Law, a pharmaceutical manufacturer can escape liability where the drug is approved by the FDA, unless the defendant withheld or misrepresented material information that would have prevented approval. The exception to the immunity, the Second Circuit found, "cannot reasonably be characterized as a state's attempt to police fraud against the FDA." Moreover, "all of the claims advanced by Appellants in this case are premised on traditional duties between a product manufacturer and Michigan consumers. None of them derives from, or is based on, a newly-concocted duty between a manufacturer and a federal agency." Finally, "proof of fraud against the FDA is not even an element of a products liability claim like the one here brought. The existence of properly-obtained FDA approval becomes germane only if a defendant company chooses to assert an affirmative defense made available by the Michigan legislature." See Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006). However, the U.S. Supreme Court granted certiorari to review the decision. Warner-Lambert v. Kent, No.06-1498 (Sept. 25, 2007).

FDA Preamble, Preemption Rejected in Vioxx and Zyprexa MDLs. The MDL Judges in both Vioxx and Zyprexa have rejected the 2006 Preamble and Defendants' claims of preemption. As found by Judge Fallon: "The 2006 Final Rule does not carry the force of law and does not purport to interpret a specific statutory or regulatory provision" and hence "the Court will defer to the FDA's current views only to the extent that they have the 'power to persuade.'" As the FDA itself had consistently recognized that State Law claims could co-exist with Federal Regulation of prescription drugs up until January 24, 2006, "the agency's statements on preemption in the preamble to the 2006 Final Rule lack the 'power to persuade.'" See In re Vioxx Products Liability Litigation, MDL No. 1657, 2007 WL 1952964 (E.D.La. July 3, 2007); and, In re Zyprexa Products Liability Litigation, No. 04-MD-1596, 2007 WL 1678078 (E.D.N.Y. June 11, 2007).

The U.S. Supreme Court Rejects Philip Morris’ Claim of Preemption under the Federal Officer Removal Statute. Philip Morris has, with mixed success, removed suits relating to the design and marketing of “light” cigarettes to Federal Court based on the contention that they were operating under the dictates of the FTC; hence, the claims are effectively challenges against the Government’s method for testing and labeling cigarettes; and, therefore, because Philip Morris is simply carrying out the dictates of the Federal Government, the company was “acting under” an officer or agency of the U.S. for jurisdictional purposes, as provided in 28 U.S.C. 1442(a)(1). The U.S. Supreme Court, in a unanimous decision, rejected this argument. The Court rejected the argument that the company was analogous to a government contractor because a private contractor “is helping the government to produce an item that it needs. The assistance that private contractors provide federal officers goes beyond simple compliance with the law and helps officers fulfill other basic governmental tasks.” Addressing the issue of whether the FTC delegated the authority for testing tar and nicotine levels to the industry in 1987, the Court put aside, for the sake of argument, the fact that the plaintiffs were challenging the way in which Philip Morris designed its cigarettes, not the way in which it or others in the industry conducted cigarette testing. The Court then noted that “we have found no evidence of any delegation of legal authority from the FTC to the industry association to undertake testing on the Government agency’s behalf.” A private company’s “compliance (or noncompliance) with federal laws, rules, and regulations does not by itself fall within the scope of the statutory phrase ‘acting under’ a federal ‘official.’” See Watson v. Philip Morris, No. 05-1284 (June 11, 2007).

U.S. Supreme Court Asks for Position of Solicitor General in FDA Preemption Case. The Vermont Supreme Court held, in October of 2006, that the federal Food Drug and Cosmetic Act does not preempt state law tort claims for damages. Concluding that there was no conflict preemption, (as the drug manufacturer conceded that there was neither express preemption nor an intent by Congress to occupy the field, and as "the FDA and the state share the purpose of encouraging pharmaceutical companies to alter their drug labels when they are inadequate to protect consumers"), the court gave no deference to the January 2006 Preamble, in which the FDA purports to interpret the FDCA as preemptive. On Wyeth's application for certiorari from the U.S. Supreme Court, the Court, on May 21st, invited the Solicitor General to provide the position of the United States. See Levine v. Wyeth, No. 2004-384 (Vt. Oct. 27, 2006), petition for cert filed, No. 06-1249 (Mar. 12, 2007), Solicitor General invited to submit brief, 2007 WL 1461080 (May 21, 2007).

Louisiana Supreme Court Requires Case-Specific Evidentiary Basis to Support Failure to Warn Claim Under the LPLA. Relying on a 1991 appellate decision which concluded that the manufacturer of a hair product should have instructed the user to perform a preliminary allergy test before applying the product, plaintiff brought a failure to warn claim against a different manufacturer on the same basis. Reversing the verdict in favor of plaintiff, the Louisiana Supreme Court held that "the trial court erred in simply relying on the facts presented in Thomas v. Clairol, where such instructions were given, to find that Alberto-Culver should have also given an instruction, for the facts presented in that case provided no evidentiary factual basis to support the trial court's finding in this case." The Court notes that: "We do not imply the adoption of a per se rule that expert testimony is always necessary. Rather, we simply point out that no evidence was introduced to satisfy plaintiff's burden of proof." See Jack v. Alberto-Culver, USA, 2006-1883 (La. 2/22/07), 949 So.2d 1256.

Second Circuit, Applying Vermont Law, Allows Proof of Defect by Circumstantial Evidence. Following the Third Restatement on Torts, the Second Circuit predicted that the Vermont Supreme Court would adopt the "Malfunction Theory", according to which it "may be inferred that the harm sustained by the plaintiff was caused by a product defect existing at the time of sale or distribution, without proof of a specific defect, when the incident that harmed the plaintiff: (a) was of a kind that ordinarily occurs as a result of product defect; and (b) was not, in the particular case, solely the result of causes other than product defect existing at the time of sale or distribution." Because the district court should have taken into consideration plaintiffs' expert testimony that excluded all possible ignition sources aside from a defect in the coffee maker, summary judgment was reversed. Allstate v. Hamilton Beach, No. 04-6282, 2007 U.S.App.LEXIS 189 (2d Cir. Jan. 5, 2007). [Case further discussed on the "What's New in Spoliation and E-Discovery?" page.]

West Virginia Supreme Court Rejects Preemption under the Federal Mine Safety and Health Act. Workers who suffered from silicosis filed suit alleging that dust collection systems failed to protect them from silica dust released during operations, and that any warnings pertaining to silica dust were inadequate. The Supreme Court of West Virginia answered two certified questions: (1) Are state law negligence, product liability, and breach of warranty claims against manufacturers of roof bolter dust collection systems preempted by the Federal Mine Safety and Health Act? And (2) Are state law failure to warn claims against manufacturers of roof bolter dust collection systems preempted by the Act? Rejecting preemption on both counts, the Court notes that "Congress has clearly expressed its intent that states may adopt more stringent standards than those found in the Act. This Court must give effect to Congressional intent." Further, the Court recognized that "'the purpose of the Act is to protect the safety of the miner.' Quite frankly, it seems to us that enforcement of a more stringent standard governing dust collectors would have the effect of better protecting the health and safety of miners by further limiting the amount of respirable silica that they breathe while operating roof bolters." Finally, "while this Court agrees that compliance with federal standards is compelling evidence on the defendant's behalf in any state law claim, such claims are not completely foreclosed." See Davis v. Eagle Coal & Dock, No.33054, 2006 W.Va.LEXIS 144 (W.Va. Dec. 4, 2006).

Kentucky District Court Rejects FDA Preamble on Preemption. In a failure-to-warn case arising out of the use of the prescription drugs, Elidel and Protopic, Judge Hood noted that the FDA's position had been inconsistent, and concluded that, while "to the degree that the FDA seeks to address ambiguities in the FDCA or in its own regulations, we will give that opinion great weight. Where, however, the agency attempts to 'supply, on Congress's behalf, the clear legislative statement of intent required to overcome the presumption against preemption,' no deference is warranted." Then, looking to Sixth Circuit precedent, the court acknowledged that prescription drug failure-to-warn claims "premised on the adequacy of the warnings approved and reviewed by the FDA" would be preempted. However, "a state law requirement to provide an additional warning would not conflict with federal regulations." The court recognized that "a manufacturer can add or strengthen a warning without FDA approval so long as the warning does not render the label misleading. 21 C.F.R. § 314.70(c)(2), 21 U.S.C. § 352(a). If the manufacturer obtains new evidence regarding a risk the FDA previously found unsubstantiated, the manufacturer may still inform the FDA and seek approval for a new label. 21 C.F.R. § 314.70(b). Finally, the regulations encourage drug manufacturers to periodically send important information, including information regarding risks, to healthcare providers. Id. § 200.5.... In this case, At the time Elidel was prescribed for Philip Weiss, the FDA had not made a conclusive finding regarding a link between the use of topical calcineurin inhibitors and increased cancer risk. In addition, NPC could conceivably have possessed information not available to the FDA that they could have communicated to the FDA, to healthcare providers, or to patients, consistent with FDA regulations. Finally, state law failure-to-warn claims would not disrupt the FDA's regulatory scheme because FDA's regulations specifically provide avenues by which pharmaceutical companies may strengthen warnings following approval of the original label." Hence, the motion to dismiss was denied. See Weiss v. Fujisawa Pharmaceutical Co., No. 5:05-527, 2006 U.S.Dist.LEXIS 86179 (E.D.Ky. Nov. 28, 2006). [See also: In re Medtronic, No.05-MDL-1726, 2006 U.S. Dist. LEXIS 86199 (D.Minn. Nov. 28, 2006)(rejecting FDA preemption in MDA case).]

Fifth Circuit Reverses Defense Verdict Based on Exclusion of Similar Incidents. After a public bid, the plaintiff bought retrofitted spacers from the defendant manufacturer to improve the performance of its electrodialysis reversal system, which was designed to reduce the salinity of water taken from a lake. After the retrofit, the system experienced problems, causing water quality to decrease and, eventually, fires that forced the plaintiff to close its water plant down. On appeal, the court held that the district court erred in excluding evidence of similar fires at other facilities that used the same retrofitted system because Article 404(b) applies only to "persons" and not to inanimate objects; the error, the court found, was not harmless because the authority could have used the other fires to rebut the defense that the plaintiff's problems were caused by poor management. The district court also erred by barring evidence documenting the manufacturer's attempts to improve the retrofitted product because contractual, not tort, issues were being litigated, and the remedial measures were relevant to causation rather than culpability. See Brazos River Authority v. GE Ionics, 469 F.3d 416 (5th Cir. 2006).

Louisiana Supreme Court Indicates that Res Ipsa is Available under the LPLA. The plaintiff was injured when a driver's side airbag deployed after she honked the horn. The plaintiff's expert opined that a clock spring malfunctioned as a direct result of its misalignment at the factory. At trial, the jury found for the defendant, but the trial court, applying the doctrine of res ipsa, entered judgment for the plaintiff on JNOV. The defendant argued on appeal that res ipsa is not available under the LPLA, which requires the plaintiff to affirmatively prove that the product is defective. (See La.R.S. 9:2800.54(D).) While rejecting application in this particular case, (due to the removal of the spring by plaintiff's expert without marking the clock spring's position), the Supreme Court could "see no reason why a plaintiff cannot use circumstantial evidence in order to make the inference that a product was unreasonably dangerous when that product left a manufacturer's control.... The defective nature of a product will not be 'presumed' by utilizing this doctrine, but rather, 'it simply gives the plaintiff the right to place on the scales, 'along with proof of the accident and enough of the attending circumstances to invoke the rule.'" See Lawson v. Mitsubishi, 05-0257 (La. 9/6/06), 938 So.2d 35.

Fifth Circuit Affirms Exclusion of Crash Test Video. Ford appealed a plaintiff verdict in a Crown Victoria roof crush case. After rejecting Ford's argument that the plaintiff failed to prove that the car was in the same or substantially same condition as the time it left the manufacturer, (as the replaced windshield in question was not relevant to the plaintiff's design defect claim), the Fifth Circuit addressed Ford's argument that it should have been permitted to present crash test video to the jury in association with Ford's expert's testimony as a demonstrative aid. "When the demonstrative evidence is offered only as an illustration of general scientific principles, not as a reenactment of disputed events, it need not pass the substantial similarity test. Such demonstrative aids, however, must not be misleading in and of themselves, and one such way that a demonstration might mislead is when, as here, the demonstration resembles the disputed accident.... Ford characterized the CRIS test as essentially depicting Ford's theory of the accident, all the while maintaining that it was offered, not as a reenactment, but only to show general scientific principles.... The similarities between Ford's theory of the accident and the conditions of the CRIS test heighten the visual evidence's prejudicial effect, and this is sufficient to justify the district court's exercise of discretion in limiting Ford's expert to oral testimony only." See Muth v. Ford, 461 F.3d 557 (5th Cir. 2006).

California Court of Appeal finds Assumption of Risk Inapplicable to Design Defect which Increased Inherent Risk of Personal Watercraft. The plaintiff was injured while riding as a passenger in a two-seater personal watercraft when she fell off into the jet stream. The First Appellate District concluded that the doctrine of primary assumption of risk did not foreclose plaintiff’s design defect claim. The manufacturer had a duty to take reasonable steps to minimize inherent risks without altering the nature of the sport of jet skiing, (at least under circumstances where the risk of orifice injury posed the gravest danger). The very nature of the defect necessarily increased the likelihood that a passenger would fall rearward and suffer orifice injuries; and, hence, as a matter of law, the defect escalated the risk of harm beyond the inherent risk of falling into the water. Ford v. Polaris Industries, 139 Cal. App. 4th 755 (Cal. App. 1st Dist. 2006).

New York Appellate Division Outlines Appropriate Scope of Discovery in Tread Separation Cases. In a tread separation case against Cooper Tire, the court noted several previous instances of “wilful disobedience” and “bad faith”. After concluding that Cooper failed to carry its burden that the ingredients of the tire in question were “trade secrets”, the court further rejected the notion that the scope of disclosure should be limited to only those tires with the “same green tire specification” as the tire in question. “Tread separation problems” the court noted, “may be present in tires other than those sharing the same green tire specifications, and thus the scope of discovery in this case should include documents relating generally to the tread separation defect or problem. To rule otherwise would mean, as the plaintiffs assert, that Cooper Tire would not produce documents in which tread separation and foreign object contamination is discussed generally. For example, the plaintiffs point to Cooper Tire's communications with government agencies, or company documents where tread separation in tires made of the same materials but not same specifications has been analyzed. The plaintiffs maintain, and we agree, that such information is of ‘vital importance irrespective of the make of tire involved (since) it contains evidence of what Cooper Tire knew of belt and tread separations.’ As plaintiffs assert, to limit disclosure to ‘same green tire specifications’ rather than to tires with the same defect of tread separation is an ‘absurdity’ since Cooper Tire will be able to conceal documents probative on the issues of notice, defectiveness and dangerousness. For the same reasons, it would be absurd to limit disclosure to the same plant as the one where the subject tire was manufactured. We have held that disclosure on the issues of the manufacturer’s notice of the alleged product defect is an essential factor in products liability and negligence actions. Thus, the plaintiffs are entitled to pre-manufacture disclosure going back to 1985, which information is material and relevant on the issue of whether Cooper Tire had notice of the alleged defective condition that resulted in tread separation. The plaintiffs have established in the record that Cooper Tire proposed a settlement of 32 pending class actions and offered their customers a free replacement tire for every steel-belted radial manufactured between 1985 and 2001 that suffered tread separation as a result of a manufacturing defect. Therefore, the motion court's ruling that the only pre-manufacturing disclosure allowed was that relating to the subject tire's design, testing and manufacture for a period limited by the court is erroneous as is the ruling that denied plaintiffs discovery as to notice of defective conditions. Mann v. Cooper Tire, 816 N.Y.S.2d 45 (N.Y. App. Div. 1st Dept. 2006). [For further discussion, see: "What’s New in Spoliation and E-Discovery?"]

Fifth Circuit Affirms Dismissal of Suit Against Manufacturer of Aircraft Maintenance Dock under LPLA. Plaintiff, while working in the cargo area, fell from an aircraft maintenance dock which was designed for use on engines. The plaintiff alleged that the dock was unreasonably dangerous under the LPLA because the locking pins were the wrong size and because an adequate warning was not provided. The district court concluded that the plaintiff's use of the dock was not reasonably anticipated and that the danger of using the dock in the manner in which he did was obvious to an ordinary user. In an unpublished per curiam, the U.S. Fifth Circuit Court of Appeals affirmed. Ross v. Pourthau Indus., No. 05-30970, 2006 U.S. App. LEXIS 18901 (5th Cir. July 27, 2006).

District Court Refuses to Dismiss Products Case Due to Spoliation Where Airbags Were Removed and Lost by Junkyard. After a fatal accident, the survivors assigned the ownership of the vehicle over to the insurance company. The car was brought to a junkyard, where the airbags were apparently removed and placed in storage. Upon inspecting the vehicle, the plaintiff’s counsel advised the junkyard that the airbags needed to be retained for litigation. By the time suit was filed, and the defendants came to inspect the vehicle, the airbags had apparently been lost, sold, or destroyed. The court notes that the nature of the claim is important to the relevance of the evidence. “Clearly, if a product was manufactured defectively, its defect is likely to be particular to the individual product. Consequently, a party’s examination of that product may be critical to ascertaining, among other things, the presence of the defect. In design defect cases, however, a party’s examination of the individual product at issue may be of lesser importance as the design defect alleged can be seen in other samples of the product. Nevertheless, examination of the individual product in question may still be of significant import in certain design defect cases where, for example, the question whether the alleged defect or some other factor caused a particular injury is at issue.” While striking the testimony of plaintiff’s expert based upon his inspection of the vehicle, the court refused to dismiss the case. Perez v. Hyundai, 440 F.Supp.2d 57 (D.P.R. 2006). [For further disucssion, see "What's New in Spoliation and E-Discovery?"]

Tenth Circuit Allows Plaintiff to Raise Alteration Theory the Morning of Trial Where Defendant Springs Change in Position on the Plaintiff After the Close of Discovery. A painter was injured when he fell from an elevated platform. A series of pre-trial procedural maneuvers, and a settlement with the manufacturer on the eve of trial, left the plaintiff with only a failure to warn claim against the distributor at trial. The Tenth Circuit found that the district court erred in striking the painter’s alteration from the pretrial order. The court of appeal found that the painter’s reliance on his original pleading constituted an excusable delay, especially in light of the fact that defendant waited until discovery was closed to change its position regarding a key fact in the case. At the same time, the distributor’s claim of prejudice was rejected because its attempt to pin responsibility for the alteration on an upstream distributor is not a defense under Oklahoma products liability law. In its ruling, the Tenth Circuit recognized that the Federal Rules of Civil Procedure are designed “to put an end to the ‘sporting theory of justice,’ by which the result depends on the skill and strategy of counsel,” and, rather, “to facilitate a proper decision on the merits.” On a different note, the court of appeal indicated that evidence of the distributor’s subsequent repair work on the guardrail did not fall within the impeachment exception to Fed. R. Evid. 407. Minter v. Prime Equipment Co., 451 F.3d 1196 (10th Cir. 2006).

Seventh Circuit Affirms Dismissal of Case Against Goalpost Manufacturer under Indiana Products Liability Act in the Absence of Sufficient Cost-Benefit Analysis. The plaintiff was rendered a paraplegic when he joined a crowd to storm the field at the end of a football game and the goalpost fell on his back. (He was not pulling on the goalpost at the time it snapped.) The district court held it was obvious to a reasonable person that a collapsing goalpost posed a risk of serious injury. In affirming the decision, the Seventh Circuit noted that, although the “open and obvious” rule had been abrogated, obviousness remained a relevant inquiry because the question of what was unreasonably dangerous depended upon the reasonable expectations of consumers and expected uses. In addition, and in any event, it was the plaintiff’s burden under the Indiana Products Liability Act to show that the cost-benefit formula demanded adopting an alternative design. Affirming dismissal, the court explained that the plaintiff’s expert’s affidavit “is comprised of mere conclusions. For the premise that fans are unaware of the risks, he offers only speculation that social pressure and publicity falsely assure them that pulling down posts is safe. (Perhaps seeing the weakness, the Bournes contend simply that people would not rip down posts if they knew the risks.) As mentioned above, Adams’s suggestion that Gilman Gear’s change in aluminum alloy in 1985 made the product less safe is nothing but innuendo. Moreover, Adams does not provide a basis on which a finder of fact could evaluate the frequency of injuries caused by goalposts, or calculate the extent to which risk would actually be reduced by the alternative designs, or justify the cost of those alternatives relative to the benefits of aluminum posts. Although Gilman Gear points out such flaws, explaining that Adams’s affidavit actually proves the infrequency of injury relative to the number of games, the Bournes retort simply that Adams’s testimony was not meant to provide those statistics. As if unaware of their burden, they say neither statistics nor testing is required because the competitors actually sell safer (according to Adams) posts (although they are 38% to 700% more expensive). But that will not do: mere existence of a safer product is not sufficient to establish liability.” Bourne v. Marty Gilman Inc., 452 F.3d 632 (7th Cir. 2006).

An Attorney in a Product Liability Suit was Sanctioned $13,691.50 for Violating a Protective Order. McDonald v. Cooper Tire & Rubber Co., 186 Fed.Appx. 930, 2006 U.S. App. LEXIS 16537 (11th Cir. June 28, 2006).

District Court in Pennsylvania Finds Failure to Warn Claims Preempted Based on the new FDA Preemption Preamble and Amicus Brief. In a case brought by surviving spouse against the makers of Paxil and its generic equivalent for failure to warn of increased risk of suicide, Judge Baylson of the Eastern Distrit of Pennsylvania found implied preemption based upon the approval of the FDA. In an amicus brief filed by the FDA in the case, as well as the 2006 "Preemption Preamble" [see 71 Fed. Register 3934-3925, discussed below], the FDA specifically rejected the notions that: (i) the FDCA imposes only minimum standards for labeling, and (ii) drug manufacturers have the ability to strengthen warnings without FDA approval. Disputing the argument that 21 C.F.R. 314.70(c) permits a manufacturer to strengthen a warning unilaterally, the FDA took the position that the dissemination of unsupported warnings "would deprive patients of efficacious treatment, thereby chilling the drug's otherwise beneficial use." While concluding that the Preamble was "interpretive" and could therefore be applied retroactively, the court noted that, given the amicus brief, prospective-only application of the Preamble would not change the result. It is not clear to what extent the decision is limited by the case-specific aspects: (a) that the agency had repeatedly determined that there was inadequate evidence of an association between adult use of SSRIs and suicidality, hence such a warning would have (arguably) been “false and misleading”; and/or, (b) at least with respect to the generic manufacturer, that this defendant was required to use the same warning label as the brand namufacturer, under the relaxed approval standards of the Hatch-Waxman Amendments. Additional claims sounding in negligence and strict liability were dismissed on other grounds. See Colacicco v. Apotex, 432 F.Supp.2d 514 (E.D.Pa. 2006).

California Court of Appeal Rejects Assumption of Risk from Off-Road Collision with Underage Operator of ATV. The defendant bought a Honda 400 EX for off-roading use by his son Matthew, then age 12. In February of 2003, the defendant took Matthew, then 14, to the Glamis sand dunes, to ride the Honda ATV. While out of Wilkins's view, Matthew drove the Honda up a blind hill at the same time Huff, the plaintiff, was approaching the hill on his ATV from the other side. The Honda flew over the crest of the hill, and while airborne, collided with Huff. Matthew apologized for the accident and said he was "out of control." Huff sustained serious injuries, and he sued Matthew and Wilkins for negligent driving and negligent entrustment, respectively. The primary assumption of risk doctrine was rejected. "Although a collision between ATVs was an inherent risk of the sport of off-roading, Matthew's failure to comply with the safety regulations was not an inherent risk, and to any extent the failure increased the risk of a collision, Huff did not assume the increased risk merely by participating in the sport." See Huff v. Wilkins, 138 Cal.App.4th 732 (Cal. 4th App. Dist. 2006).

Louisiana Court of Appeal Rejects Preemption under the Toxic Substances Control Act. The Louisiana Third Circuit Court of Appeal held that a personal injury suit under the LPLA was not pre-empted by the Federal Toxic Substances Control Act, 15 U.S.C. 2601, et seq. The court held that, because this case does not involve creation of testing requirements, preemption is only applicable where (1) a regulation imposed by the Environmental Protection Agency binds defendants, and (2) the state action constitutes a non-exempt requirement designed to protect against a risk of injury. The court reasoned that the first requirement was not satisfied because "the EPA regulates the permissible risk of exposure to PCBs, not the specific manner in which that risk is minimized. There are no requirements, such as design or use of particular materials, provided in the regulations. The lack of such language indicates that the act does not seek to regulate these considerations, leaving that task to the states." Stewart v. Rheem Mfg. Co., No. 05-726 (La. App. 3 Cir. 3/29/06), 926 So.2d 90.

New Jersey Court Rejects Application of Michigan Products Liability Act where Drugs are Manufactured in New Jersey. Robert Rowe, who lives in Michigan, became severely depressed and attempted suicide several times after his dermatologist prescribed Accutane. Rowe brought suit in New Jersey, where the drug was manufactured by Hoffmann-La Roche. The defendants sought to apply the Michigan Products Liability Act, which creates an irrebuttable presumption that a warning label approved by the FDA is adequate as a matter of law. See M.C.L. §§600.2946(5). The Superior Court of New Jersey Appellate Division, however, applied the New Jersey Products Liability Act, which provides only a rebuttable presumption that an FDA-approved warning is adequate. See N.J.S.A. 2A:58C-4. In conducting its choice-of-law analysis, the Court initially noted that “the goal of deterrence, acknowledged generally to be part of tort law, is especially important in the field of products-liability law.” The Court then went on to observe that “it is difficult to see how Michigan’s interest in protecting Michigan drug manufacturers would be furthered by applying its immunity statute to this case. Likewise, it is difficult to see that Michigan has any interest in protecting out-of-state manufacturers like defendants here. The motion judge’s finding that the primary purpose of the Michigan statute is to increase drug availability in Michigan is unsupported by the record. If in fact there was a shortage of drugs in Michigan at the time the statute was enacted, no evidence of such a shortage appears in the record before us. We know of no instance, and none has been cited to us, when a drug manufacturer has withheld distribution or sales of its product on account of any state's products liability law.” The Court also considered “the compensation aspect of governmental interest analysis in this tort case, and we perceive no Michigan interest in depriving its resident of recovery. We might view plaintiff’s home state interest differently if we were confronted with a conflict of laws related to plaintiff's own role in causing the injury, such as laws of contributory or comparative negligence” as “such a conflict would implicate the deterrence aspect of tort law as it relates both to plaintiff and defendant.” In sum, “the quality of New Jersey’s contacts in this case, when combined with its strong governmental interest in deterring the manufacture of unsafe products within its borders, substantially outweighs the countervailing Michigan contacts and governmental interests in application of the Michigan statute. Both deterrence and compensation are interests more likely to be served in this case by application of New Jersey law.” Rowe v. Hoffman-La Roche, 383 N.J.Super. 442 (App. Div. 2006).

FDA Attempts to Preempt Lawsuits Against Drug Manufacturers with Preamble to New Labeling Rules. “The FDA believes that at least the following claims would be preempted by its regulation of prescription drug labeling: (1) Claims that a drug sponsor breached an obligation to warn by failing to put in Highlights or otherwise emphasize any information the substance of which appears anywhere in the labeling; (2) claims that a drug sponsor breached an obligation to warn by failing to include in an advertisement any information the substance of which appears anywhere in the labeling, in those cases where a drug’s sponsor has used Highlights consistently with FDA draft guidance regarding the ‘brief summary’ in direct-to-consumer advertising; (3) claims that a sponsor breached an obligation to warn by failing to include contraindications or warnings that are not supported by evidence that meets the standards set forth in this rule, including §§ 201.57(c)(5) (requiring that contraindications reflect ‘known hazards and not theoretical possibilities’) and (c)(7); (4) claims that a drug sponsor breached an obligation to warn by failing to include a statement in labeling or in advertising, the substance of which had been proposed to FDA for inclusion in labeling, if that statement was not required by FDA at the time plaintiff claims the sponsor had an obligation to warn (unless FDA has made a finding that the sponsor withheld material information relating to the proposed warning before plaintiff claims the sponsor had the obligation to warn); (5) claims that a drug sponsor breached an obligation to warn by failing to include in labeling or in advertising a statement the substance of which FDA has prohibited in labeling or advertising; and (6) claims that a drug's sponsor breached an obligation to plaintiff by making statements that FDA approved for inclusion in the drug's label (unless FDA has made a finding that the sponsor withheld material information relating to the statement). Preemption would include not only claims against manufacturers as described above, but also against health care practitioners for claims related to dissemination of risk information to patients beyond what is included in the labeling.” See Requirements on Content and Format of Labeling Human Prescription Drug and Biological Products, 71 Fed. Register 3922, 3935-3936 (Jan. 24, 2006).

Second Circuit Reverses Dismissal of Product Liability Action due to Misapplication of the Discovery Rule. The plaintiff had hip replacement surgery in 1994. Due to the premature failure of the prosthesis, he suffered pain and other problems and was required to undergo a revision surgery to replace a part of the prosthesis in 1996. Plaintiff was informed by a treating physician that the original prosthesis was the subject of various product defect claims in 2001, and filed suit in 2002. The district court dismissed the product liability claim as barred under Connecticut’s three-year statute of limitations, concluding that, based on the revision surgery in 1996, and publicly available information published in medical journals in 1997, plaintiff, with a diligent effort, “could” have discovered her cause of action no later than 1998. The court of appeal reversed. “When determining whether a plaintiff failed to exercise ‘reasonable care’ in discovering a claim, the inquiry is not when the injury could have been discovered; rather, it is when the injury should have been discovered.” Bogdan v. Zimmer, Inc., No. 05-2087, 165 Fed. Appx. 883 (2d Cir. 2006).

Punitive Damage Award Reduced in Claim Against Chrysler for Defective B-Pillar in Pick-Up Truck. After the widow's husband was killed in an automobile accident, she sued the manufacturer the pickup truck that her husband had been driving, claiming that the truck was defectively and negligently designed. The jury agreed and awarded the widow $ 235,629 in compensatory damages and $ 3 million in punitive damages. On appeal, the court held that the punitive damages award was constitutionally excessive and that an award approximately equal to twice the amount of compensatory damages would comport with the requirements of due process. An application of the Gore guideposts revealed that: (1) the manufacturer's misconduct did not constitute a high degree of reprehensibility, because (a) there was no evidence that a boxed-in or supported B-pillar would have prevented the harm suffered by the husband; (b) there was a good faith dispute over whether B-pillar testing was necessary; and (c) the manufacturer's wealth had no connection to the harm suffered by the husband; (2) the ratio of punitive to compensatory damages, 13 to 1, was unjustifiably large; and (3) a wide gap existed between the punitive damage award and comparable civil penalties under 49 U.S.C.S. §§ 30165(a). Clark v. Chrysler Corp., 436 F.3d 594 (6th Cir. 2006).

Under Tennessee Law, Sixth Circuit Finds that a Forklift is a Complex Industrial Machine which Must be Evaluated under a Prudent Manufacturer Test. Plaintiff was driving his forklift along an east-west corridor at the Quebecor plant when he collided with a forklift operated by a co-worker. Brown alleged that Raymond had sold the forklift in a defective and unreasonably dangerous condition, that Raymond had provided inadequate warnings, and that the brakes were not working properly at the time of the accident. Interpreting the TPLA and the caselaw construing it, the district court concluded that only the prudent-manufacturer test--not the consumer-expectation test--applied in assessing the dangerousness of a forklift, which is a complex industrial machine. Because expert testimony was necessary to prove a prima facie case under that test and because the testimony of Brown's experts had been excluded, the district court granted partial summary judgment in favor of Raymond on the defective-design and inadequate-warning claims. The Sixth Circuit rejected the plaintiff’s argument that even complex products have simple aspects to them. The Tennessee Supreme Court’s recent decision in Brown v. Crown Equip. “helpfully clarifies that a forklift is a complex machine whose safety is best evaluated using the prudent-manufacturer test – a test under which expert testimony is required in order to reach the jury.” Brown v. Raymond Corp., 432 F.3d 640 (6th Cir. 2005).

New Supreme Court Justice Samuel Alito has participated in various products liability related decisions. Judge Alito was the author of Forrest v. Beloit Corp., 424 F.3d 344, 362 (3rd Cir. 2005) (Alito, J., concurring) (agreeing that plaintiff was entitled to new trial due to improper admission of evidence regarding the absence of prior accidents at the plant in question); and, John Wyeth & Brother, Ltd. v. CIGNA, 119 F.3d 1070 (3rd Cir. 1997) (upholding a forum-selection clause requiring Wyeth to litigate coverage issues arising out of Ativan in England). Judge Alito also participated in Jones v. Toyota Motor Sales, 94 Fed. Appx. 879 (3rd Cir. 2004) (affirming summary judgment in crashworthiness case in absence of expert testimony to support design defect claim involving issues beyond the ordinary comprehension of layman); and, City of Philadelphia v. Berretta, 277 F.3d 415 (3rd Cir. 2002) and Camden County v. Berretta, 273 F.3d 536 (3rd Cir. 2002) (affirming dismissal of nuisance actions by city and county against gun manufacturers).

Indiana Court Rules that a Pharmacy Has No Duty to Warn. A man sued his pharmacy for failing to provide appropriate product information or warnings about adverse effects. The medication was prescribed by the plaintiff’s treating physician, and the Third District Indiana Court of Appeals followed the “majority” view that there was no duty to warn. Quoting from an earlier decision, the court reasoned that: “The duty to warn of hazards associated with prescription drugs is part and parcel of the physician-patient relationship because it is best appreciated in this context. The decision of weighing the benefits of a medication against potential dangers that are associated with it requires an individualized medical judgment. This individualized treatment is available in the context of a physician-patient relationship which has the benefits of medical history and extensive medical examinations. It is not present, however, in the context of a pharmacist filling a prescription for a retail customer. The injection of a third-party in the form of a pharmacist into the physician-patient relationship could undercut the effectiveness of the ongoing medical treatment. We perceive the better rule to be one which places the duty to warn of the hazards of the drug on the prescribing physician and requires of the pharmacist only that he include those warnings found in the prescription.” Alberry v. Parkmor Drug, 834 N.E.2d 199, 202 (Ind. Ct. App. 2005).

Firearms Immunity Goes Into Effect. Congress has enacted and the President has signed the “Protection of Lawful Commerce in Arms Act” which generally bars any civil action (or administrative proceeding) in State or Federal Court brought by any person against a seller or manufacturer of firearms or ammunition for damages or other remedies resulting from the criminal or unlawful misuse of such a product by the person or a third party. See 15 U.S.C. §7901, et seq.

NHTSA proposes rule which purports to pre-empt state law. In August, the NHTSA proposed new rulemaking for roof crush standards. Although there are marginal increases in the proposed strength requirements, the Administration also included a provision which would prohibit lawsuits where the manufacturer complies with the minimum standards. See Llaurado, Litigation In Brief, AIEG, Vol. 13, No. 4 (2005); citing, Federal Motor Vehicle Safety Standards: Roof Crush Resistance, Docket No. NHTSA-2005-22143, 49 C.F.R. 571 (2005).

Louisiana Court of Appeal Holds that Recall Notice is Admissible in Design Defect Case. A used Ford caught on fire, and the insurer was subrogated to the rights of the car-owner. State Farm, as subrogree, filed an action against Ford under the LPLA. The trial court found for the plaintiff, and the First Circuit affirmed. “If the service recall bulletin had dealt with a different model year or involved a different type of speed control deactivation switch, we would conclude the trial court erred in allowing the bulletin's admission. In this case, however, the recall campaign involves the same speed control deactivation switch and the same vehicle model as Stephens’ vehicle.... Because Ford denies that the speed control deactivation switch caused the fire, any evidence tending to establish that the switch was defective and could have caused the fire is relevant. Additionally, State Farm relies on the service recall bulletin in part to establish that the switch was unreasonably dangerous in design; the fact that this component may have been the cause of fires in other 1992 Town Cars is part of that proof. Accordingly, we find no abuse of discretion.” State Farm v. Ford Motor Co., No. 2004-1311, 2005 La.App.LEXIS 2186 (La. App. 1st Cir. 6/15/05).

Korean statute of repose bars third-party claims by cargo owners arising out of casualty aboard a Panamanian vessel on a voyage from France to the United States. In 1985, Hyundai added a section to a Swedish vessel through Lloyds per contract governed by English law. The addition and subsequent repairs were performed by Hyundai in Korea. Subsequently, the vessel was purchased by a Panamanian firm, and eventually “hogged” on a voyage from France to the U.S. The shipowner brought a limitation-of-liability proceeding in the Southern District of New York, and the cargo owners asserted third-party claims against Hyundai. Applying the Lauritzen factors, the court observed that neither the law of the flag nor the shipowner’s base of operations were relevant, as the shipowner was not a party to the action. The court also rejected the relevance of the contract, as claims under COGSA are not necessarily breach of contract claims, but can be mixed claims of tort, contract and bailment law. Particularly where the citizenship of the parties pointed to no clear venue, the court applied the law where the repairs had occurred. “The place of the alleged wrongful act that gave rise to the liability is Korea, where the welding was performed. The cargo interests contend that the place of the wrongful act is the location of the casualty, that is, the Atlantic Ocean. But we have held that the place of the wrongful act is not where the vessel sinks, but where the negligence occurs. The reason for this rule is not difficult to discern because it is the state where the negligence occurs that has the greatest interest in regulating the behavior of the parties.” Therefore, Korea’s 10-year statute of repose on product liability claims barred the plaintiffs’ claims. See Rationis Enters. of Panama v. Hyundai, No. 04-4267, 2005 U.S. App. LEXIS 22323 (2d Cir. Oct. 17, 2005).

Former Supreme Court nominee Harriet Miers is noted advocate for tort reform. As noted in Business Week, “One segment of American society is cheering the appointment of Harriet Meyers: Big Business. The addition of Roberts, who spent years as a corporate litigator, was heartening to them. The prospect of Miers, who has defended the likes of Microsoft Corp. and Walt Disney Co. and has been a leading advocate for tort reform, has many executives downright giddy.” On the front lines of the tort reform revolution in Texas, Miers supported Nathan Hecht for the Texas Supreme Court in 1988, and Raul Gonzalez in 1994. Miers was then hired by the Texas Civil Justice League to lobby for punitive damage caps and limitations on medical malpractice claims. “In recent years, as the top White House lawyer, Miers has been intimately involved in the Administration’s drive to limit jury awards, create an asbestos claim trust fund, and pass business-friendly rules for class actions. In April she spoke at an annual meeting of the American Tort Reform Association, delivering a crowd-pleasing rallying cry to take on the plaintiffs’ lawyers.” See Woellert, “Business May Get More Days in Court” Business Week, Oct. 17, 2005, p.44.

Eleventh Circuit finds adverse inference insufficient where owner allows vehicle to be sold for salvage prior to inspection in crashworthiness suit. Following an accident in 1996, the plaintiff’s counsel sent a letter to Daimler Chrysler notifying Daimler Chrysler of the accident and of the airbag’s failure to deploy. Daimler Chrysler replied to Flury's letter, requesting the location of the vehicle for inspection purposes. Flury’s counsel never responded to the letter. Around six months later, the vehicle was sold off by the plaintiff’s insurance carrier as scrap. Years later, the plaintiff filed suit. The district court instructed the jury to apply a rebuttable presumption that the evidence not preserved was unfavorable to the party responsible for spoliation. The Eleventh Circuit reversed, finding that no remedy short of dismissal would suffice. See Flury v. Daimler Chrysler, 2005 U.S. App. LEXIS 21515 (11th Cir. Oct. 5, 2005).

California Supreme Court adopts “delayed discovery” rule to extend the statute of limitations in medical products claim. Brandi Fox filed a medical malpractice claim arising out of severe complications from gastric bypass surgery. During the course of discovery, the plaintiff learned that one of the devices had failed during the procedure, and attempted to add the manufacturer. The court applied a “delayed-discovery rule” under which the statute of limitations does not begin to run on a subsequent claim if the plaintiff pleads and proves that reasonable investigation at the time of initial discovery would not have revealed a factual basis for that particular cause of action. “As the allegations in this case illustrate, diligent plaintiff's investigation may only disclose an action for one type of tort (e.g., medical malpractice) and facts supporting an entirely different type of tort action (e.g., products liability) may, through no fault of the plaintiff, only come to light at a later date. Although both claims seek to redress the same physical injury to the plaintiff, they are based on two distinct types of wrongdoing and should be treated separately in that regard.” Fox v. Ethicon Endo-Surgery Inc., 110 P.3d 914, 925 (Cal. 2005).

Wisconsin Supreme Court holds that lead paint manufacturers can be liable under a “risk-contribution” theory. The court first rejected the manufacturers’ curious argument that (because the plaintiffs allegedly had an “adequate remedy” against their landlords) the Constitution barred the plaintiffs’ claim against them, and then concluded that lead paint compounds were factually similar enough to DES that the market-share-type “risk-contribution” approach adopted in Collins v. Eli Lilly, 342 N.W.2d 37 (Wis. 1984), could be utilized in the establishment of lead poisoning claims. Thomas v. Mallett, No. 2003AP1528, 2005 Wisc. LEXIS 397 (Wis. July 15, 2005).

Maryland court finds that PPI can form the basis of a breach of express warranty claim. Ordinarily, under Maryland Law, the pharmacist-patient relationship does not give rise to a duty to warn of potential adverse consequences of prescribed drugs. However, when a pharmacy chooses to develop and distribute a Patient Package Insert ("PPI"), the representations can form the basis of an express warranty. (In addition, the court rejected claims of preemption by the FDA.) Rite Aid Corp. v. Levy-Gray, 876 A.2d 115 (Md. Ct. Sp. App. 2005).

Manufacturer of oil drum installed in a production line could not invoke statute of repose relating to improvements to real property. Plaintiff was injured in 2001 by an oil drum that had been installed in 1987. The district court found that the base coating line was an improvement to real property, and that the manufacturer was thus entitled to Oklahoma’s 10-year statute of repose. The Tenth Circuit reversed, noting a general distinction between pre-fabricated mass-produced products, on the one hand, and those components which are unique in design and manufactured to fit the specifications of a particular location, on the other. Then, applying a multi-part test, (tax treatment, ownership, permanence, value enhancement, and intent), the Court concluded that the production line machinery was not an “improvement to real property” subject to the statute of repose. Durham v. Herbert Olbrich, 404 F.3d 1249 (10th Cir. 2005).

District Court rejects Pfizer claims of preemption in Zoloft suicide case. The survivor of a man who committed suicide sued Pfizer alleging its drug Zoloft contributed to his death. Pfizer argued that the failure-to-warn claims were preempted. Rejecting the manufacturer’s claims of express preemption, Judge Rosenbaum observed that “FDA regulations explicitly permitted defendant to unilaterally strengthen its warning label at any time without regulatory pre-approval. 21 C.F.R. §§ 314.70(c)(6)(iii)(A). This particular regulation was promulgated precisely to allow drug-makers to quickly strengthen label warnings when evidence of new side effects are discovered. See 30 Fed. Reg. 993 (Jan. 30, 1965). Thus, as the FDA has noted, the regulation ‘permits the addition to the drug's labeling or advertising of information about a hazard without advance approval’ by the FDA. 44 Fed. Reg. 37447 (June 26, 1979).” Then rejecting claims of express preemption, (i.e. a warning would have frustrated Congress’ goal of ensuring the scientific validity of drug label information; the viability of State Law failure-to-warn laws pressures drug manufacturers to paper their labels with unsubstantiated warnings in order to avoid lawsuits), the court found it “obvious” that state failure-to-warn claims “do not pressure manufacturers to include false or invalid warnings. Instead, they give drug manufacturers every incentive to warn of real, known risks as soon as they are discovered - even before any FDA action.” Indeed, the regulation “underscores the crucial flaw in defendant’s argument: Congress certainly did not intend to bar drug companies from protecting the public when enacting the FDCA; its goal was to protect the public.” Witczak v. Pfizer, 377 F.Supp.2d 726 (D.Minn. 2005).

Chief Justice John Roberts has represented PhRMA and Chrysler Corp. As an attorney, Roberts represented the Pharmaceutical Research Manufacturers of America (“PhRMA”) in challenge to Maine’s program offering a discount on prescription drugs to low-income citizens, see PhRMA v. Thompson, 313 F.3d 600 (D.C.Cir. 2002), and Chrysler Corp. against the NTSB regarding the recall of 91,000 vehicles due to non-compliance with Federal Regulations governing seat-belt anchorages, see U.S. v. Chrylser Corp., 158 F.3d 1350 (D.C.Cir. 1998).

Ninth Circuit holds that website intake from potential clients is not subject to disclosure. Granting a mandamus in an action where attorneys were compelled to turn over initial responses by clients on the Internet in suit against the makers of Paxil, the court re-affirmed the principle that the attorney-client privilege extends to initial consultations, even where the attorney and client acknowledge that no formal attorney-client relationship has been established. “Potential clients must be able to tell their lawyers their private business without fear of disclosure, in order for their lawyers to obtain honest accounts on which they may base sound advice and skillful advocacy. There would be no room for confusion had the communication been in the traditional context of a potential client going into a lawyer's office and talking to the lawyer. The changes in law and technology that allow lawyers to solicit clients on the Internet and receive communications from thousands of potential clients cheaply and quickly do not change the applicable principles.” See Barton v. SmithKline Beecham, 410 F.3d 1104 (9th Cir. 2005).

Florida Court of Appeal rules that pharmacists can be liable for the negligent filling of prescriptions. Despite the Florida Supreme Court's ruling in McLoed v. W.S. Morrell that a retail druggist who fills a lawful prescription of a medical doctor with an unadulterated compound cannot be held strictly liable for breach of implied warranty, an intermediate appellate court held, on June 1, 2005, that a pharmacist could be held liable for his or her negligence, such as the failure to warn customers of the risks inherent in filling certain repeated prescriptions. Powers v. Thobani, No. 4D04-2061, 2005 Fla. App. LEXIS 8384 (Fla. 4th DCA June 1, 2005). [Citing, e.g., Dee v. Wal-Mart, 878 So.2d 426, 427 (Fla. 1st DCA 2004); Riff v. Morgan Pharmacy, 353 Pa.Super. 21, 508 A.2d 1247 (1986); Pittman v. Upjohn Co., 890 S.W.2d 425, 434 (Tenn. 1994). But see: Estate of Sharp v. Omnicare, Inc., 879 So.2d 34, 35 (Fla. 5th DCA 2004); Morgan v. Wal-Mart, 30 S.W.3d 455, 466-469 (Tex. Ct. App. 2000).]

High Court rejects preemption of state law tort claims under FIFRA. Peanut farmers brought claims against Dow alleging that its Strongarm pesticide stunted the growth of their peanut plants, despite the EPA-approved label which originally advertised that "Use of Strongarm is recommended in all places where peanuts are grown." Apparently, after the plaintiffs first complained, Dow investigated, the label was subsequently changed (with approval by the EPA) to advise purchasers not to apply Strongarm to areas with pH of 7.2 or greater. Plaintiffs, however, alleging that Dow knew or should have known from the start that the pesticide would not be appropriate for their soil, sued for fraud, breach of warranty, and violation of the Texas DTPA. Dow argued that such claims were preempted under the Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA"), which provides that States "shall not impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under this subchapter." 7 U.S.C. §136v(b). Rejecting Dow's claims, the Supreme Court noted that, "for a particular state rule to be pre-empted, it must satisfy two conditions. First, it must be a requirement 'for labeling or packaging'.... Second, it must impose a labeling or packaging requirement that is 'in addition to or different from those required under this subchapter.' A state regulation requiring the word 'poison' to appear in red letters, for instance, would not be pre-empted if an EPA regulation imposed the same requirement.... Rules that require manufacturers to design reasonably safe products, to use due care in conducting appropriate testing of their products, to market products free of manufacturing defects, and to honor their express warranties or other contractual commitments plainly do not qualify as requirements for 'labeling or packaging.' None of these common-law rules requires that manufacturers label or package their products in any particular way. Thus, petitioners' claims for defective design, defective manufacture, negligent testing, and breach of express warranty are not pre-empted." Although the express warranty was part of the product's label, the Court, following its earlier decision in Cipollone, reaffirmed the principle that a cause of action for breach of an express warranty is not a requirement imposed under State Law, but "asks only that a manufacturer make good on the contractual commitment that it voluntarily undertook by placing that warranty on its product." The Court also rejected Dow's argument for preemption on policy grounds, noting that "private remedies that enforce federal misbranding requirements would seem to aid, rather than hinder, the functioning of FIFRA. Unlike the cigarette labeling law at issue in Cipollone, which prescribed certain immutable warning statements, FIFRA contemplates that pesticide labels will evolve over time, as manufacturers gain more information about their products' performance in diverse settings." At the same time, the Court providing the following guidance to lower courts: "In undertaking a pre-emption analysis at the pleadings stage of a case, a court should bear in mind the concept of equivalence. To survive pre-emption, the state-law requirement need not be phrased in the identical language as its corresponding FIFRA requirement; indeed, it would be surprising if a common-law requirement used the same phraseology as FIFRA. If a case proceeds to trial, the court's jury instructions must ensure that nominally equivalent labeling requirements are genuinely equivalent. If a defendant so requests, a court should instruct the jury on the relevant FIFRA misbranding standards, as well as any regulations that add content to those standards. For a manufacturer should not be held liable under a state labeling requirement subject to §§136v(b) unless the manufacturer is also liable for misbranding as defined by FIFRA." Bates v. Dow Argosciences, LLC, 125 S.Ct. 1788, 161 L.Ed.2d 687 (2005).

U.S. Fifth Circuit reverses verdict under the LPLA where plaintiff failed to prove – by direct evidence, with direct and specific expert testimony – that his injuries would have been more severe had the defendant's airbag deployed in collision. Driver whose head hit steering wheel during collision successfully established breach of express warranty under the LPLA. The court, however, reversed the jury award on the basis that plaintiff failed to satisfy the "proximate causation" requirement that "he sustained more severe injuries than he would have received if the air bag had deployed." Curiously, the Court found expert testimony that "the deployment of the air bag would probably have prevented Caboni's head from hitting the steering wheel" insufficient. "Caboni" the Court explained, "believes that a reasonable jury could infer that, because his head would not have hit the steering wheel had the air bag deployed, he would have suffered less severe injuries. Caboni is wrong in stating that he does not have to present expert testimony to specifically state that he sustained more severe injuries than he would have received if the air bag had deployed because the jury could reach this conclusion based on the evidence in its entirety. Whether or not the failure of the driver's side air bag to deploy 'enhanced' plaintiff's injuries, is not a part of the everyday experience of the consuming public" and therefore "reasonable jurors could not arrive at a verdict against GM." Caboni v. GMC, 398 F.3d 357 (5th Cir. 2005).

Texas District Court rules that the FDCA does not preempt state failure-to-warn claims. The estate and heirs of Bethany Cartwright sued Pfizer, alleging that it's anti-depressant drug Zoloft caused her to commit suicide. Denying the defendant's motion to dismiss, the court noted that the FDA's regulations "merely set minimum standards with which manufacturers must comply" and "expressly do not prohibit a manufacturer from 'adding [to] or strengthening a contraindication, warning, precaution, or adverse reaction.'" 21 C.F.R. §314.70(c)(6)(iii)(A). This provision, the court noted, together with 21 C.F.R. §201.57(e), make it clear that "manufacturers, not the FDA, are tasked with the responsibility of taking proactive steps once a manufacturer learns of 'reasonable evidence of an association of a serious hazard with a drug.'" With respect to Zoloft in particular, Judge Steger opined that: "Given the hearings by both Congress and the FDA regarding suicidality, the FDA's PDAC's recent decision to recommend black box warnings regarding suicidality in children and adolescents, and the numerous experts who have concluded that there is a link between SSRIs, like Zoloft, and suicidality, it would be inconceivable to this Court to argue that an additional warning regarding suicidality would be false or misleading." Rejecting, further, the argument that Texas tort law would somehow "interfere" with the FDA's objective of ensuring that all warnings are supported by scientific evidence, the court concluded that "Texas law compliments and is parallel to the FDA's regulations," as "the FDA's objective, as expressed through its regulations, demonstrate that manufacturers should provide consumers with all the safety information about their drugs as soon as the information is known, which is exactly what Texas law requires." Cartwright v. Pfizer, Inc., No. 6:04cv292, 2005 U.S.Dist.LEXIS 5599 (E.D.Tex. March 31, 2005).

Fifth Circuit rules that expert testimony is not required in defective design case against forklift manufacturer. The plaintiff was injured while operating a Crown "stand-up" forklift when, in an effort to avoid a collision with another forklift, she applied her brakes, causing her left foot to swing out of the unenclosed operator compartment, where it was crushed between the two machines as they collided. She brought suit against Crown under the LPLA, claiming that the lack of a door to the operator compartment of the stand-up forklift constitutes a design defect. The district court granted Crown's motion in limine to exclude her expert witness due to her failure to meet discovery deadlines, but denied the defendant's motion foe summary judgment, concluding that an unassisted trier-of-fact would be capable of understanding whether a door should have been incorporated into the forklift. The U.S. Fifth Circuit Court of Appeals affirmed. "Crown's argument is that, as a matter of statutory interpretation, the LPLA requires expert testimony in every instance in which a design defect is alleged. We are unable to agree.... No language or provision of the statute requires that a cause of action alleging a design defect must, as a matter of law, be supported by expert testimony. To the extent the statute allocates burdens of proof or production, it simply states that 'the claimant has the burden of proving the elements of [his or her claim].'" Malbrough v. Crown Equipment Corp., 392 F.3d 135 (5th Cir. 2004).


Stephen J. Herman, Esq.

Visit HHKC (Representing Plaintiffs in Fire and Explosion, Pharmaceutical, and other Products Liability Cases)

(Note - The views expressed on this law blog / blawg on products liability law, Federal Preemption, the FDA, tort reform, and other issues are the personal observations of Stephen J. Herman and are not intended to represent the views of Herman Herman Katz & Cotlar, Herman Mathis, LAJ, LTLA, AAJ, ATLA, Public Justice, TLPJ, Loyola Law School, the Civil Justice Foundation, or any other organization.)

Updated on July 5, 2008