June 2011

From the editors of Wolters Kluwer Law & Business, this update describes important developments from CCH products liability and safety publications.

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Products Liability

U.S. Supreme Court Finds State Law Claims Against Generic Drug Makers Preempted
Federal law preempted the state law failure-to-warn claims of two patients, who developed tardive dyskinesia, a severe neurological disorder, after taking generic metoclopramide for several years, and who alleged that the manufacturers of the generic anti-nausea drug failed to provide labels adequately warning that tardive dyskinesia can occur in patients after long-term use of the drug, the U.S. Supreme Court held, reversing opinions by the U.S. Court of Appeals for the Fifth and Eighth Circuits (sub nom. Demahy v. Actavis, Inc. [CCH Products Liability Reports ¶18,346 (ip access user)(Intelliconnect)] and sub nom. Mensing v. Wyeth, Inc. [CCH Products Liability Reports ¶18,332 (ip access user)(Intelliconnect)]). The High Court found that federal drug regulations applicable to generic drug manufacturers directly conflicted with, and, therefore, preempted, the state-law claims. The court determined it was impossible to comply with both state tort law, which placed a duty directly on all drug manufacturers to adequately and safely label their products, and with federal regulations requiring that the warning labels of a brand name drug and its generic copy must always be the same—giving generic drug manufacturers an ongoing federal duty of “sameness.” The patients’ allegations would require the manufacturers of the generic drug to use a different, stronger label, pursuant to state law, than the FDA-approved label that they actually used. Federal drug regulations, as interpreted by the FDA, the court said, prevented the generic drug makers from independently changing their generic drugs’ safety labels. The only action the generic drug manufacturers could independently take was to ask for the FDA’s assistance in convincing the brand-name manufacturer to adopt a stronger label, so that all corresponding generic drug manufacturers could do so as well. The court determined that it was enough to hold that when a party cannot satisfy its state duties without the federal government’s special permission and assistance, which would be dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for preemption purposes. Finally, the court stated that Wyeth v. Levine [CCH Products Liability Reports ¶18,176 (ip access user)(Intelliconnect)], in which the court held that a state tort action against a brand name drug maker for failure to provide an adequate warning label was not pre-empted because it was possible for the manufacturer to comply with both state and federal law under the FDA’s “changes being effective” (CBE) regulation, was not to the contrary. According to the court, the federal statutes and regulations that apply to brand name drug makers differed, by Congress’ design, from those applicable to generic drug manufacturers. The court found that the different federal statutes and regulations led to different preemption results, and that Congress and the FDA retained authority to change the law and regulations if they chose to do so. (PLIVA, Inc. v. Mensing (USSCt) CCH Products Liablility Reports ¶18,642 (ip access user)(Intelliconnect))

U.S. Supreme Court Refuses to Review Jury Award in HRT Drug Case
A petition for review submitted by a manufacturer of hormone replacement drugs, which were taken by three women who alleged that the drugs caused their breast cancers, was denied by the  U.S. Supreme Court. The drug maker had asked the U.S. High Court to review a ruling by the Nevada Supreme Court (sub nom. Wyeth v. Rowatt, CCH Products Liability Reports ¶18,540 (ip access user)(Intelliconnect)), upholding a jury’s $58 million punitive damages award to the women, who had asserted strict products liability and personal injury claims against the drug manufacturer. The jury awarded both compensatory and punitive damages. One of the Nevada court’s conclusions was that both the compensatory and punitive damages awards were supported by substantial evidence. The court found that the compensatory damages award did not shock the court’s conscience, and, thus, were not excessive. In addition, the court determined that the amounts of the punitive damages awards did not violate the drug maker’s due process rights as the awards were reasonable and proportionate to the drug maker’s actions. Further, the state supreme court stated that although the jury improperly and prematurely deliberated punitive damages, the error was cured by the jury’s re-deliberation and the district court’s subsequent granting of a remittitur—reducing the $35.1 million compensatory damages to $23 million, and the $99 million punitive damages award to $57,778,909. The first question asked by the manufacturer in its petition was whether, when a verdict has been tainted by a jury’s passion or prejudice, due process requires a trial court to grant a new trial instead of remittitur. Second, the drug maker asked whether, and in what circumstances, a trial court violates due process when it awards a substantial amount in compensatory damages but nevertheless proceeds to award punitive damages in an amount exceeding the one-to-one ration indicated in State Farm Mutual Automobile Insurance Co. v. Campbell, 538 U.S. 408 (2003) [CCH Products Liability Reports ¶16,805 (ip access user)(Intelliconnect)], and Exxon Shipping Co. v. Baker, 554 U.S. 471 (2008). (Wyeth LLC v. Scofield, Docket No. 10-1177, cert. denied June 20, 2011)

Kentucky Adopts Economic Loss Rule, Not Calamitous Event Exception
The economic loss rule, as articulated by the U.S. Supreme Court in East River Steamship Corp. v. Transamerica Delaval, Inc., 476 U.S. 858 (1980) [CCH Products Liability Reports ¶11,008], was adopted by the Kentucky Supreme Court and applied to claims arising from a defective product in a commercial setting. However, the court declined to establish an exception for losses resulting from a calamitous event. A company purchased a diffuser cell system, which consisted of a vertical turning lathe, two vertical machining centers, and a material handling system and was used to cut and shape metal. The system was built pursuant to extensive specifications supplied by the purchaser, including a requirement that the vertical turning lathe operate at a speed considerably faster than that customarily used on the manufacturer’s machines. After seven years of virtually continuous operation, an accident occurred in which parts of the system and a chunk of metal flew off the lathe and catapulted around the work space at the purchaser’s plant. No one was injured and the damage beyond the system itself appeared to have been minimal. The purchaser’s insurance company sought reimbursement from the manufacturer for repairs to the damaged machines, overtime payment to employees who did the repairs, and other related expenses, claiming negligence, strict liability, and negligent misrepresentation, among other contract theories. The court noted that the economic loss rule prevents a commercial purchaser of a product from suing in tort to recover for economic losses arising from the malfunction of the product itself, recognizing that these damages must be recovered, if at all, pursuant to contract law. Finding that the facts in this case presented a classic case for application of the economic loss rule, the Kentucky high court stated that in a commercial relationship, economic losses were best addressed by the parties’ contract and by relevant provisions of Article 2 of the Uniform Commercial Code “without disturbance by the courts via product liability theories borne [sic] of a public policy interest in protecting people and their property from a dangerous product.” Virtually all of the damages which the system purchaser sought to recover were economic losses and, thus, were subject to the rule. Furthermore, the court made clear that the rule applied regardless of whether the damage occurred through gradual deterioration or internal breakage or as a result of a calamitous event. No matter how the damage occurred, the resulting losses were essentially the same, i.e., failure of the purchaser to receive the benefit of the bargain—the core concern of contract law, according to the court. In addressing the issue of what constituted the “product itself,” the court concluded that the diffuser cell system was a single product and, therefore, the purchaser’s argument that damages to the component parts amounted to damage to other property, which would not be subject to the economic loss rule, was rejected. The purchaser submitted detailed specifications for the system as an integrated package and the fact that some of the components could be sold separately was irrelevant, the court said. The bargained-for item placed into the stream of commerce by the manufacturer pursuant to the contract was the complete system and any economic losses arising from its malfunction must be recovered pursuant to the terms of the contract. (Giddings & Lewis, Inc. v. Industrial Risk Insurers (KySCt) CCH Products Liability Reports ¶18,640 (ip access user)(Intelliconnect))

U.S. High Court: Montana Class Action Tolling Decision Stands
The U.S. Supreme Court let stand a decision by the Montana Supreme Court (sub nom. Stevens v. Novartis Pharmaceuticals Corp., CCH Products Liability Reports ¶18,553 (ip access user)(Intelliconnect)), finding that a patient’s failure to warn claims against the manufacturer of a brand name drug were timely because a pending class action had tolled the applicable statute of limitations. The drug was prescribed to treat the patient’s lymphoma-associated bone loss. While taking the drug, the patient had oral surgery and subsequently developed osteonecrosis of the jaw (ONJ). She alleged that the drug maker negligently failed to warn of the risk of contracting ONJ in patients who undergo dental surgery while on the drug. The manufacturer had asked the U.S. Supreme Court (Novartis Pharmaceutical Corp. v. Stevens, Dkt. No. 10-1196, March 30, 2011) to review the Montana Supreme Court’s opinion in a case of first impression. The Montana high court explained that it adopted the class action tolling rule—which was designed to promote judicial economy—subject to the circumstances presented in the case in order to ensure the defendants were not unfairly prejudiced. The patient’s warnings claim and the alleged resulting injury, the state court noted, were the same as, or substantially similar to, those of the class action. The state court said it was not necessary that the claims in the class action lawsuit and those in the patient’s action be identical: under modern pleading rules—the drug maker was entitled only to be on notice of the nature of claim, rather than the damages alleged, which did not need to be pleaded specifically. Thus, the manufacturer was effectively put on notice of the patient’s claim by the class action lawsuit, the court determined, and allowing class action tolling in this context did not unfairly prejudice the manufacturer for lack of notice. The petition asked the U.S. Supreme Court to decide whether tolling the statute of limitations for individual claimants based on the pendency of a mass personal injury class action violated fundamental federal due process protections when the class action provided no notice to a defendant of the identity of unnamed class members; thus, absolutely precluding the timely preservation of evidence and testimony critical to presenting an effective defense. (Novartis Pharmaceuticals Corp. v. Stevens, Dkt. No. 10-1196, cert. denied May 31, 2011)

Cert. Denied in PWC Accident Suit on Choice of Law Issue
A request by a manufacturer of a personal watercraft (PWC) for review of a choice of law issue in a personal injury action brought by a passenger on the watercraft who was injured as a result of an explosion on the craft as it was sitting twenty yards off shore of a lake in California was denied by the U.S. Supreme Court. The injured passenger’s suit against the manufacturer included claims for products liability and negligence-products liability. The manufacturer sought to apply substantive admiralty law to the trial of the case and established that the trial court agreed with it that the lake was a navigable water way under the law, that the use of PWCs was traditionally associated with maritime activity, and that the injured person’s exploding vessel accident had the potential to disrupt maritime commerce. The injured passenger argued that even if admiralty jurisdiction existed, the court needn’t apply admiralty law and that there was no conflict between his elected state law remedies and those afforded by admiralty law. The passenger opposed the application of admiralty law because it would deprive him of a jury trial. The manufacturer contended that where admiralty jurisdiction exists, courts should apply federal maritime law to achieve uniformity. The trial court denied the manufacturer’s request to apply federal maritime law, finding that when a state court has concurrent jurisdiction over a maritime case, the plaintiff has the right to choose whether he or she wants admiralty or state law to apply. The manufacturer asked the Supreme Court whether, in a products liability personal injury case arising out of an explosion of a personal watercraft on navigable waters, 28 U.S.C. 1331 and previous decisions of the U.S. Supreme Court require a state court judge to apply Federal Maritime Law on those claims for relief where conflicting standards govern liability between State law and Federal Maritime Law. (Bombardier Inc. v. Dow Chemical Canada ULC, Dkt. No. 10-1225, cert. denied June 13, 2011)

Rifle Maker Not Liable for User’s Eye Injury
A manufacturer of a bolt-action rifle was not liable for a user’s injury when he fired the rifle and the bolt was ejected into his eye and head, the U.S. Court of Appeals for the Fifth Circuit ruled, affirming a federal district court in Louisiana (Matthews v. Remington Arms Co. (WDLa) CCH Products Liability Reports ¶18,315 (ip access user)(Intelliconnect)). The user and his wife alleged that the manufacturer was liable for their damages because the rifle was unreasonably dangerous in construction and design and lacked an adequate warning. The court of appeals upheld the district court’s findings that: the bolt-assembly pin was missing, rather than out-of-specification, when the user fired the rifle; and, pursuant to the Louisiana Products Liability Act (LPLA), the manufacturer did not ‘‘reasonably anticipate’’ a user would fire its rifle after someone had removed, but failed to reinstall, the bolt-assembly pin. Further, the appellate court held that it was not error to conclude that the scope of the user’s ‘‘use’’ of the rifle under the LPLA included the removal of the pin and the failure to reinstall it. Thus, his ‘‘use’’ was firing the rifle with the bolt-assembly pin missing, as opposed to only firing it, the court said. The court of appeals stated that, in the light of the scope-of-use, at issue was whether it was ‘‘reasonably anticipated’’ by the manufacturer that someone would fail to reinstall the bolt-assembly pin and that the rifle would be fired in that condition. In light of the trial evidence, the appellate court concluded that it could not say that the district court clearly erred in finding that the ‘‘use’’ at issue was not ‘‘reasonably anticipated’’ by the manufacturer. (Matthews v. Remington Arms Co., Inc. (5thCir) CCH Products Liability Reports ¶18,634 (ip access user)(Intelliconnect))

Jury Verdict for Motorcycle Helmet Matter Affirmed
A jury verdict in favor of a helmet distributor in an action by the estate and wrongful death beneficiaries of a motorcycle rider who was killed when he fell off his motorcycle was affirmed by the U.S. Court of Appeals for the Fifth Circuit in an unpublished opinion. The rider was wearing a helmet distributed by the defendant when he died. The estate alleged various products liability claims, including design, manufacturing, and marketing defects. The family argued that the rider suffered a fatal basilar skull fracture because of the improper design of the helmet he wore—specifically, that the helmet appeared to offer full-face protection because it had a full-face outer shell, but actually provided only a half-shell inner liner. The distributer argued that the rider’s death was not caused by any possible defects in the helmet but was the result of an injury to his chest. The jury determined that there was no design defect in the helmet at the time it left the distributor’s possession that was a producing cause of the rider’s death. On appeal, the estate argued that the trial judge erroneously excluded evidence of alternative helmet designs and expert testimony that the helmet was “deceptive.” The court of appeals determined that the federal district court judge did not improperly restrict the family’s efforts to establish that an alternative design existed that was not unreasonably dangerous, would have provided the protection the family’s expert testified that the rider needed, and was comparable in price. The district judge’s ruling that presenting a large number of other available helmets that were similar or dissimilar to the helmet the rider was wearing would be providing the jurors with confusing evidence was not an abuse of discretion, the court of appeals said. In addition, the appellate court concluded that the family’s expert’s testimony that consumers would be deceived by the helmet’s appearance was not improperly excluded. The expert’s opinion arose from the fact that because the helmet covered the entire head, consumers would believe it provided protection for the entire head. The court of appeals found there was no adequate basis offered on which to support the expert’s opinion—i.e., that the expert had the expertise to provide a better opinion about what consumers would expect than would jurors themselves. (Navarro v. Soaring Helmet Corp. (5thCir) CCH Products Liability Reports ¶18,641 (ip access user)(Intelliconnect))

“No Defect” Finding Stands in Mortar Shell Explosion Case
In an action relating to the premature explosion of a mortar shell in a gun during a military training exercise in which the mortar shrapnel injured three Army soldiers and killed a fourth, a federal district court in Hawaii rejected the families’ request for judgment as a matter of law, or in the alternative, a new trial. The jury returned a verdict in favor of the mortar shell manufacturer’s successor corporation after a trial in which the soldiers and their families, relying on the doctrine of res ipsa loquitur, alleged the mortar shell was defective. The families introduced testimony of eyewitnesses that the soldiers were operating the mortar cannons (‘‘guns’’) properly during the training exercises, and that nothing out of the ordinary occurred before the explosion; and offered the opinion of an expert who testified that the shell was defective when it was manufactured. The manufacturer offered expert testimony in support of its theory that the mortar explosion was caused by double loading and not by a defect. The families argued that the testimony by the manufacturer’s expert, the person who investigated the cause of the mortar explosion in the case for the United States Army, was improperly admitted. They also argued that the court erred in responding to a jury question about the effect of a determination by the jury that there was not enough evidence to establish a defect in the mortar shell—to which the court responded that the jury had to return a verdict of ‘‘no defect’’ in that event. The court ruled that because the manufacturer presented sufficient evidence to support the jury’s verdict, judgment as a matter of law was not warranted. In addition, the court concluded that there was no error in the admission of the expert’s testimony or in the court’s response to the jury. Therefore, the court denied the families’ request for a new trial. (Rodriguez v. General Dynamics Armament and Technical Products, Inc. (DHaw) CCH Products Liability Reports ¶18,639 (ip access user)(Intelliconnect))

Proof of Causation Lacking in Contact Lens Solution Claim
Consumers who suffered eye infections (unrelated to the Fusarium strain) which they alleged were caused by a contact lens solution failed to produce evidence to support their negligent failure to warn claim against the solution’s manufacturer, the U.S. Court of Appeals for the Fourth Circuit held. The consumers argued that a lower court erred by imposing a requirement that they offer proof of the product’s defect in order to satisfy the elements of their negligent failure to warn claim under Puerto Rico law. They also asserted that they presented a valid claim under Puerto Rico law that the manufacturer still would be liable due to its failure to warn the consumers that they could suffer eye infections notwithstanding their use of the solution—even in the absence of a product defect. The court ruled that even if Puerto Rican law supported the consumers’ claim, the record was devoid of any evidence supporting it. The lower court had excluded as unreliable the consumers’ only causation evidence. Therefore, there was no genuine issue of material fact to support the consumers’ claim, the appellate court said. In addition, an argument by the injured consumers that the lower court erred in imposing a requirement of general causation when the laws of Puerto Rico did not recognize that requirement was rejected by the Fourth Circuit. According to the consumers, Puerto Rican courts rejected the concept of general causation, and, instead, focused on whether plaintiffs were able to adduce evidence of “adequate cause.” However, the distinction failed to persuade the court. Under either standard, the court found that the consumers were required to prove that a product defect in the contact lens solution caused their injuries. As the consumers failed to present reliable expert testimony showing that the solution caused their injuries, the lower court’s determination that there was no genuine issue of material fact to support the consumers’ claims against the solution’s manufacturer was left
undisturbed. (Fernandez-Pineiro v. Bausch & Lomb (4thCir) CCH Products Liability Reports ¶18,631 (ip access user)(Intelliconnect))

Causation Evidence Sufficient for Jury in Tainted Pot Pie Case
An injured, fifteen year-old consumer, who alleged that he ate a name brand turkey pot pie that was contaminated with salmonella and that the salmonella caused him severe illness and ultimately appendicitis, which resulted in the removal of his appendix, presented sufficient evidence to create an issue of material fact regarding causation, a federal district court in Maryland ruled. The expert testimony of the consumer’s treating physician that the salmonella was most likely the cause of the consumer’s appendicitis was admissible in support of the consumer’s causation theory. The court also found that the consumer presented sufficient circumstantial evidence to establish a genuine dispute of material fact as to the existence of a defect in the pot pie. Around the same time of the consumer’s illness, several independent laboratories identified the exact same salmonella serotype in several of the manufacturer’s turkey pot pies. Therefore, the court concluded that although the consumer could not present tests conducted directly on the pot pie that he consumed in order to prove the pot pie was contaminated with salmonella, he was able to present strong circumstantial evidence to that end. Finally, the court held that the testimony of the consumer’s treating physician was based on a sufficiently valid and reliable diagnostic method and was, therefore, admissible evidence. The manufacturer of the pot pie had argued that the physician’s testimony should be excluded under Daubert v. Merrell Dow Pharmaceuticals, Inc. [CCH Products Liability Reports ¶13,494 (ip access user)(Intelliconnect)] because his differential diagnosis was unreliable, his reasoning was not scientifically valid because he relied on his “experience and clinical knowledge” to make his assessment and not any specific peer-reviewed publication, and his opinion was overly prejudicial. Specifically, the manufacturer asserted that the physician’s differential diagnosis was deficient and unreliable because he did not properly consider all alternatives. The court ruled, however, that a valid differential diagnosis need not rule out definitively every possible alternative. The physician’s differential diagnosis needed only to determine the most likely cause of the medical malady and did not need to determine the only possible cause. Moreover, the court found that the physician considered several potential causes of the appendicitis in light of the consumer’s medical history and a review of relevant literature. Although the physician previously had not observed personally a case in which appendicitis was caused by salmonella, he relied on his extensive clinical experience, a comprehensive literature review, and a thorough differential diagnosis grounded in reliable scientific methods to form his conclusions, which were, therefore, relevant and reliable under Daubert, the court ruled. Therefore, the court held that the physician’s testimony would not create substantial unfair prejudice or jury confusion. (T.W. v. Conagra Foods, Inc. (DMd) CCH Products Liability Reports ¶18,632 (ip access user) (Intelliconnect))

Product Safety

Amendments to Bicycle Regulations Issued
The Consumer Product Safety Commission (CPSC) has amended its bicycle regulations, which were first promulgated in 1978 and last amended in 2003, to reflect new technologies, designs, and features in bicycles, and to clarify that certain provisions or testing requirements do not apply to specific bicycles or bicycle parts. The final rule also incorporates comments received in response to the proposed rule on track bicycles, carbon fiber material and marking on seats. The final rule also clarifies several ambiguous and confusing provisions, corrects typographical errors, and removes an outdated reference. CPSC did not expect the changes to result in product modifications in order for manufacturers to comply with its requirements and did not impose any additional testing or recordkeeping burdens. The clarifications and exceptions resulting from the amendments could result in modest cost savings to small businesses in the form of more focused testing or the elimination of unnecessary testing. Accordingly, the Commission believes that the final rule will not have a significant economic effect on a substantial number of small entities. The final rule was effective June 13, 2011. (CCH Consumer Product Safety Guide ¶42,053 (ip access user) (Intelliconnect))

New Federal Safety Rule for Hair Dryers Approved
The establishment of a new federal safety rule requiring hand-supported hair dryers to have an immersion protection device has been unanimously approved by the Consumer Product Safety Commission (CPSC). The new rule provides CPSC with more authority to stop shipments of non-complying hair dryers at U.S. ports of entry, and issue recalls for non-complying hair dryers. CPSC has identified hand-supported hair dryers that lack an immersion protection device as posing a substantial product hazard to consumers, because these dryers are typically used in bathrooms, near water sources, including the sink, bathtub, and lavatory, and the uninsulated, electrically energized wires in the hair dryer present a risk of shock and electrocution to consumers. The Consumer Product Safety Improvement Act (CPSIA) of 2008 provided CPSC with authority to establish federal safety rules for consumer products that have demonstrated substantial compliance with a voluntary standard or set of guidelines, and defined “substantial product hazard,” as “a product defect that creates a substantial risk of injury to the public.” Current industry standards require manufacturers to incorporate a device into the hair dryer that prevents shock and/or electrocution hazards when it contacts water. Nevertheless, industry voluntary standards, which require an immersion protection device, have contributed to a significant decline in electrocutions or electrical shock incidents related to immersion or contact with water because majority of manufacturers and distributors of hand-supported hair dryers comply with these voluntary industry standards. (CPSC News Release #11-242, June 9, 2011, (CCH Consumer Product Safety Guide Report No. 989, June 20, 2011)

Rulemaking Requested for Gas Fireplace Fronts Safeguards
The CPSC has received a petition from Carol Pollack-Nelson, Ph.D., requesting it to initiate rulemaking proceedings to require safeguards for the glass fronts of gas vented fireplaces. According to the petitioner, based on the National Electronic Injury Surveillance System database (NEISS), between 1999 and March 2009 more than 2,000 children, ages 0-5 years old, suffered burn injuries on gas fireplaces. The petitioner believed that this state of affairs is due to a combination of factors, including “the high surface temperature of the fireplace glass, the accessible location of the glass front, the attractiveness of fire to young children, and the lack of consumer awareness of the hazard.” The petitioner argued that passive interventions, such as an “integral safety screen,” are needed to protect children and asked the Commission to develop a mandatory standard for gas fireplaces that would require a protective barrier, guard, or other device for any accessible surface that, if contacted, is hot enough to cause severe burns. The Commission also received a subsequent request from Mr. William S. Lerner to initiate rulemaking proceedings to require a “high temperature warning system,” which would “project a clear high temperature alert onto the glass front of the fireplace that will remain visible from the time the fireplace is lit until the glass is cool enough to touch safely.” Comments on the petition must be received by August 8, 2011. (CCH Consumer Product Safety Guide ¶58,171 (ip access users) (Intelliconnect)

NHTSA Issues Changes to Crash Test Dummies Regulations
The National Highway Traffic Safety Administration (NHTSA) has issued a final rule correcting or making minor changes to some of the drawings for a 50th percentile adult male side crash test dummy called the “ES-2re.” These changes to drawings, incorporated by reference into NHTSA regulations in June 2008 [CCH Consumer Product Safety Guide ¶41,981 (ip access users) (Intelliconnect)], came in response to requests from test dummy manufacturers First Technology Safety Systems and Denton ATD. This final rule also corrects dimensional errors in a figure which depicts the pendulum used in the neck qualification tests of several of the crash test dummies, including the Hybrid III and ES-2re test dummies. Many of the requested changes were entirely corrective. Other requested changes were minor but more substantive and a notice of these changes was deemed by the agency as beneficial. In addition, this rulemaking is not considered a significant regulatory action because it only corrects or makes slight changes to the existing regulations. These changes will not affect the cost of any of the test dummies and no further regulatory evaluation was necessary. This final rule takes effect on November 29, 2011, and petitions for reconsideration of the final rule must be received not later than July 18, 2011. (CCH Consumer Product Safety Guide ¶42,054 (ip access users) (Intelliconnect))

NHTSA Amends Motorcycle Helmet Standards
The National Highway Traffic Safety Administration (NHTSA) has amended, effective May 13, 2013, Federal Motor Vehicle Safety Standard (FMVSS) No. 218, “Motorcycle helmets,” which specifies performance requirements for motorcycle helmets, to reduce traumatic brain injury and other types of head injury and to make it easier for state and local law enforcement officials to enforce state laws requiring the use of helmets meeting that standard. NHTSA has found that some motorcyclists use helmets, known as novelty helmets, which are not certified as FMVSS No. 218 compliant and which have been shown in testing to fail all or almost all of the standard’s safety performance requirements. Some novelty helmet users attempt to make their helmets appear to be compliant by misleadingly attaching labels that have the appearance of legitimate “DOT certification labels.” The final rule revises the existing requirements for the “DOT certification label” and other labels and adds new requirements to make it more difficult to label novelty helmets in a misleading manner. Other changes made by the amendments will aid the agency enforce the standard by setting reasonable tolerances for certain test conditions, devices, and procedures. In particular, the amendments provide for a quasi-static load application rate for the helmet retention system; revises the impact attenuation test by specifying test velocity and tolerance limits and removing the drop height test specification; provides tolerances for the helmet conditioning specifications and drop assembly weights; and revises requirements related to size labeling and location of the DOT symbol. (CCH Consumer Product Safety Guide ¶42,052 (ip access users) (Intelliconnect))