The Supreme Court of Montana ruled that a mother’s lawsuit may proceed against the city government over an injury her daughter suffered on a public playground. The mother, suing on behalf of her minor daughter, argued that the city breached a duty to maintain safe premises by failing to provide material of a safe enough depth to protect children from injury during falls. The ruling in Gatlin-Johnson v. City of Miles City, No. D.A. 12-0129, slip op. (Mont., Dec. 21, 2012) overturned a lower court’s order dismissing the lawsuit after finding that the city did not owe a duty of care to the injured child.
Tiffany Gatlin took her eight year-old daughter, Alyssa Gatlin-Johnson, to Riverside Park in Miles City, Montana in July 2002. The city owned and operated the park, and it designed a playground area there and installed and maintained playground equipment. Alyssa fell from a slide and suffered a serious head injury. The previous year, Gatlin discovered, the city had conducted a review of maintenance and safety in its park system. A review committee recommended surface protection around the playground equipment as a means of preventing injuries. Additionally, the city’s insurer recommended establishing “fall zones” underneath playground equipment, based on guidelines promulgated by the U.S. Consumer Product Safety Commission. These fall zones would have surfacing designed to minimize injuries by providing surface material to cushion falling children. At the time of the accident, the city was using bark chips in the fall zone of the slide.
The U.S. Food and Drug Administration (FDA) recently suspended the registration of a peanut butter facility in New Mexico after an investigation linked its products to a nationwide salmonella outbreak. The FDA’s order prohibits the facility from introducing any food products into inter- or intrastate commerce. It issued the order under authority granted to it by the Food Safety Modernization Act of 2011 (FSMA), which provides the FDA with authority to shut down facilities for serious risks to public health. The company will have an opportunity to contest the order, but the FDA will only lift the order when it finds the company has remedied the problems.
The outbreak of Salmonella Bredney sickened forty-two people nationwide, including three in Connecticut. According to the Centers for Disease Control and Prevention (CDC), twenty-eight percent of the victims required hospitalization, but no deaths were reported. Children under ten years of age accounted for sixty-one percent of victims. Investigations by the CDC, the FDA, and various state health agencies identified Trader Joe’s Valencia Peanut Butter as a likely source of the contamination. Sunland, Inc. manufactures the product at a facility in Portales, New Mexico. Sunland announced a voluntary recall of Creamy Salted Valencia Peanut butter on September 24, 2012. It later expanded the recall to cover a total of 240 products manufactured at its Portales plant between March 2010 and September 2012, as well as raw and roasted peanuts originating from the plant.
A recent decision from a Maryland federal court places limits on an online database of consumer product information maintained by the Consumer Product Safety Commission (CPSC). The website, SaferProducts.gov, contains reports of injuries or other damages related to consumer products. A company, after the CPSC denied its request to remove a report about one of its products it claimed was incorrect, filed an anonymous lawsuit to enjoin publication of the report. The court ruled in Company Doe v. Tenenbaum, No. 8:11-cv-02958, slip op. (D. Md., Oct. 22, 2012), that the CPSC may not publish the report on the website. It also offered guidance to businesses, which should also be of interest to consumers and their attorneys, regarding objections to records in the database.
The Consumer Product Safety Improvement Act of 2008 (CPSIA) directed the CPSC to create an online database, accessible to the public, containing information of consumer product safety. 15 U.S.C. § 2055a. The database was to consist of reports of damage or injury submitted by consumers; information provided by government entities, public safety organizations, medical providers, and childcare providers; CPSC notices regarding hazardous products; and comments received on existing records. Id. at § 2055a(b)(1). Information submitted by consumers is required, according to the statute, to include a description of the product and identification of the manufacturer, a description of the claimed injury or damage, the identity of the consumer submitting the report, and a verification that the consumer is submitting true and correct information. Id. at § 2055a(b)(2)(B). The CPSC must submit reports to the manufacturer or labeler identified in the report, and allow them an opportunity to make comments or objections.
A Connecticut Superior Court judge granted summary judgment to a general contractor in two asbestos lawsuits in late November, ruling that it is not a “manufacturer” or “seller” within the meaning of the Connecticut Products Liability Act (CPLA). The court dismissed causes of action for violations of the CPLA and wrongful death in both Mazzaia v. A.O. Smith Corp., et al, No. CV-11-5029478 (Conn. Super. Ct., Nov. 29, 2012); and Selvidio v. Alfa Laval, Inc., et al, No. CV-11-6017088 (Conn. Super. Ct., Nov. 26, 2012). These cases may represent an important limitation on products liability claims in Connecticut.
Both cases involved decedents who allegedly developed mesothelioma, a form of cancer that primarily affects the lungs, due to asbestos exposure while working at a Pfizer Corp. plant in Groton, Connecticut. Donald Mazzaia’s executor alleged that he suffered asbestos exposure while serving in the U.S. Navy between 1959 and 1963 and while working for General Dynamics and Pfizer between 1963 and 1979. Joseph Selvidio’s executor alleged that he was exposed to asbestos-containing products while working at the Pfizer plant from 1973 to 1979. Both lawsuits alleged violations of the CPLA and liability under the Connecticut wrongful death statute.
The defendant that filed the motions for summary judgment, Skansa USA Building, Inc., is the successor-in-interest to W.J. Barney Corp. Barney had a contract with Pfizer to build its Groton facility, which was in effect from 1946 to 1977. In 1977, the two companies signed a new contract for “maintenance and general services” at the plant. Mazzaia at 4. According to affidavits produced by Skansa, the company did not sell or distribute materials unless directed to sell surplus products by Pfizer. Its responsibilities were almost entirely related to construction and maintenance, and while it purchased materials as part of providing services to Pfizer, Pfizer had the option of procuring materials independently of Barney.
A court violated the free speech rights of a pharmaceutical sales representative when it convicted him of conspiring to introduce a misbranded drug into interstate commerce. The Second Circuit held in United States v. Caronia, No. 09-5006-cr (2nd Cir., December 3, 2012), that the defendant’s conviction for off-label marketing of the drug Xyrem was based primarily on his speech. It further held that the U.S. Food and Drug Administration’s (FDA’s) off-label regulations were too broad to further the legitimate interest of ensuring safe and consistent drug labeling.
Pharmaceutical companies must obtain FDA approval for specific uses before they may introduce new drugs to the marketplace. Once a drug is in the market, however, the FDA generally does not regulate how physicians promote it to patients. This is partly based on an understanding that doctors may legitimately prescribe drugs for “off-label” uses specific to their patients. The FDA prohibits “misbranding” of a drug, meaning introduction of a drug by a manufacturer with information that differs from its “intended use,” which includes false or misleading information, or uses that could be “dangerous to health.” Caronia at 7, 7 n. 4. The law imposes criminal penalties on pharmaceutical companies and representatives who misbrand drugs, but it does not expressly criminalize promotion of drugs for “off-label” uses.
Xyrem is a product of Jazz Pharmaceutical, formerly known as Orphan Medical. It is a central nervous system depressant used to treat narcolepsy. Its active ingredient, gamma hydroxybutrate (GHB), is also known as a “date rape drug” because larger doses can cause a person to lose consciousness quickly. Its FDA approval included strict limitations, with only two approved uses for narcolepsy patients.
A woman filed a wrongful death lawsuit against the federal government earlier this year, alleging that an incorrect diagnosis and incorrect dosages of medication caused her sister’s 2010 suicide. The plaintiff in Grese v. United States claims that doctors with the Department of Veterans Affairs (VA) continued her sister on a medication known to have serious psychiatric side effects even after she had attempted suicide. The suit alleges multiple breaches of applicable standards of care for doctors and other medical professionals, and demands $5 million in damages.
The decedent, Kelli Grese, served in the U.S. Navy and was discharged in 1997, according to the Hampton Roads Daily Press. She began receiving treatment from the VA for psychiatric issues sometime afterwards, including medication and therapy, for post-traumatic stress disorder, substance abuse, and depression. Doctors diagnosed her with attention deficit disorder in 2008, according to the plaintiff’s complaint, and prescribed stimulant medications. Grese checked into a private psychiatric hospital in March 2009 where she received a diagnosis of severe depression. Doctors at the private hospital classified her at the time as a suicide risk, and noted that she suffered from paranoia and delusional thinking. After her discharge from the psychiatric hospital, the complaint alleges that the VA doctors did not modify her treatment plan despite changes in her condition.
Two insurance companies have filed suit in a federal court in Illinois, seeking a declaratory judgment that they are not obligated to defend or indemnify Phusion Products in a series of products liability and wrongful death lawsuits. Phusion manufactures the alcohol-based “energy drink” Four Loko, which has been the subject of multiple controversies and lawsuits in recent years. The current suit, Netherlands Insurance, et al v. Phusion Projects, Inc., et al, is at least the second suit declaratory judgment brought by The Netherlands Insurance Company and Indiana Insurance Company regarding Four Loko.
Phusion markets Four Loko in many areas as an “energy drink” that also contains alcohol. Like many popular energy drinks, it contains stimulants like caffeine and guarana. According to the Register Citizen, a 24-ounce can also contains an equivalent amount of alcohol as five shots of vodka. The beverage is popular among college students, but numerous cases of accidental overdose have reportedly resulted from excessive consumption.
A common allegation is that the effect of the stimulant ingredients, which may include a high level of caffeine, masks the effects of the alcohol, causing people to continue drinking past the point where they might have otherwise stopped. Recent lawsuits have alleged that consumption of the beverage proximately caused various injuries or deaths, including car accidents and shooting deaths. Several states, including Connecticut, have sought distributors’ cooperation in suspending shipments of the beverage, and Phusion has reportedly begun to sell non-caffeinated versions of the product in some states.