Articles Posted in Products Liability

An appellate court ruled in favor of a pharmaceutical company in an appeal of a summary judgment order and a jury verdict in a multi-district products liability lawsuit. Secrest v. Merck, Sharp & Dohme Corp., part of In re: Fosamax Products Liability Litigation, No. 11-4358-cv (2nd Cir., Jan. 30, 2013). The Second Circuit affirmed a district court’s order granting summary judgment for the defendant (PDF file) on a failure to warn claim, and in a separate ruling issued the same day, it affirmed a jury verdict in favor of the defendant on a design defect claim. Several days after the court’s ruling, a federal jury ruled in favor of a different plaintiff on a failure to warn claim. The two cases illustrate the difficulty of proving causation and damages in large pharmaceutical cases.

Fosamax, the drug at the center of the litigation, was used to treat osteoporosis in women going through menopause. An alleged link between the drug and osteonecrosis of the jaw (ONJ), a condition in which the jawbone begins to die, led to a wave of products liability lawsuits around the country. Some plaintiffs also allege that the drug contributed to femur fractures and other bone injuries. The Judicial Panel on Multidistrict Litigation consolidated most of the pending federal lawsuits in the U.S. District Court for the Southern District of New York.

Plaintiff Linda Secrest filed suit against Merck, Fosamax’s manufacturer, in Florida in 2006, asserting causes of action for design defects and failure to warn of the drug’s risks. She claimed that she took Fosamax from June 1998 until March 2003, and then began taking it again under a different doctor in December 2003 through April 2005. She developed ONJ around March 2004. The trial court granted the defendant’s motion for summary judgment on her failure to warn claim, and a jury entered a verdict in Merck’s favor in October 2011 on the design defect claim.
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A pharmaceutical sales representative’s conviction for conspiracy to introduce a misbranded drug into interstate commerce violated his rights to free speech under the First Amendment, according to the Second Circuit’s ruling in United States v. Caronia, No. 09-5006-cr, slip op. (2nd Cir., Dec. 3, 2012). The court held that the representative’s speech, consisting of the off-label marketing of a drug, was the principal basis for the government’s criminal case, and that the regulations regarding such marketing were overbroad for the goal of maintaining safe drug labeling. The decision adds an interesting and important dimension of constitutional law to the issue of drug safety and medication errors.

The drug at the center of the case is Xyrem, a central nervous system depressant used for narcolepsy. It has a reputation as a “date rape drug” because its active ingredient, gamma hydroxybutrate, can cause abrupt loss of consciousness in sufficiently large doses. It is therefore subject to strict regulations as to its approved uses. The U.S. Food and Drug Administration (FDA) has only approved it for two uses, both related to narcolepsy: excessive daytime sleepiness and cataplexy, a sort of temporary paralysis associated with the condition. Xyrem was developed by Orphan Medical, which is now part of Jazz Pharmaceutical.

Before a pharmaceutical company may introduce a new drug into the marketplace, it must obtain approval from the FDA for specified uses, and the law states that its marketing may only reference these approved uses. The federal Food, Drug, and Cosmetic Act (FDCA) prohibits drug companies and their representatives from introducing “misbranded” drugs into the marketplace, which may include information that is “false or misleading,” or that suggests uses that are “dangerous to health.” Caronia, slip op. at 7, n. 4. The law does not, however, prohibit “off-label” promotion of drugs by physicians when speaking directly to patients. For pharmaceutical companies and their sales representatives, the FDCA imposes criminal penalties for misbranding drugs, but it does not specifically criminalize “off-label” promotion of drugs.
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A nationwide outbreak of fungal meningitis, traced to medications from a Massachusetts compounding pharmacy, has prompted lawmakers and others to propose strengthening oversight and regulation of compounding pharmacies around the country. These pharmacies currently have no consistent system of federal oversight, although state governments have a wide range of regulations intended to promote drug quality and patient safety. Indiana’s Board of Pharmacy responded to the meningitis outbreak with reassurances about its oversight.

Two bills introduced towards the end of the last session of the 112th Congress sought to give the U.S. Food and Drug Administration (FDA) additional regulatory authority over certain compounding pharmacies, but neither bill made it out of committee. H.R. 6584, The Verifying Authority and Legality In Drug (VALID) Compounding Act, would have subjected compounding pharmacies that act as drug manufacturers to the same FDA regulations as drug manufacturing companies. It also would have required pharmacies to label compounded drugs to indicate that the FDA had neither inspected nor approved the drug, required reporting of adverse reactions to compounded drugs, and created a public “Do Not Compound” list.

H.R. 6638, the Supporting Access to Formulated and Effective (SAFE) Compounded Drugs Act, would have mandated FDA registration for all compounding pharmacies, labeling of all compounded drugs, and FDA production standards and training programs for state health officials. It also would have required disclosure to patients that they are receiving a compounded drug, and improvements to communication between federal and state health regulators. Both bills were referred to the House Subcommittee on Health, where they died at the end of the 112th Congress.
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A lawsuit filed by an anonymous company sought to remove allegedly false or misleading information about the company’s product from an online product safety database maintained by a federal agency. The plaintiff in Company Doe v. Tenenbaum, No. 8:11-cv-02959, slip op. (D. Md., Oct. 22, 2012), alleged that a report submitted to the website described injuries or damages that were not caused by its product. The court reviewed Congress’ intent in mandating the creation of the website and ruled that reports in the database need to show a direct connection between the product and the injury. It granted the plaintiff’s motion for summary judgment and ordered that the report in question be sealed. The court’s opinion offers important insight for consumers into how federal courts may view the fundamental standards of proof in products liability claims.

Congress mandated the creation of an online database of product safety information in the Consumer Product Safety Information Act of 2008 (CPSIA). 15 U.S.C. § 2055a. The Consumer Product Safety Commission (CPSC) launched SaferProducts.gov in accordance with the law’s requirements. The database contains product safety information obtained from medical professionals, government entities, safety organizations, child care organizations, and reports submitted by consumers. Id. at § 2055a(b)(1). Consumers submitting reports must provide their own names and contact information, along with descriptions of the product and the damage, the identity of the manufacturer or labeler, and a verification stating that the information is true and correct. Id. at § 2055a(b)(2)(B). The law requires the CPSC to provide any manufacturer or labeler identified in consumer-submitted reports with copies of those reports, with an opportunity to comment on or dispute the consumer’s charges. Id. at § 2055a(c).
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“Energy drinks,” a general category of drinks with high levels of stimulants like caffeine, taurine, and guarana, have been the subject of much scrutiny in recent years, as their excessive consumption has allegedly led to multiple injuries and deaths. Four Loko, an energy drink that also contains alcohol, has been especially controversial, earning the nickname “Blackout in a Can” among many college students. A series of lawsuits has alleged that the stimulants in the beverage mask the effects of the alcohol, leading to over-consumption, risky behavior, and in some cases, injury or death.

Two insurance companies, including one based in Indiana, have filed a federal lawsuit requesting a declaration that they are not obligated to defend or indemnify Four Loko’s manufacturer, Phusion Projects, in these lawsuits. The companies have reportedly already obtained a similar declaratory judgment, meaning that it may prove difficult for future claimants to recover damages from the beverage maker.

The mixture of caffeine and alcohol, according to doctors quoted by Fort Wayne’s WANE News, can pose serious health risks by concealing the depressive effect of the alcohol content and making the individual more likely to continue drinking. The person might not feel drunk because of the caffeine content, so the person is allegedly also more likely to engage in risky behaviors like driving.
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A welder filed a products liability lawsuit, claiming that defects in the shirt he was wearing caused it to catch fire while he was operating a plasma torch. The suit, Hathaway v. Cintas Corporate Services, Inc., also asserted causes of action for breach of warranty and negligence. The District Court for the Northern District of Indiana granted summary judgment for the defendant on the breach of warranty and products liability claims, but allowed the negligence claim to proceed.

Plaintiff Rex Hathaway worked for Quik Cut, Inc. as a welder and plasma torch operator. His employer used uniforms provided by the defendant, Cintas Corporate Services. The rental agreement between Quik Cut and Cintas provided that Cintas would furnish work clothes and provide laundry and repair services. Hathaway was operating a plasma torch, a machine used to cut various types of metal, on February 12, 2009. Sparks from the plasma torch allegedly caused Hathaway’s shirt, a 100% cotton shirt provided by Cintas, to catch fire, and he suffered severe burns over much of his body.

Hathaway filed suit against Cintas, asserting causes of action for negligence, breach of warranty, and products liability. His wife also brought a cause of action for loss of consortium. Hathaway alleged that the shirt had both a manufacturing defect and a design defect, and he claimed that Cintas was liable for failure to warn of the risk of injury.

Cintas moved for summary judgment on the negligence, breach of warranty, and products liability claims. The court first ruled that the plaintiff’s breach of warranty claim was subsumed by his products liability claims. The court held that because the plaintiff did not claim economic damage for the loss of the shirt, the breach of warranty claims were based in tort, and were therefore part of the products liability claim under the Indiana Products Liability Act (IPLA).
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An Illinois appellate court overturned a $30 million verdict in favor of a chemical-flavoring plant worker who claimed that a chemical used in popcorn butter flavoring caused him permanent lung damage. The verdict in Solis v. BASF Corporation was reportedly the largest in a series of popcorn flavoring lawsuits. The appellate court reviewed the question of whether Illinois’ statute of limitations barred the plaintiff’s claim, and ruled that the trial court erred by rendering a directed verdict for the plaintiff on that issue.

The plaintiff, Gerardo Solis, began a nearly two-decade career in the flavoring industry in 1987. His job duties, according to the court’s opinion, often involved working with or near butter flavorings containing the chemical diacetyl. Solis worked at Flavorchem from 1998 to 2006. He spent two years as a compounder, which involves mixing different ingredients to create a final flavor product. He was then promoted to supervisor, but continued primarily working in the area of the plant that produced powder flavorings. He claimed that he noticed an increase in the plant’s use of diacetyl, particularly in butter flavorings for popcorn, beginning in 2000, and that he experienced significant exposure to the chemical from 2000 to 2004.

Diacetyl provides the buttery flavor and aroma in popcorn and other food products. It has been linked to respiratory problems in workers with prolonged exposure, including bronchiolitis obliterans, an inflammation of the small airways in the lungs. This can cause a permanent loss of pulmonary function in some cases. A recent study also found a link between diacetyl and a brain protein believed to contribute to Alzheimer’s disease. Solis received a diagnosis of bronchiolitis obliterans in June 2006. He allegedly suffered permanent lung damage and was eventually told he needed a lung transplant.
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Indiana has been one of the hardest-hit states in a nationwide fungal meningitis outbreak that has caused more than three hundred illnesses and over twenty deaths in eighteen states. Health officials believe an injectable medication from a Massachusetts pharmacy is the source of the infection. The pharmacy has recalled the medicine and ceased its facility’s operations. It is already facing lawsuits from victims alleging injury from a defective product, and Indiana state officials are seeking to suspend its license. Some victims may also be pursuing causes of action for medical negligence against the doctors and healthcare facilities that prescribed or administered the allegedly contaminated drugs.

At least forty-three reported cases, out of a national total, so far, of 328, are in Indiana. Three of the Indiana patients have died. The total death toll, as of October 25, 2012, is twenty-four. Investigations by the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have determined that the fungal infection came from injections of methylprednisolone acetate, a steroid-based anti-inflammatory medication used to treat back pain. Authorities traced contaminated vials to the New England Compounding Center (NECC) in Framingham, Massachusetts. They suspect that the contamination occurred during the compounding process.

Victims are suffering from fungal meningitis, an infection affecting the spinal cord. Other types of meningitis may result from communicable viral or bacterial infections, but fungal meningitis is not contagious between people. It usually develops when an infectious fungus species gets into the bloodstream, such as through an injection, and spreads to the victim’s spine. The CDC believes it has identified the fungal species Exserohilum rostratum in at least fifty-two patients. The disease can be fatal, particularly in patients with compromised immune systems, and it can cause severe headaches, nausea, light sensitivity, and disorientation.
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After decades working on repair and maintenance of railroad locomotives, a man developed malignant mesothelioma. He sued multiple companies for alleged asbestos exposure, and the executor of his estate substituted in as plaintiff upon his death. After dismissal by the district court, which was upheld by the appellate court, the U.S. Supreme Court considered the matter in Kurns v. Railroad Friction Products Corp., 132 S. Ct. 1261 (2012). It affirmed the lower courts’ findings that a federal statute preempted the plaintiffs’ state tort claims.

The federal statute in question, the Locomotive Inspection Act (LIA), 49 U.S.C. § 20701 et seq., was passed by Congress in 1915. The law requires railroad carriers to maintain locomotives “in proper condition and safe to operate.” 49 U.S.C. § 20701(1). The statute generally preempts state law claims for locomotive-related injuries. In Napier v. Atlantic Coast Line Railroad Co., 272 U.S. 605 (1926), the Supreme Court reviewed the scope of the LIA’s preemption. It held that the law preempts lawsuits brought by railroad workers as well as passengers. The question presented in the Kurns case was whether it also preempted claims for injuries caused by alleged toxic exposure related to locomotive repair and maintenance, as opposed to injuries in locomotive accidents.

The decedent, George Corson, worked for the Chicago, Milwaukee, St. Paul & Pacific Railroad for about twenty-seven years as a machinist and welder, beginning in 1947. He performed locomotive repair by installing brakeshoes, and he performed maintenance on locomotive boilers by removing insulation. His last year of employment at the railroad was 1974. Several decades later, in 2005, Corson was diagnosed with malignant mesothelioma, a form of lung cancer associated with exposure to asbestos.
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