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Articles Posted in Products Liability

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When a party takes a case to trial and does not get the result they had hoped for, they can sometimes appeal the lower court’s decision to an appellate court to have the case reviewed. Most states, including Indiana, have three levels of courts: trial, intermediate appellate, and supreme. As the name implies, the trial court is where a trial takes place. If a party is not satisfied with a ruling, they may appeal to the intermediate appellate court. If that court finds against the party again, they can file another appeal in the state supreme court. In some very limited and specific circumstances, a party may be able to make one final appeal to the United States Supreme Court.

A court, however, will not hear any issue merely because a party was not satisfied with the ultimate result; there must be some legal issue that is the basis of the appeal. Often, these are evidentiary rulings made by the trial judge.

Trial judges are supposed to follow rules of evidence, which dictate what kinds of evidence are admissible at trial. If evidence that was not supposed to be considered by the jurors is put before the jury, that may result in reversible error. Similarly, if a judge prevents a party from admitting evidence that should have been admitted, that too can qualify as reversible error. However, a party almost always has to “preserve” the error by objecting when the adverse ruling is made.

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The New York Court of Appeals, which is the highest state appellate court in New York, recently released a decision affirming two lower court decisions to exclude a plaintiff’s proposed expert witnesses in a personal injury case filed on behalf of a child who was born with serious birth defects and disabilities alleged to have resulted from his mother inhaling gasoline fumes while she was pregnant with him. The plaintiff in Sean R. v. BMW of North America, LLC alleged that a defective fuel line in the mother’s car caused her to breath toxic levels of gasoline vapor while she was pregnant and resulted in the serious disabilities from which the child continues to suffer.

The New York Court of Appeals agreed with the rulings of the other courts and found that two of the plaintiff’s proposed experts in the case did not rely on generally accepted scientific principles to reach the conclusions that supported the plaintiff’s case, so their testimony should not be heard by the jury. As a result of this final ruling, the plaintiff will not be compensated for the injuries that he alleged were caused by the negligence of the defendant.

Pregnant Mother-To-Be Continuously Smells Gasoline Vapors While Driving

The plaintiff’s mother had purchased a car from the defendant in 1989, and within two years of buying the car, she began to notice a strong smell of gasoline while driving. According to the recently released opinion, she was also able to smell the vapor from her home when the car was parked in the garage. After taking the car into the dealer, she was told they could not find a problem. Shortly after the problem of gasoline vapors arose, the woman became pregnant with the plaintiff. After the gasoline odor worsened, the plaintiff’s father brought the car back to the dealer, and a fuel leak was found in the engine compartment, caused by a split hose. The leak was fixed, but the plaintiff’s mother had driven 6,458 miles over the course of eight months while the leak was present, and part of that time she was pregnant with the plaintiff.

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Earlier this month, the Eighth Circuit Court of Appeals decided a case in favor of a woman whose husband was killed when a gun in his friend’s possession accidentally discharged. The court’s opinion in the case, O’Neal v. Remington Arms Company, held that the plaintiff submitted enough proof of negligence on the part of the gun manufacturer for the case to proceed towards trial.

The Facts of the Case

According to the court’s written opinion, Remington used a “Walker trigger” in weapons dating back to 1971. At some point between then and now, Remington was made aware that there was a potential defect in the trigger mechanism, and that the gun may fire when the safety is turned off, even though the trigger was not pulled. Remington, knowing this, did not recall the roughly 20,000 rifles affected by the potential hazard and allowed them to remain for sale and in the market.

In 2008, the plaintiff’s husband went hunting with some friends. He loaned his Remington rifle to one of his friends. At some point on the hunting trip, the friend pulled the rifle out when he spotted a deer, and the gun accidentally discharged, killing O’Neal. O’Neal’s wife filed suit against Remington for the negligent design of the trigger mechanism.

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Although the tragic events happened two years ago, lawsuits are still being filed for damages resulting from the Sugarland concert stage collapse at the 2011 Indiana State Fair. The outdoor show stage area was suffering extensive wind gusts at the time. The temporary roof structure of the stage collapsed and landed among the crowds. Seven people were killed in the event and nearly 60 were injured.The Fireman’s Fund Insurance Company is the latest to file suit, only moments before the statute of limitations expired on its claims. The company was responsible for insuring the musical instruments and equipment of the bands, which all suffered extensive damage during the collapse. The lawsuit alleges negligence and products liability. The terms of the lawsuit allege that the stage rigging was not properly erected. The suit is naming a group of parties who were responsible for varying stages of constructing, erecting, and maintaining the stage.

Sugarland, a country music duo, had not yet appeared on stage but were finishing their warm-ups when the collapse occurred. Two months after the accident the band played a free concert in Indiana to support those affected by accident. A court date of February 2014 has been scheduled to determine whether the two members of Sugarland, Jennifer Nettles and Kristian Bush, may have any share of liability for the incidences of that evening.
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Conflicts between state and federal laws governing prescription drugs led the Alabama Supreme Court to rule that a plaintiff allegedly injured by a generic drug may sue the manufacturer of its brand-name equivalent. In re Wyeth, Inc., et al v. Weeks, No. 1101397, slip op. (Ala., Jan. 11, 2013). Because the plaintiff’s claim alleged deficiencies in the warning label, and not the manufacturing process, the court found that it was “not fundamentally unfair,” slip op. at 52, to hold the defendant liable. The defendant was responsible for drafting the warnings, and the generic manufacturer’s responsibility was to reprint those warnings. The ruling could affect state-level pharmaceutical cases around the country.

The plaintiffs, a married couple, filed suit against five pharmaceutical companies, alleging that the husband suffered injuries from taking the drug metoclopramide, marketed under the brand name Reglan. The drug is used in short-term treatment of various stomach and intestinal conditions, including persistent heartburn. It has been associated with a risk of tardive dyskinesia (TD), a neurological disorder that affects body movements. The plaintiffs allege that the defendants breached a duty to warn Mr. Weeks’ physician of the risk of TD and other side effects. They concede that he never took brand-name Reglan manufactured by Wyeth, but rather generic variants manufactured by other companies. The plaintiffs claim instead that Wyeth and other brand-name manufacturers “falsely and deceptively misrepresented or knowingly suppressed facts about” the drug. Id. at 6.
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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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