Articles Posted in Products Liability

A federal bankruptcy judge entered an order approving the total damage amount requested by the debtor, a company named as a defendant in multiple asbestos exposure lawsuits. In re Garlock Sealing Techs., No. 10-31607, order (Bankr. W.D.N.C., Jan. 10, 2014). The total amount available to claimants, who are acting as creditors in the bankruptcy proceeding, is $125 million, considerably less than the claimants’ estimate of more than $1 billion. In over thirty years, asbestos litigation in the U.S. has involved claims by hundreds of thousands of individuals against thousands of companies for injuries ranging from breathing difficulties to terminal cancer. The judge’s order in Garlock expressed concern in harsh terms over seeming inconsistencies in some plaintiffs’ exposure claims. The outcome of this proceeding should not impact litigation over other dangerous products, but this decision may already influencing other asbestos cases.

“Asbestos” refers to several minerals composed of long fibers, formerly used widely in construction for sound absorption, fire-proofing, and heat and electrical insulation. It was also used to insulate electrical wires in some consumer products. Inhalation of asbestos fibers over a sustained period of time has been linked to numerous adverse health effects. “Asbestosis” is the name given to respiratory complications associated with asbestos exposure, but it has also been linked to mesothelioma, a malignant type of lung cancer.

Litigation over asbestos exposure began in the early 1980’s and has involved an estimated 730,000 plaintiffs and 8,400 defendants. Insurance payouts for asbestos-related litigation totaled $70 billion as of 2002, according to one study. Defendants have included companies that mined asbestos, sold or distributed asbestos, produced building materials or consumer products containing asbestos, or owned property in which asbestos was present. Lawsuits have relied on both products liability and premises liability theories.

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A federal appellate court approved class certification and a settlement in a class action lawsuit based on the 2010 explosion and oil spill on an oil drilling rig operated by British Petroleum (BP) in the Gulf of Mexico. In re Deepwater Horizon, et al, No. 13-30095, slip op. (5th Cir., Jan. 10, 2014). The spill led to several hundred lawsuits by individuals and businesses claiming property damage, and by individuals claiming personal injury. The recent ruling rejected a request by BP to vacate the district court order approving the settlement. While this ruling specifically involves claims for property damage, BP’s claims and the court’s ruling could also apply to personal injury class actions.

BP operated, Deepwater Horizon, an exploratory oil drilling rig in the Gulf of Mexico, about forty miles south of Louisiana. The rig was drilling a well located at a depth of about 5,100 feet underwater. On April 20, 2010, a pocket of methane gas rose into the rig, ignited, and caused an explosion that killed eleven workers and injured over a dozen. Oil flowed from the well directly into the Gulf for almost three months releasing an estimated 205 to 210 million gallons. Oil washed ashore in Texas, Louisiana, Mississippi, Alabama, and Florida, resulting in widespread reports of injured and dead wildlife, property damage, and health problems among residents of the affected areas.

BP was named as a defendant in hundreds of lawsuits. The Judicial Panel on Multidistrict Litigation (JPML) consolidated many of the claims in In re Oil Spill by the Oil Rig “Deepwater Horizon,” No. 2:10-md-02179 (E.D. La.), in August 2010 in order to address common issues as efficiently as possible. BP established a fund to pay claims known as the Gulf Coast Claims Facility (GCCF), which would eventually pay out over $6 billion. Starting in 2011, the company negotiated with the plaintiffs in the JPML case to transfer claims from the GCCF to a court-supervised fund.

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The D.C. Circuit Court of Appeals rejected a challenge by the American Tort Reform Association (ATRA) to recent changes made to a federal regulation affecting hazardous materials. The Occupational Safety and Health Administration (OSHA) amended its hazard communication (HazCom) standard in March 2012. ATRA claimed that OSHA overstepped its authority, but the court disagreed. ATRA v. OSHA, No. 12-229, slip op. (D.C. Cir., Dec. 27, 2013). While the case involves a range of complex questions of regulatory law, the bottom line is that the ruling is good for personal injury plaintiffs. The HazCom standard mandates labeling and other warnings about materials known to pose health risks to workers and consumers. The court affirmed that it does not preempt state tort law, meaning that it does not prevent plaintiffs from recovering damages in a suit for injuries brought under state law.

OSHA has authority under the Occupational Safety and Health Act to promulgate regulations promoting workplace safety, but these regulations may not supersede or preempt state law claims for injuries or wrongful death. 29 U.S.C. § 653(b)(4). The HazCom standard, 29 C.F.R. § 1910.1200, requires classification of known hazards associated with exposure to chemical products and disclosure of those hazards to workers. This disclosure takes the form of labels placed on chemical containers and “safety data sheets,” along with programs for providing this information to employees.

Since the HazCom standard was first introduced in 1983, companies have had some leeway as to the format of the labels, but in 2012, OSHA issued a new rule standardizing all labels and data sheets nationwide according to the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals. It stated that the rule would preempt state and local laws and regulations relating to labeling requirements, but not state law tort claims, such as failure to warn and products liability.

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A whistleblower lawsuit accuses several government contractors of providing material used in bulletproof vests to law enforcement agencies around the country, despite allegedly knowing about defects in the material that caused it to degrade over time and offer reduced protection. The federal government intervened in the lawsuit, and recently obtained the court’s permission to amend its complaint. United States ex rel. Westrick v. Second Chance Body Armor, Inc., et al, No. 1:04-cv-00280, mem. op. (D.D.C., Dec. 30, 2013). The suit is based on the federal False Claims Act (FCA), so it does not expressly assert products liability claims for injuries allegedly caused by defective vests or body armor. FCA cases can benefit people who have suffered injury due to design, manufacture, or marketing defects by identifying and exposing evidence that helps their cases.

The U.S. District Court for the District of Columbia described the background of the case in an order denying a motion to dismiss brought by several defendants. United States ex rel. Westrick v. Second Chance Body Armor, Inc., et al, 685 F.Supp.2d 129 (D.D.C. 2010). In 1996, Second Chance Body Armor (“Second Chance”) entered into a contract with Toyobo, a Japanese company that manufactures textiles and fibers. Toyobo supplied Second Chance with Zylon, a synthetic fiber touted as durable, long-lasting, and heat-resistant. Second Chance manufactured Ultima and Ultimax bulletproof vests using Zylon, marketing them as the “world’s thinnest, lightest, and strongest armor” with the “world’s strongest fiber.” Id. at 132.

The two companies allegedly became aware in 1998 that Zylon fibers experienced significant degradation after “exposure to light, heat, and humidity,” id., but they did not issue warnings about their findings or recall any products. Second Chance discontinued selling vests made with Zylon, notified purchasers of the problem, and urged removal of Zylon vests from service after two police officers were killed in June 2003 when bullets pierced their vests. A study by the U.S. Department of Justice (PDF file) released in 2005 found that only four out of sixty armors met all of its performance standards in ballistics tests, and concluded that the chemical breakdown of Zylon fibers was the likely cause of the performance problems.

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The U.S. District Court for the District of Columbia handed down a case earlier this year, Johnson v. QUAKER OATS COMPANY, Dist. Court, Dist. of Columbia 2013, in which it reiterated the requirements regarding standing in order to bring a lawsuit.

The plaintiff filed a lawsuit against the Quaker Oats Company for allegedly misleading him “about the nutritional and health qualities of its chewy granola bars and instant oatmeal products that contain partially hydrogenated oil.” The plaintiff claimed that the defendant’s “wide-spread marketing campaign” touting the nutritional value of those products between November 1, 2005, and November 2010 “caused” him to pay a higher price for the products that he allegedly purchased from “various individuals” or “from a vendor in the District of Columbia.” He filed the lawsuit under the District of Columbia Consumer Protection Procedures Act, claiming damages in excess of $90,000.

The Quaker Oats company filed a motion to have the case dismissed under the Federal Rule of Civil Procedure 12(b)(1), for lack of jurisdiction on the ground that plaintiff lacks standing, and under Rule 12(b)(6) for failure to state a claim upon which relief can be granted.

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Johnson & Johnson has reportedly reached a tentative agreement in regards to a class action lawsuit involving the Articular Surface Replacement, or A.S.R., the all metal hip replacement sold by DePuy which allegedly caused widespread health complications in patients who received the device.

The tentative agreement, which requires court approval, could potentially reach $ 4 billion, making it one of the largest settlements for a medical device product liability lawsuit ever.

The payout, which would apply only to individuals who have already needed to have the device removed and replaced with another artificial hip, would result in an average compensation award of approximately $350,000 per patient. The exact amounts will vary for each individual based on various factors.

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A tool believed to help make seniors safer by keeping them from falling out of their beds, may actually be more dangerous than perceived. According to several accounts, thousands of frail, confused or elderly people have been injured and hundreds killed after becoming trapped in safety rails installed to keep them from falling out of bed.

The danger happens when the elderly individual falls asleep, and then rolls over in their sleep, becoming entrapped by the bedrail, either stuck in the device itself, or pinned between it and the mattress. Unable to break free, the individuals die from suffocation.

According to reports, there are currently no mandatory federal safety standards for bedrails designed for and marketed towards the eldery. This is in stark contrast to children’s cribs and bedrails, which by law must meet certain design criteria and pass safety tests.

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A Pennsylvania jury recently awarded a man $1.3 million for the severe injuries he sustained as a result of a fall as he was attempting to repair a 40 foot tall cell phone tower.

The lawsuit was initially filed in February of 2002, following an incident that occurred in September of 2000, when the man’s safety equipment, allegedly a defective hook on a rebar assembly, proved defective, and resulted in a bone-crushing fall that rendered him unable to work, probably for the rest of his life. He was overseeing the construction of a 350 foot communications tower.

The failed equipment caused him to fall almost straight to the ground, where he landed on his feet. As a result, he had to undergo at least nine surgeries, including three or four fusions on his right ankle and two on his left, including a more recent one on his elbow for a pinched nerve. As a result, both of his feet are fused to his ankles, his heels have screws in them, and he cannot flex or turn them. His shoes have springs in them because his feet don’t have the natural roll when he walks. He also has screws in his left elbow. He also underwent over a year of physical therapy just to walk again. He also continues to deal with pain relating to all of his injuries.

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According to reports, The Food and Drug Administration (FDA) has sent a warning letter to Intuitive Surgical, Inc., the makers of the da Vinci surgical robot, notifying the company that it violated federal procedures by circumventing the requirement of notifying the FDA prior to notifying its customers regarding problems with its product.

The FDA’s “483” letter, which has not yet been published on the agency’s website, reportedly states that during an almost two year period, the company received some 134 complaints and 83 medical device reports related to “tip cover issues” with the product.

Following these complaints, the company then allegedly sent its consumers a letter with suggestions and recommendations regarding the usage of its equipment. The letter was reportedly in response to complaints regarding arcing that was occurring in the case of damaged tip covers, which resulted in patient injury. Arcing occurs when electrical currents transfer inside of someone during the course of a surgery, somewhat like an electrical shock. The company failed to notify FDA prior to sending out the communication to its customers.

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The U.S. Supreme Court ruled recently regarding the liability of a generic drugmaker whose pain reliever left a woman severely disabled.

The lawsuit itself, Mutual Pharmaceutical Co., Inc. v. Bartlett, centered on the fact that the label for the anti-inflammatory did not carry a warning regarding the potential rare side effect of developing Stevens-Johnson syndrome (SJS), which is precisely what happened to the plaintiff in the case. It also accused the maker of producing a dangerous product. The plaintiff’s reaction was so severe, that she developed toxic epidermal necrolysis, spent 10 weeks in the hospital, suffered two incidents of septic shock, suffered burns to 60% of her body, endured a medically induced coma, and required 12 separate eye surgeries.

At the time the plaintiff took the medication, the label did not have a warning regarding the risk of SJS, although the package insert did. Following the ordeal, the FDA recommended that all drugs within this class (non-steroidal anti-inflammatory or NSAID) carry a warning regarding toxic epidermal necrolysis.

The plaintiff in the case sued the drug manufacter, claiming that the drug was defectively designed. A lower court awared her $21 million in damages, including amounts for pain and suffering, loss of enjoyment of life, and past and future medical expenses. The drugmaker appealed, alleging that federal law preempts lawsuits for the defective design of drugs against generic drugmakers; the argument being that the original manufacturer designed and sought approval from the FDA for the chemical makeup of the drug. There were also allegations regarding the label, which the drugmaker challenged on the same grounds.

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