Articles Posted in Product Liability

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The Massachusetts Appeals Court recently assessed a summary judgment in favor of the defendant manufacturer in Niedner vs. Ortho-McNeil Pharmaceutical, Inc. (No. 15-P-1272). The estate filed suit against the makers of a birth control device that was prescribed and taken by a deceased college student. The woman was first prescribed an oral form of birth control in 2008, which she took but eventually discontinued. The young woman then looked for another form of birth control and was prescribed the Ortho Evra patch (patch), which transfers synthetic forms of estrogen and progestin through the skin. Rather than daily ingestion, this method only requires direct application to the skin once a week for three straight weeks, followed by a patch-free week. After taking this second round of hormonal birth control for three months, the young woman collapsed and died in her dorm room from a pulmonary embolism. The estate filed suit, alleging breach of warranty. The central focus of this breach of warranty claim was that the birth control manufacturer failed to adequately warn of the increased risks of suffering a blood clot.

By law, a manufacturer of a product with known dangers has a duty to warn consumers who will foreseeably come in contact with the product and be subjected to those dangers. (See H.P. Hood & Sons v. Ford Motor Co., 370 Mass. 69, 75 (1976).Birth Control If communication with a consumer is unreasonable, the burden of this duty is alleviated. Specifically, this comes in the form of the “learned intermediary rule,” under which the manufacturer is not as responsible for passing the knowledge of risks to the consumer if those risks are communicated to the physicians and pharmacists handling the drug. However, case law has shifted part of this duty back to the manufacturer as patient participation has increased and the medical supervision over commonly used products, like birth control, has decreased.

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In medical treatment, patients depend upon doctors and nurses to provide the best care available under the current standards of care. Patients also hope and expect the instruments and devices used by medical staff to work, aiding in their recovery. If one of these instruments or devices fails, a patient may experience a greater injury than the condition from which they suffered originally.  metal meshWhen this occurs, civil relief is available through a product liability lawsuit, as seen in Albright v. Boston Scientific Corporation (15-P-633). The injured patient, a lady from Ohio, filed suit against the manufacturers of the pelvic mesh surgically implanted to treat her Pelvic Organ Prolapse (POP). The injured woman had the mesh implanted to assist with weakened tissue in her pelvic area after a previous surgery provided minimal to no relief. Her surgeon implanted one of BSC’s devices, which was advertised as safe for treatment of POP. The FDA had cleared the device for sale, but through the § 510(k) process in which the device is substantially equivalent to another already on the market. Under the § 510(k) process, the device does not have to undergo clinical tests for approval. At trial, the injured patient provided expert testimony that concluded the mesh oxidized and reacted with the patient’s tissue in an unexpected, untested way. The trial court, however, excluded two letters from the FDA sent to the manufacturer, as well as the medical application caution sent by the supplier of polypropylene material, which addressed some of the potential issues with the mesh.

The injured patient appealed the exclusion of this evidence, which was offered for the limited purpose of showing knowledge and notice on the part of the manufacturer that they were aware of potential problems with the mesh’s material. Both sides offered witness testimony and opinion as to what caused the injury to the patient and whether the manufacturer should have known of the risks, based on the type of materials used. The injured patient and the manufacturer also presented evidence regarding whether or not the manufacturer advised her surgeon of the known risks in its use.

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In Massachusetts, the manufacturer of a product can be held strictly liable if the product was dangerous or defective enough to cause personal injury or death. With most personal injury cases, the injured party must show they were hurt by the negligent acts of another party. In strict liability cases, no fault or tortious intent needs to be shown. 1342025_63300207.jpgStrict liability exists if the product design was defective, the manufacturing process was defective, or the product had inadequate warnings or instructions advising of its correct use.

The Massachusetts Supreme Judicial Court recently dealt with inadequate warnings on a Children’s Motrin bottle in Reckis v. Johnson & Johnson (SJC-11677). In this case, a seven-year-old girl developed a life-threatening skin disorder, toxic epidermal necrolysis (TEN), after she consumed several doses of Children’s Motrin, an over-the-counter medication with the main ingredient of ibuprofen. The parents of the child filed a claim and won at the jury trial, where they were awarded general damages over $50 million to the child and loss of consortium damages of $6.5 million for each parent. The parent company and manufacturers that produce Children’s Motrin immediately filed an appeal, alleging they should have received a judgment as a matter of law due to pre-emption by the federal Food and Drug Administration (FDA) laws, an unqualified expert witness for the injured child, and grossly excessive awards that were unsupported by the record. After hearing all arguments, the Supreme Judicial Court affirmed the lower appellate and trial court jury award to the injured child and her parents.
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To succeed in a Massachusetts personal injury case, an injured person must show that the at-fault party was more than 50% responsible for the injuries suffered. In negligence actions, the defendant must owe a duty to the injured person, and the injured person is required to show that the defendant breached this duty and caused injury as a result of the breach. Recovery is possible, even if the injured person’s actions at the time of the accident contributed to the injury, as long as the percentage of responsibility remains lower than the defendant’s. This is known as comparative negligence, and it is codified under Ch. 231, Sec. 85 of the Massachusetts General Laws. While recovery is still possible, the amount of damages awarded can be reduced by the injured person’s percentage of negligence.

construction-workers-915305-m.jpgIn Rose v. Highway Equipment Company, the Appeals Court reviewed a man’s claim against the manufacturer of a broadcast spreader for negligence and breach of warranty. The man’s hand was severely injured following an accident with the spreader while oiling the chain. For the negligence claim, the jury found the injured man to be 73% negligent and the company to be 27% negligent, which precluded any recovery because he was deemed to be predominantly responsible for his own injuries.

For the breach of warranty claim, the jury found that the man was unreasonable in his use of the equipment. As stated in the opinion, breach of warranty actions generally focus on the nature of the product, not the actions of the user, unless the user acted unreasonably. If the injured person used the product after he or she knew it was defective and dangerous, the injured person is completely barred from any type of recovery. The appellate court upheld the jury’s determination against the injured person, finding there was enough evidence to support their decision. The testimony provided during trial revealed the injured person understood the dangerous nature of the project, failed to read the safety manual, and had oiled the machine several times.
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