Articles Posted in Product Liability

The manufacturer of a product can be held accountable for a consumer’s injury if the company failed to warn of side effects. Federal law requires manufacturers of a generic drug to provide users with the same warning as the brand name product. Massachusetts’ highest court recently issued an opinion outlining when and how an injured patient can pursue a Massachusetts product liability action against the brand name manufacturer after she or he has been injured following the use of a generic prescription. The court ultimately concluded an injured patient is precluded from pursuing a negligence action against the brand name manufacturer, nor are they able to bring or join a class action claim.  However, an injured patient is able to pursue a claim of recklessness if there was an intentional failure to to update the label when the company knew or had reason to know of an unreasonable risk associated with the use of its product, since federal law requires generic medication to use warnings identical to brand name drugs.

Drug manufacturers that innovate a new product must go through a rigorous approval process overseen by the Food and Drug Administration (FDA). Drugs must be safe and effective, and they must come with a label that is accurate and adequate. The process is lengthy and expensive. In order to provide lower-cost alternatives, the U.S. Congress enacted legislation that allowed generic drugs to use an abbreviated application process as long as their product was the “bioequivalent” of its brand name counterpart. The generic manufacturer must then use the same warning label as the brand name. To balance the brand name’s research and development interest against the public’s need for affordable medicine, the brand name manufacturer enjoys an extended patent monopoly while simultaneously shouldering greater responsibilities for the adequacy and accuracy of its warning label. Generics cannot change their label without approval, but brand names can.

The case at hand arose from the use of a generic drug prescribed to treat protastic hyperplasia in those who have an enlarged prostate. After the patient began the use of this drug, he experienced several side effects, including erectile dysfunction and a decreased libido. These side effects persisted and worsened, even after he ceased taking the medicine. Eventually, the patient was diagnosed with an androgen deficiency and hypogodanism, which was connected with his use of the generic prostate drug. The condition continued and could potentially continue indefinitely. The warning label, styled after the brand name drug, warned that sexual side effects could occur but would stop after use of the drug ceased.

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The doctrine of spoliation is a legal concept developed through case law that allows trial court judges to sanction a litigant who intentionally or negligently loses or destroys evidence that they knew or should have reasonably known may be relevant to a possible Massachusetts personal injury case. This doctrine may be applied even when the spoliation occurs prior to the filing of a civil action. An appellate court in Massachusetts looked at spoliation in a negligence action stemming from a choking incident at a public school.

The case was filed after a young school child choked on meatballs served at the cafeteria in a public school.  He began choking at the end of his lunch period, and several attempts using the Heimlich maneuver and back blows proved to be unsuccessful. The food was eventually dislodged by professional emergency staff, but the child had been without oxygen for too long and sustained catastrophic brain injuries. The parents filed suit against the school and the company that manufactured the meatball.

The company that made and sold meatballs to the public school system utilized a protein solution to meet the required level of protein. The injured child’s parents asserted the use of this solution caused the meatball to have an unreasonably dangerous texture, creating a choking hazard. An expert hired by the plaintiffs recreated the meatball using the formula provided by the defendant company through interrogatory answers. At trial, the expert opined the meatball was harder to break apart and chew than others without this protein solution. The plaintiffs’ expert stated the size and texture of this meatball presented a choking risk to children.

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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.  When 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. Strict 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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