Legal Claims and Lawsuits

In contrast to pharmaceutical companies, medical device companies benefit from a limited immunity from product liability lawsuits. This immunity stems for the Medical Device Amendment to the Food, Drug and Cosmetic Act. This immunity, however, does not completely foreclose liability when a patient suffers an injury as a result of the manufacturer's failure to provide a safe product.

In cases where a patient suffers an injury as the result of a medical device, the patient's most viable claims are often against the medical device manufacturer, the supplier or distributor, and perhaps the surgeon or physician who utilized the device. If a patient suffers complications, or injury, as in a case where a revision knee surgery is necessary to repair Smith & Nephew Oxinium component, the patient may have a claim based on the theory that the medical devise manufacturer, the distributor and/or the physician failed to properly warn the patient of the device's dangers or under a theory that the device was so unreasonably dangerous and that a safer, economic design could have protected the patient from the injury incurred.

A plaintiff in an action against a medical device manufacturer for failure to warn of unreasonable dangers associated with a medical devise has three theories of recovery - negligence, strict liability, and breach of implied warranty. In a negligence action, the court considers the liability of a medical device manufacturer in terms of duty. The question the court considers is whether the manufacturer had a duty to warn, whether the manufacturer breached the duty, and whether the medical device manufacturer's breach of duty caused the injury.

In a strict liability action the court assumes that the manufacturer knew the defects of the device, whether or not the manufacturer had actual knowledge that the device posed an unreasonable danger. Under strict liability, the plaintiff needs to establish that the danger resulting from the medical device manufacturer's failure to adequately warn rendered the medical device unreasonably dangerous and therefore defective.

Regardless of the theory on which a plaintiff relies, the plaintiff must establish that the medical device manufacturer had a duty to warn either the medical professional or, under limited circumstances, the consumer, of side effects. The plaintiff must also establish the standard of care the law requires the manufacturer to adhere to in fulfilling its duty to warn; the breach of the manufacturer's duty to warn by providing an inadequate warning; and the injury the plaintiff suffered as a result of the manufacturer's failure to warn.

The duty of the medical device manufacturer to warn of a device's dangers arises from the manufacturer's knowledge of the special risks of harm associated with normal use of the device. Thus, in order to establish a duty to warn of side effects, the plaintiff must prove that use of the device in question subjected the plaintiff to a risk of injury and that the manufacturer had actual or constructive knowledge of the risk. In the case of the Oxinium component, little is known about Smith & Nephew's knowledge concerning the loosening of the knee replacement.

In a product liability case the plaintiff attempts to show that a product was unreasonably dangerous. Such a theory of recovery comes from a recognition that when mass produced products are used in normal fashion and fail to perform as expected or when they are designed in such a fashion as to be unreasonably dangerous, a injured person need not prove that the manufacturer was negligent, but instead can hold the manufacturer legally responsible upon a showing that the defective product caused their injury. The difficulty in a product's liability case arises from the requirement that the plaintiff offer a safer, and economically reasonable, alternative design to the product that caused the injury.

The plaintiff in an action against Smith & Nephew for injuries caused as a result of their knee replacement, may recover for personal injury and other consequential damages including pain and suffering, long term disability, nursing care, other medical expenses, and loss of earnings. In cases against a manufacturer based on a theory of strict liability, rather than negligence, a plaintiff may not recover damages for emotional distress and mental anguish.


If you have undergone knee replacement surgery in the past few years you should ask your physician or surgeon whether the Smith & Nephew Oxinium Genesis II or Profix II knee system was used in your procedure. Under federal law, a physician or surgeon must provide this information to patients upon request. In addition, patients are entitled to review their medical records.

The law limits the amount of time after a patient incurs an injury for the patient to file suit. The amount of time varies based on the theory of liability and the state in which the patient files the suit. If you have suffered an injury as the result of the Smith & Nephew Oxinium knee replacement component, consult a qualified attorney. A qualified attorney can help you to understand your rights and options, and ensure that you have the opportunity to seek compensation for your injuries.

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