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Posts Tagged ‘strict liability’

The doctor who gives you an experimental drug or unauthorized medical treatment is like the owner of a wild animal. Everyone knows that wild animals, like tigers or alligators, can be

dangerous and may attack if they get a chance, so they are not

allowed even one bite. The first time a wild animal attacks somebody, the owner is liable, because he should have expected it and taken precautions to protect the public. Any drug, treatment, or device that has not been approved by the Food and Drug Administration (FDA) is like a wild animal. The doctor does not have to know that you might react badly. He is exposing you to an unnecessary risk just by using it. If it injures you, he is liable.

What if you got an experimental or unauthorized drug from a friend, who brought it into the U.S. from another country? It is possible, but not very likely, that the government might prosecute her for practicing medicine without a license. But, you are out of luck. Since she did not hold herself out as a doctor, there was no doctor-patient relationship and no standard of care. You have only yourself to blame for taking professional advice and medicine from a layperson.

If a doctor is going to use a risky or experimental drug, an unauthorized medical treatment or device, he has to explain it carefully and have you sign a special consent form, which outlines all the risks and why it is necessary to take extra risks in your case. If the risks are not fully explained, and you do not consent with your eyes wide open and it harms you, you can sue in strict liability without having to show that the doctor did anything wrong, other than give you a drug, medical treatment, or device that was not approved as safe, or for a particular use, by the federal government.

In tort law, the stream of commerce theory refers to a principle that a person or entity that participates in placing a defective product in the general marketplace is strictly liable for harm caused by the product.

A Mississippi woman was give

n a vitamin shot in a doctor’s office and developed a severe infection with permanent scarring at the site of the injection. She claimed the injection had been contaminated and sued both the doctor and the manufacturer of the vitamin solution. The manufacturer said that nobody had tested the vial to show the vitamin solution was actually contaminated. However, the court said the injury was of the type

caused by a contaminated injection. The manufacturer was held liable under strict liability.

In a Texas case, a vial of medicine to be used in an eye operation was sterilized by placing it in a pan of strong formaldehyde solution. When the drug was drawn out of the vial and into a syringe, it was contaminated with the formaldehyde and caused serious eye damage. The patient sued the hospital and won. The court said that the hospital had made an implied warranty that the drug was fit for use in the eye. When it injured the patient, the hospital was liable. The woman could also have sued the manufacturer.

In a Nebraska case, a woman fell and fractured her hip. The doctors put in a prosthesis (artificial hip joint) that broke because of a manufacturing defect and had to be replaced. During the second operation, the patient died of a pulmonary embolism (blood clot to the lung). Since the second surgery would not have been necessary, if the prosthesis had not been defective, the family sued the manufacturer. They also sued the hospital as the retailer, because it had charged her insurance company for the prosthesis. Some surgeons buy their own surgical implants. If that had happened in this case, the doctor could have been held liable as the retailer. However, since he had not, and the patient’s death was not due to medical malpractice, the doctor was not sued.

There is an important exception to the stream of commerce theory. If a piece of equipment has been changed or modified in any way, after it was bought, that may cut off the liability of the manufacturer and everybody else “upstream”, who are only responsible for the device as it was sold. The people who altered it would be the only ones liable, especially if the alterations or repairs played any part in the injury. If the wheelchair’s brakes in the Wisconsin case we discussed earlier had failed because a hospital repairman had worked on them, the hospital would have been liable for the faulty repairs, and the manufacturer would have been cleared.

In some defective product cases, you can also sue the doctor for malpractice, if he had anything to do with it. An eye specialist in Illinois was implanting an artificial lens after removing a cataract. When he got the cataract ou

t of the patient’s eye, he found that the implant he planned to use was defective and could not be inserted. Since the hospital did not have a replacement available, he could not finish the operation. He had to sew up the eye without the implant and do a second operation, which went wrong and

resulted in permanent loss of vision. The court held that the manufacturer and the hospital were liable to the patient, for selling a defective product to the hospital, even though they never had anything to do with the patient.

Could the patient also sue the doctor? Yes. There is always the chance that a surgical implant will be found to be defective, damaged in handling, or accidentally contaminated, so it cannot be used. A patient obviously cannot be kept on the operating table under anesthesia, while the factory ships a replacement. So, the surgeon and the hospital have a duty to be sure that a sterile back-up is available in the operative room in case anything happens. But, that is malpractice, which is different from the strict liability we are discussing. The patient would have to show they were both guilty of negligence and failed to anticipate the mishap, which would not be too difficult.

What if you do not find out you were injured by some machine or device until a long time later, when the product that injured you has been thrown away and can no longer be examined for flaws? What if the defective wheelchair, the contaminated injection vial, or the short-circuited heating pad have been thrown away by the time your lawyer asks to have them examined? How can you prove you were injured?

The Rule Is: It does not matter. All you have to do is show your injury was of the type that could have been caused by such a defective product. Then the defense has to prove that it was not. You do not have to produce the actual item that harmed you, especially if you can show that it is no longer available.

There is a time when you do not have to prove that anybody did anything wrong. That is when you are injured by a defective product, whether it is a surgical instrument, an electrical or mechanical device, splint, or an implant. Let us say you ha

d a severe burn from an electric cautery during surgery, or your hip implant broke, or your spouse had a fatal heart attack because of a defective pacemaker. All you have to show is the product or medicine was defective or harmful, and you were injured. You do not have to show there was medical malpractice or dental malpractice.

Years ago, if a manufactured product injured someone, the only person who could bring a lawsuit was the person who had bought the product. If it injured anyone else, there was nothing they could do about it, because the law said they did not have what lawyers call Privity of Contract with the manufacturer. The manufacturer was only responsible to the people who bought its product and did not have any responsibility for other people who might use it and be injured.

In an old Wisconsin case, a mother and her infant were leaving the hospital in a hospital wheelchair. The brakes were defective and allowed the wheelchair to roll into the street, where it was hit by a car. The infant was killed. When the parents sued the company that made the wheelchair and the hospital, the judge dismissed the suit. He said the company had no responsibility to the parents, because it had not sold them the wheelchair. The hospital was not liable, because it had not manufactured the wheelchair and did not know it was defective.

That theory no longer applies to injuries caused by a defective product. Today, if you are injured by a manufactured product or device, and not by someone’s actions, every person who had anything to do with the accident can be sued under what is called the theory of Strict Liability. Lawyers call it the Stream of Commerce, because a manufactured product is like a log put into a fast-running river that crashes into things as it is swept downstream. Anyone who is damaged by it, even a thousand miles downstream, has a claim against the person who put it into the water. Once a defective product is sold

to the public, there is no way of knowing who will use it or where it will end up. So, the law says that everyone who had anything to do with putting it into the Stream of Commerce has a responsibility for whatever damage it does and can be sued by anybody who is injured by it. Under today’s law, the Wisconsin parents would be able to sue the manufacturer, wholesaler, retailer of the wheelchair, and the hospital.

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