Products liability refers to the physical agent which caused the injury or death of the patient during treatment by the doctor. The injury or death of the patient may result from the unexpected byproduct of faulty, defective, or negligently designed medical or surgical instruments or inadequate operating instructions.
In such cases of products liability, the manufacturer becomes responsible for injury or death. The doctor must prove that the manufacturer departed from standards of due care, with respect to negligent design, manufacture, assembly, packaging, failure to test and inspect for defects, or failure to warn or give adequate instructions.
If the instrument functioned satisfactorily in previous operations or for several previous years in the hospital’s possession, it is a proof that it was not defective at the time of supplying.
Later, if the instrument develops a defect through ordinary and gradual wear and tear, or if the physician or the hospital misuses the manufacturer’s medical materials, the hospital or physician owner have Products liability for the failure to inspect, test and repair such defects.
But the Products liability is on manufacturer who becomes responsible, if the doctor can prove that the subsequent development of this defect was due to negligent design, structurally inferior component material, or improper assembly. An adequate warning cautions the user to follow directions, and may also notify the risk of disregarding directions.
The manufacturer of a drug keeps a “package insert” in the drug carton or attaches it to the label of the immediate container. It bears adequate information for its use, including indications, effects, dosages, routes, methods and frequency and duration of administration, and any relevant side-effects, hazards, contraindications and precautions under which registered practitioners can use the drug safely and for the purposes for which it is intended, including all purposes for which it is advertised or represented. The burden of proving the safety and effectiveness of a new drug or new uses of an approved drug rests with the manufacturer.
The manufacturer of medicines has a legal duty to use care in research and development of drugs. Products liability is on the manufacturer, if a patient is injured due to a drug reaction due to the negligence or breach of warranty on the part of manufacturer; The manufacturer is also liable due to the harm caused by the contamination, adulteration, incorrect dosage or mistaken labeling of a drug.
Once the physician has been warned about possible side-effects (that come in Products liability area), the manufacturer has no duty to ensure that the warning reaches the patient under normal circumstances. From the information received from the manufacturer, and other medical sources, the doctor is required to inform the patient of those reasonably expected side-effects likely to occur in the particular circumstances. The manufacturer is responsible for performing studies of its material when adverse reactions are reported in articles in scientific journals.
The result of these studies must be reported to the physicians. The manufacturer is not responsible for unforeseeable or unknown dangers in case of Products liability, it is unable to discover with reasonable care. If the doctor has or should have information, knowledge, or suspicion from any source that a certain drug is likely to produce serious side-effects, he may become legally liable for prescribing it, if any substituted drug would have been adequate and satisfactory.
The manufacturer, seller or anyone in the chain of sale, may be sued by the buyer (for Products liability), by another user of the material by some third party, whose bodily injury is caused by the product. The patient has to prove that a defect in production and testing in the material existed, before it left the manufacturer’s hands and that the defect was the proximate cause of the patient’s injury.
Evidence will have to be produced as to the drug’s physical and chemical qualities, so as to show a need to warnings. It would be defective, if a drug manufacturer knew or should have known the presence of certain adverse effects and then failed to warn. Causal connection should be established between the lack of warning and resulting harm to avoid Products liability case.
MEDICAL INDEMNITY INSURANCE under products liability
It is a contract under which the insurance company agrees, in exchange for the payment of premiums, to indemnify (reimburse to compensate) the insured doctor as a result of his claimed professional negligence. The objects of Medical Indemnity Insurance are:
(1) To look after and protect the professional interests of the insured doctor.
(2) To arrange, conduct and pay for the defense of such doctors.
(3) To arrange all other professional assistance including pre-litigation advice.
(4) To indemnify the insured doctor in respect of any loss or expense directly arising from actions, claims and demands against him on grounds of professional negligence, misconduct, etc.
When any dispute or allegation of negligence arises, the society must be contacted before any admissions or correspondences are entered into.
EUTHANASIA (mercy killing) as a part of Products liability
It means producing painless death of a person suffering from hopelessly incurable and painful disease.
(1) Active or positive.
(2) Passive or negative.
Active euthanasia is a positive merciful act (and may come under Products liability), to end useless suffering or a meaningless existence. It is an act of commission, e.g. by giving large doses of drugs to hasten death. Passive euthanasia means discontinuing or not using extraordinary life-sustaining measures to prolong life. This includes acts of omission, such as failure to resuscitate a terminally ill or hopelessly incapacitated patient or a severely defective newborn infant.
It is not using measures that would probably delay death and permits natural death to occur. Voluntary euthanasia means at the will of the person, and involuntary means against the will of the person, i.e., compulsory. Non-voluntary refers to cases of persons incapable of making their wishes known, e.g., in persons with irreversible coma or severely defective infants. Euthanasia advocates the administration of lethal doses of opium or other narcotic drugs. It has no legal sanction and may be charged under Products liability.
A person providing information to another with information, guidance and means to take his own life with the intention that it will be used for this purpose is assisted suicide.
Terminal sedation (that come in Products liability) includes the administration of morphine and similar medications, which has a dual effect of relieving of pain and hastening the death (aid-in-dying). If the patient requests the same medical treatment with its known dual effects, and if the physician knowingly provides that medication by prescription so that patient can end his life, it is considered physician-assisted suicide.
Netherlands and Belgium legalized euthanasia in persons above 12 years. Strict rules govern assisted suicide. Patients must face a future of unbearable, interminable suffering and must make a voluntary, well-considered request to die. Another physician must be consulted first and life must be ended in a medically appropriate way.
IATROGENIC DISEASES: Iatrogenic disease can be defined as a disease that results from administration of a drug, or medical or surgical acts for prophylaxis, diagnosis or treatment.
DEATHS DUE TO MEDICAL CARE (Products liability)
Deaths may occur due to:
(1) Complications of anesthesia.
(2) Complications of surgery.
(3) Nonsocial infections. The use and/or misuse of urinary catheters, techniques and equipment employed in intravenous therapy, hyper-alimentation, and respiratory therapy cause most of these infections.
(4) Therapeutic misadventure.
(5) Professional negligence (that come under Products liability).
- Administration of wrong dose.
- Pharmacist dispensing wrong medicine due to illegibility of the prescription.
- Abbreviations of drugs.
- Confusing patients with similar names and to administer the correct dose to the wrong patient.
- Susceptibility of children to medication errors.
- New approved drugs may result in death from side- effects undetected in the study population.
- Patient or specimen mis-identification in laboratory testing can lead to inappropriate and potentially life-threatening therapy.
- Errors in reporting abnormal values in electrolyte analysis.
- Mismatched blood transfusion.