FDA Warning: Diabetes Drug Actos

 

The FDA has issued a warning that there may be an increased risk of bladder cancer for patients who use the drug Actos for prolonged periods of time. Patients exposed to higher cumulative doses of the drug also appear to be at an increased risk of bladder cancer. The warning comes after a 5 year study of Actos by the manufacturer. Notice about this risk will be added to the Warning and Precautions section of the prescription label.

The FDA warns that Actos should not be prescribed to patients who either have bladder cancer or have a family history of bladder cancer. Recent studies in France support these findings and use of the drug Actos has been suspended in France.

The complete Safety Announcement can be found on the FDA website.

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Medical Malpractice: Breach of the Standard of Care

The fundamental issue in all medical malpractice cases is whether or not the health care provider breached the standard of care. According to Connecticut General Statute Sec. 52-184c, the plaintiff in a medical malpractice action must prove “by the preponderance of the evidence that the alleged actions of the health care provider represented a breach of the prevailing professional standard of care for that health care provider. The prevailing professional standard of care for a given health care provider shall be that level of care, skill and treatment which, in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar health care providers.” In other words, it is incumbent on the plaintiff to find a health care provider with training and experience in the same specialty or discipline who is qualified to establish the appropriate standard of care and is of the opinion that the defendant breached that standard.  Connecticut General Statute Sec. 52-190a mandates that a complaint for medical malpractice contain a certificate of good faith that “reasonable inquiry gave rise to a good faith belief that grounds exist for an action against each named defendant.”  The statute further requires the plaintiff to “obtain a written and signed opinion of a similar health care provider, as defined in section 52-184c, … that there appears to be evidence of medical negligence and includes a detailed basis for the formation of such opinion.” The three essential questions that arise in medical malpractice questions are: 1) What is the requisite standard of care, 2) did the health care provider deviate from that standard, and 3) was the injury caused by the deviation from the standard? Connecticut courts generally require the plaintiff to produce an expert witness who will testify to “both the standard of care to which the defendant is held and the breach of that standard.”  Vitone v. WaterburyHospital, 88 Conn. App. 347, 351 n. 5, 869 A.2d 672 (2005).

Medical Malpractice: Informed Consent

Informed consent pertains to the right of a patient to receive the information necessary to make an informed decision with regard to medical treatment or therapy. In the case of Canterbury v. Spence, 464 F.2d 772, 787 (D.C. Cir.), cert. denied, 409 U.S. 1064 (1972), the court specified the following elements which should be disclosed by a physcian: “1) the ‘nature’ of the procedure, 2) the ‘risks’ and ‘hazards’ of the procedure, 3) the ‘alternatives’ to the procedure, and 4) the anticipated ‘benefits’ of the procedure.”  The so called ‘lay standard of disclosure’ was followed by Connecticut in the case of Logan v. Greenwich Hospital Assoc., 191 Conn. 282, 293 (1982).  Connecticut courts continue to apply this doctrine of informed consent. In “’Logan v. Greenwich Hospital Assn. … we adopted a lay standard and stated that under the doctrine of informed consent, a physician is obligated to provide the patient with that information which a reasonable patient would have found material for making a decision whether to embark [on] a contemplated course of therapy. . . . We repeatedly have set forth the four elements that must be addressed in the physician’s disclosure to the patient in order to obtain valid informed consent… (1) the nature of the procedure; (2) the risks and hazards of the procedure; (3) the alternatives to the procedure; and (4) the anticipated benefits of the procedure.’”Levesque v. Bristol Hosp., 286 Conn. 234, 253 (2008).

 


Car Accidents: Uninsured Motorists Insurance

The medical costs for treating injuries sustained in a serious automobile accident frequently exceed the insurance coverage limits carried by most drivers. The law in Connecticut pertaining to uninsured and underinsured motorist coverage is found in Connecticut General Statute Sec. 38-336. The purpose of this statute is to provide protection in situations where motorists either do not have insurance or have inadequate coverage: “Each automobile liability insurance policy shall provide insurance, herein called uninsured and underinsured motorist coverage … with limits for bodily injury or death not less than those specified in subsection (a) of section 14-112, for the protection of persons insured thereunder who are legally entitled to recover damages from owners or operators of uninsured motor vehicles and underinsured motor vehicles and insured motor vehicles, the insurer of which becomes insolvent prior to payment of such damages, because of bodily injury, including death resulting therefrom …”  This type of coverage pays for injuries when someone is involved in an accident with a hit and run driver, or a driver whose policy limits are not high enough to cover the cost of the injuries. Uninsured motorist insurance also covers pedestrians or bicyclists who are struck by an automobile.