Judge’s Order Nullifies $6.5 Million Verdict in Diabetes Drug Trial

In a May 1, 2013 press release Takeda Pharmaceuticals announced that the trial court judge granted the defendant’s motion for non-suit. The ruling nullifies the April 26th jury verdict.

A Los Angeles Superior Court jury awarded $6.5 million to the plaintiff Jack Cooper in the first trial involving the diabetes drug Actos (Cooper v. Takeda Pharmaceuticals America, Inc., CGC-12-518535). The jury found Takeda Pharmaceuticals liable for the failure to warn patients that Actos could cause bladder cancer. The verdict awarded $5 million in compensatory damages to Jack Cooper and $1.5 million to his wife. As many as 3000 similar lawsuits are pending in the United States.

According to the attorney representing Cooper, the Japanese drug company was aware of possible links between Actos and bladder cancer as early as 2004. However, the company waited 7 years before reporting these findings to U.S. regulators. In 2011 Actos was removed from the market in both France and Germany after studies revealed that some patients using Actos have increased risk of developing heart problems and bladder cancer.

In 2012 the British Medical Journal reported that patients who use Actos for 2 years are twice as likely to develop bladder cancer. In the same year  the Canadian Medical Association Journal published the results of a study showing that users of Actos have a 20 percent increased risk of developing bladder cancer. Canada has since removed Actos from the list of approved medications.

A “black box” warning, the strongest of the FDA warnings, informing users that Actos is linked to congestive heart failure was added to the label in 2007. In 2011 an FDA Safety Announcement informed the public that the use of Actos for more than one year might result in “increased risk of bladder cancer”. The announcement required the drug manufacturer to add this warning to the drug label.

In response to FDA demands, Takeda launched a ten year study addressing the long term risk of bladder cancer associated with Actos. Data from the first five years of the study showed that patients taking the drug for over a year have a 40 percent higher risk of developing bladder cancer. The study was completed in 2012 and the full results should be available sometime in 2013.

Defensive Medicine and Rising Health Care Cost

surgeryDespite assertions that large medical malpractice payouts are largely responsible for the rising cost of health care, a new study by doctors from Johns Hopkins suggests that these claims are mistaken. The research revealed that malpractice payouts account for less than 1 percent of medical expenditures in the United States. The study, directed by Dr. Marty Makary, associate professor of surgery and health policy at Johns Hopkins University School of Medicine, reviewed nationwide medical malpractice settlements and judgments from 2004 to 2010.  According to Makary, the data shows that legal reform efforts should focus on curtailing defensive medicine rather than establishing caps on malpractice awards and settlements. “The real problem is that far too many tests and procedures are being performed in the name of defensive medicine, as physicians fear they could be sued if they don’t order them. That costs upwards of $60 billion a year. It is not the payouts that are bankrupting the system — it’s the fear of them.” Makary maintains that the findings support the need for more research to determine procedures to prevent catastrophic errors and improve patient safety. He also asserts the need to reduce unnecessary diagnostic tests and procedures as a means to lowering health care cost.

Click here for more details about the study.

U.S. Supreme Court Ruling Blocks State From Recovering One-Third of Disabled Teens Settlement

Seal of U.S. Supreme CourtIn the U.S. Supreme Court case of Wos v. E.M.A., (No. 12-98, March 20, 2013)  the court ruled that the Federal Medicaid Act pre-empts a state’s authority to recover a portion of a Medicaid beneficiary’s personal injury settlement  when the settlement does not designate the amount attributable to payment for medical care. The ruling prevents North Carolina from being reimbursed for the $1.9 million that was spent on a child’s medical treatment.

The 13-year old girl in this case, identified as E.M.A., suffered severe injuries during her birth. In 2003 E.M.A. and her parents filed a medical malpractice lawsuit. Although expert witnesses estimated the damages to be in excess of $42 million, the insurance policy limits of the physician and the hospital largely determined the amount of the settlement. After the family settled the case for $2.8 million, the State of North Carolina claimed a third of the settlement.  The law of North Carolina allows for the Medicaid program to recover up to one-third of the total amount of any settlement or judgment in a medical malpractice case. However, the settlement did not identify the amount of the $2.8 million that accounted for medical vs. non-medical damages. The trial court ordered that one-third of the settlement be placed in escrow pending the determination of  how much the North Carolina Medicaid program was entitled to be re-imbursed.

The U.S. Supreme Court held that the law of North Carolina conflicts with the federal statute.  “The Medicaid anti-lien provision prohibits a State from making a claim to any part of a Medicaid beneficiary’s tort recovery not ‘designated as payments for medical care.'”

Hospital Safety Scores Updated

health care providers washing handsLeapfrog Group, an independent national nonprofit organization, recently concluded a study on Hospital Safety. With a focus on quality and affordable healthcare, the group launched the Hospital Safety Score project in June 2012. Hospitals were graded based on “preventable medical errors, injuries, accidents, and infections”. Of the 2618 hospitals studied, 790 received an A, 678 earned a B, 1004 earned a C, 121 earned a D, and 25 received a failing grade. Both Massachusetts and Maine demonstrated exceptional safety results with 83% of Massachusetts hospitals and 80% of Maine hospitals earning an A score.

Consumers are able to check the safety score of their local hospitals at Hospital Safety Score. For a summary of the Leapfrog Group study go to : http://www.leapfroggroup.org/policy_leadership/leapfrog_news/4971031

The Leapfrog Group encourages people who have been hurt by errors or accidents at a healthcare facility to share their stories with ProPublica, an independent organization that investigates patient safety concerns. People who wish to contact ProPublica may call the organizations hotline at (917)512-0241 or visit the online interactive web survey at: http://www.propublica.org/article/patient-harm-questionnaire.

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).