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

Despite 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.

Japanese Automakers Recall Over Three Million Cars Due to Risk of Airbags Exploding

Several of Japan’s largest carmakers announced on Thursday, April 11th, the recall of 3.4 million vehicles because of a defect in the passenger side airbags. According to a recent news release posted by American Honda, “it is possible that the passenger front airbag inflators in affected vehicles may deploy with too much pressure, which may cause the inflator casing to rupture and could result in injury.” The recall affects top-selling Japanese cars including, but not limited to, the Toyota Corolla and Camry, the Nissan Maxima, and the Honda Civic and Odyssey. Both Honda and Toyota have received reports of incidents where the airbag deployed under pressure and the casing ruptured. However, there have been no reports of injuries or deaths.

The airbags were supplied by Japan’s Takata Corporation, a company that supplies airbags and seatbelts to many of the major automobile manufactures, including Toyota, Honda, Nissan, Mazda and Ford. According to news releases, all of the vehicles covered by the recall are model years 2000 to 2003. Toyota is expected to recall over 1.7 million cars manufactured between 2000 and 2004 that were sold in North America and Europe. Honda is recalling about 1.14 million vehicles, Nissan is recalling 480,000 vehicles, and Mazda is recalling 45,500 cars, all sold worldwide.

Consumers can find out if their Toyota or Honda is affected by the recall by going to the company’s  website and entering the vehicle identification number.

Source: U.S. News & World Report, April 11, 2013; Reuters, April 11, 2013

Proposed Legislation to Require Connecticut Workers’ Compensation Benefits to Include Coverage for PTSD

Following the Newtown school tragedy, a number of emergency response workers and teachers were unable to return to work because of the emotional repercussions of what they witnessed at the scene. In response, the Connecticut Labor & Public Employees Committee introduced Senate Bill No. 823, “An Act Concerning Severe Mental or Emotional Impairment and Workers’ Compensation Coverage”.  The legislation would amend the Connecticut workers’ compensation laws to allow for claims based on emotional trauma. The current law limits workers’ compensation claims to workers who suffer physical injury. If the physical injury also results in emotional pain and suffering, the claimant may also collect for these injuries. The amendment, if passed, will most likely restrict claims based on emotional trauma to employees who are exposed to death or maiming while at work.

The Connecticut Office of Legislative Research provides the following summary of the pending legislation:

“This bill makes an employee eligible for workers’ compensation benefits if:

1. the employee’s employment caused the employee to witness the death or maiming, or immediate aftermath of the death or maiming, of at least one person;

2. the death or maiming was caused by an intentional act of another person, and not a natural cause; and

3. a licensed and board certified mental health professional diagnoses the employee with a mental or emotional impairment and determines that the impairment originated from the employee witnessing the death or maiming, or its immediate aftermath.

Except for special circumstances related to police officers and firefighters, current law does not provide workers’ compensation benefits for mental or emotional impairments unless they stem from a work-related physical injury or occupational disease.

The bill also extends all workers’ compensation benefits to (1) police officers who suffer a mental or emotional impairment caused by using, or being subjected to, deadly force in the line of the duty and (2) firefighters diagnosed with post-traumatic stress disorder caused by witnessing the death of another firefighter in the line of duty. Current law limits the benefits in these instances to treatment by a psychologist or psychiatrist approved by the Workers’ Compensation Commission.”

The Connecticut Conference of Municipalities is opposed to the bill largely because of the likely impact on municipal budgets. There is also concern that the changes would result in abuse of the workers’ compensation system by workers who witness trauma at work and file fraudulent emotional distress claims. The Insurance Association of Connecticut (IAC) is also opposing the legislation.

To read the full text of the bill see File No. 53 at the Connecticut General Assembly website.

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

In 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.'”

Dozens of Lawsuits Allege Serious Risks Associated with Mirena IUD

Manufactured by Bayer Healthcare Pharmaceuticals, the Mirena IUD was approved by the FDA in 2000 as a contraceptive and later as treatment for heavy bleeding after childbirth. The device is used by more than 2 million women in the U.S. and 15 million women worldwide. Although considered a safe form of birth control, the FDA has received thousands of reports from women claiming they have suffered serious complications from the device. Recent lawsuits allege that women who use the contraceptive are susceptible to the following risks:

• Perforation of the uterine or cervix wall
• Embedment in vaginal tissue
• Pelvic inflammatory disease
• Ovarian Cysts
• Migration out of the uterus which can result in infection or other injuries

Of the nearly 3 dozen lawsuits filed, the primary allegation is perforation of surrounding tissue.  According to the lawsuits, Bayer Healthcare Pharmaceuticals knew or should have known about the risks and neglected to provide adequate warnings to the medical community. Plaintiffs allege that the company withheld information about the risks and made false and deceptive representations concerning the safety  of the device. Although the FDA has not yet recommended a recall of the Mirena IUD, it appears likely that the manufacturer will be required to alter the warning label to include more comprehensive information about potential risks.

Click here to access the FDA’s description of the Mirena IUD, including side affects and risks.

Metal-on-Metal Hip Replacement Lawsuits

Johnson & Johnson is facing up to 10,000 law suits due to the failure of the all metal DePuy ASR hip implants. The implants were recalled in 2010 following acknowledgement on the part of Johnson & Johnson that the devices had a higher than expected failure rate. Internal documentation revealed that the company’s own estimates predicted that 37% would fail within 4.6 years. As many as 93,000 ASR hip implants were sold prior to the 2010 recall.

The first of these cases is currently being tried in Los Angeles Superior Court. The Plaintiff alleges that the defective implants released toxic amounts of metal ions causing a form of metal poisoning.  Johnson & Johnson maintains that the levels were not high enough to cause health problems. Surgeons have predominantly stopped using metal on metal devices because of evidence that the components grind together and release metal debris, resulting in damage to tissue and bone.

Last month Johnson & Johnson recalled a  2nd type of metal hip implant that is sold outside the United States. The recent recall applies to the Adept metal-on-metal hip replacement device. Research shows that these devices need to be replaced after about 7 years in 12 % of the patients. Most hip implants are made with metal and plastic and often last up to 15 years.

For more information about problems associated with these devices and the recalls visit the FDA Metal-on-Metal Hip Implants page.

Hospital Safety Scores Updated

Leapfrog 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.

Chrysler Recalls Jeep Sport Utility Vehicle Due to Airbag Defect

According to documents filed with the National Highway Traffic Safety Administration (NHTSA), Chrysler has announced a recall of 744,822 Jeep Grand Cherokee and Liberty SUVs due to a defective airbag control module. A component within the module may fail and cause the front, side curtain air bags, and/or seatbelt pretensioners to deploy during normal operation of the vehicle. “Inadvertent deployment of the airbags may increase the risk of injury and the possibility of a vehicle crash.” The recall pertains to model years 2002 through 2004.

The NHTSA investigation of this problem has revealed 215 cases where the airbags inflated inadvertantly, resulting 81 minor injuries.

Chrysler plans to correct the problem by installing a supplemental jumper harness to the control module, at no cost to the vehicle owner. The recall is anticipated to begin in January 2013. Owners of 2002-2004 Jeep Grand Cherokees and 2002-2003 Jeep Liberty SUVs who have questions should contact Chrysler at 1-800-247-9753 and reference recall #M35. Owners may also contact the NHTSA hotline at 1-888-327-4236 or visit safercar.gov and enter NHTSA ID No. 12V527000.

Death Toll for Meningitis Outbreak Reaches 23

On Monday, October 22nd, the CDC announced that 3 more people have died from the national meningitis tragedy, bringing the total deaths to 23. There have now been 297 non-fatal cases, and of the approximately 14,000 people who received the contaminated steroid, 12,000 have been contacted.

The FDA is currently investing two additional drugs made by the New England Compounding Center (NECC) that appear to be linked to the fungal meningitis outbreak. They have received reports of two heart transplant patients who developed fungal infections after being given one of these drugs during surgery. The NECC has recalled all of the drugs produced at the facility and has surrendered its state license.

According to recent press reports, a 2006 investigation of the NECC revealed inadequate contamination controls along with other insufficiencies related to operation procedures. The House Committee on Energy and Commerce has requested up to 10 years of records from the drug company. Furthermore, two members of the House Oversight Committee appealed to the Government Accountability Office to investigate the pharmacy compounding industry with a goal to reforming state and federal rules so as to prevent this type of tragedy in the future.

On Tuesday, October 23rd, Massachusetts launched a criminal investigation into the specialty pharmacy. The Massachusetts Office of Health and Human Services started investigating the pharmacy on September 26 and the “Preliminary Investigation Report of NECC” is now available online.