Massachusetts Injury Lawyer Blog

After years of close monitoring and label changes for Multaq, the Food and Drug Administration (FDA) has issued a new warning that the heart drug places some patients at an increased risk for serious cardiac events including death.

Multaq is used to treat various conditions, including patients with permanent Atrial Fibrillation (permanent AF). This is the most serious form of AF, which is an abnormal heart rhythm. The two other types are paroxysmal AF and persistent AF.

Permanent AF is a chronic condition in which sinus rhythm cannot be sustained despite treatment.

The FDA issued its Dec. 19, 2011 safety notification based on its monitoring of a 10-year study. In the communication, the FDA stated Multaq doubles the rate of cardiovascular death, stroke and heart failure in patients with permanent AF. The FDA advised healthcare professionals to:

• Not prescribe Mutlaq to patients with AF who cannot or will not be converted into normal sinus rhythm (permanent AF).
• Monitor heart rhythm by electrocardiogram at least once every three months.
• If the patient is in permanent AF, Multaq should be stopped or the patient should be cardioverted.
• Multaq is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of non-permanent AF.
• Patients prescribed Multaq should receive antithrombatic therapy.

The study the FDA acted on was called called the Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS). The study was stopped early in July 2011. The FDA said it will release more information as it becomes available.

Multaq Background
Dronedarone is the generic name for Multaq. It was approved by the FDA in 2009 to treat several conditions, including permanent AF. Manufactured by Sanof-Aventis, the drug has been prescribed to 500,000 people around the world.

Since 2009, Multaq has been subject to several FDA actions, including in 2010 a revised warning noting cases of worsening heart failure in some patients. In February 2011, the FDA changed the warning label to state that Multaq should be discontinued if liver damage is suspected.

Related Blogs and Websites

• Actos: FDA Warning About Bladder Cancer
• DePuy Hip Recall: Insurers Seek to Collect Settlements
• Transvaginal Mesh: What to Know If You've Been Injured

Continue reading "Multaq Heart Drug Warning from FDA" »

A ban on using hand-held cell phones behind the wheel was approved by the Massachusetts Legislature's Joint Transportation Committee this week.

On Thursday, the committee voted 8-0 to move forward the bill which advocates say will reduce car accidents, driving injuries and motor vehicle deaths. Some lawmakers did not vote on the ban, which was also discussed in 2010. That year, a new law took effect to reduce motor vehicle accidents by banning drivers under 18 from using cell phones to talk or text. All other drivers were banned from texting while driving.

Under the proposed cell phone ban, drivers would still be allowed to use hands-free cell phones with Bluetooth and other devices. Many safety advocates say hands-free cell phones are safer and this type of ban will help police better enforce the law. Right now, police say it is difficult to differentiate between drivers dialing a phone number and sending a text message.

As a result, police only wrote 1,100 tickets for texting while driving in the law's first year, according to the Department of Transportation. This averages one for every 200 speeding tickets issued among Massachusetts' 4.7 million drivers in the same period.

The hand-held cell phone ban will now be sent to the Massachusetts House of Representatives and Senate. The Ways and Means Committee may also consider the financial aspects of it.

If approved, Massachusetts will become the 10th state to ban any type of cell phone use while driving.

The national debate over cell phone use and car accidents has been growing stronger.
In December, the National Transportation Safety Board (NTSB) called for a nationwide ban on driver use of portable electronic devices (PEDs) while operating a motor vehicle. U.S. Secretary of Transportation Ray LaHood said he opposed including hands-free cell phones.

Click here to read more about the proposed hand-held cell phone ban in The Boston Globe.

Continue reading "Car Accidents in Massachusetts Would Be Reduced Under Cell Phone Ban" »

Hundreds of thousands of diabetes patients have been re-considering their medication plans after a recent warning from the Food and Drug Administration (FDA).

On June 15, 2011, the FDA issued a safety communication reporting that use of the oral diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.

The FDA warned that patients with active bladder cancer should not be taking pioglitazone and those with a prior history should only use it after considering the potential medical benefits against the risk for cancer recurrence.

Actos is an oral drug used to treat type II diabetes, the most common form of the illness that plagues 25.8 million Americans. Actos is manufactured by Takeda Pharmaceutical Company and co-marketed by Eli Lilly and Company. It is one of the most widely used medications on the market. Over 2 million patients filled prescriptions for it in 2010.

The communication came as the FDA placed restrictions on Avandia, another popular medication, after studies showed it increased the risk of heart attacks. Both drugs belong to the thiazolidinedione class of drugs.

The warning about Actos came as the FDA made a periodic review of an ongoing 10-year Actos study into the risk for developing bladder cancer. The study reports there may be a 40 percent greater risk for developing bladder cancer among those who take Actos for more than a year.

The FDA's warning came a new epidemiological study out of France suggested an increased risk of bladder cancer with pioglitazone use. As a result, France has suspended use of Actos and Germany has recommended new patients not be placed on the drug.

On August 4, 2011, the FDA reported it had approved new label and medication instructions for Actos. The FDA is continuing to monitor the results of Actos cancer studies.

Patients taking Actos should contact their doctors if they experience any sign of blood in the urine or a red color in the urine or other urinary pain, as these Actos complications may be signs of bladder cancer.

Click here to read the June 15, 2011 FDA Safety Communication on Actos.

Continue reading "Actos Warning From FDA" »

Massachusetts lawmakers will consider tougher laws this week to reduce car accidents associated with cell phone use.

The Legislature's Joint Commission on Transportation will hold a hearing Tuesday to discuss several bills. One proposed measure would only allow drivers to use hands-free cell phones. Another would ban drivers from using any type of cell phone within school zones.

Just nine states and the District of Columbia prohibit all cell phone use while driving. Massachusetts joins 34 other states and the District of Columbia in banning texting while driving for all drivers.

In December, the National Transportation Safety Board (NTSB) called for a nationwide ban on driver use of portable electronic devices (PEDs) while operating a motor vehicle. U.S. Secretary of Transportation Ray LaHood is opposed to including hands-free cell phones.

Texting while driving, cell phone use and other distracted driving behavior causes a large number of car accidents across the country each year. In 2009, 16 percent of fatal motor vehicle accidents involved texting while driving and other distracted behavior. Twenty percent of car accidents resulting in injury involved distracted driving.

Massachusetts' ban on texting while driving took effect Sept. 30, 2010. But Massachusetts, like other states, has found its ban hard to enforce. The law bans texting while driving in a moving car, as well as when behind the wheel at intersections. But critics say it is often difficult to tell whether a driver is texting or dialing a number.

Another challenge is Americans are sending more text messages than in the past. In June 2011, more than 196 billion text messages were sent in this country, a 50 percent increase from June 2009, according to CTIA, the international association for the wireless telecommunications industry.

There is research suggesting any type of cell phone use engages a driver enough to create a dangerous distraction. A Carnegie Mellon University study found using a cell phone behind the wheel reduces the amount of brain activity associated with driving by 37 percent. And a study from the Virginia Tech Transportation Institute (VTTI) found that headset cell phone use is not substantially safer than hand-held use.

But when drivers text behind the wheel, they are 23 times more likely to get into a car crash than normal, the VTTI study found. Sending or receiving a text takes a driver's eyes off from the road for an average of 4.6 seconds, which is the full-length of a football field for a car traveling at 55 mph.

Click here to read more about Massachusetts' proposed bans on cell phone use.

Continue reading "Massachusetts Considers Ban on Cell Phone Use While Driving" »

A new Medicare report found that U.S. hospital employees are failing to report the majority of medical errors they make or observe.

The report found only one out of seven medical errors and adverse events are being reported. In these cases, hospitals investigated, but often made no change to prevent future medical errors.

The report was issued today by the inspector general of the Department of Health and Human Services. In reviewing 293 cases in which patients had been harmed, the inspector general found 40 cases were reported to hospital managers and 28 were investigated by hospitals. Only five cases prompted change.

The inspector general estimated more than 130,000 Medicare beneficiaries experienced one or more adverse events or medical errors in hospitals in one month.

The review defined adverse events as medication errors, hospital-acquired infections,
excessive bleeding linked to blood thinner, severe bedsores and overuse of painkillers. Other adverse events at hospitals may include surgical errors, birth injuries and failure to respond to a hospital alarm.

The review found that many hospital employees were fearful about reporting medical errors after the Institute of Medicine's 1999 landmark report, which estimated up to 98,000 people die in U.S. hospitals each year from preventable medical errors.

But here, employees often failed to recognize what constitutes patient harm, did not realize patients were harmed or assumed someone else would report it. In some cases, employees thought the mistake was so common it did not require reporting.

In recent years, hospitals have been required to track medical errors and adverse patient events as part of their Medicare contract. At least 27 states, including Massachusetts, have implemented laws for mandated reporting of healthcare errors.

Following the inspector general's report, Medicare officials plan to develop a list of "reportable events" for hospitals and employees. Hospitals are also being asked to give employees their own instructions.

Click for a New York TImes article about this review.

Click for a review of state reporting laws from the National Conference of State Legislatures.

Continue reading "Medical Errors: Just 1 of 7 Reported By Hospital Staff" »

The Food and Drug Administration (FDA) is studying why some medical facilities are failing to properly sterilize medical devices for reuse in surgeries and endoscopy procedures.

The result is patients are being exposed to microscopic amounts of blood, body fluids and tissues from other patients, according to a recent FDA Consumer Update. This exposure may have resulted because the devices were not properly reprocessed, cleaned, disinfected or sterilized.

Patients are being exposed through surgical instruments such as clamps, forceps and endoscopes. Endoscopy procedures are often performed to diagnose cancer and other illness.

The FDA states that transmission of infection was extremely rare in reports it has received about patient exposure. It states the risk for acquiring an infection from a reused medical device is low.

The FDA states patients can protect themselves by learning about their medical procedure and asking their medical facility what steps it takes to reprocess surgical instruments.

The agency suggests patients also research their procedures on the websites of professional organizations, such as the American Academy of Family Physicians.

The FDA is working to prevent this type of medical malpractice by:

• Making sure manufacturers are providing clear cleaning instructions.


• Making sure hospitals and staff understand and follow the instructions.


• Improving medical device design to facilitate cleaning and sterilization.

Continue reading "Defective Surgical Instruments and Medical Devices Under FDA Scrutiny" »