Massachusetts Injury Lawyer Blog

Halloween is a much-anticipated night for children across Massachusetts, who are excited about dressing up as ghosts and goblins, going trick-or-treating and attending costume parties. Parents have a responsibility to protect children by talking to them beforehand about appropriate behavior and dangers to avoid. Here, the Massachusetts personal injury attorneys at Breakstone, White & Gluck of Boston offer tips to help parents and all adults keep the Halloween experience safe and fun for our youth:

• Never let young children go trick-or-treating without adult supervision.
• Take children for a test run of the trick-or-treat walking route during daytime hours.
• Remind children to look both ways before crossing the street and to utilize crosswalks when possible.
• Parents and children should always walk on sidewalks.
• Children should carry flashlights or glow sticks and wear reflective tape.
• Watch out for trick-or-treaters! Drive below the speed limit in residential areas and do not pass stopped vehicles in the roadway.
• Inspect treats before consumption. Discard all homemade goods and candy that poses a choking hazard.
• At your home, leave candles, pumpkins and lanterns in a place where no one can trip and injure themselves.
• Make sure costumes are flame-resistant and will not cause children to fall or trip.
• Click here for information on safe costumes from the Consumer Product Safety Commission.

A New Warning About One Type of Halloween Candy
A new government warning issued this week caught many by surprise as families prepare for Halloween. The Food and Drug Administration (FDA) reported there is a link between black licorice and an irregular hearth rhythm. If you're 40 or older, eating two ounces of black licorice a day for at least two weeks could land you in the hospital with an irregular heart rhythm or arrhythmia.

The FDA says black licorice contains the compound glyrrhizin, which can cause the body's potassium levels to fall. This can trigger abnormal heart rhythms, high blood pressure, edema, lethargy and congestive heart failure.

The good news? Licorice lovers can enjoy their candy in moderation. And if you have ever enjoyed too much licorice and experienced health problems, they are unlikely to reoccur unless you once again eat more than the recommended licorice limit. The FDA says all health complications end when black licorice consumption stops.

Click here for more information about the FDA's Oct. 25, 2011 warning about black licorice.

Continue reading "Halloween Safety and a Warning About One Candy" »

A Food and Drug Administration (FDA) advisory panel has recommended that some transvaginal mesh products be reclassified as the process for approving mesh and other medical devices comes under scrutiny.

On July 13, the FDA updated a 2008 public health notification, reporting that complications from transvaginal mesh are not rare and that it is not clear that transvaginal mesh surgery is more effective than non-mesh repair of pelvic organ prolapse (POP). Having received over 3,800 reports of complications, the FDA urged surgeons to consider other options before performing transvaginal mesh surgery.

Since then, more than 600 women have filed lawsuits over complications from transvaginal mesh, which is surgically implanted to treat both POP and stress urinary incontinence (SUI). POP occurs when a women's pelvic muscles and organs are weakened and stretched, often after child birth or hysterectomies.

Women reported painful complications such as internal mesh erosion, pain during intercourse, infection, bleeding, organ perforation and urinary problems. Corrective surgery is often required and is not always successful. In one report by Bloomberg News, a woman reported she had undergone 17 procedures to reverse damage from transvaginal mesh, including five surgeries, and is still suffering from the condition.

The FDA approved the first transvaginal mesh product, ProtoGen by Boston Scientific, in 1996. Two years later, Johnson & Johnson won approval for a similar device called Gynecare VT, but was not required to conduct human testing on it. Using the FDA's 510(k) process for medical devices, Johnson & Johnson was allowed to bypass testing by claiming the device was "substantially equivalent" to the Boston Scientific mesh product.

The FDA approves 90 percent of medical devices under the 510(k) process, including defective hip implants and external heart defibrillators that have been subject to recalls in recent years.

Critics say the 510(k) process is flawed and needs to be overhauled. In the case of Boston Scientific, the Massachusetts manufacturer recalled its surgical mesh product in 1999 as other companies were just starting to bring their product to market. There are a total of nine manufacturers of transvaginal mesh products.

In January, the FDA announced it was considering 25 changes to the 510(k) system. In July, the non-profit U.S. Institute of Medicine issued a warning about it and Congress has pushed the FDA to make changes.

As for transvaginal mesh, the FDA convened an advisory panel to review the safety of the medical device in September. The 17-member panel recommended that some transvaginal mesh be reclassified as high-risk devices and require new studies be conducted to stay on the market. The FDA has yet to make a decision.

Continue reading "FDA Considers Next Step for Transvaginal Mesh, Medical Device Approvals" »

Attention is on seat belts and occupant protection as the National Highway Traffic Safety Administration (NHTSA) observes National Teen Driver Safety Week from October 16 through October 22.

Each year, the government agency hosts this week to educate the public on protecting teens behind the wheel.

The NHTSA reports teenage drivers and passengers are the least likely to wear seat belts. But seat belts are one of the most effective ways to travel safe. Most people who die in motor vehicle accidents are vehicle occupants, many of whom were not wearing seat belts. Less than 25 percent of traffic accident fatalities are pedestrians, bicyclists and motorcyclists, according to the NHTSA.

By contrast, in 2006 seat belts saved over 1,5000 lives nationwide among passengers over 4 years old, according to the NHTSA.

The NHTSA urges parents and teens to practice safety through seat belt use, by following graduated licensing laws, developing parent-teen contracts and avoiding alcohol consumption.

Massachusetts Junior Operator Law. Many states have implemented graduated licensing laws to place restrictions on teen driving. Under the Massachusetts Junior Operator Law, in the first six months of holding a license, operators under 18 cannot drive with another passenger under 18 years old. The lone exception is they can drive with a sibling as passenger. Teen drivers are also not allowed to drive between 12:30 a.m. and 5 a.m.

Parent-teen contracts. Standard contracts are available from many insurance companies, auto clubs, state offices or you can develop your own. Click here for a parent-teen contract produced by the state of Massachusetts.

Address all areas of concern, including seat belt use, how many passengers are allowed in the car and how late teens can drive. This is important even if the state's junior operator law covers all of your concerns. The contract is between you and your teenager to create an extra level of accountability.

Alcohol. While teens are below the minimum drinking age, they carry the greatest risk for death in an alcohol-related crash. In 2006, 31 percent 15- to 20-year-old drivers involved in fatal crashes had been drinking. This increases the importance of a no-tolerance attitude and accountability among parents, teachers, sports coaches and other respected adults.

Continue reading "Focus on Seat Belt Use During National Teen Driver Safety Week" »

More than a year after DePuy Orthopaedics recalled two popular hip implants, the large number of patients affected and severity of injuries caused by metal-on-metal hip implants is starting to emerge.

The DePuy hip implant recall has broadened concern over all metal-on-metal hip implants. All-metal hip replacements are now on the track to become the largest and most expensive medical implant defect since 2007, when Medtronic recalled a defective heart device component associated with 7,700 complaints. An estimated 500,000 patients have received all-metal hip replacements.

In August 2010, DePuy recalled two ASR hip implants, the ASR XL Acetabular System, which is available to patients throughout the world, and the ASR Hip Resurfacing System, which is not available in the United States. The hip implants are defective because they cause friction between the metallic ball and socket components which are implanted to replace the femur and acetabulum.

DePuy recalled the defective medical devices after the Food and Drug Administration (FDA) received about 400 complaints in two years from patients. While most hip implants last for 15 years, data released at the time showed one in eight patients required a replacement surgery within five years of being surgically implanted with the defective DePuy hip implants.

The recalled DePuy hip implants can wear down and produce a substantial amount of metallic particles in patients' bloodstreams. Patients reported signs of metallosis, including pain, swelling, problems walking and rashes. These may be symptoms of more serious problems such as the hip implant loosening, bone fractures, joint inflammation, hip dislocation and damage to the tissue, nerves and muscles near the implant.

In the first six months of 2011, the Food and Drug Administration (FDA) received more than 5,000 reports about problems with all-metal hip implants, according to an analysis by The New York Times. The Articular Surface Replacement (A.S.R.) recalled last year by DePuy Orthpaedics accounted for 75 percent of the complaints.

Another recent study in England found that all-metal hip implants were failing early at three times the rate of hip implants made from metal-and-plastic components.

Massachusetts General Hospital in Boston and other medical facilities across the country have reported seeing a growing number of patients requiring corrective surgery, according to The New York Times. In most cases, corrective surgery takes months of rehabilitation. In some cases, complications require longer medical supervision.

In May, the FDA ordered manufacturers of all-metal hips to develop studies determining how widespread device failures are and implications for patients. But it may be several years before results of those studies are available.

If you have a defective DePuy hip implant and are experiencing pain, it is important to contact the hospital where you received your implants immediately. You should also contact an experienced Massachusetts product liability lawyer. The product liability lawyers at Breakstone, White & Gluck of Boston are experienced in handling cases involving DePuy hip implant recalls and other defective medical devices. Call us today at 800-379-1244 or use our contact form.