Boston Personal Injury Lawyer Blog

On April 30, 2012, drugwatch.com reported that Congress is moving legislation that will make some changes to how medical devices are approved for U.S. consumers. The HELP legislation includes amendments that are related to the U.S. Food and Drug Administration (FDA). Two of these amendments are looking out for consumer safety.

Massachusetts Representative Ed Markey wanted the FDA to have the ability to reject applications for devices based on previously approved and then later recalled products. The 510(k) process allows for the FDA to omit clinical trials of products.

Representative Ed Markey proposed this legislation because of the many reported complications from the transvaginal surgical mesh implants that were used to correct Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The transvaginal mesh implants were approved through the 510(k) process and many of the implants were approved based on a recalled in 1999 mesh implant from Boston Scientific.

Another large class action that would be affected by this legislation is the Depuy ASR hip implants that were recalled in August of 2010. A new law would help to prevent use of faulty products in the future.

Continue reading "MASSACHUSETTS REPRESENTATIVE SEEKS NEW LAW TO PROTECT CONSUMERS FROM FAULTY PRODUCTS" »

Many women throughout Massachusetts use birth control pills as their main form of birth control. Not even a month after Pfizer put out a recall on seven lots of birth control, Glenmark Generics has put out a recall on several lots of its birth control pills. In some packages, the pills are in the wrong order. Glenmark Generics is a company based in India. The pills that were affected by this mistake were distributed between September 21, 2011 and December 30, 2011. The company did not say how many pills or packages of pills are being recalled. The ingredients of the pills are norgestimate and ethinyl estradiol.

In these affected packages of birth control, when the blisters of pills are rotated some of the pills may not be in the proper order. This may cause the pills to be in the incorrect sequence and cause users to take the wrong pill. This problem also caused the lot number and expiration dates harder to see on the package. This recall applies only to packages that the lot numbers and expiration date are not visible.

Glenmark's birth control pills contain three different medications that are taken one a day for a week. Taking the pills out of order may cause them not to work properly and put women at risk for unwanted pregnancies. The pills are intended to be taken in a specific order. There are seven off-white pills, seven light blue pills, seven blue pills, followed by seven green placebo pills.

Continue reading "ANOTHER BIRTH CONTROL RECALL PUTS MORE WOMEN AT RISK" »

February 5-11 is Burn Awareness Week in Massachusetts. According to State Fire Marshall Stephen D. Coan, it gives us an opportunity to be reminded to take simple safety measures to prevent burn injuries.

According to a report by the Massachusetts Burn Injury Reporting System, scalds from cooking liquids, grease, hot liquids, tap water, food and steam account for 41 percent of 535 burns reported in 2010.

Children under the age of 5 are four and a half times more likely to suffer from a burn injury. Hot liquids caused 79 percent of burns in children under the age of 5. Scalds are the leading cause of burn injuries every year.

A recall on Tassimo coffee makers was recently released due to the risk of burns. More than a million Tassimo coffee makers have been recalled after dozens or reports of the brewers spraying hot liquid, coffee grounds and tea leaves.

According to the Consumer Product Safety Commission, there have been 140 reports of problems with the single cup brewers. These reports included 37 involving second degree burns.

The Tassimo coffee maker has a plastic disc that holds the coffee or tea called a "T-disc". The T-Disc in the device can burst while brewing.

Consumer Product Safety Commission also announced a recall on 4 million Tassimo espresso T-Discs after having 21 reports of problems with the products.

Continue reading "COFFEE MAKER RECALLED DUE TO BURN RISK DURING MASSACHUSETTS BURN AWARENESS WEEK" »

It was announced yesterday that New York based Pfizer is voluntarily recalling 1 million packets of widely distributed birth control pills. The U.S. Food and Drug Administration stated that 14 lots of Lo/Ovral 28 (norgestrel and ethinyl estradiol) Tablets and 14 lots of Norgestrel and Ethinyl Estradiol Tablets (generic) potentially contain inexact count of inert or active ingredients and those tablets may be out of sequence.

This recall should be of huge concern for women in Massachusetts and across the United States. Many women take birth control as part of their daily regimen and rely on these products as part of smart family planning practices. Although it is important to recognize Pfizer and the U.S. Food and Drug Administration for acting quickly, more needs to be done across the United States to ensure that defective drugs never get in the hands of consumers.

With regard to the Pfizer recall, the defective products do not pose an immediate health risk to consumers. However, continued use of these recalled drugs could lead to unintended pregnancy. Women who have been taking these defective products should use a non-hormonal form a birth control immediately and contact their doctor.

Continue reading "A RECALL ON BIRTH CONTROL PILLS BY PFZIER PUTS WOMEN AT RISK FOR UNWANTED PREGNANCY" »

Now that the holidays are over, many Massachusetts children will be enjoying all their new gifts and toys. Many children have received new bicycles and safety equipment for the holidays. There are two recalls that Massachusetts parents should be aware of before the warmer weather comes and children head out to the local park with their bicycles.

The U.S. Consumer Product Safety Commission has put out a recall on 2011 Forté Pro Carbon Road Pedals imported by Performance, Inc of North Carolina. These pedals are sold in sets of two and made to attach to cycling shoes. These pedals are made for performance bicycles. They are black with a lightweight carbon injected thermoplastic. The axle is a black and made of chromium molybdenum steel with a black steel axle. The front, top of the pedal has "Carbon" printed in red; the top middle has "EPS-R" embossed in the body with the "R" in red and on the top rear of the pedal the word "Forté" printed in white. The outer edge of the pedal has the Forté logos, crossed F's, in white. The catalog number, 50-8128, is used in all catalogs.

The recall was made after there were three reports made of the pedals breaking while in use. The pedal breaking or cracking during use could cause riders to lose control and pose a potential fall hazard, which could cause serious injuries such as traumatic brain injuries or fractures.

Another product that has been recalled is the Bicycle Helmets for Children and Youth by Triple Eight Distribution, Inc., of Port Washington, N.Y. The description from the U.S. Consumer Product Safety Commission is "multi-purpose helmets also sold for use as bicycle helmets. Little Tricky helmets are marketed for children and youth, and feature a large Little Tricky logo on both sides of the helmet. They come in one size and in black, white, pink and green. Triple Eight S/M EPS Liner helmets feature a hard black inner EPS foam liner and come in black, white, bone, blue and army green. Sector 9 S/M EPS Liner helmets feature the same EPS liner and come in gray, white, black, blue and green. Both the Triple Eight and Sector 9 helmets have an interior label indicating the size "S/M" for small/medium and a manufacture date indicated as month/year (ex. APR/2011). Only Triple Eight and Sector 9 size "S/M" EPS Liner helmets are affected."

These helmets do not comply with the safety standards of the U.S. Consumer Product Safety Commission for impact resistance. Children could suffer serious head injuries upon an impact while wearing this product. About 30,400 Helmets were that were sold at bicycle and sports stores and other retailers nationwide and online from August 2006 through November 2011 for about $40 are being recalled.

Continue reading "BICYCLE RECALLS COULD CAUSE INJURIES TO MASSACHUSETTS CHILDREN" »