Massachusetts Injury Lawyer Blog

September is the month when thousands of college students across Massachusetts settle into campus life. And many students enjoy the extra freedom of bringing a car from home to school.

But students often forget one essential step in the transition to college life and this mistake can be costly. Students who have Massachusetts car insurance policies are required to inform their insurance companies about where the car is primarily kept. Otherwise, if there is a car accident, the insurance company might disclaim coverage, leaving the accident underinsured or uninsured completely.

Even if a student is relocating a short distance, such as from Dedham to a dorm in Boston, he or she must inform his car insurance of the new location where his vehicle will be kept. The reason? Car insurance companies rate the coverage -- and therefore the cost -- on where the car is principally kept. If the car moves from a low-rated area (with fewer accidents) to a higher-rated area, the cost goes up. And if you are not paying the premium for the place where the car is principally kept, the insurance company has the legal right to disclaim coverage. And that can be nasty. 

Students who fail to report their change of address and get into a car accident can be denied the Optional Insurance coverages on their policy. Optional Insurance coverages include:

Bodily Injury: This protects you from claims against your personal property if you cause a serious car accident.

Uninsured Auto: This coverage protects you and the people in your car if the person who causes the motor vehicle accident has no insurance.

Medical Payments: The first $8,000 in medical bills and lost wages are covered under the Personal Injury Protection (PIP), part of the Compulsory Coverage all Massachusetts drivers must purchase. Medical Payments provides policy holders extra protection for medical and health insurance.

Collision Comprehensive: If you are involved in a car accident, this coverage insures the damage to your vehicle.

Insurance issues can be very complicated, and you should not hesitate to call your agent if you have any questions. 

Click here to read our article, "Understanding and Buying Massachusetts Car Accident Insurance."

Continue reading "Massachusetts Car Insurance Tips for College Students" »

The Massachusetts Appeals Court recently ruled that Metropolitan Property and Casualty Insurance Company may have violated state law when it failed to make prompt payments on a no-fault claim. The ruling reversed a trial court decision, and remanded the matter to the trial court for further proceedings on the plaintiff's claims against the insurance company for bad faith.

Importantly, the court stated that the emotional distress the plaintiff claims she suffered could be considered as part of her damages under the Consumer Protection Act, M.G.L. c. 93A. There is very limited authority in Massachusetts for emotional distress damages in claims under M.G.L. c. 93A.

The facts of the case were straightforward. Ms. Chery was injured in a car accident and obtained medical treatment. Metropolitan was responsible for personal injury protection (PIP) benefits, but failed to pay the bills within thirty days, as required by M.G.L. c. 90, Sec. 34M. The plaintiff filed suit, claiming violations of c. 90, c. 93A, and c. 176D, which governs claims and settlements. The insurance company eventually paid the bills, then claimed it could not be liable for its bad faith claims handling. The District Court judge agreed and plaintiff appealed.

The Appeals Court agreed that the claimant had no further right under the insurance contact itself, as the bills had been paid. However, the court found that there was evidence of bad faith, and the simple payment of the bills did not cure the harm caused by the delay. Among other things, the plaintiff had to file suit, incur litigation expenses, and suffer the unreasonable delay. The plaintiff also claimed that she suffered emotional distress, as her bills were put into collection, and she worried about her credit being affected. The court specifically ruled that the emotional distress damages, even though not readily quantifiable, may be considered compensable under Massachusetts law.

The case was a victory for Massachusetts consumers.

The case is Chery v. Metropolitan Property and Casualty Insurance Company, Massachusetts Appeals Court No. 10-P-103 (June 16, 2011).

Continue reading "Massachusetts Court Rules Against Insurer in Bad Faith Case - Victory for Consumers" »

The winds that lifted three inflatable bounce houses and injured 13 people in New York this weekend have put the focus on amusement ride safety as summer begins.

A gust of wind picked up the inflatable bounce houses with children playing inside in Oceanside on Long Island. Parents and bystanders ran after the inflatable houses, trying to pin them to the ground but were knocked over. Eventually the houses came to the ground on their own.

Adults and children were transported to the hospital, but no one was seriously injured.

The incident follows two similar situations in Arizona. In February, an inflatable bounce house blew over a fence and onto a roof with two girls inside. One girl was seriously injured while the other suffered minor injuries. In April, four children were injured when the inflatable jumping castle they were playing in lifted up in a dust devil. The inflatable castle blew across a busy Tucson highway and landed in the median.

In March 2010, a five-year-old boy died after falling from an inflatable ride at a Wichita, Kansas entertainment complex.

The Consumer Product Safety Commission reports that between 2003 and 2007, 31,069 people went to the emergency room after being injured on inflatable amusement rides, including bounce houses and slides. Of these, 85 percent of those injured were under the age of 15. Injuries often occur when inflatables get unhinged or there are users of different sizes.

Amusement rides and backyard toys are a staple of summer, but have come under scrutiny for their safety risks in recent years. In 2004, a 38-year-old man was killed on an amusement park ride at a Shrewsbury, Massachusetts church fair. Two other people suffered personal injuries.

The Massachusetts Department of Public Safety investigated the amusement ride death and found that the man's lap restraint was defective. The state found other riders had complained about the restraint in the days prior to the death.

The state faulted the ride's operator, Jaro Amusements, for not keeping proper maintenance records. The employee who supervised the ride was charged with manslaughter and received 2 1/2 years probation. The victim's family filed a wrongful death lawsuit against Jaro Amusements, the supervisor and other parties.

What to Know About Amusement Park Safety

• All amusement park rides must be inspected annually.


• Do not visit amusement parks or use inflatable rides in windy or rainy weather.


• When waiting in line for a ride, check the equipment. Are riders wearing seat belts and other safety equipment? Listen to people exiting the ride to hear if they complain about the equipment. If you have a bad feeling, step out of line.


• Amusement riders have a responsibility to exercise good judgment. This means obeying verbal instructions and warnings from ride operators, not riding under the influence of alcohol and drugs and not disabling safety devices.


• If you are injured on an amusement ride, the operator must report it to the state Department of Public Health. This includes injuries caused by small rented inflatable rides used at backyard birthday parties and other events.

What to Know About Rented Inflatable Amusement Rides

• If you are renting an inflatable device or other amusement ride, ask the owner when it was last inspected.


• Carefully inspect the rented piece of equipment for excessively worn and damaged materials. Do not accept it in poor condition.


• Listen carefully to the set-up instructions provided by the company renting the device.


• Limit the number of users at one time to avoid injuries.

What to Know About Backyard Trampoline Safety
Backyard trampolines may look fun, but they come with dangers. In 2008, trampoline injuries sent an estimated 100,000 victims to emergency rooms with serious injuries such as spinal cord injuries, broken bones and head injuries. In some cases, victims have been permanently paralyzed.

• Never let children jump on the trampoline without adult supervision.


• Children under the age of 6 should never use a trampoline. The journal Pediatrics calls children this age "top-heavy" and said when they fall on trampolines, they often suffer head injuries.


• Only one person should jump at a time.


• Do not allow flips or somersaults. The Consumer Product Safety Commission reports this is one of the leading causes of trampoline injuries.


• Install safety netting around the trampoline, but advise users the netting does not mean they can do flips or other unsafe maneuvers. Carefully explain they cannot bounce off it in any way.


• Cover the trampoline's steel rim and springs with a safety pad so users do not fall through the openings. Do not allow people to sit on the safety pad.


• Users should step onto the trampoline and step off. They should never jump off. This could lead to trampoline accidents.


• Follow the manufacturer's recommendations for when to replace parts. Different parts have different lifespans and failure to replace could result in serious personal injury.

Continue reading "Attention on Amusement Park Injuries" »

UPDATE

Jonathan's Sprouts of Rochester, MA, has widened the recall of its sprout products due to Salmonella contamination. The recall now includes all sell-by dates, including its conventional, organic, and bulk products. The recall includes other sprouts, such as radish, dill, and gourmet mix. Check below for stores where these products were sold. Do not eat them! Return them to the store for a refund.

More information: FDA Recall Press Release.

ORIGINAL POST

The USDA has found Salmonella, a dangerous bacteria related to food poisoning, in Jonathan's Alfalfa Sprouts products.

Salmonella, if ingested, can cause serious and sometimes fatal illness and infections in young children, frail or elderly people, and others with weakened immune systems. The symptoms of Salmonella include fever, diarrhea (possibly bloody), nausea, vomiting, and abdominal pain.

Continue reading "Salmonella in Alfalfa Sprouts Prompts Recall in Massachusetts" »

The Consumer Product Safety Commission (CPSC) has asked manufacturers to re-design window blinds so as to eliminate the risk of infant wrongful death from strangulation.

Window blind manufacturers have known about the problem for decades, starting with a federal study in the 1980s that tied 41 child strangulation deaths to drapery and blind cords.  Since then, manufacturers have dragged their feet when it comes to improving safety.

And infants are still dying. The NY Times reports that in August 2009, Kathleen Leeson put her 2-year-old son down for a nap.  A short time later, Ms. Leeson discovered her son hanging, lifeless, an inch off the floor with the window blind cord wrapped around his neck.  Further, in 2002 1-year-old Cheyenne Kaiser was found by her mother strangled sitting up in her crib, which was next to the window, with the inner window blind cord wrapped around her neck.

The CPSC has released a safety alert for concerned parents explaining the risk of personal injury and wrongful death to children from the various types of window blind cords.  In its safety alert, the CPSC makes four recommendations to help prevent these tragic strangulation injuries:

• Use only cordless window blinds in all homes where children live or visit;
• Do not place cribs, beds, or furniture close to windows where children can climb and gain access to the cords;
• Make all loose cords inaccessible; and
• In windows with looped bead chains or nylon cords, use tension devices to keep the cord taut.

Moreover, in response to the industry's unenthusiastic attempts at improving product safety, a task force of regulators, consumer advocates, and industry leaders have come together to find a solution by the fall of 2011.

The CPSC has also warned the window blind industry that, if it cannot reach a solution soon to minimize these life-threatening dangers, it may face mandatory safety regulations.

Continue reading "Window Blind Design Reconsidered After Numerous Infant Deaths" »

Over 7 million candles have been recalled due to concerns that the cup holding the candles could melt or catch fire.

The Consumer Product Safety Commission has stated that the defective products, tea light type candles, were sold under the brand names Chesapeake Bay Candle and Modern Light. 

The affected candles were sold in Massachusetts and nationwide at retailers such as Home Goods, Target, and Wegmans between July 2009 and February 2011.

The clear plastic cup holding the candles is at risk for melting or igniting during use.  There has been one consumer report of the candle's plastic cup melting during use.

Continue reading "Warning to Massachusetts Residents: Tea Light Candles Recalled Due to Holder Burn/Melt Risk" »

A salmonella outbreak in Rhode Island now includes at least twenty-one people with severe illness, and one death, according to reports from public health officials in that state. Health officials are investigating another eighteen illnesses to see if they are tied to the salmonella outbreak.

Officials are focused on zeppole and other pastries which were made by Defusco's bakery in Johnston, Rhode Island. According to news reports, investigators found pastry shells stored in boxes contaminated with raw eggs, and also found that custard used as filling was not being properly chilled.

Investigators have identified the particular strain of salmonella, known as Salmonella heidelberg, as the suspected organism responsible for the illnesses. They are now trying to determine whether the death of the elderly Rhode Island resident was caused by that particular strain.

The investigation into the food poisoning outbreak began on March 25, 2011, after nearly a dozen elderly residents of a Warwick nursing home became sick after eating pastries from Defusco's bakery. Since March 12, two dozen victims have required hospitalization for severe illness.

Salmonellosis, the disease caused by salmonella infection or salmonella toxins, leads to diarrhea, fever, vomiting and abdominal cramps. Most people recover without treatment, but in the elderly, in infants, or people with compromised immune systems, the disease can be very severe, requiring hospital admission for rehydration and antibiotic treatment to prevent the spread of infection. Severe infections can lead to reactive arthritis and death.

Prevention of salmonella illnesses is straightforward. Food which may contain the bacteria, such as chicken or pork, must be prepared properly to kill the organism and destroy any salmonella toxin. Eggs and milk, and their products, must be properly prepared, handled, and refrigerated. Infections can also occur from contact with reptiles, pet rodents, and tainted fruits and vegetables. Proper hygiene--washing hands before and after handling food--is also a common sense method of reducing the likelihood of food poisoning.

Each year over 140,000 people suffer from salmonella poisoning in the U.S. and dozens die from the illness.

Continue reading "Salmonella Outbreak in Rhode Island Now Linked to Death" »

Many Massachusetts residents use propane to cook, and to heat their homes and hot water. Many more use propane in outdoor barbeques and other appliances. While usually safe, the safety of some propane deliveries has been a recent subject of concern in Massachusetts. Earlier this month, state officials reported the company DCP Midstream of Westfield, Massachusetts, a major propane company, had distributed odorless propane to residential and commercial customers.

Without the required additive known as mercaptan, which emits a strong odor, there is no way to detect the odorless propane gas which may have leaked into the environment. The risk to consumers arises from the possibility of an explosion or fire from leaking propane gas.

In July, a 48-year-old electrician was killed in an explosion in a Norfolk, Massachusetts condominium. According to other workers at the site, there was no detectable odor of propane gas prior to the deadly explosion. The electrician was severely burned and trapped under heavy debris for over 90 minutes before he was rescued and taken to the hospital. He died the following day.

An investigation has found an undetected propane leak caused the blast. DCP Midstream was the distributor of the propane for the condominium development. It was later learned other propane supplies at the development were missing the required odorant.

In addition to faulty gas supplied by DCP Midstream, state Attorney General Martha Coakley has said her office has a "sense" some of the odorless propane in Massachusetts originated with Aux Sable Liquid Products of Illinois. That company has now warned officials there may be odorless gas in 12 states.

Breakstone, White & Gluck represents the family of the late electrician and continues to investigate. As a service to our clients, Breakstone, White & Gluck offers the following safety tips for the use of propane.

1. Contact your propane supplier if you have had a propane delivery since May 2010. State officials have announced that the deliveries of the dangerous propane from DCP Midstream began on May 1, 2010.

2. Ask your propane supplier where it obtains its propane - for work and for your home. The DCP Midstream facility had 100 local suppliers that deliver to residential and commercial customers. In the Norfolk case, EnergyUSA was the local supplier.

3. Do not attempt to inspect your system yourself. This could have the adverse effect of creating a leak. Contact your local supplier.

4. Purchase a Gas Detector. They are available for approximately $60 at your local hardware store or online.

5. Check propane valves to ensure they are in the off positions when not in use. Propane tanks on barbeques and other appliances should always be shut off after use.

6. Take immediate action if you smell gas. Mercaptan emits a strong sulfur smell. It is what you smell if your stove does not light properly. If you believe that there is a gas leak in your home, immediately evacuate and call 911. Do not turn any switches on or off before your leave the premises since even a small spark can ignite leaking gas.

Breakstone, White & Gluck remains committed to promoting safety and to the representation of individuals who may have been injured due to the negligence of others.

Continue reading "Propane Safety for You and Your Family" »

We urge government officials and farms to reconsider food safety measures after the recall of a half-billion eggs and the salmonella poisoning of over 1,300 Americans. And it is time for Congress to act on pending legislation that would strengthen the Food and Drug Administration's (FDA) ability to protect the public.

Earlier this month, Wright County Egg of Galt, Iowa issued a voluntary recall of 380 million eggs on its five farms. Shortly thereafter, the FDA and the State of Minnesota identified Hillandale Farms in Iowa as a second source of contamination. Some 550 million eggs were recalled overall.

As the agencies investigate, many are calling for government reform on several fronts.

First, there is the problem of government oversight. The FDA has authority over shelled eggs sold in the grocery store. Yet the United States Department of Agriculture (USDA) has jurisdiction over chickens and any eggs cracked before shipping. Individual states also have inspection power of farms.

These agencies may have contradicting priorities and problems with coordination. In the case of Wright County Egg, the agencies lacked any knowledge of the others' work.

A CBS News report shows state inspectors visited one of Wright County Egg's sites in April, without reporting on 27 key inspection points, including questions about on-site birds, insects and rodents.

The report explains the state inspector saw no need because the farm was assigned a full-time USDA inspector. But the USDA claims its inspector was only responsible for measuring eggs and finding cracked shells.

"When you have multiple agencies in charge of a single issue, sometimes no one's in charge," Caroline Smith Dewall, Director of Food Safety at the Center for Science in the Public Interest, told CBS News. Click here to watch the CBS News video.

Another troubling point CBS News uncovered was the frequency of inspections. Shockingly, records obtained by the news outlet show the FDA has not inspected 56 percent of the nation's food production facilities and farms in the past five years.

Consumers deserve better protection. The legislation that would address these issues is stalled in Congress. The legislation would increase the frequency of inspections and provide the FDA greater authority over food production sites.

The House passed a bill, but it has remained stalled in the Senate despite widespread, bipartisan support. The bill is essential so the Obama administration can continue to revise food safety regulations, including regulations that would improve the safety of egg production.

The Boston personal injury lawyers at Breakstone, White & Gluck support this legislation and encourage you to contact your United States Senator to urge the bill's passage.

U.S. Senator Scott Brown
317 Russell Senate Office Building
Washington D.C. 20510
Phone: (202) 224-4543

U.S. Senator John Kerry
218 Russell Bldg.
Second Floor
Washington D.C. 20510
Phone: (202) 224-2742

Continue reading "Massive Egg Recall Prompts Calls for Food Safety Overhaul" »

Just weeks after a massive children's crib recall, a portable playard tent linked to a young boy's fatal strangulation has been pulled for safety.

The U.S. Consumer Product Safety Commission (CPSC) and Health Canada, in cooperation with Tots in Mind Inc. of Salem, New Hampshire, has announced the voluntary recall of 20,000 Cozy Indoor Outdoor Portable Playard Tents Plus Cabana Kits. An additional 85 tents were recalled in Canada.

The tent is a white dome-shaped covering designed to fit over playards that contain a child. In December 2008, a two-year-old boy from Vinalhaven, Maine died when he climbed out of the playard. He was found hanging with his neck entrapped between the playard frame and the metal base rod of the tent. In this case, the tent had been tied to the playard with pieces of nylon rope and partially attached with the tent's clips because the child knew how to remove the clips.

In three other incidents, children removed the clips on the tent and were able to place their necks between the tent and the playard. The children were not injured.

The unsafe cribs were made in China and sold at Walmart, Amazon and various baby stores from January 2005 to February 2010.

Consumers should immediately stop using the playard tents. They can contact Tots in Mind to get free replacement clips. Replacement clips will be available in late August or early September.

This is the second major product safety recall affecting parents and children in recent weeks. In June, the CPSC recalled two million cribs because of an unsafe drop-side rail, which created a gap where a baby's head could become trapped. Government officials say this could lead to suffocation or strangulation.

The companies involved in the recall include Evenflow, Delta Enterprises Corp., Child Craft, Jardine Enterprises, LaJobi, Million Dollar Baby and Simmons Juvenile Products Inc.

Continue reading "Product Safety Recall: Baby Tents Pose Strangulation Risk" »

It's important to know who's providing your medical treatment and their safety record, but many Massachusetts health care consumers fail to ask the question.

The good news is the information is just a few keystrokes away. The Massachusetts Board of Registration in Medicine offers Massachusetts consumers the Physician's Profile database right online.

Click here to learn more about what you'll find on the Massachusetts physician database and for a link to the site.

Continue reading "Know Your Doctor's Safety Record" »

The Food and Drug Administration is urging parents to choose generic children's medications over Tylenol as it broadens its investigation into manufacturing facilities operated by Johnson & Johnson and its subsidiary, McNeil Consumer Healthcare.

New product safety concerns have arisen in the weeks after an April 30 recall involving McNeil's Fort Washington facility in Pennsylvania, prompting the FDA to start investigating other manufacturing sites. McNeil recalled 43 over-the-counter children's medicines it manufactures for Johnson & Johnson, including various flavors of liquid Tylenol, Motrin, Benadryl and Zyrtec. The FDA has not said how many facilities are being investigated.

McNeil Consumer Healthcare issued the April 30 recall voluntarily in consultation with the FDA. In a visit to McNeil's Fort Washington facility, FDA officials uncovered inconsistent active ingredient concentrations, extremely potent metal particles in some medicines, an inadequate testing facility, poorly trained employees and drums of raw materials contaminated with bacteria.The full inspection report is available here. 
 
Meanwhile, the House Committee on Oversight and Government Reform is scheduled on Thursday, May 27, 2010 to hold a hearing on the recent Tylenol recalls and whether McNeil properly handled consumer complaints.  In a recent Fortune Magazine interview, Johnson & Johnson Chief Executive William Weldon admitted that his company owed an apology.  Mr. Weldon has been invited to testify at the May 27 hearing.

The Pennsylvania facility has since been shut down but may resume operation once, according to Johnson & Johnson spokesman James Freeman, "we have taken the necessary corrective actions and can assure the quality of products made there".  

Tylenol has been involved in other product safety recalls in recent years. In 2008, McNeil recalled 51 types of Tylenol after consumer complaints of diarrhea, vomiting and other illness. The company said the medications - mostly all for children and infants - had been contaminated by trace amounts of a chemical used in shipping.

In 2008, McNeil recalled 21 types of children's and infants' Tylenol liquid products, saying an active ingredient did not meet all quality standards.

For additional information on the Johnson & Johnson recalls, see the FDA's website.

Continue reading "FDA Issues Tylenol Safety Warning" »

The U.S. Consumer Product Safety Commission (CPSC) has announced the voluntary recall of 1.8 million toy dart gun sets sold at Family Dollar Stores after they were involved in the asphyxiation deaths of two young boys.

The CPSC issued the recall in cooperation with the Charlotte, North Carolina discount store. The importer, Henry Gordy International, Inc., of Plainfield, N.J. refused to recall the soft, plastic toy, which poses a risk if a child places it in his mouth. The defective toy can be inhaled into the throat and prevent a child from breathing. The toy was sold exclusively through Family Dollar Stores from September 2005 through January 2009 for about $1.50.

"Parents should take these toys out of their child's hands immediately," said Massachusetts personal injury attorney David W. White of Breakstone, White & Gluck in Boston. "Given the size of this recall, you really want to take a minute to look through your toy bin if you do any shopping at the Family Dollar Stores."

A 9-year-old boy in Chicago, Illinois and a 10-year-old boy in Milwaukee, Wisconsin suffered asphyxiation deaths while playing with the toy, which was manufactured in China. No Massachusetts consumer safety problems have been announced.

Consumers should discard the toys or return them to a Family Dollar store for a full refund. For additional information, contact Family Dollar at (800) 547-0359 between 8 a.m. and 5 p.m. ET Monday through Friday, or visit the firm's website at www.familydollar.com.

For more information, read the U.S. Consumer Product Safety Commission's recall. announcement.

Continue reading "Consumer Safety Alert: 1.8 Million Plastic Toys Recalled from Family Dollar Stores" »

Another recent recall of fresh produce highlights the importance of safe food handling and rinsing even pre-washed produce.  Freshway Foods of Ohio has announced a voluntary recall of romaine lettuce after reports of food borne illnesses from possible E.coli contamination. The New York State Public Health Laboratory found E.coli 0145 in an unopened recalled bag of shredded romaine. Products affected include bags of shredded romaine lettuce with "best if used by" dates prior to May 12; bags with "best if used by" dates of after May 12 are not affected. Freshway Foods sold the recalled products to wholesalers, food service outlets and some in-store deli and salad bars in Alabama, Connecticut, Washington DC, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, West Virginia, and Wisconsin. Although these products are now off the shelves, consumers should make sure they throw away any remaining products in their homes.

Nineteen cases of illness resulting from E.coli 0145 have been reported from Michigan, New York, and Ohio; twelve of these cases required hospitalization. Symptoms of foodborne illness caused by E.coli can range from nothing to acute stomach cramps and diarrhea to kidney damage. Three of the reported cases involved a life threatening complication called hemolytic uremic syndrome which causes blocked circulation or bleeding in the brain or kidneys. People experiencing a diarrheal illness with high fever, bloody stool, prolonged vomiting that could cause dehydration, symptoms of dehydration, or if the diarrheal illness lasts longer than three days should seek medical attention.

How to Protect Yourself

Consumers can protect themselves from foodborne illness by taking simple precautions. Cook meat and eggs thoroughly, using an internal thermometer. Avoid cross contamination by keeping raw meat and eggs away from vegetables and cooked foods and washing all surfaces that come into contact with raw products thoroughly. Chill leftovers promptly if they are not going to be eaten within four hours. Handle produce with clean hands and always rinse produce, even produce that has been pre-washed, and remove the outer leaves of lettuce and cabbage. Finally, report incidents of foodborne illness to your local health department.

For more information on this specific recall, see this Food and Drug Administration press release.  For more information about foodborne illnesses in general, see the Center for Disease Control and Prevention website. For more information on E.coli specifically, see the government's food safety website. 

Continue reading "Lettuce Recall Affects 23 States, Including Massachusetts" »

Guidant LLC, a division of Massachusetts' company Boston Scientific, has plead guilty to two misdemeanor counts alleging the medical device maker failed to disclose product changes involving over 20,000 implantable heart monitor devices.

The medical device manufacturer plead guilty Monday, April 5 and will learn over the next few weeks whether U.S. District Judge Donovan Frank will accept a proposed $296 million plea deal - the largest criminal assessment ever proposed against a medical device company.

The Department of Justice accuses Guidant of changing the design of its implantable cardioverter defribrillators, or ICDs, and failing to notify the Food and Drug Administration (FDA) of subsequent problems that lead to a Class 1 medical recall - the most serious category which indicate a defective product has the potential to cause serious personal injury or wrongful death. 

Guidant's implantable cardioverter defribrillators, Ventak Prizm 2 DR and Contak Renewal 1 and 2, were designed to monitor patients for abnormal heart rhythms and deliver electric shocks to keep the heart beating properly. But Department of Justice officials say Guidant discovered as early as 2002 that Ventak had the potential to suffer an electric arc, which could short-circuit the device. Although problems continued with the defribrillator, Guidant didn't issue a warning until 2005. In at least seven cases, the devices failed to issue a lifesaving shock and the patient died.

In 2005, Guidant sent a product update to doctors, advising that a yellow warning screen indicated a potentially serious problem. However, the FDA says the company should have sent a product correction, rather than a product update, since the change reduced the risk of serious injury, and should have notified the FDA of the change within 10 days. Guidant ultimately recalled its three devices in 2005. 

Attorneys for the affected patients are now urging the court to reject the plea deal because it will not provide restitution payments to victims.  The government prosecutor has argued that the victims have other remedies for compensation and that the applicable law does not require restitution.  The prosecutor points to the fact that most of the victims have settled civil suits with the company and the company has paid out over $650 million in settlement and warranty payments.  Additionally, $42 million of the plea amount is forfeited funds and victims can petition the Justice Department for their share.

For more information on the plea deal, see this Boston Globe article and this Star Tribune article.

Continue reading "Defective Product Leads to Proposed Plea Deal in the Largest Criminal Penalty Ever Assessed Against a Medical Device Company " »