Massachusetts Personal Injury Blog

Recent Review Shows that H1N1 Vaccine is Safe

Carrie Strasser — Mon, 07 Dec 2009 17:32:10 GMT

The New York Times reported on Saturday that the H1N1 vaccine is safe and that most people who have had side effects have only suffered side effects similar to those prevalent as a result of the seasonal flu vaccine.

This new report comes from two monitoring networks, the Vaccine Adverse Event Reporting System and Vaccine Safety Datalink. Doctors, health care workers and the public can file a report with the Adverse Event Reporting System and these reports are then investigated. Safety Datalink has information on over 400,000 people who received the H1N1 vaccine in managed-care organizations.

According to the new report, “no substantial differences between H1N1 and seasonal influenza vaccines were noted in the proportion or types of serious adverse events reported.”

Dr. Thomas R. Frieden, director of the CDC, said the findings were reassuring, but still preliminary. The H1N1 vaccine has only been in widespread use for about two months and certain problems might not present themselves until later when more people are vaccinated. Dr. Frieden also stated that there was no evidence that this swine flu vaccine increased the risk of Guillain-Barre syndrome that was linked to the swine flu vaccine from 1976.

As of November 24, almost 4,000 adverse events had been reported after H1N1 vaccinations. 204 of those were considered serious.

For information on the Vaccine Adverse Event Reporting System, click here.

For information on the Vaccine Safety Datalink, click here.

For information on the safety of the H1N1 vaccine, click here.

Originally posted at InjuryBoard by Carrie Strasser

Protect Your Personal Data!!

Bruce Bierhans — Wed, 02 Dec 2009 14:21:58 GMT

We all know that identity theft can be an enormous problem for a victim, and the risk of such theft is enhanced by our use of computers. Our own Supreme Judicial Court has recognized the gravity of the problem, and effective September 1, the court adopted a policy known as "Interim Guidelines for the Protection of Personal Identifying Data in Publicly Accessible Court Documents".

An SJC press release states that the guidelines "were developed to begin to protect personal information in public documents....". Unless an exemption applies, court filings may no longer contain the complete number of any of the following information: social security number, taxpayer id number, credit card number, financial account number, drivers license number, state issued id card, passport number, or maiden name of a person's mother. Any filings may only contain the last 4 digits of any number or only the first initial of the mother's maiden name.

Think of how often a vendor, store clerk, or other individual in the daily course of business requests any of the above information. Not that it's a great revelation, but the action of the SJC does serve to stress the importance of the confidentiality of much of the above referenced personal data. Whenever you are asked for this data, you should question why it is necessary for the inquirer to possess and ask whether or not there is any reasonable alternative to providing the requested information.

When you're out shopping this holiday season, protect yourself and your identity! Happy Holidays!

Bruce A. Bierhans

Originally posted at InjuryBoard by Bruce Bierhans

New Proposal to Examine Drug Safety

Carrie Strasser — Wed, 25 Nov 2009 09:54:22 GMT

Yesterday, the New York Times reported that a new plan to monitor the safety of drugs could identify a particular drug's risks long before they might have otherwise been discovered. The study that devised this plan was published Monday in the Archives of Internal Medicine.

The authors propose a system to examine widely prescribed drugs through safety analyses that would pool data as they emerge from various clinical trials of a medication and aggregate the information for a fuller picture of a drug’s harms and benefits.

This database would be constantly updated as the results of studies were published. This could allow a "real-time" analysis of the various risks and benefits associated with certain drugs.

Dr. Joseph Ross is the lead author of the study and proposed this plan as a new model for post-market surveillance of drugs. Dr. Ross's study used Vioxx as an example and determined that Merck could have discovered the cardiovascular risks of Vioxx many years before it took the drug off the market in 2004.

Merck questioned the methods used by Dr. Ross and his colleagues in the study, stating that the categories used were too broad and included patients who suffered heart attacks after they had stopped taking Vioxx.

Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, stated that the type of cumulative analysis proposed by Dr. Ross's study requires an act of Congress. Although the FDA has increased its efforts to ensure drug safety in the past few years, critics call for Congress to grant the FDA more power and resources in order to provide detailed information to patients and doctors.

“There is this kind of dogma in medicine that you shouldn’t use any drug for the first seven years after it’s released, because it takes that long to figure out its harms and benefits,” said Dr. Michael Steinman, an assistant professor of medicine at the medical school of the University of California, San Francisco.

While there are many proponents of the study and its potential to identify drug dangers even faster, some say the number of drugs on the market today would make it nearly impossible, and perhaps too expensive, to cumulatively track every single one of them.

For more information on the FDA and prescription drugs, click here.

To read the study, click here.

Originally posted at InjuryBoard by Carrie Strasser

Stork Craft Recalls Two Million Baby Cribs

Chrissie Cole — Tue, 24 Nov 2009 13:47:00 GMT

Stork Craft Manufacturing, in conjunction with the Consumer Product Safety Commission (CPSC), announced a voluntary recall of more than two million drop side cribs.

The agency is aware of the deaths of four young children who suffocated in the cribs. Additionally, there have been 110 reports of incidents in which drop-sides detached from the cribs.

The recall includes 1.2 million Stork Craft cribs sold in the U.S. and one million sold in Canada. Approximately 150,000 of the recalled cribs carry the Fisher-Price logo.

The federal government has recalled nearly 5 million cribs in the past two years -- many of them with drop down sides.

The cribs have had ongoing hardware and assembly issues. In January, the Stork Craft recalled about 500,000 cribs because of problems with metal brackets that support the mattress. The new recall includes some of the same models from the earlier recall, CPSC said.

Consumers are urged to contact Stork Craft for a free repair kit that will convert the drop-side crib to a fixed side. In the meantime, the recalled cribs should not be used.

For more information on the recall, visit the Stork Craft Web site or call the company toll free at (877) 274-0277. #

Originally posted at InjuryBoard by Chrissie Cole

Car Crashes Into Gulf Station In Stoughton

Chrissie Cole — Mon, 23 Nov 2009 14:15:00 GMT

A vehicle went through the side of a garage at the Gulf Station following a two-car collision.

There was significant damage to the garage and both vehicles, but no one was injured in the crash.

The accident happened near the intersection of Turnpike and Page Streets at 7:45 a.m., when two vehicles, a Ford pickup truck and Saturn collided, according to Stoughton Fire Department. The accident caused the Saturn to crash into the building.

While people were in the garage at the time of the accident, no one was reported near the area of impact. The person in the truck was also uninjured.

The vehicle went through a panel of the garage and ruined some equipment but there was no serious structural damage.

Originally posted at InjuryBoard by Chrissie Cole

Burn Hazards Prompt Recall of Gas Grills

Chrissie Cole — Thu, 19 Nov 2009 08:02:00 GMT

Lucas Innovation Inc., in conjunction with the U.S. Consumer Product Safety Commission (CPSC), announced a recall of more than 660,000 Perfect Flame SLG Series Gas Grills in the U.S. and 1,700 grills in Canada. The grills were sold exclusively at Lowes stores nationwide.

According to a news release by the CPSC, the burners can deteriorate causing irregular flames and some lids can catch fire, posing a fire and burn hazard.

To this date, the company has received 40 reports of fires from the burners deteriorating and 23 reports of the lids catching fire. The agency is aware of one eye injury which required surgery and 21 incidents of minor burns to the face, arms and hands.

The model numbers included in the recall are listed below:

Model	Replacement Burners	Replacement Lid
SLG2006B	Yes	No
SLG2006BN	Yes	No
SLG2006C	Yes	No
SLG2006CN	Yes	No
SLG2007A	Yes	Yes
SLG2007B	Yes	Yes
SLG2007BN	Yes	Yes
SLG2007D	Yes	No
SLG2007DN	Yes	No
SLG2008A	Yes	Yes

Consumers should stop using the recalled grills and contact LG Sourcing for a free replacement burner and, depending on the grill model, free replacement lid.

Consumer Information: Call toll-free at (888) 840-9590 anytime, or visit www.lowes.com

Originally posted at InjuryBoard by Chrissie Cole

Maclaren Stroller Recall: What A Parent Should Do

Steven Schafer — Tue, 17 Nov 2009 00:01:00 GMT

On November 9, 2009, Maclaren USA, the American subsidiary of the British manufacturer of umbrella strollers and other children’s products, “voluntarily” recalled about 1 million strollers because of fingertip lacerations and amputations. According to the Consumer Product Safety Commission, “The stroller’s hinge mechanism poses a fingertip amputation and laceration hazard to the child when the consumer is unfolding [or] opening the stroller.”

Two earlier articles focused on the supposed “voluntary” aspect of the recall and a manufacturer’s responsibility to identify and eliminate design defects so that injuries like these don’t happen. This article speaks to what a parent who owns a recalled stroller should do.

Parents and caretakers should be skeptical about the “voluntary” nature of this recall and the accuracy of the numbers cited – Maclaren says it received 15 reports of children placing their finger in the stroller’s hinge mechanism, resulting in 12 reports of fingertip amputations in the United States.

Parents and caretakers should also be skeptical of Maclaren’s free repair kit, which appears to consist of cloth hinge covers that snap onto the frame. Covers that easily snap in place can also be easily removed, yet the unsafe pinch points remain. From a design standpoint, a guard or cover that can be easily removed without disabling the product is inadequate. One must be concerned that the next family who inherits the stroller may be unaware of the covers’ importance and may remove them for any number of reasons. Covers may be removed once they get dirty and may not be replaced. (Doesn’t Maclaren realize that peanut butter and jelly and many other substances are inherent to this product’s expected environment of use?)

If you have a recalled Maclaren stroller:

And, after careful consideration, you want to continue to use the stroller, then you should request the hinge covers from Maclaren and only use the stroller when the hinge covers are in place;
And you are not wedded to the stroller, then you do not have to settle for the hinge covers. You should write to Maclaren – emails are good; snail mail sent certified, return receipt requested, is better; both methods are best – and request a refund. If they insist on your returning the stroller first, go ahead and do that, but request that they pay the shipping costs. Maclaren can be contacted at www.maclaren.us/recall.

If you have a recalled Maclaren stroller, and you have seen your child place a finger in the hinge mechanism:

You should report this to Maclaren and either request the hinge covers or a refund (see above);
You should also report this to the Consumer Product Safety Commission. The CPSC Recall Hotline is 800-838-2772. The CPSC website is https://www.cpsc.gov/cgibin/incident.aspx.

If you have a recalled Maclaren stroller, and your child has suffered a lacerated or amputated finger or other injury from the hinge mechanism:

Do not use the stroller, with or without hinge covers;
Do not throw the stroller away, but store it in a safe, clean place;
You or an attorney should write to Maclaren and report the injury (see above);
You or an attorney should report the injury to the Consumer Product Safety Commission (see above);
You are entitled to reimbursement for your child’s medical bills (past and future) and your son or daughter is entitled to compensation for pain and suffering and disfigurement, including corrective surgery if available and indicated.

No consumer who has been injured by an unsafe product need apologize for exercising his or her legal rights. Despite the protestations of manufacturers and the insurance industry, product liability claims in the United States have led to safer roads, workplaces, schools, and homes. To illustrate, double hand controls on industrial machines prevent an operator’s hands from getting in the way of moving parts. Automobiles are now more crashworthy because of stronger structural components, padded dashboards, airbags, safety glass, seatbelts and crush zones. And children’s toys don't have small parts that can be swallowed or lead paint that can be ingested. Product liability claims pressed by consumers and their attorneys have led to these improvements.

Originally posted at InjuryBoard by Steven Schafer

Maclaren Stroller Recall: Free Repair Kit Costs More Than Its Worth

Steven Schafer — Mon, 16 Nov 2009 00:01:00 GMT

Maclaren says it received 15 reports of children placing their finger in the stroller’s hinge mechanism, resulting in 12 reports of fingertip amputations in the United States.

My last article focused on the purported “voluntary” aspect of the recall and questioned how Maclaren was gathering and maintaining reports of accidents and near-accidents. This article will focus on the manufacturer’s responsibility to identify and eliminate design defects so that injuries like these don’t happen. My next article will speak to what a parent who owns a recalled stroller should do.

Manufacturer’s Legal Duty. Under the law, a manufacturer is responsible for acting reasonably - or exercising "due care" - in designing, manufacturing and testing a product to make sure that the product is fit for a particular purpose. If there is an unsafe aspect to the product that results in injuries to the person using it, or someone close by, the manufacturer can be held responsible for the injuries on the basis of negligence, or for having breached express and implied warranties about a product’s fitness. A manufacturer must anticipate the environment in which its product will be used, taking into account the sophistication and knowledge of the operator or consumer, the location where a product will be used, and the foreseeable uses and even misuses to which the product may be placed. The manufacturer must design against reasonably foreseeable risks of injury in this context.

So, in the case of a children’s stroller, a manufacturer must anticipate that a child may place his or her hand or fingers on the stroller’s frame when a parent or caregiver is opening or closing the stroller. Just think of the mother with two or three children in tow, who is setting up or collapsing a stroller next to the family car in the parking lot at the mall. She has children to watch, bundles to handle, and traffic to look out for, all while she is opening and closing the stroller. There should be no possibility that the stroller’s hinge mechanism will allow a toddler’s finger to get in the way. Mom, dad, grandma or the babysitter cannot be held to the level of expertise of the design engineer and should not have to inspect the stroller to make sure that there are no areas where the child’s hands or fingers can be caught or pinched. We protect industrial workers by eliminating or covering exposed gears and moving parts on machinery; a stroller should be designed with no less concern for safety.

Manufacturer’s Design Responsibilities. Hazard and risk analysis has become a staple of mechanical engineering. When studying safety engineering, students learn the so-called "safety hierarchy" of design, which is intended to identify, and then eliminate or reduce the risk of injury from a hazard posed by a product.

The design engineer must identify hazards (such as a pinch point, where parts of a product can catch a part of the body and cause injury) and evaluate the chances of an injury occurring, and the severity of the injury.

Once a risk of injury has been identified, the design engineer should try to eliminate the risk entirely, by reconfiguring that part of the product. When it comes to a hinge mechanism into which little fingers can fit, perhaps the space is made larger so that fingers cannot be pinched when the hinge is opened and closed. Or, perhaps the space is made smaller so that a finger cannot possibly fit into the space.

If the risk of injury cannot be eliminated by a change in design, then the engineer should try to guard against the risk. A permanent, non-removable hinge cover might work in this instance.

If the risk of injury cannot be eliminated by a design change, or guarded against by a cover, then the designer may resort to warnings or instructions. There is a science to proper warnings and instructions. They must first alert the user with attention getting words that are commensurate to the hazard (such as DANGER in yellow against a black background, or WARNING in red and white, or CAUTION in orange and black). A proper warning should then alert the user to the hazard (such as "In-Running Rollers" or "Sharp Blade"). A proper warning should tell the user what to do or what not to do (like "Keep Hands Away from Opening") to avoid the hazard. And finally, a proper warning should tell the user the consequences if he or she disregards the warning (for example, "Placing Hands in Vicinity of In-Running Rollers May Result in Amputation or Other Serious Injury").

Legalistic warnings and instructions may give the manufacturer an argument in court, but do little to communicate to the consumer the information he or she needs to use a product safely. Warnings like “Be Careful” do not communicate necessary information.

While a manufacturer might argue that warnings and instructions are unnecessary and that the hazard is obvious or a matter of common sense, a proper warning (when the hazard cannot be eliminated by a design change or when a guard or cover will not work) might say:

WARNING

AMPUTATION POINT! OPENING IN HINGE MECHANISM MAY ACCOMMODATE A CHILD’S FINGERS

KEEP YOUR CHILD’S HANDS AND FINGERS OFF FRAME AND AWAY FROM HINGE MECHANISM WHEN OPENING AND CLOSING STROLLER

YOUR CHILD’S FINGERS MAY BE AMPUTATED OR SEVERELY CUT IF THEY ARE IN THE HINGE MECHANISM WHEN STROLLER IS OPENED OR CLOSED

Even the best warnings and instructions, however, don’t take the place of good design that eliminates the hazard and risk of injury altogether, and they don't substitute for a guard when the good design cannot eliminate the hazard and risk of injury.

Maclaren has chosen to guard against the risk of injury by offering a "free repair kit," consisting of hinge covers for the pinch points where a child's finger can be cut or amputated. The hinge covers appear to be made of cloth and snap onto the frame. A cover that easily snaps in place can also be easily removed, yet the unsafe pinch point remains. From a design standpoint, a guard or cover that can be easily removed without disabling the product, is inadequate. One must be concerned for the next family that inherits the stroller and who may be unaware of the covers’ importance, or that the covers will be removed once they get dirty. (Doesn’t Maclaren realize that peanut butter and jelly and many other substances are inherent to this product’s expected environment of use?)

The "free repair kit" might be worth just what Maclaren is charging for it, and a lot less than the $2 per stroller that Maclaren is reportedly spending on the kit.

What should a parent do?

Originally posted at InjuryBoard by Steven Schafer

Maclaren's "Voluntary" Recall of Strollers May Not Be So Voluntary

Steven Schafer — Sun, 15 Nov 2009 14:26:50 GMT

On November 9, 2009, Maclaren USA, the American subsidiary of the British manufacturer of umbrella strollers and other children’s products, “voluntarily” recalled about 1 million strollers because of reports of children suffering fingertip lacerations and amputations. According to the Consumer Product Safety Commission, “The stroller’s hinge mechanism poses a fingertip amputation and laceration hazard to the child when the consumer is unfolding [or] opening the stroller.”

This article will focus on the “voluntary” aspect of the recall. Future articles will focus on the manufacturer’s responsibility to identify and eliminate design defects so that injuries like these don’t happen, and what a parent who owns a recalled stroller should do.

Maclaren says it received 15 reports of children placing their finger in the stroller’s hinge mechanism, resulting in 12 reports of fingertip amputations in the United States.

This recall is about as voluntary as Bernard Madoff’s plea bargain, and Maclaren’s press release about as sincere as Madoff’s confession. The Consumer Product Safety Act requires a manufacturer to report consumer complaints to the CPSC where the manufacturer has notice that one of its products contains a defect that amounts to a substantial product hazard or poses an unreasonable risk of serious injury or death.

The CPSC can order a manufacturer to notify its customers and the public and to recall the product, and it can impose hefty fines if a manufacturer has withheld information, not acted quickly enough in reporting its knowledge to the CPSC, or otherwise placed the public at risk. Faced with an imminent government order, a manufacturer often decides that it’s better to cooperate with the CPSC, “voluntarily” recall a product, and offer a repair kit to consumers, than wait for the CPSC to impose harsher action. By cooperating in a “voluntary” recall, a manufacturer can spin its explanation to avert a public relations disaster and can negotiate fines.

Many consumers expressed dismay that 12 children suffered partial finger amputations before Maclaren did anything to prevent more injuries. What hasn’t yet been answered, however, is when Maclaren first learned of a child with a partial finger amputation, or first learned that a child was almost injured (making an actual injury all the more foreseeable), and how long it took the company to report the product defect to the CPSC. We also don’t know how Maclaren obtains and maintains its information on injuries.

Maclaren’s press release reaffirmed the company’s “unwavering commitment to child safety.” One would think a safety conscious manufacturer would want to provide equal protection to children in other countries, yet until consumer outrage sunk in, Maclaren initially was making the repair kits available only for U.S. consumers. The CPSC’s authority does not extend overseas, so Maclaren’s sense of voluntariness didn’t initially extend to countries that lack the United States regulatory protections, even though the strollers sold elsewhere are identical to those sold here. Maclaren says that it has received fewer reports of such injuries in the UK. Could it be that British tikes are themselves more safety conscious? Or, perhaps their fingers are less valuable than those of American children.

From product liability cases we have handled, this writer knows that it is not unusual for manufacturers to set up elaborate mechanisms to avoid learning or disclosing information about product injuries. When injuries do come to the attention of product manufacturers, many record the information in language that emphasizes consumer error in operating the product, not design defects that should have been identified and eliminated by the manufacturer. Sometimes injuries are assigned innocuous injury classifications to mask what really happened.

In the case of one children’s product made by another company, we found that the manufacturer instructed its customer service representatives who fielded consumer telephone calls not to ask if anyone was injured when a product failed. If a parent or caregiver reported an injury, the person was immediately transferred to another department that recorded basic information, but didn’t ask questions to clarify the severity of injuries or how they happened. The consumer wasn’t told that hundreds of other customers experienced the same problem. Reports were toned down to make the events seem innocuous and emphasis was placed on the parent or caregiver not properly operating the product, not on the inherent defect in the product’s design. Then, reports were not passed on to the regulatory people who were responsible for reporting the injuries to the CPSC. Years went by before the company reported the injuries to the CPSC.

This writer has learned of one little girl who suffered a partial index finger amputation long before Maclaren announced the “voluntary” recall. The child’s mother spoke to a customer service representative at Maclaren, but never received a response from the company. It’s doubtful that her complaint was included in the fifteen reports acknowledged by Maclaren.

So, we are left asking, what did Maclaren know and when did the company know it?

Originally posted at InjuryBoard by Steven Schafer

A New Study Shows that Stopping the Heart is the Best Method for Bypass Surgery

Carrie Strasser — Thu, 12 Nov 2009 10:30:54 GMT

A study published last week in the New England Journal of Medicine and reported in the New York Times found that bypass surgery performed using a heart-lung machine, or pump, was more successful in the long term than the recently popular off-pump procedures.

In the study, published Thursday in the New England Journal of Medicine, 2,203 patients were randomly assigned to have their bypass surgery on pump or off. Because the study was sponsored by the Department of Veterans Affairs, the patients were mostly men.

A year later, those who had had off-pump surgery had poorer outcomes. Fewer bypasses stayed open and patients were more likely to have needed a repeat operation or to have had a heart attack or to have died. They were no less likely to have had strokes or difficulty thinking.

Initially, doctors switched to off-pump procedures for fear that the pump could lead to strokes, memory problems or personality changes. The increasingly popular off-pump procedure requires doctors to operate on a still-beating heart.

Off-pump procedure patients had fewer blood transfusions but spent a longer period of time in the operating room. Patients of both procedures spent similar lengths of time in intensive care, on ventilators and in the hospital.

Certain surgeons who have made the off-pump procedure their common practice say they will not change because they have developed an expertise in the procedure and the study does not reflect their actual outcomes.

Approximately 20% of the over 200,000 people having bypass surgery each year opt for the off-pump procedure. In the beginning, this procedure was not easy with surgeons having to operate on a moving, beating heart. Many surgeons were pressured into learning this procedure and instruments were soon developed that assisted in keeping the heart steady.

However, despite the fact that some surgeons eventually became "experts" at off-pump procedure, the purpose of the study, says Dr. Michael Lauer, Director of Cardiovascular Sciences at the National Heart, Lung and Blood Institute, was to determine "how well will the procedure work in the hands of a typical surgeon." Dr. Lauer added that very few surgeons have actually attained a high level of expertise in this off-pump procedure.

Originally posted at InjuryBoard by Carrie Strasser