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

Steven Schafer — Mon, 16 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.”

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

Falling Down Stairs

Ken Margolin — Thu, 15 Feb 2007 07:00:00 GMT

Falling down a flight of stairs or even a few steps can cause serious injuries. Broken bones, head injury, and other trauma can result. In determining whether a stair injury case should result in a lawsuit, a number of factors need to be determined in addition to the severity of the injury. Stair injury cases are a form of premises liability litigation. Stair design is one factor to be analyzed. Knowledge of what makes stairs safe and unsafe has been circulated generally in the construction industry for many years. Age of the stairs is relevant. The owner of an older building with stairs narrower than would be designed today, for example, may not be liable for the excessively narrow stairs. There is no obligation known in the law to replace stairs, even if they would be considered unsafe if built today.

Other factors, though, are within the owner's control even in older buildings. If wear has made the surface of steps slick, treads may be required. If there is an odd curve increasing the likelihood that a walker may step off the edge suddenly or have difficulty visualizing the next step, a warning sign or strip may be necessary. Railings can reduce the risk of injuries on stairs and their absence may be negligent in some cases. Poor lighting is a common cause of falls on staircases. Many a condominium association or apartment building owner has assumed that they were free from liability from staircase falls on their premises because their stairs complied with the building code.

Compliance with building codes is important but does not necessarily mean that a stairway is not negligently designed or maintained. Building codes are minimum standards. While failure to comply with the building code is evidence in Massachusetts, of negligence, compliance does not necessarily equal due care. Any case of a fall on stairs resulting in serious injury must be assessed individually to determine whether the stairs were safe for their reasonably intended use and at all times when their use was forseeable.

Originally posted at InjuryBoard by Ken Margolin

Maclaren Stroller Recall: What A Parent Should Do

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

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'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

Cell Phone Driving Fatalities

Ken Margolin — Tue, 07 Aug 2007 16:10:00 GMT

If the sight of the driver to your right on the interstate, chatting away on his cell phone gets you angry, you've got a right to be. Various studies have shown that driving while talking on a cell phone can be as dangerous as driving with a blood alcohol level over the legal limit. Estimates of the number of U.S. traffic fatalities caused by cell phone talking while driving are generally in the 2,000 - 3,000 range with one hundred times as many injuries. The best remedy for the menace of cell phone traffic accidents, would be common sense by most drivers and a realization that the common practice is anti-social and dangerous. Failing a sudden epidemic of common sense, legislation and tough enforcement need to be implemented. Enacting legislation will be tough given the lobbying power of the cell phone industry. The effort, though, coupled with public education, can save thousands of lives each year.

Originally posted at InjuryBoard by Ken Margolin

FDA Announces Safety Review of FosaMax, Boniva Class of Drugs

Courtney Mills — Tue, 02 Oct 2007 14:06:34 GMT

The FDA released an 'early communication' to the public of an ongoing safety review regarding the drug class bisphosphonates due to potential atrial fibrillation with the use of this class of drug. The agency has requested that further data be obtained in order to assay the merits of the tendency.

Bisphosphonates are a class of drug prescribed by physicians to treat osteoporosis. These medications are sold on the market under the brand names Fosamax, Actonel, Reclast, and Boniva, and they retard the rate of bone thinning in adult men and women. These drugs also reduce the likelihood of suffering from broken bones.

The FDA made this announcement after a study in the New England Journal of Medicine this spring revealed more cases of serious atrial fibrillation associated with older female patients treated with Fosamax or Reclast than those treated with a placebo.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Courtney Mills

Can I Sue if I Receive Workers Compensation?

Ken Margolin — Fri, 20 Jul 2007 15:30:00 GMT

I have been asked this question many times over the years by clients who have received serious personal injuries at work. Workers compensation pays the injured employee regardless of whether the employer or anyone else was negligent, and even if the employee's own negligence contributed to his injuries. Worker compensation laws are essential, but they are something of a devil's bargain.

The tradeoff for certainty of payment is that the compensation is grossly inadequate in cases of death or disabling injury, and the employer cannot be sued. The personal injury attorney contacted by a person who was badly injured on the job, must look for a viable "third party defendant." The third party defendant is a person or entity, other than the employer or a fellow employee, whose negligence contributed to the injury. For example, a negligent subcontractor in a construction accident case, might be a third party defendant. If the workplace injury was caused by a defective product, the product manufacturer could be a third party defendant. Sometimes, maintenance or security on a work site, is performed by an entity other than the employer. In the appropriate case, they might be third party defendants.

In any tort case in which workers compensation insurance has been paid, the insurer has a lien on the potential recovery, from which it can recoup the money it paid to the injured employee. In Massachusetts, the lien is automatically reduced by a third, the notion being that the plaintiff's attorney's efforts benefited the comp. insurer, which should be responsible for their portions of the attorneys fees. Worker compensation insurers are often willing to reduce their liens further, in order to facilitate a settlement, enabling both the comp. insurer and the injured employee to benefit.

For more information on this subject, please refer to our section on Workplace Injuries and Discrimination.

Originally posted at InjuryBoard by Ken Margolin

Bedrails can kill patients

Steven Schafer — Wed, 25 Feb 2009 10:27:36 GMT

Despite federal safety regulations and an increased awareness of the dangers of using bedrails at long-term care facilities and hospitals, patients continue to die from suffocation, strangulation or asphyxiation.

How do these tragedies occur?

One way is when patients slip through a gap between the mattress and the bottom of the raised bedrail, their heads get stuck, and they strangle to death. Sometimes their bodies are compressed causing asphyxiation. Or patients suffocate when they get wedged between the bedrail and the side of the mattress, with their faces pressed against the mattress. These hideous entrapment deaths usually occur with elderly patients. As long ago as 1995, the U.S. Food and Drug Administration issued a Safety Alert to hospitals and nursing homes warning about entrapment hazards and safety concerns that accompany the use of bed rails.

I’m currently handling a case involving the strangulation death of an 87-year-old Massachusetts woman in 2006. The woman slid off her nursing home bed, and caught her chin on the raised bedrail. Her head became wedged between the bed rail, mattress and bed frame, with the rest of her body in a sitting position toward the floor, causing asphyxiation.

The Massachusetts Department of Public Health concluded that the woman’s mattress pad alarm and personal safety alarm had not sounded to alert the nursing staff that the woman was in distress. Nonetheless, the woman’s tragic death could have been prevented if the nursing home had taken the proper steps to identify and eliminate the risk of entrapment hazards associated with bedrails.

Compounding these tragedies is the fact that they could have been easily avoided. Long-term care facilities and hospitals can take relatively easy and inexpensive steps to protect patients from these dangers.

For example, they can install cushions to fill the gap between mattress and bedrail, much like bumpers used in a baby crib. As an alternative, they can install see-through netting to fill the gap, which provides patients better visibility from their beds. Another safeguard is to simply use thicker mattresses to eliminate the gap.

Nursing homes and hospitals have used bedrails for decades with the intention of restraining patients from falling out of bed and suffering injuries. However, medical studies actually show that bedrails can increase the likelihood of falls as elderly patients try to crawl over or around them. A safer option is to simply place a patient in a bed low to the floor with safety mats next to the bed, and avoid using bedrails altogether.

Some long-term care facilities and hospitals increase the potential for injuries and death by “mixing and matching” beds, mattresses and bedrails from different manufacturers, causing unsafe integration of bed parts. Not only that, nurses and nursing assistants often receive inadequate training on the proper use of bedrails, and effective monitoring of patients.

A related problem is that the cause of death is often misdiagnosed because the suffocation can result from a gentle compression of the body or covering of the nose and mouth. The trauma often associated with strangulation, such as bruising of the neck or a fractured hyoid bone, which lay at the base of the tongue, is not always present or may not be identified.

An even larger potential problem is that long-term care facilities and hospitals either destroy or alter their medical records (more often than you’d like to believe), which makes it harder to prove their negligence in the use of bedrails and monitoring of patients.

The sad truth remains that bedrails can cause more problems than they solve. There’s often no need to use them, yet they are continuing to be used, and people are dying or suffering serious injuries as a result.

Originally posted at InjuryBoard by Steven Schafer

Causes of Anesthesia Mortality

Ken Margolin — Tue, 30 Jan 2007 07:00:00 GMT

Despite the fact that the anesthesia profession led the way in medical error reduction techniques, there are still too many anesthesia deaths and serious injuries. When anesthesia malpractice occurs, the results are often catastrophic. With general anesthesia, the patient is helpless. Serious anesthesia errors can deprive the brain of oxygen, causing irreversible damage within minutes or result in other severe respiratory harm - for example, lung damage due to aspiration. Some errors that continue to cause death in anesthesia include: (1) misplacement of the endotracheal tube into the esophagus instead of the trachea (oxygen does not get to the lungs, and thus not to the heart or brain); (2) aspiration of noxious contents into the lungs (causing lung swelling and possible failure); (3) inadequate monitoring of oxygen saturation level of the blood (if a problem arises, the results may be fatal or irreversible damage before corrective action can be taken); (4) administration of excessive amounts of anesthesia (potentially causing cardiac arrest or other problems); (5) failure to have personnel adequately trained with proper treatment agents, to deal with an emergency if one occurs. Each of the causes just listed can be prevented if proper techniques, monitoring, and training are employed.

Originally posted at InjuryBoard by Ken Margolin

Deadly Medication Errors

Ken Margolin — Fri, 14 Sep 2007 18:00:00 GMT

The problem of medication errors has by now been well-reviewed, and efforts to minimize such errors are underway in hospitals and doctors' offices across the country. Nevertheless, the problem of medication errors has proven to be a very stubborn one. In his groundbreaking book, "To Err is Human," Lucien Leape, M.D., estimated that medication errors caused approximately 98,000 deaths per year. Given that the 40,000 +/- highway deaths each year, is often described as "carnage" on the roads, 98,000 is a sobering number.

A study reported earlier this year reviewed medication errors made on patients undergoing surgery. Astoundingly, the study estimated that 5% of adults and 12% of children suffered harm in surgery-related medication errors. Painkilling medications and antibiotics were responsible for a significant share of serious harm. As is the case in other areas of medical negligence, failures of communication caused many of the problems. The danger was particularly acute when various medical teams not working on the patient at the same time, were required to communicate effectively. Examples given were hand offs of patients from the preoperative team to the operating room team, and from the operating room to nurses in the recovery room or on the ward. These failures of medical communication will continue until the notion of patient treatment as a true team effort, is taken seriously and implemented across disciplines and hospital staffs and departments.

For more information on this subject matter, please refer to our section on Medical Malpractice and Negligent Care.

Originally posted at InjuryBoard by Ken Margolin