INSIGHTS On Massachusetts Personal Injury Law

Welcome to the SUGARMAN blog. We'll be sharing our perspectives on the state of the law and current legal issues in Massachusetts personal injury law. Issues relating to medical malpractice, construction site injuries, premises liability, product liability, motor vehicle accidents, insurance, and more will all be reviewed here by our team of lawyers who have prosecuted some of the most complex cases in Massachusetts personal injury law.

Articles Posted in Product Recalls

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With Black Friday, Small Business Saturday and Cyber Monday just behind us, and only 16 shopping days until Christmas, many people will be putting on comfortable shoes and heading to the malls and brick and mortar stores to check off everyone on their shopping lists. Before you purchase just any toy on the shelf, read through the 29th annual “Trouble in Toyland” report, released December 1, 2014 by the U.S. Public Interest Research Group (PIRG). The report outlines safety issues and provides safety guidelines, educating even the most savvy consumer (even personal injury attorneys!) about hidden dangers in children’s toys. This year’s report focuses on potential choking hazards, “toxic” toys and battery hazards. The report provides examples of multiple toys containing small parts which could be considered choking hazards, and which do not have the proper warning labels. Potentially “toxic” toys were tested for the content of several different metals and chemicals, including lead (concentration must be < 100 ppm in children's toys), chromium (concentration, when dissolved, must be 110 ppm lead, “Jake and the Neverland Pirates Tambourine”, also sold by Dollar Tree, which contains just under ten times the federal allowance for chromium at 580 ppm, and the “Hello Kitty” bracelet and hair clips accessory pack, sold by Jo-Ann Fabric and other craft stores, which contains over five times the legal concentration of Phthalates, at 5,100 ppm. Also according to the report, “Our Generation: Sydney Lee” dolls sold by Target and “Disney Junior Doc McStuffins Figurine Playsets,” sold by Amazon, do not have the proper labeling relative to choking hazards and small parts. This report helps consumers to be wary of hidden dangers in products used by small children.

Once you have carefully and conscientiously completed your holiday shopping for 2014, take a look back at all of the gifts you purchased and received last year, and check the Consumer Product Safety Commission (CPCS) website to see if there are any safety recalls on those products. Some examples of recently recalled products include 11 models of Graco strollers (fingertip amputation hazard), “Hello Kitty” themed whistles (recalled by McDonald’s due to choking hazards), and Louis Garneau aerodynamic bicycle helmets (can fail to protect the user in cold weather). It is important to be knowledgeable, so that everyone stays safe and healthy this holiday season.

When you or someone you love is injured by a defective product, a personal injury lawyer should be consulted regarding the potential liability of the manufacturer and retailer. SUGARMAN has a team of dedicated personal injury attorneys who represent those who have been injured by defective products. If you have been hurt in an accident and wish to speak to one of our attorneys regarding liability, please fill out a Contact Form, call us at 617-542-1000 or e-mail info@sugarman.com. Also, please continue following SUGARMAN’s blog, Insights on Massachusetts Personal Injury, for information on matters affecting consumers and individuals.

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With Labor Day weekend just behind us, students at all education levels are starting classes this week. According to a summer study conducted by the National Retail Federation, Americans were expected to spend nearly $75 billion on back-to-school needs and wants this year. This includes everything from clothing and traditional school supplies like pens and pencils to electronics and dorm room needs for college students. Almost anything can end up on the back-to-school list, which is why buyers should educate themselves on the latest product safety news. A number of product safety recalls were announced this summer which may affect all types of back-to-school purchases.

Back-to-school clothing makes up a large percentage of each year’s buys. On August 7, 2014, LL Bean recalled just over 5,000 girls’ sweaters sold in sizes 4-7, which came in both Fisherman’s and open stitch styles. The sweaters are being recalled because the spare button attached to the label can detach, creating a choking hazard. Consumers who purchased the sweaters should immediately remove the spare button from the inside seam before use.

Many children are sent off to school every day with a homemade lunch and a personal water bottle. On August 19, 2014, Brita, manufacturer of the well-known water filtration system, recalled just under a quarter million children’s hard plastic water bottles. The recalled items have popular children’s cartoon characters on them, hold fifteen ounces of liquid, and have hard plastic screw-on tops. The bottles are being recalled because the screw-on lids are susceptible to breaking and cracking, creating sharp pieces that pose a laceration hazard to children. Despite multiple reports of broken lids, no injuries have been reported to date.

Bean bag chairs are often found in child bedrooms and dorm rooms. As a result of two separate incidents resulting in the death of a three-year-old girl from Kentucky and the death of a thirteen year-old boy from Texas, on August 22 2014, the Consumer Product Safety Commission (CPSC) and Ace Bayou Corporation of Louisiana recalled nearly 2.2 million bean bag chairs of different shapes, sizes and colors sold by various retailers and several online giants such as Walmart.com and Amazon.com. The bean bag chairs were manufactured with zippers that open, allowing children to climb inside and suffocate or choke on the polystyrene beads that fill the chairs. To prevent tragedies like these, the voluntary safety standard pertaining to bean bag chairs requires that non-refillable chairs have permanently disabled zippers. As part of the recall efforts, Ace Bayou Corporation will provide kits to permanently disable the zippers to consumers who purchased the affected product.
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One of the most important issues surrounding Total Hip Arthroplasty (replacement) is the future of bearing surfaces. The bearing surfaces of an artificial hip joint ideally have sound wear characteristics and durability, are bio-inert and relatively easy to implant. Hip recalls, including the DePuy ASR and Stryker Rejuvenate and ABG II, represent a loss in confidence and movement away from metal-on-metal articulating surfaces. Growing reports of cobalt and chromium toxicity, device failure and revision surgery in patients implanted with metal bearings have forced surgeons and manufacturers to look to new solutions for the composition of bearing surfaces.

Future bearing surfaces will including improved polyethylene and ceramic components. Recent short-term studies have evaluated the efficacy of Vitamin E stabilized polyethylene. By adding the antioxidant Vitamin E to polyethylene under specific controlled conditions, researchers noted that the material exhibited low wear and high strength characteristics compared to polyethylene bearing surfaces on the market. Though these short-term studies are encouraging, long-term analysis is still required to understand the longevity of the material. Research is also underway to improve upon the strength of existing fourth-generation ceramics which have been engineered to inhibit cracking. Alternative new materials are also being considered for hip surfaces. Diamond-like carbon film may be a viable solution. It is known for superior tribological and mechanical properties, as well as inertness and compatibility with biomedical devices. Carbon-based composite materials also offer a potential low wear, high durability articulating surfaces. Whatever the products of the future will be, the search is underway for alternatives to metal-on-metal bearings that permit decreased joint friction and wear rates but increased strength.

SUGARMAN has a team of lawyers dedicated to handling defective and recalled hip system claims. If you have any questions regarding DePuy or Stryker hips, please fill out a Contact Form, call us at (617) 542-1000 or e-mail info@sugarman.com.

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GM recently recalled over a million of its Chevrolet Cobalt and HHR, Pontiac G5 and Solstice, and Saturn Ion Sky models. Other recent examples are the defective DePuy and Stryker hip replacements, Graco toddler and booster seat restraints, and 8.7 million pounds of Rancho beef.

When a consumer is injured or killed by a product that is subject to a recall, fairness and logic would dictate that a jury asked to decide the consumer’s suit against the manufacturer be told about the recall. However reasonable this might seem, it is not the rule in some courts. Manufacturers when sued for a product-caused injury do everything possible to try to keep the jury from hearing about the recall.

Massachusetts state courts have long followed the rule that a jury can be told of a product recall where the consumer, “…has independently proved, by expert or other testimony, that the defect that was the subject matter of the recall existed in his vehicle at the time of the accident….” Once allowed into evidence, the recall becomes part of the proof of the manufacturer’s liability. The landmark case of Carey v. General Motors Corp, setting the law in Massachusetts regarding evidence of recalls, was successfully handled at trial and on appeals by SUGARMAN attorneys.

The rule is completely different in the Federal Courts – even those located in Massachusetts. The Federal Rules of Evidence which govern Federal Court trials state: “…[w]hen measures are taken that would have made an earlier injury or harm less likely to occur, evidence of the subsequent measures is not admissible to prove: negligence; culpable conduct; a defect in a product or its design; or a need for a warning or instruction….” Recalls are generally considered subject to this rule as “subsequent remedial measures”. Although there are some exceptions to this rule, the reality is that juries rarely hear about product recalls in Federal Court trials.
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Intended to be used in total knee replacement surgeries, Stryker ShapeMatch Cutting Guides are single-use guides that assist orthopedic surgeons in accurately positioning the knee replacement components in patients. Stryker began selling the ShapeMatch in May of 2011. The device was designed to be used in conjunction with the Stryker Triathalon knee replacement system. ShapeMatch Cutting Guides direct the surgeon where to mark the bone before cutting to allow for a customized surgical approach. The ShapeMatch software uses 3D imaging data derived from a patient’s MRI or CT scans to develop these specifically tailored cutting parameters.

On April 10, 2013, the FDA announced a recall of these Stryker ShapeMatch Cutting Guides. Stryker, however, had instructed surgeons to stop using the ShapeMatch in November of 2012. A software defect causes the ShapeMatch system to render improper cutting ranges not intended by the surgeon. The result is that the depth and width of the surgical margins are too great, often leading to post-operative joint instability, fracture, chronic pain, limitation of mobility and the need for a revision surgery to correct these injuries. Stryker has recommended that all patients who received a Triathalon knee replacement in which a ShapeMatch Cutting Guide was used, to contact their surgeons if they are experiencing symptoms.

The ShapeMatch, like Stryker’s Rejuvenate and ABG II hip systems, is yet another example of a Stryker product being recalled after receiving 510(k) clearance through the FDA. Stryker anticipates a growing number of these claims, especially as patients’ knee symptoms deteriorate.

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Many patients who have been implanted with defective medical devices such as transvaginal mesh and Stryker hip implants often question how these products first entered the market and whether the Food and Drug Administration has done enough to ensure that medical devices are safe for patients. In our ongoing research, we recently came across what we believe is an informative PBS “Need to Know” special that discusses both transvaginal mesh implants and metal-on-metal hip implants. The special highlights how doctors in other countries stopped implanting metal-on-metal hips in patients long before doctors in the U.S. and also discusses how mesh manufacturers knew of risks associated with implanting mesh in women, but failed to disclose these risks to patients and their doctors.

The video can be accessed on PBS’ website.

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In recent years, there have been a number of high-profile medical device recalls and resulting lawsuits involving metal-on-metal hip implants. The first to gain widespread attention was DePuy Orthopaedics’ August 2010 recall of its ASR XL Acetabular Hip System and ASR Hip Resurfacing System. Thousands of lawsuits against DePuy and various distributors were filed throughout the country and a settlement of many of these claims appears to be imminent. In addition to the DePuy cases, there are currently thousands of lawsuits arising out of Stryker Orthopaedics’ July 2012 recall of its Rejuvenate and ABG II modular hip replacement systems.

Much of the media attention on these recalls and the hip implants has focused on the lawsuits themselves – the amount of potential settlements, the profits the manufacturers made from these recalled devices and the amount of legal fees for plaintiff and defense lawyers. What is often lost in all the lawsuit-related attention are the real-life consequences that these products can have on the patients they were designed to help.

The Stryker Rejuvenate and ABG II devices were recalled due primarily to wearing and corrosion of the metal parts of the artificial hip system. Such corrosion can result in a patient developing metal toxicity (metallosis), pseudotumors, and tissue damage in the hip area. All of these conditions can not only be painful and debilitating, but can make removal and revision very difficult for the surgeon. Further, during the corrosive process, metal ions, including cobalt and chromium, are released into a patient’s body. It is still not entirely known what the long-term adverse effects of having elevated levels of these metals may be.

Unfortunately, the only true treatment option is the removal of the hip implant. This is far from simple, and has serious short and long-term implications for the patient. A primary hip revision is a large, invasive, and painful surgery to recover from. A revision is worse. Further, because the stems of these devices are inserted down the center of the femur bone, removal is quite traumatic, and frequently results in fractures to the femur itself, which then have to be repaired with more metal hardware. The end result is a complicated and prolonged recovery process with a high potential for permanent loss of function. In addition, patients who have already gone through one hip implant surgery are again subjected to extended periods of rehabilitation, meaning there is another round of bed rest, another round of physical therapy and more time lost from work. The revision surgeries can also pose additional complications for certain patients. For example, elderly patients in need of a revision may not be surgical candidates due to other health conditions, and must retain the device in their body despite its release of ions. Some patients have such extensive tissue damage that a new hip system cannot be implanted once the recalled hip is removed, forcing them to be disabled for the rest of their lives.
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The tragic death of two young Franklin children who became trapped in a chest highlights the need for greater consumer protection and vigilance. On January 12, 2014, the two youngsters apparently were playing in the family’s “hope chest,” manufactured by Lane Furniture of Virginia, when the chest automatically locked, trapping the children and causing them to suffocate.

The automatic locking mechanism rendered the chest unreasonably dangerous. In 1996, Lane Furniture recalled 12 million chests (Lane and Virginia Maid brand cedar chests manufactured between 1912 and 1987), due to lids that automatically locked when closed. The recall followed reports of the deaths of six children.

In 2001, the U.S. Consumer Products Safety Commission (“CPSC”) fined Lane $900,000 for failing to report the entrapment problem in a timely manner, which manufacturers are required to do. The CPSC is the federal agency charged with protecting the public from unreasonable risks of serious injury or death from thousands of types of consumer products. While CPSC has jurisdiction over consumer products generally, historically it has been most active with regard to products hazardous to children. CPSC administers several federal laws directly relating to child safety such as the Child Safety Protection Act (toy safety), Flammable Fabrics Act (standards for children’s sleepwear and mattresses), Poison Prevention Packaging Act (child resistant packaging of hazardous household products and medications), Refrigerator Safety Act (to prevent accidental entrapment of children in discarded refrigerators), and more recently the Virginia Graeme Baker Pool & Spa Safety Act (includes safety requirement to prevent entrapment in drains). In addition, the CPSC has passed numerous regulations relating to the child-safety of various products. Examples include: baby bouncers and walkers, cigarette lighters, cribs and infant cushions, garage door openers, and swimming pool slides. The chest entrapments and recall follows a history of children being killed by entrapment in other consumer products, including refrigerators and car trunks.

Although it is currently unclear as to whether the chest in Franklin was of the model that was subject to the recall, the dangerous mechanism on the subject chest presented the same grave danger. Press reports available to date indicate that the Franklin family had purchased the chest in a used condition 12 years ago. Lane Furniture has reported that chests manufactured after 1987 have new “safety locks.” Although Lane launched several programs in concert with the CPSC, concentrating on lock replacement, there are still an estimated six million chests that need the locks replaced according to Lane’s website. To prevent another tragedy, CPSC urges consumers to check their “Lane” and “Virginia Maid” brand cedar chests. According to the CPSC website, the brand name “Lane” or “Virginia Maid” is located inside the cedar chest. If the lid latches shut without depressing a button on the outside of the chest, the lock needs to be replaced. Contact Lane toll-free at (800) 327-6944 Monday to Friday from 7:00 a.m. to 6:00 p.m. CT, or access their website to order the free replacement lock. Consumers should have the chest’s serial and style numbers, which are branded on the outside bottom or back of the chest, available when contacting Lane.
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In July, 2013, the FDA issued a Class II recall on the da Vinci Surgical Robot system. Class II recalls are initiated where a product “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” The da Vinci robots, manufactured and designed by Intuitive Surgical Inc. (ISI), are used in minimally invasive surgeries and allow a surgeon to use a magnified vision system and tiny instruments designed to be more maneuverable than a human wrist. The idea is that the da Vinci Surgical Robots will allow a surgeon to be even more precise during procedures, reducing the risk and harm to the patient. Numerous problems with the design and operation of these robots, however, are being discovered in operating rooms across the country.

In November, 2013, the FDA issued a damaging report concerning the safety of the da Vinci Surgical Robots. The report, which resulted from a survey of surgeons, detailed malfunctions and problems with the surgical robots, including failure of the arms to recalibrate to appropriate settings, failure of arms to make correct cuts and electrical arcing of components – all of which could be potentially dangerous or life threatening to a patient. Surgeons offered several suggestions to improve da Vinci Surgical Robots, including changes to the design of the machine and changes to the training program.
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After a mediation, Stryker, the manufacturer of the defective and recalled Rejuvenate hip implants, has agreed to settle four claims currently pending in New Jersey Superior Court. After announcing a recall of the Rejuvenate hips in July, 2012, Stryker has been sued in thousands of lawsuits brought by patients who suffered serious and sometimes lifelong injuries as a result of having the defective hip system implanted in them. In addition to these four cases that have reportedly settled for undisclosed terms, three additional cases are scheduled to be mediated in January, 2014. It remains unclear whether these four settlements will have an impact on the thousands of product liability claims that exist against Stryker throughout the country.

SUGARMAN has formed a team led by partners Stephen Sugarman and Benjamin Zimmermann to represent clients who have been injured as a result of defective Stryker Rejuvenate and ABG II hip implants. If you have any questions regarding a Stryker hip implant, please fill out a Contact Form, call Stephen or Ben at 617-542-1000 or email ssugarman@sugarman.com or bzimmermann@sugarman.com.