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 Liability

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Medtronic, one of the world’s most prominent manufacturers of medical devices, has been named in a whistleblower lawsuit alleging that it regularly promoted its spinal implants for use in the neck despite the fact that the devices were not approved for such use by the FDA and specifically were labeled as being inappropriate for the cervical spine. The specific implant was the Medtronic VERTE-STACK, which is “intended for vertebral body replacement to aid in the surgical correction and stabilization of the spine” and is part of Medtronic’s INFUSE Bone Graft system.  The whistleblower suit alleges that Medtronic defrauded government healthcare entities by charging for the implantation of the spinal implant devices when the company knew that the use was illegal or unsafe.  The company is already facing thousands of potential personal injury lawsuits related to the INFUSE products.

This lawsuit is just one example of what seems to be a common practice for medical device and pharmaceutical drug manufacturers – promoting “off-label” use of its products to physicians despite federal prohibitions against such practices and despite the risk for patient safety.  Such practices, while making millions for medical device manufacturers, pose significant and sometimes deadly risks to patients who are implanted with the devices.

The personal injury attorneys at SUGARMAN have litigated complex medical device and defective product cases for decades.  If you believe you may have a claim involving a defective medical device, please fill out a Contact Form, call us at (617) 542-1000 or e-mail info@sugarman.com.

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After the filing of multiple lawsuits as a result of birth defects in children of mothers who were prescribed Zofran (generically known as Ondanestron) to treat nausea and vomiting during pregnancy, a federal judicial panel created a consolidated docket for all Zofran cases in Massachusetts. The October 13, 2015 order from the Judicial Panel of Multidistrict Litigation will transfer 12 cases and all future Zofran cases to the Massachusetts Federal District Court to be heard by Judge Dennis Saylor. For more information on Multi-District Litigation, see our former blog post.

Zofran, manufactured by GlaxoSmithKline, LLC, is an anti-nausea drug that was approved by the Food and Drug Administration (FDA) in the early 90s to treat nausea and vomiting symptoms in patients undergoing chemotherapy or surgery. More recently, the drug has been extensively prescribed off label to treat nausea and vomiting during pregnancy, allegedly causing birth defects, such as cleft lip, cleft palate, club foot, and heart defects, resulting in the numerous product liability lawsuits.

Nausea and vomiting in pregnancy is the most common symptom associated with pregnant patients, with more than 80% of pregnant women experiencing these symptoms at some point during their pregnancy. According to a recent article published by the American Journal of Obstetrics and Gynecology (AJOG), 97.7% of prescriptions for the treatment of nausea and vomiting in pregnancy in the United States are with medications not labeled for use in pregnancy, not indicated for nausea and vomiting in pregnancy, and not classified as safe in pregnancy by the FDA. In recent years, the use of Zofran for the treatment of nausea and vomiting in pregnancy has steadily increased, and today approximately 1 in 4 pregnant American women are exposed to Ondanestron.

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Halloween is a favorite holiday for the young and young-at-heart, whether it be trick-or-treating or dressing up for a Halloween party. Regardless of your age, following the safety tips put out by the Centers for Disease Control and Prevention and the Consumer Product Safety Commission will help to keep you and your family safer this fall season.

Halloween Costumes: Choose a flame retardant fabric. When shopping for a costume, look for the label “Flame Resistant.” This label indicates that the items will resist burning and should extinguish quickly once it is removed from the ignition source.

Halloween Makeup: Always test Halloween make-up in small area first, especially on children. Remove it before bedtime to prevent possible skin and eye irritation.

Trick-or-Treating Pedestrian Safety: Purchase costumes that are light and bright enough to be clearly visible to motorists. You can also use reflective tape and carry flashlights to be seen more easily. Halloween is the perfect opportunity to teach children to practice using the crosswalk, obeying traffic signals, and looking both ways before crossing the street.

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An agreement has been reached in the case involving two Massachusetts parents who sued their son’s private school on the grounds that the school’s Wi-Fi was causing their son to become ill. On August 12, 2015, the parents filed a lawsuit against their son’s private school–the Fay School in Southborough, Massachusetts–alleging that the strength of the school’s Wi-Fi signal is causing their son to suffer an electromagnetic hypersensitive allergic reaction. The lawsuit, which was filed in the U.S. District Court, District of Massachusetts, sought $250,000 in damages as well as an injunction that would require the Fay School to hardwire its Internet connection, decrease the strength of the Wi-Fi signal, or make other accommodations for the student. On August 25, 2015, the parties filed a request that the preliminary injunction hearing, originally scheduled for September 4, 2015, be extended until September 25, 2015 in order to work out the specific terms of the undisclosed agreement.

In their complaint, the unnamed plaintiffs (referred to as “Mother” and “Father” in the complaint) contended that beginning in the spring of 2013, their son (referred to as “G” in the complaint) began experiencing headaches, itchiness, and a rash, only while he was present at school. These symptoms allegedly worsened in 2014 when the boy began to suffer bloody noses, dizziness, nausea, and heart palpitations. The 12-year-old boy has since been diagnosed with Electromagnetic Hypersensitivity Syndrome (EHS), which is a condition exacerbated by electromagnetic radiation. While the symptoms associated with EHS are acknowledged in the medical community, there is an ongoing debate about whether EHS is a bona fide medical condition.

The unnamed plaintiffs alleged that their son’s symptoms began when the Fay School installed an updated, more powerful Wi-Fi system in 2013. The parents claim that the signals emitted by the school’s Wi-Fi are stronger than those found in a typical household. In response to the parents’ concerns, the Fay School hired a company to measure and evaluate the strength of the electromagnetic signals on campus. The company found that the radio signal strength on campus was far below the permissible levels promulgated by the Federal Communications Commission. While the nature and extent of the company’s testing and findings remains largely undisclosed, there is a likelihood that it will directly influence the final terms reached in the agreement among the parties.

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On November 3, 2014, Howmedica Osteonics Corp. (Stryker) announced a National Settlement Program for patients meeting certain criteria who had received these Stryker implants. Stryker invited patients affected by the recalled Rejuvenate and ABG II hip systems to participate with the condition that substantially all eligible patients participate. The settlement program is only available to those patients who have had their Stryker implant removed prior to November 3, 2014; who registered with the program online by December 16, 2014; and who enroll in the program by a deadline which has now been extended to March 30, 2015.

We believe that there are many patients with meritorious claims who may not be aware of their rights and options. Every patient who has received one of these Stryker hip implants should immediately seek legal advice and representation including patients who (i) are not eligible for the program because they have not yet had their hip revised; (ii) believe they have already forfeited their rights by not registering or enrolling in the program; or (iii) whose claims need to be evaluated to determine whether they are appropriate for the program. We also believe that there are many patients who have not been told of the recall, or have been led into a false sense of security that their Stryker hip will not have to be removed. These patients may have meritorious claims as well and are in need of legal counsel.

The statute of limitations is rapidly approaching for some of these patients. If you know of anyone who has a Stryker Rejuvenate or ABG II hip implant, please contact or ask the patient to directly contact Ben Zimmermann or Stephen Sugarman at 617-542-1000 or e-mail bzimmermann@sugarman.com or ssugarman@sugarman.com.

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By now, almost every consumer has seen the ubiquitous Lumber Liquidators commercials advertising their hardwood laminate flooring. The company is actually the largest retailer of hardwood flooring and its stock price has risen almost ten fold since 2011. Certain products of Lumber Liquidators, however, may be very dangerous to consumers, especially small child. In an expose that aired on March 1, 2015, CBS’ 60 Minutes revealed that laminate flooring made in China for Lumber Liquidators can contain up to 20 times the level of formaldehyde allowed under the law of some states, namely California.

Formaldehyde is a chemical typically contained in the glues used to bind wood particles together in order to make the laminate flooring. It is classified as a known cancer-causing substance and has been shown to increase the risk of developing certain cancers, including nasopharyngeal cancer and leukemia. In addition, formaldehyde can cause respiratory problems, nausea and burning and irritation of sensitive areas such as the eyes, nose and throat.

It will be interesting to see Lumber Liquidators response to this investigation and early indications are that the company could face severe financial consequences as its stock price fell precipitously the day after the 60 Minutes segment aired. In addition, the company could face criminal charges as well as civil lawsuits brought by people both injured by the formaldehyde and people seeking to have their laminate flooring replaced.

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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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A federal jury in West Virginia recently returned a verdict of $3.27 million for a woman who filed suit against Ethicon, a unit of Johnson & Johnson, for injuries due to a defective transvaginal TVT-O mid-urethral sling. After a nearly two-week trial, the jury found in favor for the plaintiff, Jo Huskey, on her counts of strict liability, design defect, failure to warn and negligence. Ms. Huskey, now 52 years old, underwent the implantation procedure in 2011 for stress urinary incontinence and has suffered erosion of the mesh, which has caused severe pain and required her to undergo (unsuccessful) surgeries to remove the mesh. Ms. Huskey’s case was the first federal trial involving a claim pertaining to Ethicon’s TVT-O mesh sling, and the second case tried among the thousands that have been consolidated in multi-district litigation in West Virginia (the first ended in a win for Ethicon).

About one week following the verdict in Ms. Huskey’s trial, a Texas jury awarded $73.5 million to a woman in her case against Boston Scientific, in which she alleged that the bladder sling it manufactured caused her permanent injuries. The plaintiff, Martha Salazar, who is 42 years old, testified that she can no longer walk or sit normally as a result of the severe pain she has suffered since the Obtryx Transobturator Mid-Urethral Sling (MUS) System was implanted in 2011 to treat mild incontinence. Following the implantation, Ms. Salazar required four major surgeries and 42 additional procedures due to internal injuries caused by the sling. She is likely to require further surgery. After a two-week trial in Dallas, the jury awarded Ms. Salazar $23 million in compensatory damages and $50 million in punitive damages, the latter of which was premised on a finding of gross negligence against Boston Scientific, a company based in Natick, Massachusetts.

Over 60,000 cases against a number of mesh manufacturers currently await resolution across the country.

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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.