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The U.S. Food & Drug Administration has recently issued a new warning instructing consumers to avoid eating raw cookie dough or any other batter, even if it does not contain eggs. The agency first expressed its concern about consumers’ tendency to chew on raw dough before cooking it in 2009, when an E. coli outbreak affected raw dough products. The investigation following the outbreak revealed that a number of consumers were not aware of the dangers that can result from consuming uncooked dough products.

Now, the main event prompting the FDA’s new warning involves the recent recall of 10 million pounds of flour produced by major international food product manufacturer General Mills. Sold under the brand names of Signature Kitchens, Gold Medal, and Gold Medal Wondra, these flours may contain the Shiga toxin-producing E. coli (STEC) O121 virus. At least 42 individuals have become ill across 21 different states as a result of consuming the contaminated flour products. There have been at least 11 hospitalizations, but there have not been any reports of individuals developing hemolytic uremic syndrome, which is a common kidney-related condition that results from E. coli infections.

The FDA first discovered the presence of the potentially deadly bacterium in the flour products in late June 2016, when it collected samples from homes of ill patients located in Oklahoma and Arizona. Although E. coli O121 can be neutralized and killed through heat treatments like sauteing, boiling, frying, or baking, it can still contaminate individuals if it is transferred to countertops, utensils, or other cooking implements. Early signs of contamination include fever, headaches, nausea, vomiting, and diarrhea. Although the infection can be treated in most cases, it is particularly life-threatening in vulnerable populations like children, the elderly, and individuals who have a weakened immune system.

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In a recent case, a man filed a medical malpractice claim for an allegedly negligent surgery after the procedure left him with a fractured ankle. The man broke his ankle while repairing his truck and had to undergo surgery as a result. Soon afterward, the man underwent an additional surgery, allegedly because the initial surgery failed to properly attach the fractured pieces. The patient filed a claim against the initial surgeon, alleging that the surgeon negligently performed the surgery and the post-surgical care.

Under that state’s law, expert witnesses are required to be board-certified to provide testimony in a medical malpractice claim. The plaintiff sought to present an expert witness who was board-certified at the time of the alleged malpractice. However, the expert witness’ certification had since expired, and the defendant argued that an expert witness must be board-certified at the time he testifies to be qualified. That state’s supreme court found that a witness’ board certification is based on the board certification status at the time of the alleged malpractice rather than at the time of testimony. Therefore, the testimony was permissible.

Expert Testimony in Medical Malpractice Cases

Medical malpractice claims arise when a patient receives negligent medical care. In general, the plaintiff has to show that the provider failed to conform to an established standard of care by providing expert testimony. The use of expert testimony is required because jurors normally are not skilled in the practice of medicine, and it usually is not clear to a layperson whether or not the professional breached the standard of care. Notwithstanding this requirement, expert testimony may not be required if the negligent conduct or treatment is so obvious that even a layperson can recognize it.

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Patients who suffer serious and potentially life-threatening conditions after undergoing surgical procedures involving a duodenoscope may be entitled to compensation. Roughly 85 percent of these devices are manufactured, marketed, and sold by Olympus. Recently over 100 patients suffered infections from an antibiotic-resistant “superbug,” commonly referred to as carbapenem-resistant Enterobacteriaceae (CRE). There have been three deaths linked to the defective devices. Olympus has finally initiated a recall of the surgical scopes, but this is too late for many affected patients.

Duodenoscopes are flexible tube-based cameras that surgeons can use during procedures to see inside the human body without having to make large openings in the body. They are equipped with a light and are commonly used to help surgeons diagnose conditions in the pancreas and bile ducts. After the outbreak of superbug infections, however, it was discovered that the scopes have a design defect that makes them virtually impossible to effectively sanitize between uses. This means that bacteria from one patient was easily transferred to subsequent patients, despite the surgical staff’s attempts to sanitize the scopes. According to some reports, Olympus was aware that the devices were incapable of being sanitized effectively in 2012, but it failed to inform the medical community about the potential dangers. More specifically, a Congressional report concluded that the medical device maker did not meet the FDA’s basic requirements of transparency and openness in dealing with the superbug outbreaks related to its devices.

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Anyone who has a loved one in a nursing home dreads a phone call from the nursing home. Residents are usually elderly and often sick, and injuries and deaths are common among nursing home residents. However, one risk may be an unexpected one: the safety risk of bed rails.

Bed rails are used in nursing homes to prevent residents from falling out of bed, to help them get in and out of bed more easily, and to help them reposition themselves more easily. Yet many people are unaware of the risks. The risks include scrapes and bruising from hitting the hard rails, more serious injuries from falls if a resident tries to climb over the rails, and strangling or suffocation if a resident becomes caught between the rails and the mattress.

The U.S. Food and Drug Administration reports that from 1985 to 2009, there were 803 incidents reported of patients caught, trapped, strangled, or entangled in beds with rails. About 480 of those patients died as a result. The Food and Drug Administration recommends only using bed rails when necessary and engaging in ongoing evaluation and monitoring to optimize safety.

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A Philadelphia jury recently returned a verdict awarding a 16-year-old teenager who suffered injuries after taking Risperdal $70 million in compensation. The manufacturer of the drug is Johnson & Johnson, a major international pharmaceutical and health care products company. According to the teenager’s complaint, Johnson & Johnson failed to provide appropriate warnings with the drug that it could cause him to grow breasts, referred to in the medical community as gynecomastia. According to his complaint, the plaintiff started taking Risperdal when he was five years old to address a psychiatric disorder.

The plaintiff also alleged that Johnson & Johnson intentionally prevented doctors and health care professionals from seeing the adverse results of a study about Risperdal that showed it could cause abnormal breast growth in boys.

Risperdal is an antipsychotic medication used to treat a number of mental disorders like bipolar disorder, schizophrenia, and irritability in autism patients. Signs of gynecomastia include puffy nipples, enlarged nipples, painful breasts, nipple discharge, and breast growth. The results of gynecomastia in boys can be devastating, resulting in serious emotional and mental pain while also frequently requiring a mastectomy to remove the breast growth.

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Everyone has seen someone slip on an icy sidewalk, and the injuries can be serious. But whose duty is it to maintain the sidewalk, and what does that duty require? In a recent case, a court held that a case had to be retried when a plaintiff failed to explain what the defendant’s duty was in training its employees and how they failed to meet that duty.

In a recent case, a woman slipped and fell on an icy sidewalk at a Marriott hotel while she was staying at the hotel for business. She broke her ankle and sued the hotel for negligently maintaining its sidewalks and failing to properly train the employees who were responsible for deicing the sidewalks. The case proceeded to trial, and the jury found the hotel 98 percent at fault. The hotel appealed the decision, and the state’s supreme court reversed and ordered a new trial. The court held that the trial court should not have allowed a “negligent training theory” without having testimony on the standard of care for training employees on how to deice the sidewalk, or how that had been breached.

The court explained that the jury could not have found that the hotel was negligent in training its employees because the required standard was never explained to the jury. In other words, the plaintiff did not provide any evidence that the hotel had a duty to instruct employees about the time that deicing would remain effective. The court stated that some evidence or testimony to support the position had to be admitted before a jury could return a verdict on that specific claim. The jury could not find that the hotel breached its duty to properly train employees because the standard of care required was never explained. As a result, the court reversed the decision, and the case had to be retried.

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Wright Medical, a manufacturer of hip implants and other medical devices, has asked a federal appellate court to overrule a jury’s verdict in the first bellwether trial to take place in the Conserve metal-on-metal hip implant MDL, which is situated in the Northern District of Georgia. According to the company, a new trial is justified because it believes that the jury was allowed to take two bites at the apple.

An MDL, or multi-district litigation, is a judicial mechanism that is used to consolidate and expedite cases that involve similar claims. It is like a class action in that plaintiffs with common causes of action and common factual allegations against the same defendant are grouped together. It is different from a class action when it comes to damages, however, with each MDL plaintiff needing to prove his or her individual claim. To test legal theories, claims, and damages, the lead attorneys in an MDL conduct a bellwether trial. This involves selecting a plaintiff whose case is representative of the broader MDL plaintiffs’ claims and litigating it to see what a jury would conclude. Hundreds of lawsuits have been filed against Wright Medical, which are now pending in the MDL action.

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New construction zones pop up all the time, especially during the summer. Even when a driver is paying attention to the warnings, a driver can still misunderstand the signs and enter the wrong lane. For that reason, adequate warnings are essential.

In a recent case, a man was killed in an accident while he was driving his motorcycle through a construction zone. The man inadvertently drove into a closed lane, and when he tried to go back to an open lane, he hit an uneven surface and was thrown off his motorcycle and into traffic. The man’s estate sued the state’s transportation commission and the state’s department of transportation for failing to place proper warnings, failing to properly maintain the condition of the road, and creating hazardous driving conditions.

The defendants argued that they were immune from liability because the placement of the traffic control warning was within their discretion. The court rejected their argument and denied their immunity claim. The court noted that a governmental entity and its employees acting within the scope of employment are not liable in that state for actions that are discretionary.

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One of Johnson & Johnson’s subsidiary companies has asked a federal appellate court to enter a stay of litigation in a lawsuit involving its Pinnacle metal-on-metal hip implant device. The company is seeking this time-out, claiming that it needs to appeal a $490 million jury verdict against the medical device manufacturer. During March 2016, a federal jury in Texas returned a verdict against DePuy Orthopedics, the subsidiary in question, totaling $490 million in favor of five plaintiffs who alleged the subsidiary’s hip implant caused them serious injuries.

Following a two-month trial on the product liability claim, the jurors concluded that DePuy’s metal-on-metal hip implants, which were a spinoff model based on the Pinnacle hip implants, were designed in an unreasonably dangerous manner and that DePuy had failed to include appropriate warnings with the products about the dangers that users may face. To recover compensation in a medical device case, the plaintiff must show that the medical device was designed in an unreasonably dangerous fashion. This can also include facts showing that the company failed to include proper warnings or instructions with the device. Here, for example, the plaintiffs alleged that DePuy failed to warn patients about the likelihood of metal fragments entering patients’ bloodstreams and causing metallosis. The jury returned a verdict form awarding $130 million in compensatory damages and $360 million in punitive damages.

Prior to this, in October 2014, the first case litigating whether the Pinnacle hip implant was defective was concluded when a federal jury returned a verdict stating that DePuy was not liable for the plaintiffs’ injuries and awarding the plaintiffs zero damages.

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Moll Law Group ha presentado su primera demanda contra el fabricante de Nexium, AstraZeneca, en nombre de un residente de Tennessee que sufrió heridas graves y potencialmente mortales después de haber sido prescrito y de tomar el medicamento Nexium. Presentada en el Distrito Oeste de Tennessee, la demanda alega que los acusados sabían o deberían de haber sabido que Nexium formula un serio riesgo de lesiones renales y que el fabricante de medicamentos fallo en proporcionar las instrucciones adecuadas en relación con las consecuencias potencialmente mortales que podrían resultar del uso de la droga.

El demandante comenzó a tomar Nexium en el 2003 y continuó utilizándolo hasta el 2008, cuando fue diagnosticado con una condición grave e inducida por fármacos de nefritis intersticial aguda a través de una biopsia. Como resultado de su condición, él estaba obligado a someterse a diálisis tres veces a la semana y está en espera de un trasplante de riñón.

Nexium es un tipo de inhibidor de la bomba de protones (IBP) que se utiliza para disminuir la cantidad de ácido que produce el estómago. Este tipo de medicamento se utiliza comúnmente para tratar la enfermedad de reflujo gastroesofágico (ERGE) y la úlcera péptica (PUD). Aprobado originalmente bajo el nombre de Losec en 1988, Nexium es un medicamento IBP de segunda generación y se pretende que sea una mejoría de la versión de primera generación, comúnmente conocida como Prilosec. Continue reading →

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