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eye-321961_1280-e1696438901920The Food and Drug Administration recently updated the warning label on Horizon Pharmaceutical’s TEPEZZA. The label now includes that one of the “major recent changes” for warnings and precautions is “hearing impairment including hearing loss.”  Hearing loss is just one of four warnings. The others are hyperglycemia, exacerbation of preexisting inflammatory bowel disease and infusion reactions. If you suffered hearing loss or other harm, you should call the trusted Chicago-based dangerous drug lawyers of Moll Law Group. Billions have been recovered in lawsuits around the country with which we’ve been involved.

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Tepezza is a drug prescribed to improve symptoms of thyroid eye disease, which is a rare condition in which fatty tissue and muscles located behind the eye become inflamed such that the eye is pushed to the front and bulge outwards. The drug is supposed to mitigate the effects of double vision, proptosis, and chronic bulging eye. Unfortunately it is a drug that carries significant risks.

The new Tepezza warning provides that it can cause serious hearing impairment including hearing loss that could be permanent. Doctors are advised to evaluate a patient’s hearing before, during and after treatment with the drug and also weight the risks and benefits of treating a patient with the drug. The warning came a little less than a month after the Brazilian Health Regulatory Agency approved its use as a thyroid eye disease treatment.

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happens-770461_640-e1696440252665Bard’s PowerPort devices are implanted under the skin and pump intravenous chemotherapy and other fluid into a patient’s bloodstream. These are two-part devices with an injection reservoir and a catheter. Recently, plaintiffs in eight lawsuits against Becton, Dickinson & Company, C.R. Bard, Inc., and Bard Access Systems made a motion under 28 U.S.C. § 1407 to centralize litigation arising out of Bard’s Power Port devices in the Western District of Missouri. They allege that due to the catheters on the devices breaking, they suffered blood clots, infections, chest pain, and other life-threatening complications; many of them needed to undergo emergency surgeries to extract pieces of catheter. If you or a loved one suffered harm as a result of a Bard Power Port device, you should call the seasoned Chicago-based attorneys of Moll Law Group about your potential claim. Billions have been recovered in product liability lawsuits around the country with which we’ve been involved.

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The Panel determined that the lawsuits involved common questions of fact and that just and efficient litigation would be promoted by centralizing the case in the District of Arizona. They found that the common factual questions involve allegations that there is too great a concentration of barium sulfate used during the manufacturing of the catheter in the port devices.

This concentration, purportedly, reduces the catheter’s material integrity, which can in turn result in fracture or migration of the catheter, infection, and thrombosis. The multidistrict litigation will be looking at whether the design of the Bard port catheters requires too high a concentration of barium sulfate, as well as whether the defendant’s tested the devices sufficiently and whether they appropriately monitored and reported adverse events related to product failures.

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woman-698964_1280-e1695661666719Phenylephrine is an ingredient in popular oral decongestants branded as Vicks Nyquil Sinex Nighttime Sinus Relief, Sudafed PE, and Benadryl Allergy Plus Congestion. It was believed that the drug worked to reduce blood vessel swelling in the nasal passages, and that this got rid of congestion. These decongestants generated nearly $1.8 billion in sales in 2022. A Food and Drug Administration (FDA) advisory panel has advised that data shows over-the-counter cold and allergy medications that contain phenylephrine don’t effectively eliminate nasal congestion. A unanimous vote by the panel declared that the drug is not useful.

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The FDA only started to review over-the-counter cold medicines in 1976. Over the last 30 years, Florida pharmacy professors have pressured the FDA to do something about the efficacy of phenylephrine. Back in 1993, Dr. Leslie Hendeles wrote a paper published in a medical journal that phenylephrine didn’t work because it was destroyed in the stomach and never made it to the bloodstream. Further research over the years determined the drug was not any better than a placebo. Pandemic legislation changes FDA staffing and procedures so that they’re more in line with the rules surrounding prescription drugs, and this caused the FDA to produce an 89-page review.

While the FDA makes final decisions about drugs, they sometimes use advisory committees to give them advice and recommendations. FDA considers a committee’s advice and recommendations when deciding; in this case the advisory committee’s opinion was based on the FDA’s 89-page review.

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treatment-4099432_1280-e1693590345228The Carina Sub-Acute Care Ventilator was recently recalled in a Class I recall, which is the most significant kind of recall. With a Class I recall, it has been found that using the product could cause severe injuries or death. The manufacturer of the Carina ventilator, Draeger Medical, is voluntarily correcting the product. Adult patients can continue to use the device, but health care providers are not supposed to use these devices with their pediatric patients. If you were injured by a Carina Sub-Acute Care ventilator, please call the experienced Chicago-based product liability lawyers of Moll Law Group. We represent clients around the country and billions have been recovered in lawsuits with which we’ve been involved.

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Hospital providers use the Carina Sub-Acute Care Ventilator to help people who need assistance to breathe. This type of ventilator can be used for invasive ventilation through the trachea or for noninvasive ventilation that makes use of a mask. Draeger has recalled the ventilator because contaminants, polyether polyurethane (PE-PUR), are produced in the airpath of the device. This can cause a potential carcinogen, contaminant 1,3-Dichloropropan-2-ol, to be released. The contaminants go beyond the appropriate levels when patients who are children or infants use it for over a month.

Pediatric patients may experience severe health conditions as a result of exposure to the chemicals including death and toxic responses such as irritation, hypersensitivity, nausea, vomiting, and carcinogenic impacts. No deaths, complaints, or incidents have been reported in connection with the emission of contamination so far, but it’s still important to be alert to the issue and to seek remedies when appropriate.

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baby-1531059_1280-1024x576The new feature length documentary “Born Free: Birth in America” is a 95-minute investigation into maternal mortality in the United States, and why it’s increasingly dangerous for mothers to give birth in this country. The movie was made by Paula James-Martinez, a British journalist who became a mother in 2018. It was released on May 14, Mother’s Day, of this year. For the documentary, Ms. James-Martinez went cross-country with an all-female crew to figure out why the United States is the most expensive and dangerous developed country in which to give birth. If your loved one died while giving birth and you suspect professional negligence, call the seasoned Chicago-based medical malpractice attorneys of Moll Law Group. We represent clients around the country and billions have been recovered in lawsuits with which we’ve been involved.

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Maternal mortality is defined to include any deaths during pregnancy or deaths that occur within a year after giving birth. Common causes of maternal mortality include excessive bleeding, infection, drug overdose, and suicide.

“Born Free” includes testimony from a wide range of parents who suffered birth trauma. One of the women went through an episiotomy, which results in the vagina being cut to be wider for childbirth, against her will. A Black man whose wife bled to death after a c-section delivery was interviewed; he filed a civil rights lawsuit against the hospital alleging discrimination in treating his wife. Ms. Martinez’s goal was to get the mortality information in front of those who might otherwise not have access and give them a way to advocate for themselves.

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corona-6278444_640-e1693590561384The manufacturer Hamilton Medical Inc. has recalled its Hamilton-C1, C2, C3, T1 ventilators because they have software problems that provide no warning before a stop in the ventilators is triggered. Hamilton ventilators are used by health care providers for those who need full or partial breathing help from a mechanical ventilator. They are used when trying to transport patients within hospitals and outside them. If you were injured or a loved one died because of any of the affected ventilators, you should call the trustworthy Chicago-based product liability lawyers of Moll Law Group to determine whether you have a claim. Billions have been recovered in cases with which we’ve been involved.

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The Hamilton ventilator recall was initiated June 15, 2023. The FDA classified the recall as a serious one, a Class 1 recall, because using this type of ventilator could result in death or acute injuries. These ventilators support adult and pediatric patients, including infants and newborns. When a ventilator is used for over 91 days without a restart, it will shift to an ambient state, during which time the ventilator will alarm and display a technical fault banner on its screen. A health care provider may need to intervene, giving air to the patient with a manual resuscitating device or using a different type of device. When patients don’t breathe on their own or get a timely intervention, they could die or otherwise suffer serious health consequences.

The manufacturer sent customers an advisory that asks them to provide alternative ventilation, to switch off the ventilator power to get out of the ambient state, and to service the ventilator once the patient is safe. The model numbers that are affected are C1, T1 V2.2x, C2, and C3. They were distributed December 10, 2010 – May 1, 2023. These ventilators were installed with specific software and had neonatal options installed on them. In the United States, 21,429 units have been recalled. While there have been 80 reported complaints, there have been no injuries and no deaths connected to the recall.

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war-1447021_640

Recently, 3M agreed to pay $6.01 billion to settle lawsuits that cover about 240,000 military veterans and service members who sued due to hearing loss they alleged was the result of the manufacturers’ Combat Arms earplugs. Earlier this year, 3M tried to move the lawsuits into bankruptcy court to avoid being held liable for the full scope of damages; the deal failed.

Aearo Technologies made the Combat Arms earplugs, which the military used to train service members, including those in Iraq and Afghanistan, from 2003-2015. 3M bought Aearo. When they sued, the plaintiffs alleged that the manufacturer had concealed design flaws, altered test results, and failed to provide proper instructions for the earplugs, and that, as a result they suffered hearing loss, tinnitus and other hearing damage. Plaintiffs claimed that the defendants had used their own lab to test the earplugs and used improper testing procedures that skewed the results of a mandatory test, in order to get a different Noise Reduction Rating label than it should have gotten.

In 2019, the 3M lawsuits were consolidated before a federal judge in Florida. Aearo filed for bankruptcy in 2022, but the bankruptcy judge dismissed it on the grounds that Aearo was financially healthy and therefore shouldn’t pursue bankruptcy. In the course of the 3M litigation, 16 earplug cases went to trial. The manufacturer lost 10 cases, and around $265 million was awarded to the plaintiffs. The verdicts are included as part of the $6.01 billion settlement.

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medical-563427_640-300x200CNN covered a recent report that found hundreds of thousands of deaths and permanent disabilities are the result of misdiagnosis of disease and other conditions. Every year, around 371,000 people pass away, while 420,000 find themselves permanently disabled with loss of limbs of organs, brain damage, blindness or metastasized cancer. If you were injured by burning hot food, consult the seasoned Chicago-based lawyers of Moll Law Group. Billions have been recovered in cases with which we’ve been involved.

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Researchers gathered data from other studies to figure out how often medical conditions were not diagnosed or misdiagnosed and how that resulted in permanent disability or death. The researchers concluded that patients still should not panic because there is less than a 0.1% chance of significant harms related to misdiagnosis. Around 40% of the significant harms relate to diagnosing five relatively common diseases: lung cancer, venous thromboembolism, pneumonia, sepsis, and stroke. Stroke is misdiagnosed far more than average and gets missed in around 18% of 950,000 cases each year, which results in 94,000 permanent disabilities or deaths in a year. Spinal abscesses are misdiagnosed over 60% of the time, which leads to about 5000 significant harms each year.

The researchers believe that the study’s findings can help determine which areas should be prioritized for interventions. Heart attacks are often diagnosed successfully, but it took a decade of intense effort to address the problem of misdiagnosis and to fund that problem. Researchers think this is a model for how to address misdiagnosis of other conditions.

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child-85321_640-e1691462527572Recently, a family was awarded $800,000 in a civil lawsuits against McDonald’s and one of its franchises because their toddler was burned by hot Chicken McNuggets. The hot McNuggets fell from a Happy Meal onto the toddler’s legs, inflicting second-degree burns, similar to the earlier lawsuit from the ‘90s involving burning hot coffee. If you were injured by burning hot food, consult the seasoned Chicago-based lawyers of Moll Law Group. Billions have been recovered in cases with which we’ve been involved.

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The jury found that both the corporation and the franchise owner, Upchurch Foods, should be held accountable for failing to warn or give proper instructions on the possibility of injuries from hot nuggets dispensed at a drive through.

The damages award is intended to compensate for disfigurement, mental anguish, inconvenience, loss of enjoyment of life and pain and suffering. These damages are intended to make up for past harm suffered by the toddler and her family, along with future injuries that the jury determined are likely to be suffered in the future. Continue reading →

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justitia-2597016_1280-e1691461997979It was recently reported that a plaintiff who claimed he developed cancer from exposure to Johnson & Johnson baby powder won $18.8 million in damages from the manufacturer. This case is distinct from the gynecological cancer claims arising out of thousands of talc-based products. The plaintiff filed suit asking for monetary damages because he’d developed mesothelioma, a deadly cancer, in his heart tissue due to significant exposures to the company’s talc products since his childhood. The six week trial was the first talc lawsuit the company faced in over 2 years. If you suffered from cancer or were injured due to Johnson & Johnson talc product use or exposure, consult the seasoned Chicago-based lawyers of Moll Law Group. Billions have been recovered in cases with which we’ve been involved.

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The jury awarded the plaintiff damages to compensate him for pain and suffering and medical expenses. The man was not awarded punitive damages. Additionally, the plaintiff won’t be able to collect the judgment in the future because of a bankruptcy court order that froze most of the talc litigation.

The company’s VP of litigation has announced that Johnson & Johnson will appeal. He reiterated that the baby powder is safe and isn’t carcinogenic and doesn’t contain asbestos. In the course of closing arguments at the jury trial, the company’s attorneys also said there wasn’t evidence that connected the plaintiff’s mesothelioma to asbestos or establishing that the plaintiff was exposed to the contaminated talc. The plaintiff, meanwhile, argued that the company had covered up the contamination for decades.

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