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Draeger Medical Systems, Inc. recalled its Jaundice Meters JM-103 and JM-105 due to inaccurate readings, leading to potential misdiagnosis of jaundice in newborns. The FDA classified this as a Class I recall, indicating a high risk of severe health consequences, including death. Misinterpretation of device readings could delay necessary medical interventions. Draeger has issued updated labeling to clarify the device's purpose as a screening tool, not a diagnostic device. Legal firm Parker Waichman LLP is advocating for affected families, highlighting the serious risks posed by the defective meters.

A new lawsuit has been filed against LivaNova, formerly Sorin Group, over infections allegedly caused by their 3T heater-cooler device. The suit involves a South Carolina man who developed a serious infection after a liver transplant in 2015, attributed to the device. LivaNova's heater-coolers have been linked to a global outbreak of nontuberculous mycobacterium (NTM) infections, particularly Mycobacterium chimaera. The FDA and CDC have issued warnings about these devices, which can aerosolize bacteria into the air, posing significant health risks.

The FDA has updated the Drug Safety Labeling Changes for 35 products, revising sections on Contraindications, Warnings, Precautions, and Adverse Reactions. Notable drugs affected include Risperdal, Invokana, and Truvada, with some now carrying a Boxed Warning. Patients are advised not to alter their medication dosage without consulting a healthcare provider. For more details, consumers can view the affected drugs on the FDA website. Legal assistance is available from Parker Waichman LLP for those needing help with prescribing information.

Contact Parker Waichman LLP to start recovering compensation for hernia mesh injuries. Call 1-800-YOURLAWYER (1-800-968-7529) to discuss your case. Their legal team will assess your situation, inform you of your rights, and explain how they can help secure compensation. Protect your financial future and family well-being by not handling the claim alone or delaying action.

Zimmer Biomet's Comprehensive Reverse Shoulder System has been recalled by the FDA due to defects, leading to numerous personal injury claims. Parker Waichman LLP is investigating these claims, aiming to secure settlements for affected individuals. The firm has a strong track record in recovering damages for victims of defective medical products. A notable settlement of $350,000 was reached in 2016. The recall affects devices manufactured between 2008 and 2011, with issues like joint loosening and instability posing significant health risks, especially for older patients.

A class-action lawsuit in Chicago accuses St. Jude Medical and Abbott Laboratories of concealing defects in the lithium batteries of their Cardiac Resynchronization Therapy Defibrillators (CRT-D). The lawsuit claims St. Jude knew about the issue since 2011 but delayed informing the public and the FDA until 2016, endangering over 250,000 people in the U.S. and 400,000 globally. The defective batteries can deplete rapidly, risking strokes, heart attacks, or cardiac arrest. Parker Waichman LLP represents affected individuals, seeking justice and compensation for injuries and deaths linked to the faulty devices.

On May 31, 2017, a motion was filed to create a multidistrict litigation (MDL) for Proton Pump Inhibitor (PPI) cases in the District of New Jersey or Southern District of Illinois. The cases allege kidney injuries, such as acute interstitial nephritis, chronic kidney disease, and renal failure, from PPI use. The MDL aims to streamline pretrial proceedings for 172 lawsuits involving seven PPI drugs. Plaintiffs claim manufacturers failed to warn about the risks. Research links PPIs to kidney disease and other health issues. The primary defendant is AstraZeneca, maker of Prilosec and Nexium.

Uloric, a medication for gout, has been linked to an increased risk of death, heart attacks, and strokes, according to the FDA. Parker Waichman LLP offers legal assistance for those affected by Uloric's side effects. Their experienced attorneys are dedicated to securing compensation for individuals who have suffered complications or fatalities due to Uloric. If you or a loved one has been impacted, consider contacting them for a free consultation to discuss your legal options.

A petition for a Mirena® IUD multidistrict litigation (MDL) has been filed by Parker Waichman LLP, seeking to transfer cases to the U.S. District Court for the Northern District of Ohio. The litigation addresses claims that the Mirena® IUD, approved by the FDA in 2000, is defective and can migrate outside the uterus, causing injuries. Serious adverse events include uterine perforation, ectopic pregnancy, and pelvic inflammatory disease. The litigation aims to streamline pre-trial proceedings and avoid duplicate findings.

Parker Waichman LLP is investigating cases of retinal detachment complications linked to three cancer drugs: Opdivo, Yervoy, and Keytruda. These drugs, used to treat melanoma and other cancers, have been associated with vision loss and retinal detachment. The FDA is considering updating warning labels to reflect these risks. Patients experiencing vision changes are advised to consult their doctors and report issues to the FDA. Parker Waichman LLP offers free consultations for those affected by these complications.

Johnson & Johnson's DePuy unit is facing over 1,000 lawsuits in federal and state courts due to its metal-on-metal ASR hip implants. Plaintiffs claim the implants caused injuries, including infections and inflammation, and that DePuy was aware of the issues as early as 2007. The company recalled the ASR implant in 2010 after reports of high failure rates. Lawsuits also involve the Pinnacle implant. DePuy has committed to covering medical costs for affected patients, with potential liabilities exceeding $1 billion.

Long-term use of Proton Pump Inhibitors (PPIs) like Nexium may lead to dependency, as a study from Copenhagen University suggests. Healthy adults developed acid reflux symptoms after stopping PPIs, indicating a "rebound" effect due to increased gastrin production. While symptoms ceased three months post-treatment, researchers caution against overprescription. Despite benefits for those in need, PPIs are linked to risks such as fractures and increased cardiovascular issues when combined with Plavix. The study highlights the need for careful prescription practices.

The Dexcom G5 Mobile Continuous Glucose Monitor (CGM) has been reported to inaccurately measure blood glucose levels, leading to severe health risks such as hospitalization, coma, and even death. Over 40,000 reports of inaccuracies were filed with the FDA by mid-2017. Despite upgrades, issues persist, prompting Parker Waichman LLP to investigate injury and wrongful death claims related to the device. The FDA previously recalled several Dexcom models due to defective alarms. Parker Waichman LLP offers free case reviews for affected individuals seeking compensation for injuries or losses.

The FDA warns nursing mothers about the risk of codeine in breast milk, as some women metabolize it rapidly due to a gene variant, leading to high morphine levels. This can cause overdose in infants, with symptoms like limpness and breathing issues. While most mothers can use codeine safely, the FDA advises using the lowest dose for the shortest time and consulting doctors before taking codeine. A genetic test exists but isn't recommended for all mothers.

In 2015 and 2016, the FDA warned about bacterial contamination in heater-cooler devices, particularly the Stöckert 3T, used in cardiac surgeries. The bacteria, M. chimaera, can cause serious infections, especially in patients with implanted devices. Despite cleaning efforts, contamination persists, posing a global health risk. The CDC estimates significant exposure in the U.S., with a risk of infection between 1 in 100 to 1 in 1,000 in affected hospitals. The FDA advises against using tap water in these devices and recommends removing contaminated units from service. Legal assistance is available for affected patients.

Viberzi, a drug for irritable bowel syndrome with diarrhea (IBS-D), can cause severe side effects, including pancreatitis, especially in patients without gallbladders. The FDA has warned against prescribing Viberzi to these patients due to risks of pancreatitis and sphincter of Oddi spasms. Legal firm Parker Waichman LLP is pursuing compensation for affected patients, offering free consultations and representation on a contingency-fee basis. They emphasize the importance of seeking legal recourse for injuries caused by Viberzi, highlighting the serious nature of these complications.

A BMJ investigation revealed that Janssen, a subsidiary of Johnson & Johnson, failed to disclose safety concerns about the INRatio device used in the ROCKET-AF trial for Xarelto, an anticoagulant. The device, which measured warfarin levels, was later recalled for providing inaccurate readings. This raised questions about the trial's integrity and the approval of Xarelto. Despite setting up a safety program to monitor the device, Janssen did not share the data with the FDA or the trial's safety board. Bayer, also involved, claimed it was unaware of the program until 2016.

A lawsuit was filed on September 1, 2016, in St. Clair County Circuit Court against Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson, over the anticoagulant Xarelto. The plaintiff claims insufficient warnings were provided about the drug's risks and side effects. Despite FDA warnings about misleading advertisements, Janssen allegedly continued to promote Xarelto. The lawsuit accuses Janssen of product liability, emotional distress, fraud, negligence, and negligent misrepresentation, seeking unspecified damages. Xarelto, used for conditions like arrhythmia and deep vein thrombosis, lacks an antidote for excessive bleeding, unlike warfarin.

Plans for two new joint registries in the U.S. were solidified following the DePuy ASR hip implant recall. These registries aim to track the performance of hip and knee implants, particularly metal-on-metal devices like the DePuy ASR and Pinnacle implants, which have been associated with early failure and complications such as cobalt poisoning and metallosis. The University of Massachusetts Medical School will manage one registry, while the American Joint Replacement Registry (AJRR) will be funded by various stakeholders. Concerns exist about the potential impact of industry funding on the AJRR's independence.

Proton pump inhibitors (PPIs), used to treat conditions like GERD, are reportedly over-prescribed, with many patients taking them without a valid medical reason or for longer than necessary. This overuse raises the risk of serious side effects, including fractures, pneumonia, and C. difficile infection. The FDA has updated safety labels to reflect these risks. Concerns about PPIs' side effects and potential interactions with other medications, such as Plavix, are prompting some doctors to reconsider their prescribing practices.

Plaintiffs in the Eastern District of Louisiana allege that the chemotherapy drug Taxotere causes permanent hair loss, a risk they claim Sanofi-Aventis failed to disclose. Despite warnings in Europe and Canada, the U.S. label was updated only in 2015. Lawsuits are consolidated into a Multidistrict Litigation (MDL) to streamline the process. Studies indicate a significant percentage of patients experience persistent alopecia. Parker Waichman LLP offers free consultations for those affected. Recent reports link docetaxel, Taxotere's generic form, to severe side effects, including deaths in France.

The Federal Court has expanded proceedings to include claims against Davol Inc's defective mesh patches, beyond the original Kugel Mesh Hernia Patch recall. The FDA had issued a Class I recall for the Kugel Patch due to serious risks like bowel perforations. An FDA inspection revealed inadequate quality assurance at Davol, leading to delays in addressing issues. The court's decision now encompasses lawsuits related to other defective Davol patches, not just those with the memory recoil ring problem.

Medtronic has recalled certain Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and Implantable Cardioverter-Defibrillators (ICDs) due to a manufacturing defect involving an "out of specification gas mixture." This defect may prevent the devices from delivering necessary electrical currents, posing serious risks to patients. The recall affects devices manufactured between July 2013 and August 2017, with 48 units recalled in the U.S. This is a Class 1 recall, indicating a potential for serious injury or death. Affected customers were advised to contact Medtronic and consider device replacement.

Pulmonary embolism is a serious condition caused by blood clots in the lungs. Blood thinners like Xarelto are used to prevent clots in patients with conditions like atrial fibrillation or those undergoing certain surgeries. However, Xarelto can lead to severe bleeding, lacking an antidote unlike older anticoagulants. Patients should be vigilant for symptoms like unusual bleeding and consult doctors about risks, especially when combined with other medications. Legal actions have been taken against Xarelto's manufacturer, with legal assistance available for affected individuals.