Faraci Lange is currently investigating potential claims on behalf of United States Service members who suffered hearing injuries as a result of using defective Combat Arms™ earplugs manufactured by 3M.
Faraci Lange counsel, Kathryn Lee Bruns, recently found success in a product liability case she resolved for a Bath, New York resident who suffered severe injuries while operating a table saw that contained several design and manufacturing defects, rendering its use dangerous.
The defects included the failure to equip the saw with a user-friendly blade guard, an independent riving knife, or flesh-detecting and braking technology. The defective table saw caused the client to sustain permanent physical injuries, which required extensive medical treatment and affected his ability to engage in normal activities. The manufacturers that designed, sold and distributed the table saw were held liable for their negligence of the defective product.
Faraci Lange is one of the most experienced and recognized firms in New York State in the field of product liability law. Faraci Lange has five attorneys listed in the Product Liability category of Best Lawyers in America, by far more than any other law firm in Western New York.
If you feel you have been the victim of a defective product, please contact Faraci Lange for a free consultation or learn more here.
Takeda, Japan’s largest pharmaceutical company, announced on Tuesday that it agreed to pay $2.4 billion in settlement for thousands of lawsuits from patients and their families who claimed that the company’s diabetes drug, Actos, caused bladder cancer.
The company stated that this settlement would resolve a majority of the product liability lawsuits related to the drug and that it would cover the costs for defending the remaining cases by taking a $2.7 billion charge against earnings.
There are about nine thousand bladder cancer cases related to Actos that are still pending against Takeda. The lawyers representing the plaintiffs claim that Takeda concealed the cancer risk of the drug, which is a fairly big-selling medication for diabetes.
“We are pleased that Takeda has agreed to provide $2.4 billion to compensate thousands of deserving bladder cancer victims,” Richard J. Arsenault, one of the plaintiff lawyers, said in a statement on Tuesday. “After years of hard-fought and contentious litigation, the defendants have finally stepped up to the plate, and we applaud that effort.”
Takeda has not admitted to liability, however. Company representatives say that they settled in order to “reduce the uncertainties of complex litigation” and that the benefits of Actos outweigh any risks.
The settlement is one of the largest product-liability settlements in the pharmaceutical industry.
Click here to read the full story.
The Public Citizen wrote a letter to the U.S. Food and Drug Administration’s Office of Prescription Drug Promotion last week, asking them to stop direct consumer advertisements of several dangerous diabetes medications that are being marketed for weight loss and blood pressure reduction. The FDA has never approved these uses of the drugs, and so they have not been deemed safe or effective for weight loss or blood pressure reduction.
The diabetes drugs in question are Farxiga (dapagliflozin), Jardiance (empagliflozin), Invokana (canagliflozin), Victoza (liraglutide) and Bydureon (extended-release exenatide).
Low blood pressure is a major side effect of Farxiga and Invokana and they are being promoted for this use. The advertisements also target overweight and obese Type 2 diabetics with a weight-loss claim. These advertisements are distorting the risk-benefit analysis made by physicians and patients when deciding to use these medications.
Public Citizen is pushing the FDA to issue warning letters to these manufacturers, requiring them to withdraw these and any other advertisements containing similar off-label promotional statements. They have also called on the FDA to fine the companies involved in the off-label marketing of the five diabetes drugs for unlawfully misleading drug ads.
Read the full story here.
After the “60 Minutes” report that found high levels of cancer-causing formaldehyde in flooring sold by Lumber Liquidators aired at the beginning of the month, Capitol Hill has called on a federal investigation of the matter.
Tests performed on “60 Minutes” found dangerous levels of formaldehyde in the glues used to bind wood particles together in Lumber Liquidators’ laminate flooring from China. These levels were well above those permitted by the California Air Resources Board (CARB).
CARB’s Stanley Young stated that overexposure to formaldehyde, a known carcinogen, can cause many symptoms and, “if a consumer does feel some of these symptoms, like wheezing, or running eyes, weeping eyes, if they’re coughing or if they feel some kind of breathing problem, then it may be related to formaldehyde.”
Additionally, Denny Larson of Global Community Monitor is involved in a class action suit against Lumber Liquidators and has received over a thousand calls from consumers in just three days.
Read the full story here.
On Tuesday, Johnson & Johnson pleaded guilty to one criminal count in Philadelphia Federal court for bits of metal found in Children’s Tylenol and other medicines. The corporation will pay $25 million for poor manufacturing practices at its Fort Washington plant.
The McNeil Consumer Healthcare plant in Montgomery County had produced these children’s liquid medicine between May 2009 and April 2010, which contained metal particles such as nickel and chromium. The fine was determined based on a percentage of sales of the products during this time period.
After a customer complained to McNeil about the presence of “black specks in the liquid on the bottom of the bottle” of Infants’ Tylenol in May 2009, McNeil found 30 batches of over-the-counter liquid medicine, including Infants’ Tylenol, Children’s Tylenol, and Children’s Motrin, that contained some or all of the metal particles.
The issue was traced back to a machine part that was a composite metal, including mostly nickel as well as tin, iron, bismuth, and chromium.
According to Tuesday’s plea, J&J said it would initially spend $100 million on repairs to the McNeil facility for future use. But before it can resume production in Fort Washington, it must satisfy the FDA that it has fixed its problems outlined in a federal consent decree.
Read the full article here.
Johnson & Johnson was ordered by a California jury to pay $5.7 million to Coleen Perry, a woman who claimed one of the company’s Abbrevo vaginal-mesh implants eroded inside her, forcing her to have surgery.
This is the first verdict to find fault with the Abbrevo sling, which was launched in 2010 by J&J to treat women with incontinence. Jurors in state court in Bakersfield concluded last Thursday that J&J’s Abbrevo mesh sling was defectively designed. They also stated that officials of the company’s Ethicon unit failed to properly warn doctors and consumers about the device’s risks.
Coleen Perry was awarded $700,000 in compensatory damages and $5 million in punitive damages over the mishandling of the device.
J&J officials state that they plan to appeal the verdict because company executives do not think they mishandled the device.
Matthew Johnson, an Ethicon spokesman, said in an e-mailed statement that, “The evidence showed the TVT Abbrevo midurethral sling was properly designed and Ethicon acted appropriately and responsibly in the research, development and marketing of the product.”
Read the full story here.
Four days into the bellwether trial in West Virginia federal court, Johnson & Johnson’s Ethicon Inc has reached a settlement.
Jurors in the U.S. District Court for the Southern District of West Virginia were dismissed Friday morning after being informed that the case had concluded, according to minutes from court proceedings. A spokesman for Ethicon, Matthew Johnson, said Monday the parties had agreed to resolve the case, but declined to comment further.
The Sedars-Sinai Medical Center in Los Angeles discovered that four patients were infected with deadly bacteria from a contaminated medical scope, and 67 other people may have been exposed.
The Los Angeles hospital said Wednesday that it began investigating the possibility of patient infections after a similar outbreak at UCLA’s Ronald Reagan Medical Center that sickened seven patients, including two who died.
The ERCP Duodenoscope device makers, led by Japanese electronics giant Olympus Corp., face scrutiny for designing scopes that are difficult to clean of dangerous germs.
Federal lawmakers, consumer advocates and patients’ families have criticized both the FDA and manufacturers for failing to act sooner. The report by Cedars raises the prospect of many more disclosures, as other hospitals scour patients’ medical records and the scopes themselves looking for evidence linking infections to the devices.
The FDA wants to raise awareness among health care professionals that the complex design of ERCP endoscopes (also called duodenoscopes) may hinder effective reprocessing, which is a detailed process to clean and disinfect or sterilize reusable devices. Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.
On March 4th, the FDA announced that it has received inquiries from healthcare providers about whether they should cancel ERCP procedures based on the fact that one specific model duodenoscope manufactured by Olympus does not currently have a 510(k) clearance. The FDA is not recommending that healthcare providers cancel ERCP procedures for their patients who need them.
Although Olympus has a pending 510(k) application for this device, the company continues to market the product while the application is under review. The FDA is not taking action against Olympus because they believe that that removal of the device from the market could lead to an insufficient number of available duodenoscopes to meet the clinical demand in the United States of approximately 500,000 procedures per year.
Read the full FDA Safety Communication to learn more.
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After two patients died at UCLA’s Ronald Reagan Medical Center from contaminated duodenoscopes during a procedure known as ERCP, or endoscopic retrograde cholangiopancreatography, and five more were infected by an antibiotic-resistant superbug, including 179 others who may have been exposed, the FDA has been pushing manufacturers to prove their devices can be cleaned of this deadly bacteria.
On March 2nd, the FDA stated that it did not request the information until Spring 2014 and has given the device manufacturers three chances to validate their cleaning protocols.
The FDA said it is aware of 135 possible patient infections from January 2013 to December 2014 linked to these scopes. This has led to some criticism for the FDA as some consumer advocates and federal lawmakers believe they should have acted earlier, seeing as they were aware of these outbreaks for years.
Read the full story here.
Visit our Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes page to learn more about this issue.