FDA Identifies Repackaged Valsartan Pills That May Contain Cancer-Causing Impurities

Amid mounting concerns about the link between generic valsartan and cancer, federal drug safety officials are expanding a recall for the widely used hypertension drug, after discovering that additional companies may have repackaged valsartan contaminated with cancer-causing impurities.

In a valsartan recall update issued on July 27, the FDA indicates that additional products from three repackagers were being added to the list of potentially impacted medications.

With many consumers concerned about whether their blood pressure drug may contain a cancer-causing ingredient, the agency has also created a list of valsartan products that are not being recalled.

The initial generic Diovan (valsartan) recall was announced by the European Medicines Agency (EMA) on July 5, after batches of the active ingredient, supplied by Zhejiang Huahai Pharmaceuticals in China, tested positive for NDMA, which has been linked to a risk of liver cancer, kidney cancer and other types of cancer. That recall affected about 2,300 batches of valsartan and valsartan HCT shipped throughout Europe and Canada.

The FDA followed with its own recall on July 13, and indicated that the agency had launched an investigation to determine the scope of the contamination and the potential risk to consumers.

This latest update adds three repackagers of Teva Pharmaceuticals and Prinston Pharrmaceuticals to the total list of recalled valsartan products, including:

• A-S Medication Solutions LLC
• AvKARE
• RemedyRepack

In addition, the following companies are either in the process of recalling valsartan products, or are expected to recall them:

• Bryant Ranch Prepack Inc.
• H.J. Harkins Company, Inc.
• Lake Erie Medical, doing business as Quality Care Products LLC
• NuCare Pharmaceuticals
• Proficient Rx

The FDA notes that it is possible that not all valsartan products by these companies will be impacted by the recalls.

In addition to the updated recall lists, the FDA also released more information about the potential risks of NDMA.

The agency has determined that the Chinese manufacturer has been distributing the contaminated pills for four years. The agency also noted that animal studies have indicated NDMA has been linked to cancer risks in animal studies and that the U.S. Environmental Protection Agency (EPA) determined that consuming up to 96 nanograms of NDMA per day is considered reasonably safe for human ingestion.

“The amounts of NDMA found in the recalled batches of valsartan exceeded these acceptable levels,” the update indicates. “FDA scientists estimate that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for the full four years, there may be one additional case of cancer over the lifetimes of these 8,000 people. This assessment led to FDA’s decision to have these batches recalled.”

The FDA reviewed valsartan and similar medications in 2010, after some data suggested they may increase the risk of cancer. However, in 2011, the FDA reviewers indicated they could find no link between the drugs, known as angiotensin receptor blockers (ARBs) and cancer.

The FDA recommends patients continue taking generic valsartan until they have a replacement product, look at the drug name and company name on the label or contact the pharmacy to see if their medications are on the recall list, follow the recall instructions provided by the manufacturer, and contact their health care professional to discuss alternative treatment.

The agency also asks any patients or healthcare professionals to report any adverse events related to the use of the recalled drugs to the FDA’s MedWatch Adverse Event Reporting program.

A number of consumers who have been diagnosed with liver cancer, kidney cancer, lung cancer or suffered an acute liver injury in recent years are now reviewing whether they may be eligible for compensation through a valsartan lawsuit against the manufacturers of the generic drug, with lawyers providing free consultations and case evaluations for individuals nationwide.

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Lawsuit Alleges Invokana Use Resulted in Double Amputation, Kidney Failure

According to allegations raised in a recently filed product liability lawsuit, the side effects of Invokana resulted in a double amputation below the knee for a Texas man, as well as life-threatening cases of kidney failure and diabetic ketoacidosis. 

The complaint (PDF) was filed by Arthur Trevino, Jr. in the U.S. District Court for the District of New Jersey on July 23, naming Johnson & Johnson and its Janssen Pharmaceuticals subsidiary as the defendants.

Trevino indicates that he was prescribed the new-generation diabetes drug Invokana to improve glycemic control in November 2014, and continued to use the drug until April 2017, not knowing about the growing number of health risks linked to the medication since it was introduced by the manufacturers.

“While taking Invokana, Plaintiff developed kidney injury, and have below the knee amputations on both legs as a result of treatment with Invokana,” the lawsuit states. “As a result of his development of diabetic ketoacidosis, Plaintiff developed serious complications, such as acute kidney failure, which required multiple days of hospitalization.”

Invokana (canagliflozin) was introduced in March 2013, as the first member of a new class of diabetes drugs, known as sodium-glucose cotransporter 2 (SGLT2) inhibitors, which works in a unique way by impacting some normal kidney functions. Other members of this class include Invokamet, Jardiance, Farxiga, Xigduo and others, but Invokana has remained the biggest seller, amid aggressive marketing.

In December 2015, the FDA required Johnson & Johnson to add new diabetic ketoacidosis warnings to Invokana, indicating that the medication increases the risk of this serious condition, which typically results in the need for emergency treatment to avoid life-threatening injury. Prior to the update, the Invokana warnings failed to alert consumers about the importance of seeking immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting.

In May 2017, the FDA required an Invokana warning update regarding the risk of leg and foot amputation, which manufacturers of other similar diabetes drugs claim is a unique risk with Invokana.

The amputation case filed by Trevino will be consolidated with other Invokana lawsuits pending in the federal court system, which are currently consolidated for pretrial proceedings before one judge in New Jersey.

Following coordinated discovery and any bellwether trials held to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation, if Invokana settlements or another resolution for the claims is not reached, Bottner’s case and hundreds of others may later be remanded back to U.S. District Courts nationwide for individual trial dates.

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“Vaginal Rejuvenation” Has Serious Risks, Limited Evidence to Support Procedures: FDA

Federal regulators warn that women considering “vaginal rejuvenation” procedures should be wary, as the procedures carry many serious risks, and there is limited evidence that the procedures are safe or effective for many of the marketed purposes. 

Many different medical providers market procedures known as “vaginal rejuvenation” or cosmetic vaginal surgery, involving use of energy-based devices – commonly radiofrequency or laser – to treat symptoms related to menopause, urinary incontinence, or sexual function. However, the FDA warns that the safety and effectiveness of energy-based devices for treatment of these conditions has not been established, and they have been linked to reports of serious adverse events.

In a safety communication issued on Monday, the FDA warned about the serious risks with vaginal rejuvenation, indicating that the agency is concerned that women are being injured by the procedures.

In reviewing adverse event reports and published literature involving vaginal rejuvenation problems, the FDA has identified numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain.

Vaginal rejuvenation is advertised as a non-surgical way to treat vaginal laxity, vaginal atrophy, dryness, itching, pain during sex, pain during urination, and decreased sexual sensation. The procedure uses energy-based devices approved by the FDA for specific gynecological procedures, such as the destruction of abnormal or pre-cancerous cervical or vaginal tissue or condylomas (genital warts). However, the agency warns that the devices have not been approved for vaginal rejuvenation and may carry serious risks.

“These products have serious risks and don’t have adequate evidence to support their use for these purposes,” FDA Commission Scott Gottlieb said, in an accompanying press release. “We are deeply concerned women are being harmed.”

In one instance, a woman who underwent the “Mona Lisa Touch” laser marketed by Cynosure, reported severe bladder pain two days after the procedure. She visited multiple doctors in search of relief and was unable to resolve the problem.

Many manufacturers advertise that the devices and procedures will offer women a “better feminine life”. The procedures are described as “virtually painless” and a “no surgery” option that has “minimal risk” to the patient.

The energy-based devices have not been proven safe or effective for the conditions they are advertised for by manufacturers, the FDA warned. The agency sent seven device manufacturers warning notices indicating they plan to monitor their claims regarding the uses and outcomes of the devices.

“A large part of our work focuses on efforts to bring forth innovative, new products,” wrote FDA officials. “But we’re equally dedicated to monitoring the landscape to ensure products are delivering on their intended benefits and to ensure that if new health risks arise, we take appropriate action.”

The FDA sent warning letters to Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and Thermigen. The warning letters call for manufacturers to respond to the concerns within 30 days, otherwise enforcement actions may be taken.

Any woman who has experienced a complication or side effect after undergoing vaginal rejuvenation procedures of any kind should report the problem to the FDA using the MedWatch Adverse Event Reporting program.

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“Ride the Ducks” Lawsuits Filed Over Tragic Boat Accident

A lawsuit filed this week against the owners and operators of the “Ride the Ducks” tourist boats seeks $100 million in damages, after the captain allegedly ignored severe weather warnings that resulted in a recent incident in Missouri, where a duck boat sank, killing 17 people. 

The complaint (PDF) was filed by John D. Coleman, for himself and as the administrator of the estate of Ervin Coleman, and Lisa D. Berry and Marlo Rose Wells, for themselves and as the administrators of the estate of Maxwell Ly. Both Ervin Coleman and Maxwell Ly died in the accident. Plaintiffs filed the lawsuit in the U.S. District Court for the Western District of Missouri on July 29, naming Ripley Entertainment Inc., Ride the Ducks International LLC, and Ride the Ducks of Branson LLC as defendants and responsible parties for the deaths of  one crewmember and 16 passengers that drowned when the vehicle capsized.

Plaintiffs allege that despite known dangers associated with the designs of the World War II era amphibious vehicles used for the tours, and warnings of severe weather approaching the day of the accident, the company put profit before customer safety.

The fatal Ride the Ducks boat accident occurred on July 19, when the DUKW “Stretch Boat 7” carrying 29 passengers and two crew members set out on a tour of Table Rock Lake. The trip was initiated, despite severe storms approaching, which ultimately resulted in the boat capsizing when high waves crashed over the sides, according to the National Transportation Safety Board (NTSB) investigation.

The incident is the latest in a series of fatal and non-fatal duck boat accidents involving the amphibious vehicles that have resulted in wrongful death lawsuits.

According to the complaint, Ride The Ducks was previously warned by a private inspector that the vessels’ engines and pumps that remove water from the hulls to prevent sinking were susceptible to failing in bad weather. It also states the company was warned by the NTSB in 2000 that the vessels should be upgraded to ensure they remain upright and floating in bad weather.

The NTSB recommendation came after 13 people were killed on a Duck Boat tour in May 1999, in Arkansas. The NTSB report following that duck boat accident recommended that canopies on the vehicles be removed in vessels without reserve buoyancy, or that adequate buoyancy be installed. The NTSB indicated that if a canopy is used, it should be one approved by the Coast Guard.

Shortly after the NTSB recommendation, a former president of Ride the Ducks, who designed the boats, responded that the NTSB recommendations would require significant costs, and refused to improve the safety of the canopies or receive any certification from the Coast Guard.

Since 1977, when Ride the Ducks Corporation was founded, the lawsuits claims at least 42 people have been killed while touring on the vessels.

Critics say that blind spots, how low the boats sit in the water, and the canopy are all issues of concern. The blind spots have been linked to a number of the accidents on land, the boats appear to be easily swamped and capsized, and in the event of an incident, the canopy can trap and drown passengers even if they are wearing a life jacket.

One survivor of last week’s accident, Tia Coleman, said that the driver repeatedly told the passengers they would not need their life jackets, even when it was clear the boat was in trouble. Nine of her family members died, including her husband and three children, including two sons and a one-year-old daughter. Only she and a nephew survived from her family group. The driver of the duck boat, Kenneth McKee, did not.

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Juul Faces Lawsuits, Federal Investigation Over E-Cig Marketing

The popularity of the electronic cigarette brand “Juul” has exploded over the past two years, but a growing number of lawsuits, as well as state and federal investigations, suggest the manufacturer has targeted teenagers with products that contain twice the nicotine of cigarettes. 

Juul Labs, Inc. faces several lawsuits from parents and guardians, alleging that the company’s marketing targeted teens and resulted in their child vaping, sometimes causing addiction.

In addition, last week Massachusetts Attorney General Maura Healey announced her office is investigating Juul Labs for marketing to minors, and sent three cease and desist orders to websites selling Juul products without adequate age identification.

“Just when teen cigarette use has hit a record low, juuling and vaping have become an epidemic in our schools with products that seem targeted to get young people hooked on nicotine,” Healey said in a July 24 press release. “I am investigating JUUL and online sellers of their products to keep these highly addictive products out of the hands of children.”

The Juul is a sleek e-cigarette, which is designed to look like an elongated USB “thumb” drive. It is small, portable, and easy to conceal. In addition, it’s vapor is difficult to see, so it does not release massive visible clouds like more traditional vapes. Videos on YouTube and Instagram show teens sneaking into school bathrooms to vape, which is known as “Juuling” when using a Juul, and sneaking puffs even in class behind a teacher’s back.

Juul lawsuits and investigations center on claims that the cartridges, known as Juul pods, actual contain twice as much nicotine as a pack of cigarettes, and that the company’s marketing appears uniquely targeted toward teens.

The latest claim was filed last month by the parents of a 15-year-old boy who allegedly became addicted to nicotine after being placed in a specialized technical school where teens using Juuls was prevalent. The complaint (PDF) was filed in the U.S. District Court for the Southern District of New York by a woman identified only as L.P., on behalf of her son, a 15-year-old identified only as D.P.

The lawsuit indicates that the use of the Juul resulted in extreme addiction, falling grades, bad behavior and the fear of future health problems. Despite extreme efforts to break his dependence, his parents have been unsuccessful.

“They removed him from the specialized high school and moved him to another school (although JUULing is prevalent at the new school as well). They have removed the door from his bedroom and locked parts of their house to deprive D.P. of private places to JUUL. They have instructed school officials to place controls over D.P. so that he is not permitted to go to the bathroom unescorted and have subjected D.P. to regular nicotine urine testing,” the lawsuit states. “Yet despite all these measures, D.P. is unable to stop JUULing. Although D.P. has been able to refrain from JUUL use for short periods, he feels what he refers to as ‘urges’ return and become so powerful that he is unable to avoid JUUling even though it subjects him to disciplinary measures at home and at school.”

Focusing on teen e-cigarette use has become of special concern in recent years, as studies indicate teens are vaping in higher numbers, which may increase the risk of smoking traditional cigarettes or expose them to serious health risks.

E-cigarettes are now the most popular form of tobacco among U.S. teens, and critics have pointed out that the products are often aggressively marketed towards teens. They are sold in candy-like flavors, try to incorporate trends highly associated with teenagers, and in some cases liquid nicotine is even sold in containers meant to suggest children’s products, such as juice boxes.

FDA Juul Investigation

In a new enforcement push announced in April, the U.S. Food and Drug Administration (FDA) said it intends to put extra focus on Juul products, which are some of the most successful, and, some critics say, egregious.

Some are sold under the Juul brand, but the same type of device is made by other brands like myblu and KandyPens.

As part of an enforcement blitz in April, the FDA cited 40 retailers for violations related to illegal sales of Juul e-cigarettes to minors.

The agency also contacted eBay to address listings of Juul devices to minors. FDA officials said eBay took swift action to remove listings and voluntarily implement measures to prevent new listings to ensure the devices don’t get into children’s hands.

The FDA contacted JUUL Labs and other manufactures directly to hold them accountable for selling products appealing to teens. Additionally, the FDA requested JUUL submit documents pertaining to health effects and marketing to better understand the high rates of teen use.

Despite claims that vaping can help people quit smoking, which a number of studies have suggested is untrue; some recent studies indicate children who are receptive to e-cigarette ads are more likely to try traditional cigarettes.

Furthermore, e-cigarettes have other negative health effects, including increasing the risk of heart problems, rewiring the youth brain for addiction, exposing teens to carcinogenic chemicals, damaging the cells of the mouth leading to oral cancers, and leading to increased respiratory problems, like bronchitis, chronic cough and phlegm.

Juul officials say they are working to keep their products out of the hands of teens and have forced videos of teens using their products to be removed from social media platforms like YouTube and Instagram.

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Composix Kugel Hernia Mesh Lawsuit Filed Over Implant Failure

Problems with a Bard Composix Kugel hernia patch caused a Texas man to suffer devastating complications about ten years after it was implanted, resulting in emergency surgery that discovered the hernia mesh failed. 

The complaint (PDF) filed by Michael Loughridge in the U.S. District Court for the Eastern District of Texas on July 24, alleging that that the manufacturers knew about problems with a memory recoil ring used the design of the hernia mesh for years before it was implanted in his body.

Loughridge indicates that a Bard Composix Kugel Hernia Patch was used during a ventral hernia repair in October 2007. However, he had to undergo revision surgery to have the mesh removed in July 2016, during which his surgeon discovered that the patch had failed due to contracting, buckling and breaking at the PET ring.

The lawsuit indicates the manufacturers covered up known problems with the Composix Kugel mesh for years, intentionally concealing information from consumers and the medical community.

“No later than September 2004, Defendants uncovered serious problems with the weld process involving the memory recoil ring. Despite attempts to correct the problem at the plant, Defendants found the corrective measures to be ineffective and the process still not in control,” Loughridge’s lawsuit states. “Defendants were aware these weld issues had existed from the time the CK Patches were originally placed on the market and all current lots suffered from this dangerous defect.”

Loughridge presents claims of negligence, gross negligence, failure to warn, defective design, defective manufacturing and breach of implied warranty, seeking compensatory and punitive damages.

In recent years, Bard and Davol have faced thousands of Composix Kugel hernia mesh lawsuits over problems with Composix Kugel products, most involving allegations that the memory recoil ring around the perimeter of the mesh broke, resulting in serious internal injuries.

In 2011, C.R. Bard agreed to Kugel mesh settlements that resulted about 2,600 cases, paying about $70,000 to each plaintiff. However, the agreement left hundreds of claims unsettled, and individuals with the recalled hernia mesh implanted in their body continue to experience problems when the hernia mesh fails.

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Agreement to Settle Testosterone Cases Against Actavis Finalized, Vacating August Trial Date

The first scheduled testosterone bellwether trial involving injuries associated with the use of Androderm has been canceled, after the parties confirmed that a master settlement agreement has been fully executed, which is expected to resolve most or all of the testosterone cases filed against Actavis and it’s subsidiaries. 

The claims are part of a massive mass-tort litigation over failure to warn about the side effects of testosterone replacement therapy, which also includes claims against the makers of AndroGel, Axiron, Testim and other drugs, which have been linked to reports of heart attack, stroke, deep vein thrombosis, pulmonary embolism, blood clots and other life-threatening health problems.

There are currently more 6,000 testosterone drug cases pending in the federal court system, which are centralized before U.S. District Judge Matthew Kennelly in the Northern District of Illinois, as part of an MDL, or multidistrict litigation.

As part of the coordinated proceedings in the MDL, Judge Kennelly has scheduled a series of early “bellwether” trials against each drug maker, which are designed to help the parties gauge the relative strengths and weaknesses of their cases.

In late June, Judge Kennelly agreed to place a stay on all Androderm cases pending against Actavis, after the parties informed him that they were nearing a settlement agreement. However, at that time, he did not vacate the first scheduled Androderm bellwether trial, which was set to begin on August 6. However, in a Docket Entry (PDF) posted on July 26, the court announced that the master settlement agreement “has been fully executed”, and that the trial date is now vacated.

It is estimated that about 500 of the testosterone cases pending before Judge Kennelly involve Androderm, which was manufactured and sold by Actavis subsidiaries. No details of the potential Androderm settlement have been released.

Actavis is at least the third drug maker that decided to settle testosterone injury claims, rather than allowing cases to proceed before a jury. Auxilium Pharmaceuticals announced an agreement to settle about 1,300 Testim lawsuits earlier this year, and late last year Eli Lilly announced that it has agreed to settle all Axiron cases involving their testosterone gel.

The announced settlements are expected to resolve about one-third of the pending litigation, but no testosterone case settlements have been announced involving Androgel, which was the most widely used drug, accounting for the bulk of the lawsuits filed nationwide.

AbbVie has continued to defend cases at trial, despite being hit with several large jury verdicts. A series of 19 Androgel trials are expected to begin later this year, if additional settlements are not reached.

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Doctors Recommended Essure Birth Control Amid Millions in Payments by Bayer: Report

According to a new investigative report, Bayer paid doctors $2.5 million in consulting fees linked to the Essure birth control implant, which is now being pulled from the market amid thousands of reports involving painful and debilitating complications among women who underwent the procedure, raising questions about whether the payments improperly influenced doctor recommendations. 

The CNN exclusive report indicates that many of the doctors who received the biggest payments from Bayer, were also the device’s biggest cheerleaders, and some patients interviewed for the story said their doctors aggressively pushed the devices for permanent birth control.

The payments were made to 11,850 doctors from August 2013 through December 2017, with at least three doctors paid in excess of $100,000. Most patients were likely unaware of the financial connections when doctors recommended Essure birth control procedures as a permanent way to avoid pregnancy.

The revelation came a day after Netflix aired “The Bleeding Edge“, a documentary about the dangers of potentially unsafe medical technology and how it has being approved in the United States. Essure is spotlighted in the documentary, which describes the devastating reports of intense pain, bleeding, allergic reactions and other complications experienced by thousands of women.

On the same day the documentary was released, Bayer issued an “Open Letter” (PDF) to patients and doctors, saying that it stands behind the safety of Essure and that reported problems are misleading and inaccurate publicity.

Essure was introduced as a form of permanent protection against pregnancy, involving an outpatient procedure where coils are placed in the uterus, which develop scar tissue that prevent pregnancy. However, the device has been linked to painful and debilitating injuries when the coils migrated, perforated the uterus or Fallopian tubes, caused allergic reactions, infections or other complications.

FDA officials have confirmed that the agency received about 12,000 adverse event reports related to the Essure birth control implant last year. In April, the FDA made changes to Essure’s premarket approval, requiring both doctors and patients to sign off on a checklist of potential Essure complications.

In November 2016, following controversial hearings in the U.S., where testimony was heard from large numbers of women and medical experts, the FDA decided not to recall Essure in the United States. However, the agency did require Essure black box warnings, which are the strongest that the FDA can require a medical device carry.

On July 20, Bayer announced it was removing Essure from the U.S. market for marketing reasons on December 31, 2018. It had already removed Essure from the market in the rest of the world last year.

Bayer currently faces several thousand Essure lawsuits brought on behalf of women who have been left with devastating injuries, each raising similar allegations that the company manufactured and sold an unreasonably dangerous and defective sterilization product, withholding information about the risks associated with the procedure.

Approximately 750,000 women worldwide have been implanted with the device, and Bayer has previously estimated that 70% of those have been implanted in women in the U.S.

The manufacturer has reportedly spent about $413 million defending the Essure litigation over the last year, and may face substantially greater liability at trial if Essure settlements or another resolution for the cases is not reached.

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Recalled Whey Protein May Pose Salmonella Risk in Additional Snake Foods

Salmonella contaminated whey protein ingredients, which have resulted in massive recalls for Ritz Bits and Goldfish crackers, may have also been used in other popular snack foods, according to a recent statement issued by federal health regulators. 

In a update issued late last week, the FDA warned consumers that additional snack food recalls may be needed due to a risk of salmonella food poisoning linked to dry whey powder manufactured by Associated Milk Producers Inc. (AMPI) of Ulm, Minnesota.

The FDA, U.S. Centers for Disease Control and Prevention (CDC), U.S. Department of Agriculture (USDA) and other agencies are investigating the facility where the ingredient was manufactured and processed, and working to identify other companies that may have used the recalled whey protien, to determine whether other food still on store shelves may be contaminated with Salmonella.

AMPI announced a whey powder recall on July 24, and temporarily shut down production at its Blair, Wisconsin plant while federal officials investigate the source of contamination. AMPI announced they are collaborating with the federal agencies to take all necessary remedial actions.

To date, no cases of food poisoning or illness have been reported in relation to the recall, but millions of popular snack foods have been removed from store shelves due the risk of salmonella, which can pose a particularly serious risk for young children, who are often the primary consumers of the recalled snacks.

On July 23, Pepperidge Farms recalled issued a Goldfish recall affecting millions of boxes of popular children’s snacks. According to the manufacturer, an estimated 3.3 million units are included in the recall including certain Flavor Blasted Xtra Cheddar products, Flavor Blasted Sour Cream & Onion products, Goldfish Baked with Whole Grain Xtra Cheddar products, and certain Goldfish Mix Xtra Cheddar + Pretzel snacks. Pepperidge Farms released a complete list (PDF) of the UPC codes and expiration dates of the affected products.

The FDA also announced a Swiss Roll recall on July 23, affecting products sold under the brand names Mrs. Freshley’s, Food Lion, H-E-B, Baker’s Treat, Market Square and Great Value that were distributed nationwide, as well as under the brand name Captain John Derst’s Old Fashioned Bread that were distributed to stores in Alabama, Florida, Georgia, North Carolina, and South Carolina.

The first recall linked to the whey powder contamination was announced July 21, by Mondelez Global LLC, in which the company announced a Ritz Cracker Sandwiches and Ritz Bits recall. The recall includes six different varieties of Ritz Bitz Cheese, some Ritz Cheese Cracker Sandwiches, the 35 ounce Ritz Everything Cracker with Cream Cheese and two multipack Mixed Cookie Cracker Variety assortments.

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Taking Plavix And Aspirin Together Decreases Stroke Risk, Increases Bleeding Risk: Study

While taking the blood thinner Plavix with aspirin may decrease the risk of a recurring stroke, researchers warn that the combo also significantly increases the risk of major bleeding events. 

In a study published July 19 in the New England Journal of Medicine, researchers with the University of Texas indicate that when compared to use of just aspirin alone, major hemorrhaging was more than twice as likely to occur among patients taking as well Plavix (clopidogrel), a combination known as dual antiplatelet therapy (DAPT).

The bleeding risks were high enough, and the results conclusive enough, that the study was halted before completion for the safety of patients. When the study was stopped, 84% of the number of anticipated patients had been enrolled. Researchers said the data and safety monitoring board determined at that time that there was a high risk of hemorrhage among the patients given DAPT, and that there was enough evidence to show that there was reduced risk of stroke among those patients as well.

The study involved a randomized trial with 4,881 patients at 269 international sites. Researchers looked for patients who had suffered either a minor ischemic stroke or a transient ischemic attack (TIA) and prescribed them either Plavix plus aspirin, or aspirin alone.

According to the findings, the combination of the two medications decreased the risk of stroke by 25%. However, the risk of major hemorrhage was doubled, with 23 patients suffering major bleeding events among the Plavix and aspirin group, compared to just 10 patients who suffered similar events in the group given just aspirin.

“In patients with minor ischemic stroke or high-risk TIA, those who received a combination of clopidogrel and aspirin had a lower risk of major ischemic events but a higher risk of major hemorrhage at 90 days than those who received aspirin alone,” the researchers concluded.

A study earlier this year found that the combination of the two drugs could also increase the risk of heart attacks. In March, South Korean researchers published a study in the medical journal The Lancet, which found little benefit in giving the two drugs to patients who had recently been implanted with a coronary stent.

Patients given the two drugs for six months faced an increased risk of heart attacks and were more likely to suffer stent thrombosis.

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Not Enough Americans Getting Cancer Screening, CDC Study Reveals

Fewer Americans are getting the recommended cancer screenings that could play a critical role in ensuring proper diagnosis and timely treatments, according to the findings of a new study by federal researchers. 

In a report published by the U.S. Centers for Disease Control and Prevention (CDC), in the latest edition of the journal Preventing Chronic Disease, researchers report that cancer screening rates are down for almost all types of screenings, with the exception of colorectal cancer. Colon cancer was the only type of screening that had an increase in screening rates during the study period.

CDC researchers analyzed data from the National Health Interview Survey (NHIS) for 2000 through 2015. This focused on cancer screenings reported in 2015 among U.S. adults. It included screenings for breast, cervical, colorectal, and prostate cancers.

Overall, researchers noted there was an increase in colon cancer screening rates, but those rates were still well below national target levels set by the Healthy People 2020 initiative. Colon cancer screenings among men and women increased by 29%. However, only about 63% of women and 62% of men had a recent screening.

Other than colon cancer screenings, the number of Americans getting the recommended cancer screenings declined. This was especially true among people that don’t have health insurance.

Cervical cancer screenings, commonly known as pap tests, dropped by 4% from 2000 to 2015. Roughly 80% of women reported having a recent pap test.

Similarly, mammogram rates declined by 3%. About 72% of women reported having a recent mammogram.

Rates of prostate specific antigen (PSA) tests also dropped by 5%. Only 36% of men over 50 reported having a recent PSA.

Reduced screening rates is especially troubling considering breast, cervical, colorectal, and prostate cancers accounted for 40% of all new cancer diagnoses in 2013. They also accounted for 20% of cancer deaths.

Researchers indicate certain factors contribute to reduced cancer screenings. These include not having health insurance, not having recent contact with a doctor in the past year, and not having a usual source of health care. Decreased rates of cancer screenings were especially high among uninsured people.

The report emphasizes that public health efforts should be made to help reduce barriers for accessing medical care. Expanding insurance coverage is especially key. Researchers also recommend the use of electronic medical records with reminders for patients and doctors. Increasing providers who focus on the benefits of screening can also help urge patients to complete needed screenings.

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Lawsuit Over Fractured IVC Filter Cleared to Proceed to Trial

The U.S. District Judge overseeing all federal Bard IVC filter lawsuits has cleared the way for the next bellwether case to go before a jury in September, indicating that claims for negligent design, negligence per se, strict liability design defect, loss of consortium and punitive damages in a claim filed by Lisa and Mark Hyde can proceed to trial.

The case is one of more than 3,500 lawsuits pending in the federal court system over problems with Bard IVC filters, which are small devices implanted in the vena cava to prevent blood clots from reaching the lungs and causing a pulmonary embolism.

Each of the complaints raise similar allegations that certain retrievable blood clot filters sold in recent years were defectively designed and prone to fail. The devices have been linked to devastating injuries after they moved out of position, punctured internal organs or fracture, causing small pieces to travel throughout the body.

As part of the coordinated federal litigation, which is centralized before U.S. District Judge David G. Campbell in the District of Arizona, a series of early “bellwether” trials are currently underway, involving individual trial dates designed to gauge how juries are likely to respond to certain evidence and testimony that is likely to be repeated throughout the litigation.

In March 2018, the first bellwether trial resulted in a $3.6 million verdict, which was recently upheld during post-trial motions. However, Bard prevailed in a second trial last month, which ended in a defense verdict.

A claim filed by Lisa and Mark Hyde is set for the next trial date in September 2018, involving injuries suffered by Lisa Hyde from a fractured IVC filter. After a Bard G2X IVC filter was implanted in Lisa Hyde in February 2011, the lawsuit indicates that a CT scan revealed that the filter had tilted out of place, fractured, and perforated her vena cava wall. In addition, one of the struts was lodged in the right ventricle of her heart.

Following the complications, the filter and its broken struts were successfully removed in August 2014, and the Hydes filed a lawsuit raising a number of different claim.

In an order (PDF) issued on July 26, Judge Campbell granted the manufacturer’s request for summary judgement with respect to Plaintiffs’ claims for failure to warn, failure to recall, misrepresentation, concealment, and fraud, as well as breach of implied warranty. However, the motion to dismiss other claims, including a request for punitive damages, were rejecting, clearing the way for the case to proceed to trial on September 18.

Additional trial dates slated to begin on November 5, 2018 and February 11, 2019, and the Court has indicated that another trial may be held in May 2019.

While the outcome of these bellwether trials are not be binding of remaining claims in the litigation, they are being closely watched by parties involved, and may influence eventual negotiations to reach IVC filter settlements, which would avoid the need for thousands of separate trials to be held nationwide.

In addition to cases against Bard, another 3,750 Cook IVC filter lawsuits are centralized as part of a separate MDL, involving similar allegations of design defects. Last month, a Texas jury awarded $1.2 million in damages to a firefighter who suffered injuries from a Cook Celect filter.

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DePuy Synthes Proximal Femur Plate Lawsuit Filed Over Early Failure.

According to allegations raised in a recently filed product liability, a DePuy Synthes proximal femur plate failed only a few months after it was implanted, resulting in additional revision surgery.

The complaint (PDF) was filed by Carolyn Rokosz in the U.S. District Court for the Southern District of Iowa on July 19, indicating that design defects associated with a proximal femur plate manufactured and sold by DePuy Synthes, which was designed to hold together a fractured femur, caused it to fail and re-fracture her femur.

DePuy Synthes and its parent company, Johnson & Johnson, are named as defendants in the complaint.

Rokosz indicates that she underwent a procedure to implant a DePuy Synthes plate after she initially fractured her left femur during a fall in May 2016. However, just two months later, she went to her surgeon due to continued pain in her left leg, and an x-ray revealed that the plate had failed, and her femur had been re-fractured, according to the lawsuit.

Two days later, the leg with the failed plate “gave out” and Rokosz indicates that she suffered another fall, after which the plate was removed and replaced with another femur plate. In September 2016, after another two month period, an x-ray showed that plate had failed as well, and she had to have the second implant removed as well.

“All of the injuries and complications suffered by Ms. Rokosz were caused by the defective design, warnings, construction and unreasonably dangerous character of the DePuy Synthes femur plate in her May 13, 2016,” Rokosz’s lawsuit states. “Had defendants not concealed the known defects, the early failure rate, the known complications and the unreasonable risks associated with the use of the Synthes femur plate, Ms. Rokosz would not have allowed any Synthes Femur plate to have been implanted in her body.”

Rokosz’s lawsuit indicates that she will likely have to undergo future medical testing, invasive exploratory surgeries, treatments, and medical monitoring. It indicates that on top of the damaged femur, she has also suffered metallosis, a form of blood poisoning often caused by metal implants.

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Tivicay Side Effects May Increase Neural Tube Birth Defect Risks, Researchers Warn

New research suggests that side effects of Tivicay treatment for HIV-positive pregnant women may increase their risk of having a child with neural tube defects. 

According to preliminary findings of a study presented at the International AIDS Conference and published in an editorial in the New England Journal of Medicine on July 24, researchers indicate that when compared to other antiretrovirals, women were six to nine times more likely to have an infant with neural tube defects following pregnancy use of Tivicay, a dolutegravir-based antiretroviral.

Antiretrovirals are drugs given in combination to help slow the rate at which HIV spreads. They are used to help prevent the disease and help to treat it once a person is infected. Tivicay has shown to be quite effective and more widely tolerated, which is why the World Health Organization recommends its use. However, researchers are now questioning whether it is contributing to neural tube birth defects, which can cause large holes in the spine or prevent the top of the skull from forming properly.

Researchers from the Botswana Harvard AIDS Institute Partnership analyzed data for more than 89,000 births from pregnant women, both HIV positive and non-infected, in eight of the largest maternity wards in Botswana. This includes roughly 45% of total births in the country.

If a neural tube defect was suspected in a mother, doctors contacted researchers to confirm the defect by photographing the abnormality and conferring with experts from the U.S. A total of 86 infants with neural-tube defects were recorded overall.

While the prevalence of defects wasn’t extremely high, it was enough to indicate a potential problem, the researchers indicated. The study is ongoing and full data will be published once the study is complete.

In May 2016, Botswana changed its preferred antiretroviral therapy for all adults from Sustiva, an efavirenz based antiretroviral, to Tivicay, a dolutegravir antiretroviral. This allowed researchers to begin comparing the efficacy of Tivicay, as well as its impact on a fetus.

In April 2018, researchers detected more cases of neural-tube defects among infants born to women who started treatment with Tivicay before conception.

According to the findings, while only four of the 426 HIV-positive women taking Tivicay since before conception gave birth to children with neural tube defects, representing 0.94%, that is nine times higher than the rate of neural tube defect births among women who did not take the drug.

Among 2,800 infants born to women who started Tivicay after the women was already pregnant, there were no cases of neural tube defects.

Researchers updated the prevalence with new data from the earlier midpoint of April 2018. The new data indicated the prevalence of neural tube defects was roughly 0.67% among women who took Tivicay from conception.

While the occurrence is lower, it is still six times higher than among the other groups of women taking other antiretrovirals.

If fewer cases of birth defects are seen during the latter half of the study, the risk decreases significantly, becoming similar to the risk seen with other retrovirals. The next analysis of the data will be conducted in March 2019.

“We found a potential early signal for an increased prevalence of neural-tube defects in association with dolutegravir-based antiretroviral therapy from the time of conception,” the researchers wrote. “Our study is ongoing, and more data are needed to confirm or refute this signal, given the small number of events and the small difference in prevalence.”

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Texas Named Top State for Business

Lawsuit reform is one of the reasons Texas has become a place where businesses want to be. Once the poster child for lawsuit abuse, Texas is now a model for lawsuit reform.  For over 20 years, Citizens Against Lawsuit Abuse groups have been proud to support the lawsuit reform movement.

Read more here: Texas is CNBC’s Top State for Business in America this year

https://www.tala.com/texas-named-top-state-business/

Dicamba Drift Damaged Over 180 Acres Of Farmer’s Soybeans, Lawsuit Claims

A Nebraska farmer indicates that drifting dicamba herbicide damaged more than 180 acres of soybean crops, blaming the widespread and growing problem on the reckless promotion of Xtendimax, Engeina and Fexapan, and over-reliance on Roundup-resistant crops. 

The complaint (PDF) was filed by Shane Greckel in the U.S. District Court for the District of Nebraska on July 10, naming Monsanto, BASF, Dupont De Nemours and Company, and Pioneer Hi-Bred International as defendants.

Greckel indicates that he found significant dicamba damage to his soybean crops in June and July of 2017. The damage, spread over 180 acres, caused cupping, curling, discoloration, stunting, twisting and other deformities.

According to the lawsuit, the damage was indicative of the use of dicamba, an herbicide sold under the brand names Xtendimax, Engenia, and Fexapan. The lawsuit claims that the weed killer drifted from nearby fields, where farmers had planted soybeans genetically modified to be resistant to the weed killer. However, his were not, and the dicamba drift caused devastating consequences for his crops.

Dicamba is a synthetic herbicide, which has been used for years by farmers nationwide to control weeds. However, it has typically only been used during certain times of year. Following the promotion of crops that are resistant to the herbicide, farmers began to apply dicamba more frequently, resulting in problems when it drifts onto neighboring crops.

The case joins a growing number of dicambi crop damage lawsuits filed over the last year, each raising similar allegations that Monsanto and BASF marketed the new type of tolerant crop, which can withstand exposure to their herbicides, knowing it would cause severe and widespread damage to neighboring crops, essentially forcing other farmers to defensively plant crops using their resistent seed in future growing seasons.

Greckel’s lawsuit notes that the only reason dicamba and dicamba-resistant crops are necessary is due to the evolution of Roundup-resistant weeds, which came about due to the widespread use of Roundup weed killer and Roundup-resistant crops.

“Since introduction of genetically modified seeds designed to be resistant to the active ingredient in Roundup in 1996, over-reliance on Monsanto’s Roundup as a primary weed control herbicide created an environment in which Roundup resistant weeds flourished and proliferated across the United States,” the lawsuit states. “To retain its stranglehold on the seed and herbicide markets despite the decreasing efficacy of Roundup, and the impending loss of its patent protections for Roundup Ready seeds, Monsanto created new strains of soybean and cotton that were resistant to dicamba—an older, more toxic, and more uncontrollable herbicide.”

Complaints filed since August 2017 claim that Monsanto rushed the system and either withheld or concealed information from regulatory authorities about the volatility of Engenia, and marketed dicamba-tolerant crops without approval from regulators. The complaints allege that the manufacturer knew the use of the herbicide would endanger other nearby crops.

Farmers in several states claim that they have suffered millions of dollars in crop damage when Engenia or Xtendimax drifted onto neighboring, sensitive crops in the 2017 growing season.

According to a report issued in June, dicamba damage appears to be even worse this year, as use of the weed killer and resistant crops have spread. Many say farmers feel they have no choice, and must either buy dicamba-resistant soybeans or see their crops wither and die due to its use in other fields. A number of lawsuits have accused Monsanto of purposely designing dicamba to do crop damage in order to force farmers to buy its products.

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Wrongful Death Lawsuit Highlights History Of Deadly Drownings At Sioux Falls Park

According to allegations raised in a wrongful death lawsuit filed against a South Dakota city, over the drowning of a five year old girl at Sioux Falls Park, the city knew about prior deaths and failed to add proper safety barriers that could have prevented the tragedy. 

The complaint (PDF) was filed against Sioux Falls in the U.S. District Court District of South Dakota on July 26, over the tragic drowning of Maggie Zaiger, who died after slipping on foam covered rocks that obstruct the view of the water’s edge.

The five year old Zaiger was visiting Falls Park with her family in March, and was walking around the river bank where visitors are allowed and expected to be during walks. The exact location of Zaiger’s drowning was where two similar drownings had previously occurred and were known by the City of Sioux, according to allegations raised in the lawsuit filed by the family.

Plaintiffs claim the City of Sioux Falls knew of the apparent dangers during Spring run-offs that cause mountainous amounts of foam that looks like snow to form around and cover the rocky river’s edge, creating a slip and fall hazard into the fast flowing rocky water.

Despite the known dangers, as well as two previously recorded drownings and several other near-drownings that occurred in the same area in previous years, plaintiffs claim Sioux Falls consciously chose not to install fencing around known dangers.

Plaintiffs further claimed that long before Maggie’s drowning on March 18, the city received a written report recommending the “Best Practice” would be to fence off areas where spring runoff obstructs the river’s edge to warn visitors of dangers that may not be apparent to them, and to increase patrols during the spring time.

Depicted in the complaint are Maggie’s last moments, as her mother, Courtney Jayne, explained that she turned away to tend to her other child momentarily and when she did, Maggie reached out toward the foam and disappeared into the foam covered river.

The Argus Leader reported that at least 10 deaths and dozens of near-fatal drownings have been reported at Falls Park since 1980. Sioux Falls Fire Rescue reported to The Argus Leader they had received seven emergency rescue calls within the last five years from children and adults falling into the river and becoming trapped.

Two of the most recent fatalities involved two teenagers, Madison Wallace and Lyle Eagle. Madison was attempting to save her younger brother Garrett, who similarly to Zaiger’s incident, had fallen into the frothing water’s edge. As Madison struggled to save him, Lyle Eagle entered the water to assist Madison, however as both Madison and Lyle were able to save six year old Garrett, both of them were swept away by the strong Big Sioux River current and drowned.

Zaiger’s mother made a statement to The Argus Leader that the lawsuit is not about any amount of money to be obtained from her daughter’s death, rather it’s to hold the city of Sioux Falls accountable and compel better safety precautions at Falls Park.

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Viagra Study Involving Pregnant Women Halted Amid 11 Infant Deaths

Dutch researchers have pulled the plug on a Viagra study involving pregnant women, after the drug originally intended for treatment of erectile dysfunction may have played a part in the deaths of 11 infants. 

Researchers from Amsterdam Universitair Medische Centra (UMC) issued a press release (in Dutch) on July 23, announcing the immediate halt of the study, known as STRIDER, which was designed to evaluate whether Viagra (sildenafil) could improve fetal growth and birth outcomes in cases of severe restriction.

The study unexpectedly indicates that side effects of Viagra among pregnant women may be linked to the development of a blood vessel disease in the lungs, which can prove fatal after birth, according to the researchers.

The multinational, randomized clinical trial was initiated in 2015, with half of the pregnant women given a generic version of Viagra, and the other half given a placebo. At the time the Viagra study was halted, it involved about 183 women, half of whom were given the drug at centers in Amsterdam, the U.K., Canada, Australia and New Zealand.

Researchers said, however, that an interim analysis showed that Viagra increased the risk of both blood vessel disease in the lungs and the risk of death after birth, without showing any positive effects on fetal growth. The adverse effects actually made fetal outcomes worse, they determined.

As a result, the study has been stopped, and the expecting mothers have been told about the situation and whether they were given the placebo or Viagra, the researchers indicate. Children born to mothers who took the drug will be monitored.

Viagra is already prescribed “off-label” to some pregnant women to stimulate fetal growth, although that indication has not been approved by the FDA in the United States. While doctors are able to prescribe medications for any reason they believe is appropriate, researchers warn that the use of Viagra for this purpose should likely be stopped, based on the findings of this study.

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Essure Market Withdrawal Came Days Before Release Of Netflix Documentary Highlighting Problems

The recent decision made by Bayer Healthcare to withdraw Essure birth control implants from the U.S. market came just days before a documentary is set to air on Netflix, which will highlight serious complications linked to the permanent contraceptive coils, raising questions about whether the company was trying to avoid bad publicity. 

Netflix is set to release “The Bleeding Edge” tomorrow, which is a documentary highlighting the risks associated with certain medical technology. Essure complications are advertised as one of the central examples of new devices that caused devastating injuries.

The Bleeding Edge was created by the makers of “The Hunting Ground” and “The Invisible War”, and looks at high risk implanted devices, the problems they cause, and why most never undergo any clinical trials to make sure they are safe and effective before being widely marketed to consumers and the medical community. In addition to the Essure implant, the documentary will also look at hip replacement complications and vaginal mesh problems.

The timing of Bayer’s recent announcement that it is removing Essure from U.S. markets at the end of the year has raised some questions, as the company has been pushing back against substantial pressure from consumer and safety to have the device pulled, due to devastating injuries thousands of women have suffered.

Essure was introduced as a form of permanent protection against pregnancy, involving an outpatient procedure where coils are placed in the uterus, which develop scar tissue that prevent pregnancy. However, the device has been linked to painful and debilitating injuries when the coils migrated, perforated the uterus or Fallopian tubes, caused allergic reactions, infections or other complications.

FDA officials say the agency received about 12,000 adverse event reports related to the Essure birth control implant last year. In April, the FDA made changes to Essure’s premarket approval, requiring both doctors and patients to sign off on a checklist of potential Essure complications.

Bayer currently faces several thousand Essure lawsuits brought on behalf of women who have been left with devastating injuries, each raising similar allegations that the company manufactured and sold an unreasonably dangerous and defective sterilization product, withholding information about the risks associated with the procedure.

Last year, Essure was withdrawn from every other market in the world, except the United States. However, in May, after Gottlieb met with a number of women who claimed they were injured by the device, the FDA added new restrictions to Essure procedures, indicating that both the doctor and the patient must sign off on a checklist of potential problems, to ensure that the patient is fully informed about the risks.

In November 2016, following controversial hearings in the U.S., where testimony was heard from large numbers of women and medical experts, the FDA decided not to recall Essure in the United States. However, the agency did require Essure black box warnings, which are the strongest that the FDA can require a medical device carry.

Approximately 750,000 women worldwide have been implanted with the device, and Bayer has previously estimated that 70% of those have been implanted in women in the U.S.

The manufacturer has reportedly spent about $413 million defending the Essure litigation over the last year, and may face substantially greater liability at trial if Essure settlements or another resolution for the cases is not reached.

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J&J Ordered To Reveal Talcum Powder Ingredients by India, Amid Cancer and Mesothelioma Concerns

Health officials in India are demanding that Johnson & Johnson turns over a complete list of ingredients in Johnson’s Baby Powder and other talcum powder-based products, due to concerns that they may contain asbestos or other carcinogens, according to a recent report. 

Livemint.com published a report on July 25, indicating that anonymous sources told them that India’s Central Drugs Standard Control Organization (CDSCO) sent an email to Johnson & Johnson on July 19, asking for the list of talcum powder ingredients.

According to the sources, the request was made due to concerns about the possibility of asbestos in its Baby Powder and Shower-to-Shower products, which they said could be linked to alleged cases of talc-associated ovarian cancer.

CDSOC previously cleared the company’s products of asbestos in an earlier review in March 2016, during an inspection of a Johnson & Johnson manufacturing plant in Mumbai. However, concerns about their safety were renewed following a $4.7 billion verdict in a talcum powder trial earlier this month in Missouri.

The verdict came following a six week trial involving claims brought on behalf of 22 different women, each of whom alleged that ovarian cancer developed following years of using talcum powder around their genitals for feminine hygiene purposes. According to evidence presented at trial, the manufacturer failed to warn that talc ingredients in the powder may increase the risk of ovarian cancer when applied around the genitals.

The case was being closely watched as a potential “bellwether” for how other juries may respond to similar evidence and testimony that is likely to be repeated throughout more than 9,000 Johnson’s Baby Powder lawsuits and Shower-to-Shower lawsuits pending nationwide, each raising similar allegations that women were not adequately warned about the risk of ovarian cancer from talc-based products used around their genitals.

Several prior Missouri juries have already awarded multi-million dollar verdicts to individual women in other cases.

In the U.S., claims of asbestos in talcum powder have followed a separate track than those claiming the products caused ovarian cancer. The asbestos claims here are linked to cases of mesothelioma, a fatal lung cancer only associated with asbestos exposure.

However, sources told Livemint that Indian officials fear that the asbestos could be linked to the ovarian cancer risks as well.

Johnson & Johnson has denied that its talcum powder products contain asbestos or are linked to increased ovarian cancer risks, and have vowed to appeal all of the jury verdicts against them.

Some analysts have suggested that more big awards returned in early trial dates may provide troubling signals for Johnson & Johnson in the talcum powder litigation, suggesting that juries find the company’s trial defense lacking in credibility.

Ultimately, if the company fails to negotiate talcum powder settlements for women with ovarian canceror otherwise resolve the litigation, thousands of individual cases may be set for trials nationwide in the coming years.

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Red Light Accident Deaths Increased as Use of Intersection Cameras Decreased

Following a decline in the use of traffic cameras at intersections, safety officials indicate that there was an increase in the number of deaths from red light accidents, suggesting that properly placed red light cameras play an important role in saving lives.

The Insurance Institute for Highway Safety (IIHS) issued a press release on July 24, indicating more than 800 people were killed in crashes involving red light running in 2016, which represents an increase of 17 percent since 2012.

The numbers have risen over the last several years, as fewer communities use traffic cameras at busy intersections, which are designed to deter motorists from running red lights and preventing crashes.

In response to the findings, the Advocates for Highway and Auto Safety, AAA,  IIHS, and the National Safety Council published a red light camera checklist (PDF), which provides practical instructions for planning and implementing red light camera systems they say have been proven to reduce traffic fatalities.

“We developed the guidelines to help communities avoid the problems that have undermined programs in the past,” IIHS President David Harkey said in the press release. “We know turning off cameras results in more crashes, injuries and deaths, so it’s important that camera programs succeed.”

Intersections are one of the most dangerous areas on roadways, where high speeds and traffic traveling in different directions meet. Cities have searched for effective methods to reduce motor vehicle crashes, deaths and injuries at intersections, and recent research has shown red light cameras reduced fatalities.

Researchers reviewed traffic fatalities resulting from red light running from 2000 through 2016 and found a decrease in fatality reports as more communities implemented red light cameras. However, a decrease in the amount of communities using red light cameras has resulted in an increase in traffic deaths linked to running red lights.

As of July 2018, only 421 communities across the nation are on record using red light camera programs, which is down from the 533 recorded in 2012. Researchers have seen a 17 percent increase in the amount of traffic fatalities at intersections when comparing numbers from 2012 to 2016.

Researchers also compared red light camera crash rates in cities that stopped their programs to those that continued running theirs, and found deadly red light crashes were 30 percent higher in cities that turned off cameras than in those that left the cameras on.

The checklist includes recommendations from planning, oversight, and sustained public engagement which is important to understand the public’s acknowledgement and approval of these types of deterring system. The researchers determined it is important to run a red light intersection camera in a transparent manner that is clearly directed toward reducing fatalities, rather than just collecting revenue.

The checklist recommends communities establish an advisory board to identify where problematic intersections are located, and to increase traffic crossing signs, make cross walks more easily noticeable, implement red light cameras and task the advisory board on tracking whether progress is being made to reduce fatalities.

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Live Poultry Salmonella Outbreak Now Linked To Over 200 Illnesses, CDC Warns

A salmonella outbreak linked to backyard poultry has worsened, sickening more than 200 people throughout the United States, according to federal health officials. 

The U.S. Centers for Disease Control and Prevention (CDC) issued a multistate salmonella outbreak update on July 20, indicating that illnesses linked to live poultry have been identified in at least 44 states, and the number of illnesses has nearly doubled since late June.

Initially, the CDC reported that at least 124 people had fallen ill to the outbreak last month. In this latest update, the agency indicates that 88 additional illnesses have been reported, raising the total to 212 people.

To date, there are no reported deaths. However, 34 people have been hospitalized. More than a quarter of the people who have become ill are children under the age of five. The most recent illness was reported June 21.

The live poultry salmonella outbreak is linked backyard flocks. The chicks and ducklings came from multiple sources, including hatcheries, feed supply stores, relatives, and bought from websites.

Nearly three-quarters of people who became sick reported having contact with chicks or ducklings in the weeks before the onset of their illness.

Salmonella can cause symptoms such as severe cramps, diarrhea, chills, fever, headaches, bloody stools, nausea, and vomiting. Most symptoms last about four to seven days and can be treated at home.

In some cases, those who get the infection experience serious complications, or symptoms that last weeks or months, or may require hospitalization. Young children, people older than 65, or those with weakened immune systems are especially at risk.

More than 70 salmonella outbreaks have been linked to contact with backyard poultry flocks since 2000, according to the CDC. However, in 2017 the agency reported the largest number of illnesses linked to backyard poultry flocks ever recorded.

Despite the outbreak worsening and sickening more people, the CDC is offering the same advice as the initial update. Avoid touching live poultry or their environment. This is how the bacteria is spread. Sick birds or birds carrying the bacteria may appear healthy and clean and offer no signs of infection.

People who handle live poultry should always thoroughly wash their hands with soap and water after touching livestock or anything in their environment. Do not let children under the age of 5 touch live poultry without adult supervision and ensure children thoroughly wash their hands after handling live poultry.

Never let live poultry in the house, bathroom, or areas where food or drink is prepared, served, or stored. The current Salmonella poultry-linked investigation is ongoing and the CDC will continue to provide updates as necessary.

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Most Ambien Users Not Using Sleep Drug Safely, Researchers Warn

Drug safety experts warn that most users of the sleep medications Ambien, Edluar and Zolpimist fail to use the drugs safely. 

The Institute for Safe Medication Practices (ISMP) published a research letter this month in the medical journal JAMA Internal Medicine, indicating that more than three-quarters of Ambien (zolpidem) users do not adhere to FDA safety guidelines designed to prevent injuries and accidents due to drowsiness caused by the drug.

Amid increasing use of sleeping pills, concerns have emerged about potential side effects, including lingering effects of the medication the next day, which may result in drowsy driving accidents and other issues caused when individuals remain dangerously impaired. Several reports suggest that women may be more susceptible to these problems, but all individuals required to perform tasks requiring high levels of alertness may be at risk.

In January 2013, the FDA issued a safety alert indicating that recommended Ambien doses should be lowered, cutting the recommended dose for women in half, and indicated that doctors should prescribe all patients the lowest dose possible to treat the symptoms.

Additional warnings for Ambien, Zolpimist and other zolidem sleeping pills were approved by the FDA in May 2013, indicating that users should not drive or engage in other activities requiring mental alertness the next day after taking the medication.

According to the research letter, the FDA recommendations have gone largely unheeded. Researchers looked at data from the Medical Expenditure Survey Panel, which conducts an annual survey of medical care.

The ISMP’s findings indicate that 77% of users of Ambien, Edluar and Zolpimist, which all use the active ingredient zolpidem, failed to follow two or more FDA recommendations on using the drug safely. Most common unsafe use of the drugs involved taking two or more types at once, long-term use, and taking higher than recommended doses; particularly among women and older patients.

According to the findings, nearly 42% of users of Ambien and similar drugs combined the medication with another central nervous system depressant. More than a quarter of those were taking opioids, and just over 20% were taking benzodiazepines.

The ISMP first warned that Ambien safety issues were persisting in its 2015 QuarterWatch Report.

According to the ISMP report, the U.S. Centers for Disease Control and Prevention  found that Ambien and its generic zolpidem equivalents were the drug most linked with emergency room visits, according to adverse event data received by the FDA. According to the report, there are an estimated 10,2112 emergency department visits each year linked to Ambien use, with 25% of those requiring the person be hospitalized.

In 2014, the FDA received 1,030 serious adverse event reports where Ambien was the primary or secondary drug suspected of causing the problem.

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It’s Time to Stand Up for Summer: Ensure Our Courts Are Used for Justice, Not Greed

By Court Koenning

Search ‘summertime lawsuits’ and you’ll find personal injury lawyers at the top of your Google search, ready to file suit over a wide-range of summer-related activities.

Whether it’s slips and falls on wet surfaces like swimming pool decking, dog bites by a neighbor’s pet, burns from a charcoal grill or fireworks’ accidents, personal injury lawyers’ advertising highlights the many ways lawsuits can squash Texans’ summer fun.

Summer-time related lawsuits are the reason you don’t often see diving boards at public pools, for example. Litigation concerns spurred changes to a Texas statute in 2004 that increased required clearances for diving boards, driving them from municipal pools.

A splash-less summer is one thing, but it seems no summer activity is safe from lawsuits.  From putting on sunscreen, to taking a trip to the ballpark, to an outdoor picnic, summertime fun is ripe for litigation. That’s why we’re calling on Texans to “Stand Up for Summer.”

We want Texans to know there’s an alternative to frivolous lawsuits: an ounce of prevention, a dash of awareness and a healthy helping of common sense.

Abusive and frivolous lawsuits cost time and money – even if cases are settled – and taint some of life’s simplest pleasures.

“Stand Up for Summer” is a public awareness campaign led by Texas’ grassroots lawsuit reform movement, Citizens Against Lawsuit Abuse organizations from across Texas that are comprised of consumers and small business owners concerned about the costs and far-reaching consequences of lawsuit abuse.

Common-sense can help you avoid being on the receiving end of a lawsuit and it can help you think twice before filing an unnecessary suit, too.

Access to the courts of legitimate claims is important. We’re ever mindful that frivolous lawsuits not only often drive up costs for consumers and small business, it can quite literally take the fun out of summer, rain on your pool party or burn up your backyard cookout.

Let’s stand up for summer and for common-sense in our civil courts system.

# # #

Court Koenning, of Houston, serves on the Texans Against Lawsuit Abuse Board of Directors.

 

https://www.tala.com/its-time-stand-summer-ensure-courts-justice-greed/

Lawsuits Over Hernia Mesh Problems Mounting, As MDL Panel Considers Centralizing Bard Cases

The U.S. Judicial Panel on Multidistrict Litigation (JPML) will hear oral arguments this week about whether to consolidate and centralize all hernia mesh lawsuits filed against C.R. Bard and its Davol subsidiary, which could become the latest in a number of federal multidistrict litigations (MDLs) established for the growing number of claims filed by individuals nationwide who have suffered painful problems due to complications with different hernia mesh products. 

In addition to cases filed against Bard, there are currently more than 1,250 Ethicon Physiomesh lawsuits and 470 Atrium C-Qur mesh lawsuits pending in the federal court system, which have each been centralized for coordinated discovery and pretrial proceedings. The Ethicon cases are currently pending in the Northern District of Georgia, and the Atrium cases are pending in the District of New Hampshire.

The U.S. JPML will hear oral arguments on Thursday about whether to establish similar centralized proceedings for all Bard hernia mesh cases, which are currently pending in at least 21 different U.S. District Courts. The complaints involve problems with Bard Ventralex, Bard Perfix, Bard Composix and other polypropylene hernia mesh products sold in recent years.

In a response (PDF) filed in support of the motion last week, attorneys representing plaintiffs in the litigation indicate that the number of cases filed against Bard “will likely increase to the thousands.”

Each of the complaints raise similar allegations that the design of different polypropylene hernia mesh products were unreasonably dangerous and defective, making them prone to fail and result in the need for risky revision surgery within a few years after the original hernia repair.

In May, C.R. Bard and it’s Davol subsidiary filed a response indicating that they support centralization of the hernia mesh cases, so long as any MDL includes all lawsuits over their polypropylene mesh products, including the previously recalled Kugel hernia patch, which plaintiffs argued should be excluded from this new MDL.

The U.S. JPML is scheduled to hear oral arguments on July 26, during a hearing at the Santiago E. Campos United States Courthouse in Sante Fe, New Mexico. The panel will also determine what is the most appropriate venue for the cases.

As part of any MDL, the judge appointed to preside over the proceedings will coordinate discovery and likely schedule a series of “bellwether” trials, which are designed to gauge how juries are likely to respond to certain evidence and testimony that may be repeated throughout large numbers of cases. However, if hernia mesh settlements or another resolution is not reached following the coordinated MDL proceedings, each case would ultimately be returned back to the U.S. District Court where it was originally filed for a separate trial date in the future.

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Zimmer M/L Taper Problems Led To Revision Surgery In Both Hips: Lawsuit

A California man has filed a product liability lawsuit over problems with the Zimmer M/L Taper hip replacement system, which allegedly failed prematurely and caused him to require revision surgery in both hips. 

The complaint (PDF) was filed by Glen Davis in the U.S. District Court for the Northern District of California on July 20, indicating that Zimmer Biomet, Inc. manufactured and sold a defective hip replacement system, featuring cobalt-chromium femoral heads, which posed an unreasonable risk of harm when combined.

Davis indicates that a Zimmer M/L Taper Hip System was implanted in his right hip in December 2007, and another was used during a subsequent procedure involving his left hip in August 2008. Both hip implants included the Zimmer Versys cobalt-chromium femoral heads.

According to the complaint, Davis required revision surgery for his left hip in January 2017, and then had his right hip removed as well in March 2018. In both cases, surgeons noted that the hip implants had to be removed due to adverse local tissue reactions caused by corrosion, something the artificial hip replacements are designed to avoid, according to the complaint.

“The mechanism of failure in Plaintiff’s device was exactly the same mechanism of failure that Defendants had marketed and warranted would not occur because of the Zimmer M/L Taper Hip System design and composition,” the lawsuit notes. “It was also the same failure mechanism that the medical and scientific community had been studying and documenting in modular device designs since the 1990s.”

Zimmer-Biomet, Inc. currently faces about two dozen similar hip replacement lawsuits filed in recent months over complications involving the hip components, which are considered a metal-on-metal design.

Each of the complaints raise similar allegations that the Zimmer M/L Taper Hip Prosthesis and Zimmer VerSys Hip femoral head are defectively designed and unreasonably dangerous when paired together, with a tendency to fret and corrode, creating metal debris that gets into the patients tissue and blood, resulting in the implants failing and needing to be removed.

More than 100,000 of these Zimmer hip replacements have been implanted throughout the United States, according to recently filed court documents. As lawyers continue to investigate and review potential cases in the coming months and years, it is expected that the size of the litigation may increase rapidly.

Last month, a group of plaintiffs filed a motion to centralize all Zimmer hip lawsuits over the VerSys, M/L Taper and M/L Taper with Kinective Technology, asking the U.S. Judicial Panel on Multidistrict Litigation (JPML) to transfer cases filed in various different federal district courts to U.S. District Judge Donovan Frank in Minnesota for coordinated discovery and pretrial proceedings.

The claims are the latest in a number of litigations that have emerged in recent years over recalled and defective metal-on-metal hip replacement systems, which the JPML have previously decided to centralize as part of separate a federal MDLs, including the DePuy ASR, DePuy Pinnacle, Biomet Magnum, Wright Conserve, Stryker LFit v40, Stryker Rejuvenate and other systems.

Metal-on-metal hip designs became increasingly popular in recent years, but components manufactured and sold by various manufacturers have been linked to high rates of failure and problems that often result in the need for revision surgery within a few years.

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Study Finds Antibiotic Overuse Linked To Urgent Care Clinics

New research suggests that nearly half of urgent care patients leave with an antibiotic prescription, including many circumstances where use of the drugs is not needed. 

In a study published last week in the medical journal JAMA Internal Medicine, researchers with the U.S. Centers for Disease Control and Prevention (CDC) warn that the overuse of antibiotics at urgent care clinics may be contributing to the emergence and spread of drug-resistant bacteria.

According to the findings, about 40% of all antibiotics prescribed in the U.S. come from urgent care clinics, half the time for illnesses they are ineffective in treating, such as upper respiratory infections and bronchitis. Unnecessary use of antibiotics has been linked to a risk of so-called “super bug” infections, for which antibiotics may end up unable to treat.

Researchers analyzed data from the 2014 Truven Health Market Scan Commercial Claims and Encounters Database. This database captures claims from patients younger than 65 with employer sponsored insurance.

They also analyzed outpatient claims using facility codes to determine what type of facility the person was treated at, such as an urgent care center, retail clinic, hospital-based ER, or doctor’s office. Those were cross-referenced with data on antibiotic prescriptions identified using drug codes.

Researchers focused on antibiotic prescriptions for inappropriate uses, such as ailments that cannot be treated with antibiotics, like viral upper respiratory infections, bronchitis, asthma, allergies, influenza, ear infections, and viral pneumonia.

Health experts have long indicated using antibiotics to treat infections that are not treatable with antibiotics helps to spread antibiotic-resistant bacteria. For example, a 2015 study indicated treating bronchitis with antibiotics was ineffective because most cases of bronchitis are viral, not bacterial.

Data from the new study indicated 39% of patients who participated in urgent care visits were given antibiotic prescriptions. With 2.7 million urgent care visits in 2014, this amounts to more than 1 million patients across the country.

Among 4.8 million emergency room (ER) visits, about 15% received antibiotics, or more than 660,000 patients. Similarly, among about 60,000 retail clinic visits, 36% received antibiotics.

Of 148.5 million doctors office visits, 7% of patients got antibiotics, equaling more than 10 million prescriptions.

The study also indicated respiratory diagnoses that could not be treated with antibiotics accounted for nearly 20% of retail clinic visits. Among those visits, 14% resulted in inappropriate antibiotic prescribing for ailments like asthma or the flu.

The findings also found that 16% of respiratory diagnoses untreatable by antibiotics were seen in urgent care centers, 6% in doctors’ offices, and 5% of ER visits.

Among those, 46% of urgent care center visits, 25% of ER visits, 17% of doctor’s visits, and 14% of retail clinic visits involving respiratory ailments not treatable by antibiotics resulted in antibiotic prescriptions.

Rates involving inappropriate antibiotic prescribing from urgent care centers are three times higher than doctors office prescribing.

Antibiotic superbugs, such as hospital-acquired Clostridium difficile, have proliferated in recent years. Many point to the overuse of antibiotics as the source.

“These patterns suggest differences in case mix and evidence of antibiotic overuse, especially in urgent care centers. This finding is important because urgent care and retail clinic markets are growing,” the CDC researchers wrote. “Antibiotic stewardship interventions could help reduce unnecessary antibiotic prescriptions in all ambulatory care settings, and efforts targeting urgent care centers are urgently needed.”

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