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Johnson & Johnson Marketing of Gynecare Prolift Transvaginal Mesh Raises More Questions

Johnson & Johnson Marketing of Gynecare Prolift Transvaginal Mesh Raises More Questions

Johnson & Johnson and its Ethicon unit are again coming under scrutiny for the way it marketed its Gynecare ProLift transvaginal mesh product. According to a new report from Bloomberg News, Johnson & Johnson continued marketing the Gynecare ProLift device for months after it received a warning from the ...

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Canadian Study Confirms Actos Bladder Cancer Risk

Canadian Study Confirms Actos Bladder Cancer Risk

A new study conducted by Canadian researchers has found that users of the type 2 diabetes drug, Actos (pioglitazone), may face a higher risk of developing bladder cancer than first thought. The study, published in the British Medical Journal, found that taking Actos for two years doubles the likelihood ...

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Stryker Metal Hip Implant Component Recall Bad News for Makers of Metal-on-Metal Hip Replacement Devices

Stryker Metal Hip Implant Component Recall Bad News for Makers of Metal-on-Metal Hip Replacement Devices

Stryker’s recent recall of two metal hip implant components, the Rejuvenate Modular and ABG II modular-neck hip stems, may have dealt a serious blow to one of the key arguments medical device manufacturers have made to defend their metal-on-metal hip replacements. Facing thousands of lawsuits, the makers of ...

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First DePuy ASR Hip Implant Lawsuits Head to Trial in December, January

First DePuy ASR Hip Implant Lawsuits Head to Trial in December, January

The first trials involving lawsuits filed against DePuy Orthopaedics by recipients of its recalled ASR Hip Implants will begin later this year, and early next year. The first is slated to start on December 3, 2012 in state court in Las Vegas, Nevada. A second DePuy ASR hip implant lawsuit ...

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Actos, Avandia May Up Risk for Diabetic Macular Edema

Actos, Avandia May Up Risk for Diabetic Macular Edema

A newly published study is raising concerns that patients who take Actos or Avandia may face an increased risk of developing diabetic macular edema, an eye disorder that can result in vision loss. The study, published in the Archives of Internal Medicine, found that type 2 diabetics who use thiazolidinediones, ...

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FDA Panel Takes up Metal-on-Metal Hip Implant Safety Today

FDA Panel Takes up Metal-on-Metal Hip Implant Safety Today

The Food and Drug Administration (FDA) is convening a meeting starting today to help decide the future of metal-on-metal hip implants following high-profile recalls and mounting questions about their overall safety.

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Newly-Filed Plavix Lawsuits Claim Drug Caused Gastrointestinal Bleeds, Cerebral Hemorrhage, and TTP

Newly-Filed Plavix Lawsuits Claim Drug Caused Gastrointestinal Bleeds, Cerebral Hemorrhage, and TTP

The manufacturer of Plavix continues to be named in lawsuits alleging the blood thinner caused some patients to suffer from serious bleeding side effects. Most recently, the national law firm of Parker Waichman LLP filed nine Plavix bleeding lawsuits in state court in New York.

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Actos Bladder Cancer Lawsuit Filed by West Virginia Resident

Actos Bladder Cancer Lawsuit Filed by West Virginia Resident

Actos (pioglitazone) continues to be named in lawsuits alleging long-term use of the type 2 diabetes drug caused patients to develop bladder cancer. Just last week, the national law firm of Parker Waichman LLP filed suit against Takeda Pharmaceuticals on behalf of a West Virginia man who developed bladder cancer ...

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FDA Advisors Set to Examine Metal-on-Metal Hip Implant Safety Concerns

FDA Advisors Set to Examine Metal-on-Metal Hip Implant Safety Concerns

Thousands of people with metal-on-metal hip implant devices could soon get some answers from the U.S. Food & Drug Administration (FDA) about the dangers they face. Tomorrow, the agency will convene a panel of outside medical experts to examine the safety record of metal-on-metal hip replacements, and recommend the ...

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Smith & Nephew Recalls Metal-on-Metal Hip Implant Component

Smith & Nephew Recalls Metal-on-Metal Hip Implant Component

Medical device maker, Smith & Nephew, just issued a recall for a metal-on-metal hip implant component, a part of one of its all-metal hip replacement systems.

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Sun Pharmaceutical’s Effexor Recalled for the Second Time This Year

Sun Pharmaceutical Industries Ltd. has recalled 68,000 bottles of the antidepressant Effexor (venlafaxine), in the second recall of the drug this year, the Food and Drug Administration (FDA) said.

In both instances, the recalled drug was manufactured at the Indian generic drug maker’s plant in Halol in the state of Gujarat. The drugs were recalled after they failed to dissolve properly in quality tests, the Wall Street Journal reports. The earlier recall, in June, was for 252,000 bottles of Effexor. Continue reading

Posted in Defective Products, Pharmaceuticals, Product Recalls, Recalled Drugs |

Stelara Linked to Risk of Serious Skin Conditions

Stelara, a drug used to treat moderate to severe plaque psoriasis and active psoriatic arthritis, has been linked to a risk of severe skin conditions. According to a safety announcement issued on November 21st on Health Canada’s website, Stelara has been associated with cases of exfoliative dermatitis and erythrodermic psoriasis. These reactions, which occur within a few days of receiving the medication, can be severe and lead to hospitalization.

Stelara is manufactured by Janssen. The safety announcement states that the product monograph for Stelara will be updated to include the risk of these serious skin conditions. The letter, addressed to physicians, notes that the symptoms of exfoliative dermatitis and erythrodermic psoriasis may be the same. Healthcare professionals are advised to inform patients of these symptoms and report them. If a drug reaction is suspected, use of the drug should be discontinued. Continue reading

Posted in Legal News |

Patients with Knee Problems May Want to Reconsider before Undergoing Knee Replacement

Getting a total knee replacement may seem like an appealing option for someone suffering from sore and creaky knees, but these devices may not be as beneficial as one would hope, according to Well, the New York Times health blog. In 2012, more than 600,000 knee replacement surgeries were performed compared to about 250,000 just 15 years ago.

Manufacturers of knee replacements often claim that the devices have a wide variety of benefits, offering increased mobility, less pain and overall a more youthful lifestyle. However, a growing body of evidence shows that many patients should try other methods to improve their knees first. Research suggests that many people are undergoing the procedures prematurely and gaining limited benefit. Figures from the American Academy of Orthopaedic Surgeons shows that in between the ages of 45 and 64, the number of knee replacements increased drastically by 205 percent between 2000 and 2012. The increase was only 95 percent in people 65 and older. Continue reading

Posted in Legal News |

Energy Drinks Can be Deadly for Children

New research shows that children face serious and possibly deadly side effects from the consumption of energy drinks.

Between 2010 and 2013, poison control centers received more than 5,000 reports of people who got sick from energy drinks, NBC News reports. Many of the cases involved serious side effects, such as seizures, irregular heart rhythmor dangerously high blood pressure, the researchers told a meeting of the American Heart Association. Children under age 6 often consumed energy drinks without knowing what they were drinking. Dr. Steven Lipshultz, co-author of the study and head of pediatrics at the Children’s Hospital of Michigan, said, “They . . . found it in the refrigerator, or left by a parent or an older sibling.” Continue reading

Posted in Food Products, Health Concerns |

Regulators Review Death Risk Associated with Long-Term Use of Duel Antiplatelet Therapy

Preliminary data from a clinical trial has prompted safety regulators to review the safety of using duel antiplatelet therapy long-term. On Sunday, the U.S. Food and Drug Administration (FDA) issued a safety announcement stating that it was evaluating this data.

The data stemmed from The Dual Antiplatelet Therapy (DAPT) trial; findings were published in the New England Journal of Medicine on November 16th. Although the study found a decreased risk of heart attacks and clot formation in stents with 30 months of dual antiplatelet therapy, there was an overall higher risk of death compared to 12 months of treatment. Researchers looked at patients who underwent dual treatment with the aspirin plus either clopidogrel (Plavix) or prasugrel (Effient) after undergoing stent implantation. Stents are often used in patients with narrowed arteries; they are essentially tubes that are intended to maintain blood flow and keep the vessels open.

“We are communicating this safety information while we continue to evaluate the results from this trial and other available data. We will communicate our final conclusions and recommendations when our evaluation is complete.” the FDA stated. Continue reading

Posted in Legal News |

Johnson & Johnson to Pay More than $2.2 Billion in Civil and Criminal Settlements

Health care giant Johnson & Johnson and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil cases arising from allegations relating to the drugs Risperdal (risperidone), Invega (paliperidone) and Natrecor (nesiritide). The allegations include promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to Omnicare Inc., the largest pharmacy provider to nursing homes.

The global resolution is one of the largest health care fraud settlements in U.S. history, with criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion, according to a news release from the Department of Justice. Continue reading

Posted in Health Concerns, Legal News, Pharmaceuticals |

Compensation Claim Deadline Extended for Victims of Defective GM Ignition Switch

The deadline to file an injury or death claim related to General Motors Co.’s ignition switch defect has been extended by one month. Wall Street Journal reports that the GM compensation expert extended the deadline as a result of pressure from safety advocates, politicians and attorneys. Continue reading

Posted in Legal News |

Overtreatment with Anticoagulant May Raise the Risk of Dementia

Long-term overtreatment with the anti-clotting drug warfarin, combined with antiplatelet therapy with aspirin or clopidigrel (Plavix) to prevent stroke, may raise the risk of dementia in people with atrial fibrillation.

The research was presented at the American Heart Association’s Scientific Sessions 2014, MedicalXpress reports. Continue reading

Posted in Health Concerns, Pharmaceuticals, Plavix |

Walgreens Customers Overcharged for Medical Records, Reports Allege

Walgreens, the largest drug retailer in the United States, allegedly overcharged some customers for medical records. At least one lawsuit has been filed alleging that the firm violated state laws by charging overly high fees. The man suing Walgreens alleges he was charged a flat fee of $55 for his medical records.

The suit argues that state law puts a cap on the maximum amount a company is allowed to charge. In this case, the legal limit is $24.81 in handling charges, $0.93 per page for the first 25 pages, $0.62 per page for the next 25 pages and $0.31 for any more than 50 pages. By intentionally exceesing these limits, Walgreens perpetrated the “common scheme of fraud” and violated the Illinois Consumer Fraud and Deceptive Business Practices Act and the Uniform Deceptive Trade Practices Act, the lawsuit alleges. The company is also accused of trying to cover-up the scheme by describing fees in an ambiguous, unclear way. Walgreens is also accuse of common fraud law and unjust enrichment in the suit. Continue reading

Posted in Legal News |

Laundry Detergent Pods Pose Poisoning Risk to Young Children

A report to appear today in the journal Pediatrics says there has been a significant increase in the number of children suffering adverse effects from exposure to the popular laundry detergent “pods” sold across the country.

The pods have become popular because of their convenience – the user does not have to measure the detergent or fabric softener. But many of the pods are colorful and attractive to young children, who eat the pods or inhale the ingredients when they break the outer shell of the pod. If ingested, the highly concentrated detergent in the pods can cause excessive vomiting, lethargy, and gasping, according to Consumer Reports magazine. In some reported cases, victims stopped breathing and required ventilation support. A summary on the Pediatrics web site reports that “17,230 children younger than 6 years [were] exposed to laundry detergent pods in 2012–2013. From March 2012 to April 2013, the monthly number of exposures increased by 645.3%, followed by a 25.1% decrease from April to December 2013” Fox News reports (fox17online.com). Continue reading

Posted in Defective Products, Health Concerns |

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