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FDA Metal-On-Metal Hip Replacement Investigation Is Flawed, Researchers Say

FDA Metal-On-Metal Hip Replacement Investigation Is Flawed, Researchers Say

The U.S. Food & Drug Administration’s (FDA) metal-on-metal hip replacement investigation is flawed, according to researchers.

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Smith & Nephew Says Metal-on-Metal Hip Replacement Controversy Slowing Sales of Birmingham Hip Resurfacing System

Smith & Nephew Says Metal-on-Metal Hip Replacement Controversy Slowing Sales of Birmingham Hip Resurfacing System

Medical device maker Smith & Nephew has reported a drop in sales of its metal-on-metal hip implant devices. According to the company, hip implant sales were down 2 percent during the first quarter of 2012, largely because its Birmingham Hip Resurfacing System suffered from an association with other metal-on-metal hip ...

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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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Metal-on-Metal Hip Implant Lawyer Takes Issue with Statements Made by DePuy Orthpaedics Official During FDA Meeting

Metal-on-Metal Hip Implant Lawyer Takes Issue with Statements Made by DePuy Orthpaedics Official During FDA Meeting

An attorney with a national law firm that represents victims of alleged metal-on-metal hip implant injuries has expressed dismay at some statements made last week regarding the regulation of all-metal hip replacement devices by an official with DePuy Orthopaedics. According to Daniel Burke, Senior Litigation Counsel at Parker ...

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Study Finds Plavix May Only Benefit Smokers

Study Finds Plavix May Only Benefit Smokers

An emerging study finds that blood thinner Plavix may only benefit smokers. Plavix (clopidogrel) is prescribed for the prevention of blood clots and heart attacks, and has been linked to serious side effects, including the heart attacks and strokes it is supposed to prevent, gastrointestinal and cerebral bleeding, bleeding ulcers, ...

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Another Metal-on-Metal Hip Replacement Lawsuit Filed in DePuy ASR Hip Implant Litigation

Another Metal-on-Metal Hip Replacement Lawsuit Filed in DePuy ASR Hip Implant Litigation

A vital food safety program was saved from budget cuts this week, enabling the country’s largest—although considered by experts to be far too small—produce-safety testing program to continue.

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1,000+ Australians Join DePuy ASR Hip Implant Class Action Lawsuit

1,000+ Australians Join DePuy ASR Hip Implant Class Action Lawsuit

A class action lawsuit filed in Australia over DePuy Orthopaedics’ recalled metal-on-metal ASR Hip Implants has signed up more than 1,000 plaintiffs. The attorneys representing the Australian ASR Hip Implant lawsuit plaintiffs recently told The Courier-Mail that damages in the lawsuit are expected to be worth more than $200 million. One ...

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Parker Waichman Representing Another Louisiana Plaintiff in Actos Bladder Cancer Lawsuit

Parker Waichman Representing Another Louisiana Plaintiff in Actos Bladder Cancer Lawsuit

A Louisiana man has become the latest to claim that his taking the type 2 diabetes drug Actos resulted in developing bladder cancer. He has filed a lawsuit against the Japanese manufacturer of the drug and the marketer of it in the U.S., claiming they failed to warn about this ...

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First Bard Avaulta Transvaginal Mesh Lawsuit Scheduled for February Trial in MDL

First Bard Avaulta Transvaginal Mesh Lawsuit Scheduled for February Trial in MDL

The first test trials in the federal C.R. Bard Avaulta transvaginal mesh litigation will most likely start next year, according to a report from Bloomberg News. About 600 lawsuits involving Bard Avaulta transvaginal mesh products are currently pending in the multidistrict litigation underway Charleston, West Virginia. U.S. District Judge Joseph ...

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Johnson & Johnson’s Ethicon Division to End Sales of Gynecare Prolift, Three Other Transvaginal Mesh Devices

Johnson & Johnson’s Ethicon Division to End Sales of Gynecare Prolift, Three Other Transvaginal Mesh Devices

Johnson & Johnson’s Ethicon Inc. division revealed yesterday that it will end sales of its Gynecare Prolift device and three other transvaginal mesh products. The plan to stop selling the four products was set forth in a letter filed by the company in the Ethicon transvaginal mesh multidistrict litigation ...

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FDA Warning About Surgical Tool That May Spread Cancer

On Monday, the Food and Drug Administration (FDA) updated an earlier safety alert to advise that the power morcellator should no longer be used in uterine surgeries for “the vast majority” of women because of the risk of spreading cancer.

The power morcellator cuts uterine tissue into small pieces that can be removed through tiny incisions made during minimally invasive surgery, and this makes it a popular tool for fibroid removal and some hysterectomies. But if a woman has an undetected cancer, the rapidly spinning blades can fling malignant cells around inside her abdomen, spreading the cancer, the New York Times reports. Though fibroids are benign, they can hide uterine sarcoma, an aggressive cancer that can be rapidly fatal once it spreads. Continue reading

Posted in Defective Medical Devices, Health Concerns |

Radiation from Cell Phones Linked to Brain Cancer, Study Suggests

Cell phone use is linked to a risk of brain cancer, a study published in the International Journal of Oncology suggests. Researchers analyzed the relationship between mobile phone use and glioma, a specific type of brain cancer that has a 0.005 percent chance of being diagnosed. The study found a 300 percent increased risk among participants who used cell phones for more than 25 years compared to those who used wireless phones for a year or less. A tripled rate of gliomas therefore correlates to 0.015 percent, or 15 out of 100,000 people being diagnosed, Business Tech reports.

The study found that the risk of brain cancer was 70 percent higher in people who used cell phones for more than a year compared to those used them for one year or less. The authors stated that the number of years of use is just as important as the number of hours of mobile phone use. A quarter of the participants spent 2,376 or more using their phones over their lifetime; this equates to roughly 40 minutes a day over ten years. Compared to people who never used cell phones or used them less than 39 hours in their lifetime, this group was associated with a 250 percent increased risk of brain tumors. Continue reading

Posted in Legal News |

Hookah Smoking May Increase Leukemia Risk

Researchers from San diegohave found that smoking hookah – a type of flavored tobacco – could lead to an increase in leukemia.

Hookah smoke doubles exposure to benzene, which the U.S. National Toxicology Program classifies as a Group 1 carcinogen, a substance that is proven to cause cancer in humans. The World Health Organization (WHO) says there is no safe level of exposure for the chemical. Continue reading

Posted in Health Concerns, Toxic Substances |

Health Canada Warns of Insulin Pump Tubing Detachment

Insulin pump infusion sets manufactured by Medtronic of Canada Inc., Roche Diagnostics, LifeScan Canada Inc, and Auto Control Medical Inc. have a risk of tubing detachment, according to a safety notification issued by Unomedical a/s in consultation with Health Canada. The alert, dated November 21st, warns that there have been growing reports of tubing become detached from the connect/disconnect location.

Insulin pumps deliver insulin to diabetic patients through a catheter. They can be programmed to administer small doses of insulin continuously or a larger dose close to mealtime to control blood sugar. Continue reading

Posted in Legal News |

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 |

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