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Pradaxa Named in Most FDA Adverse Event Reports for Deaths, Hemorrhage, Kidney Failure and Stroke

Pradaxa Named in Most FDA Adverse Event Reports for Deaths, Hemorrhage, Kidney Failure and Stroke

The controversial blood thinner, Pradaxa, surpassed all other drugs monitored by the U.S. Food & Drug Administration (FDA) in adverse event reports made to the agency last year. According to the Institute for Safe Medicine Practices’ (ISMP) latest QuarterWatch report, Pradaxa also topped the list for reports of deaths, ...

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Pradaxa Associated with more Complications than Warfarin, According to Early Study Findings

Pradaxa Associated with more Complications than Warfarin, According to Early Study Findings

Early results from the largest study to date to compare Pradaxa and warfarin indicate that in a real-world setting, Pradaxa causes more complications than decades-old warfarin. The preliminary study results were announced last week, during the 2012 Thrombosis and Hemostasis Summit of North America.

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Three Injured, Long Island Railroad Train Hits Car on Tracks

Three Injured When Long Island Railroad Train Hits Car on Tracks

3 people, injured on Wednesday at 1:20 p.m. when a LIRR train hit a livery cab on the tracks west of Wyandanch station. The train engineer, who suffered a shoulder injury.

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Toxic Nano-Particles from Failing Metal-on-Metal Hip Replacements May Pose Long-Term Health Risks

Toxic Nano-Particles from Failing Metal-on-Metal Hip Replacements May Pose Long-Term Health Risks

According to a new study, failing metal-on-metal hip implants generate toxic nano-particles that release Cobalt 2+ ions, which not only cause inflammation in surrounding tissue, but have the potential to cause long-term damage to the genetic material of cells. According to a report published by Medicalxpress.com, this “genotoxicity” could ...

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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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Transvaginal Mesh a Nightmare for Thousands of Women

Transvaginal Mesh a Nightmare for Thousands of Women

Thousands of women who have received transvaginal mesh surgical implants to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are now living a nightmare, thanks to debilitating pain, bleeding, infection and other serious complications. According to the Sun-Sentinel, many of the women injured by transvaginal mesh claim ...

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Exploding Tanks Kill Jeep Drivers 18 months after Recall

Exploding Gas Tanks Continue to Kill Jeep Drivers 18 months after Recall

Chrysler recalled Jeeps with exploding gas tanks more than 18 months ago, but 1 million+ of these vehicles have not been fixed as the death toll continues to rise.

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MTA Bus Crash and Two Cars Injures 23 at Utica Ave. & Clarendon Rd

Crash Involving MTA Bus and Two Cars Injures 23

Police are investigating an accident in Brooklyn on Wednesday afternoon that injured 23 people, 3 of them critically, when a car was knocked into the path of an MTA bus.

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Older Patients Face Heart Attack Risk Following Surgery

Older Hip Implant, Knee Replacement Patients Face Heart Attack Risk Following Surgery

An emerging report reveals that older hip implant and knee replacement patients face increased heart attack risks following surgery. The risk for acute myocardial infarction (AMI) was seen in the first two weeks after these surgical procedures.

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New York Man Claims Biomet Metal-on-Metal Hip Implant Caused Pain, Disability

New York Man Claims Biomet Metal-on-Metal Hip Implant Caused Pain, Disability

A New York man claims his metal-on-metal hip implant was defective and required replacement within a year of receiving it. This has left him facing a lifetime of pain, disability, and rising medical costs.

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Oil Spill into Yellowstone River Raises Concerns about Nation’s Aging Pipelines

As a community downstream from the January 17 Poplar Pipeline oil spill into the Yellowstone River works to treat benzene contamination of its water supply, concerns are being raised about oversight of the nation’s aging pipeline network.

Federal investigators and pipeline company officials were trying to determine the cause of the 40,000-gallon spill, which contaminated downstream water supplies in the city of Glendive, Montana, The Associated Press (AP) reports.  Continue reading

Posted in Benzene, Health Concerns, Oil Spills, Toxic Substances |

FDA-Approval Does Not Ensure Safety or Effectiveness of Drugs

When a drug is approved by the U.S. Food and Drug Administration (FDA), it may give some the impression that it is proven to be safe and effective for a certain condition. An investigation by the Milwaukee Journal Sentinel, however, shows that this is not necessarily true. By focusing on new diabetes drugs that have been on the market, the investigation suggests that FDA approval is no guarantee of safety or efficacy.

Diabetes medications such as Januvia, Byetta and Victoza were linked to 3,000 deaths and about 20,000 hospitalizations in the last decade. Furthermore, the report showed that none of the 30 new diabetes drugs have been shown to decrease the risk of key complications associated with the condition, such as heart attacks, stroke and blindness. Continue reading

Posted in Legal News |

Study Suggests Hormonal Contraceptives Linked to Increased Brain Tumor Risk

Study Suggests Hormonal Contraceptives Linked to Brain Tumor

Study Suggests Hormonal Contraceptives Linked to Brain Tumor


A study of Danish women of reproductive age suggests that long-term use of hormonal contraceptives is associated with an increased risk of brain tumors.

Hormonal contraceptives, which contain female sex hormones, are commonly prescribed in pill form. “The Pill” first became widely available in the 1960s and gave women all over the world control over childbearing. The new study, which appeared in the British Journal of Clinical Pharmacology, reports that taking a hormonal contraceptive for at least five years is associated with a possible increase in the woman’s risk of developing a rare tumor, glioma of the brain, Science 2.0 reports.   Continue reading

Posted in Health Concerns, Pharmaceuticals | Tagged , , , , |

British Health Agency Strengthens Warnings about Valproate Risk in Pregnancy

British Health Agency Strengthens Warnings about Valproate

British Health Agency Strengthens Warnings about Valproate


The Medicines and Healthcare Products Regulatory Agency (MHRA), Britain’s drug regulatory agency, has issued a statement urging healthcare professionals to give women better information on the risk of birth defects when Depakote and other valproate medicines are used during pregnancy. These medications are used to treat epilepsy and bipolar disorder.

Following a European review last year, which found that up to 40 percent of children born to women who take valproate during pregnancy may have developmental disorders and other birth defects, MHRA moved to strengthen product information. The agency is making informational booklets available to healthcare professionals and patients and the leaflet in the drug packing is being updated with stronger warnings about the risk of developmental disorders in children exposed to valproate during pregnancy. The review found that of 35,000 women prescribed valproate, 375 become pregnant per year while taking it. Continue reading

Posted in Birth Defects, Depakote, Health Concerns, Pharmaceuticals | Tagged , , , , , |

Whistleblower Wins Retaliation Lawsuit

Whistleblower Wins Retaliation - Canaveral National Seashore

Whistleblower Wins Retaliation – Canaveral National Seashore


A whistleblower who reported misconduct at Canaveral National Seashore has won a retaliation ruling against the U.S. Department of Interior, Florida Today reports. The former employee filed a suit in 2011 alleging misconduct, including contracting violations and nepotism. Continue reading

Posted in Legal News | Tagged , , , , |

British Recall of Smith & Nephew Renasys Wound Care System for Infection Risk

British Recall of Smith & Nephew Renasys Wound Care System

British Recall of Smith & Nephew Renasys Wound Care System


The British Medicines and Healthcare Products Regulatory Agency (MHRA) has announced the recall of Smith & Nephew Renasys negative pressure wound care devices because of the risk of maceration, infection, loss of negative pressure, or unrecognized bleeding in wounds if there is a blockage in the vacuum system of the affected devices.

A negative pressure wound therapy (NPWT) device is an electric pump system that applies a vacuum to chronic, deep cavity wounds. The systems use disposable components such as foam or gauze dressings and tubing. If a blockage in the system is not detected, fluid from the wound can build up and leak from the dressing, according to the MHRA. The affected devices may not detect blockages and the alarm will not sound even if the dressing has visibly lifted from the wound. Continue reading

Posted in Defective Medical Devices | Tagged , , , , |

FDA Safety Warning for Bone Graft Products in Patients Under 18

FDA Warning for Bone Graft Products in Patients Under 18

FDA Warning – Bone Graft Products/Patients Under 18


The Food and Drug Administration has issued a safety alert to healthcare providers, patients, and parents and guardians that bone graft devices containing recombinant proteins or synthetic peptides should not be the first treatment considered for patients under age 18.

Certain recombinant proteins and synthetic peptides mimic bone growth substances normally found in the body and may be added to a carrier and then surgically implanted in a patient with a bone defect to promote new bone growth or to replace or heal existing bone. The FDA has approved devices such as Medtronic Infuse for orthopedic and dental use only in patients over the age of 18 who are done growing (skeletal mature). The labeling for each product provides the specific indications for use. The FDA has not evaluated their safety and effectiveness in patients under age 18, who are considered skeletally immature. Any product that affects bone growth has the potential to negatively impact skeletal development by altering normal bone formation and growth, especially if implanted near open growth plates. Continue reading

Posted in Defective Medical Devices, Medtonic Infuse | Tagged , , , , |

What Action Will the FDA Take on E-cigarettes?

What Action Will the FDA Take on E-cigarettes?

What Action Will the FDA Take on E-cigarettes?


As health and quality concerns trouble the e-cigarette industry, experts and the public await the Food and Drug Administration (FDA)’s action to regulate the devices.

E-cigarettes, battery-powered devices that heat nicotine liquid into an inhalable vapor, have been touted as a means to wean smokers from traditional cigarettes. They do not produce smoke, and there is no carcinogenic tar produced in burning tobacco in traditional cigarettes. But smokers are not adopting the devices in the numbers expected, The New York Times reports, and some experts argue that e-cigarette manufacturers see them not as a cessation device but as a way to introduce nonsmokers, in particular young people, to smoking. Continue reading

Posted in Health Concerns, Toxic Substances | Tagged , , , , |

Two Leading Cancer Groups Issue Call for Regulation of E-cigarettes and Research on Health Risks

Cancer Groups Call for E-cigarettes Regulation/Research

Cancer Groups Call for E-cigarettes Regulation/Research


In a joint statement, the American Society of Clinical Oncology and the American Association for Cancer Research have called on the federal government to move quickly to regulate e-cigarettes and increase research on their health effects.

These leading research and treatment organizations asked the Food and Drug Administration (FDA) to make final proposed regulations for “electronic nicotine delivery systems.” Peter Paul Yu, president of the 35,000-member oncology society, said the groups’ members “are concerned that e-cigarettes may encourage nonsmokers, particularly children, to start smoking and develop nicotine addiction,” the journal Science reports. The cancer research society, with 33,000 members, expressed the need for research into the health effects of e-cigarettes. Manufacturers claim that e-cigarettes help reduce smoking rates and are safe, but, Yu said, “we will not know for sure until these products are researched and regulated.” Continue reading

Posted in Arcadia Ohio Norfolk Southern Train Derailment, Health Concerns, Toxic Substances | Tagged , , , , |

Former Executives Accuse Health Technology Firm of Fraud

Former Executives Accuse Health Technology Firm of Fraud

Former Executives Accuse Health Technology Firm of Fraud


Two former executives of the health technology firm NantHealth claim in a recently filed lawsuit that the company made fraudulent claims about the reliability of its system, which links patient information gathered by medical devices.

The executives also allege that NantHealth, which is owned by a billionaire doctor, may have used donations to attract federal funds so a hospital could buy its products. The wrongful termination lawsuit was filed in federal court in Panama City, Florida, last week, The New York Times reports. NantHealth counters that the former employees had demanded $2 million to prevent them from spreading false information about the company. Continue reading

Posted in Legal News | Tagged , , , , , |

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