Monthly Archives: October 2015

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Medtronic Sprint Fidelis Leads Vulnerable to Fracture after ICD Switch

Medtronic Sprint Fidelis leads are vulnerable to fracture following ICD switch, says a new study published in the June issue of the journal Heart Rhythm.

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Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit

A shareholder lawsuit alleging Medtronic Inc. illegally promoted the off-label use of its Infuse bone growth product has been granted class action status by U.S. District Judge Paul Magnuson of Minnesota. According to a report from Law360.com, the Medtronic Infuse off-label promotion lawsuit was filed by several institutional investors on ...

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National Law Firms Calls for More FDA Action on Actos Bladder Cancer Threat

A national law firm is not satisfied with the way the U.S. Food & Drug Administration (FDA) has handled warnings regarding Actos (pioglitazone) bladder cancer risks. In a statement published today, Parker Waichman LLP called on the FDA to compel Takeda Pharmaceuticals, the maker of the type 2 diabetes drug, ...

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Study Finds SSRI Antidepressant Side Effects Outweigh Their Benefits

A new study is raising more concerns about the safety of commonly used antidepressants, including selective serotonin reuptake (SSRI) inhibitor antidepressants. Investigators who conducted the study, which is published in the journal Frontiers in Psychology, posit that increased knowledge of the negative effects of SSRIs and other antidepressants could reduce ...

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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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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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U.K. Regulators Issue Additional Guidance for Metal-on-Metal Hip Implant Recipients

Regulators in the U.K. are once again issuing advice to doctors and other healthcare professionals involved in the follow-up of patients with metal-on-metal hip replacement devices. In an alert issued by the Medicines and Healthcare products Regulatory Agency (MHRA), guidance is provided for four groups of metal-on-metal hip implant ...

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Research Suggest Fracking Chemicals Can Pollute Aquifers

A new study suggests fluids used during the hydraulic fracturing (fracking) process could migrate through underground fractures and contaminate water aquifers.

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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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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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Nursing Home Abuse Lawsuit Filed after Strangulation Death

Nursing Home Abuse Lawsuit Filed after Strangulation Death

There are questions of abuse and neglect surrounding the death of a nursing home resident in North Carolina. According to Star News Online, Mary Bowling was an 89-year-old widow at Carolina Rivers Nursing and Rehabilitation Center. Her death certificate and … Continue reading

Posted in Legal News | Tagged , , , , |

European Medicines Agency Seeks Market Suspension of Medtronic InductOs

Euro Medicines Agency Seeks Suspension of Medtronic InductOs

The European Union’s medical device regulator has recommended suspension of the marketing authorization for Medtronic’s InductOs bone growth device until issues at a U.S. plant that makes a component of the device are resolved. The European Medicines Agency (EMA) launched … Continue reading

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

Texas Compounding Pharmacy Recalls Possibly Contaminated Sterile Drug Products

Texas Compounding Pharmacy Recalls Contaminated Products

A Dallas, Texas compounding pharmacy that has previously been cited for safety issues by the Food and Drug Administration (FDA), once again faces problems with the federal drug regulator. Downing Labs in Farmers Branch was cited for failing to investigate … Continue reading

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

Device Used During Surgery Linked to 8 Infections, 4 Deaths at PA Hospital

Device Used During Surgery Linked to 8 Infections, 4 Deaths

A device used to heat and cool a patient’s blood during heart surgery has been linked to infections in 8 patients at a Pennsylvania hospital. The New York Times reports that four of those patients have died, but it is … Continue reading

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

Invokana Increases Risk of Bone Fractures, FDA Warns

Invokana Increases Risk of Bone Fractures

The Food and Drug Administration (FDA) issued a safety announcement in September warning patients and health care providers of an increased risk of bone fractures in patients taking the type 2 diabetes drugs Invokana and Invokamet (canagliflozin). The FDA deemed … Continue reading

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

FDA Requires Drug Interaction Studies for Kayexalate

FDA Requires Drug Interaction Studies for Kayexalate

The Food and Drug Administration (FDA) is requiring the manufacturer of the potassium-lowering drug Kayexalate to conduct studies to investigate Kayexalate’s potential to affect how other medications work. The approved labeling for Kayexalate (sodium polystyrene sulfonate) describes its potential to … Continue reading

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

Popular Acid Reflux Medications Associated with Serious Side Effects

Popular Acid Reflux Medications

Protein pump inhibitors, a class of widely used acid reflux medications that includes Nexium (esomeprazole), Prevacid (lansoprazole), and Prilosec (omeprazole). can have serious side effects. Dr. Shoshana J. Herzig of Harvard Medical School told the New York Times that they … Continue reading

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

Due to Fire Risk, Toyota Recalls 6.5M Cars

Due to Fire Risk, Toyota Recalls 6.5M Cars

Due to a defect in the driver’s side window that presents a fire hazard, Toyota is recalling 6.5 million vehicles. The recall affects roughly 2 million cars in the US. The problem is that the power-window master switch may have … Continue reading

Posted in Legal News, Product Recalls, Toyota Recall | Tagged , , , , |

Does the Flu Vaccine Carry Risks?

Does the Flu Vaccine Carry Risks?

As flu season is upon us, some may wonder whether there are any risks associated with getting the flu vaccine. This is addressed in a recent New York Times Ask Well blog, which responds to a reader question that asks … Continue reading

Posted in Health Concerns, Legal News | Tagged , , , |

FDA Updates Contraindications for Myrbetriq

FDA Updates Contraindications for Myrbetriq

The U.S. Food and Drug Administration (FDA) has updated the label on Myrebetriq to include a new contraindication and additional information in the Warnings and Precautions section. The revised label now states that the drug, which is used to treat … Continue reading

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