Monthly Archives: July 2015

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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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FDA Urged to Ban Powdered Caffeine

FDA Urged to Ban Powdered Caffeine

Pennsylvania Senator Robert Casey has written to the Food and Drug Administration (FDA) to urge the agency to ban powdered caffeine, a dietary supplement.

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West Virginia Man Claims Metal-on-Metal DePuy Pinnacle Hip Replacement Led to Pain, Elevated Cobalt Levels

A West Virginia man fitted with a metal-on-metal version of DePuy Orthopaedics’ Pinnacle Hip Implant System has filed suit against the company and its parent, Johnson & Johnson, alleging the device caused him to suffer pain and elevated cobalt levels. The Plaintiff is being represented by the national law ...

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Medtronic Infuse Studies Faulted for Downplaying Side Effects

Medtronic Inc.’s published studies for its Infuse bone graft product may have downplayed serious side effects, according to an analysis published last year in The Spine Journal. The study, which drew on U.S. Food & Drug Administration (FDA) documents and other data sources, suggests that up to half of ...

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Medtronic Infuse Lawsuit Alleges Off-Label Use Cause Painful Complications

A man in Louisiana has filed suit against Medtronic Inc. over injuries allegedly cause by off-label use of its Infuse Bone Graft product. The plaintiff, who received Infuse during transforaminal spinal lumbar fusion surgery, claims that the bone growth protein caused unwanted bone growth along his spine, worsening the back ...

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FDA Warning for Bone Graft Products in Patients Under 18

FDA Safety Warning for Bone Graft Products in Patients Under 18

FDA issued safety alerts to patients, parents & guardians, bone graft devices w/recombinant proteins or synthetic peptides not to be the first treatment for 18 & under.

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Crash on N.State Pkwy Kills Port Jefferson Station Man

Single-Car Crash on Northern State Parkway Kills Port Jefferson Station Man

81-year-old Port Jefferson Station man was killed in a crash at 4:57 a.m.. He lost control of the vehicle traveling west on Northern State Pkwy, on exit 42, Dix Hills.

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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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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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FDA Failed to Warn Public of Serious Side Effect Linked to Antibiotic Levaquin

FDA Failed to Warn Public of Levaquin Side Effect

The Food and Drug Administration (FDA) failed to disclose a serious side effect associated with the family of antibiotics known as fluoroquinolones identified in a 2013 agency report. In an investigation, Cleveland television station ABC5 obtained a 2013 FDA report … Continue reading

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

European Regulators Review Medtronic’s InductOs in Light of Contamination Issues

European Regulators Review Medtronic’s InductOs

The European Medicines Agency (EMA) will be reviewing Medtronic’s InductOs following reports of contamination problems at a site that manufacturers one of the product’s components. InductOs is an implantable bone development product used in patients undergoing spinal fusion in the … Continue reading

Posted in Legal News, Medtonic Infuse | Tagged , , , |

UPPAbaby Strollers and RumbleSeats Recalled for Choking Hazard

UPPAbaby Strollers and RumbleSeats Recalled

On July 23, the Consumer Product Safety Commission (CPSC) announced the recall of about 79,000 UPPAbaby strollers in the U.S. and Canada because the foam covering of the bumper bar could pose a choking hazard. The recall includes the UPPAbaby … Continue reading

Posted in Defective Products, Product Recalls | Tagged , , , |

Children’s Breathing Difficulties Prompt Recall of Shiley Neonatal and Pediatric Tracheostomy Tubes

Children's Breathing Difficulties Prompt Recall

Infants and children switched from older to newer models of Medtronic Shiley Neonatal and Pediatric Tracheostomy tubes developed breathing difficulties and this prompted Medtronic Inc. to recall 8,192 of the tubes in May. In its recall announcement, the Food and … Continue reading

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

Berkeley’s Cell Phone Radiation Warning is First in US

Berkeley’s Cell Phone Radiation Warning is First in US

Berkeley’s cell phone ordinance, which requires retailers to warn consumers about the potential risk of radiation with cell phones, is the first measure of its kind to be passed. In May, the City Council unanimously passed the ordinance, titled Right … Continue reading

Posted in Cellular Phone, Legal News | Tagged , , , , |

Stronger Warning Label Placed on Non-Aspirin NSAIDs

Stronger Warning Label Placed on Non-Aspirin NSAIDs

The warning labels on non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) are being strengthened to reflect the the risk of heart attack and stroke, the U.S. Food and Drug Administration (FDA) announced. The agency already warned of this risk in 2005, but … Continue reading

Posted in Legal News | Tagged , , , , |

FDA Investigating Potential Health Risks of Brain Deposits of Gadolinium-Based MRI Contrast Agents

Health Risks of Brain Deposits of Gadolinium-Based MRI

Recent studies have shown that gadolinium-based contrast agents (GBCAs) used in magnetic resonance imaging (MRI) deposit in the brain of some patients who have repeated scans. The Food and Drug Administration (FDA) is investigating possible health risks of such deposits. … Continue reading

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

Study: Antibiotics Associated with Increased Risk of Juvenile Arthritis

Antibiotics Associated with Increased Risk of Juvenile Arthritis

The use of antibiotics was linked to an increased risk of cancer in a study conducted by researchers from Rutgers University, University of Pennsylvania and Nemours A.I. duPont Hospital for Children. Findings showed that children who were exposed to antibiotics … Continue reading

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

Class 2 Recall Issued for Nearly 2,000 Medtronic MiniMed Insulin Pumps

Class 2 Recall for 2,000 Medtronic MiniMed Insulin Pumps

Medtronic has recalled nearly 2,000 units of its MiniMed 640G insulin pumps, according to a notification posted on the U.S. Food and Drug Administration’s (FDA’s) website. The device was distributed in the following 10 European countries: Australia, Czech Republic, Denmark, … Continue reading

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

Chrysler Agrees to Record Fines and Penalties and Must Buy Back Defective Vehicles

Chrysler Agrees to Record Fines & Penalties

Fiat Chrysler Automobiles could pay up to $105 million in fines and penalties and must buy back defective vehicles in an agreement with the federal government that will also require an independent monitor to oversee future vehicle recalls. The automaker … Continue reading

Posted in Defective Products, Motor Vehicles | Tagged , , , , |

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