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FDA Advisory Panel Wrestling with Metal-on-Metal Hip Replacement Safety

FDA Advisory Panel Wrestling with Metal-on-Metal Hip Replacement Safety

An advisory panel for the U.S. Food & Drug Administration (FDA) began a highly-anticipated meeting yesterday to discuss the safety of metal-on-metal hip implants. Among other things, the panel of outside experts is being asked to make recommendations regarding the best practices for monitoring patients with metal-on-metal hip replacements. ...

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Transvaginal Mesh Lawsuit Trial

$5.5 Million Awarded to Plaintiffs in First Transvaginal Mesh Lawsuit Trial

An award of $5.5 million has been made in the first trial over a transvaginal mesh lawsuit. The jury found against medical device maker, C.R. Bard, and its Avaulta Plus transvaginal mesh. The jury agreed that Bard’s Avaulta Plus transvaginal mesh caused numerous and painful injuries in a California woman. ...

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New York Property Owners Challenge Binghamton Fracking Ban

New York Property Owners Challenge Binghamton Fracking Ban

According to a Reuters report, the landowners believe the Binghamton, N.Y., city council and Mayor acted against proper protocol when voting to ban fracking drilling the the city. Instead, they feel the city should have consulted with the Broome County Planning Commission before approving the ban.

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Tennessee Resident Files Pradaxa Bleeding Lawsuit Following Cerebral Hemorrhage

Tennessee Resident Files Pradaxa Bleeding Lawsuit Following Cerebral Hemorrhage

A man from Tennessee has filed a lawsuit against the maker of Pradaxa, claiming that the blood thinner caused him to suffer a cerebral hemorrhage. The complaint alleges Boehringer Ingelheim Pharmaceuticals, Inc. concealed knowledge that Pradaxa can cause Serious, life-threatening bleeds, and did not warn that Pradaxa bleeding side effects ...

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Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit

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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Majority of Metal-on-Metal Hip Implant Failures Occur within Two Years, Study Finds

Majority of Metal-on-Metal Hip Implant Failures Occur within Two Years, Study Finds

A newly published metal-on-metal hip replacement study is reporting that the majority of failures occur early, within two years of surgery. The study, published in the journal Orthopedics, is just the latest to indicate that close follow-up of metal-on-metal hip implant patients is warranted.

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Boston Scientific Transvaginal Mesh

Tennessee Woman Alleges Boston Scientific Transvaginal Mesh Product Caused Painful Injuries

More reports of painful injuries are being linked to transvaginal mesh. This time, a Tennessee woman has filed a lawsuit against Boston Scientific over its Advantage Transvaginal Mid-Urethral Sling System.

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Western Pennsylvania Familes File Suit Over Alleged Fracking Pollution

Western Pennsylvania Familes File Suit Over Alleged Fracking Pollution

Three families in western Pennsylvania believe a leading hydraulic fracturing (fracking) company and two water testing labs are conspiring to produce false results that show natural gas drilling is not contaminating their private water wells.

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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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$18 Million Settlement Finalized over Flushmate Exploding Toilets

flushmate_explosionAn $18 million settlement is being finalized over Flushmate exploding toilets, manufactured by Sloan Valve Company. The initial lawsuit, originally filed in 2012, alleged that the Series 503 Flushmate III Pressure-Assist Flushing System manufactured by Sloan can unexpectedly explode, causing injury and property damage. Continue reading

Posted in Legal News |

Putting Cell Phone in Your Bra could Lead to Breast Cancer, Dr. Oz Warns

Cell-Phone-in-Your-BraDr. Mehmet Oz is warning against placing your cell phone in your bra, a habit that many women do out of convenience. “When it comes to cell phones, the bra has become the new purse,” Dr. Oz said on an episode of the Dr. Oz show that aired Aug. 26th. Continue reading

Posted in Legal News |

Supreme Court Rejection of Pfizer RICO Case Appeal Could Unleash Cases

PfizerThe US Supreme Court’s rejection of  an appeal from drug maker Pfizer, letting stand a First Circuit ruling that the drug company improperly marketed the epilepsy drug Neurontin to Kaiser Foundation Health Plan, could unleash a flood of cases

Pfizer must pay Kaiser $142 million in damages for violating the Racketeer Influenced and Corrupt Organizations (RICO) Act and an additional $65.4 million for violating the California Unfair Competition Law (UCL). Continue reading

Posted in Health Concerns, Pharmaceuticals |

Drug Maker, Teva, Recalls Parkinson’s Disease Medication as it may be “Super Potent”

tevaTeva Pharmaceutical Industries just issued a recall of one lot of its generic Parkinson’s disease combination medication, carbidopa/levodopa, over it potentially containing too much of an active pharmaceutical ingredient.

Teva Pharmaceutical Industries indicated that the recall, which has been deemed a Class II, involved 3,881 bottles of carbidopa/levodopa 25 mg/100 mg, according to FiercePharmaManufacturing. Teva also indicated that stability testing revealed that the recalled carbidopa/levodopa may be what the drug maker described as “super potent.” The voluntary recall is for the entire United States. Continue reading

Posted in Pharmaceuticals, Product Recalls |

Researchers Study Whether Chemicals in the Environment Increase the Risk of Diabetes

Diabetes ConceptResearchers at the University of Buffalo will be studying how chemicals in the environment affect the risk of diabetes and metabolic conditions.  According to an article posted on the university’s website, the National Institute of Environmental Health Sciences has awarded a two-year $436,751 grant to Margarita L. Dubocovich, PhD and Rajendram V. Rajnarayanan, PhD to study this issue.   Continue reading

Posted in Legal News |

FDA Issues Injunction Against BioAnue Laboratories

FDA-Issues-Injunction-Against-BioAnue-LaboratoriesA federal court order demands that BioAnue Laboratories of Rochelle, Georgia stops illegally marketing its products as treatments for disease, the U.S. Food and Drug Administration (FDA) announced on its website. The court order, which was signed on July 23, 2014 in the United States District Court for the Middle District of Georgia, says that BioAnue’s products were sold as supplements but were illegally marketed as treatments for conditions such as cancer, HIV/AIDS, heart disease, chronic obstructive pulmonary disease and diabetes. The FDA did not approve these products for those uses.

In February 2012, the FDA issued a warning lette Continue reading

Posted in Legal News |

Government Will Withhold Up to One Third of Payment Records in Launch of Physician Payment Database

Launch-of-Physician-Payment-DatabaseFor next month’s launch of the Open Payment database showing payments to physicians from pharmaceutical companies and medical device makers, about one-third of the records will be withheld because of data inconsistencies.

The release of payment information – intended to promote greater transparency about possible conflicts of interest in medicine – is mandated under the Physician Payment Sunshine Act, a provision of the 2010 Affordable Care Act, according to the non-profit investigative journalism group ProPublica. Continue reading

Posted in Legal News |

Court’s Discovery Order in C.R. Bard Litigation Expected to Streamline Litigation Process

Court’s-Discovery-Order-in-C-R-Bard-LitigationThe court overseeing the C.R. Bard transvaginal mesh litigation has put new discovery rules in place that are expected to streamline the discovery process in this litigation. The discovery procedures will specifically impact Collection and Preservation of Evidence in a multidistrict litigation (MDL) that was organized over C.R. Bard’s transvaginal mesh devices in the United States District Court, Southern District of West Virginia.

According to the Court, the new rules will provide that “discovery in this proceeding may involve the collection, division, storage, preservation, and production of biomaterials evidence for which special handling, division, storage, and preservation would be warranted.” The Order followed a stipulation requested by the parties involved in the MDL and involved a petition to the Court to enter an “evidence preservation protocol order,” that would be applicable for existing and future actions in the litigation. Continue reading

Posted in Defective Medical Devices, Transvaginal mesh |

DEA Announces Stricter Classification for Hydrocodone Combination Painkillers

DEA-Announces-Stricter-ClassificationThe Drug Enforcement Administration (DEA) has announced the reclassification of hydrocodone combination products from Schedule III to Schedule II under federal law. Schedule II drugs are substances known to be dangerous, prone to abuse, or could lead to severe psychological or physical dependence.

Combination hydrocodone painkiller products were previously regulated as Schedule III products under the law. Schedule III is the DEA category for substances that have accepted medical use, moderate potential for abuse, and the potential for dependency, according to the DEA definition. As a Schedule II substance, hydrocodone combination products will be subject to more stringent prescribing controls, such as bans on refills, Regulatory Affairs Professionals Society (RAPS) reports. Continue reading

Posted in Defective Products, Health Concerns, Pharmaceuticals |

CDC Whistleblower Exposes Data Manipulation in Vaccine and Autism Study

Data-Manipulation-in-Vaccine-and-Autism-StudyAccording to a study by Focus Autism Foundation, a whistleblower revealed the manipulation of scientific data in a 2004 study on autism and age of vaccination with  the measles, mumps, and rubella (MMR) vaccine.

A research scientist working for the Centers for Disease Control and Prevention (CDC) helped Dr. Brian Hooker of the Focus Autism Foundation uncover data manipulation by the CDC that obscured a higher incidence of autism in African-American boys who received the MMR vaccine earlier than 36 months of age.   Continue reading

Posted in Health Concerns |

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