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First DePuy ASR Hip Implant Lawsuits Head to Trial in December, January

First DePuy ASR Hip Implant Lawsuits Head to Trial in December, January

The first trials involving lawsuits filed against DePuy Orthopaedics by recipients of its recalled ASR Hip Implants will begin later this year, and early next year. The first is slated to start on December 3, 2012 in state court in Las Vegas, Nevada. A second DePuy ASR hip implant lawsuit ...

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Fracking Boom Changing Way of Life in Pennsylvania’s Northern Tier

Fracking Boom Changing Way of Life in Pennsylvania's Northern Tier

In just a few years, the impact of hydraulic fracturing (fracking) drilling on northeastern Pennsylvania is hard to miss. Thousands of natural gas wells have been opened in that area specifically in the last five years as companies look to exploit the vast Marcellus shale formation about two miles below the ...

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Medtronic Infuse Lawsuit Alleges Off-Label Use Cause Painful Complications

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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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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Smith & Nephew Recalls Metal-on-Metal Hip Implant Component

Smith & Nephew Recalls Metal-on-Metal Hip Implant Component

Medical device maker, Smith & Nephew, just issued a recall for a metal-on-metal hip implant component, a part of one of its all-metal hip replacement systems.

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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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Johnson & Johnson Facing More Metal-on-Metal Hip Implant Woes, as DePuy Pinnacle Complaints Rise

Johnson & Johnson Facing More Metal-on-Metal Hip Implant Woes, as DePuy Pinnacle Complaints Rise

Having already spent around $3 billion on its DePuy Orthopaedics ASR hip implant recall, Johnson & Johnson is facing another potential debacle involving a metal-on-metal version of its Pinnacle Hip Replacement System. According to a report from Reuters, Johnson & Johnson and its DePuy unit already face some 1,600 metal-on-metal ...
Canadian Study Confirms Actos Bladder Cancer Risk

Canadian Study Confirms Actos Bladder Cancer Risk

A new study conducted by Canadian researchers has found that users of the type 2 diabetes drug, Actos (pioglitazone), may face a higher risk of developing bladder cancer than first thought. The study, published in the British Medical Journal, found that taking Actos for two years doubles the likelihood ...

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

Teva 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

Researchers 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

A 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

For 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

The 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 |

Cymbalta Plaintiffs Seek to Have 28 Suits Centralized in a Multidistrict Litigation

Cymbalta-Class-Action-LawsuitThe plaintiffs in 28 lawsuits over the antidepressant drug Cymbalta have asked the U.S. Judicial Panel on Multidistrict Litigation (JPML) to centralize the actions in California (In Re: Cymbalta Products Liability Litigation).

The plaintiffs allege that drug maker Eli Lilly & Co. deceived patients about the negative withdrawal reactions they would experience when they ended treatment with Cymbalta (duloxetine).  The reactions include “brain zaps” – electric shock sensations – and other adverse health reactions. On August 15, 2014, the plaintiffs asked the U.S. Judicial Panel on Multidistrict Litigation (JPML) to centralize their lawsuits in a multidistrict litigation in California. “Coordination of these lawsuits will ensure that redundancies and discovery efforts are not duplicated,” said Gary Falkowitz, managing attorney at Parker Waichman LLP. Continue reading

Posted in Clear Care Contact Lens Cleaning Solution, Health Concerns, Legal News, Pharmaceuticals |

Antibiotic May Raise Heart Risks for Some Patients

Antibiotic-Raise-Heart-RisksA new study in the BMJ suggests that the antibiotic clarithromycin may increase some patients’ risk of dying from heart-related causes.

Clarithromycin is prescribed for millions of people each year, HealthDay reports. The Danish research group that conducted the study said their findings require confirmation. Clarithromycin and the antibiotic roxithromycin are drugs in the group of antibiotics called macrolides. The researchers believe that macrolides increase the risk of potentially deadly heart rhythm problems in some patients. The study was published online in the BMJ on August 19. Continue reading

Posted in Health Concerns, Pharmaceuticals |

Class I Recall: Diamondback 360 Peripheral Orbital Atherectomy System

Recall_Peripheral_Orbital_Atherectomy_SystemThe U.S. Food and Drug Administration (FDA) just announced that Cardiovascular Systems is recalling some lots of its Diamondback 360 Peripheral Orbital Atherectomy Systems.

The agency has deemed this recall a Class I, its most serious type of recall designation and one that involves situations in which a reasonable probability that use of the recalled product may cause serious adverse health consequences, or death. Continue reading

Posted in Defective Medical Devices, Product Recalls, Recalled Medical Devices |

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