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Tentative Ohio Fracking Regulations Criticized as too Lax

Tentative Ohio Fracking Regulations Criticized as too Lax

Lawmakers in Ohio have tentatively passed new regulations governing hydraulic fracturing (fracking) drilling but they’ve immediately been criticized for being too favorable to the natural gas and oil industries.

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Johnson & Johnson’s Ethicon Division to End Sales of Gynecare Prolift, Three Other Transvaginal Mesh Devices

Johnson & Johnson’s Ethicon Division to End Sales of Gynecare Prolift, Three Other Transvaginal Mesh Devices

Johnson & Johnson’s Ethicon Inc. division revealed yesterday that it will end sales of its Gynecare Prolift device and three other transvaginal mesh products. The plan to stop selling the four products was set forth in a letter filed by the company in the Ethicon transvaginal mesh multidistrict litigation ...

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Actos Whistleblower Lawsuit Questions Avandia Researcher’s Financial Ties to Takeda

Actos Whistleblower Lawsuit Questions Avandia Researcher's Financial Ties to Takeda

A prominent researcher has been implicated in an alleged cover-up of Actos side effects, according to a report from TheHeart.org. An Actos whistleblower lawsuit unsealed earlier this year has alleged financial connections between the Cleveland Clinic’s Dr Steven Nissen and the maker of Actos “should be considered when analyzing Actos’s ...

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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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Decision on Pradaxa Bleeding Lawsuit Multidistrict Litigation Expected Soon

Decision on Pradaxa Bleeding Lawsuit Multidistrict Litigation Expected Soon

Victims of alleged Pradaxa injuries are awaiting word on whether their lawsuits will be consolidated in a multidistrict litigation. According to a report from The Madison Record, so far just over two dozen Pradaxa bleeding lawsuits have been filed in federal courts throughout the U.S.

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FDA Metal-On-Metal Hip Replacement Investigation Is Flawed, Researchers Say

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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Metal-on-Metal Hip Replacement Device

Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device

Wright Medical Inc. took steps in to 2006 to convince the U.S. Food & Drug Administration (FDA) to reject pre-market approval of rival Smith & Nephew’s Birmingham metal-on-metal hip implant. Wright Medical, which makes two metal-on-metal hip replacement devices, the Conserve and the Lieneage device, filed a citizen petition ...

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Study Linking Z-Pak to Increased Death Risk Being Reviewed by FDA

Study Linking Z-Pak to Increased Death Risk Being Reviewed by FDA

The U.S. Food & Drug Administration (FDA) is reviewing a new study that reported an increased risk of sudden, heart-related deaths among people using the antibiotic Zithromax (azithromycin), known popularly as Z-Pak. In a statement issued late yesterday, the FDA said patients being treated with Zithromax should not stop taking ...

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Actos Side Effects Lawyers Says Whistleblower Revelations Could Boost Bladder Cancer, Heart Failure Lawsuits

Actos Side Effects Lawyers Says Whistleblower Revelations Could Boost Bladder Cancer, Heart Failure Lawsuits

An attorney with a prominent personal injury law firm says an Actos whistleblower lawsuit filed earlier this year could strengthen legal claims alleging the type 2 diabetes medication caused some users to develop bladder cancer and heart failure.

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EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects

EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects

Regulators in Europe have again asked Boehringer Ingelheim, the manufacturer of the blood thinner Pradaxa, to update the drug’s label with additional information regarding Pradaxa bleeding side effects. According to the European Medicines Agency (EMA), the new guidance should include more specific information on when Pradaxa must not be used, ...

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Medtronic Makes Final Payment to Settle Kickbacks Lawsuit over CRM products

Medtronic has made the final payment in an $11.1 million settlement over allegations that it used kickbacks to promote the use of its cardiac rhythm products. According to a press release issued by the office of Eric Schneiderman, the U.S. Attorney General for New York, the company’s final payment of $362,362 will be split among the Medicaid programs in 46 states and the District of Columbia. Continue reading

Posted in Legal News |

Bipartisan Congressional Group Seeks Reauthorization of Zadroga 9/11 Act

A bipartisan group of U.S. senators and representatives has introduced legislation to reauthorize the James Zadroga 9/11 Health and Compensation Act, to continue programs providing medical treatment and compensation to 9/11 responders for another 25 years.

Senators Kirsten Gillibrand and Chuck Schumer and seven other senators introduced the legislation in the Senate. The House bill was introduced by Representatives Carolyn Maloney, Jerrold Nadler, Peter King, and 37 others. New York City’s mayor, Bill de Blasio, along with 9/11 first responders, community survivors, and union leaders joined the effort to reauthorize the programs, 9/11 Health Watch reports. Continue reading

Posted in Health Concerns, Toxic Substances, Zadroga Act Claims |

Study: Artificial Sweeteners May Raise Blood Sugar, Promote Obesity

Artificial-Sweeteners-May-Raise-Your-Blood-SugarA new study involving artificial sweeteners has found that the additives may be making Americans fatter.

The study revealed that artificial sweeteners may trigger “dramatic” blood sugar disturbances in people and mice. This appears to happen because of the way in which the sweetening additives alter the gut’s bacterial populations, or microbiota, according to the National Post. The microbiota are an intricate ecosystem of bacteria and microorganisms that live in the gut.

The study, conducted by scientists in Israel, was released Wednesday by the journal, Nature. The research calls for a reassessment of the use of artificial sweeteners, which are one of the most widely used food additives globally, wrote the National Post. Continue reading

Posted in Defective Products, Food Products |

Study Finds No Evidence of Effectiveness and Safety of Newer Joint Replacement Devices

Joint-Replacement-DevicesIn light of the failure of articular surface replacement and large head size metal-on-metal joint replacement devices, scientists, doctors, and health policy professionals have highlighted the need for a more thorough and evidence-based introduction of joint replacement devices and for the development of an infrastructure for timely evaluation of these devices.

In a recently published study in the BMJ, a group of researchers, led by Dr. Marc J. Nieuwenhuijse, systematically evaluated the evidence concerning the introduction of five innovative, relatively recent, and already widely implemented devices used in total joint replacement. The research team evaluated comparative data from clinical trials, observational studies, and large national arthroplasty registries to study effectiveness and safety of the new devices versus existing, well proven, comparable devices. The five technologies reviewed are ceramic-on-ceramic bearings, modular femoral necks, and uncemented monoblock (not metal-on-metal) acetabular cups in total hip replacement, and high flexion implants and gender-specific implants in total knee replacement. Continue reading

Posted in Defective Medical Devices, Metal Hip Implants |

Expert Witness in Chantix Case Seeks Pfizer Documents

Chantix-CaseAn expert witness in the multidistrict litigation over Chantix (varenicline), a smoking cessation drug, has moved to unseal court records in advance of a Food and Drug Administration (FDA) meeting to consider whether the drug should carry a warning about suicide risk.

Dr. Joseph Glenmullen, an expert causation witness for the plaintiffs, and Thomas Moore, a drug-safety researcher, called for the unsealing of thousands of Pfizer Inc. internal documents, National Law Journal reports. Both wrote about how smoking cessation treatments like Chantix are associated with a higher incidence of depression, suicide and violence toward other people. The two experts “want to ensure the public debate about the psychiatric side effects of Chantix includes a balanced scientific record, which was examined in depth in the Chantix litigation,” according to court documents.  The FDA meeting is scheduled for Oct. 16. Continue reading

Posted in Chantix, Pharmaceuticals |

Exxon’s Attempt to De-Certify Class Action Lawsuit is Countered

Exxons-Attempt-to-De-Certify-Class-Action-LawsuitExxon Mobil’s attempt to de-certify the class action status of a couple’s lawsuit should be denied, the couple’s attorney argued. According to Arkansas Democrat Gazette, a federal judge granted class action status to the lawsuit, which was filed over an oil spill in Mayflower. Exxon Mobil has petitioned to appeal this decision. Continue reading

Posted in Legal News |

FDA Continues to Express Concern Regarding e-Cigarettes

electronic-cigaretteThe U.S. Food and Drug Administration (FDA) has stated that the exact health effects of e-cigarettes remain unknown. E-cigarettes provide a different nicotine delivery system that, instead of providing smoke, provides vapor.

Not unexpectedly, the makers of e-cigarettes argue that their products are safer than traditional cigarettes; however, the FDA has questions concerning the fairly new nicotine products, according to Daily News Journal. “While e-cigarette aerosol may contain fewer toxicants than cigarette smoke, studies evaluating whether e-cigarettes are less harmful than cigarettes are inconclusive,” the FDA indicated in a recent report. The agency also questioned claims that e-cigarettes may be of help in smoking cessation, indicating in the report that, “No e-cigarette has been approved by FDA as a cessation aid.” Continue reading

Posted in Defective Products, Health Concerns |

Portico TAVR Heart Device Implants Halted Over Safety Concerns

Portico-TAVR-Heart-Device-Implants-HaltedDevice maker St. Jude Medical has halted implantation of the Portico transcatheter aortic valve replacement (TAVR) over safety concerns that surfaced in U.S. clinical trials.

The Portico TAVR device is intended for patients with severe aortic stenosis (narrowing) who are at high risk for open-heart valve replacement surgery or who cannot have surgery. In an email to Medscape, the company confirmed that it had halted implantation worldwide while evaluating “recent cases of reduced valve leaflet mobility that were reported from a small number of CT scans performed approximately 30 days after implant in the U.S. IDE [investigational device exemption] study.” Continue reading

Posted in Defective Medical Devices |

DePuy Executive Questioned about Pinnacle Hip Implant Safety Studies in Bellwether Trial

Pinnacle-Hip-Implant-Safety-StudiesOn Monday, a DePuy executive was questioned about whether or not the company properly analyzed the dangers of the metal-on-metal Pinnacle hip implant. According to Reuters, Depuy worldwide vice president of clinical research Pamela Plouhar took the stand in the bellwether trial.

There are over 6,000 Pinnacle lawsuits consolidated in Dallas federal court. The first to go to trial was filed on behalf of a 58-year old Montana woman who received two metal-on-metal versions of the Pinnacle hip implant in 2009. Her lawsuit, filed in 2012, alleges that the defective devices released cobalt into her bloodstream and caused it to jump up to 85 times the normal level. Continue reading

Posted in Legal News |

Newer Joint Replacement Systems May Offer No Benefit

Newer-Joint-Replacement-SystemsAccording to a systematic review published online September 9th in the BMJ, there is no evidence to support the use of 5 newer joint replacement devices compared to analogous products that have been on the market longer. In fact, the risk of undergoing revision surgery is higher with some of the newer systems.

The study was led by Marc J. Nieuwenhuijse, MD, PhD from the Patient Centered Comparative Effectiveness Program and US Food and Drug Administration Medical Device Epidemiology Science and Infrastructure Center, Department of Public Health, Weill Cornell Medical College, New York, City; the Department of Orthopaedics, Leiden University Medical Center, the Netherlands; and the Office of Surveillance and Biometrics, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD. He and his colleagues wrote that “[N]ew technologies are being introduced to the commercial market without sufficient high quality evidence for improved benefit over existing, well proven, and safe alternative implant solutions…[T]he status quo regarding the introduction of new device technologies is not acceptable.” Continue reading

Posted in Legal News |

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