Author Archives: Lillian Chiu

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Federal DePuy ASR Hip Implant Trials Likely to Start This Year

It looks as though the first trials in the DePuy ASR hip implant multidistrict litigation could begin sometime later this year. According to a report from Bloomberg News, during a status conference held yesterday in Florida, attorneys for both plaintiffs and the defense told U.S. District Judge David Katz that ...

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Toxic Nano-Particles from Failing Metal-on-Metal Hip Replacements May Pose Long-Term Health Risks

According to a new study, failing metal-on-metal hip implants generate toxic nano-particles that release Cobalt 2+ ions, which not only cause inflammation in surrounding tissue, but have the potential to cause long-term damage to the genetic material of cells. According to a report published by Medicalxpress.com, this “genotoxicity” could ...

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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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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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J.J. Fuds, Inc. Pet Food Recalled - Listeria Contamination

J.J. Fuds, Inc. Pet Food Recalled Over Potential Listeria Contamination

J.J. Fuds, has recalled a specific lot of its J.J. Fuds Chicken Tender Chunks Pet Food over potential contamination with the dangerous, Listeria monocytogenes pathogen.

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FDA Panel Takes up Metal-on-Metal Hip Implant Safety Today

The Food and Drug Administration (FDA) is convening a meeting starting today to help decide the future of metal-on-metal hip implants following high-profile recalls and mounting questions about their overall safety.

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Dozens Receive Nonsterile Simulated Saline Solution

Dozens-Receive-Nonsterile-Simulated-Saline-Solution

The FDA said last week that more than 40 patients had received intravenous simulated saline that was not sterile and was not intended for human use.

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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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Stryker Issues Voluntary Recall for Rejuvenate Modular and ABG II Hip Implant Components

Stryker Orthopedics is recalling two metal-on-metal hip implant components, its Rejuvenate Modular and ABG II modular-neck hip stems. According to a notice posted on Stryker’s website, risks associated with the Rejuvenate Modular and ABG II modular-neck hip stems include the potential for fretting and/or corrosion at or about ...

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Medtronic Plans Layoffs, as Infuse Bone Graft Controversy Continues to Weigh on Spinal Business

Medtronic’s spinal division continues to take a huge hit thanks to the controversy surrounding its Infuse Bone Graft product. According to a report from MassDevice.com, the company’s latest earnings report stated that the division saw Infuse sales decline 26% in the first quarter of 2012, and now Medtronic is talking ...

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Congresswoman Calls for FDA Regulation after Veteran is Injured by Exploding E-Cigarette

Congresswoman Calls for E-Cigarette FDA Regulation

The use of electronic cigarettes has been on the rise in their short time on the market. While they are touted as being a safer alernative to traditional cigarettes and as a cessation tool, there are still public health and … Continue reading

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FDA Drug Approvals on the Rise

FDA Drug Approvals on the Rise

Data shows that the U.S. Food and Drug Administration (FDA) is approving most drugs that come their way. BioMedTracker, a division of publishing giant Informa that helps investors track events in the pharmaceutical industry, was commissioned by Forbes to conduct … Continue reading

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Some Drug Testing May be Unreliable, Investigation Suggests

Some Drug Testing May be Unreliable

Certain drug testing protocols may be changing soon in Tampa. FOX 13 reports that Hillborough Circuit Judge Gregory Holder and his fellow judges want the FDLE to test suspected drugs immediately in felony cases. The change would mean that they … Continue reading

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Study Suggests Teens are More Likely to Try Smoking if they Try E-Cigarettes

Teens are Likely to Try Smoking if they Try E-Cigarettes

A new study led by researchers from the University of Southern California found that teenagers who try e-cigarettes are more likely to try traditional cigarettes and other tobacco products. The authors say that the findings support the need to regulate … Continue reading

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APA Calls for Greater Parental Controls in Violent Video Games

APA Calls for Greater Parental Controls in Violent Games

A review conducted by the American Psychological Association (APA) task force on violent media indicates that violent video games are linked to increased aggressive behavior. Based on these findings, the APA is calling for more parental controls over violent content … Continue reading

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Residents in Care Homes have Greater Risk of Dehydration, Study Finds

Residents in Care Homes have Greater Risk of Dehydration

A recent study found that individuals from care home were more likely to suffer from dehydration compared to those living in their own homes. The study, conducted by Wolff et al (2015), looked at first admission of patients 65 years … Continue reading

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Additional Monitoring Needed for Medical Devices

Additional Monitoring Needed for Medical Devices

In an article published by the Lexington Herald-Leader, a Kentucky physician calls for greater regulation of medical devices. Dr. Kevin Kavanagh of Somerset, Kentucky, who is also board chairman of Health Watch USA, writes that patients will continue to be … Continue reading

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After Learning that Essure Meeting Coincides with Papal Visit, Essure Advocates Criticize FDA

Essure Advocates Criticize FDA

Advocates for women who say they suffered injuries related to the permanent birth control device Essure say that the U.S. Food and Drug Administration (FDA) intentionally scheduled a panel meeting the same day as Pope Francis’ first-ever papal address. The … Continue reading

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FDA Updates Gilenya Label to Include Cases of Rare Brain Infection

FDA Updates Gilenya Label to Include Cases of Brain Infection

In a Drug Safety Communication issued Tuesday, the U.S. Food and Drug Administration warned that the multiple sclerosis drug Gilenya was linked to two cases of rare brain infection. One definite case of progressive multifocal leukoencephalopathy (PML) and one probable … Continue reading

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FDA Reports of Bleeding Complications, Other Adverse Events with LVADs

FDA Reports of Bleeding Complications with LVADs

Left ventricular assist devices (LVADs) help the heart pump blood to the rest of the body in patients who have advanced heart failure. There are currently two LVADs approved by the U.S. Food and Drug Administration (FDA): the HeartMate II … Continue reading

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