Monthly Archives: February 2015

Featured Stories

Pradaxa Named in Most FDA Adverse Event Reports for Deaths, Hemorrhage, Kidney Failure and Stroke

The controversial blood thinner, Pradaxa, surpassed all other drugs monitored by the U.S. Food & Drug Administration (FDA) in adverse event reports made to the agency last year. According to the Institute for Safe Medicine Practices’ (ISMP) latest QuarterWatch report, Pradaxa also topped the list for reports of deaths, ...

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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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Another Metal-on-Metal Hip Replacement Lawsuit Filed in DePuy ASR Hip Implant Litigation

A vital food safety program was saved from budget cuts this week, enabling the country’s largest—although considered by experts to be far too small—produce-safety testing program to continue.

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Transvaginal Mesh a Nightmare for Thousands of Women

Thousands of women who have received transvaginal mesh surgical implants to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are now living a nightmare, thanks to debilitating pain, bleeding, infection and other serious complications. According to the Sun-Sentinel, many of the women injured by transvaginal mesh claim ...

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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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Metal-on-Metal Hip Replacement Concerns Grow in Canada

Canadian patients and doctors are voicing more concerns about metal-on-metal hip replacements, as health regulators around the world continue to investigate the safety of the devices. According to a report from the CBC, four companies have recently either recalled or suspended sales of metal-on-metal hip replacement devices, while a number ...

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Canadian Warning Issued for Actos Bladder Cancer Side Effect Risk

Health Canada has become the most recent national drug regulator to issue a warning about Actos and bladder cancer. Last month, the agency warned that interim results from a 10-year-study indicated that patients taking Actos for more than a year faced an increased risk of bladder cancer. Health Canada also ...

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Geodon the antipsychotic drug can Cause Deadly Skin Reaction

Geodon can Cause Deadly Skin Reaction, FDA Warns

The FDA has required a new warning label for the antipsychotic drug Geodon (ziprasidone) to include the risk of a potentially fatal skin reaction.

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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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FDA Advisors Set to Examine Metal-on-Metal Hip Implant Safety Concerns

Thousands of people with metal-on-metal hip implant devices could soon get some answers from the U.S. Food & Drug Administration (FDA) about the dangers they face. Tomorrow, the agency will convene a panel of outside medical experts to examine the safety record of metal-on-metal hip replacements, and recommend the ...

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Following Deadly Outbreaks, FDA Questions Device Makers about Duodenoscope Cleaning Procedures

FDA Questions Device Makers about Duodenoscope Cleaning Procedures

In light of a recent outbreak linked to contaminated duodenoscopes, the U.S. Food and Drug Administration (FDA) is questioning manufacturers about their methods for cleaning the devices, the New York Times reports. The specialized scopes, which have been linked to … Continue reading

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HeartWare Recalls Older Ventricular Assist System Controllers

HeartWare Recalls Ventricular Assist System Controllers

HeartWare International is issuing a voluntary Urgent Medical Device Recall in the United States related to older HeartWare Ventricular Assist System controllers distributed in the U.S. during the clinical trial period prior to Food and Drug Administration (FDA) approval in … Continue reading

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

AliveCor Recalls Heart Monitor App Because of Crashes

AliveCor Recalls Heart Monitor App Because of Crashes

AliveCor has recalled its AliveECG app version 2.1.2 for the Apple iOs operating system because the app crashes on use. The recall affects 5,600 active users on Apple’s iOS operating system, according to the Food and Drug Administration (FDA) recall notice. … Continue reading

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Malware Comes Preinstalled with Some Lenovo Laptops

Malware Comes Preinstalled with Some Lenovo Laptops

Lenovo users may be getting more than they bargained for with their new laptops. Mashable reports that some Lenovo products come preinstalled with adware called Superfish, which breaks secure website connections and makes sensitive user information vulnerable to security threats. … Continue reading

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Johnson & Johnson Hit with $2.5 Million Verdict in Risperdal Case

Johnson & Johnson Hit with $2.5 Million Verdict in Risperdal Case

A Philadelphia jury hit a Johnson & Johnson unit with $2.5 million in damages in a case accusing the drug maker of failing the parents and doctors of an autistic boy about risks associated with the antipsychotic drug Risperdal. During … Continue reading

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GE MRI Systems Recalled Due to Disabled Magnet Rundown Units

GE MRI System Recalled Due to Disabled Magnet Rundown Units

Earlier this month, GE Healthcare recalled 12,968 MRI systems due to a disabled Magnet Rundown Unit (MRU) in India. When this unit is disabled, it can slow the removal of a magnetic object from the scanner. This can lead to … Continue reading

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FDA Knew Medical Devices Can Transmit Superbugs but Did Not Act

FDA Knew Medical Devices Transmit Superbugs but Did Not Act

Experts in hospital-acquired infections say that health regulators have known since at least 2009 that certain reusable medical devices can transmit lethal infections but have not recommended any new safety requirements. The latest outbreak involving duodenoscopes may have exposed 179 … Continue reading

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More than 12,000 GE MRI Systems Recalled Due to Potentially Life-Threatening Issue

More than 12,000 GE MRI Systems Recalled

A Class I recall has been issued for more than 12,000 MRI systems manufactured by General Electric, Modern Healthcare reports. The recall was issued because of a potentially life-threatening problem that can occur when parts are not connected properly. Many … Continue reading

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Warning to UCLA Hospital Patients Exposed to Drug-Resistant Superbug

Warning to UCLA Hospital Patients Exposed to Superbug

One hundred seventy-nine patients at UCLA Ronald Reagan Medical Center have been told they may have been exposed to a drug-resistant “superbug” during endoscopy procedures that infected seven patients and may have contributed to two deaths. Patients who may have … Continue reading

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Artificial Coloring in Soda Increases Cancer Risk, Study Finds

Artificial Coloring in Soda Increases Cancer Risk

A new study has found that drinking at least one can of soda per day may significantly increase the risk of cancer. Research conducted by the Johns Hopkins Bloomberg School of Public Health found that some caramel colorings in soda … Continue reading

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