Tag Archives: Duodenoscope

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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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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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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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Conspiracy Claims in Talcum Powder Case Survive Motion to Dismiss

Conspiracy Claims in Talcum Powder Case Survive Motion to Dismiss

E. District of Missouri denied motion to dismiss conspiracy claims. Lawsuit alleges the defendants conspired to misrepresent true dangers with use of talcum powder.

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Metal-on-Metal Hip Implant Lawyer Takes Issue with Statements Made by DePuy Orthpaedics Official During FDA Meeting

An attorney with a national law firm that represents victims of alleged metal-on-metal hip implant injuries has expressed dismay at some statements made last week regarding the regulation of all-metal hip replacement devices by an official with DePuy Orthopaedics. According to Daniel Burke, Senior Litigation Counsel at Parker ...

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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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U.K. Regulators Issue Additional Guidance for Metal-on-Metal Hip Implant Recipients

Regulators in the U.K. are once again issuing advice to doctors and other healthcare professionals involved in the follow-up of patients with metal-on-metal hip replacement devices. In an alert issued by the Medicines and Healthcare products Regulatory Agency (MHRA), guidance is provided for four groups of metal-on-metal hip implant ...

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British Recall of Smith & Nephew Renasys Wound Care System

British Recall of Smith & Nephew Renasys Wound Care System for Infection Risk

The MHRA announced the recall of Smith & Nephew Renasys wound care devices - risk of maceration, infection, loss of negative pressure, or unrecognized bleeding in wounds.

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Do Vitamin Drinks Pose Health Risks?Do Vitamin Drinks Pose Health Risks?

Do Vitamin Drinks Pose Health Risks?

Scientists are concerned vitamin drinks are contributing to levels of vitamins and other nutrients that are not only unnecessary, but potentially harmful.

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West Virginia Man Claims Metal-on-Metal DePuy Pinnacle Hip Replacement Led to Pain, Elevated Cobalt Levels

A West Virginia man fitted with a metal-on-metal version of DePuy Orthopaedics’ Pinnacle Hip Implant System has filed suit against the company and its parent, Johnson & Johnson, alleging the device caused him to suffer pain and elevated cobalt levels. The Plaintiff is being represented by the national law ...

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Olympus Faces Wrongful Death Lawsuit over Contaminated Duodenoscope

Olympus Faces Wrongful Death Lawsuit over Duodenoscope

A wrongful death lawsuit against Olympus America, Olympus Medical Systems Corp. and Custom Ultrasonics has been filed over the use of an allegedly contaminated medical scope. The suit was filed on behalf of a woman whose husband died of an … Continue reading

Posted in Defective Medical Devices, Duodenoscope, Legal News | Tagged , , , , |

Following Superbug Outbreaks, FDA Mandates Safety Studies from Scope Manufacturers

FDA Mandates Safety Studies from Scope Manufacturers

The U.S. Food and Drug Administration (FDA) is ordering duodenoscope manufacturers to study how the devices are cleaned. The safety studies are prompted by a series of antibiotic-resistant bacterial infection outbreaks in the United States linked to contaminated scopes. The … Continue reading

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FDA Warns About Difficulty of Effectively Disinfecting Duodenoscopes

FDA Warns About Difficulty of Effectively Disinfecting Duodenoscopes

The Food and Drug Administration (FDA) has issued a safety communication to raise awareness that the design of ERCP endoscopes (also called duodenoscopes) may impede effective disinfection of the reusable devices. The FDA says recent reports associate multidrug-resistant bacterial infections … Continue reading

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FDA Never Approved Scopes Implicated in Superbug Outbreak

FDA Never Approved Scopes Implicated in Superbug Outbreak

The U.S. Food and Drug Administration (FDA) never approved the model of duodenoscope implicated in the recent superbug outbreak at Ronald Reagan UCLA Medical Center, CNN reports. Between October to January, the scopes spread the superbug carbapenem-resistant Enterobacteriaceae (CRE) to … Continue reading

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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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