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Medical Device Recall Decisions

The decision to recall a product has profound effects on a company’s image and its bottom line. Medical device companies regularly monitor product performance such as failure rates, time on the market, and safety and health impact to the patient. When complaints from physicians and/or patients about a medical device are received, they alert the » Read More

Device Packaging Issues

When it comes to medical devices, packaging is second only to the product’s design. Poor packaging, which may impact a device’s sterility and safety, can cause harm and even death to a patient. Medical device packaging issues triggered the highest number of FDA recalls in the decade between 2007 and 2017, with the exception of » Read More

Johnson & Johnson Recalls/Lawsuits

Consumers who are unaware of major health-related product recalls may experience serious complications from using them. There have been claims that they may cause cancer, severe allergic reactions, metal poisoning, and other serious health problems. One company that has been involved in countless recalls and lawsuits is Johnson & Johnson. Johnson & Johnson and its » Read More

Essure Birth Control Sales End

The controversial Essure birth control device will no longer be marketed in the United States. Pharmaceutical giant Bayer recently announced it will no longer sell the device, as of December 31, 2018. This effectively ends all sales, since Essure is no longer available in other countries. The device, made from flexible coils, is designed to » Read More

Medical Device Lawsuits

Defective medical products can cost their manufacturers a lot of money. Recently, a Philadelphia jury awarded $2.5 million in damages related to use of Gynecare TVT-Secur mesh for treating incontinence. The patient experienced severe pain and had to undergo multiple surgeries to remove the device. Ethicon, the manufacturer, was fined $17.5 million in punitive damages. » Read More

Medical Device Recalls Increase in 2018

Knowing a company’s track record on medical device recalls could prove to be important when determining whether to utilize a specific medical device. Recalls of medical devices are on the rise. In the first quarter of 2018, there were more recalls than during that same time frame in 2017. The first quarter of 2018 had » Read More

Can Hip Replacements Do More Harm than Good?

A bad hip can lead a person to consider the possibility of obtaining a hip replacement.  Yet before deciding on the type of hip replacement, be aware of pending lawsuits against the manufacturer. One company, Smith and Nephew, has had many lawsuits associated with its R3 Acetabular Hip Replacement. The History of the Smith and » Read More

FDA Recalls HeartMate 3 LV Assist Device

In May 2018, less than a year after approval, the Federal Food and Drug Administration (FDA) issued a Class I recall on HeartMate 3, a medical device which is inserted into patients to treat heart failure. The device assists in pumping blood in the left ventricle of the heart of patents who are at risk » Read More

Essure Complications and Medical Device Lawsuits

In 2002, the Federal Food and Drug Administration (FDA) approved Essure. Essure was designed as a medical device to prevent pregnancies in women. Women are inserted with two of the devices, which resemble a coil, one in each fallopian tube, to assist the body in creating a natural blockage in the tubes in order to » Read More

Unsecured Medical Devices and Hospital Computer Security Risks

Clinicians are able to deliver more efficient patient care with connected devices and remote monitoring. Constant monitoring and telemedicine have been proven beneficial in determining causes of illnesses for patients. However, when devices, medical or non-medical, are equipped with connectivity and sensors, security risks and vulnerabilities are typically identified and uncovered. Medtronic, Boston Scientific, and » Read More

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