product liability

March 19, 2018

Appeals Court Weighs in on Hybrid Medical Device Lawsuit

When it comes to medical device litigation, such as those involving defective hip replacement or knee replacement hardware, many of these devices are subject to the Medical Device Amendments of 1976. New medical devices are given a class designation – Class I, II or III – to indicate degree of risk, with Class III medical devices posing the greatest risk. A device that is designated as a Class III under the MDA is given express preemption from state requirements (which can be different or more stringent than federal rules), as noted in the 2008 U.S. Supreme Court case of Riegel v. Medtronic, Inc. In effect, this means such product liability lawsuits must be pursued in federal court.

But what happens if the medical device consists of components that have different class designations? These are becoming increasingly common in everything from hip implant devices to pain dispensing pumps. It’s created a jurisdictional conflict, with plaintiffs and defendants arguing over which courts should handle these matters.

Now, it appears we have some direction. The U.S. Court of Appeals for the Third Circuit recently issued a precedential ruling in a case of first impression filed by a plaintiff who alleged a British medical device maker negligently designed a hip replacement system. The ruling is the first time a court has taken on the question of whether product liability claims concerning a device made of components in different classifications are preempted by federal law. Answer: They are. That meant plaintiff’s claims of negligence, strict liability and breach of warranty were expressly preempted and dismissed. However, the court reversed dismissal of plaintiff’s other claims that were adequately pleaded and not preempted, namely off-label promotion in violation of federal law and loss of consortium (filed by his wife). Those claims will proceed. Continue reading

March 7, 2017

New Infant Carrier Standard Aims to Prevent Baby Injuries

by Jeffrey S. Glassman

With the goal of helping to reduce child injuries and deaths, the U.S. Consumer Product Safety Commission recently rubber-stamped updated federal safety guidelines for infant carriers, specifically of the sling variety. This mandatory standard applies to those sling carriers caregivers wear to transport a single infant or toddler, usually up to 35 pounds, though some go up to 50 pounds.

The designs can range from hammock-like products that are mostly unstructured and hang from the caregiver’s body to a wrap of fabric that girds around the adult’s body. The caregiver wears the carrier, and once the child is inside, he or she is supported by either one or both shoulders of the adult. The carrier can be used either in front or in back, either with the child facing away or toward the adult, or else reclined in the front.

Updated federal safety standards are based on the most recently updated standard voluntarily adopted by the industry and outlined by ASTM International. However, there is an additional requirement regarding label attachments. ASTM F2907-15 is the standard, and it establishes the performance requirements, testing methods and manufacturing requirements that must be met in order to ensure that use of these sling carriers is safe. Continue reading

January 24, 2017

Samsung Uses New Measures to Attain Recall Compliance

by Jeffrey S. Glassman

For quite some time, it has been known that the new Samsung Galaxy Note 7 Smartphones have defective batteries and other components that can result in the devices exploding. This can cause serious personal injury and has caused users to be severely burned. These phones are also not allowed on airplanes, since an explosion on a plane could be catastrophic for hundreds of passengers. Not only can they not be taken as carry on, they cannot be checked in baggage, even if they are powered down. The reason for this is because the battery can explode even when the phone is not on or being operated.

While the company has voluntarily agreed to recall the device and provide users with a refund, for whatever reason, some users are not willing to return the defective smartphones. It seems they would rather run the risk of the phone exploding or bursting into flames in a user’s pocket and are not returning them to Samsung. Continue reading

July 12, 2016

Tarceva Makers to Pay $67M for False Claims

by Jeffrey S. Glassman

Two drug companies have been ordered to pay $67 million over false claims made regarding the efficacy of cancer drug Tarceva, the U.S. Justice Department announced.

The drug is approved for some patients who suffer from non-small cell lung cancer or pancreatic cancer. However, OSI Pharmaceuticals LLC and Genetech Inc. reportedly misled consumers about how effective the drug was in treating non-small cell lung cancer.

This settlement was reached after allegations that between January 2006 and December 2011, the two drug makers promised the product would be effective for non-small cell lung cancer patients. What they failed to disclose was that research had shown it only worked if the patients hadn’t ever smoked or had any sort of mutation in their epidermal growth factor receptor. The latter is a protein that has been traced to the spread of cancerous cells. Continue reading