Federal Court Rejects Jane Doe’s Wrongful Conception Claims Too
3/21/17
By: Shaun Daugherty
It made headlines when several families around the county sued Atlanta based sperm bank Xytec Corp. for claims that they were lied to regarding the specific characteristics of a donor that had been responsible for the birth …
How Fine is the Line Between Medical Malpractice and Life in Prison?
2/22/17
By: Shaun Daugherty
It was all over the major news networks and the print media. On Monday, February 21, 2017, a Dallas, Texas jury sentenced Dr. Christopher Duntsch, neurosurgeon, to life in prison for a “botched surgery.” While he was …
FDA’s Draft Guidance on When to Submit A 501(k) Bolsters Potential for Medical Device Manufacturers to Argue that State Tort Claims are Impliedly Preempted
9/8/16
By: Michael Bruyere and Amanda Hall
On August 8, 2016, the FDA issued draft guidance on “Deciding When to Submit a 510(k) for a Change to an Existing Device.” Current regulations provide that a manufacturer of a medical device must …
OCR Casts a Wider Net on HIPAA Breaches
8/29/16
By: Agne Krutules
Under the Health Insurance Portability and Accountability Act (HIPAA), covered entities and their business associates have duties under the Privacy Rule and the Security Rule to protect patient health information. The U.S. Department of Health and Human …
FDA Continues to Fight the First Amendment But Facteau Deals Another Blow
8/18/16
By: Kristian Smith
Last month, a federal jury in Massachusetts acquitted two executives of medical device company Acclarent, Inc. of 14 felony counts of fraud related to off-label promotion of Acclarent’s “Stratus” device. United States v. Facteau, et al. stemmed …
From 3D Printing to 4D Printing – New Advances in Science Implicate Changes in Existing Products Liability Law
2/25/16
By: Amanda K. Hall
On January 25, 2016, researchers at Harvard University and The University of Illinois Urbana-Champaign detailed their creation of “4D-Printed” structures –made by mimicking the way orchids and other plants move and twist – that could ultimately …
Insurance Application Omissions Not Enough to Rescind Policy
1/19/16
By: Kristian Smith
Insurers may need to pay closer attention to insurance applications. A Pennsylvania jury recently ruled that an insurer knew (or should have known) about omissions on an insurance application, preventing the insurer from rescinding the policy.
In …
Drug Distributors May Find Themselves Without a Defense
12/23/15
By: Michael Bruyere and Kristian Smith
Rising prescription drug abuse has put drug distributors under scrutiny in the last few years. Now, pharmaceutical companies are being sued for the economic costs associated with the epidemic, but they may not be …
FDA Approves First Drug Made by 3D Printing
9/1/15
By: Mike Bruyere
Additive manufacturing, or 3D printing, reached a significant milestone this month when the FDA approved the production of an epilepsy medication that will be marketed under the name Spritam. The new drug, developed by Aprecia, controls seizures …
11th Circuit Rules Cruise Lines Can Be Sued for Medical Malpractice
12/3/14
By: Laura Broome
The 11th Circuit recently ruled that cruise ships may be sued for medical malpractice, negating any reliance by cruise ship companies upon the defense of immunity in cases of medical malpractice. In Patricia Franza v. Royal …
Stacking Up the States on Medical Malpractice Payments
11/3/14
By: Michael Eshman
The National Practitioner Data Bank published a state-by-state chart of medical malpractice adverse actions and payments over a 10 year period from 2003-2013. In Georgia, for instance, there were 3,392 medical malpractice payments out of approximately …
Is it Legal to Involuntarily Quarantine People Exposed to Ebola?
10/30/14
By: Kevin R. Stone
Recently, a nurse who was exposed to Ebola in West Africa was involuntarily quarantined in a New Jersey hospital. She was then released back to her home in Maine. Although she tested negative for Ebola …