Pharmaceutical Company Held Liable for Lawyer’s Suicide
4/27/17
By: Kristian N. Smith A federal jury in Illinois recently held GlaxoSmithKline liable for the death of a Reed Smith LLP partner, Stewart Dolin. The jury found that the generic version of GSK’s Paxil caused Mr. Dolin to take his own life, awarding $3 million to his widow. Dolin began taking the generic version of…
Ethical Code Does Not Prevent Expert Testimony
4/24/17
By: Shaun Daugherty In a recent, factually interesting decision by an Illinois Court of Appeal, a defense verdict in a dental malpractice case was overturned for a variety of reasons related primarily to the defendant’s expert’s use of skulls during his testimony. However, one of the side issues also piqued my interest. The case involved…
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 of 36 children through the bank. The bank had promoted donor 9623 as having a…
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 initially arrested on five counts of aggravated assault, the 13-day trial apparently focused on one 74-year…
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By: Michael Bruyere and Amanda Hall On August 8, 2016, the FDA issued draft guidance on “Deciding When to Submit a 510(k) for a Change to an Existing Device.”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 submit a premarket notification submission to the FDA at least 90 days before beginning to…
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 Services, Office for Civil Rights (OCR) regional offices are required to investigate all reported breaches…
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 the distribution of Acclarent’s Relieva Stratus Microflow Spacer (“Stratus”) for off-label use. Although Stratus…
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 lead to advances in the way medical devices are created both in the United States…
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 May 2015, H. J. Heinz Co. filed suit against Starr Surplus Lines Insurance Co. for…
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 able to rely on their insurance companies for a defense. Pending a decision by the…
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 brought on by epilepsy, and is the first drug produced by a 3D printer to…
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 Caribbean Caribbean Cruises, Ltd., 2014 WL 580229 (11th Cir. 2014), the 11th Circuit definitively recognized the…