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1
FDA Continues Its Press On Medical Device Cybersecurity
Did you know that October is National Cybersecurity Awareness Month? Neither did we, until we started poking around the FDA's recent press release announcing that it intends to update its guidance...
United States
15 Oct 2018
2
Federal Health Fraud Penalties Are Rising Once Again
The Department of HHS has just announced annual inflation-related increases to CMPs in its regulations, including those promulgated by the Office of Inspector General, the Centers for Medicare & Medicaid Services...
United States
12 Oct 2018
3
Even In California, Failure To Report Requires Something Reportable
It would seem to go without saying that for a defendant to be liable for the purported "common-law" claim of failure to report adverse events to the FDA, there must actually be some adverse events that needed to be reported.
United States
12 Oct 2018
4
DOJ Issues Updated Best Practices On Cyber Incidents; Incorporates CISA
On September 27, 2018, as part of the Department of Justice's (DOJ) cybersecurity roundtable discussion, the DOJ's Cybersecurity Unit issued Best Practices for Victim Response and Reporting...
United States
12 Oct 2018
5
What About Erie?
If a court acknowledges that no state or federal appellate courts in the jurisdiction have addressed the question before it, we think at a minimum there also should be an acknowledgement of the Erie doctrine.
United States
12 Oct 2018
6
Government Urges Reversal Of Third Circuit Fosamax Decision
We would be hard pressed to think of a recent judicial decision we have blasted as hard or often as the Third Circuit's Fosamax opinion. We deemed it the worst case of 2017.
United States
10 Oct 2018
7
OIG Gives Stamp Of Approval For Innovative Warranty Program
The Office of Inspector General (OIG) recently approved a medical device manufacturer's innovative proposed warranty program ...
United States
10 Oct 2018
8
Can We Play, Too?
Not too long ago we read a non-drug/device decision, Hale v. State Farm Mutual Automobile Insurance Co., 2018 WL 3241971 (S.D. Ill. July 3, 2018), which left us shaking our heads.
United States
10 Oct 2018
9
New Jersey Amends Combined Reporting, Adopts Marketplace Facilitator Law
As part of Governor Murphy's efforts to "modernize" business taxes, New Jersey enacted sweeping changes to its corporation business tax, including combined reporting and market sourcing for services.
United States
9 Oct 2018
10
Buckman Preemption Fatal To Claim For Violation Of The FDCA In IVC Filter Case
Next week, under pressure from the Drug and Device Law Lifelong Best Friend, we are participating in a "murder mystery dinner theatre" in the "conservatory" of a local cemetery.
United States
8 Oct 2018
11
FTC Takes Action Against "iV Cocktails"
Last week, the FTC brought its first action against a company marketing and selling intravenously injected therapy products, or "iV Cocktails" as they are often called.
United States
6 Oct 2018
12
United States
6 Oct 2018
13
Texas Court Smites Church's Promotion Of Bad Medicine
Gather round brothers and sisters, and hear the word of the Texas Court of Appeals. Today's sermon addresses the intersection of religion and regulation.
United States
5 Oct 2018
14
Reed Smith And The #Seeher Movement
Reed Smith is pleased to announce that it is the first law firm to become a member of the #SeeHer Movement, an initiative which aims to create a more accurate portrayal of women in the media.
United States
4 Oct 2018
15
Western District Of Wisconsin Rejects Stream Of Commerce Jurisdiction
We have written a lot about personal jurisdiction. We certainly haven't lacked for defense favorable decisions since Bristol-Myers Squibb Co. v. Superior Court
United States
4 Oct 2018
16
Federal Regulation Of Virtual Currency And Digital Tokens: Preemption, Jurisdiction, And Clarity. But Will States Push Back?
In September of this year, certain congressmen expressed their intention to preempt state regulation of virtual currency regulation. Rep. Darren Soto (D-Fla.) ...
United States
3 Oct 2018
17
NY Issues Final Guidance On Key Sexual Harassment Laws – Empire State Employers Must Take Immediate Action
As we previously reported, on October 9, 2018, two landmark New York State laws concerning sexual harassment prevention take effect. These laws require that all Empire State employers:
United States
3 Oct 2018
18
The Next Lexecon?
We had occasion not long ago to reread closely Lexecon v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26 (1998), the Supreme Court decision that clipped the wings of transferee judges...
United States
3 Oct 2018
19
FTC Continues Aggressive Enforcement Of Privacy Shield
On Thursday, September 27, the FTC announced settlements with four companies, IDmission, LLC, mResource LLC, SmartStart Employment Screening, Inc., and VenPath, Inc., following allegations that the companies falsely...
Worldwide
2 Oct 2018
20
Feds Investigate Ad Agency Media Buying Practices
According to the Wall Street Journal, federal prosecutors in Manhattan have opened an investigation into media-buying practices in the advertising industry ...
United States
2 Oct 2018
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