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Searching Content indexed under Food, Drugs, Healthcare, Life Sciences by Reed Smith ordered by Published Date Descending.
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1
PML Valsartan Order
Few things raise our blood pressure as much as the MDL process. MDL stands for Multi-District Litigation, but the M might as well stand for Mutilating and the D for Distorting.
United States
13 Sep 2019
2
Utah Decision Yields Decidedly Mixed Results
We had been waiting for the Utah Supreme Court's decision in Burningham v. Wright Medical for some time. As we pointed out in a blogpost when Burningham was first certified by the district court
United States
12 Sep 2019
3
Recent Traction In FDA's Development Of The 503A And 503B Bulks Lists
Just as the U.S. Food & Drug Administration ("FDA") promised in its 2019 compounding priorities statement, FDA published a notice and proposed rule in the Federal Register
United States
11 Sep 2019
4
Why Should FDA Warning Letters Be Any Different?
We've blogged numerous times about the tentative, non-final, and informal status of FDA warning letters (and untitled letters and similar enforcement precursors
United States
10 Sep 2019
5
Shameless Plug: Discount Code For Our Readers To 2019 ACI Drug & Device Conference
As your bloggers – at least those without school-aged children – begin to mourn the dawning end of summer, we do at least see one bright spot in the ever-shortening days
United States
10 Sep 2019
6
A Second Lipitor Cert Petition, This Time Raising Personal Jurisdiction
California courts continue to find ways to exercise personal jurisdiction over out-of-state defendants, even when there is little or no dispute that the Constitutio
United States
9 Sep 2019
7
Telemedicine And The Learned Intermediary Rule
Somebody asked Bexis the other day whether he thought that the increasing reliance on "telemedicine" – physician consultations taking place online,
United States
4 Sep 2019
8
Georgia Court Makes Short Work Of PMA Medical Device Case
It's not a long decision – but there's still a lot to it. Maybe that's because there wasn't a lot to plaintiff's complaint. Regardless, Sharp v. St. Jude Medical, S.C., Inc., 2019
United States
2 Sep 2019
9
Mixed Treatment Of Clinical Trial Liability On Summary Judgment
A little knowledge is a dangerous thing. A jack of all trades is a master of none. These cutesy little phrases throw some derision toward one who
United States
30 Aug 2019
10
CMS Issues Final FY 2020 Medicare Ipps/Ltch Update, Including New Medical Device Technology Policies
The Centers for Medicare & Medicaid Services (CMS) has finalized Medicare acute inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system (PPS) rates and policies for...
United States
30 Aug 2019
11
Prescription Medical Product Causation – Expert Required − Part Three
Because we didn't want to split Pennsylvania, this part is a little longer, and part two a little shorter, than average.
United States
27 Aug 2019
12
About That Brand Memo . . .
Issued in January 2018, the so-called Brand Memo reminded Department of Justice (DOJ) attorneys that "[g]uidance documents cannot create binding requirements that do not already exist by statute or regulation."
United States
23 Aug 2019
13
Hip Hip Hurray For D.Utah Rulings In Hip Implant Case
Today's post looks at a case where a defendant was in the wrong place. You might say the same thing about us. As you read this, we are on summer holiday.
United States
23 Aug 2019
14
Medicare Payments To Inpatient Rehabilitation Facilities To Rise 2.5% In FY 2020 Under Final CMS Rule
The Centers for Medicare & Medicaid Services (CMS) has published its final rule to update the Medicare inpatient rehabilitation facility (IRF) prospective payment system (PPS) for fiscal year
United States
23 Aug 2019
15
CMS Issues Final Medicare Inpatient Psychiatric Facility Update For FY 2020
The Centers for Medicare & Medicaid Services (CMS) will increase Medicare inpatient psychiatric facility (IPF) prospective payment system (PPS) payments by 1.5%, or $65
United States
23 Aug 2019
16
Medicare Sequestration Extended Through FY 2029 Under New Budget Law
While the latest federal budget agreement signed into law earlier this month provides a reprieve from statutory budget caps for certain defense and domestic programs, it extends Medicare sequestration cuts for an...
United States
22 Aug 2019
17
Prescription Medical Product Causation – Expert Required – Part Two
What follows is the second part of our extensive 50-state of cases precluding plaintiffs from proceeding with claims in the absence of admissible expert support. Part One was last week.
United States
22 Aug 2019
18
CMS Proposes Medicare ESRD PPS Update For CY 2020
The Centers for Medicare & Medicaid Services (CMS) has proposed updating Medicare end-stage renal disease (ESRD) prospective payment system (PPS) rates by 1.7% for calendar year 2020
United States
22 Aug 2019
19
CMS Proposes Medicare DMEPOS Policy Updates, Including New Methodology For Pricing New Codes
The Centers for Medicare & Medicaid Services (CMS) is planning a potentially-significant overhaul of Medicare pricing rules for new items of durable medical equipment (DME), prosthetics, orthotics and supplies (DMEPOS)
United States
22 Aug 2019
20
Tenth Circuit Finally Shuts The Door Completely On Cerevny
We've been posting about this case since 2016 when the district court first dismissed plaintiff's failure to warn claim as preempted on the grounds that there was clear evidence the FDA would have rejected the warning...
United States
21 Aug 2019
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