This document is a memorandum from a federal judge denying a pharmaceutical company's motion for summary judgment in a products liability case regarding antidepressants. The judge found that the company, Wyeth, did not provide clear evidence that the FDA would have rejected stronger suicide warnings on the drug Effexor during the time period in question. While Wyeth argued the FDA rejected certain petitions, the judge noted Wyeth itself had changed Effexor's label in 2003 regarding suicide risks, and the FDA did not reject this change until later imposing its own warning. Therefore, the plaintiffs' state law claims regarding inadequate warnings were not preempted by federal law.
Msnd scallion v. monsanto complaint 18-161Carson Thurman
Marshall W. Scallion and Brooke Scallion, individually and on behalf of Scallion Farms Partnership v. Monsanto Company, BASF Corporation, BASF SE, E.I. dupont Nemours and Company, and Pioneer Hi-Bred International, Inc.; In the United States District Court for the Northern District of Mississippi, Oxford Division; Cause No.: 3:18-CV-161-MPM-RP
Jpml1testosterone low testerone litigaiton brief in support of transfermzamoralaw
Testosterone and Low-T Drugs Under Investigation
AndroGel - Manufactured by AbbVie
AndroDerm - Manufactured by Actavis
Axiron - Manufactured by Eli Lilly and Company
Bio-T-Gel - Manufactured by Teva Pharmaceuticals
Fortesta - Manufactured by Endo Pharmaceuticals
Striant - Manufactured by Columbia Laboratories
Testim - Manufactured by Auxilium Pharmaceuticals
Testopel - Manufactured by Auxilium Pharmaceuticals
Delatestryl - Manufactured by Indevus Pharmaceuticals
Depo-Testosterone - Manufactured by Pharmacia & Upjohn Company
Msnd scallion v. monsanto complaint 18-161Carson Thurman
Marshall W. Scallion and Brooke Scallion, individually and on behalf of Scallion Farms Partnership v. Monsanto Company, BASF Corporation, BASF SE, E.I. dupont Nemours and Company, and Pioneer Hi-Bred International, Inc.; In the United States District Court for the Northern District of Mississippi, Oxford Division; Cause No.: 3:18-CV-161-MPM-RP
Jpml1testosterone low testerone litigaiton brief in support of transfermzamoralaw
Testosterone and Low-T Drugs Under Investigation
AndroGel - Manufactured by AbbVie
AndroDerm - Manufactured by Actavis
Axiron - Manufactured by Eli Lilly and Company
Bio-T-Gel - Manufactured by Teva Pharmaceuticals
Fortesta - Manufactured by Endo Pharmaceuticals
Striant - Manufactured by Columbia Laboratories
Testim - Manufactured by Auxilium Pharmaceuticals
Testopel - Manufactured by Auxilium Pharmaceuticals
Delatestryl - Manufactured by Indevus Pharmaceuticals
Depo-Testosterone - Manufactured by Pharmacia & Upjohn Company
I am not a Mom of a fallen hero of the iraq war, i am a mom of a fallen hero of the Duchennes Muscular Dystrophy war, but during this holday season, I know there are so many Mom's that are hurting, so this is my tribute to US!
I am not a Mom of a fallen hero of the iraq war, i am a mom of a fallen hero of the Duchennes Muscular Dystrophy war, but during this holday season, I know there are so many Mom's that are hurting, so this is my tribute to US!
Ohio Healthcare Providers - Definition of "Medical Record" and Where It Is St...Robert Graziano
The Ohio Supreme Court ruled the state law definition of “medical record” is not limited to the data maintained in the provider’s medical records department.
Reed Code Blue Health Care Science edition 8thChaps 1,2, and 3.docxsodhi3
Reed Code Blue Health Care Science edition 8th
Chaps 1,2, and 3
THE PURPOSE OF THESE QUESTIONS IS TO HELP YOU REFINE YOUR ANALYSIS & BUSINESS COMMUNICATIONS SKILLS. These are the criteria on which you will be graded.
Short Answer
1. Summary: In 1 BRIEF paragraph, explain what happened in these 3 chapters.
2. Chapter 1: Based on Chapter 1, what is the major issue facing the hospital? What is the relationship between Hap & Del, and why was Hap taking Del on the fishing trip?
3. Chapter 2: Based on Chapters 1 & 2, profile Ed Wycoff, and explain why he asked Dr. Amos to make the proposal to the Board of Directors to replace Hap rather than do it himself.
4. Chapter 3: 2 questions –
· In your opinion, how did Selman handle his firing? Would you have done anything differently?
· In your opinion, how did Wes handle his being hired? Would you have done anything differently?
Module 03 Written Assignment - A Case Study of Healthcare Fraud
Write your answers in the space provided for each of the questions below:
1. What is your initial response to the case study? (Please include one or two paragraphs in this section.)
2. Who was the main perpetrator of fraud? What types of fraud did they commit and what do you think the motivation was for their actions?
3. Looking beyond the main perpetrator, there were numerous other organizations and people involved in the fraud(s). List at least two others involved and describe their contribution to the crimes.
4. How could the health care fraud(s) in this case study have been stopped? Or at least minimized and not have gone on for years?
5. At the end of the case study in the Discussion section, the authors reference some potential cuts in payments to doctors. How do you think these cuts could affect the amount of financial fraud within the health care system? How could doctors react to the cuts in a manner that is not fraud?
A Case Study of Healthcare Fraud
Timothy E. Paterick, MD, JD,* Zachary R. Paterick,† and Gerald F. Fletcher, MD‡
he healthcare landscape is changing with the depressed economic times we have encountered in the United States. The anticipated Medicare cutbacks have created angst among physicians and healthcare institutions. This case is a clear reminder to individual physicians and medical institutions that when faced with potential future payment cutbacks and a changing and uncertain financial landscape for the U.S. healthcare system,
the overriding responsibilities of physicians and medical institutions must always be for the medical welfare of patients and exercising proper fiduciary responsibility.
Key words: False claims; patient safety; fiduciary responsibility; Medicare and private insurance payment; payment reduction for medical specialty services.
T
On December 31, 2008, in the United States District Court, W.D. Louisiana, Mehmood M. Patel, MD, was charged with 91 counts of healthcare fraud violating 18 U.S.C § 1347 and one count of criminal forfeiture pursuant to 18 ...
NCAA CONCUSSION MDL, ORDER AND PLAINTIFFS EXECUTIVE COMMITTEEmzamoralaw
The NCAA will also provide concussion education to athletes, coaches and trainers before each season. And medical personnel will be present at each “contact sport,” including football, lacrosse, wrestling, ice hockey, field hockey, soccer and basketball.
The $70 million figure could include as much as $15 million in attorney fees and up to $750,000 in out-of-pocket expenses. NCAA insurers are expected to pay at least part of the settlement, NCAA Chief Legal Officer Donald Remy said on the association’s website.
attorneys listed in the settlement as counsel for the plaintiff class are Seattle-based Steve W. Berman of Hagens, and Mark Zamora of The Orlando Law Firm P.C. in Decatur, Ga. AMONG OTHERS
First LowT Complaint filed in Georgia Punitive Damagesmzamoralaw
Court documents filed in the U.S. District Court, Northern District of Illinois indicate that four testosterone treatment lawsuits were filed on February 4, 2014, on behalf of men who allegedly suffered serious heart problems due to the use of AndroGel. Among other things, the complaints raise questions about the marketing of prescription testosterone therapies, and accuse the manufacturers of the medications of promoting them as treatments for fatigue, low libido, and other problems associated with the aging process. The complaints further allege that these marketing tactics led to many patients being prescribed testosterone therapy, despite having normal levels of the hormone. (Case Nos: 1:14-cv-00776, 1:14-cv-00780, 1:14-cv-00777, and 1:14-cv-00772)
First LowT Complaint filed in Georgia Punitive Damages
Baumgardner
1. Case 2:05-cv-05720-JF Document 87 Filed 08/31/10 Page 1 of 4
IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF PENNSYLVANIA
RENEE NOLL BAUMGARDNER, et al. : CIVIL ACTION
:
v. :
:
WYETH PHARMACEUTICALS : NO. 05-5720
RENEE NOLL BAUMGARDNER, : CIVIL ACTION
COREY FOSTER BAADSGAARD, :
MELODY BROWN, : NOS. 06-2518
LEAH CRAIG CHUMBLEY, : 06-2519
PAULETTE FORD, JOAN HENNING, : 06-2520
JAMES W. HILL, SHARON RODGERS, : 06-2521
LORRAINE AND ROBERT SLATER, : 06-2522
JAME CHARLEA TIERNEY : 06-2523
: 06-2524
v. : 06-2525
: 06-2526
WYETH PHARMACEUTICALS : 06-2527
MEMORANDUM
Fullam, Sr. J. August 31, 2010
The ten sets of plaintiffs in this series of related
cases are persons or surviving family members of persons who took
the antidepressant Effexor (the regular or the extended release
version) between August 8, 2000 and August 4, 2003. They have
filed a products liability suit against the manufacturer of
Effexor, Wyeth Pharmaceuticals, asserting that Wyeth failed to
provide adequate warnings of Effexor’s risks, particularly the
danger that those taking the drug might try to harm themselves or
2. Case 2:05-cv-05720-JF Document 87 Filed 08/31/10 Page 2 of 4
others. The plaintiffs’ claims have been consolidated for
pretrial discovery.
Wyeth has filed a motion for summary judgment arguing
that the plaintiffs’ state-law tort claims must be dismissed as
preempted by federal law; specifically because the plaintiffs’
claims under state law would require the defendant to provide
different or additional suicide-related warnings for Effexor,
while federal law, during the time periods relevant here,
provided that the then-existing suicide-related warnings were
appropriate.
The parties agree that in light of the United States
Supreme Court’s decision in Wyeth v. Levine, 129 S. Ct. 1187
(2009), the narrow issue for the Court is whether the defendant
has presented “clear evidence that the FDA would not have
approved a change to [the drug’s] label.” Levine, 129 S. Ct. at
1198. Only if a defendant makes that showing will the
plaintiffs’ state-law tort claims be preempted; Wyeth has not
done so.
Wyeth argues that the FDA would have rejected any
additional suicide-related warnings that it provided because, at
all times before 2003, it was the FDA’s scientific judgment that
there was no association between suicide and antidepressants. As
evidence, Wyeth points to the FDA’s rejection of three citizen
petitions, which sought the removal of antidepressants from the
2
3. Case 2:05-cv-05720-JF Document 87 Filed 08/31/10 Page 3 of 4
market or the strengthening of their suicide-related warnings, as
well as various statements and reports made by the
Psychopharmacological Drugs Advisory Committee, a group
commissioned by the FDA, which concluded that the connection
between antidepressants and suicide was not scientifically
supportable. None of this evidence proves that the FDA would
have rejected relevant warnings had Wyeth, the manufacturer,
proposed them. In attempting to, in effect, shift the
responsibility for its labeling decisions onto the FDA, Wyeth has
lost sight of the Supreme Court’s statement that “the
manufacturer bears responsibility for the content of its label at
all times.” Levine, 129 S. Ct. at 1197-98.
According to Wyeth, there is “clear evidence” that the
that the FDA would have rejected a new warning. Wyeth did
propose a change to Effexor’s label in 2003, adding a pediatric
precaution to Effexor’s package insert to state in part “[i]n
pediatric clinical trials, there were increased reports of
hostility and, especially in Major Depressive Disorder
[patients], suicide-related adverse events such as suicidal
ideation and self-harm.” Wyeth asserts that in March 2004, the
FDA directed it not to use the proposed labeling, however, after
closely examining the record, it seems to me that the FDA did not
reject the defendant’s proposed labeling change, but let the
defendant’s then-existing label stand until early 2004 when the
3
4. Case 2:05-cv-05720-JF Document 87 Filed 08/31/10 Page 4 of 4
FDA decided to issue a different, and arguably more comprehensive
warning to Effexor users and their families and prescribers of
the drug. The plaintiff has pointed to the Congressional
testimony of the FDA’s Director of the Office of Drug Evaluation,
given in 2004, which asserts that Wyeth was permitted to
unilaterally strengthen Effexor’s warnings until a different
warning was imposed on antidepressant manufacturers by the FDA.
Other cases examining the warning labels on antidepressants have
reached the same conclusion. See Mason v. SmithKline Beecham
Corp., 596 F.3d 387 (7th Cir. 2010); Forst v. SmithKline Beecham
Corp., 639 F. Supp. 2d 948 (E.D. Wis. 2009); Aaron v. Wyeth, No.
07-927, 2010 WL 653984 (W.D. Pa. Feb. 19, 2010). The reasoning
in those cases is persuasive.
In sum, the defendant has not shown that the FDA would
not have approved a change to Effexor’s label. The defendant’s
motion for summary judgment is denied.
An order will be entered.
BY THE COURT:
/s/ John P. Fullam
John P. Fullam, Sr. J.
4