See "Lupron and Fraudulent Data" at right.
Lupron PERSONAL INJURY / PRODUCT LIABILITY LAWSUITS:
The following *incomplete* list of lawsuits against Lupron's manufacturer entail its prescription to 'treat' prostate cancer, endometriosis, fibroids, and infertility - and are listed in no particular order.
For further information on cases and Document Numbers ("Doc. #'s") listed below, search PACER for case names and #'s. (PACER - Public Access to Court Electronic Records; requires registration and a fee).
MALES- litigation involving Lupron and prostate cancer:
09-23-11: USA v. Ulysses Currie, et al, US District Court, District of Maryland. Criminal case No. 1:10-cr-00532-RDB (This lawsuit, while it does involve Lupron, is not a lawsuit against Lupron's manufacturer) -- State Senator Ulysses Currie, when facing charges including bribery, extortion, and making false statements to the FBI, claims Lupron made him feel "fuzzy". ... 10-26-11: Senator Currie's urologist testified Lupron "has side effects that include forgetfulness and loss of reasoning ability." ... 10-26-11: Senator's defense made the claim that the Senator's "memory and mental capacity has been diminished by injections of a drug called Lupron". ... 10-25-11: Senator's urologist testified that Senator's "mental acuity does seem to have decreased some" ... "about 25 - 30% of [urologist's] patients on Lupron experience some cognitive effects. They forget things ... they get lost driving somewhere they would never be lost before." Urologist states "it was hard to get [Senator] to understand. You had to say things more than once." ... On 11-08-11 the Senator was "acquitted of all charges. Senator's attorneys paint[ed] a portrait of a man who was disorganized, sloppy ... prone to memory lapses, in part because of side effects of [lupron]."
Larry Roper v. TAP (Filed in Greenville Division, US District Court, South Carolina, Case No. 2011-23-2468; case transferred to Northern District of Illinois, Case. No. 1:12-cv-05722). Roper "alleged that as a result of Lupron, he suffered including but not limited to rheumatoid arthritis, a spinal compression fracture, and cardiac problems." (Doc. #11). Case settled, closed 10-15-2012.
41 year old woman with "Lupron-induced dementia" reports cannot sue in Michigan
Burns v. TAP (sued 1994, settled 1997; Maryland). See Burns' lawyer state TAP "refused to produce documents until I agreed I would keep them secret ...", as reported in the last part of this Boston Herald 08-22-99 article.
Moore et al v. TAP, (Texas Southern District Court, Case No. 4:2007cv00824), Filed 3/12/07. Helen Moore asserted "neurological, psychological and orthopedic problems" (Doc. # 8). Case dismissed 5-23-07.
Carter v. TAP (U.S. District Court, W.D. Texas, San Antonio Division, 2004). No. SA-03-CA-0182. Pamela Carter began suffering "abnormal physical problems" after her second injection of Lupron. She suffered from "general pain to her body, depression, suicidal ideation, hair loss, weight gain, impairment of visual acuity, joint pain, neurological abnormalities, personality changes, memory loss and interference with cognitive abilities." (Doc. # 29). Case dismissed 11-02-04, motion for summary judgment granted.
Henderson v. TAP, (NC Middle District Court, Case No. 1:2007cv00431), Filed 5/31/07. Nicole Henderson "suffered from extreme fatigue, dizziness, a feeling that her heart was "racing", mental confusion, thoughts of suicide, headaches, heart palpitations, chest pain, GERD, body aches and spasms, bone pain, anxiety-depression, visual & auditory hallucinations, skin problems, hiatal hernia, hypersensitivity to sound and light, and esophageal cysts leading to loss of voice and dysphasia." (Doc. #3). Plaintiff filed to dismiss the complaint without prejudice on 06-05-07, and TAP consented.
Rita Carter v. TAP Holdings, TAP Pharmaceuticals, Abbott. (US District Court, Northern District Illinois; Case No. 1:99-cv-07681). 12-29-99 case "remanded to Circuit Court of Cook County, Ill. [3-1] remanding case to state court terminating case." (Doc. # 5)
Saraney et al v. TAP, (Ohio Northern District Court, Case No. 1:2004cv02026), Filed 10/6/04. Kathleen Saraney's claim of bone and back pain, and osteopenia were dismissed by summary judgmement on 01-16-07 (Doc. #32).
Gantner v. TAP, Abbott (Cook County, Ill. Docket No. 96-L-011379). Filed 10-02-96. The 'Amended Complaint' (filed 07-23-97) states: "Deborah Gantner suffered paralysis, numbness, neurological disorders and skin lesions and she was otherwise internally injured and damaged, and Plaintiff became and was and has so remained from thence hitherto, sick, sore, lame and distorted and has suffered great pain as a result thereof, and Plaintiff says that by reason thereof she has been and in the future will be hindered and prevented from earning and acquiring divers great gains and profits which she might otherwise have made and obtained and the Plaintiff has become liable for and has expended large sums of money endeavoring to be healed and cured of her said injuries." [three 3.75 mg injections rec'd]. Case dismissed by Stipulation or Agreement on 12-07-98.
Villarreal v. TAP (Sacramento County, CA. Docket No 528453). Filed 07-22-92. Kristin Villarreal had one injection in July 1991, and subsequently "suffered repeated episodes of syncope and/or passed out over a long period of time which resulted in further injuries" (TAP's "Separate Statement of Undisputed Material Facts", 04-11-94). Dismissed without prejudice 05-11-94.
Grissom and Grissom v. TAP Pharmaceuticals, Case No. 3:01-cv-384-LC, U.S. District Court for the Northern District of Florida, Pensacola Division. Filed 09-26-01. Case settled 03-21-02. Protective order in place (Doc. #55).
DeSouza v. TAP Pharmaceuticals, Inc.(U.S. District Court, CN. Docket No. 3:03-CV-2247(MRK), 2006). Connie DeSouza claimed within 24 hours of her one injection of Lupron she began to experience blurry vision; and is "permanently disabled and has been diagnosed as legally blind." (Doc. #46, p. 12). Case was settled 05-02-06.
Larsen v. TAP, Abbott (Orange County, CA. Case # SACV00-919, State Court Case No. 00CC03834). Dismissed without prejudice, 2000. See this link's 11-26-07 post/entry by Louise Larsen --- "Lupron stole my health from me. I tried to sue Pro Se in Orange County, CA and couldn't get a lawyer to help me before my time ran out. TAP harrassed me non-stop about the lawsuit. It was hell."
Klein v. TAP (NV District Court, Case No. 2:2008cv00681), Filed 5/27/08. (Scrolll below for details on Karin Klein v TAP).
K.P. v. TAP.
LUPRON CLASS ACTIONS -
Lupron PRODUCT LIABILITY / PERSONAL INJURY CLASS ACTION LAWSUITS:
Cardenas and Paulsen v. Abbott, Takeda, TAP (US District Court, Eastern District of New York, Brooklyn. Case No. CV10-1745.) Filed 04-20-10 originally on behalf of 2 plaintiffs (Consuelo Cardenas and Terry Paulsen) - subsequently 2 additional plaintiffs were added (Magdalyn Dustin and Suzanne Preston), however ultimately 3 plaintiffs were dismissed, leaving Terry Paulsen as the sole plaintiff. Terry "was a healthy registered nurse before Lupron. Ms. Paulsen's health, life, career and future were irrevocably destroyed by Lupron. Ms. Paulsen is permanently disabled." (Dkt. #130). Terry suffers from, among others, chronic pain and joint disorders, seizures, vascular insufficiency, and chronic insomnia and exhaustion. The Paulsen case was transferred to the US District Court, Northern District of Illinois (Case No. 11 C 4860), and plaintiff's attorney abruptly retired mid-case, leaving Terry Paulsen literally up a legal creek without a paddle. Terry, unaware of her legal obligations as a "pro se" litigant ('for self', without an attorney), failed to meet a deadline and her case was dismissed October 1, 2013. Motions were written on behalf of Terry Paulsen asking the court to, among others, vacate the dismissal. On April 29, 2014, the judge granted Terry's motion to vacate the dismissal and directed the court clerk to reopen this case. Unable to find an attorney, Terry filed notice of voluntary dismissal without prejudice on 05-30-14 (Dkt. # 144).
Arnett, Ehly, Grabner, Page, Rybicki v. TAP (US District Court, Middle District, Tampa FL. No. 8:03-CV-304-T-26TBM; 2003). Filed 01-02-03. [Note: this case provides illustration of the extensive medical care sought and required post-Lupron - in that, within just a few years of Lupron prescription, "approximately 125 physicians" were collectively identified as having treated the 5 women plaintiffs (Doc. #63, p. 13)]. Case was settled 05-06-04.
Inevitably, future class action lawsuits will be filed.
Example of Attorney Letters Rec'd re: lupron litigation
Lupron MEDICAL MALPRACTICE :
$4,000,000 wrongful death jury verdict
Kuha v. Andrew J. Friedman MD, Brigham & Women's Hospital (Suffolk County, Superior Court, MA. Docket No.97-3725, 1997). Case settled.
Millican v. Harvard Community Health Plan, Boston IVF, Natalie Schultz MD, Mahmood Niaraki MD, Brian Walsh MD, Selwyn Oskowitz MD, Michael Alper MD (Suffolk County, MA. Supreme Judicial Court, Docket No. 98-P-1472; heard 2001; case initially filed 1992). Case denied.
Millican DISCOVERY: ANSWERS TO INTERROGATORIES:
Natalie Schultz MD's Answers to Interrogatories (of note, see also "Natalie Schultz - rude and unprofessional ... a doctor NOT to go to ... one of the WORST" by A.T.)
Mahmood Niaraki MD's Answers to Interrogatories
Brian Walsh MD's Answers to Interrogatories
Boston IVF's Answers to Interrogatories (of note, see also 'Not the Place to Go' and other telling reviews)
Harvard Community Health Plan's Answers to Interrogatories
Michael Alper MD's Answers to Interrogatories
Harvard Community Health Plan's Response to Request for Production of Documents
Affidavit of Michael Alper MD
Affidavit of Brian Walsh MD
Boston IVF Patient Brochure: Page describing Lupron:
Lupron BILLING FRAUD, PRICE INFLATION LAWSUITS
2001: TAP a 'criminal enterprise' - to pay gov't $875 million to settle fraud case
2001: U.S. Dept. of Justice - "TAP settles charges"
Review of billing fraud details
Memorandum and Order Approving Settlement and Certifying the Class
Lupron (billing) Settlement
Prescription Access Litigation 12-01-04 Press Release: TAP to pay "$150 million to settle with victims of Lupron scheme"
In Re: Lupron Marketing & Sales Practice Litigation
Leftover 11.4 million from Lupron price inflation class action settlement may go to Harvard (05-21-09)
Existing claimants denied $11.4 million 'leftover' funds (05-19-09)
04-25-12: 'Lupron Settlement Surplus Funds Update' ... "Letting judge dish out charity not a good idea"
04-24-12: In Re: Lupron Marketing & Sales Practice Litigation (Case No. 10-2494, 11-1329; 1st Cir. Apr. 24, 2012), US Court of Appeals has affirmed the decision of the US District Judge to allocate the 'surplus' $11.4 million to Dana Faber / Harvard Cancer Center and the Prostate Cancer Foundation to study diseases that lupron 'treats' (instead of distributing the funds to lupron purchasers, lupron victims, &/or the 'Consortium' --- See May 2009 letter to Judge for further information.). Law firm says "clients plan to petition the U.S. Supreme Court for certiorari", but to no apparent effect. March 31, 2014 report shows cy press funds continue to investigate prostate cancer while female indications/diseases are ignored.
12-23-10: Plaintiffs in lupron settlement funds ignored, and research into health problems of lupron victims ignored ... Judge awards $11.7 million surplus lupron settlement funds to Harvard prostate cancer researchers.
(flashback) ... 11-16-10: Judge orders dispersement of lupron Class Settlement Funds ... First Cy Pres Payments to Dana Faber/Harvard Cancer Center ($400,000). Note: the plaintiffs who were awarded the settlement funds are NOT being given the surplus settlement funds)
(flashback) ... 05-21-09: Leftover 11.4 million from Lupron price inflation class action settlement may go to Harvard ... 05-19-09: Existing claimants denied $11.4 million 'leftover' funds
11-18-10: Brief Review of 2 Florida urologists' black market diversion & Medicare fraud re: lupron
11-30-98: TAP Pharmaceuticals, Plaintiff-appellant v. U.S. DHHS; Healthcare Financing Administrators; Palmetto Government benefits Administrators, Defendants-appellees.U.S. government's motion to dismiss TAP's complaint is affirmed.
The following are details re: the lawsuit KARIN KLEIN v. TAP/Abbott:
Re: 'Klein v. TAP/Abbott', Read Medical Expert Statement from Dr. David B. Redwine, renowned endometriosis expert, describing (among others) enticements by TAP to prescribe lupron, TAP's medical fraud, and the Dr.'s conclusion that lupron is "unsafe and harmful in addition to being ineffective."
Re: 'Klein v. TAP/Abbott', Read Medical Expert Statement from Dr. Gueriguian, describing the dangers and disabling effects of lupron.
12-9-13: Supreme Court DENIED Lupron victim Karin Klein's petition.
According to the Supreme Court Clerk, 'friend of the court' briefs (Amici curiae briefs) submitted in support of Petitioner Klein were not accepted by the Supreme Court because the briefs were not written by an attorney admitted to Supreme Court Bar.
Is there *ONE* attorney admitted to the Supreme Court Bar that IS AWARE, and thus could inform the Court, of the information within Lupron Victims Hub's amicus brief??? -- See Lupron Victims Hub provides Amicus curiae ('friend of the court') brief to Supreme Court on behalf of Karin Klein and ALL lupron victims. Specifically see pages 12-14 and 19-20 of brief (which are pages 25-27 and 32-33 in document; and which detail explosive information). The Court Clerk stated a copy of Lupron Victims Hub's amicus brief will be kept in the Klein case file record, but "cannot be allowed into chambers".
Another 'friend of the court' (amicus) brief was filed in support of Karin Klein by Rose Colombo of 'Women Fight Back' - this amicus also was 'not allowed in chambers, but will be kept in the Klein case file record'.
Therefore, the Klein petition was decided and denied by the Supreme Court without the Court ever even knowing about the amici submitted in support of Klein. The Supreme Court denied Klein's petition without having ever read the amici and without the Court gaining any understanding of the information contained therein. If 'nearly every Supreme Court Justice hasn't "gotten to" email', when do you suppose the Justices will get around to looking at the internet, or when might they get around to looking at amici submitted by knowledgeable people who happen to not be an attorney admitted to the Supreme Court Bar?
Karin Klein has one last available opportunity, and is presently filing a pro se petition for rehearing to the Supreme Court.
11-01-13: Law360 - "Supreme Court asked to take up Lupron Labeling Suit"
10-31-13: 'Klein v. TAP/Abbott' put on Supreme Court Docket
10-28-13: Read Karin Klein's Petition to the U.S. Supreme Court , which identifies instances of GROSS injustices re: Lupron, and which beg for legal recourse.
10-29-13: Lupron Victims Hub has sent a request to MA. Senator Elizabeth Warren and MA. Senator Ed Markey, asking them to please file an amicus brief ('friend of the court') on behalf of Karin Klein, who has undergone an unacceptable horror post-lupron and through the courts (i.e., scroll below to "SOMEONE - EVERYONE (- ANYONE - ??"), resulting in denial of due process and violation of 14th Amendment. Karin's case has nation-wide importance and relevance to not only all lupron victims, but to all consumers. Amici filed for a case can be noteworthy to the Supreme Court, and raise the potential for the Supreme Court to hear a case. (Most cases are never heard). If Karin's case is never heard - where does Karin go for justice? What happens to all the other lupron victims?
If you would like to help Karin - and by extension, ALL lupron victims - please contact your Senators and Representatives, asap (*deadline* for filing amici = November 27, 2013), and urge Congress to file a friend of the court brief in support of Karin Klein and every other lupron victim. Abbott and it's doctors, in lupron court proceedings, *cannot* be allowed to utter lupron 'falsehoods' (lies) while the lupron victim plaintiff is legally handcuffed and prevented from showing the jury the true facts. Remind your Senators and Represenatives of the number and names of towns of people from your state who have signed the Petition2Congress asking them for an investigation into lupron. (i.e. Scroll to page 4 here for the names and number of Massachusetts' towns that have signed the petition for the year 2013 alone; and read 13 other lupron victims' 'stories' on pages 4-6 here.)
10-24-13: ABC News Las Vegas KTNV airs coverage of Karin Klein's case. See also here.
On 10-22-13, Dr. David Redwine posted in FaceBook's Lupron Victim group the following statement: ... "I compiled a nearly 300 page review of the studies that were placed under court seal in August 2011. These studies showed systematic and repetetive examples of data manipulation. The end result is that the true risks of Lupron are understated. I sent my review to the FDA in late 2011. They did an extensive first level review and are near the end of a second level review. The FDA has said that they will have completed their review by Nov 15. I hope they do the right thing and remove Lupron from the market and refer the case to the US DOJ."
10-11-13: Listen to 1st Radio Interview of Karin Klein by Rose Colombo (founder, 'The Justice Club' at Freedomizer Radio Online). Klein has November 2013 deadline for Amicus support for US Supreme Court petition. Hear Karin's 2nd Radio Interview on 10-16-13.
Should Klein fail to obtain Amicus ('friend of the court' brief) and fail to prevail in her Supreme Court petition - any and all other subsequent lupron product liability cases will likely never be started, filed, or pursued.
Klein's August 7, 2013 Motion for Stay of Mandata Pending Petition to the Supreme Court for Certiorari - Rehearing Denied July 30 ... :
" ... This is indeed a question of national importance. Lupron, in the [3.75 mg] forumation taken by Ms. Klein is popular and widely prescribed across the country. The court's erroneous label ruling will likely impact other women as they seek to hold Abbott responsible for devastating medical conditions they allege are caused by Lupron - complications that the prior labels show Abbott was previously aware of but chose not to warn against. ... "
07-30-13: Re: 'Klein v. TAP/Abbott' - Klein was Denied Rehearing (Docket #86).
Despite the facts and despite the injustices (briefly detailed below), "The petition for rehearing, and the petition for rehearing en banc [we]re denied" by this court. ... The next step for 'Klein v. TAP/Abbott' would be to petition the U.S. Supreme Court.
06-25-13: Klein Petition for Rehearing submitted . 06-25-13: Amended Petition Rehearing With Decision (Docket # 82)
See also Docket #89: Klein's letter, petition for rehearing, attachments & enclosures sent to Ninth Circuit Court (cc'd to President Obama & others) - which revealed, among others, that Klein's trial attorney "told [Klein] that Abbott offered him money (attorney's fees & costs) to drop my case [Klein v. TAP/Abbott]!" (see page 3)
re: Klein v. TAP/Abbott --- (see "TAKE NOTE" below)
SOMEONE - EVERYONE ( - ANYONE - ?? ) needs to critically analyze exactly how "justice" is 'applied' when lupron is involved:
To examine just *one* aspect of Klein's 2011 jury trial (jury found in favor of TAP/Abbott) and Klein's 2013 appeal: -- Klein claims that, in 2005 when she was prescribed "Lupron depot 3.75 mg for endometriosis", she was *not* warned about the adverse event of thyroid disease (which she developed post-lupron) and that there was *no* warning in the 2005 lupron label concerning the adverse event of thyroid disease - therefore TAP/Abbott is guilty of "failure to warn".
However, TAP/Abbott, in prior "Lupron depot 3.75 mg for endometriosis" labels, DID WARN consumers of thyroid adverse events. But during Klein's 2011 trial, the District Court would NOT allow the jury to see *any* prior "Lupron depot 3.75 mg for endometriosis" labels which evidenced this thyroid adverse event.
TAKE NOTE: The 9th Circuit ruling denying Klein's appeal states: "The district court did not abuse its discretion in excluding the challenged Lupron labels because they ALL contain information regarding the side effects of **DIFFERENT** formulations of Lupron, rendering them insufficiently relevant, unduly prejudicial, and likely to confuse the jury." (emphasis mine).
Say what?? WHEN has a Circuit Court ever MISSTATED FACTS?? And WHY would a Circuit Court MISSTATE FACTS??
Klein wished the jury to see "Lupron depot 3.75 mg for endometriosis" labels prior to 2005 (evidencing thyroid adverse events) - and the Circuit Court states these pre-2005 "Lupron depot 3.75 mg for endometriosis" labels were a "different forumulation" from the 2005 "Lupron depot 3.75 mg for endometriosis" that Klein took. NOT TRUE!!!!! ... repeat: NOT TRUE!!! Lupron 3.75 mg for endometriosis, whether 2005, pre-2005, or post-2005 is the SAME formulation!!!! Pre-2005 "Lupron depot 3.75 mg for endometriosis" ARE NOT, as the Court states, "DIFFERENT FORMULATIONS" from the 2005 "Lupron depot 3.75 mg for endometriosis" Klein received. HOW can the Circuit Court make this FALSE statement???????
And just how "confusing" to the jury could it be to hear and see that pre-2005 "Lupron depot 3.75 mg for endometriosis" labels contained a thyroid warning, but the 2005 "Lupron depot 3.75 mg for endeomtriosis" Klein received did not?
In addition, in 1986, *before* there was even a "3.75 mg depot (monthly) lupron" (which was approved in 1990), and, more significantly, *before* there was even any "depot" formulation of lupron (the first "depot lupron", 7.5 mg, was approved in 1989), TAP/Abbott knew that it's one and *only* formulation of lupron (the daily leuprolide acetate injection) had caused "thyroid enlargement" (i.e., see 1986 TAP Lupron product label, under "Endocrine System"; and see also 1991 'Facts and Comparisons'). Past Abbott foreign lupron product labels also state lupron ("Lucrin") is associated with "thyroid enlargement" (i.e., see 1995 Australia label). And the adverse event "Hyperthyroidism" had been reported to TAP/Abbott and the FDA since the '90's.
However, in the 2005 lupron product label provided to Klein, no such warning about any thyroid disease is mentioned.
TAP/Abbott's expert witness in the Klein 2011 jury trial, Dr. Richard Blackwell (who has a history of receiving TAP grant money to study lupron - i.e. see 'Birmingham Center', "The Leuprolide Study Group"), stated under oath during Klein's jury trial that "... it is absolutely biologically impossible for Lupron to affect the thyroid gland. No textbook, no article has ever supported that contention. It's simply biologically impossible." (emphasis in original) (see Appellant Opening Brief, p. 20). Klein's Appellant Opening Brief continues: "In fact, the prior labels for Lupron 3.75 mg admitted an association with [the use of lupron and] thyroid disease and extreme bone density loss - as does the current foreign label. Yet, these adverse events have been removed from the current US women's label." (emphasis mine) (Appellant Opening Brief, p. 20).
How can TAP/Abbott employ an expert to falsely claim "it is absolutely biologically impossible for Lupron to affect the thyroid gland" when a simple search of PubMed reveals medical journal articles (prior to Klein's lupron prescription) that identify an association of lupron with thyroid disease; i.e. "The role of leuprolide acetate therapy in triggering auto-immune thyroiditis" (2005); "Possible induction of Grave's disease & painless thyroiditis by GnRHa's [lupron/buserelin]" (2003); "The first report to demonstrate the association of thyroid disorder with leuprolide injections" (2000).
But during the Klein 2011 trial, the District Court refused to allow *any* reference to medical journal articles identifying the known adverse event of thyroid disease associated with lupron, and the District Court refused to allow *any* reference to any prior foreign or US labels or any current foreign labels that would identify the documented adverse event of thyroid disease associated with lupron. Instead, the District Court would allow *only* the 2005 label to be shown the jury --- the 2005 label which is missing the warning about known, prior, thyroid adverse events associated with lupron.
Moreover - it is unheard of that a Circuit Court would misstate facts.
So, to reiterate this bewildering travesty of justice:
TAP/Abbott *has* documented in prior US, prior foreign, and in current foreign lupron labels that it (TAP/Abbott) knows lupron IS associated with thyroid disease, but curiously TAP/Abbott removed this 'little bit of info' from the 2005 lupron label (the year of Klein's lupron prescription; therefore Klein was not warned of thyroid dangers), and Abbott has removed this thyroid warning from current US women's label as well.
The District Court curiously would only allow the 2005 label to be discussed, which, being devoid of any thyroid warning, created the illusion for the jury that there were NO thyroid adverse effects for Klein to have been warned about --- and so by a legal sleight of hand, Klein's claim of "failure to warn" was made to disappear.
TAP/Abbott's witness is a doctor with a history of receiving grant money from TAP/Abbott to study lupron, and curiously this 'expert' proclaims "it's simply biologically impossible for lupron to affect the thyroid gland" (a scientifically FALSE claim uttered under oath) .... while the District Court curiously refused to allow the jury to hear *any* discussion of the medical journal articles EVIDENCING an association of lupron with thyroid disease - which would have destroyed the credibility of TAP/Abbotts' expert witness in the eyes of the jury.
And then, on 2013 appeal of these obviously biased, mind boggling, smacking-of-injustice withholdings from the 2011 jury, the 9th Circuit Court (in a mere 2 day deliberation) determines that "Klein has not even remotely established that the district court exhibited such a high degree of favoritism or antagonism as to make fair judgment impossible." 9th Circuit Ruling was delivered on 05-17-13: ... Klein v. TAP/Abbott - "District Court ruling AFFIRMED".
And, in affirming, the Circuit Court MISSTATES FACTS, alleging that "Lupron depot 3.75 mg for endometriosis" pre-2005 is a "different formulation" from 2005 "Lupron depot 3.75 mg for endomtriosis"
Readers should contrast the above 9th Circus Court mentality ("Klein has not even remotely established that the district court exhibited such a high degree of favoritism") with the statement in Klein Amicus Brief: (p. 6) - "[Klein was] entirely shackled in the evidence she was allowed to present. It is particularly galling to have qualified (and expensive) expert witnesses on hand to testify, only for them to be shut down before the jury and precluded from offering competing expert opinions. The pattern shown by the record is deeply disturbing. Virtually every discovery and evidentiary ruling, and other orders of significance, went for one party [TAP/Abbott]. Klein was not entitled to a perfect trial, but at least an evenhanded one. Such a onesided proceeding was not the fair trial our system demands." (emphasis mine).
This bewildering fiasco is indeed deeply disturbing, and mighty curious - and it begs for a propr legal remedy, as well as a vigorous investigation and public exposure.
Can someone please tell me - HOW can a doctor give false testimony under oath, and WHEN has a Circuit Court EVER misstated facts?
And what happens to Karin Klein and ALL the other lupron victims seeking legal "justice"?
05-14-13: Klein Appeal Hearing was Held today without oral argument. There is no set time limit for the Court's decisions, but most cases are decided within 3 to 12 months.
05-06-13: Karin Klein's appeal hearing ordered submitted without oral argument.
04-08-13: Appeal Brief of Karin Klein v. TAP/Abbott/Takeda filed. Oral arguments to be presented May 14th
06-06-12: US Court of Appeals, 9th Circuit: Klein v. TAP/Abbott/Takeda appeal filed
06-06-12: Klein's Appellant's Opening Brief
06-15-12: Klein's Amicus Brief - "Miscarriage of Justice" - "Deeply Disturbing"
09-21-11: Jury verdict in Klein v. TAP has been appealed. Case 2:08-cv-00681-RLH-RJJ - Document 310. Klein v. TAP (NV District Court, Case No. 2:2008cv00681), Filed 5/27/08.
08-10-11: Lupron verdict in Las Vegas trial deals blow to victims. Plaintiff has until September 21, 2011 to appeal verdict.
08-01-11: The FIRST lupron lawsuit to be scheduled for TRIAL - 'Klein v. TAP/Abbott', in Nevada (case listed below) - begins on 08-01-11 with jury selection. All other prior lawsuits to date have been settled out of court, with secrecy agreements ("gag orders"). 'Klein v. TAP/Abbott' is scheduled for trial. See: "Trial for 'Overpriced Poison' Lupron begins in federal court" - Judge will not allow the admission into evidence any former U.S. lupron labels, foreign labels, warnings in PDR, scientific journals, MedWatch (adverse event) forms, or any information related to TAP's pleading guilty to a felony.
08-01-11: Follow 'Klein v. TAP/Abbott' on Twitter. See DeLuca & Nemeroff's lupron page. Watch DeLuca & Nemeroff's video: "Lupron health dangers for Lupron victims"
Re: 'Klein v. TAP/Abbott', Read Medical Expert Statement from Dr. David B. Redwine, renowned endometriosis expert, describing (among others) enticements by TAP to prescribe lupron, TAP's medical fraud, and the Dr.'s conclusion that lupron is "unsafe and harmful in addition to being ineffective."
Re: 'Klein v. TAP/Abbott', Read Medical Expert Statement from Dr. Gueriguian, describing the dangers and disabling effects of lupron.
Example of Attorney Letters Rec'd re: lupron litigation
05-11-15: A new, individual plaintiff lawsuit was filed in Northern District of Illinois - 'Terry Paulsen vs. Abbott Labs, Takeda, TAP', Case No.: 1:15-cv-04144.
Terry, an ICU RN and avid horsewoman prior to becoming disabled post-lupron, had been one of four plaintiffs in a prior class action lawsuit in which the attorney retired mid-case. (For further details, scroll in Left column to 'Class Actions'). Now having found another attorney, Terry has filed a new complaint as a sole plaintiff.
There is no information on any Lupron class action lawsuits at this time.
Read Medical Expert Statement from Dr. David B. Redwine, renowned endometriosis expert, describing (among others) enticements by TAP to prescribe lupron, TAP's medical fraud, and the Dr.'s conclusion that lupron is "unsafe and harmful in addition to being ineffective." .... Read Medical Expert Statement of Dr. John Gueriguian (a former FDA Medical Officer involved in the initial FDA approval of lupron for palliative treatment of prostate cancer), describing the dangers and disabling effects of lupron.
A number of law firms, attorney brokers, and consumer websites have posted informational notices online about Lupron and litigation, but to the best of my knowledge not one case has been filed by any of these groups. The following links are provided not with the expectation that these law firms will provide legal assistance, but rather these links are provided for informational purposes only: i.e., see here or here and here or here and here and here (the latter website erroneously states that Lupron's manufacturer "has not yet added any warning labels for long-term health problems", but, in fact, a number of warnings have been added, i.e., these).
2015 Salkowlaw.com (a legal firm that refers potential clients to attorneys) states: "Many class action lawsuits [vs. Lupron] have come about ... you may be entitled to compensation based upon the various Lupron class action suits that are taking place all over the country."
While I would like to think the above information is accurate, I cannot confirm that "various Lupron class action suits are taking place all over the country". Numerous class action lawsuits involving Lupron and billing fraud/price inflation have taken place throughout the country (see Left column, scroll below for info), but to the best of my knowledge the only class action lawsuits involving Lupron and personal injury/product liability were the 2 former cases 'Cardenas et al' and 'Arnett et al' (see Left column, scroll below for info).
And it should be mentioned that at the above Salkowlaw.com's Lupron page, there is an erroneous claim made - specifically that "[Lupron] does not prevent a person from having children later because the injections can be stopped when one wishes to try for kids". In fact, "Infertility", "Menstrual irregularities", "Premature Menopause", "Menopause", and "Abortion spontaneous" have all been reported to the FDA as adverse reactions to Lupron. And in an independent review of Lupron's raw data from the endometriosis clinical trials, Dr. Redwine found "62.5% of patients had not regained baseline estrogen levels by one year after stop of study ... This is definitive evidence of long-term damage to ovarian function" (see page 26 in this amicus curiae brief submitted to US Supreme Court regarding Lupron).
TAKE NOTE regarding the matter of HOMICIDE and Lupron ... the FDA has rec'd a MedWatch report for Lupron with a reported adverse event of "Homicide". Scroll below, to end of 'Introduction to this page', for further details.
Lupron and FRAUDULENT DATA:
As a result of Klein v. TAP/Abbott, Karin Klein's medical expert witness, Dr. David Redwine, had access to TAP/Abbott's endometriosis clinical trial data (which is under federal court seal, and thus not available for public inspection). As cited in pages 12 to 14 in a brief to the US Supreme Court (found at pages 25 to 27 of document), Dr. Redwine discovered evidence of fraudulent data and altered outcomes within the thousands of pages of TAP/Abbott's raw clinical trials data.
In 2011, Dr. Redwine submitted a 300-page 'Lupron Review' to the FDA ("Leuprolide - the "D" is Silent"), alerting and informing the FDA of the fraudulent data and altered outcomes discovered within this 1980's endometriosis clinical trials raw data. In 2013, the FDA responded and "determined that no regulatory action is needed" . The FDA response failed to address - or even mention - the fraudulent data and altered outcomes brought to its attention. This data has been hidden from the FDA during, and since, Lupron's FDA approval for 'pain management of endometriosis" - data that has been hidden for 30 years! If the FDA, tasked to ensure public safety, is not interested in investigating this 'circumstance' - exactly who would be interested? (Take note that several weeks ago, a top US scientific official quit in frustration over a "remarkably dysfunctional HHS bureaucracy"). See Open Letter to FDA from Lupron Victims Hub, mailed 3-17-14 and unanswered to date.
Recently, many pharmaceutical giants are releasing all their clinical trial data into accessible and searchable databases (see here, and here and here) - but AbbVie, like TAP and Abbott before it, sought to hide clinical trial data on its drugs (which includes Lupron). See EMA v. AbbVie (here also) --in which AbbVie (formerly known as TAP/Abbott) sued the European Medicines Agency (EMA) to prevent public disclosure of its clinical trial data. On April 2, 2014, the European parliment voted for clinical transparency; and as reported April 3, 2014, AbbVie dropped its case against EMA ... "AbbVie's efforts to impose secrecy on European regulators were scandalous" and "the time for secrecy is over". However, note that while AbbVie has acquiesced to transparency of its clinical trial data in Europe, in the U.S. TAP/Abbott/AbbVie still maintains a court seal on its endometriosis Lupron clinical trials data, preventing any public disclosure of the data from these endo trials.
See also the Takeda study on 'depression/suicide and GnRHa use' and note the censure of 'Study Results', 'Discussion' and 'Conclusions' on pages 4 - 7, and ponder the TOTAL BLACK-OUT of 'Key Findings' and 'Conclusions' for pages 87 - 175 (88 pages totally redacted). This data was censored because "disclosure would be prejudicial to commercial interests." For further details on the redaction of results of this study, see post under 'Noteworthy News', with a date of "rec'd December 2012", on 'Homepage'. (And take note that Takeda, after hiding data about its drug 'Actos', was just ordered to pay $6 Billion in damages.)
WHY does TAP/Abbott/AbbVie, and Takeda, need to keep their Lupron data redatced, out of the public view and under seal?? --- WHAT are they hiding?
Introduction to this page:
Much has been written about the infamous "Lupron billing fraud case" netting $875 million dollars for the US government (see left, below, @ 'Billing Fraud Lawsuits''). However, this page will focus on litigation involving the health risks of lupron as opposed to lupron’s billing fraud lawsuits. At the time of the government's investigation into lupron's billing fraud, I tried to interest the US Attorneys' office into an investigation of lupron's adverse health effects - to no avail.
If you are thinking of suing AbbVie, Abbott, TAP (the latter corporation now defunct, but 'exists on paper for purposes of litigation') or your doctor because of lupron-related health problems, you will need to find a lawyer and doctor - notoriously difficult feats post-lupron. At any given time, law firms in several states are investigating possible claims involving lupron, and any further developments will be posted here. In my opinion, a massive class action lawsuit is inevitable.
Be aware of your state’s statute of limitations on filing a lawsuit … there is a finite period of time (varies from state to state, and generally is 2 or 3 years) in which you/your lawyer can file suit (unless belated discovery or fraud can be proven), so it is imperative that you understand ‘the clock begins ticking’ as soon as you realize you may have been harmed. If you write a letter of complaint or concern about lupron's effects upon you to your doctor, state medical board, any state or federal agencies, or the drug company (or place a telephone call to the drug company), your written/spoken words are on record and could serve as a record in any future litigation. Obtain copies of your medical records, and keep a log of your symptoms, complaints, and doctor's visits. Keeping a log of your written and telephone communications can be very helpful, especially when memory is an issue.
At left, please find an incomplete list of lawsuits involving lupron - as more cases become known, and as I find misplaced slips of papers with other case names on it, more cases will be posted to this list. These particular lawsuits have been brought to my attention either through the newspaper, word of mouth, by internet chatrooms or message boards, or receipt via email, or searches of the internet, Justia, Lexis Nexis and PACER. The documents attached to several of the product liability or medical malpractice suits at left are all publicly available documents, found within court files that anyone can access if you know the case name, docket number, county, and state.
All past lupron cases against TAP that I am aware of have been dismissed and/or quietly settled, with reported secrecy agreements and 'gag orders'. Only one lupron litigation case has ever made it to trial - in 2011, in Nevada, the first Lupron lawsuit trial began; 'Klein v. TAP/Abbott. A trial should allow public scrutiny and exposure of the dangers, problems and casualities of lupron. But in 'Klein v. TAP/Abbott', much evidence was suppressed from the jury (i.e., lupron adverse event reports, and published medical studies identifying thyroid adverse effects), and Abbott's medical expert committed perjury under oath (stating lupron could not affect the thyroid) - and the jury ruled in favor of Abbott on 08-10-11. See 'Klein v. TAP' at left, below, for further information detailing the judicial travesty involved in this case.
The lawsuits identified only by initials at left are lawsuits I am aware of but for which at present I don’t have any docket number or documents for validation, so these cases will remain unnamed until/unless more information is acquired.
In my own medical malpractice lawsuit involving lupron, many lawyers told me I “most definitely ha[d] a case, but without laws and standards [in the field of reproductive medicine] – and without a medical expert” they were unable to help me. I was told “if you can find the medical expert, we’ll take the case”. At the time of my lawsuit (1992) there was no medical expert willing to speak the truth about the risks and consequences of lupron (but that has thankfully changed), so I had to file my own lawsuit “pro se”(for self) - without an attorney - and without a medical expert. In the place of "medical expert testimony", I submitted to the court a statement by the National Lupron Victim Network providing expert testimony on lupron (see here), and additional testimony by Gena Corea (see here). I never expected to prevail in my lawsuit, but rather wished to leave 'a paper trail' in the courts for those who followed me. (There was no internet back then!)
I’ve included relevant portions of my brief to the Massachusetts Supreme Judicial Court at left fyi (@ 'Lupron Medical Malpractice') - the omitted portions pertain to matters unrelated to lupron (i.e., breach of confidentiality, breach of contract, bond). Also at left, I've included questions and answers relevant to lupron during discovery in my lawsuit ('Millican Discovery'). These interrogatories are from 1993, and my questions at that time were basic - but some of their answers are just plain incredulous - such as "the side effects to lupron are minimal". The page from Boston IVF Clinic's patient brochure describing lupron actually says that side effects to lupron are basically limited to ill men with prostate cancer!
If you should know of additional lawsuits (past or present) involving lupron/leuprolide/leuprorelin or other relins (other GnRHa's, i.e., nafarelin, buserelin, goserelin, histrelin, triptorelin) - please email the case name and state, and if known, the docket number and county; and I will try to obtain further information from the courts for posting here. If you have court documents which you would be willing to share, please forward by snail mail (see 'Contact' for address). And if you are the recipient of a TAP secrecy agreement involving a settled lupron litigation, please consider mailing a redacted (whited-out) copy so this (blank) TAP secrecy agreement can be posted for all to see.
Thank you in advance to anyone willing to help bring exposure to the devastation that is lupron.
If posting this public information has brought disquiet to any plaintiffs, I truly regret this - but I believe the need to know (on the part of present and future victims, the public, lawyers, and the medical community) outweigh consideration for sensitivities.
The ultimate goal is to expose the extent of the serious iatrogenic illnesses causally related to lupron, to provide remedy (medicolegal advocacy) for those injured, and to ensure that lupron never harms again.
Lupron and Homicide:
I have rec'd a request and authorization from an inmate at the Arizona State Prison, Michele Millikan, to relay her situation and to publicize a copy of her MedWatch form reporting the adverse event of Homicide while on lupron. First, here is a little background information:
At least as early as 1994 the lupron adverse event of "homicidal ideation" was reported to the FDA (by an OB/Gyn who felt the "homicidal ideation" evidenced during the patient's treatment for endometriosis was 'due to lupron / hypoestrogenism'). And it should be noted that a patient was dropped from the 1988 endometriosis lupron clinical trials due to "severe mood, dream-like state".
The FDA has rec'd MedWatch reports of the following adverse events to lupron (list is *not* inclusive): "depersonalization", "hallucinations", "memory loss", "memory disorder", "anxiety", "dream abnormalities", "emotional instability","disturbances in thinking", "thinking abnormally", "mood instability", "mental impairment", "depression", "manic reactions", "psychosis", "delusions", "paranoid reactions", "personality disorder", "suicide attempts", "psychotic depression", "suicide ideation", "suicide",
and "homicidal ideation" (and now "homicide").
*Any* lupron 'drug review website' can be searched to find reports of lupron users feeling "in a brain fog", "not like myself", "angry", "paranoid", "delusional", "belligerant", "aggressive", "crazy", "psychotic", "experiencing memory loss", etc. Other various women's issues websites also contain similar posts: for just one example, search HysterSisters for "homicide and lupron". And elsewhere, On this one page alone, references to altered mental status while on lupron can be found -- see entry 'dated 2-10-12' to read post "'out-of-body' experiences, to the point I didn't know who I was" (17 yo endo patient); see entry 'dated 6-2-12' to read post "Absolutely batshit crazy disposition ... my crazy out of control behavior and moods so bad my boyfriend and I did not survive" (40 yo fibroid patient); see entry 'dated 6-12-12' to read post "EXTREME CRAZYNESS! I literally went crazy. Major anger issues. Wasn't myself at all." (30 yo endo patient); see entry 'dated 7-8-12" for "SEVERE panic" (48 yo endo patient).
In a former FaceBook post, one woman asked "Has anyone else has bouts of I guess I would call it amnesia where you losing [sic] a certain amount of time but then comes back within a few hours? and what did you do for it and did you find someone willing to help? (no one is listening. They told me to go to the ER what a waste went there and they said there was nothing they could do). I couldn't even remember marrying my husband. I remembered him thank God but I couldn't remember us getting married. What's next forgetting who my kids are?"
Michele Millikan's May 28, 2013 report to the FDA of the adverse event of homicide to lupron appears to be the first reported homicide associated with lupron or any other GnRHa. Many other drugs have been associated with "Homicide" - should lupron/leuprolide be on this list? Are there other cases similar to Michele's circumstances that have gone unreported?
Michele is currently serving an 18 year prison sentence for 2nd degree murder of her husband, committed while in a dissociative state (abnormal/altered state of mind) apparently caused/induced by lupron. Since Michele had a history of depression prior to lupron's use, and was depressed on lupron, she should not have been prescribed lupron in the first place and/or lupron should have been discontinued. (According to a 1993 study 'Adverse effects of leuprolide acetate depot treatment' ... : "Two of the most disturbing adverse effects experienced by women receiving lupron were depression and short-term memory loss. ... Although the mechanism of these symptoms are unclear, GnRH-a treatment should be discontinued if depression or short-term memory loss develops.")
In Michele Millikan's MedWatch form filed with the FDA (and mailed to me, along with other documents), in 'Section 5' of the form ("Describe event/problem"), Michele wrote "See attached page". The following is a copy of that attached page (filed May 28, 2013):
"MedWatch 'Attached Page' of Michele Millikan:
Several days after my 6th injection of Lupron Depot, in some kind of an impossible-to-understand and difficult-to-explain 'fugue state', I killed my husband with a gunshot to the head while he was sleeping. I have NO MEMORY of waking up at 4 am in the morning on May 25, 1993 (or of the evening before) and I have NO MEMORY of retrieving the gun - the only memory of this horrific event I have is I do remember holding the gun pointed at him and thinking 'what am I doing?' With no further memory, and without any intent, and as if I had no control over my actions, I apparently did shoot and kill him. In shock afterwards, and, again, in an impossible-to-understand and difficult-to-explain state of mind, I told the police it was an 'accidental gun discharge as my husband was putting the gun away', and his death was ruled "inconclusive" in 1993. It was very hard for me to accept the truth that I had to have killed my husband. The severe guilt and utter confusion of how and why I could have done what I apparently did ate at me until 2001 when, against legal advice, I confessed to the police. I am now serving year 11 of the 18 year prison sentence I received for 2nd degree murder.
Our marriage was not perfect and like many marriages had its problems, but we had plans for the future, and were in the process of trying to conceive; and never once had I ever thought of harming, never mind killing my husband. I grew up in a Christian home, attended a Christian School, my father was the founder of a Biblical Counseling and Training Center, and both my husband and I worked at this Center. I did experience feelings of depression related to my infertility and marital stress, but I had no history of any kind of anger issues or emotional instability, had no prior criminal record - not even a speeding ticket. Committing this homicide was and is incomprehensible to me and to those who know me.
But recently I have learned that Lupron has a known history of causing serious, abnormal psychological symptoms, and I have been made aware that the FDA database contains the following reports: "disturbances in thinking", "memory loss", "thinking abnormally", "emotional instability", "mood instability", "mental impairment", "psychosis", "delusions", "paranoid reactions", "personality disorder", "suicide attempts", "suicide", and "homicidal ideation". And I have been made aware of countless public internet postings of women discussing the effects of Lupron and reporting "homicidal ideation", "extreme craziness", "severe mood swings", "out of body experiences", "wasn't myself at all", "not in control of my emtions", "foggy brain", "I didn't recognize myself in my behaviors", "memory loss", "very forgetful", "I turned into a different person", "doing some strange things I would have never done before", "severe episode of anger outburst; threatened to kill my boyfriend", and thousands more comments like these.
Since 1993 I have been plagued by the incomprehensibleness of my apparent actions - now I feel that finally there is an explanation for what happened to my mind and for what happened to my husband. Because of the extremely atypical and violent nature of my apparent actions, the timing of the Lupron injections with my 'fugue state', my life-long stable mental status, and my warm, even-tempered disposition before and since the event, I now strongly believe that Lupron was the causative factor in this homicide.
I also want to report to the FDA that while taking Lupron I suffered from numerous side effects - severe hot flashes, burning up from the inside out and soaking clothes, joint pain, irregular heart beat, depression, and memory lapses. To this day I continue to experience joint pain, irregular heart beat, and serious memory loss. In addition, I also have chronic headaches, numbness in the face, and shooting pains in my back, brain, eyes and chest."
In light of Michele's discovery of the known lupron adverse mental status effects, and the fact that these serious mitigating effects were not considered in her sentencing, Michele is now attempting to explore a possible reduction or commutation of her remaining sentence (she has served 11 years of her 18 year sentence).
Transcripts of Michele's Grand Jury proceedings state that "With regards to mental capacity, at this point in time, that would not be a probable cause determination. That would have to be a determination by the trial judge. It is something you should not take into consideration in your determinations." (emphasis mine). ... In transcripts of the judge's Sentencing of Michele, he states: "And I considered in mitigation the mental state of Michele Millikan, at the time of the offense. I cannot say that I understand it, but it's clear that although Michele Millikan did understand the nature of right and wrong and that this act was wrong, her mental state was -- if there is such a word -- not norm at the time of the event. For a combination of factors that is described by the psychologist in the report that is written to me. And it is too lengthy to go over in detail at this time. It's the Judgment of this Court that the Defendant should be sentenced to the aggravated term of 18 years in the Department of Corrections because this Court thinks the aggravating factors outweigh the mitigating factors." (emphasis mine) The "too lengthy" psychologist's report, in fact, states "all indicators are that Ms. Millikan was in a dissociative state of mind immediately prior to and during the death of [her husband]. Thus, Ms. Millikan can not be said to have intended to cause the death." Contrary to the judge's assessment that "it's clear  Michele Millikan did understand the nature of right and wrong and that this act was wrong ...", in fact, the psychologist's report states otherwise.
It is hoped that a second look at Michele's circumstances can take place, this time with a clinically accurate understanding of the mitigating factors created by lupron's adverse psychological effects. Although the psychologist's report noted that in the months before the homicide, Michele was found to have a "clinically significant mood alteration", no mention of or association to lupron was ever made or considered. The introduction of the impact of adverse lupron mental status effects should be given the consideration it deserves.
Michele's family and friends have remained steadfastly by her side, are committed to helping her, and are likewise relieved to have some answers to explain Michele's inexplicable actions ("No one who knows Michele can understand how this could have happened".) They have reached out, asking if anyone who might have had abnormal mental state and/or violent experiences on lupron to contact them, as they are trying to find enough evidence to justify asking for a new trial or pardon. To date, they have heard from a woman in Ohio who is willing to testify on Michele's behalf that while she was on lupron, she experienced inexplicable moods and behaviors resulting in her attacking her husband, hitting him in the head and requiring stitches.
If you, or someone you know, have or has experienced (or is experiencing) any of the above reported adverse psychiatric effects from lupron, or know of any instances of violence or homicide committed by someone on lupron, and would like to help Michele, please contact Michele's friend Erin Moosbrugger at firstname.lastname@example.org, or email here.