Court Selects 2 Testosterone Cases Against Lilly for Bellwether Trials

testosterone2The US District Court for the Northern District of Illinois selected two cases as Lilly Bellwether Trial cases in In re Testosterone Replacement Therapy Product Liability Litigation, MDL 2545.

There are 6,090 lawsuits over testosterone replacement treatments against Eli Lilly and other drug companies before US District Judge Matthew F. Kennelly in the multidistrict litigation docket. Lilly makes Axiron testosterone topical solution.

The cases set for trial are:

  • Plaintiff Tracy Garner who suffered a myocardial infarction, Case No 1:15-cv-02045
  • Plaintiff John Debroka, Jr., who suffered a deep vein thrombosis, Case No. 1:15-cv-09246

All the actions involve plaintiffs (or their survivors) who used one or more testosterone replacement therapies and contend that their (or their decedent’s) use of the drugs caused their injuries, which include:

  • heart attack
  • stroke
  • deep vein thrombosis
  • pulmonary embolism

On January 31, 2014, the U.S. Food and Drug Administration announced that it was “investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.” Plaintiffs filed the actions in the wake of this announcement.

In March 2015, the FDA issued a safety communication, cautioning men against taking testosterone products for low testosterone levels associated with aging. The agency also required companies manufacturing these drugs to change their labels to clarify the proper usages for their products. Manufacturers were also required to add warnings about the risks of heart attack and stroke associated with taking these drugs.

All testosterone replacement therapy actions share factual questions about general causation and the background science about the role of testosterone in the aging body, as well as involve common regulatory issues in light of the FDA’s announcement and subsequent actions, if any.

The hormone has been used off-label to treat a range of symptoms such as loss of energy, decreased muscle mass and reduced libido.

The defendants include:

  • AbbVie Inc. and Abbott Laboratories Inc. (collectively Abbot)
  • Eli Lilly and Co. and Lilly USA LLC
  • Endo Pharmaceuticals
  • Actavis, Inc.
  • Auxilium Pharmaceuticals, Inc.
  • Pfizer, Inc.
  • Pharmacia

Read More

Pharma and Med Device Companies Pay Doctors $2 Billion for “Consulting”

bribe doctor kickbackEven though it is illegal to pay kickbacks to doctors, pharmaceutical and medical device companies are paying $2 billion in general payments to 618,000 physicians each year, in addition to another $600 million a year to teaching hospitals, according to a ProPublica database.

General payments cover promotional speaking, consulting, meals, travel, gifts and royalties, but not research, as shown in its Dollars for Docs database.

The 10 drugs for which companies spent the most in payments to physicians in 2015 — many of which are targets of mass tort litigation —  were:

  1. Blood thinner Xarelto ($28.4 million).  In Re: Xarelto Products Liability Litigation in Philadelphia, hundreds of plaintiffs charge that the blood-thinning drug caused gastrointestinal bleeding, hemorrhagic strokes or death.
  2. Rheumatoid arthritis drug Humira ($24.9 million)
  3. Diabetes drug Invokana ($20.9 million). The Judicial Panel for Multidistrict Litigation (JPMDL) has created new MDL 2750 for Invokana (Canagliflozin) Products Liability Litigation in New Jersey.
  4. Hepatitis C drug Viekira ($19.2 million)
  5. Blood thinner Eliquis ($18.8 million). Bristol-Meyers Squibb Company and Pfizer Inc. have filed a motion to create new MDL No. 2757 in New York to hear Eliquis (Apixaban) products liability litigation.
  6. Diabetes drug Bydureon ($18.5 million)
  7. Testosterone drug Androgel ($15.3 million). US District Judge Matthew F. Kennelly has set June 5, 2017, for the start of first of six AbbVie bellwether trials in MDL 2545, in the Testosterone Replacement Therapy Products Liability Litigation in the Northern District of Illinois.
  8. Thyroid drug Synthroid ($14.7 million)
  9. Synthetic hormone Lupron ($14.3 million)
  10. Diabetes drug Victoza ($11.9 million).

“We’ve shown that physicians who receive payments from the industry tend to prescribe more brand-name drugs than those who don’t. Several academic studies later had similar findings. We also recently reported that companies continue to work with thousands of doctors who have received disciplinary sanctions against their licenses,” ProPublica states.

The disclosures included in Dollars for Docs were required under the Physician Payments Sunshine Act, a part of the 2010 Affordable Care Act.

For example, Janssen has paid $106 million to 141,294 doctors in connection with Xarelto, Invokana, Risperdal and many other drugs. From August 2013 to December 2015, Janssen paid:

Richard Aguilar
Internal Medicine
Huntington, CA
$345K
Gregory Mitchell
Specialist
Annapolis, MD
$290K
Bruce Bode
Endocrinology, Diabetes & Metabolism
Atlanta, GA
$286K

 

Read More

FDA Adds Addiction Warning to Testosterone

testosterone2The FDA approved class-wide labeling changes for all prescription testosterone products, adding a new Warning and updating the Abuse and Dependence section to include new safety information from published literature and case reports about the risks of abuse and dependence of testosterone and other anabolic androgenic steroids (AAS).

The Anabolic Steroids Control Act of 1990 placed AAS, including testosterone, in Schedule III of the Controlled Substances Act. Testosterone and other AAS are abused by adults and adolescents, including athletes and body builders.

Nearly 6,300 actions are consolidated before US District Judge Matthew F. Kennelly in MDL 2545, in the Testosterone Replacement Therapy Products Liability Litigation in the Northern District of Illinois. All the actions involve plaintiffs (or their survivors) who used one or more testosterone replacement therapies and contend that their (or their decedent’s) use of the drugs caused their injuries, which include:
  • heart attack
  • stroke
  • deep vein thrombosis
  • pulmonary embolism

All of these cases involve Androgel, a testosterone drug manufactured by AbbVie. Judge Kennelly has set June 5, 2017, for the start of first of six AbbVie bellwether trials

Danger of high doses

On January 31, 2014, the U.S. Food and Drug Administration announced that it was “investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.” Plaintiffs filed the actions in the wake of this announcement.

In March 2015, the FDA issued a safety communication, cautioning men against taking testosterone products for low testosterone levels associated with aging. The agency also required companies manufacturing these drugs to change their labels to clarify the appropriate usages for their products. Manufacturers were also required to add warnings about the risks of heart attack and stroke associated with taking these drugs.

Abuse of testosterone, usually at doses higher than those typically prescribed and usually in conjunction with other AAS, is associated with serious safety risks affecting the heart, brain, liver, mental health, and endocrine system.  Reported serious adverse outcomes include heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility. Individuals abusing high doses of testosterone have also reported withdrawal symptoms, such as depression, fatigue, irritability, loss of appetite, decreased libido, and insomnia.

The manufacturers of two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, were required to include a boxed warning on the products’ labels.

The new warning will alert prescribers to the abuse potential of testosterone and the serious adverse outcomes, especially those related to heart and mental health that have been reported in association with testosterone/AAS abuse.  In addition, all testosterone labeling has been revised to include information about adverse outcomes from abuse and dependence of testosterone/AAS. The Warning and Precautions section advises prescribers of the importance of measuring serum testosterone concentration if abuse is suspected.

Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Prescription testosterone products are FDA-approved as hormone replacement therapy for men who have low testosterone due to certain medical conditions. Examples of these conditions include failure of the testicles to produce testosterone because of genetic problems, or damage to the testicles from chemotherapy or infection.

Read More

Judge Sets 6 Bellwether Trials in Testosterone Mass Torts Litigation

testosterone2US District Judge Matthew F. Kennelly has set June 5, 2017, for the start of first of six AbbVie bellwether trials in MDL 2545, in the Testosterone Replacement Therapy Products Liability Litigation in the Northern District of Illinois.

Discovery deadlines start in September for more than 5,500 cases currently pending. All the actions involve plaintiffs (or their survivors) who used one or more testosterone replacement therapies and contend that their (or their decedent’s) use of the drugs caused their injuries, which include:

  • heart attack
  • stroke
  • deep vein thrombosis
  • pulmonary embolism

On January 31, 2014, the U.S. Food and Drug Administration announced that it was “investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.” Plaintiffs filed the actions in the wake of this announcement.

In March 2015, the FDA issued a safety communication, cautioning men against taking testosterone products for low testosterone levels associated with aging. The agency also required companies manufacturing these drugs to change their labels to clarify the appropriate usages for their products. Manufacturers were also required to add warnings about the risks of heart attack and stroke associated with taking these drugs.

All testosterone replacement therapy actions share factual questions about general causation and the background science regarding the role of testosterone in the aging body, as well as involve common regulatory issues in light of the FDA’s announcement and subsequent actions, if any.

The hormone has been used off-label to treat a range of symptoms such as loss of energy, decreased muscle mass and reduced libido.

The defendants include:

  • AbbVie Inc. and Abbott Laboratories Inc. (collectively Abbot)
  • Eli Lilly and Co. and Lilly USA LLC
  • Endo Pharmaceuticals
  • Actavis, Inc.
  • Auxilium Pharmaceuticals, Inc.
  • Pfizer, Inc.
  • Pharmacia

All of these cases involve Androgel, a testosterone drug manufactured by AbbVie.

The first case, which is slated to begin July 2017, was filed by Jeffrey Konrad. Konrad claims he suffered a myocardial infarction after taking Androgel. The order of the remaining cases will be determined at a later date. Once these trials are completed, Judge Kennelly is expected to select a second group of bellwether trials that will include Axiron, Testim, Androderm and other testosterone products.

Read More

MDL 2545 Created in Illinois for Testosterone Products Liability Litigation

AndrogelThe US Judicial Panel on Multidistrict Litigation transferred 45 actions pending in four districts (listed below in Schedule A) to the Northern District of Illinois on June 6, 2015, and assigned them to Judge Matthew F. Kennelly for consolidated pretrial proceedings. The panel renamed the MDL caption to In re: Testosterone Replacement Therapy Products Liability Litigation.

The defendants include:

  • AbbVie Inc. and Abbott Laboratories Inc. (collectively Abbot)
  • Eli Lilly and Co. and Lilly USA LLC
  • Endo Pharmaceuticals
  • Actavis, Inc.
  • Auxilium Pharmaceuticals, Inc.
  • Pfizer, Inc.
  • Pharmacia

FDA investigation

On January 31, 2014, the U.S. Food and Drug Administration announced that it was “investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.” Plaintiffs filed the actions in the wake of this announcement.

All the actions involve plaintiffs (or their survivors) who used one or more testosterone replacement therapies and contend that their (or their decedent’s) use of the drugs caused their injuries, which include heart attack, stroke, deep vein thrombosis, and pulmonary embolism. All testosterone replacement therapy actions share factual questions about general causation and the background science regarding the role of testosterone in the aging body (possibly including examination of the recent studies that prompted the FDA investigation), as well as involve common regulatory issues in light of the FDA’s announcement and subsequent actions, if any.

Henning v. AbbVie, Inc., Case: 1:14-cv-03384, is a representative example of a complaint. This case involves the prescription drug AndroGel, which is manufactured, sold, distributed and promoted by the Defendants AbbVie Inc. and Abbott Laboratories Inc. as a testosterone replacement therapy.

Defendants misrepresented that AndroGel is a safe and effective treatment for hypogonadism and a condition they referred to as “low testosterone,” when in fact the drug causes serious medical problems, including life threatening cardiac events, strokes, and thrombolytic events.

AndroGel causes the hematocrit level to increase, thereby thickening the blood. This effect, if not monitored and controlled properly, can lead to life threatening cardiac events, strokes and thrombolytic events. Defendants failed to adequately warn physicians about the risks associated with the AndroGel and the monitoring required to ensure their patients’ safety.

Defendants engaged in aggressive, award-winning direct-to-consumer and physician marketing and advertising campaigns for AndroGel. Further, Defendants engaged in an aggressive unbranded ―disease awareness‖ campaign to alert men that they might be suffering from ―low T or ―low testosterone.

Plaintiff Thomas Henning of Lansdale, Pennsylvania used AndroGel, according to his prescription, from May 2011 to February 2014. 60. On May 10, 2012, he suffered a STEMI – i.e., an ST segment elevation myocardial infarction – which is a heart attack that results when a coronary artery becomes completely blocked by a blood clot. Prior to using AndroGel, Plaintiff had no history of myocardial infarction or other heart attack.

SCHEDULE A

District of Colorado

SCHENKEIN v. ABBVIE, INC., ET AL., C.A. No. 1:14-00910                                       14cv4254

Northern District of Illinois

AURECCHIA V. ABBVIE INC. ET AL., C.A. No. 1:14-00772 MARINO v. ABBVIE, INC., ET AL., C.A. No. 1:14-00777 MYERS v. ABBVIE, INC., ET AL., C.A. No. 1:14-00780 CRIPE v. ABBVIE, INC., ET AL., C.A. No. 1:14-00843 JOHNSON v. ABBVIE, INC., ET AL., C.A. No. 1:14-00877 KELLY, SR. v. ABBVIE, INC., ET AL., C.A. No. 1:14-00879

GIBBY, ET AL. v. ABBVIE, INC., ET AL., C.A. No. 1:14-00917 HARDEE, ET AL. v. ABBVIE, INC., ET AL., C.A. No. 1:14-00918 LAU v. ABBVIE, INC., ET AL., C.A. No. 1:14-01298 BARTHOLIC v. ABBVIE, INC., ET AL., C.A. No. 1:14-01427 O’DONNELL v. ABBVIE, INC., ET AL., C.A. No. 1:14-01428 BLADES, ET AL. v. ABBVIE, INC., ET AL., C.A. No. 1:14-01471

CARPENTER, ET AL. v. ABBVIE, INC., ET AL., C.A. No. 1:14-01472 HUMPHRIES, ET AL. v. ABBVIE, INC., ET AL., C.A. No. 1:14-01473 DOBBS v. ABBVIE, INC., ET AL., C.A. No. 1:14-01474

HEADLEY v. ABBVIE, INC., ET AL., C.A. No. 1:14-01475 HUGHES, ET AL. v. ABBVIE, INC., ET AL., C.A. No. 1:14-01476 JACKSON, ET AL. v. ABBVIE INC., C.A. No. 1:14-01477 GORDON v. ABBVIE, INC., ET AL., C.A. No. 1:14-01478 JONES, ET AL. v. ABBVIE, INC., ET AL., C.A. No. 1:14-01479 KING, ET AL. v. ABBVIE, INC., ET AL., C.A. No. 1:14-01480 LEWIS, ET AL. v. ABBVIE, INC., ET AL., C.A. No. 1:14-01481 SAYLOR, ET AL. v. ABBVIE, INC., ET AL., C.A. No. 1:14-01482 CATAUDELLA v. ABBVIE, INC., ET AL., C.A. No. 1:14-01483 BAILEY v. ABBVIE, INC., ET AL., C.A. No. 1:14-01663 GORDON v. ABBVIE, INC., ET AL., C.A. No. 1:14-01665 WHITE v. ABBVIE, INC., ET AL., C.A. No. 1:14-01667 MONTGOMERY v. ABBVIE, INC., ET AL., C.A. No. 1:14-01668 ORTIZ v. ABBVIE, INC., ET AL., C.A. No. 1:14-01670

DELEON v. ABBVIE, INC., ET AL., C.A. No. 1:14-01673 DULA v. ABBVIE, INC., ET AL., C.A. No. 1:14-01726 LAROCHE v. ABBVIE, INC., ET AL., C.A. No. 1:14-01826

Northern District of Illinois (continued)

GEORGE v. ABBVIE, INC., ET AL., C.A. No. 1:14-02085 LUECK v. ABBVIE, INC., ET AL., C.A. No. 1:14-02140 EMMONS v. ABBVIE, INC., ET AL., C.A. No. 1:14-02221 DARBY, ET AL. v. ABBVIE, INC., ET AL., C.A. No. 1:14-02227 KOMRADA V. ABBVIE INC. ET AL., C.A. No. 1:14-02429

Eastern District of Louisiana

PEULER, ET AL. V. AUXILIUM PHARMACEUTICALS, INC., C.A. No. 2:14-0065814cv4255

LOCOCO, ET AL V. ABBVIE, INC., ET AL., C.A. No. 2:14-00774 BARRIOS, ET AL. V. ABBVIE, INC., ET AL., C.A. No. 2:14-00839

Eastern District of Pennsylvania

TEJEDA v. ABBVIE, INC., ET AL., C.A. No. 2:14-00946 HUSTED V. ABBVIE INC., ET AL., C.A. No. 2:14-02111

ALBRIGHT, ET AL. V. ABBVIE INC., ET AL., C.A. No. 2:14-02112 HARRIS, ET AL. V. ABBVIE INC., ET AL., C.A. No. 2:14-02113

 

Read More