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.

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FDA Advises Discussing Options Before Using Essure Permanent Birth Control

essureThe FDA recommended on Nov. 15 that health care providers thoroughly discuss available sterilization and birth control methods with their patients, including their benefits and risks of Bayer’s Essure permanent birth control system.

Essure labeling now includes the addition of a boxed warning and a Patient Decision Checklist, both intended to support patient counseling and understanding of benefits and risks associated with Essure, as well as what to expect during and after the Essure procedure. The boxed warning includes safety statements to clearly communicate significant side effects or adverse outcomes associated with this device and information about the potential need for removal.

A California judge ordered that all California product liability lawsuits brought against Bayer Corporation and several subsidiaries involving its Essure birth control device will be coordinated before a single judge in Alameda County Superior Court going forward. The case is Essure Product Cases and Coordinated Actions, Judicial Council Coordination Proceeding No. 4887.

Sterilization options

The Patient Decision Checklist provides key information about the device, its use, and safety and effectiveness outcomes, of which the patient should be aware and discuss with her doctor as she considers her sterilization options. Bayer also incorporates important modifications to the patient counseling and device removal sections of the labeling to provide physicians with additional guidance in these critical areas.

Bayer revised the physician instructions for use and patient labeling consistent with FDA’s recently finalized guidance: Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization.

Essure is a permanently implanted birth control device for women (female sterilization). Implantation of Essure does not require a surgical incision. In the procedure, a health care provider inserts flexible coils through the vagina and cervix and into the fallopian tubes – the tubes that carry the eggs from the ovaries to the uterus. Over a period of about three months, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs, thus preventing conception. Essure is considered a permanent form of birth control and therefore is not intended to be removed.

Over the past several years, the FDA has been examining the growing number of adverse event reports associated with the use of Essure. Reported adverse events include persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions. Some women have had surgical procedures to remove the device. In addition, Essure failure, and, in some cases, incomplete patient follow-up, have resulted in unintended pregnancies.

 

 

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FDA Publishes New Medical Device Reporting for Manufacturers


fda-logo
The FDA issued a new Medical Device Reporting for Manufacturers, describing its current regulation on reporting and record keeping requirements applicable to manufacturers of medical devices for device-related adverse events and certain malfunctions.

These requirements are contained in its Medical Device Reporting (MDR) regulation at Title 21, Code of Federal Regulations (CFR), Part 803, as authorized by section 519 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations.

The MDR regulation provides a mechanism that allows the FDA to identify and monitor adverse events (deaths and serious injuries) and certain malfunctions involving medical devices. The goal is to detect and correct problems in a timely manner. The requirements of the MDR regulation are enforced under the authority of the FD&C Act. The enforcement mechanisms include seizure, injunction, civil money penalties, and criminal prosecution.

The MDR regulation also includes adverse event reporting and record keeping requirements for medical device user facilities (e.g., a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, outpatient treatment facility), importers of medical devices, and medical device distributors.

Basic requirements

Manufacturers, including foreign manufacturers, of legally marketed medical devices in the United States are required to:

  • Submit reports of MDR reportable events involving their medical devices [21 CFR 803.10(c) and 803.50];
  • Develop, maintain, and implement written procedures for the identification and evaluation of all medical device events (e.g., malfunctions, serious injuries and deaths) to determine whether the event is an MDR reportable event.
  • Establish and maintain complete files for all complaints concerning medical device events.

For manufacturers, “MDR reportable events” are events that manufacturers become aware of that reasonably suggest that one of their marketed devices may have caused or contributed to a death or serious injury, or has malfunctioned and the malfunction of the device or a similar device that they market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur .

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Plaintiffs Settle Risperdal Case with Johnson & Johnson in Philadelphia Court

Risperdal causes gynecomastia, or enlarged breasts, in men.
Risperdal causes gynecomastia, or enlarged breasts, in men.

The parties in a case charging that a boy who took Risperdal, causing him to grow female breasts, settled for an undisclosed amount with Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. Meanwhile, appeals continue over when the statute of limitations begins to run for victims of the Risperdal side effects.

  • A total of 2,085 Risperdal products liability cases are pending in the Complex Litigation Center of the Philadelphia Court of Common Pleas.
  • Another 300 cases are pending in the Superior Court of Los Angeles.

J&J Suppressed Science

In the Philadelphia case that settled, the plaintiff started taking Risperdal at age six for Asperger’s syndrome. N.F. v. Janssen Pharmaceuticals, Case No. 13500998. It would have been the sixth case to go to trial over evidence that Janssen hid a scientific link between the antipsychotic drug and male breast growth, or gynecomastia.

Jason Itkin of Arnold & Itkin in Houston, TX.
Plaintiff attorney Jason Itkin of Arnold & Itkin in Houston, TX.

Risperdal was approved by the U.S. Food and Drug Administration in 2002 to treat schizophrenia, but was not cleared for use in children until 2006.

Evidence that the company lied  about the scientific link and hid it from the Food and Drug Administration led to a $70 million jury verdict against Janssen on July 1. The case is Andrew Yount v. Janssen Pharmaceuticals Inc. et al., case number 1304002094, in the Court of Common Pleas of Philadelphia County, Pennsylvania. 

The jury in the Yount case found that J&J intentionally falsified, concealed, or destroyed material evidence,” states a press release from Arnold & Itkin.

“During trial, evidence that became known in the case as ‘Tab 4,’ was publicly revealed for the first time. Tab 4 includes scientific data showing a link between Risperdal and gynecomastia. The lawyers made a case that J&J intentionally kept Tab 4 secret- withholding it from the FDA and keeping it out of published scientific studies,” the press release states.

Janssen knew about a key safety analysis since 2002, but failed to give it to the FDA, as they should have, when looking to get Risperdal approved for children, according to New Brunswick Today.

In 2013 the Department of Justice penalized Johnson & Johnson for more than $2.2 billion to resolve criminal and civil investigations allegations include off-label marketing and kickbacks to doctors and pharmacists relating to Risperdal.

Appeal over Statute of Limitations

A appeals panel of the Pennsylvania Superior Court may decide in three cases whether plaintiffs should have been reasonably aware that Risperdal caused breast enlargement as of June 30, 2009, starting the statute of limitations.

In January 2015 Judge Arnold L. New, the Coordinating Judge of the Complex Litigation Center, ruled that plaintiffs had two years to file a claim starting from the 2009 date. In Re: Risperdal Litigation, case numbers 576 EDA 2015, 590 EDA 2015 and 2451 EDA 2015, in the Superior Court of the State of Pennsylvania.

Judge New said the potential connection between Risperdal and gynecomastia had been revealed in several medical journals and media reports, and added to the drug’s warning label.

In oral arguments in September, plaintiff attorneys argued to the appeals court that the trial judge had improperly attempted to set a global accrual date for Risperdal claims that didn’t conform to the individual experiences of the two men whose cases served as a springboard for the ruling.

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New MDLs Consolidate Cases for Abilify, Roundup, Talc and Taxotere

Consolidating thousands of lawsuits involving Abilify schizophrenia drug, Roundup herbicide, Talc powder and Taxotere cancer drug, US Judicial Panel on Multidistrict Litigation (JPML) in Washington, DC, created new multidistrict litigation (MDL) dockets for the mass tort cases.

This is good news for plaintiffs. In due course the assigned courts will create short-form complaints and plaintiff fact sheets, facilitating the filing of new actions. Each litigation will be led by a plaintiff’s steering committee appointed by the judge, who will set a discovery schedule and select representative cases for bellwether trials.

abilifyAbilify (Aripiprazole)

Responding to a motion from all the parties, the JPML created new MDL 2734, In re: Abilify Products Liability Litigation, supervised by US District Judge M. Casey Rodgers in the Northern District of Florida. The ruling consolidates 22 actions filed in 12 district courts against Bristol-Myers Squibb Company, Otsuka Pharmaceutical Co., Ltd. and Otsuka America Pharmaceutical, Inc.

Plaintiffs allege that Abilify, an atypical anti-psychotic medication commonly prescribed to treat schizophrenia, bipolar disorder, depression, and Tourette syndrome, can cause compulsive gambling behaviors. All the actions involve factual questions relating to whether Abilify was defectively designed or manufactured, whether defendants knew or should have known of the alleged propensity of Abilify to cause compulsive gambling behaviors in users, and whether defendants provided adequate instructions and warnings with this product.

For more information read FDA Links Abilify to Compulsive Gambling, Eating, Shopping and Sex

WHO-says-Roundup-probably-causes-cancerRoundup (Glyphosate)

Granting the plaintiffs’ motion, the JPML created the new MDL No. 2741, In Re: Roundup Products Liability Litigation, supervised by Judge US District Vince Chhabria in the Northern District of California. Monsanto opposed consolidation. There are 21 actions pending in 14 districts. Including the potential tag-along actions, there are now 37 actions pending in twenty-one districts. More than ten different law firms represent plaintiffs in these actions, which are spread across the country.

These actions share common factual questions arising out of allegations that Monsanto’s Roundup herbicide, particularly its active ingredient, glyphosate, causes non-Hodgkin’s lymphoma. Plaintiffs each allege that they or their decedents developed non-Hodgkin’s lymphoma after using Roundup over the course of several or more years. Plaintiffs also allege that the use of glyphosate in conjunction with other ingredients, in particular the surfactant polyethoxylated tallow amine (POEA), renders Roundup even more toxic than glyphosate on its own.

For more information read New Illinois Lawsuit Charges Monsanto’s Roundup Causes Cancer

talc johnson & johnsonTalcum Powder

The JPML created the new MDL 2738, In Re: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices and Products Liability Litigation, supervised by US District Judge Freda L. Wolfson in the District of New Jersey. There are 10 actions in 8 districts.

The plaintiffs allege that they or their decedents developed ovarian or uterine cancer following perineal application of Johnson & Johnson’s talcum powder products (namely, Johnson’s Baby Powder and Shower to Shower body powder). Two of the actions are consumer class actions brought on behalf of putative classes of women who allege that defendants deceptively marketed the talcum powder products for feminine hygienic use without disclosing talc’s carcinogenic properties. All the actions involve factual questions relating to the risk of cancer posed by talc and talc-based body powders, whether the defendants knew or should have known of this alleged risk, and whether defendants provided adequate instructions and warnings with respect to the products.

For more information read Behind the $55 Million Talc Verdict: J&J Knew About Cancer Risks Since the 1970s

taxotere hair lossTaxotere (Docetaxel)

The JPML created new MDL No. 2740, In Re: Taxotere (Docetaxel) Products Liability Litigation, supervised by Chief US District Judge Chief Judge Kurt Engelhardt in the Eastern District of Louisiana. The litigation consists of 33 actions pending in 16 districts. The panel also has been notified of 56 related actions pending in 25 districts.

Plaintiffs in these actions each allege that they experienced permanent hair loss as a result of using Taxotere. All actions will require discovery regarding the design, testing, manufacturing, marketing, and labeling of Taxotere. The defendant is Sanofi-Aventis U.S. LLC.

All the actions share common factual questions arising out of allegations that Taxotere (docetaxel), a chemotherapy drug, causes permanent hair loss, that defendants were aware of this possible side effect and failed to warn patients, and that defendants marketed Taxotere as more effective than other chemotherapy drugs when other drugs were equally effective without the associated permanent hair loss.

For further information read FDA Releases New Patient Info for Taxotere (Docetaxel) Cancer Drug

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Bard Can Look Into Plaintiffs’ Communications With FDA Regarding IVC Filters

Bard Denali IVC Filter
Bard Denali IVC Filter

US District Judge David G. Campbell overseeing the C.R. Bard IVC filter multidistrict litigation ruled on Sept. 6 that the company can conduct discovery into the plaintiffs’ alleged efforts to influence the Food and Drug Administration.

But the company cannot inquire into the plaintiffs’ communications with NBC Nightly News or third-party litigation funding. The case is In Re: Bard IVC Filters Products Liability Litigation, MDL Docket No. 2641 in Arizona.

Bard said in its motion that it wants to discover any role plaintiffs or their counsel had with the FDA that may have biased the agency, that may reflect improper motivation for the letters and that signals that the letters lack “trustworthiness” for admissibility.

Bard also said five NBC Nightly News stories about Bard’s IVC filters have become the “focal point” for the plaintiffs and they have interviewed Bard witnesses after their appearance in the stories. Bard said the plaintiffs’ communications with NBC could have biased the stories and are thus relevant to Bard’s defense.

No Work Product Protection

Judge Campbell ordered the plaintiffs to respond to interrogatories about their contact with the FDA. He said the requests are relevant to the defense and “proportional to the needs of the case.”

“Plaintiffs have placed and will continue to place much emphasis on the FDA letters, and information regarding Plaintiffs’ role in securing those letters or otherwise influencing the FDA’s actions is plainly relevant to the defense,” the judge wrote.

The plaintiffs argued that the FDA information would be hearsay, but the judge said “information need not be admissible in evidence to be discoverable under Federal Rule of Civil Procedure 26(b)(1).”

“Plaintiffs claim that their communications with the FDA are protected work product because they reveal mental impressions and strategies of counsel, but courts have widely held that communications with government regulators that might prompt government action that could prove beneficial in private litigation waive any work product protection,” the judge said.

As to discovery into the NBC stories, Judge Campbell denied the motion because the plaintiffs assured the court that the stories will not be used at trial.

There are 810 cases in the MDL.

For recent news developments, read:

Proof! C. R. Bard, Inc. has been Settling IVC Filter Cases

IVC Filter Cases Settling Quietly as Litigation Grows

 

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PharmaTech Recalling Diocto Liquid Stool Softener Because of Bacteria

bacteriaThe FDA is alerting healthcare professionals that PharmaTech LLC, Davie, Florida, is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories, Livonia, Michigan.

The agency confirmed the product has been contaminated with Burkholderia cepacia, a bacteria linked to an outbreak in five states.

Burkholderia cepacia is the name for a group or “complex” of bacteria that can be found in soil and water. The bacteria are often resistant to common antibiotics. Burkholderia cepacia poses little medical risk to healthy people; however, it is a known cause of infections in hospitalized patients. People with certain health conditions, like weakened immune systems or chronic lung diseases (particularly cystic fibrosis), may be more susceptible to infections with Burkholderia cepacia, according to Outbreak News Today.


Also read:

Essure Litigation Update Post FDA Action

$11.75 Million Settlement Proposed in Caldera Transvaginal Mesh Class Action

FDA Warns about Lead Poisoning with Best Bentonite Clay


In addition, FDA has received several adverse event reports of B. cepacia infections in patients. Some of these reports identify liquid docusate sodium products manufactured by companies other than PharmaTech. FDA and the Centers for Disease Control and Prevention continue to investigate the extent of this issue to identify other potentially contaminated liquid docusate sodium products.

PharmaTech manufactures the oral liquid docusate sodium, which is distributed nationwide by Rugby with a Rugby label in one pint (473 mL) bottles. The FDA joins the CDC in recommending that clinicians not use any liquid docusate sodium product as a stool softener or for any other medical purpose.

In June, a multi-state outbreak of Burkholderia cepacia infections started. These infections have occurred primarily in ventilated patients without cystic fibrosis and who are being treated in intensive care units.

Rugby Laboratories is a leading provider of Over the Counter, vitamin, and nutritional supplement products. “With more than 40 years of history, Rugby® has a comprehensive portfolio of products designed to enhance the quality of life for our consumers while reducing the cost of purchasing their medications,” its website states.

 

 

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