Cases

Biomet (M2a)
DePuy (ASR, Pinnacle)
Smith & Nephew (R3)
Stryker (ABGII, Rejuvenate)
Wright Medical (Conserve)
Zimmer (Durom)

Medical device

Hip replacement

Hip replacement

Total hip arthroplasty (hip replacement) works to reduce or eliminate pain and increase mobility for people experiencing hip pain or loss when conservative management and treatment has failed.

Defective hip implants can loosen or become misaligned over time, causing pain and requiring revision surgery to correct. Patients who have received metal-on-metal hip implants can develop metallosis (metal poisoning), also requiring replacement. In June of 2012, a panel of FDA commissioned experts reported that there was no reason for surgeons to continue using metal-on-metal hip replacement systems. Although concerns remain about the durability of ceramic hip implants, studies have shown that the majority of adverse patient outcomes involve metal-on-metal hip implants, prompting the FDA to order postmarket studies of metal-on-metal hip systems that resulted in recalls of hip devices.

Due to the large number of pending and potential lawsuits, the Judicial Panel on Multidistrict Litigation (JPML) has coordinated federal proceedings into Multi District Litigations (MDL) in Ohio, New Jersey, and Texas against manufacturers DePuy and Zimmer. State court cases against several different manufacturers are pending, including a Judicial Council Coordinated Proceeding (JCCP) for DePuy hip implant lawsuits in San Francisco (JCCP 10-004649).

Firm partner Steven J. Skikos was appointed as Plaintiffs’ Co-lead Counsel, part of the Plaintiffs’ Executive Committee, for the MDL No. 2197 in Ohio. Partner Mark Crawford has been appointed to serve on the Discovery Committee for the federal MDL.

Bair Hugger Total Temperature Management System
Warm Touch
Mistral-Air

Medical device

Used in surgical procedures and for prevention of hypothermia

Peri-prosthetic joint infection leading to complications including irrigation & debridement, revision surgeries, and amputation

Severe, life threatening infection

Forced air warming (“FAW”) systems are blankets used during surgical procedures to keep the patient warm in hopes of reducing post-surgical complications.

Most operating rooms are kept clean by positive pressure air flow pushing all the contaminants to the floor. However, FAW systems produce heat, which creates a convection current and brings the unclean air up into the surgical field. With the increased use of FAW systems in operating rooms, the incidence of post-surgical infections has increased, notably peri-prosthetic joint infections during hip and knee device implant procedures, leading to revisions, two stage revision surgeries, and even amputations.

Litigation is pending in state court in Minnesota against 3M, the manufacturer of the Bair Hugger, and a Multi District Litigation (“MDL”) is anticipated to be formed in federal court.

Benicar (olmesartan medoxomil)
Benicar HCT (olmesartan medoxomil-hydrochlorothiazide)
Tribenzor (olmesartan medoxomil, amlodpine, hydrochlorothiazide)
Azor (amlodipine and olmesartan medoxomil)

Angiotensin receptor blocker

Hypertension

Villous atrophy
Sprue-like enteropathy
Chronic diarrhea
Vomiting
Dehydration
Weight loss
Malnutrition

Benicar (olmesartan) is prescribed for the treatment of hypertension and one of the 10 most widely prescribed drugs in the United States. However, Benicar can cause severe and permanent gastrointestional problems including villous atrophy, or a destruction of the villi lining the small intestines, and sprue-like enteropathy, often misdiagnosed as Celiac’s Disease. Symptoms present as chronic diarrhea, vomiting, severe dehydration, malnutrition and staggering weight loss.

On July 3, 2013, the Food and Drug Administration issued a Safety Communication, highlighting the dangers Benicar and other olmesartan products can cause. In 2014, several lawsuits against Daiichi Sankyo, the maker of Benicar, were filed in both state and federal court, and that number is expected to grow, as Benicar remains on the market.

Fosamax (alendronate sodium)
Boniva (risedronate sodium)
Actonel (ibandronate sodium)
Reclast (zoledronic acid)

Bisphosphonate

Osteoporosis

Atypical femur fracture

T

Fosamax and its generic version, Alendronate Sodium, is a bisphosphonate, a class of drug designed to prevent bone loss and aid in the treatment of osteoporosis. Fosamax was approved for use by the FDA in 1995 and several other bisphosphonates and their generics gained approval shortly thereafter, with Actonel joining the market in 1997 and Boniva in 2003.

Evidence suggests, however, that long term use of bisphosphonates can lead to spontaneous atypical femur fractures (AFF) in those taking the drug, leading to excruciating femur breaks, often necessitating a need for surgical repair.

In 2010, the FDA updated safety information on the label of Fosamax and other bisphosphonates warning of the increased risk of AFFs.

In September 2011, the FDA again recommended increasing the cautionary language on the product labels for bisphosphonates, including Fosamax, Actonel, and Boniva.

A Multi District Litigation (MDL) for Fosamax femur fractures was created in 2011 in the United States District Court for the District of New Jersey (2243).  In California, the Judicial Counsel Coordinated Proceedings (JCCP) was created in Orange County Superior Court in front of Judge Ronald Bauer (4644).

Partners Steven Skikos and Mark Crawford were both appointed by the judge to serve as Co-Lead Counsel in the California JCCP, and also serve on the Plaintiff’s Executive Committee.

GranuFlo
Naturalyte

Sodium diacetate

Hemodialysis

Sudden cardiac arrest
Cardiopulmonary arrest
Cardiac arrhythmia
Cardiovascular death

Fresenius is the largest dialysis services and products company in the United States, operating approximately 1,800 dialysis clinics domestically and shipping their products to facilities nationwide. Since 2003, Fresenius has manufactured two products, GranuFlo and NaturaLyte, used in the treatment of acute and chronic renal failure during hemodialysis. Both products have been linked to causing metabolic alkalosis due to an excess of alkaline bicarbonate or acid deficiency. The resultant electrolyte imbalance leads to an increased risk of cardiovascular death and injury.

A Fresenius internal memo acknowledged the increased risk of injury and death from cardiac events following exposure to GranuFlo and Naturalyte, yet the company did not alert the FDA. The memo was anonymously leaked to the FDA, which then issued a Class 1 recall of Granuflo in March 2012. The FDA later issued safety communications to healthcare providers and dialysis clinics warning them of the higher risk of injury and death Fresenius’ products may cause in hemodialysis patients. Fresenius responded by announcing in June 2012 that it would place updated labels on its Granuflo and Naturalyte products. The products are still being used in clinics across the country.

In March 2013, a multi-district litigation (MDL) was formed for federally filed cases in the District of Massachusetts. Trials in the MDL are tentatively set to begin in early 2016, and Missouri state court cases begin fall 2015.

InFuse Bone Graft

Medical device

Spinal fusion surgery for degenerative disc disease

Nerve damage
Chronic pain

Medtronic Inc. is the world’s largest provider of medical equipment, and in 2002, the FDA approved Medtronic’s use of the Infuse Bone Graft system in anterior lumbar fusion surgery only. Prior to Infuse, individuals undergoing spinal surgery would first need surgery to take bone from the hip to be used to stabilize the spinal column. Infuse uses a genetically engineered protein to promote bone growth. As a result, surgeons can eliminate bone graft surgery.

Infuse has been linked to numerous serious side effects, including various types of cancer and male infertility. In 2008, the FDA issued a warning that off-label use was not safe, yet evidence suggests Medtronic encouraged surgeons to use Infuse for a variety of procedures. Off-label Infuse usage has led to numerous health problems, including swelling in the neck, uncontrolled bone growth in the spine, nerve injuries, and other severe problems.

In 2011, Congress took interest in Medtronic’s activities after it discovered the company paid $20 million to physicians who conducted studies on Infuse and stated the product produced no negative side effects, despite evidence to the contrary. Congress released a report in 2012 indicating that Medtronic promoted the off-label use of Infuse without disclosing associated risks. In June 2013, the results of two independent reviews concluded that Infuse is no more effective than a bone graft, while carrying increased risks of cancer.

Claims against Medtronic are pending in various venues across the country.

Invokana
Invokamet
Farxiga
Xigduo XR
Jardiance
Glyxambi

SGLT2 inhibitor

Treatment of Type II Diabetes

Diabetic ketoacidosis
Renal failure

Invokana and other drugs in the Glifozin class came on the market in 2013 for the treatment of Type II Diabetes.

In a person without diabetes, sugars within the blood are metabolized by insulin processes, with normal blood sugars entering the kidney and going through a reabsorption to be reutilized within the body. By contrast, a diabetic often has too much sugar in the blood stream to be reabsorbed, therefore an emergency mechanism kicks in to filter the excess sugar through the kidneys and into the urine. This is a short term solution to a metabolic problem, however, and the kidneys are not designed to sustain this type of overload.

Invokana works to block the reabsorption process and capitalize on this biological emergency mechanism, putting strain on the kidneys, which can lead to renal failure, and leaving high levels of acid in the blood resulting in ketoacidosis. High levels of acid in the blood pose a significant risk of cardiovascular events.

Litigations against the manufacturer of these drugs, including Johnson & Johnson, are pending in a variety of state and federal venues across the country.

IVC Filters

Medical device implant

Prevention of pulmonary embolism

Filter fragmentation or fracture
Fragmentation embolism
Pulmonary embolism
Perforation of vessel walls
Filter migration
Filter tilt or shift
Infection
Death

IVC filters are devices surgically implanted into the inferior vena cava below the renal branches and attached to the wall of the vessel to filter out blood clots and prevent pulmonary embolism. While anticoagulant medication is the first choice for clot prevention, IVC filters were initially developed for permanent placement and use where anticoagulant medication is unsuccessful or contraindicated.

Retrievable IVC filters were developed around 2002 to 2003 for use in a patient population where removal was possible once a medical condition improves, such as with trauma patients or those undergoing orthopedic procedures. However, removal becomes increasingly complex the longer the IVC is left in place. Both permanent and retrievable IVC filters pose substantial risks.

In August 2010, the FDA issued a safety communication regarding retrievable IVC filters. The agency was concerned about doctors not retrieving IVC filters intended for short-term placement, exposing patients to substantial health risks.

Litigation is pending in state and federal court against the two manufacturers with the largest share of IVC filters on the market, C.R. Bard and Cook. Multidistrict Litigation (“MDL”) number 2570 is pending against Cook in the Southern District of Indiana before the Honorable Judge Laura A. Briggs, and it is anticipated that an MDL will be formed for the Bard litigation as well.

Lipitor (atorvastatin)

Statin

Hyper cholesterol

Type II diabetes

Lipitor (atorvastatin) is a medication marketed by Pfizer and prescribed by physicians to lower cholesterol and triglyceride levels thus reducing the risk of heart attack, stroke, and other dangerous health complications. Unfortunately Lipitor can cause serious side effects, including elevation in blood sugar levels which carries an increased risk for the development of new-onset Type II Diabetes, especially in women.

In 2012, the Food and Drug Administration issued a Safety Communication, calling for label changes and periodic monitoring of patients taking statins such as Lipitor. Lawsuits against Pfizer are currently pending across the country, with over 2000 coordinated in Multi District Litigation (MDL) 2502 before Judge Richard M. Gergel in the United States District Court for the State of South Carolina.

Mirena (levonorgertel)

Intrauterine device

Birth control

Migration
Organ perforation
Surgical removal

Mirena is an intrauterine device (IUD) that releases levonorgestrel, a chemical used to prevent pregnancy and treat heavy menstrual bleeding. The Food and Drug Administration (FDA) approved Mirena for use as a contraceptive in 2000, and approved Mirena to treat menstrual bleeding in 2009. Mirena is sold by Bayer, a German company with subsidiaries in the United States and across the world.

In April 2013, these claims were consolidated into Multi District Litigation (MDL) 2434 before the Honorable Cathy Siebel in the Southern District of New York. Suits are also pending in Bergen County Superior Court in New Jersey, being heard under New Jersey’s Multicounty Litigation process. (In Re: Mirena Litigation; Case No. 297)

Power morcellators

Surgical device

Tissue extraction from:

• Myomectomy
• Hysterectomy
• Oophorectomy
• Salpingectomy

Leiomyosarcoma
Endometrial stromal sarcoma
Carcinosarcoma
Endometrial adenocarcinoma

Power morcellators are surgical devices used during laparoscopic and robotic procedures such as hysterectomies or myomectomies to remove tissue from the body. The devices work by breaking the tissue into smaller pieces that are vacuumed out of the body. However, if this tissue contains previously undiagnosed cancer, the fragmentation technique of the power morcellators can spread the cancer throughout the uterus, facilitating rapid and increased metastization.

The Food and Drug Administration released a Safety Advisory in April 2014 on the serious side effects caused by power morcellation. In July 2014, one of the main manufacturers of the device, Johnson & Johnson, issued a recall of its product, although several manufactuers including Lumenis Ltd., LiNa Medical, Karl Storz, and Smith & Nephew still have their products on the market. Lawsuits against the several manufacturers are starting to be filed in a variety of venues across the county, and, due to the serious nature of the side effects caused by power morcellation, many are expected to follow.

Onglyza (saxagliptin)
Kombiglyze (saxagliptin and metformin)

Dipeptidyl peptidase-4 (DPP-4) inhibitor

Type 2 diabetes

Heart failure

Onglyza and Kombiglyze are used to help control high blood sugar in patients with type 2 diabetes. These drugs were developed by Bristol-Myers Squibb (BMS) and in 2007, AstraZeneca joined with BMS to market the drugs. The Food and Drug Administration (FDA) approved Onglyza in July 2009 and Kombiglyze in November 2010.

In February 2014, the FDA requested additional data from the manufacturer of these drugs based on a study published in the New England Journal of Medicine (NEJM) that reported an increased rate of hospitalization for heart failure. In April 2015, after reviewing the data, an FDA Advisory Committee voted 14 to 1 to add a new heart failure warning to the drug label. The one person who voted against the label change wanted to pull the drug from the market.

Reglan (metoclopramide)

Benzamide

Treatment of GERD
Prevention of nausea, vomiting, and heartburn

Tardive dyskinesia
Parkinsonism
Neuroleptic malignant syndrome
Depression

Reglan (metoclopramide) is used to treat gastric esophageal reflux disease (GERD) and prevent nausea, vomiting, and heartburn. There are many generic forms of Reglan that contain metoclopramide.

According to a medication guide published by the Food and Drug Administration (FDA), serious side effects of Reglan may include tardive dyskinesia (TD), Parkinsonism, neuroleptic malignant syndrome (NMS), depression, and thoughts of suicide

Risperdal (risperidone)
Invega (paliperidone)

Atypical antipsychotic

Schizophrenia
Bipolar disorder
Irritability associated with Autism in children (post 2006)

Gynecomastia
Excessive weight gain
Galactorrhea

Risperdal (risperidone) was approved by the FDA in 1993 for use in treating bipolar disorder and schizophrenia. In 2006, the FDA approved Risperdal to treat irritability associated with Autism in  children.  Manufactured by Janssen, a subsidiary of Johnson & Johnson, Risperdal was at one time its highest selling drug, accounting for $24.2 billion in sales from 2003 to 2010.

In addition to its FDA approved uses, the drug has been prescribed off-label in an attempt to treat other mental conditions, including anxiety, obsessive-compulsive disorder (OCD), dementia and post-traumatic stress disorder (PTSD). Off-label Risperdal use has been linked to profound negative consequences.

Risperdal can stimulate prolactin, a hormone associated with milk production. As a result of hyperprolactinemia, a notable side effect for some children or men taking Risperdal is gynecomastia, or enlarged breasts. Reports have indicated that some users even experience galactorrhea or milk production. In addition to the disruption of hormones Risperdal causes, the growth of breasts in a child, adolescent or a man is likely to cause lasting psychological and mental harm. Moreover, a mastectomy, or other surgical removal of breast tissue, is the only treatment known to remove gynecomastia.

At the state and federal levels, there have been numerous claims involving Johnson & Johnson’s failure to accurately state the risks involved with Risperdal. These claims also involved Johnson & Johnson’s practice of awarding kickbacks to physicians and facilities which prescribed Risperdal for off-label uses.

As of 2015, there have been two trials, both of which were held in Philadelphia, with one victory for the plaintiffs and one for the defense.

The California litigation is in Los Angeles Superior Court and is overseen by Judge William Highberger. There have been several hundred lawsuits filed in California thus far, with more anticipated. Gregory Skikos and Mark Crawford of Skikos, Crawford, Skikos & Joseph, hold leadership positions as co-liaison counsel in the California litigation.

Celexa (citalopram)
Effexor (venlafaxine)
Lexapro (escitalopram)
Paxil (paroxetine)
Prozac (fluoxetine)
Zoloft (sertraline)

Selective serotonin re-uptake inhibitor (SSRI)
Serotonin–norepinephrine reuptake inhibitor (SNRI)

Antidepressants

Birth defects
Autism

Antidepressant medications which fall into the class of drugs known as SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin-norepinephrine reuptake inhibitors) are frequently prescribed to treat depression and anxiety, as well as other mood disorders. Frequently these drugs are prescribed to women of child-bearing age.

The first SSRI drug to be introduced to the market was Prozac (1988), followed by Zoloft (1991), Paxil (1996) Celexa (1998), Effexor (1999), and Lexapro (2002).

Studies have shown that use of SSRIs or SNRIs during the first trimester of pregnancy is associated with increased risk of autism and congenital birth defects including cardiac defects, spina bifida, and neural tube defects as well as others.

In April 2012, Multi District Litigation (MDL) 2342 was created for Zoloft cases in the Eastern District of Pennsylvania before the Honorable Cynthia M. Rufe. Hundreds of cases against the various SSRI manufacturers are also pending throughout the country in a range of state court venues, including California.

Androgel (testosterone)
Androderm (testosterone)
Axiron (testosterone)
Bio-T-Gel (testosterone)
Delatestryl (testosterone enanthate)
Depo-Testosternone (testosterone cypionate)
Fortesta (testosterone)
Striant (testosterone)
Testim (testosterone)
Testopel (testosterone)

Androgen

Hormone replacement

Heart attack
Myocardial infarction
Congestive heart failure
Stroke
Pulmonary embolism
Deep vein thrombosis (DVT)
Death

Testosterone therapy was approved by the FDA starting in approximately 2000 to treat conditions related to hypogonadism, a condition associated with genetic disorders or procedures such as chemotherapy. However, manufacturers of the product have created their own disease of “low testosterone” to market their product as a treatment for a wide variety of symptoms related to aging.

Testosterone therapy is most often administered as a gel, patch, or injection. The market leaders are Androgel and Axiron.

Recent studies have linked testosterone treatments to an increased risk of heart attack, myocardial infarction, congestive heart failure, stroke, pulmonary embolism, deep vein thrombosis, and death. Individual cases have been filed against the manufacturers of testosterone therapy low products in a variety of state and federal court venues across the country.

Transvaginal Mesh

Medical device

Pelvic Organ Prolapse (POP)
Stress Urinary Incontinence (SUI)

Surgical repair
Bowel problems
Dyspareunia
Erosion
Extrusion
Infection
Fistula
Neuromuscular problems
Organ perforation
Pain
Recurrence
Scarring
Urinary problems

Pelvic Organ Prolapse (POP) is a condition in which the bladder, vagina, uterus, rectum, or bowel has dropped from its normal position, and Stress Urinary Incontinence (SUI) is a condition of bladder leakage. Transvaginal mesh implants are used to correct symptoms of both POP and SUI. The failures and side-effects of the devices can lead to devastating injuries, some of which require surgical repair, and can include bowel problems, dyspareunia, erosion, extrusion, fistula, infection, neuromuscular problems, organ perforation, pain, recurrence, scarring, and urinary problems.

In July 2011, the Federal Drug Administration (FDA) issued a public safety update regarding complications of transvaginal mesh for treatment of prolapse, stating that mesh repairs are no more effective than non-mesh repairs for treating prolapse. In September 2012, the FDA stated it was considering reclassifying transvaginal mesh as a high-risk device and ordered post-market studies from several manufacturers.

Several different Multi District Litigations (MDL) are pending against several defendants in the United States District Court for the Southern District of West Virginia against the Honorable Judge Goodwin as well as in several state court venues

Tylenol (acetaminophen)

Over the counter analgesic

Pain and fever reduction
Allergy, cold, cough and flu symptom relief

Liver failure

An over-the-counter (OTC) medication, Tylenol is used to treat symptoms of many illnesses, including the common cold and flu. Tylenol and related products are manufactured by McNeil PPC, Inc., a subsidiary of Johnson & Johnson.

The active ingredient in Tylenol is acetaminophen, which is linked to acute liver failure damage. Overdose can occur when an individual takes an OTC drug containing acetaminophen and a prescription drug containing it as well. However, even when this product is taken as directed, liver failure can occur.

Over the years, McNeil has made numerous changes to Tylenol’s warning labels in response to the risk of liver failure.

In April 2013, the United States District Panel on Multidistrict Litigation transferred claims to the U.S. District Court, Eastern District of Pennsylvania creating MDL 2436.

Xarelto (rivaroxaban)

Factor Xa inhibitor

Anticoagulant

Uncontrolled internal bleed events
Intracranial hemorrhage
Death

Xarelto (rivaroxaban) is a Factor Xa Inhibitor, or anticoagulant, approved in 2011 for the prevention of blood clots that can lead to injuries such as deep vein thrombosis (DVT) and pulmonary embolism (PE). Xarelto is the second most prescribed drug for lowering the risk of stroke in patients with atrial fibrillation.

Manufacturer Janssen Pharmaceuticals, Inc. aggressively marketed Xarelto as the convenient alternative to other similar medications because it required no routine blood testing or monitoring. Xarelto’s high degree of variability, when left unchecked, creates a dangerous situation wherein the blood may become too thin, leading to uncontrolled bleed events. These events cause serious health risks and complications, and in some cases, can lead to death.

Multi District Litigation (MDL) number 2592 was formed in United States Eastern District of Louisiana the before the Honorable Judge Eldon E. Fallon, and several claims have been filed, with many more anticipated to follow both there and throughout the country.

Gianvi
Ocella
Yasmin
Yaz

Oral contraceptive

Birth control
Menstrual regulation

Deep vein thrombosis (DVT)
Pulmonary embolism
Stroke
Death

Yaz, Yasmin and their generic versions, Ocella and Gianvi, are birth control pills that are prescribed for daily use.  According to the Food and Drug Administration (FDA), these oral contraceptives have a higher risk of severe side effects than other birth control options.

In April 2012 the FDA updated the safety information for Yaz, Yasmin, Ocella, and Gianvi and required boxed warnings for their life-threatening effects including:

• Deep vein thrombosis
• Pulmonary embolism
• Stroke
• Death

Steven Skikos is the State-Federal Liaison Counsel to the consolidated California litigation in the MDL.  Steven is also Plaintiffs’ Co-Liaison Counsel and serves on the Plaintiffs’ Executive Committee in the California Coordinated Proceeding.

Jane Joseph is a member of the Science Committee, and Mark Crawford is a member of the Discovery Committee in the MDL.

Zimmer Persona Knee Implant

Medical device

Total knee replacement

Implant loosening leading to:

• Pain
• Bone and tissue damage
• Revision surgery

Persona: The Personalized Knee System was first introduced to the market by manufacturer Zimmer, Inc. in 2012 as a cementless knee replacement system.

Quickly thereafter adverse events such as radiolucent lines, or large gaps between the implant and bone, and implant loosening led to a voluntary recall of the product on March 12, 2015 by Zimmer, Inc.

Nearly 12,000 Personas have been distributed worldwide, and it is expected that several thousand lawsuits will be filed across the country.

Zofran (ondansetron)

Antiemetic

Treatment of nausea and vomiting

Birth Defects, including:

• Cardiac defect
• Septal defect
• Cleft palate
• Kidney defects
• Neural tube defects
• Craniosynostosis
• Gastroschisis

Zofran is manufactured by GlaxoSmithKline and received approval in 1991 as an antiemetic for chemotherapy treatment in cancer patients and in the mid 1990’s as a treatment for post-operative nausea.

Nevertheless, Zofran has been marketed and prescribed “off-label” to pregnant women since 1998 as an anti-nausea medication.  Zofran works by inhibiting serotonin activity within the brain, and when a fetus is exposed to the drug, can lead to serious birth defects including cardiac defects, especially septal defects and cleft palate. Zofran has also been associated with other injuries including kidney defects, neural tube defects, craniosynostosis and gastroschisis.

An application is pending before the Judicial Panel on Multidistrict Litigation (JPML) for the coordination of the thousands of anticipated Zofran lawsuits.