Mass Torts Update for Plaintiff Attorneys

Sponsored by The National Trial LawyersAugust 31, 2016

Presented by John RayMass Tort Nexus

About John Ray• FDA regulatory expertise and skills

gained in pharmaceutical and medical device industries• Senior Consultant at Mass Tort Nexus,

Fort Lauderdale, Florida• Director, HTC Pharmaceutical Division

for 14 years• Brenau University in Atlanta, Magna

Cum Laude

Today’s agenda• New Pradaxa docket in Connecticut• IVC Filter• Xarelto• Fluoroquinolone antibiotics• Emerging: Roundup litigation

RoundUp Litigation (glyphosate)

RoundUp HistoryThe original Roundup herbicide1, containing the active ingredient glyphosate, was introduced in 1974.

It is probable that a majority of the worlds population has been exposed to RoundUp (glyphosate) via direct or indirect Exposure.

IRAC Changes Classification On March 20th 2015 The International Agency for Research on Cancer changed the Classification of Glyphosate to Group 2A“The herbicide glyphosate (gly-phos-ate) and the insecticides malathion and diazinon were classified as probably carcinogenic to humans (Group 2A).”

IARC Process for Assessment of Cancer Risk

• Group 1: Carcinogenic to humans• Group 2A: Probably carcinogenic to humans• Group 2B: Possibly carcinogenic to humans• Group 3: Unclassifiable as to carcinogenicity

to humans• Group 4: Probably not carcinogenic to

humans

IRAC Findings • Sufficient evidence of cancer in mice and rats that

were fed glyphosate over several years• Strong evidence of carcinogenicity from

mechanistic or cellular studies that explain how glyphosate may cause cancer• Limited evidence of cancer in humans from

epidemiologic studies of people, particularly pesticide applicators and farmworkers

What to ExpectPreemption Challenges Discovery Disputes Causation ChallengesNovel Legal TheoriesTrips to the Supreme CourtAgra-Politics

Learn More About the Round Up Litigation

Timothy Litzenburg of the Miller Law Firm will be speaking about the Round Up Litigation at the September Mass Tort Nexus Course. Tim is one of the attorneys involved with the motion for consolidation currently before the JPML.Contact Barbara Capasso at 954-383-3932 or barbara@masstortnexus.com for information on the Sept 23-26 Four Days to Mass Tort Success Course. More information related to the round up litigation can be found at: www.masstortnexus.com

Xarelto

Xarelto Injuries

• Uncontrolled Bleeding Events Due to Lack of Antidote and One Time Per Day Dosing• Ischemic Strokes (efficacy) due to One Time Per Day

Dosing • Other Blood Related Injuries

Current Xarelto Consolidations

• Xarelto Federal MDL Eastern District of Louisiana before Judge Eldon Fallon.• Philadelphia Court of Common Pleas Consolidation

before Judge Arnold New.

Choosing PA Court as VenueDiversity Issue States:

• California • Delaware• Indiana• New Jersey • Pennsylvania

Ischemic vs Hemorrhagic Stroke

More Information on Xarelto Joe Osborne, a member of the Xarelto Science Committee in the Federal MDL will be speaking at the Sept. 23-26 Four Days to Mass Tort Success Course in Fort Lauderdale. Contact Barbara Capasso at 954-383-3932 or barbara@masstortnexus.com for information on the Sept 23-26 Four Days to Mass Tort Success Course. More information related to the Xarelto litigation can be found at: www.masstortnexus.com

Pradaxa

Not Pradaxa MDL II• HHD-CV13-5036974-S - CONNECTICUT PRADAXA LITIGATION v.

BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. Docket Notice issued 05/02/2013.

Pradaxa cases can no longer be filed in the Federal MDL per post settlement order from that court.

Pradaxa cases may still be filed in the Connecticut Consolidation.

Information, orders and forms for the Connetticut Pradaxa Litigation ca be found on www.masstortnexus.com.

CONNECTICUT PRADAXA PRODUCTS LIABILTY

LITIGATION• No prior case filed in the Federal MDL?• Client not represented (signed) prior to 05/28/2014• Applicable Law Injury w/o death: Connecticut in

non-death cases. ( 3 year SOL)• Applicable Law Death: State of original jurisdiction. • Applicable SOL Injury: 3 years ending 07/27/2017

for non-death cases. No case filed after this date will be viable in the Connecticut Litigation

IVC Filters

IVC Filter Injuries Tilt

FractureMigration

PenetrationEmbedment

Embolization Implanted with a Permanent IVC Filter?

FDA IVC Filter Update May 2014 • Recommendations/Actions:

The FDA recommends that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from pulmonary embolism is no longer needed.• The FDA encourages all physicians involved in the

treatment and follow-up of patients receiving IVC filters to consider the risks and benefits of filter removal for each patient. A patient should be referred for IVC filter removal when the risk/benefit profile favors removal and the procedure is feasible given the patient’s health status

IVC Filter Manufacturers

CR Bard/ Bard PV B. Braun Medical Inc

Cook Medical /William Cook EU Crux Biomedical

Rex Medical/Argon Medical ALN Implants

Cordis (J&J) Edwards Lab

Boston Scientific Corp Volcano Corporation*

Current Federal IVC Filter MDLs• Bard IVC Filter Product Liability MDL 2641 US District Court Arizona Judge David Campbell

• Cook Medical IVC Filter Product Liability MDL 2570 US District Court Southern District Indiana Judge Richard L Young

Cordis Motion to Consolidate

• SUPERIOR COURT OF THE STATE OF CALIFORNIA FOR THE COUNTY OF ALAMEDA • NOTICE OF MOTION AND MOTION FOR

CONSOLIDATION OF CASES Date: June 28, 2016

• Document related to the Cordis Consolidation can be found at www.masstortnexus.com

Rex Medical Argon Medical A number of cases have been filed in the Philadelphia Court of Common Pleas. These cases are before Judge Arnold New and assigned to the complex litigation track.

Evolution of IVC Filter LitigationThere are similarities between the Transvaginal Mesh Litigation and the IVC Filter Litigation in so far as there are multiple manufacturers and all of their products are arguably defective.The IVC Filter Litigation however, differs from the TVM litigation due to the fact that in TVM, discovery of the fact that all TVM products were defective occurred in a short time frame.Initially it was believed that only certain brands and models of IVC Filters were defective, not all products. This belief was inaccurate and has caused the IVC Filter Litigation to evolve in a less organized manner than TVM.

Inherently Defective Product Gained FDA Approval

• IVC Filters were on the market prior to the Medical Device Act of 1976 and known to be problematic.• No IVC Filter* was ever proven to be safe and

effective. How did this happen?• It was a matter of timing.• The *Cook Birds Nest Filter was the only filter to

ever be approved via the PMA process. A modified version was approved via the 510k Process in 2008.• All IVC Filters are inherently defective.

Bard 10-Q September 2015•While the company intends to vigorously

defend Filter Product Claims that do not settle, including through litigation, it cannot give any assurances that the resolution of these claims will not have a material adverse effect on the company’s business, results of operations, financial condition and/or liquidity.

Cook IVC Filter Settlements A large number of stipulated dismissals with prejudice in cases where no motion to dismiss had been filed, have occurred.

This pattern generally indicates the settlement of individual cases.

Cook Medical is a private company and therefore is not obligated to make any public disclosures regarding settlements.

More Information on IVC Filter Litigation

John Dalimonte will be part of the panel of the September Mass Tort Nexus Course. John serves on the Steering Committee for the Bard and Cook MDLs.Contact Barbara Capasso at 954-383-3932 or barbara@masstortnexus.com for information on the Sept 23-26 Four Days to Mass Tort Success Course.

More information related to the IVC Filter litigation can be found at: www.masstortnexus.com

Fluoroquinolones

About Fluoroquinolones• The fluoroquinolones are a family of broad

spectrum, systemic antibacterial agents that have been used widely as therapy of respiratory and urinary tract infections.

• Approximately 28 Million U.S. Patients are prescribed Fluoroquinolones annually.

Brands of Fluoroquinolones

• Levaquin (levofloxacin)+• Cipro (ciprofloxacin)+• Cipro Extended Release * (ciprofloxacin XR) • Avelox (moxifloxacin)+• Noroxin (norfloxacin)+• Floxin (ofloxacin)+• Factive (gemifloxacin)+• Moxifloxacin Injection (Moxifloxacin) • Ofloxacin * (Ofloxacin)

* available only as generic + generic available

Risk Outweigh Benefits• [ 05-12-2016 ] The U.S. Food and Drug

Administration is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.

July 2016 FDA New Black Box • [ 7-26-2016 ] The U.S. Food and Drug Administration

(FDA) approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. As a result, we revised the Boxed Warning, FDA’s strongest warning, to address these serious safety issues. We also added a new warning and updated other parts of the drug label, including the patient Medication Guide.

Fluoroquinolones and Aortic Aneurysm• Recent studies have found that use of the

antibiotic medication Fluoroquinolones may increase the risk of aortic aneurysm, a potentially fatal side effect that occurs when a bulge develops in the aorta, the largest artery in the body.• Collagen disruption leading to connective tissue

disorders are associated with tendon rupture and Aortic Aneurysm.• Aortic Aneurysm have an extremely high mortality

rate.

Fluoroquinolone AA Studies • JAMA Internal Medicine published a study by researchers in Taiwan

which found that fluoroquinolone antibiotic users may face a doubled risk of aortic dissection and/or aortic rupture within 60 days of beginning treatment with the drugs. The study’s authors warn that “Clinicians should continue to be vigilant for the appearance of aortic aneurysm and dissection in high-risk patients treated with fluoroquinolones.”

• Another study in the British Medical Journal (BMJ) featured research by Canadian doctors who determined that the risk of aortic aneurysm may be up to 3x higher in patients treated with fluoroquinolones. The researchers warned against over-use of the medications, stating “Reducing unnecessary fluoroquinolone treatments or prolonged courses might have possibly prevented more than 200 aortic aneurysms” in the 1.7 million patients whose medical records they examined.

More Information on Fluoroquinolone Litigation

Ryan Thompson will be on the Panel for the September Mass Tort Nexus Course.Ryan will be discussing the following litigatons:

FluoroquinolonesTaxotereOnglyza

Contact Barbara Capasso at 954-383-3932 or barbara@masstortnexus.com for information on the Sept 23-26 Four Days to Mass Tort Success Course. More information related to the these litigations can be found at: www.masstortnexus.com