1.
Mass Torts Update for
Plaintiff Attorneys
Sponsored by The National Trial Lawyers
August 31, 2016
Presented by John Ray
Mass Tort Nexus

2.
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

3.
Today’s agenda
• New Pradaxa docket in Connecticut
• IVC Filter
• Xarelto
• Fluoroquinolone antibiotics
• Emerging: Roundup litigation

4.
RoundUp Litigation (glyphosate)

5.
RoundUp History
The 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.

6.
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).”

7.
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

8.
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

9.
What to Expect
Preemption Challenges
Discovery Disputes
Causation Challenges
Novel Legal Theories
Trips to the Supreme Court
Agra-Politics

10.
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

11.
Xarelto

12.
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

13.
Current Xarelto Consolidations
• Xarelto Federal MDL Eastern District of Louisiana
before Judge Eldon Fallon.
• Philadelphia Court of Common Pleas Consolidation
before Judge Arnold New.

14.
Choosing PA Court as Venue
Diversity Issue States:
• California
• Delaware
• Indiana
• New Jersey
• Pennsylvania
Ischemic vs Hemorrhagic Stroke

15.
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

16.
Pradaxa

17.
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.

18.
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

19.
IVC Filters

20.
IVC Filter Injuries
Tilt
Fracture
Migration
Penetration
Embedment
Embolization
Implanted with a Permanent IVC Filter?

21.
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

22.
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*

23.
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

24.
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

25.
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.

26.
Evolution of IVC Filter Litigation
There 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.

27.
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.

28.
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.

29.
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.

30.
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

31.
Fluoroquinolones

32.
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.

33.
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

34.
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.

35.
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.

36.
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.

37.
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.

38.
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:
Fluoroquinolones
Taxotere
Onglyza
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