DePuy ASR Hip Implant

Cases
Settlement Agreement

Prof. George Conk

Fordham law School

DePuy ASR Settlement

ASR metal on metal hip implant

FDA substantial equivalence review

High failure rate

Tardy warnings

Product withdrawn from market

voluntarily
DePuy ASR Settlement

Available Causes of action

* State tort claims no preemption

* implied warranty
* 402A `strict liability
* manufacturing defects
* design defects
* warning defects
Products Restatement 2(b)
Reasonable alternative design
defect
DePuy ASR Settlement

 6 (c) Design defects

products restatement

(c) A prescription drug or medical device

is not reasonably safe due to defective
design if the foreseeable risks of harm
posed by the drug or medical device are
sufficiently great in relation to its
foreseeable therapeutic benefits that
reasonable health-care providers, knowing
of such foreseeable risks and therapeutic
benefits, would not prescribe the drug or
medical device for any class of patients.
Not embraced by courts
DePuy ASR Settlement

Product Liabililty Restatement

Design defect & warning claims

3rd restatementSection 2

* Practical and feasible alternative safer

design unreasonably omitted rendering
product not reasonably safe
Inadequate warnings regarding risks and
safe use
Manufacturing defects
DePuy ASR Settlement

Barker v. Lull Engineering (CA 1978) TWO PRONGS

A product is defective in design

Consumer expectations

(1) the product has failed to perform as

safely as an ordinary consumer would
expect when used in an intended or
reasonably foreseeable manner, or

Risk-Utility
(2) in light of the relevant factors
discussed below, the benefits of the
challenged design do not outweigh the
risk of danger inherent in such design.

Ch. 8 Product Liability

Barker v. Lull Engineering (CA 1978)

Risk/utility test
A product may be found defective in
design, even if it satisfies ordinary
consumer expectations, if through
hindsight the jury determines that the
product's design embodies 'excessive
preventable danger,' or, in other
words, if the jury finds that
the risk of danger inherent in the
challenged design outweighs the
benefits of such design.
Ch. 8 Product Liability

Barker v. Lull Engineering (CA 1978)

The risk-utility factors to determine strict

liability in tort

(1) the gravity of the danger posed by the

challenged design

(2) the likelihood that such danger would

occur

Ch. 8 Product Liability

Barker v. Lull Engineering (CA 1978)

(3) the mechanical feasibility of a safer

alternative design

(4) the financial cost of an improved design,

and

(5) the adverse consequences to the product

and to the consumer that would result from an

alternative design.

Ch. 8 Product Liability

Settlement Agreement

Between

DePuy Orthopaedics, Inc.

And

The Counsel Listed on the Signature

Pages Hereto
Dated As Of November 19, 2013

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Comprehensive but not global

- settlement

U.S. claimants only QUSCs

MDL 2197 In re DePuy Orthopaedics, Inc.
ASR Hip Implant Products Litigation
California
Illinois
New Jersey

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A private settlement agreement

An MDL, not a class action

Establishes a fund

Fund administrator

Settlement oversight committee

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A private settlement program

No admission of liability or injury

Covers filed and unfiled ASR claims by

those whose hips were revised prior to

August 31, 2013

DePuy - no administrative responsibility

Administrator chosen by DePuy and the

Settlement Oversight Committee
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Exclusions

Trauma related revision surgery

Infection-related revision surgery

Femoral side surgery without cup

revision

Pinnacle hip implant claims

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Aggregate Limit and Liens

Part A $2.475 billion +/-

Part B maximum funding obligation

$475,000,000

Liens to be satisfied (Medicare,

Medicaid, ERISA plans)

Punitive damage claims waived

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Threshold, requirements, and

time limits

94% participation threshold

Interested attorneys to report all
claims
J&J walk Away Deadline
Product usage proven by
contemporaneous medical records
General release required
Unrepresented claimants
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Dispute resolution

Three special masters appointed to

resolve eligibility disputes, etc.

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Qualifying Base Award 5.1

Part A $250,000

Part B Bilateral/Extraordinary
Injury Fund

Subject to liens and counsel fees, etc.

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Reduction for length of implantation

Implantation Length from date of ASR

Index Surgery to date of ASR Revision
Surgery (X)ASR XL Base Award Amount
Funding
11

180 days < X < 5

Years $250,000
5 Years X < 6 Years $225,000
6 Years X < 7 Years $200,000
7 Years X 8 Years $150,000
Unrepresented: 71%
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Other reductions

ASR XL implanted as a revision device

20% +/- reduction
Body Mass Index reductions 10 20%
Death w/i 5years of revision surgery up
to 25% as set by SOC
Age reductions starting at age 70 4 %
15%

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Minimum Part A Base Awards

Implantation Length
% - 6 years $150,000
6 7 years $125,000
7 8 years $100,000
(proportiona l reductions for the
unrepresented)

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Extraordinary injury claims

Death
Heart attack or stroke
Infection and post ASR re-revisions
Foot Drop
Dislocation and revision
Pulmonary embolism or DVT
Re-Revision surgery
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Part B Extraordinary injury Award

Process

Determined by SOC

Claimants must allow access to medical

records, rog answers, etc.

No other discovery

Decisions entirely on the papers

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Administrative expenses

Borne by claimants
$10 million initia contribution by DePuy
(reduces aggregate)
6% shall be paid to common benefit fund
by DePuy
Claims rocessor: Brown Greer, PLC
Fund shall be audited

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Lien Resolution

Each QUSC shall identify, all Qualified

Lienholders

DePuy will be responsible for the

negotiation and resolution of Assumed
Liens asserted by Qualified Lienholders

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