Thomas P. Redick Gene Editing RT7 October 24, 2017 NC - - PowerPoint PPT Presentation

Thomas P. Redick Gene Editing RT7 October 24, 2017 NC Biotechnology Center

• Background: Starlink & Liberty Link
• Facts of Viptera Corn Launch by

Syngenta

• Major Issues to Raised in 2017 Syngenta

Trial & up to $1.5 Billion Settlement

• Implications of Potential Legal Rulings
• n Innovation in Biotech Crops

Starlink corn broke liability ground

 Illegal in U.S. food supply (massive

recall)

Huge Economic Liability for disrupting

corn exports & U.S. recall

Small Personal Injury settlement ($6

million for alleged allergy injuries)

Commingling of Starlink was “physical

injury” with economic loss recoverable despite “stranger economic loss doctrine”

 1999 – Illegal release from

field trials.

 2006 -- Key export markets

in rice disrupted

 No US recall, USDA

promptly approved its release.

 2010 -- Summary judgment

allows negligence etc.

 Settlements over 1.2 bil.

LL Rice Planting Distance Target

• A. Hokkaido, Japan - 300 m.
• B. 120 ft. – Dr. Linscombe

Top Rice Expert

• C. 30 ft. Bayer Contract
• D. 12 ft. USDA

LL Rice Planting Distance Target

• A. Hokkaido, Japan - 300 m.
• B. 120 ft. – Dr. Linscombe

Top Rice Expert

• C. 30 ft. Bayer Contract
• D. 12 ft. USDA

LL Rice Planting Distance Target

• A. Hokkaido, Japan - 300 m.
• B. 120 ft. – Dr. Linscombe

Top Rice Expert

• C. 30 ft. Bayer Contract
• D. 12 ft. USDA

LL Rice Planting Distance Target

• A. Hokkaido, Japan - 300 m.
• B. 120 ft. – Dr. Linscombe

Top Rice Expert

• C. 30 ft. Bayer Contract
• D. 12 ft. USDA

LL Rice Planting Distance Target

• A. Hokkaido, Japan - 300 m.
• B. 120 ft. – Dr. Linscombe

Top Rice Expert

• C. 30 ft. Bayer Contract
• D. 12 ft. USDA

LL Rice Planting Distance Target

• A. Hokkaido, Japan - 300 m.
• B. 120 ft. – Dr. Linscombe

Top Rice Expert

• C. 30 ft. Bayer Contract
• D. 12 ft. USDA

LL Rice Planting Distance Target

“God” & USDA (Will Bayer’s Act of God Defense work for a field trial?)

• A. Hokkaido, Japan - 300 m.
• B. 120 ft. – Dr. Linscombe

Top Rice Expert

• C. 30 ft. Bayer Contract
• D. 12 ft. USDA

• Farmers who did not buy from Syngenta

were economically harmed by commingling.

• National Corn Growers Association policy

allowed sale without China approval given the benefits – corn growers need to fight resistant insects with new modes of action

• Bunge NA warned Syngenta of China

becoming potentially “major” market in 2011.

• Syngenta sued Bunge citing NCGA

policy in 2011, nearly all claims dismissed by court.

• China corn buying increases 2011-2013 –

importing traces of Viptera for two years.

• Nov. 2013 – China turns away US corn

citing presence of Viptera.

• Nat’l Grain and Feed Ass’n 2014 report

says over $3 billion in economic loss.

• Grain trade and grower class actions filed

in Q3 2014 across the Corn Belt.

 Grower lawsuits seek billions for price

impacts, alleging:

 Syngenta “misrepresentations” re China

approval status are alleged - recklessness.

 Syngenta has a duty to prevent loss of

foreseeable major export market like China.

 Negligent disruption of export grain flows.  Growers consolidated -- federal KC KS court

• December 2014 – Syngenta gets

China approval for Viptera, dismissed Bunge case.

• Syngenta motions for dismissal and

summary judgment trim complaint.

• Trial required for claims for

negligence etc. remaining in 2017.

• Settled for $1.5 billion on Sept 25, 2017

• Negligence (not Nuisance)
• Did Syngenta have a duty to third parties to seek

approval in FORSEEEABLE major markets before commercial launch?

• Stranger Econ Loss bar recovery?
• What is a “major” market?

 Should biotech seed companies have to wait for

“major market approval” before sale of GM crop?

 Will this long wait hurt growers more?

 Scope and Provability of Damages  Drop in Corn Prices Lead to Recoverable

Economic loss?

 Certified Class Action make recovery easier?  Punitive Damages  Could Syngenta’s alleged misrepresentations

give rise to punitive damages liability?

 Test Trials Teed up for later in 2018

• Who Runs U.S. Agriculture Options
• Should US policy, including common law claims,

allow trading partners like the EU and China to dictate what can be grown by U.S. Farmers?  Could such liability risk seriously impede

innovation in biotech crops?

 Novel plant breeding methods (genetic editing) will

transform industry, bring benefits and enhanced safety in food and environment.

 High cost to seek overseas approval – when new laws

are being drafted under the Cartagena Protocol on Biosafety, will more nations become “foreseeable” major markets?

 Will identity-preserved production (IPP)

like specialty crops grow in closed-loops pending overseas approvals?

Monsanto corn handling – issue in SYN trial RR2 XTEND lacked EU approval 2016 Dow Agro E3 Soy 2018 IPP; wait EU-China

 Some “output trait” crops (e.g. high oleic

soybeans) need IP to meet purity stds.

 Can the smaller genetic editing companies

afford to keep contained and wait years?

 “Anticipatory” common law nuisance

Canada’s Hoffman case denied an injunction

 Illinois court enjoined a feedlot even after

regulatory permit issued by state.

 Threat of suit is a powerful tool to enforce strict

costly stewardship on biotech seed company

 File Federal Suit, seek mediation

 Economic impact creates nuisance liability

for Syngenta that could have been mediated.

 Big seed cos do costly stewardship for

major markets

 Smaller gene-editing cos. lack $  U.S. Biotech Crops Alliance brings grain

and seed companies and growers together for liability avoidance plans

 Metrics -- Stewardship for biotech crops &

• verseas approvals helps to prevent

disruptive, costly litigation.

 Worst billion dollar cases could have been

prevented through management of liability risks (gregate Starlink-LL rice)

 No EU/China approval? Economic risks can

be managed most effectively by US growers

 Foresight for emerging liability threats

requires a facilitated interdisciplinary team.

 Stewardship will play major role in securing

future pipeline from damaging liability cases.

 Know Before You Grow, NAT’L CORN GROWERS ASS’N,

http://www.ncga.com/for-farmers/know-before-you-grow

 EXCELLENCE THROUGH STEWARDSHIP,

http://excellencethroughstewardship.org/

 Thomas P. Redick, Drew Kershen et al., “Innovation and Liability

in Biotechnology: Transnational and Comparative Perspectives”. (Edward Elgar press) (2010) http://www.amazon.com/Innovation-Liability-Biotechnology- Transnational-Perspectives/dp/1847206646

 Lewis Bass and Thomas P. Redick, Products Liability: Design and

Manufacturing Defects, 2017-2018 ed. (The West Group), (2017). http://legalsolutions.thomsonreuters.com/law- products/Treatises/Products-Liability-Design-and- Manufacturing-Defects-2017-2018-ed/p/104867917