Corporate StrategiesThat Win Trials

Corporate StrategiesThat Win Trials

Jan DoddPamela YatesAton Arbisser

1999 Avenue of the StarsLos Angeles, California

(310) 788-1015

Corporate themes Trial themes Corporate themes Trial themes

• Think Safety

• Write Safety

• Talk Safety

• Think Safety

• Write Safety

• Talk Safety

Think safety at every step of product cycleThink safety at every step of product cycle

• Design

• Testing

• Warnings

• Planning/Marketing

• Responding to customer complaints

• Recalls

• Risk assessment

• Design

• Testing

• Warnings

• Planning/Marketing

• Responding to customer complaints

• Recalls

• Risk assessment

Design for safety?Design for safety?

GM memo: “Analyzing these figures indicates that the fatalities related to accidents with fuel fed fires are costing General Motors $2.40 per automobile . . .”

GM memo: “Analyzing these figures indicates that the fatalities related to accidents with fuel fed fires are costing General Motors $2.40 per automobile . . .”

Moseley v. General Motors resulted in a $101 million Moseley v. General Motors resulted in a $101 million punitive damages award by the jury, punitive damages award by the jury,

reversed on appeal and settled before retrial.reversed on appeal and settled before retrial.

Design for safety?Design for safety?

Resulted in a $125 million punitive damages award, Resulted in a $125 million punitive damages award, reduced by trial judge to $3.5 millionreduced by trial judge to $3.5 million

“total cost of $ 15.30 would have made the fuel tank safe in a 34 to 38-mile-per-hour rear-end collision * * * Harley Copp, a former Ford engineer and executive in charge of the crash testing program, testified that the highest level of Ford's management made the decision to go forward with the production of the Pinto, knowing that the gas tank was vulnerable to puncture and rupture at low rear impact speeds creating a significant risk of death or injury from fire and knowing that ‘fixes’ were feasible at nominal cost.”Grimshaw v. Ford Motor Co., 119 Cal.App.3d 757, 774-77 (1981)

““total cost of $ 15.30 would have made the total cost of $ 15.30 would have made the fuel tank safe in a 34 to 38fuel tank safe in a 34 to 38--milemile--perper--hour hour rearrear--end collision * * * Harley end collision * * * Harley CoppCopp, a former , a former Ford engineer and executive in charge of the Ford engineer and executive in charge of the crash testing program, testified that the crash testing program, testified that the highest level of Ford's management made the highest level of Ford's management made the decision to go forward with the production of decision to go forward with the production of the Pinto,the Pinto, knowing that the gas tank was vulnerable to puncture and rupture at low rear impact speeds creating a significant risk of death or injury from fire and knowing that ‘fixes’ were feasible at nominal cost.”Grimshaw v. Ford Motor Co., 119 Cal.App.3d 757, 774-77 (1981)

Testing for safety?Testing for safety?

“No clinical trial myth” repeated by witnesses“No clinical trial myth” repeated by witnesses

Novartis Tested Tavist-D on PeopleNovartis Tested Tavist-D on People

No strokes

No meaningful increase in blood pressure

No strokes

No meaningful increase in blood pressure

Over 1000 subjects

Novartis Animal Studies Showed PPA SafeNovartis Animal Studies Showed PPA Safe

Human dose ≤ 1 mg/kg

Wide margin of safety

Human dose ≤ 1 mg/kg

Wide margin of safety

Up to 5000 mg/kg of PPA No strokes

N33-08

N33-11

Compliance with government safety standards can be considered in deciding design defect claims

Compliance with government safety standards can be considered in deciding design defect claims• “the FDA, is the regulatory body charged with

protecting the public health by ensuring that drugs are safe and effective. While the FDA's standards and decisions do not immunize a drug manufacturer from liability, they are nevertheless entitled to ‘serious consideration’ on the issue of the safety of PPA at the time of appellants' injuries.” O'Neill v. NovartisConsumer Health, Inc., 147 Cal. App. 4th 1388, 1395-96 (2007) (citations omitted)

• “the FDA, is the regulatory body charged with protecting the public health by ensuring that drugs are safe and effective. While the FDA's standards and decisions do not immunize a drug manufacturer from liability, they are nevertheless entitled to ‘serious consideration’ on the issue of the safety of PPA at the time of appellants' injuries.” O'Neill v. NovartisConsumer Health, Inc., 147 Cal. App. 4th 1388, 1395-96 (2007) (citations omitted)

Safety warningsSafety warnings

Q: Okay...you’ve identified up to between 10 and 20 times that you felt there were parts of the labeling package inserts that needed modification, adding, changing in someway.

A: Correct.Q: On any of the occasions that you

felt that way, did those changes get made?

A: Possibly.Q: “Possibly,” meaning what?A: Maybe.Q: Meaning you don’t know?

Q: Okay...you’ve identified up to between 10 and 20 times that you felt there were parts of the labeling package inserts that needed modification, adding, changing in someway.

A: Correct.Q: On any of the occasions that you

felt that way, did those changes get made?

A: Possibly.Q: “Possibly,” meaning what?A: Maybe.Q: Meaning you don’t know?

Safety warningsSafety warnings

Marketing v. safetyMarketing v. safety

• “rush to market”

• “blockbuster drug”

• “rush to market”

• “blockbuster drug”

Marketing v. safetyMarketing v. safety

Marketing v. safetyMarketing v. safety

• “excited” about “treatment” for millions of people “for the rest of their lives”

• “excited” about “treatment” for millions of people “for the rest of their lives”

Talk about safety in planning documentsTalk about safety in planning documents

N33-15d

Marketing v . safetyMarketing v . safety

Q. And you were perfectly content to sell that product to consumers?

A. I was perfectly content not only to sell it to consumers, but to administer it to my own children, to use it myself and recommend it to my friends.

Responding to customer complaintsResponding to customer complaints

This case was initially received on 20JUL1999 but was not classified as serious until information from the patient’s legal counsel was received on 21JUL2004.

This case was initially received on 20JUL1999 but was not classified as serious until information from the patient’s legal counsel was received on 21JUL2004.

Responding to customer complaintsResponding to customer complaints

Recall should say safetyRecall should say safety

• In the space of a few days in 1982, seven people died after taking cyanide-laced capsules of Extra-Strength Tylenol. Many predicted that the Tylenol brand would never recover. But J&J communicated it placed consumers first by recalling 31 million bottles of Tylenol from store shelves, introducing a new tamper-proof package, and offering replacement product free of charge.

• Today, consumers believe Tylenol means safety.

• In the space of a few days in 1982, seven people died after taking cyanide-laced capsules of Extra-Strength Tylenol. Many predicted that the Tylenol brand would never recover. But J&J communicated it placed consumers first by recalling 31 million bottles of Tylenol from store shelves, introducing a new tamper-proof package, and offering replacement product free of charge.

• Today, consumers believe Tylenol means safety.

Recall or not to recallRecall or not to recall

“them” refers to another company who withdrew product rather than fight recall

“them” refers to another company who withdrew product rather than fight recall

Recalls should say “safety”Recalls should say “safety”

• “The company discloses problems on its own timetable because it believes both the law and the commission's enforcement practices are unreasonable.”

• Mattel “should be able to evaluate hazards internally before alerting any outsiders, regardless of what the law is.”

– Wall Street Journal, 9/4, attributes these quotes to Mattel Chairman and Chief Executive, Robert Eckert.

• “The company discloses problems on its own timetable because it believes both the law and the commission's enforcement practices are unreasonable.”

• Mattel “should be able to evaluate hazards internally before alerting any outsiders, regardless of what the law is.”

– Wall Street Journal, 9/4, attributes these quotes to Mattel Chairman and Chief Executive, Robert Eckert.

Recalls should say safetyRecalls should say safety

• “Mattel Inc. has said its highest priority is protecting children by pulling defective products off store shelves as soon as hazards emerge.”

• “Mattel Inc. has said its highest priority is protecting children by pulling defective products off store shelves as soon as hazards emerge.”

Recalls: Lesson from MattelRecalls: Lesson from Mattel

1. Do Go Public with a “Safety is our Priority” message.

2. Do Respond Promptly:

• promise a full investigation

• apologize

• review/revise Q.C. standards

3. Do Comply with all Consumer Product Safety Commission (CPSC) Rules

• 24 hour reporting for all claims of potentially hazardous product defects (with few exceptions).

1. Do Go Public with a “Safety is our Priority” message.

2. Do Respond Promptly:

• promise a full investigation

• apologize

• review/revise Q.C. standards

3. Do Comply with all Consumer Product Safety Commission (CPSC) Rules

• 24 hour reporting for all claims of potentially hazardous product defects (with few exceptions).

Marketing safetyMarketing safety

Safety risk assessmentSafety risk assessment

1. Review labeling and instructions

Is there a written rationale for what is on the package/instructions?

What warnings are given and not given?

2. Review customer complaint procedures

Are systems in place so problems would be promptly communicated to decisionmakers?

Do complaints describing serious problems show proper response?

3. Review advertising/promotions

Do they communicate a safety message?

1. Review labeling and instructions

Is there a written rationale for what is on the package/instructions?

What warnings are given and not given?

2. Review customer complaint procedures

Are systems in place so problems would be promptly communicated to decisionmakers?

Do complaints describing serious problems show proper response?

3. Review advertising/promotions

Do they communicate a safety message?

• STOP

• THINK

• SAFETY

• STOP

• THINK

• SAFETY

It’s All About SafetyIt’s All About Safety

It’s All About SafetyIt’s All About Safety