111

1

LawLytics

Phone: (800) 713- 0161

Email: info@LawLytics.com

Website: www.LawLytics.com

MASS TORTS MARKETING: TAXOTERE

222

2

INTRODUCTION

Victoria BluteLawLytics Community Manager

333

3

WHAT IS LAWLYTICS?

LawLytics is the leading website system for lawyers who want their marketing to work without wasting time or money.

Unlike full-service marketing companies, our system adapts as the law firm’s needs evolve, so our members don’t overpay.

Unlike do-it-yourself software, our system was built for lawyers, so our members don’t struggle or miss opportunities.

444

4

PRESENTING

• Admitted in WI in 1981• Sr. Legal Marketing Strategist, LawLytics• Editor, The National Trial Lawyers• Former Editor, Mass Tort Nexus• Former Editor of Lawyers.com• Former Editor of The ABA Journal• Former Director of Marketing, Sidley Austin• Legal marketing blogger

Larry Bodine, JDSr. Legal Marketing Strategist

555

5

TAXOTERE

• 1,491 cases

• Chief US District Court Judge Kurt D. Engelhardt

• New Orleans, Eastern District of Louisiana

• MDL 2740, In re: Taxotere (Docetaxel) Products Liability

Litigation

666

6

TAXOTERE: A BLOCKBUSTER DRUG

• Sales went as high as $3.1 billion in 2010.

• More than 3 million women were noted to have a history of breast cancer in the US.

• Roughly 75 percent of those women were prescribed Taxotere.

777

7

TAXOTERE: A FAST GROWING MDL

• MDL created October 4, 2016 with 33 cases

• January 2017: 700 cases

• Today: 1,491 cases

888

8

TAXOTERE & ALOPECIA

• Drug causes permanent, total hair loss (alopecia):

• Scalp

• Eyebrows

• Eyelashes

• Pubic hair

999

9

ABOUT ALOPECIA

Hair loss is a common side effect related to chemotherapy drugs.

However, permanent alopecia is not.

101010

10

ABOUT ALOPECIA

• Alopecia is a disfiguring condition, especially for women.

• Mental anguish, economic damages including loss of work or inability to work due to psychological damage

• Plaintiffs must have experienced hair loss for 6 months or longer

• Must have been treated with Taxotere between 2006-2016

111111

11

TAXOTERE DEFENDANTS

• Sanofi-Aventis US LLC

• Global pharmaceutical company based in France

• Sanofi SA

• Aventis Pharma SA

• Sanofi-Aventis US LLC headquartered in Bridgewater, NJ

121212

12

ALLEGATIONS

• The drug’s manufacturer failed to warn patients and physicians about therisk of permanent alopecia

• Company knew about permanent hair loss and covered it up

• Sales force falsely claimed Taxotere was better than a competing drug that does not cause hair loss

131313

13

LINKING TAXOTERE TO HAIR LOSS

1998:

Spanish Breast Cancer Research Group finds that 9.2 percent of patients who took Taxotere have alopecia for up to 10 years

141414

14

LINKING TAXOTERE TO HAIR LOSS

2006:

Scot Sedlacek, MD:

6.3 percent of patients treated with Taxotere experience hair growth less than 50 percent of the rate prior to chemo treatment up to 7 years after treatment was completed.

151515

15

LINKING TAXOTERE TO HAIR LOSS

Sedlacek findings:

• Survey of nearly 500 patients Sedlacek treated between 1994-2004

• Patients received different treatments, including Taxotere

• Female chemotherapy patients who were not given Taxotere did not develop persistent alopecia

161616

16

LINKING TAXOTERE TO HAIR LOSS

In study’s conclusion, Sedlacek advised:

“Such an emotionally devastating long-term toxicity… must be taken into account when deciding on adjuvant chemotherapy

programs in women who likely will be cured of their breast cancer.”

171717

17

LINKING TAXOTERE TO HAIR LOSS 2009:

In Europe, Taxotere began to include warnings of potential permanent hair loss.

2012:

Annals of Oncology study found that “permanent and severe alopecia is a newly reported complication” of the drug regimen including Taxotere.

In Canada, an alopecia warning is included on the label for Taxotere.

181818

18

LINKING TAXOTERE TO HAIR LOSS 2014:

• National Cancer Research Institute Cancer Conference

• Paper presented by UK scientists find that 15.8 percent of patients reported persistent scalp hair loss 3 years after completing Taxotere treatments.

“5 patients reported no regrowth of eyebrows, 2 patients reported no eyelash regrowth, 6 no regrowth of nostril hair and 14 no regrowth to other parts such as legs.”

191919

19

LINKING TAXOTERE TO HAIR LOSS

2015:

Hair loss warning finally included on the labels for Taxotere sold in the United States.

202020

20

TAXOTERE: FDA ACTIONS

• Sanofi-Aventis ran its own Taxotere clinical trials from 1990-1992

• First approved in Dec. 1996 by FDA for lung cancer treatment

• 2006: FDA expands use to include breast cancer, head and neck cancer, gastric cancer, and prostate cancer

• Dec. 2015: FDA adds statement to safety labeling: “Cases of permanent alopecia have been reported.”

212121

21

DAMAGES

• Hair is part of the way that many people identify and value themselves

• We recognize people by their hair

• Intense emotional effect from losing one’s hair

• Possible jury perception: It’s a cosmetic issue, complaint is about a person’s appearance

222222

22

CALIFORNIA LAWSUIT• Plaintiff: Ami Dodson

• March 14, 2016 in the Northern District of California

• Plaintiff underwent left breast biopsy on March 3, 2010 where cancer was discovered

• Plaintiff underwent chemotherapy that included Taxotere.

• Neither plaintiff nor her treating healthcare providers were aware of or informed by defendants that disfiguring, permanent alopecia can occur following treatment with Taxotere.

232323

23

TAXOTERE CASE UPDATES

• Dec. 2016:

Judge orders lawyers to engage in continuous general settlement discussions

• May 2017: Generic Taxotere lawsuits allowed in federal MDL

• Half of cases against generics

• Taxotere lost its patent protection in 2010

242424

24

TAXOTERE CASE UPDATES

The case is now in discovery.

• Court heard discovery motions on August 7, 2017

• Next status conference on August 18, 2017

• Parties have submitted 10 cases to the court to be considered for bellwether trials.

• February 2018: Court will select cases for bellwether trials to begin in September 2018.

252525

25

TAXOTERE’S MARKETING

• It is alleged that Sanofi-Aventis’ sales force falsely told doctors that Taxotere was clinically more effective than its competitor drug, Taxol.

• Taxol does not cause permanent hair loss.

• Lawsuits argue that Sanofi-Aventis falsely marketed Taxotere by claiming it was more effective and safer than Taxol.

262626

26

TAXOTERE’S MARKETING

• 2008: New England Journal of Medicine concludes that Taxol is more effective than Taxotere

• FDA notifies Sanofi-Aventis that its advertising is false or misleading because it presents unsubstantiated superiority claims and overstates the efficacy of Taxotere.

• FDA says marketing materials misbranded the drug in violation of the Federal Food, Drug and Cosmetic Act.

272727

27

IT’S A GOOD TIME TO GET INVOLVED

Fill-in-the-blanks forms:

• Amended Master Long Form Complaint

• Plaintiff Fact Sheet

• Exemplar Short Form Complaint

282828

28

IT’S A GOOD TIME TO GET INVOLVED

• Attorney can represent client located anywhere in the US

• Enter an appearance, let plaintiff’s steering committee do the work

• Attorneys should devote efforts to getting clients

• Early in the litigation; MDL created less than a year ago

• Cost to acquire is low

292929

29

TAXOTERE: MARKETING BY EDUCATION

A website provides effective educational marketing:

• Symptoms and side effects• Types of injuries caused by Taxotere• FDA warnings• New medical research• Medical options to treat adverse events

303030

30

THE CONTENT PROBLEM

You need content.

Will you write it?

Will you delegate it?

Excellent!

Youneed

content.

No

Yes

Yes

No

313131

31

MARKETING YOUR MASS TORTS PRACTICE

How LawLytics can help you market your mass torts practice

323232

32

THANK YOU

Web: www.LawLytics.com

Phone: (800) 713-0161