Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-cand-3_05-md-01699/USCOURTS-cand-3_05-md-01699-216/pdf.json

Nature of Suit Code: 365
Nature of Suit: Personal Injury - Product Liability
Cause of Action: 28:1332 Diversity-Product Liability

---

U

nite

d

States District C

o

u

rt

For the Northern District of California

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

U

nite

d

States District C

o

u

rt

For the Northern District of California

IN THE UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF CALIFORNIA

IN RE: BEXTRA AND CELEBREX

MARKETING SALES PRACTICES AND

PRODUCT LIABILITY LITIGATION,

__________________________________/

This order relates to:

All Bextra Purchase Claims Actions

 /

No: CV-05-1699 CRB

MDL 1699

MEMORANDUM AND ORDER RE:

MOTION TO DISMISS PURCHASE

CLAIMS MASTER BEXTRA

COMPLAINT

These putative class action lawsuits arise out of the marketing and sale of the pain

relief prescription drug Bextra. Now pending before the Court is the Pfizer defendants’

motion to dismiss. After carefully considering the papers filed by the parties, and having had

the benefit of oral argument, as well as further briefing after argument, the Pfizer defendants’

motion is DENIED in part and GRANTED in part with leave to amend.

ALLEGATIONS OF THE PURCHASE CLAIMS 

MASTER BEXTRA COMPLAINT

Non-steroidal anti-inflammatory drugs (“NSAIDs”) have been widely used for pain

relief for several years; however, NSAIDs have certain side effects, including gastrointestinal

(“GI”) toxicity which results in thousands of deaths every year. Purchase Claims Master

Bextra Complaint (“Complaint”) ¶ 6. Defendants (hereinafter referred to as “Pfizer”)

developed Celebrex and later Bextra, both known as Cox-2 inhibitors, with the hope that they 

Case 3:05-md-01699-CRB Document 509 Filed 08/24/06 Page 1 of 6
U

nite

d

States District C

o

u

rt

For the Northern District of California

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

2

would have fewer GI side effects than traditional NSAIDs and thus become “blockbuster”

drugs with sales in the billions of dollars. Id. ¶¶ 7-8, 56. The Food and Drug Administration

(“FDA”) approved Celebrex for sale in the United States in 1999. Id. ¶ 56. Pfizer sought

approval for Bextra, a second generation Cox-2 inhibitor, in January 2001. Id. ¶ 57. In

November 2001, the FDA approved Bextra for treatment of primary dysmenorrhea and

arthritis, but not for acute pain. Id. ¶ 60-61. The FDA also concluded that Pfizer could not

market Bextra as having fewer GI symptoms than other NSAIDs and instead required Pfizer

to warn that use of Bextra presents certain GI risks. Id. ¶ 61.

Long before Pfizer obtained approval of Bextra, studies of Celebrex and Vioxx made

Pfizer aware that Cox-2 inhibitors, such as Bextra, pose serious cardiovascular risks. Id.

¶¶ 62-77. A Pfizer study completed in 2004 showed a statistically significant increase in

cardiovascular adverse events in patients treated with Bextra for seven days following

coronary artery bypass surgery compared to those treated with a placebo. Id. ¶ 79. By

November 2004, the FDA had received nearly ninety reports of severe skin reactions to

Bextra. Id. ¶ 81. Accordingly, in December 2004, the FDA required Pfizer to add a

cardiovascular warning to the Bextra label as well as a warning about the risk of lifethreatening skin conditions. Id. ¶ 78. 

On April 7, 2005, the FDA requested Pfizer to voluntarily withdraw Bextra from the

market on the ground that “the overall risk versus benefit profile of Bextra is unfavorable,”

due to NSAIDs’ “increased risk for serious cardiovascular (CV) adverse events,” Bextra’s

“increased risk of serious skin reactions,” “and the fact that Bextra has not been shown to

offer any unique advantage over the other available NSAIDs.” Id. ¶ 88. In particular, the

FDA concluded that there are no “studies that show a GI safety benefit,” or “better efficacy

compared to other products.” Id. ¶ 89. Pfizer immediately suspended Bextra sales. Id. ¶ 90.

Notwithstanding its knowledge of Bextra’s risks and lack of superiority, Pfizer

marketed Bextra to consumers and medical professionals as a “breakthrough” drug providing

important clinical advantages over older and far less expensive NSAIDs. Id. ¶¶ 9, 16, 91. 

Pfizer’s Bextra marketing scheme was deceptive because Pfizer (1) failed to warn of the

Case 3:05-md-01699-CRB Document 509 Filed 08/24/06 Page 2 of 6
U

nite

d

States District C

o

u

rt

For the Northern District of California

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

3

drug’s increased cardiovascular risks, see, e.g., id. ¶¶ 14, 85, 92, 111; (2) failed to warn of

potentially life-threatening skin reactions, see, e.g., id. ¶¶ 14, 92, 111; and (3) falsely claimed

that Bextra provides superior pain relief and safety, including fewer GI side effects, than

traditional NSAIDs. See, e.g., id. ¶¶ 14, 17, 92-101.

Pfizer’s marketing was successful: in 2004 Bextra achieved $1.2 billion in sales. Id.

¶ 114. Class members purchased Bextra “even though a monthly supply was much more

expensive than other NSAIDs.” Id. ¶ 113. Bextra sold “for $2.53 to $6.45 per day

depending on dose, while NSAIDs sold for as little as $0.21 to $0.31 per day.” Id. ¶ 18. “If

Defendants had not engaged in the wrongful marketing, advertising and promotion of Bextra,

Plaintiffs and Class Members would have paid for other equally available, less expensive

NSAIDs and other pain medications.” Id. 

PROCEDURAL HISTORY

Plaintiffs filed several putative class actions seeking damages for their purchases of

Bextra at an inflated price as a result of Pfizer’s allegedly deceptive marketing scheme. The

Multi-District Litigation Panel transferred all of the Bextra purchase claims, as well as the

product liability personal injury actions, to this Court. At plaintiffs’ request, and over

Pfizer’s objection, the Court allowed plaintiffs to file a Purchase Claims Master Bextra

Complaint. The Complaint includes four claims for relief: (1) RICO; (2) state consumer

protection laws; (3) unjust enrichment; and (4) breach of warranty. Plaintiffs seek damages

on behalf of a national class of all Bextra “End-Payors located in the United States, including

Consumers and Third Party Payors, who purchased and/or paid for Bextra.” Complaint ¶ 3.

On August 16, 2006, the Court issued a Memorandum and Order granting in part and

denying in part Pfizer’s motion to dismiss the Purchase Claims Master Celebrex Complaint

on preemption grounds. The Court will not repeat the analysis and discussion set forth in

that Order and will instead refer to the Order as appropriate.

//

//

//

Case 3:05-md-01699-CRB Document 509 Filed 08/24/06 Page 3 of 6
U

nite

d

States District C

o

u

rt

For the Northern District of California

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

4

DISCUSSION 

Pfizer moves to dismiss the Complaint on the ground that all of the claims conflict

with the FDA’s regulation of Bextra. In particular, Pfizer moves to dismiss plaintiffs’ claims

alleging that Pfizer failed to warn of Bextra’s cardiovascular risks and failed to warn of the

risk of serious skin conditions on the ground that the FDA considered and determined exactly

what warnings Pfizer must provide. Pfizer also contends that plaintiffs’ claims alleging that

Pfizer should never have applied for FDA approval of Bextra or, at a minimum, should have

stopped selling Bextra before being asked to do so, see Complaint ¶ 85, 87, likewise conflict

with the FDA’s determination that Bextra was safe and effective for use consistent with the

FDA-approved label. Finally, Pfizer argues that the false advertising claims based on

Pfizer’s allegedly marketing Bextra as having fewer GI side effects and greater efficacy than

traditional NSAIDs are also preempted because Pfizer submitted all of its marketing material

to the FDA for review.

Plaintiffs’ opposition to the motion to dismiss appears to abandon any claims based on

the failure to warn of cardiovascular or skin disease risks, or based on Pfizer’s decision to

sell Bextra in the first place; indeed, plaintiffs do not even mention these claims when

discussing why their claims do not conflict with the regulatory authority of the FDA. See

Opposition at 1, 7, 10-11. Instead, plaintiffs explain that they challenge only Pfizer’s

promotion of Bextra in a manner inconsistent with Bextra’s FDA-approved label and, in

particular, Pfizer’s promotion of Bextra as offering improved gastrointestinal toleration

notwithstanding the FDA’s determination that Bextra has no fewer GI side effects than

traditional NSAIDs. Id. Accordingly, plaintiffs’ claims based on Pfizer’s failure to warn of

cardiovascular and skin disease risks, as well as their apparent claim that Pfizer should not

have offered Bextra for sale, are dismissed. The dismissal is with leave to amend to plead

claims consistent with the Court’s ruling on the Purchase Claims Master Celebrex

Complaint; that is, to plead claims that do not seek to hold Pfizer liable for failing to advise

consumers and physicians of a statement that the FDA has considered and found

scientifically unsubstantiated. See August 16, 2006 Memorandum and Order at 13. 

Case 3:05-md-01699-CRB Document 509 Filed 08/24/06 Page 4 of 6
U

nite

d

States District C

o

u

rt

For the Northern District of California

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

5

Plaintiffs’ claims alleging that Pfizer falsely marketed Bextra as having fewer GI

symptoms and greater efficacy than traditional NSAIDs are not preempted. There is no

evidence that the FDA ever determined that Bextra is more effective or has fewer GI side

effects than traditional, less expensive NSAIDs; to the contrary, the Complaint alleges that

the FDA specifically determined that it is not and does not. See, e.g., Complaint ¶ 61. Thus,

there is no conflict between plaintiffs’ claims and a determination of the FDA. For the

reasons stated in the August 16, 2006 Memorandum and Order at 15-17, the FDA’s review of

Pfizer’s promotional material is insufficient to support a finding of a conflict warranting

preemption. Accordingly, Pfizer’s motion to dismiss these claims on conflict preemption

grounds is denied.

Pfizer also argues that even if the false advertising claims are not preempted, plaintiffs

have not identified any, or at least sufficient, Pfizer promotional activities directed at the

United States. The Complaint, however, alleges that Pfizer “aggressively marketed Bextra

directly to medical professionals . . . in order to leverage pressure on third-party payors,

medical care organizations, and large institutional buyers (e.g., hospitals) to include Bextra

on their formularies. Bextra’s marketing campaign specifically targeted [those medical

professionals], and was designed to convince them of both the therapeutic and economic

value of Bextra.” Complaint ¶ 13. Pfizer does not cite any authority that suggests that to

state a claim and survive a Rule 12(b)(6) motion plaintiffs must identify the specific

promotional activities they challenge. Pfizer’s motion must be made on summary judgment,

not a motion to dismiss.

CONCLUSION

For the reasons stated above and in the Court’s August 16, 2006 Memorandum and

Order, Pfizer’s motion to dismiss plaintiffs’ claims alleging a “failure to warn” and a “failure

to pull Bextra from the market” is GRANTED with leave to amend. Pfizer’s motion to 

//

//

//

Case 3:05-md-01699-CRB Document 509 Filed 08/24/06 Page 5 of 6
U

nite

d

States District C

o

u

rt

For the Northern District of California

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

G:\CRBALL\2005\1699\orderrepurchaseclaimsbextra.wpd 6

dismiss the false advertising claims as preempted and on the ground that plaintiffs have not

sufficiently alleged false promotional activities in the United States is DENIED.

IT IS SO ORDERED.

Dated: August 24, 2006 

CHARLES R. BREYER

UNITED STATES DISTRICT JUDGE

Case 3:05-md-01699-CRB Document 509 Filed 08/24/06 Page 6 of 6