Silvagnoli-Collazo, et al v. Aventis Pharmaceutical, et al

Filing 236

ORDER granting 169 motion for summary judgment. Signed by Judge Raymond L. Acosta on 9/30/08. (ans)

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF PUERTO RICO

WINSTON MENDEZ MONTES DE OCA, et al., Plaintiffs, CIVIL NO. 02-2608 (RLA) v. ADVENTIS PHARMA, et al., Defendants.

ORDER GRANTING DEFENDANT'S MOTION FOR SUMMARY JUDGMENT Defendant AVENTIS PHARMACEUTICALS, INC. ("AVENTIS") has moved the court to enter summary judgment on its behalf dismissing the instant suit. The court having reviewed the arguments presented by the parties as well as the extensive documentation submitted for review hereby finds dismissal is warranted. BACKGROUND This action was originally instituted on October 28, 2002, by WINSTON MENDEZ MONTES DE OCA, his wife, NORMA SILVAGNOLI COLLAZO, and their children asserting negligence claims and products liability pursuant to art. 1802 of the Puerto Rico Civil Code, Laws of P.R. Ann. tit. 31, § 5141 (1990). The suit was based on a cancerous tumor developed by MR. MENDEZ purportedly caused by his use of Lantus®, an insulin product manufactured by the defendant. MR. MENDEZ subsequently died on May 5, 2003, as a consequence of his cancer and his children, as heirs to his personal cause of

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action, substituted him in these proceedings pursuant to Rule 25 Fed. 3 R. Civ. P. 4 In their complaint1 plaintiffs allege that AVENTIS failed to 5 directly 6 associated with the use of Lantus®. Plaintiffs further allege that 7 MR. MENDEZ's use of the Lantus® insulin in his left thigh was the 8 direct and proximate cause of his cancerous tumor. 9 AVENTIS argues that (1) plaintiffs' claims are barred by the 10 learned 11 establish the necessary causal relationship between the use of 12 Lantus® and decedent's cancer; (3) the expert evidence shows that, 13 based on the size and location of the tumor and the fact that it 14 appeared within a few months of a single injection of the product, it 15 is biologically implausible for the tumor to have been caused by the 16 use of Lantus®, and (4) the claims are time-barred. 17 Because 18 provided by the learned intermediary defense we need not address the 19 other 20 judgment request. 21 SUMMARY JUDGMENT STANDARD 22 Rule 56(c) Fed. R. Civ. P., which sets forth the standard for 23 ruling on summary judgment motions, in pertinent part provides that 24 25 26 The original complaint was amended twice. See First Amended Complaint (docket No. 23) and Second Amended Complaint (docket No. 38).
1

warn

the

consumer

of

the

purported

hazards

and

risks

intermediary

doctrine;

(2)

plaintiffs

have

failed

to

we

find that

AVENTIS

is

entitled

to

the

immunity

arguments

raised

by

defendant

in

support

of

its

summary

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they shall be granted "if the pleadings, depositions, answers to 3 interrogatories, 4 affidavits, if any, show that there is no genuine issue as to any 5 material fact and that the moving party is entitled to a judgment as 6 a matter of law." 7 Cir. 2000); Barreto-Rivera v. Medina-Vargas, 168 F.3d 42, 45 (1st Cir. 8 1999). The party seeking summary judgment must first demonstrate the 9 absence 10 DeNovellis v. Shalala, 124 F.3d 298, 306 (1st Cir. 1997). 11 issue exists if there is sufficient evidence supporting the claimed 12 factual disputes to require a trial. Morris v. Gov't Dev. Bank of 13 Puerto Rico, 27 F.3d 746, 748 (1st Cir. 1994); LeBlanc v. Great Am. 14 Ins. Co., 6 F.3d 836, 841 (1st Cir. 1993), cert. denied, 511 U.S. 15 1018, 114 S.Ct. 1398, 128 L.Ed.2d 72 (1994). 16 it might affect the outcome of a lawsuit under the governing law. 17 Morrissey v. Boston Five Cents Sav. Bank, 54 F.3d 27, 31 (1st Cir. 18 1995). 19 "In ruling on a motion for summary judgment, the court must view 20 `the facts in the light most favorable to the non-moving party, 21 drawing all reasonable inferences in that party's favor.'" Poulis22 Minott v. Smith, 388 F.3d 354, 361 (1st Cir. 2004) (citing Barbour v. 23 Dynamics Research Corp., 63 F.3d 32, 36 (1st Cir.1995)). 24 Credibility issues fall outside the scope of summary judgment. 25 "`Credibility determinations, the weighing of the evidence, and the 26 A fact is material if A genuine of a genuine issue of material fact in the record. Sands v. Ridefilm Corp., 212 F.3d 657, 660-61 (1st and admissions on file, together with the

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drawing of legitimate inferences from the facts are jury functions, 3 not those of a judge.'" Reeves v. Sanderson Plumbing Prods., Inc., 4 530 U.S. 133, 150, 120 S.Ct. 2097, 147 L.Ed.2d 105 (2000) (citing 5 Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255, 106 S.Ct. 2505, 6 91 L.Ed.2d 202 (1986)). See also, Dominguez-Cruz v. Suttle Caribe, 7 Inc., 202 F.3d 424, 432 (1st Cir. 2000) ("court should not engage in 8 credibility assessments."); Simas v. First Citizens' Fed. Credit 9 Union, 170 F.3d 37, 49 (1st Cir. 1999) ("credibility determinations 10 are for the factfinder at trial, not for the court at summary 11 judgment."); Perez-Trujillo v. Volvo Car Corp., 137 F.3d 50, 54 (1st 12 Cir. 1998) (credibility issues not proper on summary judgment); 13 Molina Quintero v. Caribe G.E. Power Breakers, Inc., 234 F.Supp.2d 14 108, 15 determinations, no room for the measured weighing of conflicting 16 evidence such as the trial process entails, and no room for the judge 17 to superimpose his own ideas of probability and likelihood. In fact, 18 only if the record, viewed in this manner and without regard to 19 credibility determinations, reveals no genuine issue as to any 20 material fact may the court enter summary judgment." Cruz-Baez v. 21 Negron-Irizarry, 360 F.Supp.2d 326, 332 (D.P.R. 2005) (internal 22 citations, brackets and quotation marks omitted). 23 In cases where the non-movant party bears the ultimate burden of 24 proof, he must present definite and competent evidence to rebut a 25 motion for summary judgment, Anderson v. Liberty Lobby, Inc., 477 26 113 (D.P.R. 2002). "There is no room for credibility

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U.S. at 256-257, 106 S.Ct. 2505, 91 L.Ed.2d 202; Navarro v. Pfizer 3 Corp., 261 F.3d 90, 94 (1st Cir. 2000); Grant's Dairy v. Comm'r of 4 Maine Dep't of Agric., 232 F.3d 8, 14 (1st Cir. 2000), and cannot rely 5 upon "conclusory allegations, improbable inferences, and unsupported 6 speculation". 7 Cir. 2000); 8 (1st Cir. 1994); Medina-Muñoz v. 9 5, 8 (1st Cir. 1990). 10 THE FACTS 11 AVENTIS and its predecessor at all relevant times developed, 12 manufactured and sold a prescription drug product known as Lantus®. 13 Lantus® is a synthetic human insulin product approved by the 14 Food and Drug Administration of the United States Department of 15 Health and Human Services ("FDA") for the treatment of Type I and 16 Type II diabetes. 17 Lantus® 18 alleviate the inconvenience to patients of twice-daily administration 19 and to provide more stable blood sugar levels. 20 Pursuant 21 Lantus®, 22 studies in both rats and mice. A statistically significant increased 23 incidence of malignant fibrous histiocytoma ("MFH") tumors occurred 24 in male rats. 25 26 The results of these studies were notified to the FDA. No. 49,078, AVENTIS conducted two-year carcinogenicity to its Investigational New Drug Application for was designed for once per day administration, to R.J. Reynolds Tobacco Co., 896 F.2d Maldonado-Denis v. Castillo-Rodríguez, 23 F.3d 576, 581 Lopez-Carrasquillo v. Rubianes, 230 F.3d 409, 412 (1st

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New Drug Application 21-081 was submitted to the FDA on April 9, 3 1999, seeking approval of the Lantus® drug. 4 The FDA approved Lantus® as safe and effective for the treatment 5 of Type I and Type II diabetes on April 20, 2000. 6 The FDA-approved prescribing information for Lantus®, which is 7 included in the package insert, reads as follows: 8 Carcinogenesis, Mutagenesis, Impairment of Fertility: In 9 mice and rats, standard two-year carcinogenicity studies 10 with insulin glargine were performed at doses up to 0.455 11 mg/kg, which is for the rat approximately 10 times and for 12 the mouse approximately 5 times the recommended human 13 subcutaneous stating dose of 10 IU (0.008 mg/kg/day), based 14 on mg/m2. The findings in female mice were not conclusive 15 due to excessive mortality in all dose groups during the 16 study. Histiocytomas were found at injection sites in male 17 rats 18 statistically 19 groups. These tumors were not found in female animals, in 20 saline 21 different vehicle. The relevance of these findings to human 22 is unknown. 23 MR. MENDEZ was diagnosed with diabetes in 1983. 24 On January 20, 1995, MR. MENDEZ began taking Humulin Insulin 25 injections to treat his diabetes. Prior to initiation with Lantus®, 26 control, or insulin comparator groups using a significant) in acid vehicle containing (statistically significant) and male mice (not

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MR. MENDEZ administered twice daily injections of Humulin, sometimes 3 in the abdomen and sometimes in the thigh. 4 Concerned that the insulin medication he was taking at the time, 5 i.e., Humulin 70/30, might be discontinued, MR. MENDEZ went to see 6 his 7 TRABANCO informed MR. MENDEZ and his wife, who was also present, that 8 there was a new insulin product on the market, Lantus®, which had the 9 advantage of only having to be injected once a day. 10 MR. MENDEZ was given two samples of Lantus® by DR. TRABANCO on 11 July 5, 2001. Decedent only used those sample vials and never 12 purchased Lantus®. 13 Included within the Lantus® packaging given to decedent was the 14 product information/package insert for Lantus®. 15 MR. MENDEZ used Lantus® for approximately one to two months.2 16 In early August 2001, MR. MENDEZ injected the Lantus® a single 17 time in his upper left thigh. Within a few days thereafter the 18 injected area became painful and hard and started to bother decedent. 19 On October 17, 2001, an MRI showed a large mass in decedent's 20 left thigh. 21 22 23 24 25 26 According to defendant decedent discontinued using the product in late August 2001 whereas plaintiffs contend that he used it through the end of September 2001. However, this time difference does not affect our ruling.
2

endocrinologist,

DR.

CESAR

TRABANCO,

on

July

5,

2001.

DR.

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A biopsy of the tumor was performed on October 26, 2001, which 3 was 4 Variant, Invasive, High Grade." 5 MR. MENDEZ died on May 5, 2003, of Sarcoma stage 4. 6 The FDA-approved language contained in the product's Package 7 Insert fully disclosed the carcinogenic potential of Lantus® to 8 physicians. This Package Insert was included in the packaging of the 9 Lantus® samples provided to MR. MENDEZ. 10 THE LEARNED INTERMEDIARY DOCTRINE 11 Plaintiffs allege that AVENTIS is liable due to its failure to 12 warn the consumers directly of the purported hazards and risks posed 13 by the use of Lantus®. 14 Pursuant to art. 1802, there are three elements required for 15 proving negligence claims: (1) a duty, (2) negligent breach of that 16 duty and (3) a damage flowing from the negligent act or omission. 17 Cruz-Vargas v. R.J. Reynolds Tobacco, Co., 348 F.3d 271, 275-76 (1st 18 Cir. 2001). 19 The Puerto Rico Supreme Court has adopted a strict liability 20 approach for claims arising from damages resulting from defective 21 products. In Mendoza v. Cerveceria Corona, Inc., 97 P.R.R. 487, 499 22 (1969) the Supreme Court noted that "the most equitable rule and the 23 one 24 establishing the manufacturer's strict liability to the consumer." 25 See also, Aponte-Rivera v. Sears Roebuck de P.R., Inc., 144 D.P.R. 26 of greatest congruence with the public policy is that of diagnosed as "Fibrous Malignant Histiocytoma, Giant Cells

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CIVIL NO. 02-2608 (RLA) 830, 838 (1998) or ("The seller doctrine for the of strict liability by

Page 9 of the or

3 manufacturer 4 dangerous products applies in our jurisdiction."); Rivera-Santana v. 5 Superior Packaging, Inc., 132 D.P.R. 115, 125 (1992) ("In an effort 6 to meet Puerto Rico's social needs, by judicial act, and as a 7 question 8 manufacturer's strict liability rule for defective products.") 9 There are three types of defects which trigger application of 10 strict liability principles. These are: manufacturing defects, design 11 defects and defective warnings. Aponte-Rivera, 144 D.P.R. at 839-40; 12 Rivera-Santana, 132 D.P.R. at 128; Montero-Saldaña v. Am. Motors, 13 Corp., 107 D.P.R. 452, 462 (1978); Collazo-Santiago v. Toyota Motor 14 Corp., 149 F.3d 23, 25 (1st Cir. 1998); Caraballo-Rodriguez v. Clark 15 Equip. Co., Inc., 147 F.Supp.2d 66, 71-72 (D.P.R. 2001). 16 In order to prove their failure to warn claim plaintiffs must 17 establish that: "`(1) the manufacturer knew, or should have known the 18 risk 19 instructions, or those provided were inadequate; (3) the absence of 20 warnings made the product inherently dangerous; (4) the absence of 21 adequate 22 plaintiff's injury.'" Cruz-Vargas v. R.J. Reynolds Tobacco, Co., 348 23 F.3d 271, 276 (1st Cir. 2001) (citing Aponte-Rivera, 144 D.P.R. at 24 840). 25 26 warnings or instructions was the proximate cause of inherent in the product; (2) there were no warnings or of public policy, we have laid down and adopted the damages caused defective

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CIVIL NO. 02-2608 (RLA) The Doctrine

Page 10

3 In strict liability cases involving prescription drugs the legal 4 approach in the failure to warn context has been sui generis. "In a 5 typical strict products liability case, the manufacturer's duty to 6 warn extends to the consumer of the product. Where the product is a 7 prescription 8 manufacturer's duty to warn runs to the physician rather than the 9 patient." Garside v. Osco Drug, Inc., 976 F.2d 77, 80 (1st Cir. 1992). 10 This rule is known as the "learned intermediary doctrine" 11 whereby 12 consumers directly of dangers or risks posed by the use of its 13 product. Rather, this duty extends exclusively to the prescribing 14 physicians. "Under the learned intermediary doctrine, manufacturers 15 of prescription drugs escape liability for failure to instruct and 16 warn 17 physicians responsible for prescribing the medication." In re Meridia 18 Prods. Liab. Litig., 328 F.Supp.2d 791, 811 (N.D. Ohio 2004). 19 The 20 adequate 21 difference is that the warnings are directed at the physician and not 22 the patient who is the ultimate consumer. The manufacturer's duty is 23 fulfilled once it adequately warns the physician. Garside, 976 F.2d 24 at 80. "[W]here prescription drugs are concerned, the manufacturer's 25 duty to warn is limited to an obligation to advise the prescribing 26 warnings of the risks of each product it sells. The doctrine does not exempt manufacturers from providing consumers so long as they adequately instruct and warn a prescription drug manufacturer has no duty to warn drug, however, it is widely accepted that the

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physician of any potential dangers that may result from the drug's 3 use." Reyes v. Wyeth Lab., 498 F.2d 1264, 1276 (5th Cir. 1974). 4 This doctrine seems to be widely accepted, see Thom v. Bristol5 Myers Squibb Co., 353 F.3d 848, 852 (10th Cir. 2003) (adopted in 6 forty-four 7 incorporating variations thereof,3 and has been applied in Puerto 8 Rico. See i.e., Guevara v. Dorsey Lab. Div. of Sandoz, Inc., 845 F.2d 9 364, 366 (1st Cir. 1988) ("prescription drug manufacturer has a duty 10 to adequately warn prescribing physicians of hazards posed by the use 11 of its drugs... The warning is directed not to the ultimate user but 12 to the doctor prescribing the drug"); Pierluisi v. E.R. Squibb & 13 Sons, Inc., 440 F.Supp. 691, 694 (D.P.R. 1977) ("It is the prevailing 14 general rule that the duty of adequate warning by the manufacturer of 15 an ethical drug is discharged by its warning of hazards to doctors.") 16 Rationale 17 The 18 physician 19 standpoint, whether or not the drug is appropriate for a patient 20 under his care. 21 Prescription drugs are likely to be complex medicines, 22 esoteric in formula and varied in effect. As a medical 23 expert, the prescribing physician can take into account the 24 25 26 North Carolina General Statutes §99B-5(c); Ohio Revised Code § 2307.76(C); New Jersey Statutes § 2A:58C-4, and Mississippi Code § 11-1-63(c)(2).
3

jurisdictions);

some

states

have

enacted

statutes

reasoning is in a

behind better

this

theory to

is

that

the from

prescribing a medical

position

decide,

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propensities of the drug, as well as the susceptibilities 3 of his patient. His is the task of weighing the benefits of 4 any medication against its potential dangers. The choice he 5 makes 6 judgment bottomed on a knowledge of both patient and 7 palliative. Pharmaceutical companies then, who must warn 8 ultimate purchasers of dangers inherent in patent drugs 9 sold over the counter, in selling prescription drugs are 10 required to warn only the prescribing physician, who acts 11 as 12 consumer. 13 Reyes v. Wyeth Lab., 498 F.2d at 1276. 14 "[I]t is for the prescribing physician to consider warning 15 labels supplied by the drug manufacturer, as well as other medical 16 literature and sources and the personal medical history of his or her 17 patient, in coming to an independent medical judgment whether to 18 prescribe the medication in question." Colacicco v. Apothex, Inc., 19 432 F.Supp.2d 514, 545 (E.D.Pa. 2006). "The underlying premise of 20 this doctrine is that patients rely on their doctors' expert judgment 21 - not any materials included on the label or in the drug packaging 22 when deciding which drugs to use and how to use them." In re Meridia, 23 328 F.Supp.2d at 811. 24 Because the warning is directed at the prescribing physician, 25 its adequacy is assessed with reference to the physician, not the 26 a `learned intermediary' between manufacturer and is an informed one, an individualized medical

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patient. That is, the information provided must allow the physician 3 the opportunity to render adequate professional advise regarding the 4 use of a particular course of treatment. "Thus, for drugs available 5 only by prescription, warning labels are targeted at doctors, not 6 individual users." Colacicco, 432 F.Supp.2d at 545. 7 The protection offered by the doctrine vanishes if the warnings 8 to the physicians are found to be inadequate. "[T]he doctrine only 9 applies if the facts support the conclusion that a drug manufacturer 10 adequately warns doctors of a drug's dangers; it does not shield drug 11 manufacturers 12 physicians would not permit the physicians to adequately advise their 13 patients." Id. at 546; In re Meridia, 328 F.Supp.2d at 811. 14 Exceptions 15 Some exceptions to the learned intermediary doctrine have arisen 16 in response to particular situations where the underlying factors 17 justifying the rule have been altered. 18 One exception pertains to mass immunizations which the courts 19 have exempted because the underlying physician-patient is lacking. 20 See, i.e., Reyes v. Wyeth Lab. (polio vaccine administered at clinic 21 by nurse); Davis v. Wyeth Lab., 399 F.2d 121, 131 (9th Cir. 1968) 22 (even though vaccine "denominated a prescription drug it was not 23 dispensed as such. It was dispensed to all comers at mass clinics 24 without an individualized balancing by a physician of the risks 25 involved.") 26 from liability if the warnings they provided to

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Another instance where prescription drugs have been taken out of 3 the 4 reasoned that "[w]hereas a patient's involvement in decision-making 5 concerning use of a prescription drug necessary to treat a malady is 6 typically minimal or nonexistent, the healthy, young consumer of oral 7 contraceptives is usually actively involved in the decision to use 8 `the pill,' as opposed to other available birth control products, and 9 the prescribing physician is relegated to a relatively passive role." 10 MacDonald v. Ortho Pharm. Corp., 394 Mass. 131, 136-37, 465 N.E.2d 65 11 (Mass. Sup. Ct. 1985). See also, Odgers v. Ortho Pharm. Corp., 609 12 F.Supp. 867, 878 (E.D. Mich. 1985) (grounds for applying learned 13 intermediary doctrine inapposite in oral contraceptive situations 14 because "patient does not rely on the physician to nearly the same 15 degree when it comes to choosing a method of contraception as in a 16 decision regarding a therapeutic drug.") But see, Gurski v. Wyeth17 Ayerst Div. Of Am. Home Prods. Corp., 953 F.Supp 412, 416 (D.Mass. 18 1997) (quaere if exception applies when birth control drug used 19 solely for therapeutic reasons). 20 It has also been suggested that in cases of direct to consumer 21 advertisement 22 intermediary rule should not apply. 23 In Perez v. Wyeth Lab., Inc., 161 N.J. 1, 734 A.2d 1245, 1255-56 24 (N.J. Sup. Ct. 1999) the court extensively discussed the rationale 25 behind the learned intermediary doctrine and found it lacking in 26 by the drug manufacturing companies the learned scope of this doctrine are oral contraceptives. The court

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CIVIL NO. 02-2608 (RLA) c a s es of direct marketing of contraceptive capsules

Page 15 surgically

3 inserted in a female patient. The court reasoned that for this 4 particular product there was an active participation of the patients 5 in deciding which drug or device to use; there was no real concern 6 that the patient-physician relationship would be affected, and the 7 users relied on the FDA-approved warnings. 8 However, this approach has not been widely accepted. See, 9 Colacicco, 432 F.Supp. 547 n.30 and cases cited therein (declining to 10 apply the DTC exception "because, in the eight years since Perez, the 11 New Jersey Supreme Court case making an exception to the [learned 12 intermediary 13 decided, no state has joined New Jersey."); See also, Beale v. 14 Biomet, Inc., 492 F.Supp.2d 1360, 1376 (S.D.Fla. 2007) ("While Perez 15 court found that the law should be changing in response to changes in 16 the marketing strategies by drug manufacturers, New Jersey is the 17 only state to have done so."); In re Meridia, 328 F.Supp.2d at 812 18 n.19 (rejecting its application as widely unaccepted). 19 The Evidence 20 It 21 accompanying the insert of the Lantus® product which were provided to 22 decedent4 were legally adequate with respect to decedent's physicians 23 24 25 26 Plaintiffs admit that the insert accompanied the vials but argue that decedent was not proficient in English and that MRS. SILVAGNOLI only read the part dealing with its administration.
4

doctrine]

for

direct-to-consumer

advertising,

was

is

uncontested

that

the

warnings

and

instructions

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Page 16

and in compliance with the applicable governmental regulations and 3 requirements. 4 DR. ESAM DAJANI, plaintiffs' expert witness, opined in his 5 report that the "professional product labeling of LANTUS provided to 6 physicians fully disclosed the carcinogenicity potential of the 7 product". He noted, however, that the "product labeling provided to 8 patients did not disclose this important issue." (Emphasis ours). 9 During his deposition DR. DAJANI confirmed this conclusion when 10 specifically asked regarding this point: 11 Q. You think the FDA and Aventis did a good job with 12 the end result of the labeling that went to physicians? 13 A. Correct. 14 Q. Your criticism is with respect to the information 15 that went to patients, is that correct: 16 A. Correct. 17 Depo. Tr. 206 lines 4-11. 18 In support of their direct to consumer advertising argument 19 plaintiffs submitted various documents, internet material and TV news 20 clips 21 advertising campaign for Lantus®. Defendant argues that this evidence 22 does not qualify as direct to consumer advertising because it was 23 either directed to medical professionals or was not prepared by 24 AVENTIS. Given today's ruling, there is no need for us to address 25 these arguments. 26 purportedly published by the defendant as part of its

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At the outset, we must inescapably conclude that Lantus® does 3 not even remotely fall within the limited type of prescription drugs 4 that 5 intermediary doctrine. Further, plaintiffs have failed to explain why 6 the circumstances surrounding this particular product should trump 7 the 8 physician, 9 manufacturer and consumer/patient, is generally in the best position 10 to evaluate the potential risks and benefits of ingesting a certain 11 drug and to advise the patient accordingly." Garside, 976 F.2d at 80. 12 Further, 13 necessary causal connection between the alleged direct to consumer 14 advertising and his or her injuries, it is imperative that evidence 15 of having responded to the advertising be introduced precisely to 16 obviate the underlying rationale of the doctrine. See, In re Norplant 17 Contraceptive Prods. Lit., 165 F.3d 374, 379 (5th Cir. 1999) (declined 18 to 19 plaintiffs 20 materials issued [by the manufacturer.") 21 Even assuming that Lantus® is amenable to the direct to consumer 22 advertising exception, the record in this case is devoid of any 23 evidence intimating that decedent even saw informational material 24 regarding Lantus® prior to his visit to DR. TRABANCO on July 5, 2001. 25 Rather, the evidence points to the physician initially suggesting 26 "actually saw, let alone relied, on any marketing exempt from learned intermediary rule absent evidence that as part of a plaintiff's need to establish the as the `learned intermediary' standing between the reasons for the rule to the effect that "the prescribing courts have exempted from the application of the learned

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that MR. MENDEZ try the new product and provided him the two sample 3 vials.5 4 At no point do any of the plaintiffs specifically indicate, as 5 part of their summary judgment burden, that decedent was swayed by 6 advertising promoted by AVENTIS to the general public which promotion 7 lead MR. MENDEZ to request the product from his physician. 8 According to plaintiffs, "Norma Sivagnoli saw advertisements 9 when her husband was taking Lantus®".6 Decedent's children also 10 mentioned having seen promotional material, advertisements, brochures 11 and a journal of Lantus® as well as TV advertisements. However, none 12 indicate that decedent was privy to this informational material prior 13 14 15 16 17 18 19 20 25. 21 22 23 24 25 26 Plaintiffs' Counterstatement of Uncontested Material Facts (docket No. 180) ¶ 26 (emphasis ours). In her deposition MRS. SILVAGNOLI specifically testified that she could not remember whether she had seen Lantus® TV adds "before or after" her husband had started using the medication. NORMA IRIS SILVAGNOLI COLLAZO 12/7/05 Depo. Tr. 31.
6

Plaintiffs admitted the following defendant's Statement of Uncontested Material Facts (docket No. 169) which read as follows: 24. Concerned that the insulin medication he was taking at the time, Humulin 70/30, might be discontinued, Mr. Mendez went to see his endocrinologist Dr. Cesar Trabanco [on July 5, 2001]... Dr. Trabanco informed Mr. Mendez and his wife, Norma Iris Silvagnoli collazo, who was also present, that there was a new insulin product on the market, Lantus®, that had the advantage of only having to be injected once a day. Mr. Mendez was given two samples of Lantus® by Dr. Trabanco on July 5, 2001.

5

(Emphasis ours). See also, NORMA IRIS SILVAGNOLI COLLAZO 12/7/05 Depo. Tr. 7-8.

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to July 5, 2001.7 Plaintiffs merely argue, in a conclusory fashion, 3 that 4 allegation, without more, is not sufficient to defeat defendant's 5 learned intermediary defense. 6 Faced with this factual scenario, we find that plaintiffs have 7 failed to adequately meet their burden in opposing defendant's well8 grounded summary judgment request. 9 CONCLUSION 10 Based on the foregoing, the Motion for Summary Judgment filed by 11 AVENTIS (docket No. 169)8 is GRANTED. 12 Accordingly, the Second Amended Complaint is DISMISSED based on 13 the 14 accordingly. 15 IT IS SO ORDERED. 16 San Juan, Puerto Rico, this 30th day of September, 2008. 17 18 19 20 21 22 23 24 25 26 See Plaintiffs' Opposition (docket No. 182); Defendant's Reply (docket No. 199) and Plaintiffs' Sur-Reply (docket No. 209).
8

defendant

conducted

direct

to

consumer

advertising.

This

learned

intermediary

defense.

Judgment

shall

be

entered

S/Raymond L. Acosta RAYMOND L. ACOSTA United States District Judge

Plaintiffs' Counterstatement of Uncontested Material Facts (docket No. 180) ¶¶ 27-29.

7