Mendez Montes De Oca v. Adventis Pharma

• Decision Date: 30 September 2008
• Docket Number: Civil No. 02-2608 (RLA).
• Parties: Winston MENDEZ MONTES DE OCA, et al., Plaintiffs, v. ADVENTIS PHARMA, et al., Defendants.
• Court: U.S. District Court — District of Puerto Rico

579 F.Supp.2d 222

Winston MENDEZ MONTES DE OCA, et al., Plaintiffs, v. ADVENTIS PHARMA, et al., Defendants.

Civil No. 02-2608 (RLA).

United States District Court, D. Puerto Rico.

September 30, 2008.

Mauricio Hernández-Arroyo, Esq., Ponce, PR, for Plaintiffs.

Eric A. Tulla, Esq., José A. Bague-Soto, Esq., Rivera Tulla & Ferrer, Hato Rey, PR, PHV K.C. Green, Dinsmore & Shohl, LLP, Cincinnati, OH, for Defendants.

ORDER GRANTING DEFENDANT'S MOTION FOR SUMMARY JUDGMENT

RAYMOND L. ACOSTA, District Judge.

Defendant AVENTIS PHARMACETICALS, 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 MEDEZ MONTES DE OCA, his wife, NOMA 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 action, substituted him in these proceedings pursuant to Rule 25 Fed. R.Civ.P.

In their complaint¹ plaintiffs allege that AVENTIS failed to directly warn the consumer of the purported hazards and risks associated with the use of Lantus®. Plaintiffs further allege that MR. MEDEZ's use of the Lantus® insulin in his left thigh was the direct and proximate cause of his cancerous tumor.

AVENTIS argues that (1) plaintiffs' claims are barred by the learned intermediary doctrine; (2) plaintiffs have failed to establish the necessary causal relationship between the use of Lantus® and decedent's cancer; (3) the expert evidence shows that, based on the size and location of the tumor and the fact that it appeared within a few months of a single injection of the product, it is biologically implausible for the tumor to have been caused by the use of Lantus®, and (4) the claims are time-barred.

Because we find that AVENTIS is entitled to the immunity provided by the learned intermediary defense we need not address the other arguments raised by defendant in support of its summary judgment request.

SUMMARY JUDGMENT STANDARD

Rule 56(c) Fed. R. Civ. P., which sets forth the standard for ruling on summary judgment motions, in pertinent part provides that they shall be granted "if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." Sands v. Ridefilm Corp., 212 F.3d 657, 660-61 (1st Cir.2000); Barreto-Rivera v. Medina-Vargas, 168 F.3d 42, 45 (1st Cir.1999). The party seeking summary judgment must first demonstrate the absence of a genuine issue of material fact in the record. De-Novellis v. Shalala, 124 F.3d 298, 306 (1st Cir.1997). A genuine issue exists if there is sufficient evidence supporting the claimed factual disputes to require a trial. Morris v. Gov't Dev. Bank of Puerto Rico, 27 F.3d 746, 748 (1st Cir.1994); LeBlanc v. Great Am. Ins. Co., 6 F.3d 836, 841 (1st Cir.1993), cert. denied, 511 U.S. 1018, 114 S.Ct. 1398, 128 L.Ed.2d 72 (1994). A fact is material if it might affect the outcome of a lawsuit under the governing law. Morrissey v. Boston Five Cents Sav. Bank, 54 F.3d 27, 31 (1st Cir.1995).

"In ruling on a motion for summary judgment, the court must view `the facts in the light most favorable to the non-moving party, drawing all reasonable inferences in that party's favor.'" Poulis-Minott v. Smith, 388 F.3d 354, 361 (1st Cir.2004) (citing Barbour v. Dynamics Research Corp., 63 F.3d 32, 36 (1st Cir.1995)).

Credibility issues fall outside the scope of summary judgment. "`Credibility determinations, the weighing of the evidence, and the drawing of legitimate inferences from the facts are jury functions, not those of a judge.'" Reeves v. Sanderson Plumbing Prods., Inc., 530 U.S. 133, 150, 120 S.Ct. 2097, 147 L.Ed.2d 105 (2000) (citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986)). See also, Dominguez-Cruz v. Suttle Caribe, Inc., 202 F.3d 424, 432 (1st Cir.2000) ("court should not engage in credibility assessments."); Simas v. First Citizens' Fed. Credit Union, 170 F.3d 37, 49 (1st Cir.1999) ("credibility determinations are for the factfinder at trial, not for the court at summary judgment."); Perez-Trujillo v. Volvo Car Corp., 137 F.3d 50, 54 (1st Cir.1998) (credibility issues not proper on summary judgment); Molina Quintero v. Caribe G.E. Power Breakers, Inc., 234 F.Supp.2d 108, 113 (D.P.R.2002). "There is no room for credibility determinations, no room for the measured weighing of conflicting evidence such as the trial process entails, and no room for the judge to superimpose his own ideas of probability and likelihood. In fact, only if the record, viewed in this manner and without regard to credibility determinations, reveals no genuine issue as to any material fact may the court enter summary judgment." Cruz-Baez v. Negron-Irizarry, 360 F.Supp.2d 326, 332 (D.P.R.2005) (internal citations, brackets and quotation marks omitted).

In cases where the non-movant party bears the ultimate burden of proof, he must present definite and competent evidence to rebut a motion for summary judgment, Anderson v. Liberty Lobby, Inc., 477 U.S. at 256-257, 106 S.Ct. 2505, 91 L.Ed.2d 202; Navarro v. Pfizer Corp., 261 F.3d 90, 94 (1st Cir.2001); Grant's Dairy v. Comm'r of Maine Dep't of Agric., 232 F.3d 8, 14 (1st Cir.2000), and cannot rely upon "conclusory allegations, improbable inferences, and unsupported speculation". Lopez-Carrasquillo v. Rubianes, 230 F.3d 409, 412 (1st Cir.2000); Maldonado-Denis v. Castillo-Rodriguez, 23 F.3d 576, 581 (1st Cir.1994); Medina-Munoz v. R.J. Reynolds Tobacco Co., 896 F.2d 5, 8 (1st Cir.1990).

THE FACTS

AVENTIS and its predecessor at all relevant times developed, manufactured and sold a prescription drug product known as Lantus®.

Lantus® is a synthetic human insulin product approved by the Food and Drug Administration of the United States Department of Health and Human Services ("FDA") for the treatment of Type I and Type II diabetes.

Lantus® was designed for once per day administration, to alleviate the inconvenience to patients of twice-daily administration and to provide more stable blood sugar levels.

Pursuant to its Investigational New Drug Application for Lantus®, No. 49,078, AVENTIS conducted two-year carcinogenicity studies in both rats and mice. A statistically significant increased incidence of malignant fibrous histiocytoma ("MFH") tumors occurred in male rats. The results of these studies were notified to the FDA.

New Drug Application 21-081 was submitted to the FDA on April 9, 1999, seeking approval of the Lantus® drug.

The FDA approved Lantus® as safe and effective for the treatment of Type I and Type II diabetes on April 20, 2000.

The FDA-approved prescribing information for Lantus®, which is included in the package insert, reads as follows:

Carcinogenesis, Mutagenesis, Impairment of Fertility: In mice and rats, standard two-year carcinogenicity studies with insulin glargine were performed at doses up to 0.455 mg/kg, which is for the rat approximately 10 times and for the mouse approximately 5 times the recommended human subcutaneous stating dose of 10 IU (0.008 mg/kg/day), based on mg/m.² The findings in female mice were not conclusive due to excessive mortality in all dose groups during the study. Histiocytomas were found at injection sites in male rats (statistically significant) and male mice (not statistically significant) in acid vehicle containing groups. These tumors were not found in female animals, in saline control, or insulin comparator groups using a different vehicle. The relevance of these findings to human is unknown. MR. MENDEZ was diagnosed with diabetes in 1983.

On January 20, 1995, MR. MENDEZ began taking Humulin Insulin injections to treat his diabetes. Prior to initiation with Lantus®, MR. MENDEZ administered twice daily injections of Humulin, sometimes in the abdomen and sometimes in the thigh.

Concerned that the insulin medication he was taking at the time, i.e., Humulin 70/30, might be discontinued, MR. MEDEZ went to see his endocrinologist, DR. CESAR TRABANCO, on July 5, 2001. DR. TRABANCO informed MR. MEDEZ and his wife, who was also present, that there was a new insulin product on the market, Lantus®, which 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. Decedent only used those sample vials and never purchased Lantus®.

Included within the Lantus® packaging given to decedent was the product information/package insert for Lantus®.

MR. MENDEZ used Lantus® for approximately one to two months.²

In early August 2001, MR. MENDEZ injected the Lantus® a single time in his upper left thigh. Within a few days thereafter the injected area became painful and hard and started to bother decedent.

On October 17, 2001, an MRI showed a large mass in decedent's left thigh.

A biopsy of the tumor was performed on October 26, 2001, which was diagnosed as "Fibrous Malignant Histiocytoma, Giant Cells Variant, Invasive, High Grade."

MR. MENDEZ died on May 5, 2003, of Sarcoma stage 4.

The FDA-approved language contained in the product's Package Insert fully disclosed the carcinogenic potential of Lantus® to physicians. This Package Insert was included in the packaging of the Lantus® samples provided to MR. MENDEZ.

THE LEARNED INTERMEDIARY DOCTRINE

Plaint...