Hoffman-Rattet v. Ortho Pharmaceutical Corp.

• Citation: 135 Misc.2d 750,516 N.Y.S.2d 856
• Decision Date: 20 May 1987
• Docket Number: HOFFMAN-RATTET and R
• Parties: Elaineobert Rattet, Plaintiffs, v. ORTHO PHARMACEUTICAL CORP., Dr. Hugo Tejada and Dr. Marcia Storch, Defendants.
• Court: United States State Supreme Court (New York)

Page 856

516 N.Y.S.2d 856

135 Misc.2d 750

Elaine HOFFMAN-RATTET and Robert Rattet, Plaintiffs, v. ORTHO PHARMACEUTICAL CORP., Dr. Hugo Tejada and Dr. Marcia Storch, Defendants.

Supreme Court, New York County IAS Part 29.

May 20, 1987.

Rosenberg, Minc, Bryer & Armstrong by Daniel C. Minc, New York City, for plaintiffs.

Patterson, Belknap, Webb & Tyler by John D. Winter, New York City, for defendant Ortho.

STANLEY L. SKLAR, Justice.

This application for renewal/reargument of defendant Ortho Pharmaceutical Corporation's summary judgment motion raises issues previously unresolved in New York concerning the availability of summary judgment to a pharmaceutical manufacturer based upon an affidavit from an "informed intermediary," namely, the physician who prescribed the manufacturer's product.

First, this court holds that the drug manufacturer has the burden of proving by means of a physician's affirmative statement that, even if adequately warned, the treatment provided would have been virtually identical to that actually rendered. Summary judgment is appropriate only when that burden has been met to the level of negating the existence of a genuine factual issue. Second, in attempting to meet that burden, unless the physician's statement is self-disserving, the issue of the credibility of the physician's affidavit should ordinarily be left for the trier of the facts and should not be resolved by the court on a motion for summary judgment.

Ortho has failed to provide the necessary evidence to negate the existence of a genuine issue of material fact. In addition, it has failed to establish as a matter of law that it discharged its duty to adequately inform plaintiff's physician of the newly discovered risks attributed to the intrauterine device.

Accordingly, its application is denied.

Additional Facts

Ortho, in the instant motion, seeks to fill in the gaps in the affidavits appended to its earlier motion.

Specifically, it appends the affidavit of Chris McDowell, an Ortho employee, who states that the "Dear Doctor" letter "was mailed on November 4, 1977 to all obstetricians, gynecologists and family practitioners in the United States." In addition, Ortho provides the supplemental affidavit of Dr. Storch, in which she claims that "[p]rior to December 1977, I received a 'Dear Doctor' letter and revised package insert for Lippes Loop." Dr. Storch also states that when she inserted the Lippes Loop into Ms. Hoffman-Rattet, she (Dr. Storch) was aware that "infertility was a possible complication of pelvic infection." Dr. Storch also reiterates the assertion contained in her original affidavit ... namely, that at the time of the insertion she was aware that there was a risk of PID associated with IUDs, including the Lippes Loop. Finally, Dr. Storch claims that she prescribed Lippes Loops after December, 1977.

Ortho now argues that this additional data, coupled with that furnished on the original application, establish (1) that the updated material was sent by Ortho to Dr. Storch and that she received it before she saw Ms. Hoffman-Rattet in December, 1977 and, therefore, Ortho discharged its duty to adequately warn Dr. Storch; (2) that even if Dr. Storch did not read this new material before seeing Ms. Hoffman-Rattet in December, 1977, because Dr. Storch did prescribe the Lippes Loop after December, 1977, presumably after she read the update, one can infer that had Dr. Storch read it before seeing Ms. Hoffman-Rattet, any treatment provided would not have varied from that actually rendered; and (3) because Dr. Storch independently knew that some Lippes Loop users suffered from PID and that PID could lead to infertility, her actions constituted an intervening cause of Ms. Hoffman-Rattet's injuries sufficient to relieve Ortho of all liability as a matter of law.

I shall now address, seriatim, each of these arguments, none of which justifies summary judgment in Ortho's favor.

Update--Conveyed/Received

With respect to whether the new warnings were conveyed, Ortho now provides its employee's affidavit, confirming that they were sent in November, 1977. Aside from the fact that this information could have been provided on the original motion and no excuse has been offered for the failure to do so, because it is an assertion exclusively within the knowledge of the moving party it is subject to an attack on credibility. Cohen v. St. Regis Paper Co., 64 N.Y.2d 656, 658, 485 N.Y.S.2d 246, 474 N.E.2d 606 (1984). Although, where an issue of credibility is involved the granting of summary judgment is generally inappropriate [Frame v. Markowitz, 125 A.D.2d 442, 509 N.Y.S.2d 372 (2d Dept, 1986); Koen v. Carl Co., 70 A.D.2d 695, 416 N.Y.S.2d 396 (3d Dept, 1979) ], here Dr. Storch also claims to have received the updated warnings. Because it was not necessarily in her best interests to so have admitted, the court will assume for purposes of this motion that they were received. See: Albouyeh v. County of Suffolk, 62 N.Y.2d 681, 683, 476 N.Y.S.2d 522, 465 N.E.2d 29 (1984); Wolfgruber v. Upjohn Co., 72 A.D.2d 59, 63, 423 N.Y.S.2d 95 (4th Dept, 1979), aff'd 52 N.Y.2d 768, 436 N.Y.S.2d 614, 417 N.E.2d 1002.

Dr. Storch, while admitting that she received the update before seeing the plaintiff in December, 1977, never admitted that she (Dr. Storch) read it. If Dr. Storch did not in fact read the new warnings this may have been due to the inadequacy of the "Dear Doctor" letter.

"An adequate warning is one reasonable under the circumstances. Sterling Drug, Inc. v. Yarrow, 408 F.2d 978, 992, 993 (9th Cir, 1969); Ortho Pharmaceutical Corp. v. Chapman, 388 N.E.2d [541] at 553 [Ind.App.1979]. A warning may be inadequate in factual content, in expression of the facts, or in the method by which it is conveyed. Ortho Pharmaceutical Corp. v. Chapman, 388 N.E.2d at 552." Brochu v. Ortho Pharmaceutical Corp., 642 F.2d 652, 657 (1st Cir, 1981). The manufacturer must bring home the warnings to the doctor. Richards v. Upjohn Co., 95 N.M. 675, 625 P.2d 1192, 1196 (Ct. of App., 1980); Wooderson v. Ortho Pharmaceutical Corp., 235 Kan. 387, 681 P.2d 1038, 1050 (Sup.Ct., 1984) cert den. 469 U.S. 965, 105 S.Ct. 365, 83 L.Ed.2d 301. Warnings may be inadequate if they "could have been reasonably found to be lacking in emphasis, timeliness and attention inviting qualities ... [or where they are] reluctant and lacking in a sense of urgency." Sterling Drug, Inc. v. Yarrow, 408 F.2d 978, 994 (8th Cir, 1969); Ross v. Jacobs, 684 P.2d 1211, 1214 (Ct. of App., Oklahoma, 1984).

In the instant case a jury could reasonably find the "Dear Doctor" letter to have been inadequate. As noted above, the letter somewhat reluctantly seemed to indicate that Ortho was only sending it out because the FDA required it of all IUD manufacturers. Thus, a doctor receiving it could believe that the new warning contained generalizations about all IUDs. Dr. Storch, having participated in Lippes Loop studies, may have believed that her specific knowledge about the Lippes Loop superseded any generalized information. Further, the letter made no mention of newly discovered dangers.

Moreover, as also indicated above, the letter suggested that the new FDA regulation dealt with prospective users only in that it stated that "according to the regulation [the Patient Information Booklet] is to be given to all patients who desire a Lippes Loop prior to the insertion." It also recited that Ortho believed that the doctor would find the Booklet and Package Insert useful "when you are considering the Lippes Loop for your patients."

Accordingly, a jury could find that a physician in Dr. Storch's position might reasonably have believed it unnecessary to read the new materials unless that physician was contemplating prescribing a Lippes Loop for a patient for the first time. Thus, the evidence submitted does not meet the New York standard, to obtain summary judgment, that the warnings are adequate as a matter of law. Cooley v. Carter-Wallace, Inc., 102 A.D.2d 642, 649, 478 N.Y.S.2d 375 (4th Dept, 1984); Baker v. St. Agnes Hosp., 70 A.D.2d 400, 421 N.Y.S.2d 81 (2d Dept, 1979).

Later Users

Ortho also argues that, because Dr. Storch did indeed prescribe the Lippes Loop for new patients after receiving the "Dear Doctor" letter, it (Ortho) is relieved of liability because this means that had Dr. Storch read the updated material before seeing Ms. Hoffman-Rattet, she (the plaintiff) would have continued to use the Lippes Loop.

This assertion is speculative only. New patients, before using the Lippes Loop, had to be given, pursuant to the new FDA regulation, an information booklet, presumably because it was deemed necessary that they play a more active role in choosing a means of birth control and that they be well informed before deciding to opt for the Lippes Loop. Accordingly, had Dr. Storch read the updated material before seeing Ms. Hoffman-Rattet, we do not know whether she (Dr. Storch) would have decided to give the Patient Information Booklet to Ms. Hoffman-Rattet as she (Dr. Storch) presumably did with new users after December, 1977. Nor do we know that even had the doctor done so whether this would have caused Ms. Hoffman-Rattet to ask that the IUD be removed. Accordingly, what Dr. Storch did with respect to new Lippes Loop users is irrelevant with respect to Ms. Hoffman-Rattet.

Intervening Cause

Ortho also asserts that even if Dr. Storch did not read the new warnings before seeing Ms. Hoffman-Rattet in December, 1977 because she (Dr. Storch) knew at the time of the insertion of the Lippes Loop of the association between the loop and contracting PID, and that PID could lead to infertility, her actions were intervening events which relieved Ortho of liability.

Before reaching the substance of this claim I must address a threshold issue ... credibility. Ortho argues that Dr. Storch's admissions regarding her independently acquired knowledge must be credited as a matter of law because she...