Opinion
No. 3386.
October 20, 2005.
OPINION
Plaintiff, Carolyn Leffler, appeals this Court's Order dated August 30, 2005 granting the Wyeth Defendants' ("Wyeth") Motion for Summary Judgment. For the following reasons, this Court's Order should be AFFIRMED.
I. BACKGROUND
Plaintiff Leffler commenced the within Phen-Fen Mass Tort action by Complaint on June 26, 2003, alleging that she developed moderate mitral regurgitation from her ingestion of prescription diet drugs, Pondimin and/or Phentermine ("diet drugs"), manufactured by Wyeth. (See Leffler Short Form Complaint, ¶ 4). Donald S. Robertson, M.D. is the only physician listed in plaintiff's Complaint as having prescribed diet drugs for Ms. Leffler. (See Complaint, ¶ 5). Dr. Robertson was never deposed in this case. The basis of Leffler's action is that Wyeth's failure to warn of the association between diet drugs and heart valve damage was the cause of her injury.
On August 1, 2005, Wyeth moved for summary judgment against the Plaintiff arguing that Leffler was unable to prove that a different warning regarding the association between the ingestion of diet drugs and her injury would have prevented her physician from prescribing her the diet drugs. Wyeth further argued that without evidence that a warning of valvular heart disease would have caused her physician to alter his prescription practices, Leffler is unable to establish that Wyeth's failure to warn was the proximate cause of her alleged injury.
Plaintiff filed a Response setting forth the following material position:
1. A genuine issue of material fact is raised by the Affidavit of Dr. Harris Busch. (Ex. 1 to Plaintiff's Response, p. 3, Affidavit of Dr. Busch). Plaintiff asserts that Dr. Busch can testify that no reasonable health care professional would have prescribed these drugs.
2. Plaintiff suggests that the Defendants' position is unjust in that "if your prescriber dies before you file suit (or is otherwise unavailable for depositions), you have no suit!?" (Plaintiff's Response, p. 3).
3. Plaintiff is entitled to a rebuttable presumption — a heeding presumption. (Plaintiff's Response, p. 3).
4. The law of Pennsylvania should follow that of New York and New Jersey which permits a Plaintiff to testify that had the manufacturer warned the physician, the physician would have passed those warnings on to the Plaintiff who would then have decided not to take the drug.
After the entry of summary judgment, as aforestated, the Plaintiff appealed to the Superior Court on September 30, 2005. The Plaintiff filed a Concise Statement of Matters Complained of on Appeal Pursuant to Pa. R.A.P. 1925(b) on October 17, 2005 in response to the Order of the Court, essentially contending as follows:
1. Plaintiff's basis for the appeal is that she had no obligation to depose her prescribing physician by the discovery deadline (she could have taken a trial preservation deposition and/or brought her prescribing physician to testify live at trial).
2. Plaintiff had the ability to use expert testimony that no reasonable physician would have prescribed Wyeth's diet drugs had they been informed of the actual risks of valvular heart disease, et al.
3. Plaintiff was not obligated to designate an expert to establish that she suffered a "compensable injury". (It should be noted at the outset that the issue involved in this case is not whether a "compensable injury" was sustained by the Plaintiff, but whether the Plaintiff established causation between the ingestion of diet drugs and her injury).
a) Whether Plaintiff's summary judgment evidence raised material issues of fact precluding summary judgment for Defendants;
b) Whether the trial court applied an unduly restrictive interpretation of proximate cause;
c) Whether Plaintiff is entitled to a rebuttable heeding presumption that had her prescribing doctor been given a warning he would have heeded the warning and either told her of the risk or refused to prescribe the drug.
II. DISCUSSION
"After the relevant pleadings are closed, but within such time as not to unreasonably delay trial, any party may move for summary judgment in whole or in part as a matter of law." Pa. R.C.P. 1035.2. "A proper grant of summary judgment depends upon an evidentiary record that either (1) shows the material facts are undisputed or (2) contains insufficient evidence of facts to make out a prima facie cause of action or defense, and, therefore, there is no issue to be submitted to the jury."Biernacki v. Presque Isle Condos. Unit Owners Ass'n, 828 A.2d 1114, 115-116 (Pa.Super. 2003) (quoting Grandelli v. Methodist Hospital. 777 A.2d 1138, 1143-44 (Pa.Super. 2001)). Where a motion for summary judgment is based upon insufficient evidence of facts, the adverse party must come forward with evidence essential to preserve the cause of action and if he fails to do so, the moving party is entitled to judgment as a matter of law. See id.
The standard for reviewing a trial court's grant of summary judgment is well established: the reviewing court must "view the record in the light most favorable to the non-moving party and resolve all doubts as to the existence of a genuine issue of material fact in its favor."Haney v. Pagnanelli, 830 A.2d 978, 980 (Pa.Super. 2003) (quotingJuniata Valley Bank v. Martin Oil Co., 736 A.2d 650, 655 (Pa.Super. 1999)). "In reviewing a grant of summary judgment, the appellate Court may disturb the trial court's order only upon an error of law or an abuse of discretion." Biernacki, 828 A.2d at 116.
The purpose of summary judgment under Rule 1035.2 is "to eliminate cases prior to trial where a party cannot make out a claim or a defense after relevant discovery has been completed." Miller v. Sacred Heart Hosp., 753 A.2d 829, 833 (Pa.Super. 2000) (quoting Eaddy v. Hamaty, 694 A.2d 639, 643 (Pa.Super. 1997). A plaintiff "must state a prima facie case before he will be allowed to proceed to trial." Eaddy, 694 A.2d at 643.
At issue in the instant case is whether the record before this court contained sufficient evidence to permit Leffler to proceed to trial. Specifically, Wyeth argued that under the learned intermediary doctrine, Leffler needed to show that had her physician, Dr. Robertson, received a different warning regarding the association between diet drugs and valvular heart disease, he would have altered his prescribing habits and thus her injury would have been avoided. After careful review of the record, this court concluded that Leffler failed to carry her burden, and summary judgment was warranted.
"There is no question that manufacturers of potentially dangerous drugs are held to a high degree of care." Incollingo v. Ewing, 282 A.2d 206, 219 (Pa. 1971). But unlike the duty imposed on most product manufacturers, Pennsylvania courts have repeatedly refused to impose strict liability on manufacturers of prescription drugs. See Hahn v. Richter, 673 A.2d 888, 891 (Pa. 1996) ("[W]here the adequacy of warnings associated with prescription drugs is at issue, the failure of the manufacturer to exercise reasonable care to warn of dangers, i.e., the manufacturer's negligence, is the only recognized basis of liability"); Baldino v. Castagna, 478 A.2d 807, 810 (Pa. 1984) ("[A]ssuming proper preparation and warning, a manufacturer of drugs is not strictly liable for unfortunate consequences attending the use of otherwise useful and desirable products which are attended with a known but apparently reasonable risk"); Incollingo v. Ewing, 282 A.2d at 219-20. Pennsylvania courts have recognized that "there are some products which, in the present state of human knowledge, are quite incapable of being made safe for their ordinary and intended use. These are especially common in the field of drugs." Coyle v. Richardson-Merrell, Inc., 584 A.2d 1393, 1385 (Pa. 1991) (citingRestatement of Torts Section 402A (1965), Comment k).
Accordingly, a "manufacturer [of prescription drugs] is liable only if he fails to exercise reasonable care to inform those for whose use the article is supplied of the facts which make it likely to be dangerous."Baldino, 478 A.2d at 810. This duty to warn runs not to the patient or the general public, however, but to the prescribing physician.See Incollingo, 282 A.2d at 220 ("Since the drug was available only upon prescription of a duly licensed physician, the warning required is not to the general public or to the patient, but to the prescribing doctor"); Rosci v. Acromed, Inc., 669 A.2d 959, 969 (Pa.Super. 1995) ("The intended "user" in a case involving a prescription drug or device is, of course, the prescribing physician"); Leibowitz v. Ortho Pharm. Corp., 307 A.2d 449, 457 (Pa.Super. 1973) ("It is for the prescribing physician to use his own independent medical judgment, taking into account the data supplied to him from the drug manufacturer, other medical literature, and any other source available to him, and weighing that knowledge against the personal medical history of his patient, whether to prescribe a given drug."); Demmler v. SmithKline Beecham Corp., 671 A.2d 1151, 1154 (Pa.Super. 1996) ("a prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient" and weigh "the benefits of any medication against its potential dangers."). In discussing the rationale behind what has come to be known as the "learned intermediary" doctrine, the Leibowitz court explained:
In approving a drug for marketing purposes, the F.D.A. is ever mindful of risks inherent in the use of a proposed drug. It also approves same because of the benefit said drug may have for the public as a whole. Every surgical procedure carries certain risks, as do driving an automobile or crossing an intersection. As different standards apply in the case of prescription drugs and over-the-counter drugs (the former requiring that the prescribing physician exercise the final judgment in each case), the risks must be balanced against the utility to the public-at-large. The warnings are directed to the prescribing physician who must make that balancing judgment in light of his personal knowledge of the patient's medical history.
Leibowitz, 307 A.2d at 457-58.
Furthermore, "assuming that plaintiff[s] [has] established both duty and a failure to warn, plaintiff[s] must further establish proximate causation by showing that had defendant issued a proper warning to the learned intermediary, he would have altered his behavior and the injury would have been avoided." Demmler, 671 A.2d at 1155. Significantly, "[i]n the event that a warning is inadequate, proximate cause is not presumed." Id. Thus, where defendant has moved for summary judgment, in order to proceed to trial, the burden is on plaintiff to come forward with evidence to show that a different warning would have caused her physician to change his prescribing habits. Id., 671 A.2d at 1155. "To create a jury question, the evidence introduced must be of sufficient weight to establish some reasonable likelihood that an adequate warning would have prevented the plaintiff from receiving the drug.Id. Absent proof that a more thorough or more explicit warning would have prevented plaintiff's use of the drug, she cannot establish that defendants' alleged failure to warn was the proximate cause of her injuries. Id.
In the instant case, it is undisputed that the drugs Pondimin and/or Phentermine are available only by prescription. There is also no question that Leffler was under the care of Dr.Robertson during the period that she took Pondimin and/or Phentermine. Thus, Wyeth's duty ran directly to Dr. Robertson as Leffler's prescribing physician.
Plaintiff cites Demmler, supra, at Page 1155 as providing its legal basis for alleging error of this Court in granting summary judgment because Plaintiffs say that they "adduced sufficient evidence of some reasonable likelihood that an adequate warning would have prevented the Plaintiff from receiving the drug."
However, a clear reading of that entire Page 1155 ofDemmler, supra, reveals that Plaintiffs have taken Demmler out of context. Demmler cites as follows at Page 1155:
". . . In the duty to warn context, assuming that plaintiffs have established both duty and a failure to warn, plaintiffs must further establish proximate causation by showing that had defendant issued a proper warning to the learned intermediary, he would have altered his behavior and the injury would have been avoided . . . In the event that a warning is inadequate, proximate cause is not presumed . . . To create a jury question, the evidence introduced must be of sufficient weight to establish . . . some reasonable likelihood that an adequate warning would have prevented the plaintiff from receiving the drug . . ." (emphasis supplied)
Thus, it is not mere "sufficient evidence" (as quoted fromDemmler in ¶ 12 of Plaintiffs' Statement of Reasons) but "evidence . . . of sufficient weight to establish . . . some reasonable likelihood that an adequate warning would have prevented the plaintiff from receiving the drug." The evidence of sufficient weight to establish a reasonable likelihood is evidence that the learned intermediary, Dr. Robertson, and only Dr. Robertson, would provide to the effect that he,Dr. Robertson, would have altered his behavior. That is theexpress language of Demmler.
Accordingly, an affidavit or testimony of Dr. Busch as to what a "reasonable physician" would have done with appropriate knowledge is not admissible, is irrelevant and is contrary to the legal standard long established under Pennsylvania law.
The mere fact that for some unknown reason Plaintiff did not take the deposition of Dr.Robertson, to preserve his testimony during his lifetime while the instant case was pending, provides no justification for a change or expansion of existing law. Any absence or death of a material witness in any litigation is a risk that falls upon the party who depends upon that witness to satisfy his burden, in this case the Plaintiffs burden.
Accordingly, no material issue of fact existed as to causation and the Plaintiff failed to supply evidence satisfying her burden in that regard. The affidavit of Dr. Busch did not satisfy that burden or create any material issue of fact. Without evidence from Robertson,himself, that he would not have prescribed the diet drugs, Leffler is unable to establish that Wyeth's alleged failure to warn was the proximate cause of her injuries. See Demmler, supra.
In an attempt to avoid summary judgment in the absence of any testimony from Dr. Robertson, Leffler argues that she would have followed an adequate warning had Wyeth provided one. This so-called "heeding presumption" was first adopted in Pennsylvania in Coward v. Owens-Corning Fiberglass Corp., 729 A.2d 614 (Pa.Super. 1999). InCoward, an asbestos product liability action, our Superior Court discussed at length the adoption of strict liability in this Commonwealth. See id., 729 A.2d at 618-620. Specifically, in adopting strict liability under Section 402A, our Supreme Court molded Pennsylvania jurisprudence to "assure injured plaintiffs a right of recovery, regardless of fault, if their injuries were caused by a product lacking any element necessary for its intended use."Id. at 619. In an attempt to further these policy objectives, theCoward court adopted the heeding presumption in cases "where warnings or instructions are required to make a product non-defective and a warning has not been given" and shifted the burden of production to manufacturers of such products. See id. at 621.
Plaintiff's assertion that a "heeding presumption" relieves her of the burden of proving proximate cause ignores the express case law of Pennsylvania. Pennsylvania courts have consistently declined to apply any heeding presumption in pharmaceutical and most other product liability cases, strictly limiting the application of any such presumption to claims arising from involuntary workplace exposure to asbestos. See, e.g., Goldstein v. Phillip Morris USA, Inc., 854 A.2d 585, 587 (Pa.Super. 2004) (citing Viguers v. Phillip Morris USA, Inc., 837 A.2d 534, 538 (Pa.Super. 2003); see also Moroney v.General Motors Corp., 850 A.2d 629, 634 n. 3 (Pa.Super. 2004) (refusing to apply heeding presumption to failure to warn claim unrelated to asbestos) (citing Viguers, 837 A.2d at 537). Plaintiff's opposition failed to disclose that the Supreme Court of Pennsylvania just recently affirmed the Superior Court's decision restricting application of the heeding presumption to occupational injury cases. Viguers v. Phillip Morris USA, Inc., No. 40 EAP 2004, 2005 WL 2386105 (Sept. 28, 2005). The heeding presumption is inapplicable here, and it is irrelevant to Plaintiff's claims.
The cases cited by the Plaintiff in her Response on page 5, relating to decisions by the Supreme Court of New York and the Supreme Court of New Jersey, regarding the physician's responsibility to pass on to the patient the information that enables the patient to use the product safely are not the law of Pennsylvania as enunciated byDemmler, supra, and thus are not applicable to this case.
Finally, the assertion that this Court applied "unduly restrictive interpretation of proximate cause" is an argument that the policy of the learned intermediary doctrine, enunciated by our appellate courts, is unjust. That is an argument for our appellate courts as this trial court is bound by this established doctrine. Accordingly, there is no merit in the Plaintiff's Appeal.
III. CONCLUSION
For the foregoing reasons, this Court concludes that Leffler cannot establish that Wyeth's alleged failure to warn of the risk of valvular heart disease was the proximate cause of her injury. Therefore, summary judgment was warranted and this Court committed no error.