Opinion
OPINION
Norman Ackerman, J.
Plaintiff, Kathryn S. Gronninger, appeals this Court's Order dated August 30, 2005 and entered August 31, 2005, granting the Wyeth Defendants' (" Wyeth" ) Motion for Summary Judgment and dismissing Plaintiff's claims with prejudice. For the following reasons, this Court's Order should be AFFIRMED.
I. BACKGROUND
Plaintiff commenced the within Phen-Fen Mass. Tort action by Complaint on July 1, 2003, alleging that she developed moderate mitral regurgitation from ingesting the prescription drugs, Pondimin and/or Phentermine (" diet drugs" ). ( See Complaint, page 2). Both the Plaintiff and the Defendants agree that the prescribing physician, Dr. McMechan, " has not been deposed and will not be--he is now dead." ( See Defendants' Motion, p. 2; see also Plaintiff's Concise Statement of Matters Complained of on Appeal Pursuant to Pa. R.A.P. 1925(b), p. 1). Nowhere in the record do we have the date of death of Dr. McMechan and, therefore, the mere assertion by the Plaintiff in her Concise Statement of Matters Complained of that " she had no ability to depose her dead prescribing physician by the discovery deadline" is not a conclusion supported by record facts and accordingly may not even be considered as an excuse for the failure of the Plaintiff to preserve Dr. McMechan's testimony.
On August 1, 2005, Wyeth moved for summary judgment arguing that Gronniger was unable to prove that a different warning regarding the association between the ingestion of Pondimin and/or Phentermine and valvular heart disease would have prevented Dr. McMechan from prescribing her the Pondimin and/or Phentermine. Wyeth further argued that without this evidence, Gronniger cannot prove that Wyeth's alleged failure to warn was the proximate cause of her alleged injury.
In response to Wyeth's motion, Plaintiff Gronniger argued essentially as follows:
1. A genuine issue of material fact is raised by the Affidavit of Dr. Harris Busch who states:
In my opinion, if Wyeth had adequately warned regarding the medical risks associated with the use of fenfluramine and dexfenfluamine, no reasonable healthcare professional would have prescribed these drugs.
See Exhibit 1, Affidavit of Dr. Busch, p. 3 P8.
2. Plaintiff herself will bear the burden of establishing a proximate cause between Wyeth's failure to warn and the Plaintiff's valvular heart disease.
3. It is manifestly unjust to assert that Plaintiff has no right to recover " if your prescriber dies before you file suit (or is otherwise unavailable for deposition)." (It must be noted again that we do not know the date of Dr. McMechan's death, whether it was before or after suit was filed. In any event, it will be seen infra that whatever the date of death, the burden of establishing causation under the learned intermediary doctrine is upon the Plaintiff, the risk of her doctor's death being placed squarely upon the Plaintiff).
4. Plaintiff is entitled to a rebuttable heeding presumption.
5. 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.
On September 30, 2005, Plaintiff Gronniger filed this Appeal. On October 17, 2005, Gronniger filed a Concise Statement of Matters Complained of on Appeal Pursuant to Pa. R.A.P. 1925(b), essentially contending as follows:
1. Plaintiff had no ability to depose her dead prescribing physician by the discovery deadline.
2. Plaintiff had the ability to rely on 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.
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, 1115-1116, 2003 PA Super 247 (Pa.Super. 2003) (quoting Grandelli v. Methodist Hospital, 2001 PA Super 155, 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, 2003 PA Super 261, 830 A.2d 978, 980 (Pa.Super. 2003) (quoting Juniata Valley Bank v. Martin Oil Co., 1999 PA Super 199, 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 1116.
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., 2000 PA Super 161, 753 A.2d 829, 833 (Pa. Super. 2000) (quoting Eaddy v. Hamathy, 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 Gronniger to proceed to trial. Specifically, Wyeth argued that Gronniger failed to establish proximate causation because she was unable to prove that Dr. McMechan would have altered his prescribing habits had he received a warning which included the association between Pondimin and/or Phentermine and valvular heart disease. After careful review of the record, this court concluded that Gronniger 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, 444 Pa. 299, 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, 543 Pa. 558, 673 A.2d 888, 891 (Pa. 1996) (" Where 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, 505 Pa. 239, 478 A.2d 807, 810 (Pa. 1984) (" Assuming 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., 526 Pa. 208, 584 A.2d 1383, 1385 (Pa. 1991) (citing Restatement 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., 447 Pa.Super. 403, 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., 224 Pa.Super. 418, 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., 448 Pa.Super. 425, 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, " in 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 drug Pondimin and/or Phentermine is available only by prescription and that Dr. McMechan was the only physician to prescribe Pondimin and/or Phentermine for Gronniger. Thus, Wyeth's duty ran directly to Dr. McMechan as Gronniger's prescribing physician.
As previously noted, to state a prima facie case, Gronniger had the burden to establish proximate cause by coming forward with evidence of sufficient weight showing that had Wyeth provided an adequate warning regarding Pondimin and/or Phentermine ingestion and valvular heart disease, Dr. McMechan would have changed his prescribing habits and she would not have received the drug. See Demmler, supra. This she failed to do.
Gronniger offers absolutely no evidence, either testimonial or documentary, regarding Dr. McMechan's prescribing of Pondimin and/or Phentermine for her. The record before this Court also is devoid of what attempts, if any, Gronniger made to locate Dr. McMechan and secure either his testimony or his records. The mere fact that Gronniger' failed to provide evidence from Dr. McMechan 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 Gronniger' burden. Without some evidence that Dr. McMechan would have changed his prescribing habits, there can be no issue to present to the jury.
Plaintiff Gronniger, in this case, did not provide any record as to:
1. What efforts were made by plaintiff to locate Dr. McMechan and determine his availability to testify; or
2. If the Plaintiff could locate Dr. McMechan and he was available to testify, why his testimony was not preserved.
While in extreme circumstances, there might be an interesting argument for the appellate court to consider the liberalization of the learned intermediary doctrine, the absence of an explanatory record in this case does not justify such a review. The burden to produce such an explanatory record falls on the Plaintiff Gronniger, who has the burden to prove causation which cannot be satisfied with mere assertions. Without evidence from Dr. McMechan, himself, that he would not have prescribed the Pondimin and/or Phentermine, Gronniger is unable to establish that Wyeth's failure to warn was the proximate cause of her injury. See Demmler, supra.
Accordingly, it is clear that the Plaintiff's citation of the Demmler case, supra, is inaccurately out of context.
Contrary to Gronniger' assertions, the affidavit of Dr. Busch, attesting to what a " reasonable doctor" would have done had a different warning been supplied is insufficient evidence to create a material issue of fact and satisfy her burden on proximate causation. As Demmler, supra , makes clear, the evidence required to establish a reasonable likelihood is evidence that the learned intermediary, namely, Dr. McMechan, and only Dr. McMechan, would provide to the effect that he, Dr. McMechan, would have altered his behavior. Accordingly, an affidavit or testimony of Dr. Busch as to what a " reasonable doctor" would have done with appropriate knowledge is not admissible, is irrelevant and is contrary to the legal standard long established under Pennsylvania law.
Gronniger similarly attempts to avoid summary judgment in the absence of evidence from Dr. McMechan by arguing that that she is entitled to a rebuttable presumption that Dr. McMechan would have followed an adequate warning had Wyeth provided one and either told her of the risk or refused to prescribe the drug.
The so-called " heeding presumption" was first adopted in Pennsylvania in Coward v. Owens-Corning Fiberglas Corp., 1999 PA Super 82, 729 A.2d 614 (Pa.Super. 1999). In Coward, 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, the Coward 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., 2004 PA Super 260, 854 A.2d 585, 587 (Pa. Super. 2004) (citing Viguers v. Phillip Morris USA, Inc., 2003 PA Super 446, 837 A.2d 534, 538 (Pa. Super. 2003); see also Moroney v. General Motors Corp., 2004 PA Super 104, 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. , 584 Pa. 120, 881 A.2d 1262, 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 citation of authority from the Supreme Court of New York and the Supreme Court of New Jersey is not applicable to this case where the appellate courts of Pennsylvania have long established its own Learned Intermediary Doctrine.
III. CONCLUSION
For the foregoing reasons, this Court concludes that Gronniger 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's Order should be AFFIRMED.
By the Court:
NORMAN ACKERMAN
Coordinating Judge, Complex Litigation Center