Opinion
SUPERIOR COURT NO. 1493 EDA 2005.
Court's Order AFFIRMED.
OPINION
Norman Ackerman, J.
Plaintiff, Mary Anderson (" Anderson" ), and Husband-Plaintiff, Scott Anderson, appeal this Court's Order dated April 20, 2005, granting the Wyeth Defendants' (" Wyeth" ) Motion for Summary Judgment. For the following reasons, this Court's Order should be AFFIRMED.
I. BACKGROUND
Plaintiff Anderson commenced the within Phen-Fen Mass. Tort action by Complaint on January 31, 2003, alleging that she developed mitral and aortic valve regurgitation, aortic insufficiency and pulmonary hypertension resulting in mitral and aortic valve replacement surgery and stroke, all from her ingestion of prescription diet drugs, Pondimin, Redux and Adipex/Phentermine (" diet drugs" ), manufactured by Wyeth. See Anderson Short Form Complaint, PP5, 7 (Exhibit " A" to Summary Judgment Motion); Plaintiffs' Fact Sheet Section IV. A. (Exhibit " B" to Summary Judgment Motion); Husky Clinic Prescription Record (Exhibit " C" to Summary Judgment Motion). Dr. A.B. Husky is the only physician listed in Plaintiffs' Complaint as having prescribed diet drugs for Mrs. Anderson. See Complaint P6.
Dr. Husky's office has provided all parties with seven pages of medical records in this case. These seven pages constitute a complete set of Dr. Husky's records. Dr. Husky died on October 17, 2003, fifty years of age, approximately ten months into the pendency of this action. See Plaintiffs' Emergency Motion for Reconsideration, at p. 3, which was denied by this Court on May 9, 2005. Dr. Husky was never deposed in this case before his death. Thus, his testimony has not been preserved. However, during her deposition, Mrs. Anderson testified regarding her recollection of Dr. Husky's prescription of diet drugs:
Q. Did Dr. Husky tell you anything about the drugs that he prescribed for you?
A. After awhile, he told me he was cut off.
Q. Okay.
A. And I couldn't have them no more.
Q. Did he tell you anything else that you recall about those drugs.
A. No.
See Deposition of Mary Anderson, 15:20-16:6 (Exhibit " D" ). There is absolutely no other testimony or evidence of any sort regarding Dr. Husky's prescription of diet drugs for Mrs. Anderson or Dr. Husky's decision to discontinue that prescription. The basis of Anderson's action is that Wyeth's failure to warn of the association between diet drugs and heart valve damage was the cause of her injuries.
On March 21, 2005, Wyeth moved for summary judgment against both Plaintiffs arguing that Anderson was unable to prove that a different warning regarding the association between the ingestion of diet drugs and her injuries 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 prescribing practices, Anderson is unable to establish that Wyeth's failure to warn was the proximate cause of her alleged injuries.
Plaintiffs filed a Response to Wyeth's Motion for Summary Judgment setting forth the following material position:
Anderson " took the diet drug for approximately one year from January, 1996 through February, 1997 while under the care of her family physician, Dr. Husky. On September 15, 1997, Defendant withdrew Pondimin from the market after incidents of heart valve damage were reported in its users. In February, 2001 at age forty-three, Plaintiff was hospitalized with severe chest pain. She underwent a battery of tests and was diagnosed with valvular heart disease. The tests revealed that Mrs. Anderson required surgery as soon as possible to replace her damaged mitral and aortic valves with mechanical heart valves. That surgery was performed on April 30, 2001. Almost one year later on April 26, 2002, Mrs. Anderson suffered a massive cerebrovascular accident. To this day she struggles daily with substantial cognitive and physical impairments resulting from the stroke, which affect her day to day life and as well as the lives of her husband and children who care for her."
Plaintiffs attached an affidavit of William H. Pentz, M.D., a board certified cardiologist, who in his affidavit " . . .offers insight into how a reasonable physician would respond to warnings of valvular heart disease had they been included in the product label. . . a reasonable physician who was properly warned of the significant risk of valvular heart disease would look to other treatment options for the management of obesity. Further, a reasonable physician would engage in a thorough cardiac evaluation of the patient prior to prescribing this drug, and warn the patient concerning the potential dire consequences of taking the drug." See Affidavit of William H. Pentz, M.D. attached to Plaintiffs' Response as Exhibit " A" . Plaintiffs claim that the affidavit of Dr. Pentz " creates a factual question for the jury sufficient to defeat summary judgment."
On April 20, 2005, after consideration of Wyeth's motion, Andersons' Response thereto, Wyeth's Reply Brief and Plaintiffs' Response to Wyeth's Reply Brief, this Court granted summary judgment in Wyeth's favor and against Plaintiffs, Mary and Scott Anderson. On April 26, 2005, Plaintiffs filed an Emergency Motion to Reconsider this Court's Order dated April 20, 2005 which was denied on May 9, 2005.
On May 12, 2005, Andersons filed a Concise Statement of Matters Complained of on Appeal Pursuant to Pa. R.A.P. 1925(b), essentially contending:
. . .
11. The trial court erred in granting summary judgment to the Defendant-Appellee Wyeth on the issue of negligence in the failure to warn cause of action. When viewed in a light most favorable to the Plaintiffs-Appellants, there were material issues of fact to be determined by the finder of fact as to the failure to warn cause of action. See Thompson Coal Co. v. Pike Coal Co., 488 Pa. 198, 412 A.2d 466, 468 (Pa. 1979) (noting that in a motion for summary judgment, " the moving party has the burden of proving the nonexistence of any genuine issue of material fact." ); see also Marks v. Tasman, 527 Pa. 132, 589 A.2d 205, 206 (Pa. 1991) (" The record must be viewed in the light most favorable to the nonmoving party, and all doubts as to the existence of a genuine issue of material fact must be resolved against the moving party." ).
12. The trial court erred in granting summary judgment to the Defendant-Appellee Wyeth on the issue of negligence in the failure to warn cause of action because Plaintiffs-Appellants adduced sufficient evidence of " some reasonable likelihood that an adequate warning would have prevented the plaintiff from receiving the drug." Demmler v. Smithkline Beecham Corp., 448 Pa.Super. 425, 671 A.2d 1151, 1155 (Pa. S.Ct. 1996). Accordingly, summary judgment should not have been granted to Defendant-Appellee Wyeth.
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, 2003 PA Super 247, 828 A.2d 1114, 1115-1116 (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 Anderson to proceed to trial. Specifically, Wyeth argued that under the learned intermediary doctrine, Anderson needed to show that had her physician, Dr. A.B. Husky, 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 Anderson 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. 263, 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[] [has] established both duty and a failure to warn, plaintiff[] 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 drugs Pondimin, Redux and Adipex/Phentermine are available only by prescription. There is also no question that Anderson was under the care of Dr. Husky during the period that she took Pondimin, Redux and Adipex/Phentermine for weight loss. Thus, Wyeth's duty ran directly to Dr. Husky as Anderson's prescribing physician.
Plaintiffs cite 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." See P12 of Statement of Reasons.
However, a clear reading of that entire Page 1155 of Demmler, 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 from Demmler in P12 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. Husky, and only Dr. Husky, would provide to the effect that he, Dr. Husky, would have altered his behavior. That is the express language of Demmler .
Accordingly, an affidavit or testimony of Dr. Pentz 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 Plaintiffs did not take the deposition of Dr.Husky, 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 Plaintiffs failed to supply evidence satisfying their burden in that regard. The affidavit of Dr. Pentz did not satisfy that burden or create any material issue of fact. Without evidence from Dr. Husky, himself, that he would not have prescribed the diet drugs, Anderson 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. Husky, Anderson 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 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.
After review of existing Pennsylvania case law, we conclude that the " heeding presumption" is not applicable to the instant case as it has been applied exclusively to strict liability claims. It is well-settled in this Commonwealth that negligence is the only recognized basis of liability for failure to warn for manufacturers of prescription drugs. See Incollingo, 282 A.2d at 219. Through Incollingo and its progeny, Pennsylvania courts have repeatedly declined to impose strict liability on prescription drug manufacturers. See Hahn, supra ; Coyle, supra ; Baldino, supra ; Incollingo, supra ; Rosci, supra ; Leibowitz, supra. Our courts have emphasized this guiding principle by repeatedly ruling that in such cases the manufacturers' duty runs not to the patient but to the physician. See Incollingo, 282 A.2d at 220. Anderson has not provided, nor have we found, any Pennsylvania cases where the heeding presumption has been applied to failure to warn cases involving prescription drugs. Therefore, Anderson's argument that she is entitled to a presumption that she would have heeded a warning of the risk of valvular heart disease, had Wyeth provided one, and refused to take the diet drugs, flies in the face of Pennsylvania jurisprudence and thus fails.
Plaintiffs finally suggest that the case of Makripodis v. Merrell-Dow Pharmaceutical, Inc., 361 Pa.Super. 589, 523 A.2d 374, 375-78 (1987) supports their position. Plaintiffs argue that in the instant case, because it " completely" failed to provide " adequate warnings to the medical community, no prescribing physician could have accurate or sufficient information about the connection between Pondimin and valvular heart disease while the drug was on the market." Plaintiffs suggest that the prescribing physician and the entire medical community at large were " kept as ignorant of the risks associated with the drug as the general public" and, thus, there can be no " learned intermediary." See Plaintiffs' Response to Reply Brief of Defendant, p. 3.
The term " learned intermediary" does not mean that he is " learned" because of information obtained from the pharmaceutical manufacturer but rather because of his own training and experience. Plaintiffs provide no authority for the elimination of the " learned intermediary doctrine" under these circumstances. If testimony of Dr. Husky had been obtained and presented by Plaintiffs that he would not have prescribed the diet drug had he been aware of the risks, proximate cause would have been established. The nature of the warning or lack thereof without such testimony of Dr. Husky does not " eliminate" the learned intermediary doctrine.
Makripodis does not purport to limit or eliminate the learned intermediary doctrine and Demmler, supra , makes it clear that such doctrine remains in full force and effect. It is only when the warning to the prescribing physician is improper or inadequate that the prescribing physician's testimony, as to the effect of such warning on him, is scrutinized pursuant to the learned intermediary doctrine. Makripodis is a strict liability case (p. 375) and pharmaceutical drug cases subsequent to Makripodis can only be based upon negligence and not strict liability ( Hahn v. Richter, supra ). Therefore, Makripodis is not applicable to the case at bar which is a negligence case. (In Makripodis, strict liability was sought to be imposed upon a retail pharmacist and that effort failed). Finally, there was no need in Makripodis to explore the issue of causation which is admittedly the determining issue in this case because Makripodis found that no duty to warn existed as to the retail pharmacist in that case.
III. CONCLUSION
For the foregoing reasons, this Court concludes that Anderson cannot establish that Wyeth's alleged failure to warn of the risk of valvular heart disease was the proximate cause of her injuries. Therefore, summary judgment was warranted and this Court committed no error.
By the Court:
NORMAN ACKERMAN Coordinating Judge, Complex Litigation Center