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holding that the learned intermediary doctrine precluded a UTPCPL personal injury claim brought by patient plaintiff
Summary of this case from In re Actiq Sales and Mktg. Practices Litig..Am. Fed'n of StateOpinion
OPINION
I. FACTUAL AND PROCEDURAL HISTORY
Defendants Richard J. Wurtman, M.D., and Judith Wurtman, Ph.D., began investigating dexfenfluramine hydrochloride for possible approval by the Food and Drug Administration in the early 1970's. In 1980, after discovering that dexfenfluramine hydrochloride suppressed one's appetite for carbohydrates, Defendant Massachusetts Institute of Technology (hereinafter " MIT" ) was issued a " use" patent. In 1988, Defendants Richard J. Wurtman, Judith Wurtman and MIT founded Defendant Interneuron Pharmaceuticals, Inc. to market dexfenfluramine hydrochloride as a weight loss treatment drug. The Food and Drug Administration approved the use of dexfenfluramine hydrochloride in 1995.
Defendants American Home Products Corporation (hereinafter " AHP" ) and Wyeth-Ayerst Laboratories Company, a subsidiary of Defendant AHP, manufactured, promoted, marketed and distributed dexfenfluramine hydrochloride in Pennsylvania under the trade name " Redux."
Plaintiffs Rosemarie and Thomas Luke instituted this action by Complaint on March 19, 1998. Plaintiffs' claims arise out of Plaintiff Rosemarie Luke's use of the prescription drug dexfenfluramine hydrochloride, commonly known as " Redux." Rosemarie Luke consulted with Defendant Charles R. Grubb, D.O., an associate of Defendant Warren Medical Associates, P.A., for weight loss treatment. Defendant Grubb subsequently prescribed Redux to Mrs. Luke. After taking Redux for several months, Mrs. Luke began having difficulty breathing. She was subsequently diagnosed with primary pulmonary hypertension. Because of the debilitating effects of primary pulmonary hypertension, she is currently on a waiting list for a double lung transplant.
Defendants AHP, Wyeth-Ayerst Laboratories Company, Interneuron Pharmaceuticals, Inc., Richard J. Wurtman, Judith Wurtman, and Massachusetts Institute of Technology filed preliminary objections. Plaintiffs replied to the preliminary objections. Oral arguments were held and briefs were submitted. The matter is now ready for disposition.
II. DISCUSSION
A. Preliminary Objections of Defendants Massachusetts Institute of Technology, Richard J. Wurtman, M.D., and Judith Wurtman, Ph.D.
Defendants Massachusetts Institute of Technology, Richard J. Wurtman, M.D., and Judith Wurtman, Ph.D., contend that they are not subject to the personal jurisdiction of this Court.
Standard of Review and Burden of Proof
Personal jurisdiction refers to the authority of a court over the parties. See Encelewski v. Associated-East Mortgage Co., 262 Pa.Super 205, 396 A.2d 717 (Pa. S.Ct. 1978). Attacks on personal jurisdiction must be raised by preliminary objection; if such objection is not made, it is deemed to be waived. See Pa.R.C.P. 1006(e).
When sustaining a preliminary objection that would dismiss an action, the objection should only be sustained in the clearest of cases. See Hall-Woolford Tank Co., Inc. v. R.F. Kilns, Inc., 698 A.2d 80 (Pa. S.Ct. 1997). The evidence must be considered in the light most favorable to the non-moving party. See id.
The party challenging a court's jurisdiction has the initial burden of supporting the jurisdictional objection. See id. The challenging party may not rest on a mere allegation of lack of personal jurisdiction; the party must affirmatively present evidence in support of their objection. See Maleski by Taylor v. D.P. Realty Trust, 653 A.2d 54 (Pa.Commw. Ct. 1994). Once that burden is established, the party asserting jurisdiction assumes the burden of establishing both statutory and constitutional support for a court's exercise of in personam jurisdiction. See Hall-Woolford, 698 A.2d at 82.
A court may exercise two forms of personal jurisdiction -- general or specific. See Derman v. Wilair Services, Inc., 404 Pa.Super 136, 590 A.2d 317 (Pa. S.Ct. 1991). A court's choice of jurisdiction will set the stage for its jurisdictional analysis.
General jurisdiction arises out of a defendant's continued and systematic contacts with the forum state. See id. This basis for jurisdiction is used when a claim does not arise out of or is unrelated to the defendant's contact with the forum. See Leonard A. Feinberg, Inc. v. Cent. Asia Capital Corp., Ltd., 936 F.Supp. 250 (E.D. Pa. 1996).
Specific jurisdiction exists when the claim arises out of the defendant's contacts with the forum state. See id. Unlike general' jurisdiction, specific jurisdiction requires a nexus between the suit and the contacts with the forum state; this basis for jurisdiction arises when plaintiff's claim is related to or arises out of defendant's contacts with the forum. See id.
For a court to exercise jurisdiction under either theory, there must be a legally recognized relationship between the state and the person over whom the state seeks to exercise jurisdiction. See In re Huck, 435 Pa. 325, 257 A.2d 522 (Pa. 1969). Pennsylvania courts have the power to exercise jurisdiction over a non-resident defendant if (1) the jurisdiction is authorized by statute and (2) the exercise of jurisdiction comports with constitutional principles of due process. See Graham v. Mach. Distribution, Inc., 410 Pa.Super 267, 599 A.2d 984 (Pa. S.Ct. 1991). Pennsylvania's long-arm statute authorizes a court to exercise jurisdiction over non-residents " 'to the fullest extent allowed under the Constitution of the United States' and jurisdiction may be based 'on the most minimum contact with this Commonwealth allowed under the Constitution of the United States.'" Kenneth H. Oaks, Ltd. v. Josephson, 390 Pa.Super 103, 568 A.2d 215, 216 (Pa. S.Ct. 1989) (quoting 42 Pa.C.S. § 5322 (b)).
The Due Process Clause of the Fourteenth Amendment to the United States Constitution requires a non-resident defendant to have " certain minimum contacts with [the forum] such that the maintenance of the suit does not offend 'traditional notions of fair play and substantial justice.'" Kubik v. Letteri, 532 Pa. 10, 614 A.2d 1110, 1113 (Pa. 1992) (quoting Int'l Shoe Co. v. Washington, 326 U.S. 310, 316, 66 S.Ct. 154, 90 L.Ed. 95 (1945)) (emphasis in original). Adjudicating this standard involves a two-part analysis: (1) a determination of whether sufficient minimum contacts exist; and (2) a determination of whether the assertion of personal jurisdiction is fair and reasonable. See Kubik, 614 A.2d at 1115 (adopting the approach established in Burger King Corp. v. Rudzewicz, 471 U.S. 462, 105 S.Ct. 2174, 85 L.Ed.2d 528 (1985)).
A determination of minimum contacts depends upon the court finding that the non-resident defendant could reasonably expect to be haled into the courts of the forum state. See Kubik, 614 A.2d at 1115. The mere foreseeability of contacts with the forum state is insufficient by itself to create minimum contacts. See id. " [T]he defendant must have purposefully directed its activities to the forum and conducted itself in a manner indicating that it has availed itself of the forum's privileges and benefits such that it should also be subject to the forum state's laws and regulations." Hall-Woolford, 698 A.2d at 82-83. Accordingly, contacts with the forum state cannot be random, fortuitous, or attenuated. See id.
Next, a court must determine whether it is reasonable and fair for a defendant to be brought into its jurisdiction. The United States Supreme Court listed several factors to be considered in this regard:
(1) the burden on the defendant, (2) the forum state's interest in adjudicating the dispute, (3) the plaintiff's interest in obtaining convenient and effective relief, (4) the interstate judicial system's interest in obtaining the most efficient resolution of controversies, and (5) the shared interest of the several states in furthering fundamental substantive social policies.
Kubik, 614 A.2d at 1114 (citing Burger King, 471 U.S. at 474).
When considering whether, notwithstanding the fact that sufficient minimum contacts exist, the assertion of personal jurisdiction is fair and reasonable, a court must carefully evaluate the facts because there are occasions when the assertion of jurisdiction is fair based on a " lesser showing of minimum contacts than would otherwise be required." Burger King, 471 U.S. at 477.
Although a court is guided by the foregoing standards, no precise formula exists for determining whether the standard as set forth by the United States Supreme Court in International Shoe and the Pennsylvania Supreme Court in Kubik has been satisfied. A court must examine the facts of each case to determine if jurisdiction is proper. See Kubik, 614 A.2d at 1114.
Defendants MIT and the Wurtmans challenge the personal jurisdiction of this Court by establishing the following uncontradicted facts and arguing the following in their sworn Preliminary Objections:
a. As to Defendant Massachusetts Institute of Technology: (1) MIT is not incorporated in Pennsylvania or qualified as a foreign corporation of this state; (2) MIT does not conduct continuous and systematic business within Pennsylvania; (3) MIT was not present or domiciled when process was served in this case; (4) the alleged causes of action in Plaintiffs' Complaint do not arise from any act or omission on MIT's part within or outside Pennsylvania; (5) MIT has no minimum contact with Pennsylvania which are sufficient to establish jurisdiction; (6) MIT has no office or other place of business in Pennsylvania; (7) MIT does not have any license or business certificate issued by any Pennsylvania government entity or political subdivision; (8) MIT has no financial assets in Pennsylvania; (9) MIT has no real property or other physical assets in Pennsylvania; (10) MIT has no employees who work in Pennsylvania; and (11) MIT does not contract to supply services or other things in Pennsylvania. See Preliminary Objections of Defendant Massachusetts Institute of Technology.
b. As to Defendant Richard J. Wurtman, M.D., and Judith Wurtman, Ph.D.: (1) neither party was present in Pennsylvania when process was served; (2) neither party is a Pennsylvania citizen or was domiciled in Pennsylvania when process was served; (3) neither consents to the exercise of jurisdiction; (4) Plaintiffs' cause of action do not arise from any act or omission by Doctors Wurtman within or outside Pennsylvania; (5) neither party has minimum contacts with Pennsylvania sufficient to establish jurisdiction; (6) neither party owns, uses, or possesses real property or other physical assets in Pennsylvania; and (7) neither party has bank accounts or financial assets in Pennsylvania. See Preliminary Objections of Dr. Richard J. Wurtman and Preliminary Objections of Dr. Judith Wurtman.
Defendants' assertion, in sworn preliminary objections, that this Court has no personal jurisdiction over them remains unrebutted by Plaintiffs. Plaintiffs made no record or attempt to establish circumstances by which personal jurisdiction can be conferred over Defendants MIT and the Wurtmans by this Court. In their sworn Reply to the respective Preliminary Objections submitted by Defendants Massachusetts Institute of Technology, Richard J. Wurtman, M.D., and Judith Wurtman, Ph.D., Plaintiffs either generally denied Defendants' preliminary objections or asserted in a general denial that they lacked sufficient information or knowledge upon which to form a belief as to the truth of the allegations asserted. Plaintiffs made no affirmative allegation in their reply, nor did they produce an independent record of circumstances which our Supreme Court requires upon which personal jurisdiction over Defendants MIT and the Wurtmans could be based. Plaintiffs submitted a brief in support of their objection to Defendants' Preliminary Objections alleging grounds on which jurisdiction could be conferred. However, it is a rule too often repeated that unsworn facts asserted in brief form are not part of the record. See Erie Indem. Co. v. Coal Operators Cas. Co., 441 Pa. 261, 272 A.2d 465 (Pa. 1971). Facts must appear in the record, otherwise a court is not permitted to consider them. See id.
See also Cooper v. Commonwealth, 700 A.2d 553, 554 (Pa.Commw. Ct. 1997); Larson v. Diveglia, 549 Pa. 118, 700 A.2d 931, 935 (Pa. 1997); Otterson v. Jones, 456 Pa.Super 388, 690 A.2d 1166, 1170 (Pa.Super 1997); South Whitford Assocs. Inc. v. Zoning Hearing Bd. of W. Whiteland Township, 157 Pa.Commw. 387, 630 A.2d 903, 907 (Pa.Commw. Ct. 1993); Dwight v. Girard Med. Ctr., 154 Pa.Commw. 326, 623 A.2d 913, 917 (Pa.Commw. Ct. 1993); Van Mastrigt v. Delta Tau Delta, 393 Pa.Super 142, 573 A.2d 1128, 1132 n.3 (Pa. S.Ct. 1990).
Based on the record, this Court is unprepared to exercise personal jurisdiction over Defendants MIT and the Wurtmans because there are insufficient facts to meet the standards required for general and specific jurisdiction. In view of this ruling, we do not consider the additional preliminary objections and demurrer presented by MIT and the Wurtmans.
Had this Court considered the allegations asserted by Plaintiffs in their brief in opposition to Defendants MIT and the Wurtmans' preliminary objections, there appears, nevertheless, to be no basis for our jurisdiction. The only contact MIT and the Wurtman's have to, or within, Pennsylvania is through their corporation, Interneuron Pharmaceuticals. Such contact with the forum is insufficient to establish jurisdiction because a defendant is generally not individually subject to personal jurisdiction under Pennsylvania's long-arm statute merely based on actions conducted in a corporate capacity. See Aircraft Guar. Corp. v. Strato-Lift, Inc., 974 F.Supp. 468 (E.D. Pa. 1997). See also Nat'l Precast Crypt Co. v. Dy-Core of Pennsylvania, Inc., 785 F.Supp. 1186 (W.D. Pa. 1992).
The balance of the preliminary objections raised by Defendants American Home Products Corporation, Wyeth-Ayerst and Interneuron Pharmaceuticals are discussed below.
B. Preliminary Objections of Defendants American Home Products Corporation, Wyeth-Ayerst and Interneuron Pharmaceuticals
1. Count III - Demurrer to Plaintiffs' Claim of Implied Warranty of Merchantability and Fitness for a Particular Purpose
Defendants American Home Products, Wyeth-Ayerst and Interneuron Pharmaceuticals individually argue that a demurrer should be granted dismissing Count III of Plaintiffs' Complaint which alleges that defendants breached the implied warranty of merchantability and fitness for a particular purpose.
The controlling standard of review when examining a preliminary objection in the nature of a demurrer is well established. The moving party must admit as true all material facts set forth in the complaint, as well as all inferences reasonably deductible therefrom. See Powers v. Dept. of Health, 121 Pa.Commw. 321, 550 A.2d 857 (Pa.Commw. Ct. 1988). The question presented by the demurrer is whether on the facts averred the law says with certainty that no recovery is possible. See Balsbaugh v. Rowland, 447 Pa. 423, 290 A.2d 85 (Pa. 1972). Where doubt exists as to whether a demurrer should be sustained this doubt should be resolved in favor or overruling it. See Gekas v. Shapp, 469 Pa. 1, 364 A.2d 691 (Pa. 1976).
Defendants argue that there is no cause of action for a breach of implied warranty in prescription drug cases, citing Makripodis by Makripodis v. Merrel-Dow Pharms, Inc., 361 Pa.Super 589, 523 A.2d 374 (Pa. S.Ct. 1987), in support of its position. The essence of the warranty of merchantability is that the item sold is fit for the ordinary purposes for which such goods are used. See Wisniewski v. Great Atlantic & Pacific Tea Co.., 226 Pa.Super 574, 323 A.2d 744, 746-47 (Pa. S.Ct. 1974).
Although the Makripodis decision is not directly on point, it is instructive. In Makripodis, the Superior Court directly addressed the issue of whether a pharmacist who dispenses a prescription drug pursuant to the prescription of a licensed physician impliedly warrants that the drug is safe for ordinary purposes. See Makripodis, 523 A.2d at 375. The Superior Court held that a pharmacist who dispenses a prescription drug warrants only that (1) he compounded the drug prescribed with due care in the strength and quantity prescribed; (2) he used proper methods in compounding process; (3) the drug is pure and unadulterated; and (4) he labeled the drug in accordance with the directives of the physician's prescription. See id. at 377. In its discussion the Superior Court stated, inter alia :
Prescription drugs may pose a threat to the safety of certain identifiable segments of the public, or may be dangerous when used in conjunction with other drugs or substances, or may be harmful if taken by persons suffering from certain diseases or conditions. 'There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. . . .many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician.' Restatement (Second) of Torts § 402A, comment (k). . . . Thus, we find that the very nature of prescription drugs themselves precludes the imposition of a warranty of fitness for 'ordinary purposes' . . .
Id. at 376-77 (emphasis added).
The discussion in Makripodis analyzing the nature of prescription drugs applies in the instant action. Dexfenfluramine hydrochloride, like most prescription drugs, may never be able to be manufactured so that it is safe for every user. Nonetheless, the public utility of the drug may outweigh the potentially dangerous risk dexfenfluramine hydrochloride poses to some individuals. Therefore, the Makripodis holding that prescription drugs preclude the imposition of a warranty of fitness for ordinary purposes in cases against pharmacists would reasonably appear to apply in this case against the drug manufacturer. Accordingly, we find that there is no cause of action for a breach of implied warranty in prescription drug cases involving drug manufacturers and Defendants demurrer to Count III of Plaintiffs' Complaint will be granted.
2. Count IV - Preliminary Objection to Plaintiffs' Claim of Breach of Express Warranty
Defendants preliminarily object to Count IV of Plaintiffs' Complaint on the ground that that count fails to aver any material facts on which a claim for breach of express warranty can be based.
Rule 1019(a) of the Rules of Civil Procedure states that " [t]he material facts on which a cause of action or defense is based shall be stated in a concise and summary form." Pa.R.C.P. 1019(a). The theory of pleading is that the essential facts will be pleaded so prolonged and expensive deposition are unnecessary. See Driefer v. Hershey Estates. Inc., 81 Pa. D & C 302 (1951). A Plaintiff's complaint should notify the defendant of the claims by stating the grounds upon which those claims are based and identifying the issues in dispute. See Dickerson v. Brind Truck leasing, 362 Pa.Super 341, 524 A.2d 908 (Pa. S.Ct. 1987).
Count IV of the Complaint does no more than state: " Defendants' communication to the consumer who would use the drug and physicians who would purchase it, made without reference to the drug's potential for harm, amounted to an express warranty of the safety of the drug for use in aiding in weight loss and weight loss maintenance." Plaintiffs' Complaint, P 135.
Plaintiffs' allegations pertaining to Count IV generally and broadly aver that an express warranty existed. However, the Count fails to state what the warranty allegedly covered, when it was made, by whom it was made and to whom it was directed. Defendants' preliminary objection is granted and Plaintiffs will be granted leave to amend Count IV of the Complaint within thirty (30) days of the filing hereof. Further, if the express warranty is written, a copy of the material part of the writing must be attached to the complaint pursuant to Rule 1019(h) of the Pennsylvania Rules of Civil Procedure.
3. Count V - Preliminary Objection to Plaintiff's Claim of Strict Liability
Count V of Plaintiffs' Complaint alleges that Defendants are strictly liable for Plaintiffs' injuries because they violated the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 352, by misbranding dexfenfluramine hydrochloride by failing to give adequate warnings. See Count V of Plaintiffs' Complaint.
Count V must be dismissed because the Federal Food, Drug and Cosmetic Act does not provide a basis for recovery for private plaintiffs. See Mellon v. Barre-Nat'l Drug Co., 431 Pa.Super 175, 636 A.2d 187, 189 (Pa. S.Ct. 1993) (" it has uniformly been held that there are no private causes of action under the Food, Drug and Cosmetics Act 21 U.S.C. § § 301 et seq ." ).
4. Count VI - Preliminary Objection to Plaintiffs' Claim of " Strict Liability in Tort"
Plaintiffs allege in Count VI that Defendants are strictly liable because they promoted and maintained dexfenfluramine hydrochloride on the market with knowledge of the unreasonable risk the drug posed to the public in general, and the Plaintiff specifically.
In view of the imprecision of Plaintiffs' allegations in Count VI, and difficulty in ferreting out the theory espoused, the term " Strict Liability in Tort" is an unfortunate caption which leads to an inference Plaintiff is suggesting that negligence principles apply in strict liability cases. The absence of fault concepts in strict liability cases is too well known to discuss further.
Defendants, in their brief, characterize Count VI as a claim in strict liability, based on Defendants' alleged mislabeling of dexfenfluramine hydrochloride and the failure to give proper warnings. Plaintiffs contend that Count VI does not deal with the adequacy of warnings; rather, Count VI is based on Defendants' distribution of a defective and unreasonably dangerous product due to its side effects, namely primary pulmonary hypertension.
Pennsylvania courts ordinarily impose strict liability on manufacturers of products sold " in a defective condition unreasonably dangerous to the user or consumer" under Section 402A of the Restatement (Second) of Torts. However, " the strict liability rules for prescription drugs. . .are somewhat different under Pennsylvania law." Mazur v. Merck & Co., Inc., 964 F.2d 1348, 1353(3d Cir. 1992) (applying Pennsylvania law). Prescription drugs fall into the category of " unavoidably unsafe products" set forth in comment k to Section 402A of the Restatement. See Incollingo v. Ewing, 444 Pa. 263, 282 A.2d 206, 219 (Pa. 1971). Recognizing that drug manufacturers are held to a high degree of care, our Supreme Court in Incollingo stated that " neither the law of Pennsylvania, nor, so far as we are aware, the law of other states has imposed strict liability upon a drug manufacturer merely because of dangerous propensities of the product ." Id. (emphasis in original).
Section 402A is entitled " Special Liability of Seller of Product for Physical Harm to User or Consumer."
The Incollingo court went on to find that the strict liability rule of Restatement Section 402A is inapplicable in a case involving a prescription drug. Further, the Court held that the standard of care required for a manufacturer of prescription drugs is set forth in Section 388 of the Restatement (Second) of Torts which concerns the liability of a supplier of a chattel known to be dangerous for its intended use. See id. at 220 n.8; see also Hahn v. Richter, 427 Pa.Super 130, 628 A.2d 860, 865 (Pa. S.Ct. 1993).
§ 388. Chattel Known to be Dangerous for Intended Use
Because of the inherently dangerous nature of all prescription drugs and their limited legal accessibility through a prescription issued by a licensed physician, and assuming that there was proper preparation and warning, Pennsylvania law provides that a manufacturer of prescription drugs is not strictly liable under Section 402A for injuries resulting from otherwise useful and desirable products. See Hahn, 628 A.2d at 866. A drug manufacturer is only liable if it fails to exercise reasonable care to inform physicians of the facts which make it likely to be dangerous for its intended use. See Incollingo, 282 A.2d at 221. See also Hahn, 628 A.2d at 866. A drug manufacturer's warning need not accompany the product to the patient. See Baldino v. Castagna, 505 Pa. 239, 478 A.2d 807, 810 (Pa, 1984); see also Ramirez v. Richardson-Merrell, Inc., 628 F.Supp. 85, 87 (E.D. Pa. 1986). However, where the manufacturer of a prescription drug was alleged to have caused injury by providing inadequate warnings to physicians about the dangers associated with the use of the drug, the consumer may have a negligence action against the manufacturer. See Hahn v. Richter, 543 Pa. 558, 673 A.2d 888, 891 (Pa. 1996). The decisions of Incollingo and Baldino, as well as comments j and k " make it clear that 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." Hahn, 673 A.2d at 891.
Based on premises asserted by both parties, no liability can attach. Plaintiffs sole recourse, based on the allegations in Count VI, appears to be by asserting a claim in accordance with the instruction of the Incollingo case. Accordingly, we dismiss Court VI with leave to amend that count in conformity to this opinion.
Had Plaintiffs' claim been based on the adequacy of warnings as Defendants allege, Defendants could not be found strictly liable for failing to adequately warn Plaintiff because a manufacturer of prescription drugs is liable only if it fails to exercise reasonable care to inform physicians, for whose use the prescription drug is supplied, of the facts which make it likely to be dangerous for its intended use. See Incollingo v. Ewing, 444 Pa. 263, 282 A.2d 206, 220 n.8 (Pa. 1971). Drug manufacturers generally have no duty to warn the general public. See Baldino v. Castagna, 505 Pa. 239, 478 A.2d 807 (Pa. 1984).
5. Count VIII - Preliminary Objection to Plaintiff's Claim Alleging Violation of the Pennsylvania Unfair Trade Practices and Consumer Protection Law
Defendants preliminarily object to Count VIII of Plaintiffs' Complaint, which alleges violation of the Pennsylvania Unfair Trade Practices and Consumer Protection Law (hereinafter " UTPCPL" or " the Act" ). Plaintiffs' Complaint states that Defendants (1) failed to provide Plaintiffs with a full and accurate description or dexfenfluramine hydrochloride and (2) knowingly and intentionally misrepresented, concealed or made false claims to Plaintiffs regarding dexfenfluramine hydrochloride. Such false and misleading misrepresentations and omissions form the basis of Plaintiffs' cause of action under the UTPCPL.
The UTPCPL makes unlawful unfair methods of competition and deceptive practices in the conduct of any trade or commerce. See 73 P.S. § 201-3; see also Gatten v. Merzi, 397 Pa.Super 148, 579 A.2d 974, 976 (Pa. S.Ct. 1990) (the Gatten court held that the UTPCPL does not apply to physicians rendering medical services). The Act condemns various misrepresentations and other fraudulent conduct that creates a likelihood of confusion or misunderstanding. See 73 P.S. § 201-2(4). The intent of the Act is to prohibit unlawful practices relating to trade or commerce and of the type associated with business enterprises. See Foflygen v. R. Zemel. M.D., 420 Pa.Super 18, 615 A.2d 1345, 1354 (Pa. S.Ct. 1992).
Plaintiffs couch their argument in terms of misrepresentations and omissions of material facts made to them by Defendants regarding the benefits and detriments of using dexfenfluramine hydrochloride. Specifically, Plaintiffs allege that Defendants failed to provide Plaintiff Rosemarie Luke with a full and accurate description of dexfenfluramine hydrochloride and had a duty to inform or warn users like Plaintiff about prescription drugs. Under the " learned intermediary doctrine," a manufacturer of prescription drugs must direct information and warnings to prescribing physicians, not the patient. See Taurino v. Ellen, 397 Pa.Super 50, 579 A.2d 925 (Pa. S.Ct. 1990). There can be no cause of action based on Defendants' alleged omissions because Defendants had no duty to disclose any information directly to Plaintiff.
Further, to permit a cause of action under the UTPCPL in this case would effectively make a drug manufacturer the absolute guarantor of the anticipated results and effects of a prescription drug. Pennsylvania law, however, recognizes that some prescription drugs by their very nature can never be made safe. See Makripodis by Makripodis v. Merrell-Dow Pharm., Inc., 361 Pa.Super 589, 523 A.2d 374 (Pa. S.Ct. 1987). An inconsistency would result if we were to hold that drug manufacturers must guarantee that prescription drugs are completely safe. The premise behind the UTPCPL was not meant to engender such a result.
Defendants additionally preliminarily object to Count VIII claiming that it (1) fails to allege factual averments identifying the source of alleged misrepresentations or omissions of material fact; (2) fails to aver any factual allegations as to when and where the alleged misrepresentation or omissions occurred; (3) fails to aver factual allegations concerning a causal connection between the alleged misrepresentation or omission of material fact and Plaintiff's ingestion of dexfenfluramine hydrochloride and alleged injuries; and (4) fails to set forth facts to support the elements of common law fraud as required by Pennsylvania law.
Because we hold that Plaintiffs' have no cause of action under the UTPCPL against a manufacturer of prescription drugs, these additional preliminary objections are moot.
WHEREFORE, we enter the following:
ORDER OF COURT
AND NOW, this 18th day of November, 1998, it is hereby ORDERED, ADJUDGED and DECREED that:
1. The preliminary objection of Defendants Massachusetts Institute of Technology, Richard J. Wurtman, M.D. and Judith Wurtman, Ph.D. attacking this court's jurisdiction over them is sustained, and the Counts against them are dismissed.
2. The demurrer to Plaintiffs Count III claiming implied warranty of merchantability and fitness for a particular purpose is granted, and Count III is dismissed.
3. The remaining Defendants' preliminary objection to Count IV is granted. Plaintiffs are granted leave to amend Count IV in accordance with the accompanying opinion within thirty (30) days of this Order.
4. The remaining Defendants' preliminary objection to Count VI, Plaintiffs claim of strict liability, is granted, and Count VI is dismissed; Plaintiffs are granted leave to amend Court VI in accordance with the accompanying opinion within thirty (30) days of this order.
5. The preliminary objection to Count VIII, Plaintiffs' claim that Defendants violated the Pennsylvania Unfair Trade Practices and Consumer Protection Law is sustained, and Count VIII is dismissed.
BY THE COURT:
JAMES C. HOGAN, JUDGE
One who supplies directly or through a third person a chattel for another to use is subject to liability to those whom the supplier should expect to use the chattel with the consent of the other or to be endangered by its probable use, for physical harm caused by the use of the chattel in the manner for which and by a person for whose use it is supplied, if the supplier
(a) knows or has reason to know that the chattel is or is likely to be dangerous for the use for which it is supplied, and
(b) has no reason to believe that those for whose use the chattel is supplied will realize its dangerous condition, and
(c) fails to exercise reasonable care to inform them of its dangerous condition or of the facts which make it likely to be dangerous.