Hahn v. Richter

• Decision Date: 16 July 1993
• Citation: 427 Pa.Super. 130,628 A.2d 860
• Parties: , Prod.Liab.Rep. (CCH) P 13,700 Charles D. HAHN, Appellant, v. Howard A. RICHTER, M.D. and The Upjohn Company, Appellees.
• Court: Pennsylvania Superior Court

Page 860

628 A.2d 860

427 Pa.Super. 130, Prod.Liab.Rep. (CCH) P 13,700

Charles D. HAHN, Appellant, v. Howard A. RICHTER, M.D. and The Upjohn Company, Appellees.

Superior Court of Pennsylvania.

Argued Sept. 9, 1992.

Filed July 16, 1993.

Before ROWLEY, President Judge, CAVANAUGH, McEWEN, DEL SOLE, BECK, TAMILIA, KELLY, POPOVICH and FORD ELLIOTT, JJ.

KELLY, Judge:

In this Opinion, we are called upon to determine whether the trial court committed reversible error by refusing to submit to the jury the appellant's, Charles D. Hahn's, requested instruction that a manufacturer of prescription drugs may be held strictly liable under the Restatement of Torts (Second) § 402A for an allegedly deficient warning contained in a prescription drug package insert. The trial court ruled that such an instruction was precluded under Comment K of Restatement of Torts (Second) § 402A. We agree. Thus, we affirm the judgment entered in favor of the appellee, the Upjohn Company.

The relevant facts and procedural history are as follows. On December 29, 1976, the appellant sustained an injury to his back during the course of his employment as a warehouseman at Acme Markets. Performance of this job required the appellant to do a large amount of heavy lifting. As a result of his back injury, the appellant came under the care of Dr. Howard A. Richter. Dr. Richter diagnosed the appellant's injury as a herniated disc and recommended that appellant undergo surgery to repair the disc. The appellant agreed and the surgery was performed by Dr. Richter at Lankenau Hospital on January 27, 1977. On February 22, 1977, the appellant was discharged from the hospital. In March, 1977, the appellant received Dr. Richter's written permission to return to his job as a warehouseman.

Shortly after returning to work, the appellant suffered a recurrence of extreme pain in his back. The appellant returned to Dr. Richter who advised him to stay home from work and rest. When the appellant's pain did not subside, he was readmitted to Lankenau Hospital from May 18, 1977 to May 28, 1977. During this hospitalization, Dr. Richter noticed that the appellant was developing arachnoiditis, which is a scarring of the arachnoid nerves in the lower back. (N.T. 6/8/89 at 28-29). After the arachnoiditis was discovered, the appellant received his first intrathecal injection ¹ of Depo-Medrol, a drug manufactured by the appellee, the Upjohn Company (Upjohn), even though intrathecal injection was not a Federal Drug Administration (F.D.A.) approved usage for the drug. ² Upon receiving the first intrathecal injection of Depo-Medrol, the appellant's back pain subsided and he received Dr. Richter's permission to return to work on July 18, 1977.

On September 26, 1977, the appellant suffered a relapse of back pain while at work and returned to the hospital until October 15, 1977. During this hospital stay, the appellant had three epidural blocks administered to him. After being released from the hospital, the appellant returned home until extreme pain in his back and left leg forced his re-hospitalization on October 19, 1977. While in the hospital, the appellant consulted with Dr. Richter and Dr. James Meadowcroft, both of whom advised the appellant that a spinal fusion would be necessary. The appellant agreed to have the spinal fusion performed by Dr. Meadowcroft. At this time, the appellant also gave his permission to Dr. Richter to remove the previously discovered scar tissue while Dr. Meadowcroft was performing the spinal fusion. During this operation, Dr. Richter administered the second intrathecal injection of Depo-Medrol to the appellant.

Following the appellant's second operation, he continued to experience worsening pain in his left leg. The appellant was readmitted to Lankenau Hospital on January 14, 1978 and a third intrathecal injection of Depo-Medrol was administered by Dr. Richter. The third intrathecal administration of Depo-Medrol alleviated the appellant's symptoms significantly, and Dr. Richter and Dr. Meadowcroft advised him that he could return to work if he were assigned to light duty. However, a light duty assignment was unavailable at the Acme Markets warehouse, so appellant did not return to work at that time.

In May, 1978, the appellant's pain in his back and left leg returned and Dr. Richter administered a fourth intrathecal injection of Depo-Medrol. The cycle of relief through the intrathecal administration of Depo-Medrol and relapse continued throughout the remainder of 1978, 1979, and early 1980, with the appellant receiving four additional intrathecal administrations of Depo-Medrol from Dr. Richter. During this time period, the appellant, with Dr. Richter's permission, sporadically returned to work. The last day the appellant worked was December 30, 1979. Shortly thereafter, on February 4, 1980, the appellant received his eighth and final intrathecal injection of Depo-Medrol; however, the pain in his back and left leg did not diminish at all. The appellant was admitted to the hospital in early March, 1980 and given a myelogram. The result of the myelogram revealed that the appellant had extensive arachnoiditis. Dr. Richter recommended additional surgery to remove the extensive scar tissue which resulted from the arachnodities. The appellant consented. During the course of the surgery, a nerve root was severed, which caused the appellant to suffer a host of serious permanent injuries.

On February 23, 1982, the appellant filed a writ of summons naming Dr. Richter, Dr. Meadowcroft, and Dr. Qualls, together with Upjohn as defendants. A two count complaint was subsequently filed on July 1, 1982. In Count I, the appellant alleged that the defendant physicians were negligent in their treatment of him and failed to exercise the requisite standard of care required of physicians with their respective specialities. Specifically, in Count I, the appellant alleged that the defendant physicians breached the standard of care by: (1) recommending repeated surgery without adequate indication that the benefits outweighed the risks; (2) recommending that the appellant prematurely return to his warehouseman job before he had properly healed; (3) repeatedly intrathecally injecting him with Depo-Medrol despite known dangers of which the defendant doctors were or should have been aware existed. In Count II, the appellant sued Upjohn alleging that Upjohn was aware, or should have been aware, that the intrathecal injection of Depo-Medrol caused arachnoditis and the formation of scar tissue within the spinal canal, and that despite this knowledge, Upjohn failed to adequately and fully warn physicians of the serious risks attendant to the intrathecal use of Depo-Medrol.

During the next seven years, all parties conducted extensive discovery. On May 24, 1985, the appellant discontinued all of his claims against Dr. Meadowcroft and Dr. Qualls. On the same day, the appellant also executed a joint tortfeasor's release in favor of Dr. Richter in exchange for valuable consideration. However, Dr. Richter remained a party defendant to the litigation as to the questions of liability and the possible apportionment of damages.

At the jury trial, both the appellant and Upjohn presented extensive evidence regarding the drug, Depo-Medrol, and its intrathecal use. The appellant's evidence showed that although intrathecal use of Depo-Medrol was not an approved application of the drug at the time of its market approval by the F.D.A. in 1959, Upjohn was fully aware that it was being used in this manner by some physicians. The appellant also presented evidence that revealed that Upjohn had filed a supplemental New Drug Application (N.D.A.) with the F.D.A. in 1963, seeking to add intrathecal administration as an approved use of Depo-Medrol. In furtherance of its supplemental New Drug Application, Upjohn conducted various clinical investigations regarding the intrathecal use of Depo-Medrol until terminating its supplemental N.D.A. application on April 3, 1969. The appellant maintained that before terminating its campaign for F.D.A. approval of the intrathecal use of Depo-Medrol, Upjohn received various reports from physicians conducting the clinical investigations as early as 1965, establishing a connection between the intrathecal use of Depo-Medrol and the development of arachnoiditis. The appellant asserted that after receiving these negative reports, Upjohn merely dropped its campaign to get Depo-Medrol approved for intrathecal use without attempting to alert any physicians already using Depo-Medrol intrathecally on their patients that the drug may cause arachnoiditis. The appellant presented evidence which showed that Upjohn did not place a warning on the package insert that arachnoiditis had been reported when Depo-Medrol was used intrathecally until it was directed to do so by the F.D.A. in early 1977. The appellant also presented evidence that Upjohn did not place a warning on the package insert that Depo-Medrol was not recommended for intrathecal use until it was required to do so by the F.D.A. in May of 1980.

In its defense, Upjohn explained that it had ceased trying to get F.D.A. approval for the intrathecal use of Depo-Medrol for economic reasons. Upjohn also presented evidence which showed that the early reports it received concerning a connection between the intrathecal administration of Depo-Medrol and the development of arachnoiditis occurred in clinical investigations involving patients with multiple sclerosis and that arachnoditis is symptomatic of that disease. Upjohn elicited further evidence which established that Dr. Richter had diagnosed that the appellant had arachnoiditis before Depo-Medrol was ever intrathecally administered to him. Dr. Richter also testified that he had not consulted the Physician's Desk Top Reference Book, a reference book which contains all of the package inserts for the various F.D.A. approved prescription drugs, regarding Depo-Medrol...