Worsham v. A.H. Robins Co.

• Citation: 734 F.2d 676
• Decision Date: 18 June 1984
• Docket Number: No. 82-5935,82-5935
• Parties: 15 Fed. R. Evid. Serv. 1670 Margaret Sharon WORSHAM, Plaintiff-Appellee, v. A.H. ROBINS COMPANY, Defendant-Appellant.
• Court: United States Courts of Appeals. United States Court of Appeals (11th Circuit)

Page 676

734 F.2d 676

15 Fed. R. Evid. Serv. 1670

Margaret Sharon WORSHAM, Plaintiff-Appellee, v. A.H. ROBINS COMPANY, Defendant-Appellant.

No. 82-5935.

United States Court of Appeals,

Eleventh Circuit.

June 18, 1984.

Fowler, White, Burnett, Hurley, Banick & Strickroot, Henry Burnett, Miami, Fla., E. Duncan Getchell, Jr., McGuire, Woods & Battle, James Sanderlin, Richmond, Va., for defendant-appellant.

Eugene Stearns, Alan H. Fein, Miami, Fla., for plaintiff-appellee.

Appeal from the United States District Court for the Southern District of Florida.

Before ANDERSON and CLARK, Circuit Judges, and DUMBAULD ^*, District Judge.

CLARK, Circuit Judge:

This products liability action was brought against A.H. Robins (Robins) for serious illness from infection suffered by Margaret Worsham while she was wearing a Dalkon Shield, an intrauterine contraceptive device (IUD) manufactured by the company. Ms. Worsham claimed that the Dalkon Shield that she had been wearing caused her to suffer a serious form of pelvic inflammatory disease (PID) known as a tubo-ovarian abscess.

In 1978, Margaret Worsham was an unmarried, 34-year-old registered nurse when the events leading up to the lawsuit occurred. Ms. Worsham became ill and went to the emergency room on June 16. Although she was advised twice, at the emergency room and later by her gynecologist, to enter the hospital, she delayed doing so until June 22. Once in the hospital, Ms. Worsham's condition (pelvic infection made serious by an abscess) worsened and she underwent a complete hysterectomy (removal of the ovaries, uterus and fallopian tubes). The Dalkon Shield worn by Ms. Worsham was removed and discarded at the hospital. It was not introduced into evidence at trial.

Evidence was presented to the jury which could and evidently did lead them to reach the following conclusions. The tubo-ovarian abscess suffered by Ms. Worsham was caused by the Dalkon Shield. There were design and manufacturing problems with the Dalkon Shield which made it a possible source for PID. Once inserted, the Dalkon Shield, like other IUDs, sits in the uterus of the wearer. The tailstring, which allows the wearer to tell if the Shield is in place and provides the method of removal, hangs from the uterus into the vagina. The Dalkon Shield tailstring, unlike other IUDs sold in the 1970s which used monofilament tailstrings, was a multifilament suture. This bundle of individual nylon fibers was enclosed by a nylon sheath. The multifilament tailstring had a "wicking tendency," a tendency to carry fluids and bacteria up through the fibers. A double knot tied at the head of the tailstring was included to prevent the movement of bacteria into the uterus. Evidence was presented, however, to show that the tailstring sheath had a tendency to lose integrity just below the double knot. This loss of integrity could come at the time the tailstring was tied to the Shield or if the sheath deteriorated over time in situ (in place in the body). When the Shield was in situ, the part of the tailstring just below the double knot was in the uterus. A break in the sheath would allow bacteria growing in the tailstring to escape directly into the uterus. Bacteria normally grow in the vagina. A constant stream of bacteria going from the vagina through the tailstring into the uterus, a sterile or bacteria free organ, can lead to infection. There is evidence that Robins knew of the wicking tendency in 1971 and that the sheath would crack or deteriorate over time in 1972. Robins never did any testing on when the string would deteriorate in situ. Nevertheless, in a question and answer brochure written for wearers of the product (1972), Robins indicated the Shield could protect them from conceiving for several years and that some women had been protected for five years or longer. Ms. Worsham had worn her Shield for a little over five years when she became ill in 1978. By 1975, Robins knew of tests which indicated that bacteria grew in the tailstrings and that a sample of some strings showed breaks in the nylon sheath. Robins received reports, in addition to the small number of adverse reaction complaints it had on file, that there was an association between pelvic infection and the Dalkon Shield tailstring. Robins never considered the complaints sufficient to require it to take any action other than listing "infection" as a problem in 1972 labeling and later PID as an adverse effect in its October 1973 labeling. After Robins became aware of an association between septic abortion and the IUD in 1973-74, the company advised doctors to remove the Shield from patients who became pregnant. In June 1974, Robins withdrew the product from the market and decided not to remarket. Since that time, Robins issued no warnings to women still wearing Dalkon Shields that they should discontinue use of them.

The causes of tubo-ovarian abscess in women of Ms. Worsham's age group were identified as gonorrhea (the most common cause), endometriosis, appendicitis, gunshot, stab and knife wounds, trauma to the abdomen, surgical complications and infections following delivery and radiation treatment for various forms of cancer in the reproductive organs. None of these causes appeared likely with regard to Ms. Worsham while there was testimony that the Shield was responsible.

As a result of this infection, Ms. Worsham underwent surgery which left her without the ability to bear children. A jury awarded Ms. Worsham compensatory damages of $2,500,000 and punitive damages of $1,000,000. On February 19, 1982, a final judgment was entered on the jury verdict in the amount of $1,750,000 in compensatory damages (the jury had found the plaintiff to be 30% responsible for the injuries she suffered due to her failure to timely seek hospital care) and $1,000,000 in punitive damages. Robins moved for post-trial relief including judgment notwithstanding the verdict or a new trial or other appropriate relief, including remittitur. The trial judge ruled that a new trial would be granted unless the plaintiff remitted all compensatory damages above $950,000 and all punitive damages above $500,000. An amended final judgment reflecting the remittitur was entered on August 4, 1982.

Claiming that the relief afforded through remittitur below was inadequate, Robins filed a notice of appeal and raised eight issues: (1) the plaintiff failed as a matter of law to prove that there was a defect in her Dalkon Shield and therefore the claims upon which plaintiff prevailed should not have gone to the jury; (2) in submitting the question of defect to the jury, the court erred in its instructions; (3) evidence was insufficient as a matter of law to show that Robins failed to act as a reasonably prudent pharmaceutical company; (4)-(6) the court improperly admitted evidence (hearsay documents, one exhibit at the close of evidence after defendant had relied on a ruling that the document was inadmissible, evidence of other lawsuits and claims against the company); (7) the claim for punitive damages failed as a matter of law; and (8) the court erred by amending a jury interrogatory after deliberations had begun. Finding the evidence sufficient to support the jury verdict and the alleged trial errors nonexistent or harmless, we affirm.

I. Defect and Causation

Ms. Worsham's case was submitted to the jury on four theories of liability. ¹ The first three theories required a showing that the product in question was defective. The first claim in strict liability alleged that the Shield was defective and unreasonably dangerous. The second and third claims, of negligent design and manufacture and negligent failure to warn, could not have been reached unless the jury found defect. The jury found for the plaintiff on all three theories.

Robins claims that the plaintiff as a matter of law failed to prove such a defect. By making this argument, Robins, in effect, asks this court to rule that the plaintiff's first three claims should not have gone to the jury. At the close of evidence, Robins moved for a directed verdict on the question of the defective product because the plaintiff had not shown that there was a break in the sheath of her Dalkon Shield and therefore had not shown causation. In response to that motion, the plaintiff argued that she had disproved any possible alternative to infection resulting from a cracked Dalkon Shield. The key issue is the determination of whether plaintiff was required to prove a break in the sheath which had been discarded during surgery.

The standard for determining whether there is sufficient evidence to submit a case to the jury following a motion for a directed verdict has long been established. The court should consider all evidence, not just that which supports the non-mover's case, in the light and with all reasonable inferences most favorable to the party opposed to the motion. Boeing Co. v. Shipman, 411 F.2d 365, 374-75 (5th Cir.1969) (emphasis added). The case should go to the jury if there is substantial evidence, evidence of such quality and weight that reasonable and fair-minded jurors in the exercise of impartial judgment might reach different conclusions, opposed to the motion for directed verdict. A mere scintilla of evidence cannot present a question for the jury. There must be a conflict in substantial evidence to create a jury question. Id. This case presents a typical jury question of how to determine what caused an injury and whether that cause was a defective product.

Reviewing the motion for directed verdict made at trial leads us to conclude that Robins is arguing that there was a lack of substantial evidence. Robins claims that the jury could find causation only through speculation. Robins' position is that the plaintiff's theory of defect centered on the claim that the plastic sheath surrounding the tailstring of the Shield would break and thereby permit bacteria to travel up the tailstring and infect the person...