In re Prempro Products Liability Litigation

Decision Date31 January 2008
Docket NumberNo. 07-1822.,07-1822.
PartiesIn re PREMPRO PRODUCTS LIABILITY LITIGATION, Helene Rush, Appellant, v. Wyeth, doing business as Wyeth, Inc., doing business as Wyeth Pharmaceuticals, Appellee.
CourtU.S. Court of Appeals — Eighth Circuit

William A. Newman, argued, Dallas, TX, Les Weisbrod and William B. Curtis, on the brief, Dallas, TX, for appellant.

F. Lane Heard, III, argued, Washington, DC, John W. Vardaman, Jr. and Stephen L. Urbanczyk, Washington, DC, and Lyn P. Pruitt, Little Rock, AR, on the brief, for appellee.

Before RILEY, MELLOY, and COLLOTON, Circuit Judges.

RILEY, Circuit Judge.

Helene Rush (Rush) was prescribed the Wyeth, Inc. (Wyeth) estrogen products Premarin and Prempro for symptoms related to menopause. Rush took the drugs for nearly ten years, beginning in August 1989. Rush was diagnosed with breast cancer in June 1999. Six years later, in March 2005, Rush filed this lawsuit alleging Wyeth's products caused her breast cancer. Rush's case is part of the multi district litigation (MDL) on Hormone Replacement Therapy (HRT). A jury found Rush failed to prove: (1) Wyeth inadequately warned about the drugs' risks, (2) the drugs were defective in design, and (3) Wyeth was negligent, or (4) any of these claims proximately caused her breast cancer. Rush moved for a new trial which was denied.

On appeal, Rush argues the district court1 erred by (1) giving incorrect instructions to the jury, (2) allowing undisclosed and improper expert testimony, (3) disallowing Rush's expert opinions, and (4) failing to instruct the jury on fraud.

The jury also found against Wyeth on Wyeth's statute of limitations defense, finding Wyeth failed to prove Rush either knew, or should have discovered by the exercise of reasonable diligence, the causal connection between the Wyeth estrogen products and her breast cancer. Wyeth asserts (1) Rush's claims are time barred, and (2) her labeling claim was preempted by federal law.

We affirm without reaching Wyeth's issues.

I. BACKGROUND

In 1989, at age 55, Rush began taking prescribed estrogen products manufactured by Wyeth for symptoms related to menopause. Rush's physician, Dr. Cynthia Frazier (Dr. Frazier), prescribed HRT for the treatment of vaginal atrophy. Before beginning the therapy, Dr. Frazier discussed with Rush the benefits and risks of the medications.

In 1992, an abnormality was discovered in Rush's breast. At that time, Dr. Frazier discussed with Rush the association between breast cancer and HRT and that Rush "may want to stop hormones." After another breast abnormality was found the next year, Rush stopped the HRT treatment for eight months before deciding to resume HRT.

Rush took the product Premarin until 1996, when her new gynecologist, Dr. Karen Kozlowski (Dr. Kozlowski), switched Rush to Prempro. Dr. Kozlowski told Rush with HRT "there was a slight risk of cancer." Rush took these drugs for nearly ten years until, in June 1999, she was diagnosed with breast cancer.

Rush relied solely on her doctors' advice in deciding to take HRT. Rush did not rely on any product advertisements. Rush did receive patient information sheets with her monthly Premarin and Prempro prescriptions. These information sheets explicitly warned that some studies suggested breast cancer was a possible danger or risk of the medications if taken "for prolonged periods of time and especially if higher doses are used." While Rush admits receiving the information sheets, she denies ever reading them.

During the entire time Rush was taking Premarin and Prempro, and continuing to this day, these drugs were approved by the Federal Drug Administration (FDA) as safe and effective. Before the FDA approved Prempro, the FDA specified the wording and placement of breast cancer warnings on the product labeling.

On March 18, 2005, Rush filed her lawsuit alleging Wyeth's hormone drugs caused her breast cancer. The case filing was nearly six years after Rush was diagnosed with breast cancer.

II. DISCUSSION
A. Jury Instructions

Jury instructions are reviewed for abuse of discretion. Slidell, Inc. v. Millennium Inorganic Chems., Inc., 460 F.3d 1047, 1054 (8th Cir.2006). "We afford the district court broad discretion in choosing the form and language of the instructions" and "will reverse a jury verdict only if the erroneous instruction affected a party's substantial rights." Id. "[O]ur review is limited to a determination of whether the instructions, taken as a whole and viewed in the light of the evidence and applicable law, fairly and accurately submitted the issues to the jury." Id.

1. Assumption of Ordinary Care Instruction

Arkansas Model Jury Instruction (AMI) 602 states, "Every person using ordinary care has a right to assume, until the contrary is or reasonably should be apparent, that every other person will use ordinary care. To act on that assumption is not negligence." Rush asserts the district court erred in giving this instruction because only a plaintiff—but never a defendant—may assume that others will use ordinary care based upon the Arkansas Supreme. Court's interpretation in England v. Costa, 364 Ark. 116, 216 S.W.3d 585, 590 (2005) ("Generally speaking, when the instruction is utilized in a contributory negligence case, the phrase `every person' in the instruction is intended to refer to the plaintiff.").

Wyeth counters that Justice Imber's concurring opinion in England specified "[t]he instruction is not limited to plaintiffs alleging negligence against defendants." Id. at 592 (Imber, J., concurring). Further, Wyeth notes the AMI's commentary states, "England . . . held that [AMI 602] should only be given where there is evidence of negligence on the part of a party claiming damages." Ark. Model Jury Instr., Civil AMI 602 cmt.

Wyeth asserts evidence of Rush's negligence was presented, thereby rendering this instruction proper. Specifically, Wyeth asserts Rush's admission, that she never read the warnings Wyeth included with each prescription, was evidence of negligence. Furthermore, reading England to restrict the instruction only to a case where a plaintiff is alleging contributory negligence may be overly restrictive. In any event, England does not apply directly to the facts of this case and is not controlling.

Even if giving the assumption of ordinary care instruction was erroneous under England's logic, this instruction did not affect Rush's substantial rights. The instruction did not direct the jury to find Wyeth was not negligent if Rush did not read the warnings. Instead, the instruction only explained Wyeth was not negligent in assuming Rush would read the warnings. The jury could still have found Wyeth negligent and. Wyeth's warnings were inadequate. Thus, assuming this instruction was given in error, the instruction was not unfairly prejudicial and any error was harmless. The district court's decision to include this instruction was not an abuse of discretion.

2. Failure to Warn Instruction

Rush challenges Instruction 14, regarding the failure to warn, because this instruction directed the jury that it must find for Wyeth if the jury found Rush was aware of the dangers posed by using Premarin (with progestin) or Prempro before Rush's breast cancer diagnosis. In an action for negligent failure to warn, this court has held, "if a user is already, aware of the dangers, the lack of warning is not the proximate cause of the injury." Crook v. Kaneb Pipe Line Operating P'ship, 231 F.3d 1098, 1103 (8th Cir.2000). As such, the focus is on whether or not Rush was aware of the dangers posed by the Wyeth drugs, Premarin (with progestin) and Prempro.

Arkansas recognizes the existence of the Learned Intermediary Doctrine. See Hill v. Searle Labs., 884 F.2d 1064, 1070 (8th Cir.1989). Under this doctrine, a physician acts as a learned intermediary between a pharmaceutical manufacturer and the physician's patient. As such, "a warning to the physician is deemed a warning to the patient." Ehlis v. Shire Richwood, Inc., 367 F.3d 1013, 1016 (8th Cir.2004) (internal brackets omitted). "[A]dequate warnings to prescribing physicians obviate the need for manufacturers of prescription products to warn ultimate consumers directly." Id.

While the Learned Intermediary Doctrine provides that adequate warning to a patient's physician can suffice to defeat a patient's failure to warn claim, this doctrine does not preclude informing a patient directly. "[I]f a user is already aware of the dangers, the lack of warning is not the proximate cause of the injury." Crook, 231 F.3d at 1103. The goal is to assure either the patient or the patient's physician, as a proxy for the patient, is aware of the dangers. If the patient is independently aware of the dangers, then a failure of the manufacturer to warn adequately of the danger is irrelevant.

The district court's instruction accurately reflects Arkansas law and did not prejudice Rush. Rush's assertion, that this portion of the law created "a total bar to recovery" under the doctrines of assumption of risk and contributory negligence, is incorrect. Rush's claim is a negligence claim based upon Wyeth's failure to warn. The district court's jury instruction accurately reflected Arkansas law because the jury was only directed to find for Wyeth if the jury determined Rush was aware of the dangers before her diagnosis with breast cancer. The trial court did not abuse its discretion.

3. Failure to Instruct on Fraud

Wyeth moved for summary judgment on Rush's fraud claim, which the district court granted. Rush does not appeal the grant of summary judgment, but instead asserts the district court erred in failing to instruct the jury on Rush's fraud claim because evidence offered in support of other claims was sufficient to warrant this instruction.

To prove fraud, Rush must show a justifiable reliance on a false representation of a material fact. Tyson Foods, Inc. v. Davis, 347 Ark....

To continue reading

Request your trial
35 cases
  • Walton v. Bayer Corp..
    • United States
    • U.S. Court of Appeals — Seventh Circuit
    • 23 May 2011
    ...for a particular patient. E.g., Ackermann v. Wyeth Pharmaceuticals, 526 F.3d 203, 207 (5th Cir.2008); In re Prempro Products Liability Litigation, 514 F.3d 825, 830 (8th Cir.2008); Pittman v. Upjohn Co., 890 S.W.2d 425, 429 (Tenn.1994). The prescribing physician is the “learned intermediary......
  • Portz v. St. Cloud State Univ. & Minn. State Colls. & Universities, Civil No. 16–1115
    • United States
    • U.S. District Court — District of Minnesota
    • 26 February 2018
    ...Court may allow an expert to testify about "basic math" that involves "simple deductive reasoning." See In re Prempro Prods. Liability Litig. , 514 F.3d 825, 831 (8th Cir. 2008). Moreover, Dr. Lopiano is an expert in the application of Title IX to institutions of higher education. (Lopiano ......
  • Cook v. City of Bella Villa
    • United States
    • U.S. Court of Appeals — Eighth Circuit
    • 2 October 2009
    ...reverse a jury verdict only if the erroneous instruction affected a party's substantial rights.'" Id. (quoting In re Prempro Prods. Liab. Litig., 514 F.3d 825, 829 (8th Cir.2008)). "`[O]ur review is limited to whether the instructions, taken as a whole and viewed in the light of the evidenc......
  • McCabe v. Mais
    • United States
    • U.S. District Court — Northern District of Iowa
    • 2 October 2008
    ...or partial new trial is an extraordinary remedy. Further, a jury is presumed to follow a court's instructions. In re Prempro Prods. Liab. Litig., 514 F.3d 825, 832 (8th Cir.2008) (citing Weeks v. Angelone, 528 U.S. 225, 234, 120 S.Ct. 727, 145 L.Ed.2d 727 (2000)). Here, the court instructed......
  • Request a trial to view additional results

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT