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In re Prempro Products Liability Litigation

July 13, 2006


The opinion of the court was delivered by: Wm. R.Wilson,Jr. United States District Judge


Pending is Defendant's Motion for Summary Judgment re: the Learned Intermediary/ Proximate Causation (Doc. No. 83). Plaintiff has responded and Defendant has replied.*fn1 Also pending is Defendant's Motion for Summary Judgment re: Specific Claims (Doc. No. 90). Plaintiff has responded and Defendant has replied.*fn2 The parties presented oral arguments on June 22-23, 2006. Supplemental briefs on the learned intermediary issue were also filed.*fn3


According to Plaintiff's complaint, she began taking prescription hormone replacement therapy ("HRT") to treat her menopausal symptoms.*fn4 (In spite of this, in her objections to Defendant's statement of material facts not in dispute, Plaintiff objects to this statement and asserts she took HRT for cardiac benefits*fn5 -- this is puzzling but Defendant states that this change is of no moment insofar as the current motion for summary judgment is concerned). Plaintiff alleges ingestion of HRT medications caused her to develop breast cancer. Plaintiff asserts negligence,*fn6 design defect, fraud, and failure to warn.*fn7


Summary judgment is appropriate only when there is no genuine issue of material fact, so that the dispute may be decided on purely legal grounds.*fn8 The Supreme Court has established guidelines to assist trial courts in determining whether this standard has been met:

The inquiry performed is the threshold inquiry of determining whether there is the need for a trial -- whether, in other words, there are any genuine factual issues that properly can be resolved only by a finder of fact because they may reasonably be resolved in favor of either party.*fn9

The Court of Appeals for the Eighth Circuit has cautioned that summary judgment is an extreme remedy that should only be granted when the movant has established a right to the judgment beyond controversy.*fn10 Nevertheless, summary judgment promotes judicial economy by preventing trial when no genuine issue of fact remains.*fn11 I must view the facts in the light most favorable to the party opposing the motion.*fn12 The Eighth Circuit has also set out the burden of the parties in connection with a summary judgment motion:

[T]he burden on the party moving for summary judgment is only to demonstrate, i.e.,"[to point] out to the District Court," that the record does not disclose a genuine dispute on a material fact. It is enough for the movant to bring up the fact that the record does not contain such an issue and to identify that part of the record which bears out his assertion. Once this is done, his burden is discharged, and, if the record in fact bears out the claim that no genuine dispute exists on any material fact, it is then the respondent's burden to set forth affirmative evidence, specific facts, showing that there is a genuine dispute on that issue. If the respondent fails to carry that burden, summary judgment should be granted.*fn13

Only disputes over facts that may affect the outcome of the suit under governing law will properly preclude the entry of summary judgment.*fn14


A manufacturer's duty to warn generally extends to the ultimate user of a product; however, the learned intermediary doctrine is an exception to this rule.*fn15 The learned intermediary doctrine "provides that a drug manufacturer may rely on the prescribing physician to warn the ultimate consumer of the risks of a prescription drug [because] [t]he physician acts as the 'learned intermediary' between the manufacturer and the ultimate consumer."*fn16 Therefore, if an adequate warning is provided to the prescribing physician, the manufacturer is relieved of its duty to warn the patient, regardless of what the physician communicated to the patient. In circumstances where a manufacturer fails to adequately warn the physician, the failure to warn "is not the proximate cause of a patient's injury if the prescribing physician had independent knowledge of the risk that the adequate warning should have communicated."*fn17

Defendant contends that Plaintiff cannot establish that "the alleged failure to warn or misrepresentations were the proximate cause of their breast cancer,"*fn18 because:

Plaintiff's doctors and the rest of the medical community already knew that breast cancer was a risk associated with hormone therapy when they prescribed it to [Plaintiff] . . . WHI did not change what doctors already knew about the relative and absolute ...

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