Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

CHWAT v. SMITHKLINE BEECHAM CORP.

April 7, 1993

ESTELLE CHWAT, Plaintiff,
v.
SMITHKLINE BEECHAM CORP., Defendant.



The opinion of the court was delivered by: EUGENE H. NICKERSON

 NICKERSON, District Judge:

 Plaintiff pro se brought this diversity action against defendant, a pharmaceutical company, alleging that defendant was negligent in failing to inform her of a possible allergic reaction to its product "Ecotrin," a coated delayed-release aspirin manufactured by defendant since 1956. Plaintiff seeks $ 2 million in damages.

 Defendant moves for summary judgment.

 Plaintiff is not represented by an attorney. She says that in her attempts to retain one she has spoken to at least twenty-one attorneys who declined to accept her case on a contingency fee basis because they found it too weak.

 I.

 The affidavits, exhibits and plaintiff's deposition show that most of the critical facts are not in dispute.

 Defendant manufactures Ecotrin, which contains .023 mg. per caplet of the dye "FD&C Yellow No. 6" (Yellow No. 6). Ecotrin meets or exceeds all applicable standards under the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 -394.

 The entry regarding Ecotrin in the Physician's Desk Reference lists "gastrointestinal symptoms" as a possible adverse reaction to aspirin and FD&C Yellow No. 6 as an inactive ingredient.

 Yellow No. 6 is one of the most commonly used color additives and is present in numerous drugs and prepared foods. Prior to 1986, the United states Food and Drug Administration (FDA) required manufacturers to list Yellow No. 6 as an ingredient because it suspected the dye was an allergen. But in 1986, after reviewing the studies and finding "no clear cases of hypersensitivity," the FDA concluded that no warning for Yellow No. 6 was warranted.

 Defendant has received 37 complaints about Ecotrin, of which 1.3 billion pills have been sold from January 1988 to October 1989, and has no record of any lawsuits brought for alleged injuries from Ecotrin. Plaintiff submits a computer-generated list from the FDA dated October 19, 1992, listing 69 undated complaints about Ecotrin.

 Plaintiff describes the symptoms of her alleged allergic reaction as follows: "throat closing; severe heaviness in chest; rectal bleeding; pains in stomach; inflamed esophagus, intestine and stomach; spitting up blood . . . ." Plaintiff also alleges that as a result of ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.