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From Health Law Daily, May 23, 2013

Consumer’s manufacturing defect claim against drug manufacturer alleging presence of bloody latex fails

By Sarah E. Baumann, JD

A consumer could not proceed with her manufacturing defect claim against the seller of a pharmaceutical powder because she did not provide any evidence of a defect (Bell v Par Pharmaceutical Companies, Inc., May 21, 2013, Pratt, T). The court struck from the record photographs that the consumer allegedly took of the now-missing foreign objects that were allegedly included in the product because she consistently claimed that no photographs existed until three years after the incident. The federal district court therefore granted the seller’s motion for summary judgment.

Background. Pamela Bell purchased cholestyramine powder sold by Par Pharmaceuticals, Inc. to treat high cholesterol after her gallbladder was removed. The powder was manufactured in bulk by Calatent Parma Solutions, Inc. (Calatent) and packaged by Sharp Corporation (Sharp). In July 2009, Bell mixed one scoop of powder from a previously opened can and mixed it with water. She felt a foreign object in her mouth, which she spat out. Further examination revealed that there were two off-white latex glove fingertips with jagged edges in her cup, and the mixture appeared “blood red” instead of its typical light orange color. Although she experienced nausea, she did not seek treatment. Three separate blood tests did not reveal the presence of any condition resulting from exposure to foreign blood. Bell sued Par Pharmaceuticals, Inc. and its holding company Par Pharmaceutical Companies, Inc. (collectively Par).

Bell kept the cup and its contents on a nightstand until October 2009; thereafter, she stored it in a plastic bag in her refrigerator. A viewing of the cup at a deposition in April 2012 showed evaporated cholestyramine mixture, but no latex pieces. In September 2012, Bell’s roommate presented photos of the cup and its contents at her deposition; up until that point, Bell had maintained that no photos existed. Par moved to strike the photographs and related testimony and also moved for summary judgment of the case; Bell filed a motion to strike the declarations of two of Par’s witnesses.

Motions to strike. Bell moved to strike portions of the declaration of T. Duane Gosser, Quality Assurance Manager for Calatent, as well as the entire declaration of Barbara H. Ost, Vice President Quality Assurance Manager at Sharp, alleging that they did not personally observe the manufacturing and packaging of the cholestyramine powder. The court denied Bell’s motion, nothing that a general presumption as to personal knowledge sufficient for attestation purposes exists for employees or corporate representatives who review business documents that the company had a duty to record.

Par moved to strike the photographs, as well as the related deposition testimony of Bell’s roommate. Over the course of three years, Bell repeatedly denied the existence of any photographs of the cup and its alleged contents. Her roommate later brought photos to her deposition without prior warning, claiming that she and Bell had simply forgotten about them. Federal Rule of Civil Procedure 37(c)(1) states that if a party fails to provide information or identify a witness as otherwise required, the party cannot use that information or witness to supply evidence, “unless the failure was substantially justified or is harmless.” The court determined that the presentation of the photographs which had been sought for years, particularly in light of the disappearance of the alleged foreign objects, placed Par at a disadvantage in case preparation. As a result, it granted Par’s motion to strike both the photographs and related testimony.

Summary judgment. Bell violated Local Rule 56-1(b) by failing to include a section labeled “Statement of Material Facts in Dispute” in her reply to Par’s motion for summary judgment; in fact, she stated that she did not dispute Par’s facts. As a result, the court accepted Par’s recitation of the facts as true and proceeded to evaluate the motion for summary judgment.

The Indiana Products Liability Act (IPLA) (IC-34-20-1-1 et seq.) governs all actions brought by a user or consumer against a manufacturer or seller for physical harm caused by a product. Bell’s claim alleged a manufacturing flaw. However, the IPLA contains a rebuttable presumption that a product is not defective and the seller is not negligent if the product complied with all requirements at the time of sale by the manufacturer. Gosser and Ost’s declarations triggered the presumption, which Bell failed to rebut. She did not demonstrate that the product was in a defective condition, as she provided no evidence of the alleged foreign objects and failed to rebut Par’s expert opinion that the latex, as stored, could not have disintegrated. Furthermore, she did not provide evidence that the alleged pieces actually came from Par, since she failed to dispute evidence that: there were no reported accidents at either Calatent or Sharp during the time that her powder was manufactured and packaged; Sharp would have detected an overweight can of powder in its packaging process; and Calatent employees actually used blue nitrile gloves, rather than off-white latex gloves. Finally, Bell was unable to demonstrate that she suffered physical harm. As a result, the court granted Par’s motion for summary judgment.

The case number is 1:11-cv-01454-TWP-MJD.

Attorneys: Frederic Xavier Shadley (Ulmer & Berne LLP) for Par Pharmaceutical Companies, Inc. and Par Pharmaceuticals, Inc.

Companies: Par Pharmaceutical Companies, Inc.; Par Pharmaceuticals, Inc.

MainStory: TopStory CaseDecisions PLDrugNews IndianaNews

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