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Phelps v. Wyeth, Inc.

United States District Court, D. Oregon

September 26, 2014



ANN AIKEN, District Judge.

Plaintiffs filed this action on June 12, 2009, for personal injuries allegedly suffered by plaintiff Betty Phelps as a result of being prescribed and ingesting Reglan/metoclopramide for treatment of gastric esophageal reflux disease (GERD). Although plaintiffs alleged several claims, at this stage, the only remaining claim is plaintiffs' assertion that defendant Pliva failed to update its generic metoclopramide product label in 2003 and 2004 to match the warning on the Reglan brand-name product.

Plaintiff Betty Phelps alleges her doctors prescribed and she ingested metoclopramide tabl.ets from November 2002 to at least August 2009, and that use of the drug caused her to develop the movement disorder tardive dyskinesia. Federal regulations require manufacturers of generic drugs to update their package inserts to match inserts of the name-brand counterpart. Pliva's metoclopramide package insert did not match the Reglan insert after FDA-approved label changes in 2003 and 2004, in that it omitted the warning that "THERAPY SHOULD NOT EXCEED 12 WEEKS IN DURATION." Treatment with metoclopramide can cause tardive dyskinesia, a risk that increases with the duration of treatment and the total cumulative dose. Plaintiff's claim has been interpreted as one asserting violation of Oregon's products liability statute. See Or. Rev. Stat. § 30.900.

Although defendants sought summary judgment on multiple occasions previously in this litigation, after finally obtaining plaintiff's medical records, defendant Pliva now asserts that the remaining products liability claim is barred under the applicable statute of limitations. Accordingly, Pliva contends it is entitled to judgment as a matter of law on plaintiff's sole remaining claim.


Plaintiff's gastroenterologist, Dr. Craig Chamberlain, prescribed Reglan (as did her primary care physician) and the prescriptions were allegedly filled with Pliva's generic version in 2002 and from 2004 to 2008.

On March 8, 2007, plaintiff's neurologist, Dr. Andrew Lockfield, noted "definite parkinsonism, which could conceivably just be a Reglan side effect, " but he wanted to obtain a brain MRI scan to rule out normal pressure hydrocephalus or other mimics of Parkinson's disease. Clark Decl. Ex. 4 at 4 (doc. 379-4).[1] Plaintiff discussed Parkinson's-like symptoms with Dr. Lockfield and he told her on March 8, 2007, that he thought her use of Reglan was "causing or contributing" to her problems. Betty Phelps Dep. at 18-20 (attached to Clark Decl. (doc. 379-1)). Similar to plaintiff's recollection that Dr. Lockfield discussed problems associated with the use of Reglan, Dr. Lockfield stated that he believed he discussed the Parkinson's-like side effects of the drug. Lockfield Dep. at 30-31 (attached to Clark Decl. (doc. 379-7)). Dr. Lockfield also suggested to plaintiff that she should discuss with her gastroenterologist whether there was an alternative to the Reglan/metoclopramide. Lockfield Dep. at p. 31 (doc. 379-7).

Plaintiff returned to Dr. Lockfield on April 4, 2007. Clark Decl. Ex. 4 at 6-8. Plaintiff told Dr. Lockfield that the Sinemet improved her symptoms substantially. Id . Ex. 4 at 6. Dr. Lockfield asked plaintiff to discontinue the Reglan and check with Dr. Chamberlain about using a replacement medication for her GERD that would not be expected to cause parkinsonism. Id . Ex. 4 at 7. Plaintiff confirms that Dr. Lockfield told her to stop taking Reglan. Betty Phelps Dep. at 23 (doc. 379-1).

Dr. Chamberlain met with plaintiff on April 16, 2007. Dr. Chamberlain told plaintiff that he was concerned with the use of Reglan "in that it was causing or contributing to some of her symptoms." Chamberlain Dep. at 83 (attached to Clark Decl. (doc. 379-5)). Dr. Chamberlain agreed that plaintiff should discontinue Reglan and prescribed a replacement. Id. at 83-84. Dr. Chamberlain believes that both plaintiffs Betty and Delbert Phelps were aware that Reglan was playing a role in her movement disorder. Id. at 84.

On June 14, 2007, Dr. Lockfield noted that after discontinuing metoclopramide, plaintiff developed uncontrollable orofacial movements and he was concerned that this could represent tardive dyskinesia unmasked by stopping Reglan. Clark Decl. Ex. 4 at 9 (doc. 379-4).

On July 19, 2007, Dr. Lockfield noted that the apparent tardive dyskinesia presumably ·related to the long-term use of Reglan. Id. at 11, 12. Because of the misery plaintiff was suffering, Dr. Lockfield suggested she temporally go back on Reglan despite the fact that it could worsen tardive dyskinesia in the long-term. Id. at 12. Plaintiff told Dr. Lockfield that she would "rather experience the parkinsonism and accepts the possibility of worsened tardive dyskinesia to get relief of the intolerable symptoms she was experiencing" unresolved by replacement medications. Id .; see also Lockfield Dep. at 74 (doc. 379-7). Plaintiff was aware that the Reglan was thought to be the cause of tardive dyskinesia and that further use might worsen it in the long run, but she was willing to accept that to get short-term relief.

After referral to Dr. Arnie Peterson of the Movement Disorder Clinic at Oregon Health and Sciences University on March 24, 2008, plaintiff began tapering off Reglan/metoclopramide and eventually stopped in November of 2009.


As noted above, plaintiff's remaining claim is a product liability claim under Or. Rev. Stat. § 30.900. ...

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