Man unsure of the safety of his medicine

Breaking news and expert analysis on legal and compliance issues

[Back To Home][Back To Archives]

From Products Liability Law Daily, April 23, 2015

Patient’s claims that Vioxx caused her heart disease survive

By John W. Scanlan, J.D.

A patient who alleged that taking Vioxx caused her heart disease presented sufficient evidence on specific causation and proximate causation for her case to move forward, the U.S. District Court for the Eastern District of Louisiana ruled in denying summary judgment to Merck Sharp & Dohme Corporation (Merck), the drug’s manufacturer. The court also reopened discovery to resolve certain disputed issues of fact (In re Vioxx Products Liability Litigation (Jo Levitt v. Merck Sharp & Dohme Corp.)), April 20, 2015, Fallon, E.).

Background. Jo Levitt was prescribed Vioxx, a nonsteroidal anti-inflammatory drug, in summer 1999 by Dr. Hartman, her dermatologist, at her request. In October, she was diagnosed with fibromyalgia by Dr. Arthur Katz, a rheumatologist, for which he prescribed Vioxx. He noted that she already was taking it on an as-needed basis, but decided that she should start taking it daily, and wrote her a new prescription for it.

Merck, the maker of Vioxx, asserted that Dr. Katz had independently prescribed Vioxx to Levitt, but she disagreed and further stated that she had asked Dr. Hartman for Vioxx after having seen advertisements for the drug. A medical record from February 2000 indicated that Dr. Hartman switched her Vioxx prescription to Relafen, another nonsteroidal anti-inflammatory medication.

In March 2000, the patient was hospitalized and diagnosed with unstable angina and coronary heart disease, and received an angioplasty and two heart stents. Two months later, she experienced heart pains and had double-bypass surgery after it was found that her stents had severely narrowed. She continued to take Vioxx until Dr. Katz changed her prescription in April 2002 to Bextra, a non-steroidal anti-inflammatory drug used in the treatment of osteoarthritis and rheumatoid arthritis. Dr. Katz testified that he changed the prescription because of a change in her insurance coverage, but Levitt asserted that he changed it after Merck changed the warning label for Vioxx.

In September 2004, Merck withdrew Vioxx from the market after a clinical trial showed it increased the risk of cardiovascular thrombotic events such as heart attack and ischemic stroke. Thousands of suits were brought against Merck that were consolidated into MDL 1657, and after several trials, a $4.85 master settlement agreement was announced in 2007 to resolve most Vioxx claims. Levitt brought claims against Merck in 2006 for strict liability, negligence, negligence per se, breach of express warranty, and breach of implied warranty. Her case was transferred to the MDL, but she chose not to opt into the master settlement, and instead exercised her right to proceed with her suit.

In 2013, she designated five expert witnesses, including Dr. Jay Schapira, to address specific causation regarding her two heart attacks, Dr. David Egilman, to address specific causation regarding other injuries, and three others to address general causation and damages. She also disclosed her cardiologist, Dr. Thomas Rosamond, and reserved the right to call any other treating physicians and providers. Merck deposed only Dr. Arnold Katz. After Levitt informed Merck in 2014 that she was withdrawing Dr. Schapira as an expert witness, Merck moved for summary judgment on specific causation and on proximate causation.

Specific causation. Although Merck asserted that the patient had no designated expert to establish specific causation for her heart attacks after she withdrew Dr. Schapira as an expert, the court denied Merck’s request for summary judgment. The two heart attacks were the only injuries alleged in her complaint, but Levitt’s plaintiff profile form (PPF) also described arterial plaque, stenosis, and aggressive heart disease. The court observed that a dictionary definition of “heart attack” is “an acute episode of heart disease,” and that Merck reasonably should have anticipated that the patient would present not only evidence of her two heart attacks but also evidence of any related cardiovascular conditions. Her amended PPF put Merck on notice in 2009 of her claimed heart disease. As a result, the court found that there would be no prejudice to Merck by allowing her to proceed with these claimed injuries.

Proximate causation. Summary judgment also was denied on the issue of proximate causation because the court found there were material facts in dispute as to whether Dr. Hartman continued to prescribe Vioxx for the patient and whether Dr. Hartman would have prescribed it if given an adequate warning. Merck asserted that Dr. Katz was the only relevant prescribing physician for the purpose of the learned intermediary doctrine, but the February 2000 medical record from Dr. Katz showed that Dr. Hartman continued to prescribe Vioxx as of that date. The court noted that no party had taken the testimony of Dr. Hartman.

Further, the patient had raised a genuine question of Dr. Katz’s credibility regarding his statement that he would have prescribed Vioxx to her with a black box warning as to its cardiovascular risks. She argued that the learned intermediary doctrine did not apply to her failure to warn claim because Dr. Katz was a paid speaker and investigator for Merck. While mere evidence of a consulting relationship was not sufficient to prove that the doctor had failed to exercise independent judgment, the court determined that further discovery was necessary.

Going forward. While ordering additional discovery to resolve the disputed issues, the court reserved judgment as to whether the failure to warn claim encompassed all of the patient’s claims besides her defective design claim; whether the defective design claim was preempted by federal law; and whether the court should apply the “Direct-to-Consumer” exception to the learned intermediary doctrine, which Missouri courts had neither accepted nor rejected.

The case is No. 06-9757 (MDL No. 1657).

Attorneys: Daniel A. Thomas (Daniel A. Thomas, Attorney at Law) for Jo Levitt. John Christian Aisenbrey (Stinson Morrison Hecker, LLP) for Merck & Company, Inc.

Companies: Merck & Company, Inc.

MainStory: TopStory WarningsNews ExpertEvidenceNews DesignManufacturingNews DrugsNews LouisianaNews MissouriNews

Products Liability Law Daily

Introducing Wolters Kluwer Products Liability Law Daily — a daily reporting service created by attorneys, for attorneys — providing same-day coverage of breaking news, court decisions, legislation, and regulatory activity.


A complete daily report of the news that affects your world

  • View full summaries of federal and state court decisions.
  • Access full text of legislative and regulatory developments.
  • Customize your daily email by topic and/or jurisdiction.
  • Search archives for stories of interest.

Not just news — the right news

  • Get expert analysis written by subject matter specialists—created by attorneys for attorneys.
  • Track law firms and organizations in the headlines with our new “Who’s in the News” feature.
  • Promote your firm with our new reprint policy.

24/7 access for a 24/7 world

  • Forward information with special copyright permissions, encouraging collaboration between counsel and colleagues.
  • Save time with mobile apps for your BlackBerry, iPhone, iPad, Android, or Kindle.
  • Access all links from any mobile device without being prompted for user name and password.