Earp et al v. Novartis Pharmaceuticals Corporation
ORDER regarding 109 Motion for Clarification of Order. Counsel should read the order in its entirety for all information. Signed by Chief Judge James C. Dever III on 4/9/2014. (Sawyer, D.)
IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF NORTH CAROLINA
JIMMY EARP and PATRICIA EARP,
On September 11, 2013, the court granted in part and denied in part N ovartis Pharmaceuticals
Corporation's (''Novartis") motions to exclude expert testimony, including Novartis's motion to
exclude the testimony of Professor Wayne Ray. [D.E. 100] 7; see [D.E. 76]. The court did not
discuss Novartis's motion to exclude the testimony of Professor Ray in the text of its order. On
March 14, 2014, Novartis filed a motion for clarification of the court's September 11, 2013 order,
and asks the court to specify its rulings on each of its asserted challenges to Professor Ray's
testimony [D.E. 109].
Professor Ray is a qualified expert and has a reliable basis to offer testimony regarding
general causation. The court will permit Professor Ray to testify about the relative risk and
attributable risk of developing osteonecrosis of the jaw ("ONJ") through the use of intravenous
bisphosphonate ("IV BP") drugs (Table 5 meta-analysis), causation based on his Bradford-Hill
analysis, and causation based on case and adverse event ("AE") reports, including those reports he
has not personally reviewed. The court also will permit Professor Ray to opine that it is biologically
plausible that IV BP drugs increase the risk ofONJ, that approximately 5% of patients receiving IV
BP drugs develop ONJ, and that Novartis could have concluded in 2003 that IV BP drugs cause
ONJ. The court will not, however, permit Professor Ray to opine that there is a higher risk of
developing ONJ through the use of Zometa than through the use of Aredia (Table 6 meta-analysis),
or opine that ONJ is not "rare" in cancer patients treated with IV BP drugs.
SO ORDERED. This __1_ day of April2014.
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