June 6 (Reuters) -
As U.S. District Judge Karen Marston in Philadelphia takes
the helm of litigation involving Ozempic and similar drugs,
she'll step into a lively fight where early battle lines have
already been drawn.
A former federal prosecutor who was nominated to the
bench in 2019 by Donald Trump, Marston was selected by the
Judicial Panel on Multidistrict Litigation on Thursday to take
over product liability proceedings that plaintiffs' lawyers
expect to include more than 10,000 personal injury lawsuits.
The case had been assigned in February to U.S. District
Judge Gene E.K. Pratter. She died suddenly on May 17 from
chronic obstructive pulmonary disease, the Philadelphia Inquirer
reported.
Her colleagues on the bench in the Eastern District of
Pennsylvania said in a statement that her passing was "a
tremendous loss."
Over the past three weeks, lawyers told me they continued
working without day-to-day judicial supervision to tee up a host
of issues including the all-important plaintiff fact sheet - a
form where individual litigants detail their alleged injuries
and other personal information.
"Both sides are interested in moving the litigation as
quickly as we can," plaintiffs' co-lead counsel Jonathan Orent
of Motley Rice told me. "A delay of even three or four months
can be quite significant for (clients) who are not able to work
or take care of themselves."
Marston, who did not immediately respond to a request for
comment, has already scheduled a status conference for Monday
afternoon.
A spokesperson for Novo, which is represented by outside
counsel led by Loren Brown of DLA Piper, said via email that the
company maintains the allegations are false and without merit.
Brown declined comment on the litigation.
Eli Lilly ( LLY ), repped by a team including James Hurst of
Kirkland & Ellis, has denied the allegations as well. Hurst
declined comment.
It's certainly not the first time an MDL has been reassigned
mid-stream. Last month, for example, product liability
litigation involving the blood pressure medication Valsartan was
transferred to U.S. District Judge Renee Bumb after her
colleague on the New Jersey bench, Judge Robert Kugler,
announced his retirement.
What's different here is how sudden the judge's passing was
and its abrupt -- albeit short-lived -- interruption of the
litigation. (Pratter issued a 23-page opinion in another case
just three days before her death.)
Marston can expect the multidistrict litigation to receive
extensive media attention, given the widespread use of the
medications amid the so-called obesity epidemic in the U.S.
About one in eight U.S. adults have taken a drug belonging
to the GLP-1 class of medications, my Reuters colleagues
reported in May, citing a Kaiser Family Foundation poll. The
self-injectable drugs include Novo Nordisk's diabetes drug
Ozempic and weight-loss treatment Wegovy, along with Eli Lilly's ( LLY )
Mounjaro, Trulicity and Zepbound.
Plaintiffs in court documents say the drugmakers failed to
adequately warn that their medications can potentially cause
"prolonged, life-threatening digestive dysfunction." Alleged
side-effects include gastroparesis, which prevents the stomach
from emptying properly, as well as severe vomiting, bowel
obstruction and gall bladder injuries.
The judge taking over the case will face litigation battle
lines that have already emerged.
For Marston, one looming issue will be finalizing the
plaintiff's fact sheet, which will provide individual data on
what defense counsel term "critical dispositive issues"
including claimants' alleged injuries, other medical conditions,
product identification and symptom onset.
Plaintiffs' lead co-counsel Sarah Ruane of Wagstaff &
Cartmell told me all sides are "close to ready to go" on the
form, though they don't agree on how the information should then
be used to weed out claims.
Defense counsel in court documents see the potential to use
the fact sheet responses to narrow the litigation, noting that
some claims may be time-barred, while others might involve
counterfeit or compounded products for which Novo and Eli are
not liable.
They also flag claims by plaintiffs who "lack an objective
diagnosis" of gastroparesis. Symptoms like nausea, indigestion
and bloating are "shared with numerous other conditions,"
defense lawyers say. Moreover, they argue that gastroparesis is
a "known complication" of type 2 diabetes - exactly what Ozempic
and Mounjaro are approved to treat - so how to prove the drugs
are to blame?
Plaintiffs' lawyers oppose any proposal "that would result
in the premature dismissal of claims, or in the adoption of a
single, restrictive test for proving causation" of
gastroparesis.
They reject defense suggestions that their clients should
undergo a gastric emptying study to prove their injuries,
arguing that such a test "may be inconclusive, unavailable, and,
depending on an expert's clinical judgment, unnecessary to prove
injury."
More broadly, they argue any attempt to use data points from
the fact sheet as the basis for winnowing claims via early
summary judgment invite "oversimplification" and run contrary to
the Federal Rules of Civil Procedure.
Instead, the plaintiffs team, which also includes co-lead
counsel Parvin Aminolroaya of Seeger Weiss and Paul Pennock of
Morgan & Morgan, are calling for additional discovery and
bellwether trials to test the cases.