(The opinions expressed here are those of the author, a
columnist for Reuters.)
By Jenna Greene
June 6 (Reuters) - One of the "wonderful things" about
the legal profession, U.S. District Judge Gene E.K. Pratter told
about 70 people during the first case management hearing in
litigation involving Ozempic and similar drugs, is the chance to
continually learn.
The 75-year-old jurist at the March hearing in Philadelphia
sounded eager to tackle the product liability multidistrict
litigation that plaintiffs lawyers expect to include more than
10,000 personal injury lawsuits, according to a transcript of
the proceedings.
Pratter at the hearing scheduled a "science day" for the
parties to educate her about the weight loss and diabetes drugs.
"More detailed than an overview that you'd give a third grader,
okay, but I am also not interested in going to medical school,"
she said.
But Pratter suddenly died 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."
It also leaves the high-profile litigation involving the
GLP-1 medications temporarily rudderless pending appointment of
a new judge to oversee the case, which a clerk for the Judicial
Panel on Multidistrict Litigation told me will remain in the
Eastern District of Pennsylvania.
In the interim, lawyers say they're doing what they can
without the day-to-day supervision of a judge, teeing 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."
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 but said Pratter was
"extremely well-regarded by both sides in the case."
Eli Lilly ( LLY ), repped by a team including James Hurst of
Kirkland & Ellis, has denied the allegations as well. A
spokesperson said the company is "deeply saddened by Judge
Pratter's passing." 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 interruption of the litigation. (Pratter issued a
23-page opinion in another case just three days before her
death.) Her husband Robert Pratter, a lawyer at Cohen,
Placitella & Roth, did not respond to a request for comment.
Whoever takes over the Ozempic MDL can expect the
proceedings 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.
The first issue is likely to 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.
For the new judge, it's likely to be a lively fight.