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Column: Ozempic litigation in limbo after judge's death
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Column: Ozempic litigation in limbo after judge's death
Jun 6, 2024 10:25 AM

(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.

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