(The opinions expressed here are those of the author, a

columnist for Reuters.)

By Alison Frankel

Aug 28 (Reuters) - Every judge presiding over

consolidated mass torts cases in federal court faces the same

dilemma: What is the best way to proceed efficiently in these

sprawling cases while simultaneously preserving the rights of

individual plaintiffs?

Consolidated mass torts litigation, as you know, typically

consist of hundreds or thousands of personal injury claims by

people who all have their own stories to tell.

But litigating their cases one-by-one would strain court

resources. So our federal judicial system has created a

consolidation process for pre-trial discovery and motions,

allowing a single judge to rule on issues that affect most or

all of the cases that have been swept together. The goal is to

promote consistency and efficiency without forgetting that each

case must ultimately stand or fall on its own.

That tension was at the heart of an early dispute in closely

watched multidistrict litigation over the alleged side effects

from diabetes and weight-loss drugs - including Ozempic, Wegovy

and Mounjaro - sold by Novo Nordisk and Eli Lilly ( LLY )

.

The defendants asked U.S. District Judge Karen Marston of

Philadelphia to make threshold rulings on three pivotal

questions that, in their view, cut across all of the cases that

have been or are expected to be filed in the consolidated

litigation. The plaintiffs firms leading the case opposed the

request, insisting that the defendants' proposal disregarded the

facts and circumstances of individual plaintiffs' cases.

Marston mostly sided with Lilly and Novo Nordisk in an Aug.

23 order that could potentially squelch the litigation before it

really gets going.

You need some background to understand why. The vast

majority of plaintiffs who have already filed suits or are

expected to bring claims allege that after they began taking

Ozempic or similar medications, they developed a condition

called gastroparesis, in which their stomachs stopped (or

slowed) the passage of food to their small intestines. The

plaintiffs assert that labels on the drugs failed to provide

adequate warning that the medication could cause gastroparesis

or related symptoms.

The drugs' labels unquestionably disclose the risk of

gastrointestinal side effects such as nausea and vomiting. So if

plaintiffs cannot prove they suffered from gastroparesis, as

opposed to other gastrointestinal side effects, Novo Nordisk and

Eli Lilly ( LLY ) will have stronger arguments that plaintiffs' claims

are pre-empted by warnings on the drugs' labels.

The defendants told Marston last month that there is only

one surefire way to diagnose gastroparesis objectively, through

a specific clinical test. But most of the plaintiffs in the MDL,

they said at a July 10 hearing, did not have that test and are

instead alleging gastroparesis based on symptoms and other

factors.

Novo Nordisk counsel from DLA Piper and Lilly lawyers from

Kirkland & Ellis asked the judge to decide, as a threshold

matter based only on expert witnesses, what evidence plaintiffs

must provide in order to support their gastroparesis claims.

The defendants also asked Marston to decide, as a matter of

law, whether their drugs' labels pre-empt some or all of the

plaintiffs' claims. Lilly, in particular, cited the rigorous

U.S. Food and Drug Administration approval process for its

medications, which, it argued, have from the beginning included

"strong and repeated severe gastrointestinal warnings."

In addition, the defendants called on the judge to find, as

a matter of law, that no reliable scientific evidence supports

plaintiffs' claims that their drugs cause ailments other than

those disclosed in warning labels.

Deciding these critical, across-the-board legal issues at

the beginning of the case, defendants said, would drastically

streamline the litigation - especially if the companies prevail.

But lead plaintiffs' lawyers from Motley Rice, Seeger Weiss,

Morgan & Morgan and Wagstaff & Cartmell told Marston it would be

premature to consider the issues without developing a full

factual record in bellwether cases.

Judges overseeing MDLs, they said, routinely rule on

pre-emption and causation defenses - but they almost always wait

for evidence to emerge in trials involving representative

plaintiffs instead of ruling in a vacuum, based only on expert

testimony.

That's especially important, the lawyers said, in the

context of diagnosing gastroparesis. Marston should hear from

treating physicians, they argued, before setting an

across-the-board standard based on a diagnostic test that many

plaintiffs had no access to.

"This is a very unique thing that the defendants are asking

the court to do," argued Jonathan Orent of Motley Rice at the

July 10 hearing. "We deserve the opportunity to put faces and

facts and individual circumstances before the court."

Marston was unpersuaded. She said plaintiffs can offer

evidence from treating physicians and can argue after her

cross-cutting decisions that her rulings should not apply to

particular plaintiffs. The judge also put off a ruling on

defendants' request for an early decision on general causation.

But she agreed with Lilly and Novo Nordisk that it made

sense to rule now, when the litigation is in its early stages,

on how gastroparesis must be diagnosed and whether the

defendants' labels provided adequate warnings. She did not need

to hear from individual plaintiffs, the judge said, to answer

purely legal questions that cut across the entire litigation.

Plaintiffs' lawyers declined to provide a statement on

Marston's ruling. Novo Nordisk did not respond to a query.

An Eli Lilly ( LLY ) spokesman said Marston's ruling "will

accelerate resolution" of lawsuits that the company considers

meritless.

"Lilly believes it is critical that only sound science makes

its way into the courtroom," the company said via email.

Plaintiffs' lawyers said at the July 10 hearing that no MDL

judge has ever front-loaded so many pivotal questions.

Defendants argued that at least four other MDL courts have opted

to rule on general causation before wading into bellwether

trials. Either way, mass torts lawyers on both sides of the bar

will be watching to see how Marston's process plays out.

And if Lilly and Novo Nordisk manage to kill or even

substantially trim the litigation, you can be sure future

defendants will try similar gambits.