Editors' (re)View: J&J can contest talc scientific evidence; SCOTUS mifepristone hearing met with skepticism

March 29, 2024
Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of March 25

J&J can contest talc scientific evidence

In an interesting plot twist to its ongoing legal saga, Johnson & Johnson has been granted a chance to contest the scientific evidence linking its talc products to ovarian cancer, as decided by U.S. District Judge Michael Shipp.

This ruling, emerging from Trenton, New Jersey,  came after Judge Shipp, who took over the case in 2023, cited the need for a reevaluation of the evidence amid evolving scientific and legal standards. This development comes after J&J's attempt to resolve these litigations through a subsidiary's bankruptcy was thwarted, signaling a resumption of trials that had been stalled from 2021 to 2023.

The litigation's future now hinges on a July 23 deadline for J&J to make its case, with outcomes from previous trials, including a $2.1 billion verdict against J&J in 2021. Amidst the legal turmoil, the change in federal rules governing expert testimony, a key factor in Shipp's decision, adds another layer of scrutiny to the evidence presented in court.

As J&J prepares to defend its talc products once more, the litigation serves as a pivotal examination of how scientific evidence shapes product liability lawsuits in the U.S. — Andrea Corona 

SCOTUS mifepristone hearing met with skepticism

Early this week, the U.S. Supreme Court heard oral arguments in a review of a lower court decision that would make the abortion drug mifepristone less accessible.

If SCOTUS upholds the lower court ruling, the access restrictions on mifepristone that were eased would be reinstated. In 2016, in an effort to make the drug more accessible, the FDA changed the drug's REMS program. These changes increased the maximum gestational age to 70 days, eliminated the in-person dispensing requirement, allowed non-doctors to prescribe and administer mifepristone, and eliminated reporting of non-fatal adverse events. 

The case marks the first abortion-related hearing since the court reversed Roe v. Wade in 2022.

At issue more than abortion and mifepristone access seemed to be the fundamental requirement for lawsuits: standing. In order for the case to have legal standing, the doctors who brought the original lawsuit, the Alliance for Hippocratic Medicine, need to prove they suffered actual injury.

In other words, in how many scenarios were doctors who object to abortion-related care faced with patients who needed medical assistance for an incomplete mifepristone-induced abortion, and how did that situation cause concrete injury to the doctor? (Spoiler, the answer was zero.)

Both conservative and liberal justices questioned whether doctors couldn’t just object to abortion-related care, rather than force a nationwide ban on mifepristone. “I’m worried that there is a significant mismatch … between the claimed injury and the remedy that’s being sought,” said Justice Ketanji Brown Jackson.

The hearing appears to be good news for the FDA and mifepristone drugmaker, Danco Labs. If the court decides the case has no legal standing, then it will never have to hear the arguments over mifepristone’s safety. For now, that means nothing will change, but it’s likely not the last anti-abortion arguments the courts will see. —Karen Langhauser


About the Author

Karen P. Langhauser | Chief Content Director, Pharma Manufacturing

Karen currently serves as Pharma Manufacturing's chief content director.

Now having dedicated her entire career to b2b journalism, Karen got her start writing for Food Manufacturing magazine. She made the decision to trade food for drugs in 2013, when she joined Putman Media as the digital content manager for Pharma Manufacturing, later taking the helm on the brand in 2016.

As an award-winning journalist with 20+ years experience writing in the manufacturing space, Karen passionately believes that b2b content does not have to suck. As the content director, her ongoing mission has been to keep Pharma Manufacturing's editorial look, tone and content fresh and accessible.

Karen graduated with honors from Bucknell University, where she majored in English and played Division 1 softball for the Bison. Happily living in NJ's famed Asbury Park, Karen is a retired Garden State Rollergirl, known to the roller derby community as the 'Predator-in-Chief.' 

About the Author

Andrea Corona | Senior Editor