David Robinson Rochester Democrat and Chronicle
Published 2:54 PM EDT Apr 3, 2019
New Yorker Giacomo Lo Re died after taking a diabetes drug that federal regulators later warned may cause infections like the one that killed him.
Now, Lo Re’s widow, Venera, is suing the drug’s maker, New Brunswick-based Johnson & Johnson, claiming the pharmaceutical giant and affiliates misled the public about its risks in pursuit of related drug sales that totaled $1.1 billion in 2017, according to court and financial records.
The lawsuit also accused health care providers, including Rochester Regional Health, of failing to properly treat the man from Wayne County in upstate New York in connection to his wrongful death at 68.
Further, Venera’s lawyer contends Lo Re was not alone as others taking the drug, Invokana, are potentially at risk of similar deadly infections.
“As more and more evidence of what side effects are caused by the taking of Invokana come to light, we are very aware there might be many more people out there with these conditions,” said Kelly Wolford, the lawyer.
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To understand the stakes, consider that more than 1.5 million people take Invokana, according to the drug maker’s website.
Johnson & Johnson’s lawyer referred a phone call to its affiliate Janssen Pharmaceuticals, which declined to answer questions about the case in an emailed statement.
The drug company’s statement described Invokana as an important medicine, used along with diet and exercise, to lower blood sugar in adults with type 2 diabetes.
“With real world experience including more than 19 million prescriptions to date, we are confident in its overall safety profile, and will continue to defend against the claims raised in this litigation,” Janssen officials stated.
Rochester Regional Health and Alexander Medical Group doctors involved in the case have denied medical malpractice allegations in court filings.
The Monroe County Supreme Court lawsuit has been removed to federal court in New York. Johnson & Johnson has requested it join an ongoing court battle involving more than 1,100 cases related to Invokana risks, including kidney failure and ketoacidosis, court records show.
The 1,100-plus cases were consolidated in federal court in New Jersey, which is setting up an undisclosed settlement fund to address related claims, court records show.
But Wolford said the prior court battle insufficiently addressed the sepsis that killed Lo Re, as well as the drug company’s failures in timely disclosing Invokana’s risks.
“Our argument is they didn’t manufacture a safe drug, and it was a failure to warn us to the side effects, the real true side effects that are affecting the people who take the drug,” she said.
Concerns about the drug’s risks prompted the U.S. Food and Drug Administration last year to issue an infection warning connected to Lo Re’s death, court records show.
‘Early intervention’ drug
Lo Re, who wasn’t using insulin, started taking Invokana to improve his quality of life as described in the drug’s marketing, according to the lawsuit and Wolford.
On the drug company’s website, for instance, patient testimonials describe how taking Invokana improved their lives, such as women who talked of weight loss and increased energy helping them to travel and spend time with family and friends.
They also described the drug as a simpler alternative to other diabetes treatment, a key aspect of Lo Re’s lawsuit.
“It’s not a last chance medication … they use this as an early intervention,” Wolford said.
The lawsuit claims the drug companies knew the risk associated with Invokana was greater than the risk with other diabetes drug therapies, yet knowingly made material misrepresentations and omissions of fact.
Lo Re’s son Ray spoke to the family’s frustration at broken promises of a better life through medicine.
“I don’t understand how they approve it if people are losing limbs and people are dying: How does it happen?” Ray asked, referring to the Food and Drug Administration, or FDA.
“I just feel like these pharmaceutical companies make so much money and they get a little lawsuit and they just pay it off and just push it aside,” he said.
Ray’s wife, Maria, added to the comments.
“I think one person is enough for someone to say that’s someone’s life and the FDA should definitely go in and rethink about it and, if possible, shut it down,” she said.
The case comes amid heightened consumer advocate and government scrutiny of drug side effects following high-profile recalls involving cancer links in blood-pressure medicine.
A family’s loss
Lo Re’s family described him as a hard-working immigrant whose American dream turned into a medical nightmare.
“Coming from Sicily, they really didn’t have much and so when he came here and had the opportunity he was given here to work, it was like he struck gold,” said Ray Lo Re, recounting his father’s arrival in Rochester about 50 years ago.
Ray’s wife, Maria, expanded on the thought.
“He came from sleeping a family of six in one bed to coming to the U.S. and grabbing everything this country has and saying, ‘I’m going to provide a life for my family’ ” she said.
After starting in construction, Lo Re worked as a machinist at Kodak and Delco. In retirement, his days were filled with long walks, gardening, wine-making, family time and playing handy man to anybody in need, family said.
Ray and Maria, who live in Webster, cried often as their tales of Lo Re’s vitality shifted to his untimely death.
“That’s why it’s such a shock, he was fine on Wednesday and then all of sudden on Friday we’re taking him to the emergency room and he’s gone; it’s just mind-boggling,” Ray said.
Yet the tears quickly yielded to frustration at the circumstances involved.
“I have a lot of anger, I’m really upset because I feel like my father was the kind of person…that would’ve lived into his nineties,” Ray said.
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Much of the family ire targeted drug makers and government regulators that approved Invokana despite side-effect warnings, such as the rare, potentially deadly flesh-eating genital infection connected to Lo Re’s death.
“My father-in-law for sure would have wanted us to do something because it was such a wrongful death…He was not a sick man,” Maria said.
Then, Ray described why his mother wants the drug pulled from the market.
“It’s basically like somebody went up to my father and shot him in the head, like he got killed,” he said.
The medical treatment
What follows are takeaways from the lawsuit’s account of what happened after Lo Re began taking Invokana.
Lo Re’s rapid health decline unfolded before doctors who missed warning signs about the drug’s side effects, which wouldn’t be revealed for more than a year after his death.
Lo Re first started feeling off about a month after being prescribed Invokana on Sept. 22, 2016.
At the time, his mild discomfort while urinating and genital skin irritation didn’t raise serious red flags for his primary care physician, Dr. Sylvia Park. She recommended some basic anti-itch skin creams and a follow-up visit in three months.
But Lo Re didn’t make it to that visit.
On Jan. 27, 2017 he showed up at Immediate Care Penfield, an affiliate of Rochester Regional Health. His complaints of fever, diarrhea, vomiting, chills and headache, as well as worsening pain, led to a diagnosis of urinary stones connected to diabetes.
The urgent care’s Dr. Richard Sullivan sent Lo Re home with prescriptions for a painkiller and urinary aid, along with instructions to go to the emergency department if the pain got really bad.
After deteriorating overnight, however, Lo Re went to Rochester Regional Health’s emergency department in the morning and died later that day. An autopsy revealed sepsis as the cause of death.
More than a year later, the FDA in August 2018 issued a warning about the increased risk of Fournier’s gangrene, a rare but serious genital infection, for Invokana and related type 2 diabetes drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors.
The lawsuit contends Lo Re had a Fournier’s gangrene infection that led to sepsis.
Wolford said Lo Re’s death underscored the need for further review of Invokana outside of the previous settlement, which focused on other side effects than the infection and sepsis risks.
“There are probably other people out there who suffered maybe not as substantial a loss as Mr. Lo Re, but a lot more people out there who’ve suffered from various infections, and that’s always a concern from a consumer protection standpoint,” she said.
From the approval of Invokana in March 2013 to May 2018, the FDA identified 12 cases of Fournier’s gangrene in patients taking SGLT2 inhibitors, the lawsuit said. That’s compared to only six cases in review of other anti-diabetic drug classes over a period of more than 30 years.
The FDA also reported from March 2016 through September 2018, there were 4,891 reported cases of infections and infestations associated with SGLT2 inhibitors, including 248 cases of sepsis, 1,326 cases of fungal infection and 591 cases of gangrene, according to the lawsuit.
There are no warnings regarding sepsis in the original warnings or the current warnings, court records show.
Despite knowing about the increased risk of serious infections, Johnson & Johnson and affiliates did not warn patients of the risk “but instead continued to promote and distribute Invokana, mislead physicians and the public, and minimize unfavorable findings,” the lawsuit said.
Federal regulators aren’t blameless either, Wolford said, citing how Invokana has since been approved for additional uses among cardiac patients.
“From a consumer standpoint they’re just not doing what they’re there for,” she said.
Venera Lo Re has opposed including her husband’s wrongful death lawsuit in the prior Invokana settlement, which is in federal court in New Jersey. The next court proceedings are expected in April.
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