A Legacy for Lucian: Mother who lost newborn son tries to make sure it doesn't happen to others

Emily Mitchell holds a photo of her deceased son, Lucian, signed by visitors to his memorial service.
Emily Mitchell holds a photo of her deceased son, Lucian, signed by visitors to his memorial service.
photo Emily Mitchell lost her first son after he was born with a heart defect she believes was caused by using a generic drug that didn't carry a warning label about its potential risks. Mitchell testified before the FDA about her history of taking fluoxetine, the generic form of Prozac, which was prescribed to her during her pregnancy.

Other warning label troubles

Prozac/fluoxetine is not the only drug that has updated its label because of health hazards connected with taking it. Here are some others: * Phenergan/promethazine hydrochloride (motion sickness, nausea, some allergy symptoms): First released in 1951, in 2000 a warning was issued that it should not be given to children under 2 years old; in 2004, the FDA required a "black box" (reserved for fatal dangers) warning label because of cases of respiratory problems, including fatalities, for children 2 and under. Brand-name manufacturer Wyeth has stopped making Phenergan, but generics are still available. * Reglan/metoclopramide hydrochloride (for gastrointenstinal problems): On the market in 1979, in 2009 a warning was issued that it can cause tardive dyskinesia, whose symptoms are uncontrollable facial tics and arm, leg movements. * Darvon or Darvocet/propoxyphene hydrochloride (for pain relief): On the market in 1957, in 2010 a warning came out that it has serious toxicity to the heart. When the FDA discovered how widespread the danger was, it ordered the drug removed from U.S. shelves. * Cylert/pemoline (for adult hyperactivity disorder): On the market in 1975, a warning was issued in 1997 that it could cause liver failure. In 2005, its brand name manufacturer, Abbott Laboratories, stopped making Cylert; no further warning updates have been made for antipsychotic & elderly dementa): First marketed in 1967, a warning was issued in 2007 that it could cause sudden death and heart-related side-effects. In 2008, the FDA required a "black box" (reserved for fatal dangers) warning label. Source: Public Citizen Report on Generic Labeling 2013

Emily Mitchell kissed Lucian as medics prepared the Erlanger hospital Angel Bus to speed the newborn baby to Vanderbilt University since his heart was too fragile for a helicopter flight. She noticed for the first time that her son's eyes were as blue as sapphires, sparkling and alert. He gazed at her so sweetly, so trusting, she silently promised him that she would fight for his life.

Her pregnancy and all the sonograms had been normal, yet her baby was born with a malformed heart. The day she first saw Lucian at Vanderbilt, a hole had been cut into his chest and was crammed with plastic tubes attached to machines that kept his blood flowing.

"My husband and I had named him Lucian Xavier, which means 'A House Filled with Light'; we were so overjoyed when we learned I was pregnant with our first son," Emily says, her own blue eyes brimming with tears. "We overcame so many obstacles."

Her husband had triumphed over an attention deficit disorder so severe, social workers worried he would never be able to live on his own. Emily was raised by a single mom on the verge of poverty. Yet they both landed full-time jobs after graduating from high school and created a happy home for their toddler Zoe, who was eager to share storybooks and stuffed animals with her new baby brother.

Now their focus was on being near Lucian, hoping he could sense their love. Money for gas and meals in Nashville were donated by her husband's co-workers at the bar where he worked. Wal-Mart, Emily's employer, extended her pregnancy leave. Nashville's Ronald McDonald House gave them free rooms.

Lucian Xavier Mitchell was born on April 15, 2011. Seven days later, a Vanderbilt cardiologist told Emily that her son could not be saved, but he should not die without feeling his mother's arms around him. Nurses gently draped a blanket over the baby's chest to hide the hole and tubes and nestled him in her arms.

Lucian died a few minutes later on April 22, Emily's birthday.

No warnings

A week after her baby died, Emily saw a TV commercial warning that pregnant women who took Prozac or a generic called fluoxetine had a higher risk of giving birth to babies with heart malformations. Emily was put on fluoxetine during her pregnancy after she began having panic attacks so severe they were interfering with her job. If an attack hit while she was driving, she pulled off the road to wait it out.

Her OB-GYN reassured her repeatedly that the drug was safe for pregnant women and nothing on the drug's label indicated otherwise.

Emily contacted the lawyer in the TV ad, who told her something most Americans and many doctors don't know: Warning labels on generic drugs can be dangerously outdated.

The U.S. Food and Drug Administration forbids generic drug makers from updating their labels with warnings of potential health hazards until after the brand-name manufacturer does so. And even after the manufacturer makes the change, it may be months before the generic drug actually has an updated warning label -- which normally refers to those long flyers folded inside a prescription drug's box, detailing the side effects and hazards.

And there's little a person can do if the drug causes harm before a warning label is issued. In Pliva v. Mensing, the U.S. Supreme Court ruled in 2011 that a patient who's injured due to flawed labeling cannot sue the generic drug maker because it can't change the label unless the brand-name manufacturer does so.

Eli Lilly, the maker of Prozac, did not respond to emailed and phone requests for comment. There are several manufacturers of generic fluoxetine; those contacted did not respond to requests for comment.

In January 2011, however, Eli Lilly issued a statement to its employees and pharmaceutical reps stating: "There is some evidence of a possible small increase in the risk of cardiac malformations (e.g., ventricular and septal defects) associated with use of fluoxetine." The warning was included in a flyer that ran 25 pages; the new warning was on page 16.

And it would be difficult for a lay person to decipher how big a danger was posed given the wording: "Results of a number of published epidemiological studies assessing the risk of fluoxetine exposure during the first trimester of pregnancy have demonstrated inconsistent results. More than 10 cohort studies and case-control studies failed to demonstrate an increased risk for congenital malformations overall."

By spring 2012, most fluoxetine makers had updated their labels.

Changing the rules

Emily Mitchell, now 30 years old, has no hope of suing or getting a settlement from a drug maker, but a lawsuit is not her goal. The lawyer she found through the TV ad told the nonprofit American Association for Justice about her. The Washington, D.C.-based AAJ is a nationwide organization that wants to make the American judicial and federal regulatory systems more fair, egalitarian and efficient by researching legislative and regulatory solutions to problems and petitioning Congress, federal regulatory agencies and courts to implement reforms. To this point, it has gathered 23,922 signatures on a petition asking the FDA to change its regulations so generic drug makers can update their labels when they become aware of health hazards.

When Emily talked with lawyers from the AAJ, she found a mission. It was beyond her power to save her son's life, but she is determined that his death will be meaningful. This March, the AAJ paid to fly her to suburban Washington, D.C., so she could testify at hearing in which she asked the FDA to change its rules.

But the multi-billion pharmaceutical and generic drug industries don't want the rule changed. More than a dozen of their lawyers and officers testified at the same hearing.

Washington, D.C.-based Generic Pharmaceutical Association spokesman Steven Arnoff says drug makers worry that, if the FDA allows generic drug makers to be responsible for updating their own labels, patients will be able to sue when a label is inadequate. The American Pharmacists Association also opposes the rule change for fear that injured patients might target pharmacists in tort liability lawsuits.

"The Generic Pharmaceutical Association shares the FDA goals to promote and protect public health," GPA President Ralph Neas said in a statement. "However, the proposed rule creates a scenario where disparate and potentially conflicting information from multiple manufacturers for single medicines could be widespread, causing confusion and putting patient safety, access and savings at risk."

Critics dispute that point because similar generic and brand-name drugs may have identical active ingredients but often contain different fillers and inactive ingredients, which is why some patients are allergic to a generic but can take a brand-name. Last month, Dr. Janet Woodcock, director of the FDA Center for Drug Evaluation and Research, testified at an FDA hearing that "concerns related to temporary differences in labeling between generic drugs and their corresponding brand drugs are outweighed by the benefit to the public health."

The FDA decision on whether to change the rule is expected in the fall. And Big Pharma and generic drug makers are already rallying to the battle line. Officials with the Generic Pharmaceutical Association vow to sue the FDA if it changes the regulation.

"The regulatory branch would be changing the law by executive fiat," Neas told reporters in a September press conference. "We would be forced to go into court."

Some drug makers implored Congress to attack any such rule change with legislation. And the pharmaceutical industry wields enough financial heft to make an impression on Capitol Hill. According to the Center for Responsive Politics, Eli Lilly alone contributed $162,000 to Democratic House representatives and $221,875 to Republicans in the House in 2014.

What doctors don't know

When Emily saw her doctor at Lucian's memorial service, she told the OB-GYN about fluoxetine's dangers. Emily says the doctor was skeptical until she Googled "fluoxetine" and "heart malformation" on her smartphone right there at the service.

"She said, 'I can't believe this! We have monthly meetings with pharmaceutical reps so we can learn about any new dangers or hazards,'" Emily recalls. The reps had said nothing about fluoxetine dangers, the doctor told Emily, who is still a patient and an admirer of the doctor.

Emily's doctor declined to speak on the record for this story.

All this comes as no surprise to Dr. Michael Carome, who directs health research for the consumer advocacy nonprofit Public Citizen. He worries that doctors have become too reliant on ambitious pharmaceutical reps, who often have no formal medical education and who court health-care professionals with lunches, dinners, gifts and travel junkets in an effort to sell their wares.

"In fairness to doctors, 85 percent of drugs prescribed are generics and there are tens of thousands of generic drugs out there and hundreds of studies about different side effects," Carome says. Under those circumstances, doctors don't have time to examine every study's methodology to see how effectively it evaluates health risks, he says.

The pharmaceutical industry has offered a counter proposal for a change in FDA rules that would make a label change contingent on the FDA documenting a health hazard and ordering a new warning be added to the label. Carmone dismisses the proposal as hopeless to implement.

"The FDA's budget and staff has been cut so often by Congress, it doesn't have the resources to monitor those studies either," he continues. "And there's no incentive for generic drug makers to do a robust job of monitoring health studies since they can't be held responsible for their labels' accuracy."

But there's another even more-frightening problem with the current rule making a generic drug maker wait for the brand-name manufacturer to decide whether a health hazard is worthy of changing the label.

"There are hundreds of generic drugs out there for whom no brand name exists; the manufacturer stopped making the brand name years ago, so no one is monitoring health or safety studies to update the label," Carmone says. "It happens all the time. A manufacturer decides he can't make money off a brand name, so he discontinues it. But the generics are still made and prescribed to patients."

Both Carmone and Aronoff agree there can be a lag time of months between the moment a brand-name manufacturer issues a warning and the generic drug maker updates its label to reflect the change. Aronoff's organization made a proposal of an electronic notification system linking everyone -- the FDA, brand names, generics -- who needs to know when a label update is needed. Of course, everyone has yet to agree on who orders the update.

Meanwhile, Mitchell has decided to do more than write congressmen and email the FDA. She is working as a maid at a home for the elderly where she makes an effort to chat with Alzheimer's patients and play them musical recordings and show them pictures that engage them, however fleetingly.

She also has applied for a federal Pell Grant to help pay for her dream: Return to college and become a radiologist so she can spot a health problem developing before it takes a patient's life.

"I hope Lucian would have been proud that I was his mommy," she says softly.

Contact Lynda Edwards at or ledwards@timesfreepress.com or 423-757-6391.

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