February 2013

Could go either way.  Probably won’t have any effect on whether or not injured consumers can sue if they took generics.

Hamburg said FDA has collected $125 million in GDUFA fees for 2013 so far. However, she noted, the budget situation and sequestration have “significant implications” for using generic user fees and budget dollars. Budget cuts under the Budget Control Act of 2011–known as sequestration–are scheduled to be implemented at the beginning of March, while legislation funding the federal government expires at the end of March. In September 2012, a report from the White House Office of Management and Budget classified all budgetary resources available to FDA, including user fees, as subject to sequestration (10 PLIR 1332, 10/12/12).

Source: FDA’s Drug Center Creating New Office Of Pharmaceutical Quality, Hamburg Says | Bloomberg BNA

I’d like to introduce you to Jared Fink, who works for my firm as a Pharmacovigilance Specialist. What is a Pharmacovigilance Specialist, you ask? Well, every pharmaceutical company in the world has a team of folks who scour medical literature, the Internet, and other sources to look for signs that their drugs are causing harm. The men and women in those positions scour the medical literature and brief management on new and existing trends in product safety. They then prepare internal reports with candid assessments of whether they think a given study is important enough to merit further investigation. In other words, a Pharmacovigilance Specialist acts as the eyes and ears of a pharmaceutical company with respect to the medical community.

Jared does the same sort of work for us. He spends his days going through current and some not-so-current medical studies to determine what the risks are of drugs and medical devices on the market.  If he believes that a drug or device is more dangerous than the manufacturer lets on, he lets us know and we investigate whether or not we want to file lawsuits against the manufacturer of the drug or device.  And if we’re already sure we want to pursue a certain type of lawsuit, Jared helps us find the appropriate scientific evidence to back up our cases.

A big part of Jared’s job is summarizing lengthy and complicated scientific studies about drugs and medical devices. I don’t want all of his hard work to stay buried in our private network, so I have Jared blog about his findings. I think you’ll find that Dangerous Drugs has the most in-depth analysis of the science behind the lawsuits and most of that analysis comes from Jared. It’s important to me that Jared’s work is published on the open Internet because many of the studies he reviews are not published on the open Internet. Instead, they’re buried behind the pay walls of academic journals and are not accessible to the average citizen.   

Jared Fink graduated with honors from The College of Wooster, where he received a Bachelor’s of Arts in Philosophy. In addition to his senior thesis project titled “Authenticity and Art,” which resulted in a 96-page thesis with oral defense, as an undergraduate Jared managed genetics research for Dr. Amy Jo Stavnezer of the Neurology Department at the College of Wooster. For five summers, Jared worked in psychiatric research at the University of Michigan under Dr. Israel Liberzon, where his research focused on the neurobiological and genetic foundations for a number of psychiatric conditions.

I learn a great deal every time I read one of Jared’s blog posts, and I’m sure you will, too.

Scalia fans everywhere will cringe at the thought of using an amicus brief filed by Waxman on this issue, but setting that prejudice aside, this is kind of a big deal:

Here’s even more powerful evidence of Congress’s intent: a newly filed amicus brief filed by Senator Tom Harkin (D-Iowa) and Representative Henry Waxman (D-California, and, yes, the Waxman of Hatch-Waxman) in support of Bartlett. Harkin and Waxman, who are represented by Allison Zieve of the Public Citizen Litigation Group, say lawmakers’ intentions couldn’t be clearer. If Congress wanted federal regulation to preclude personal injury suits, it would have said so. It’s no accident that Congress did not, according to the brief.

“The notion that FDA regulation broadly pre-empts design-defect claims against prescription drug manufacturers finds no support in the text or purpose of the FDCA, runs counter to the … provision addressing product liability law and ignores more than 75 years of history in which damages suits and federal drug approval have co-existed,” the brief said. “Congress is well aware of its authority to pre-empt state damages actions, and with respect to prescription drugs, as with (over-the-counter) drugs, it has not done so. Moreover, in recent years, following litigation addressing whether federal regulation pre-empts state-law claims regarding injuries caused by drugs, both chambers of Congress have considered pre-emption of state-law claims concerning drugs. Yet Congress has taken no action to change the historical framework through which state law controls whether injured patients have a tort remedy.”

Source: Victim in SCOTUS generics case has powerful amici: Harkin and Waxman

Back in January the Alabama Supreme Court issued a ruling that enabled individuals who took generic drugs to sue the brand-name manufacturer.  Not surprisingly, the brand-name companies are not happy:

BIRMINGHAM, Alabama — Brand name makers of a drug used to treat acid reflux and other digestive problems today asked the Alabama Supreme Court to reconsider its January opinion that people who take generic equivalents of a drug can sue the brand name manufacturers.

The U.S. Chamber of Commerce, the Business Council of Alabama, and four other groups also filed court briefs today supporting that request, saying the court’s earlier ruling could have far-sweeping consequences on healthcare, as well as other industries, in Alabama.

Source: Brand-name drug makers ask Alabama Supreme Court to reconsider ruling that generic drug consumers can sue them | al.com

Way back in 2010, I wrote a blog post about the “prison rape” of one of the companies that manufactured the drugs improperly administered by Dr. Dipak Desai.  Now another defendant is on the hook:

Officials with Health Plan of Nevada knew in the late 1990s about Desai’s poor reputation after a doctor who was employed at one facility informed the company that Desai was cutting corners and compromising patient safety, Eglet said.

Source: UnitedHealth Unit Liable for Doctor’s Errors, Lawyer Says – Bloomberg

I’m actually much more open-minded about this defendant’s culpability.  If what the article says is true – the insurer had actual knowledge that the Dr. was a menace – it does raise serious questions as to why the insurer kept the doc on the approved list.  It will be interesting to see how the trial ends.

Published in a 1997 edition of The British Journal of Psychiatry by the medical researchers M.L. Dahl et al., a letter to the editor titled “Paroxetine withdrawal syndrome in a neonate” aimed to describe and characterize neonatal withdrawal from Paxil® addiction through exposure to the drug during gestation.

This letter describes a case report, a description of a single case of Paxil® withdrawal symptoms in a newborn.  The mother of this child used Paxil® daily during the third trimester of pregnancy, and thankfully, the child was born at a normal weight and was delivered at a full term.[1]

However, after 12 hours of life, the child was “transferred to the neonatal department for observation because of increased respiratory rate (80 per minute) and jitteriness.  During the next hours he developed increased muscle tone and tremor.”[2]

A number of tests performed on the newborn, however, did not reveal any abnormalities: “C-reactive protein, hemoglobin  blood gases, blood glucose, electrolytes, ionized calcium and ultrasound of the brain were all normal.”[3] (emphasis added)  Doctors concluded that these symptoms were caused by exposure to Paxil® used by the mother during pregnancy.

Fortunately, after four days, the child was discharged with generally good health, though still suffering from prolonged jitteriness.[4]

Due to the fact that this report was published so early, the author writes that “As very little information is available for the newer antidepressants, including SSRIs, they are not recommended during pregnancy.”[5] (emphasis added)

Because the warning label for Paxil® was not changed to include anything about risk for adverse neonatal outcomes until 2005 when the FDA required the manufacturer to do so, a number of Paxil birth defect lawsuits are currently being filed.

If you or a loved one used Paxil® during pregnancy and your child was born with neonatal abstinence syndrome, please do not hesitate to contact our team of Paxil® birth defect lawyers at the information provided below.  We have the experience, resources, and skills needed to fight even the largest pharmaceutical companies and win the justice your family deserves.

At your convenience, you may reach our team by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us for a free, no-obligation case consultation.

Our SSRI Birth Defects Lawsuit Information page is a great place to start if you have any questions about SSRIs and Birth Defects.


[1] Dahl, M.L. (1997) “Paroxetine withdrawal syndrome in a neonate” British Journal of Psychiatry Correspondence. Vol. 171; pp. 391-392

[2] Ibid.

[3] Ibid.

[4] Ibid.

[5] Ibid.

In 2007, medical researchers J. Alexander Cole et al. published a report on the increased likelihood of congenital malformations in infants whose mothers used Paxil® (paroxetine) during pregnancy and found some startling results.

This study, titled “Paroxetine in the first trimester and the prevalence of congenital malformations,” published in the journal Pharmacoepidemiology and Drug Safety, tracked 1835 children born to 1780 mothers who used Paxil® during pregnancy, and compared the health of those children to 4198 children born to 4072 mothers who used other antidepressants during pregnancy.[1]

Results showed that Paxil use during pregnancy increased the risk for birth defects by a factor of nearly 90%.[2]  For heart malformations specifically, use of Paxil® raised the risk of these birth defects by about 46%.[3]

When researchers controlled for time of Paxil® use during pregnancy, it was found that if a mother used Paxil® during the first trimester, her child is more than twice as likely to be born with birth defects.[4]  The authors of this paper also cite research that has shown Paxil® use may place children at a four-fold increased risk for birth defects.[5]

Heart defects found to be associated with Paxil® use included aortic stenosis, atrial septal defects, patent ductus arteriosus, ventricular septal defects, and pulmonary stenosis.[6]  These birth defects are serious malformations of the heart that often require surgery, and may be fatal.

Though this article does not include biochemical information describing how Paxil® causes these birth defects, it goes great length to demonstrate that Paxil® causes birth defects.  Because warning labels on Paxil® did not include any information about the increased risk for birth defects until 2005 when a limited new warning was placed on the Paxil® label as required by the FDA, a number of Paxil birth defects lawsuits are currently being filed.

If you used Paxil® during pregnancy and your child was born with a congenital malformation, please do not hesitate to contact our team of Paxil birth defects lawyers at the information provided below.  We have the skills, resources, and experience required to go up against even the largest of pharmaceutical companies and secure the compensation you and your family deserve.

At your convenience, you may reach us by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us for a free, no-obligation case consultation.  We are here to help you and yours every step of the way.

Our SSRI Birth Defects Lawsuit Information page is a great place to start if you have any questions about SSRIs and Birth Defects.


[1] Cole, J.A. et al. (2007) “Paroxetine in the first trimester and the prevalence of congenital malformations” Pharmacoepidemiology and Drug Safety Vol. 16; pp. 1075-1085.

[2] Ibid.

[3] Ibid.

[4] Ibid.

[5] Ibid.

[6] Ibid.

Published in a 2000 edition of the Journal of Perinatology, Dr. Chandrakala Mohan and Dr. John Moore present a case review of an infant suffering from fluoxetine (Prozac®) intoxication at birth.  Prozac® is a type of antidepressant known as a selective serotonin reuptake inhibitor (SSRI) that regulates levels of serotonin in the brain, since serotonin is a chemical that plays a role in mood regulation.  It has also recently been shown that serotonin plays an important role in fetal development, and that SSRI drugs pass through the placenta and affect the developing brain of the fetus.

The presently discussed Mohan and Moore (2000) piece demonstrates the characteristics of a syndrome known as fluoxetine toxicity in a newborn.  This child, male, was born several weeks prematurely, at normal weight – 3270 grams,[1] to a mother who had used fluoxetine from the end of the first trimester to term.

When a baby is born, doctors perform a series of tests on the newborn to ensure that it stabilizes well after birth and adjusts to life outside the womb normally.  Doctors score a newborn on what is known as an “APGAR test,” with data taken at one, five, and occasionally ten minutes after birth.  MedlinePlus, a prominent online medical encyclopedia provided by the United States National Library of Medicine, explains the APGAR test as follows:

“The APGAR test is done by a doctor, midwife, or nurse. The health care provider will examine the baby’s:

  • Breathing effort
  • Heart rate
  • Muscle tone
  • Reflexes
  • Skin color

Each category is scored with 0, 1, or 2, depending on the observed condition.

Breathing effort:

  • If the infant is not breathing, the respiratory score is 0.
  • If the respirations are slow or irregular, the infant scores 1 for respiratory effort.
  • If the infant cries well, the respiratory score is 2.

Heart rate is evaluated by stethoscope. This is the most important assessment:

  • If there is no heartbeat, the infant scores 0 for heart rate.
  • If heart rate is less than 100 beats per minute, the infant scores 1 for heart rate.
  • If heart rate is greater than 100 beats per minute, the infant scores 2 for heart rate.

Muscle tone:

  • If muscles are loose and floppy, the infant scores 0 for muscle tone.
  • If there is some muscle tone, the infant scores 1.
  • If there is active motion, the infant scores 2 for muscle tone.

Grimace response or reflex irritability is a term describing response to stimulation such as a mild pinch:

  • If there is no reaction, the infant scores 0 for reflex irritability.
  • If there is grimacing, the infant scores 1 for reflex irritability.
  • If there is grimacing and a cough, sneeze, or vigorous cry, the infant scores 2 for reflex irritability.

Skin color:

  • If the skin color is pale blue, the infant scores 0 for color.
  • If the body is pink and the extremities are blue, the infant scores 1 for color.
  • If the entire body is pink, the infant scores 2 for color.”[2]

With five testing categories and a maximum score of 2 per category, the overall maximum APGAR score is ten.  A score of 10 indicates that the child is adjusting well to life outside the womb, and a score of 0 indicates that the newborn is not developing well after birth.

When the child discussed in the Mohan and Moore (2000) was born, his APGAR scores were “4, 7, and 9 at 1, 5, and 10 minutes, respectively,”[3] after birth.  This tells us that immediately after birth, the child’s condition was poor, but quickly improved in a ten-minute span.

Four hours after birth, doctors write that “the baby was tachypneic, with respiratory rate of 100/minute, and was in respiratory distress with grunting, flaring, and retractions.”[4]  Stating that a child is tachypneic simply means that the child has a high breathing rate, though this is made clear by noting that the child’s breath rate was 100/min, while the normal range for an infant is 30-60/min.[5]

Though the high breath rate subsided after 24 hours,[6] at about 36 hours after birth, the baby was found to be “increasingly jittery”[7] and “had three to four episodes of seizure-like activity… characterized by twitching of the face and eyebrows, grimacing, roving movements of eyes, and flailing movements of upper and lower extremities.”[8]  At 48 hours after birth, the child was transferred to a neonatal intensive care unit.[9]

At this point, the child had “petechiae on the abdomen, chest, and extremities”[10] and scleral icterus[11] (a yellowish hue of the skin).  Many tests, including an electroencephalogram did not show any clear reason for the child’s symptoms.[12]  “Skin manifestations resolved between 48 and 72 hours, but seizure-like activity peaked, with five to eight episodes per day.  By 144 hours, jitteriness and tremulousness decreased and feedings were started.  There was resolution of symptoms over the next 48 hours; feeding was advanced, and the infant was discharged from the hospital at 172 hours of age.[13]

Fortunately, a neurodevelopmental examination performed four months after birth showed that the child was developing normally.

Discussing the neonatal complications of this child in general, Mohan and Moore write that,

“Fluoxetine … may be responsible for the central nervous system side effects as described in reports of toxicity in adults; these side effects include nervousness, tremors, jitteriness, and occasionally seizures.  Bruising and bleeding disorders with increased hematoma frequency at birth have also been described with fluoxetine exposure in utero.[14][15]

Mohan and Moore also note that Chambers et al (1996) had found previously that developing children exposed to Prozac® late in gestation are more than three times as likely to have “poor neonatal adaptation, including jitteriness, cyanosis on feeding, and respiratory difficulties” as children who were exposed to Prozac® early in gestation.[16]

The report concludes by stating that “Although no life-threatening complications have been noted in infants exposed to maternal fluoxetine, the present report suggests that marked motor automatism, including seizure-like activity, can be expected in preterm infants.  Because [Prozac®] is metabolized primarily in the liver, the prematurity of the infant and the immaturity of the liver may account for the multisystem involvement and the protracted course.”[17]

This article may be used in a Prozac® birth defects lawsuit to illustrate to court that since at least the year 2000, and even before that – for the authors cite research illustrating the negative neonatal outcomes for children exposed to Prozac® in utero dating back to 1996 – the manufacturers of Prozac® knew, or should have known, the dangers of their product.

If you used Prozac® during pregnancy, unaware of the increased risk for birth defects and poor neonatal outcomes posed to your child by your use of Prozac® and your child was bone with Prozac® toxicity or a Prozac® birth defect, you may be entitled to compensation for your child’s injuries.  Please do not hesitate to contact our team of Prozac® birth defect lawyers for a free, no-obligation case consultation by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us.

We are here to help you every step of the way.

Our SSRI Birth Defects Lawsuit Information page is a great place to start if you have any questions about SSRIs and Birth Defects.


[1] Mohan, C.G. & Moore, J.J. (2000) “Fluoxetine Toxicity in a Preterm Infant” Journal of Perinatology Vol. 20; pp. 445-446

[2] “APGAR: MedlinePlus Medical Encyclopedia” MedlinePlus. U.S. National Library of Medicine. National Institutes of Health. © 1997-2013 A.D.A.M., Inc. Available at <http://www.nlm.nih.gov/medlineplus/ency/article/003402.htm> Updated 24 January 2013, Accessed 18 February 2013.

[3] Mohan, C.G. & Moore, J.J. (2000) “Fluoxetine Toxicity in a Preterm Infant” Journal of Perinatology Vol. 20; pp. 445-446

[4] Ibid.

[5] “http://www.health.ny.gov/professionals/ems/pdf/assmttools.pdf” Department of Health. New York State. Available at <http://www.health.ny.gov/professionals/ems/pdf/assmttools.pdf> Accessed 18 February 2013

[6] Mohan, C.G. & Moore, J.J. (2000) “Fluoxetine Toxicity in a Preterm Infant” Journal of Perinatology Vol. 20; pp. 445-446

[7] Ibid.

[8] Ibid.

[9] Ibid.

[10] Ibid.

[11] Ibid.

[12] Ibid.

[13] Ibid.

[14] Stanford, MS., Patton, JH. (1993) “In utero exposure to fluoxetine HCl increases hematoma frequency at birth” Phamacol Biochem Behav Vol. 45; pp. 959-962

[15] Mohan, C.G. & Moore, J.J. (2000) “Fluoxetine Toxicity in a Preterm Infant” Journal of Perinatology Vol. 20; pp. 445-446

[16] Ibid.

[17] Ibid.

In 2001, a research paper from a team based in Norway, headed by H. Nordeng, presented the results of a study titled “Neonatal withdrawal syndrome after in utero exposure to selective serotonin reuptake inhibitors [(SSRIs)],” the main conclusion of which was that “Neonatal withdrawal syndrome can occur after third trimester in utero SSRI exposure.”[1]

This study reviews five cases of neonatal withdrawal syndrome in children exposed to SSRIs before birth, three of whom were exposed to Paxil® (paroxetine), one exposed to Prozac® (fluoxetine), and one exposed to Celexa® (citalopram).

Nordeng et al. write that the main symptoms of neonatal withdrawal syndrome from SSRI antidepressant exposure during pregnancy include “irritability, constant crying, shivering, increased tonus, eating and sleeping difficulties and convulsions.”[2]  Symptoms were stated to begin within the first few days of life[3] and “lasted up to one month after birth.”[4]  It is important to note here that “all mothers used normal dosing of SSRIs.”[5] (emphasis added)

Shortly after birth, each infant was scored using the Neonatal Abstinence Score (NAS), a test to determine whether a child had become addicted to medications or drugs the mother used during pregnancy.  A “score of above 4 points suggests withdrawal symptoms, and a score of above 8 points indicates withdrawal symptoms in need of medical treatment.”[6]

Case 1 – Exposure to Paxil® before birth

This child was born full term with normal weight,[7] but was admitted to the hospital after 5 days[8] for symptoms including “severe irritability”[9] and problems eating and sleeping.  The NAS score of this child was 18 upon admission,[10] indicating SSRI withdrawal symptoms in dire need of medical treatment.  With feeding tube and medication,[11] the child’s symptoms eventually subsided, and fortunately, after about six months, the child was developing normally.[12]

Case 2 – Exposure to Paxil® before birth

In this case, a mother who had used Paxil® “during the last 4 [months] of her pregnancy” gave birth to a full-term, well-adapted child at normal birth weight.  However, shortly after birth, the child exhibited a dramatically increased rate of breath,[13] “had increased tonus with increased reflexes, [and] was shivering”[14].  The authors write that “The symptoms were interpreted as withdrawal symptoms caused by the mother’s use of paroxetine.”[15]  After about ten days, and with constant medication, the child’s symptoms resolved.[16]

Case 3 – Exposure to Paxil® before birth

This child was born at full term, at a normal weight, to a mother who had used Paxil® until four days before the birth of her child.  A few days after birth, the child was admitted to the hospital for “irritability, inconsolable crying and increased tonus,”[17] and because of “weak sucking,”[18] the child had to use a feeding tube for nourishment.[19]  Again, the authors write that “The symptoms were interpreted as withdrawal symptoms with a neonatal abstinence score above 8.”[20]  With medication taken every six hours,[21] after four weeks, the child was discharged,[22] though “still shivering and had a slightly increased tonus, but he was now able to suck, and his weight had increased.”[23]

Case 4 – Exposure to Prozac® before birth

This child, exposed to 20mg of Prozac® daily before birth, was born after only 27 weeks and at a dramatically decreased birth weight, and was thus quickly transferred to a neonatal intensive care unit.  With a NAS score above 8, doctors concluded that symptoms of irritability, agitation, and convulsions were attributable to maternal use of SSRI medications during pregnancy.[24]  After one week, these symptoms resolved, but due to prematurity, the child was not discharged from the hospital for three months.[25]

Case 5 – Exposure to Celexa® before birth

This child, born to a mother who used Celexa (20mg/day) after the 5th month of pregnancy, was born at normal birth weight and full-term.  With a NAS score of 4-6, no medical treatment was required,[26] but symptoms of increased muscle tone in the extremities and jitteriness in the neck were observed.[27]  After one week, the jitteriness subsided, but the child was released, though with increased muscle tone remaining.[28]

Discussing the findings of this study as a whole, the authors emphasize that case reports such as these cannot illustrate the frequency of these occurrences, nor do they themselves constitute a causal relationship between maternal use of SSRIs during pregnancy and the onset of neonatal abstinence syndrome.  Nonetheless, we must also heed the conclusions of the physicians in contact with these children who believed and documented time and time again that the symptoms observed resulted from this maternal medication use.

The authors of this piece conclude that “there is an urgent need for more knowledge.  This can only be acquired by close follow-up after birth of newborns exposed to SSRIs in utero.”[29]

SSRI Birth Defect Lawsuits

Because the warning labels for Paxil®, Prozac®, and Celexa® do not include information regarding the possibility of neonatal abstinence syndrome in children born to mothers who used these drugs during pregnancy, a number of SSRI birth defect lawsuits are currently being filed.  If you used an SSRI during pregnancy and your child was born with neonatal abstinence syndrome, please do not hesitate to contact our team of Paxil® birth defects lawyers, Prozac® birth defects lawyers, and Celexa® birth defects lawyers at the information provided below.

We have the experience, resources, and skills required to secure the justice your family deserves.  At your convenience, you may contact our team by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us for a free, no-obligation case consultation.  We are here to help you every step of the way.

Our SSRI Birth Defects Lawsuit Information page is a great place to start if you have any questions about SSRIs and Birth Defects.


[1] Nordeng, H. (2001) “Neonatal withdrawal syndrome after in utero exposure to selective serotonin reuptake inhibitors” Acta Pædiatr Vol. 90; pp. 288-291

[2] Ibid.

[3] Ibid.

[4] Ibid.

[5] Ibid.

[6] Ibid.

[7] Ibid.

[8] Ibid.

[9] Ibid.

[10] Ibid.

[11]Ibid.

[12] Ibid.

[13] Ibid.

[14] Ibid.

[15] Ibid.

[16] Ibid.

[17] Ibid.

[18] Ibid.

[19] Ibid.

[20] Ibid.

[21] Ibid.

[22] Ibid.

[23] Ibid.

[24] Ibid.

[25] Ibid.

[26] Ibid.

[27] Ibid.

[28] Ibid.

[29] Ibid.