Preconception tort liability: recognizing a strict liability cause of action for DES GrandChildren

Courts should recognize the validity of preconception tort liability and allow a strict liability cause of action in third-generation DES cases

Abstract:

image of PubMed NCBI The Endocrine Society logo
This 1991 Note addresses the validity of preconception tort liability in the context of third-generation DES cases.

DES cases are breaking new ground in tort litigation. In March 1990, J. David Roberts filed a $ 2,000,000 lawsuit in the United States District Court for the District of Columbia against drug manufacturer Eli Lilly and Company,  alleging that his in utero exposure to DES caused his daughter’s cancer.  Roberts sued under theories of strict liability, emotional distress, breach of warranty, negligence and misrepresentation. He also alleged that DES manufacturers conspired to produce the drug after they knew of its dangers.

Over the past decade more than 1,000 “DES daughters” have filed lawsuits against the manufacturers of DES, alleging that their in utero exposure to the drug caused various reproductive tract abnormalities, including cancer. Plaintiffs now allege that their grandmothers’ use of DES during pregnancy caused genetic damage leading to cancer in third generations. This Note addresses the validity of preconception tort liability in the context of third-generation DES cases. Plaintiffs in preconception tort liability cases have sought recovery under both negligence and strict liability causes of action. Courts should recognize the validity of preconception tort liability and allow a strict liability cause of action in third-generation cases.

Sources

  • Preconception tort liability: recognizing a strict liability cause of action for DES grandchildren, NCBI, PMID: 1812769, 1991;17(4):435-55. LexisNexis, Excerpt, 1991.
More DES DiEthylStilbestrol Resources

Egg Freezing poses Health Risks to Women and possibly to Children

Facebook and Apple’s egg freezing “benefit” is ill-advised for multiple reasons

Genetics and Society” press statement

Center for Genetics and Society logo image
The Center for Genetics and Society encourages responsible uses and effective societal governance of human genetic and reproductive technologies .

The decision by Facebook and Apple to offer their female employees a $20,000 benefit to freeze their eggs for later use with in vitro fertilization is ill-advised for numerous reasons, says the Center for Genetics and Society (CGS). These include the significant but under-studied risks of egg retrieval for women, and the dearth of evidence about potential long-term health risks to children born as a result of the egg-freezing process.

The firestorm of critical response to the companies’ new policy has focused on important concerns including the high failure rates of IVF, the pressure to defer childbearing that the policy represents, and Silicon Valley companies’ lack of attention to family-friendly workplace policies, including paid leave and schedule flexibility that would enable work-family balance.

So far, however, there has been little focus on a critical concern: egg retrieval poses serious health risks to women. “Getting your eggs frozen is neither a simple nor a safe procedure,” said Marcy Darnovsky, PhD, executive director of CGS. “Retrieving multiple eggs involves injections of powerful hormones, some of them used off-label and never approved for egg extraction. The short-term risks range from mild to very severe, and the long-term risks are uncertain because they haven’t been adequately studied – even though the fertility industry has been using these hormones for decades.”

The hormonal drugs used to hyper-stimulate ovary production can cause what is known as ovarian hyperstimulation syndrome (OHSS) in the short term. Mild cases of OHSS are characterized by nausea, bloating, and discomfort. Serious cases are relatively infrequent but can require hospitalization for complications including intra-abdominal bleeding, ovarian torsion, and severe pain. Deaths, fortunately rare, have been reported.

The severity and frequency of long-term risks, including infertility and cancer, are not well established because of inadequate follow-up studies of women who have undergone egg retrieval. The risks to children born from frozen eggs are also under-studied, although the chemicals used in the freezing process are known to be toxic.

Furthermore, encouraging egg freezing may commit more women to undergoing IVF, which has been linked to an increase in stillbirths, cesarean sections, preterm deliveries, multiple gestations, and higher rates of fetal anomalies.

Both the American College of Obstetricians and Gynecologists and the American Society for Reproductive Medicine have issued guidelines explicitly discouraging women from utilizing egg freezing for elective, non-medical reasons.

“Why are Facebook and Apple endorsing a technique that encourages their employees to put their health at risk?,” Darnovsky asked. “Paying for egg freezing is being presented as a benefit for women, but it may be that discouraging women from balancing work and family is really a benefit to the companies.” ”

Sources and more information:
  • Egg freezing poses health risks to women, geneticsandsociety, October 15th, 2014.
  • Freezing Eggs Puts Women and Infants’ Health at Stake, NYTimes, 17 October 2014.
  • Silicon Valley offers egg freezing to employees – but is it safe?, MNT, 17 October 2014.

Robotic Surgery: more complications, higher expense for some conditions

For benign ovarian surgery, conventional laparoscopy causes fewer complications and is less expensive

With the rapid rise in the cost of cancer care, we need to make sure that public policies encourage comparative studies prior to widespread dissemination of new technologies

… “For benign gynecologic conditions, robot-assisted surgery involves statistically significant increase in complications during surgery and is associated with substantially greater costs than conventional laparoscopic surgery, according to a study by researchers at Columbia University Medical Center (CUMC)“…

Sources and more information:

Ovarian Cancer New Test to differentiate between Tumour Stages

1 in 69 women will develop ovarian cancer in her lifetime

Abstract

The BMJ
Evaluating the risk of ovarian cancer before surgery using the ADNEX model to differentiate between benign, borderline, early and advanced stage invasive, and secondary metastatic tumours: prospective multicentre diagnostic study.

Objectives
To develop a risk prediction model to preoperatively discriminate between benign, borderline, stage I invasive, stage II-IV invasive, and secondary metastatic ovarian tumours.

Design
Observational diagnostic study using prospectively collected clinical and ultrasound data.

Setting
24 ultrasound centres in 10 countries.

Participants
Women with an ovarian (including para-ovarian and tubal) mass and who underwent a standardised ultrasound examination before surgery. The model was developed on 3506 patients recruited between 1999 and 2007, temporally validated on 2403 patients recruited between 2009 and 2012, and then updated on all 5909 patients.

Main outcome measures
Histological classification and surgical staging of the mass.

Results
The Assessment of Different NEoplasias in the adneXa (ADNEX) model contains three clinical and six ultrasound predictors: age, serum CA-125 level, type of centre (oncology centres v other hospitals), maximum diameter of lesion, proportion of solid tissue, more than 10 cyst locules, number of papillary projections, acoustic shadows, and ascites. The area under the receiver operating characteristic curve (AUC) for the classic discrimination between benign and malignant tumours was 0.94 (0.93 to 0.95) on temporal validation. The AUC was 0.85 for benign versus borderline, 0.92 for benign versus stage I cancer, 0.99 for benign versus stage II-IV cancer, and 0.95 for benign versus secondary metastatic. AUCs between malignant subtypes varied between 0.71 and 0.95, with an AUC of 0.75 for borderline versus stage I cancer and 0.82 for stage II-IV versus secondary metastatic. Calibration curves showed that the estimated risks were accurate.

Conclusions
The ADNEX model discriminates well between benign and malignant tumours and offers fair to excellent discrimination between four types of ovarian malignancy. The use of ADNEX has the potential to improve triage and management decisions and so reduce morbidity and mortality associated with adnexal pathology.

Sources and more information:

  • Evaluating the risk of ovarian cancer before surgery using the ADNEX model to differentiate between benign, borderline, early and advanced stage invasive, and secondary metastatic tumours: prospective multicentre diagnostic study,
    The BMJ 2014;349:g5920, 15 October 2014.
  • New test to distinguish between ovarian tumours,
    NHS Choices, October 16 2014.
  • New test ‘helps identify best ovarian cancer treatment’,
    BBC News Health, October 16 2014.

Doctors must pay Close Attention to Patient Feedback

Know Your Source: Protecting Patients from Unsafe Drugs

The Know Your Source FDA program

Pay Close Attention flyer image
Know Your Source: Protecting Patients from Unsafe Drugs.

The number of Rogue Wholesale Drug Distributors selling fake or unapproved prescription drugs in the U.S. market is growing…
The U.S. Food and Drug Administration warned that doctors need to:

  • be vigilant when purchasing medicines
  • verify that their supplier is licensed by the state
  • know the source for prescription drugs.

Sources and more information:

  • Know Your Source: Protecting Patients from Unsafe Drugs, FDA ucm389121, 09/23/2014 .
  • Reducing the Threat of Counterfeit and Unapproved Drugs in Clinical Settings, brookings, 2013/07/19.
On Flickr®

U.S. Companies emitted about 26 Tons of BPA in the Air in 2013…

BPA is also contaminating the air near manufacturing plants…

BPA in the air, image via Barb Henry

As concerns mount over people’s exposure to the plasticizer bisphenol A in everyday products, it’s also contaminating the air near manufacturing plants: U.S. companies emitted about 26 tons of the hormone-disrupting compound in 2013.

Although research is sparse, experts warn that airborne BPA could be a potentially dangerous route of exposure for some people. Of the 72 factories reporting BPA emissions, the largest sources are in Ohio, Indiana and Texas, according to the Environmental Protection Agency’s Toxics Release Inventory. ”

… continue reading BPA in the air: Manufacturing plants in Ohio, Indiana, Texas are top emitters, on environmentalhealthnews, October 14, 2014.

RethinkThePink: dealing with Pink Stuff during Breast Cancer awareness…

What is pink washing?

Baker Hughes pink drill image
Pinkwashing: pink drill bits being rolled out for breast cancer awareness month by Baker Hughes.

#PinkWashing is the act of appearing to support the fight against breast cancer by slapping a pink label on a product that most likely contains ingredients or elements linked to causing cancer. Many companies even raise the price of products or create a limited edition product to boost their profits, while only donating a meager portion of that profit to research treatments.

#RethinkThePink: stop buying products from companies that engage in pinkwashing as they stock your stores full of toxins – and profit off this deadly disease.

#ThinkBeforeYouPink: a campaign as a direct call to STOP THE DISTRACTION of pink ribbon marketing and culture.

Join Mamavation and The Campaign for Safe Cosmetics and The Breast Cancer Fund on Wednesday, Oct. 15th 6pm PST/9pm EST to learn more about pinkwashing, breast cancer prevention and how you can #RethinkthePink.

Sources and more information:
  • #RethinkthePink: Stop Companies Profiting Off Your Charity While Breast Cancer Still Kills, Mamavation, September 30, 2014.
  • Fracking company’s pink drill bits spark outrage, MNN, Oct 13, 2014.
  • Visit ThinkBeforeYouPink website and campaigns.
  • Beyond the Pink: From Awareness to Prevention, BreastCancerFund.
  • Watch these pink washing videos on YouTube.

Egg Freezing becomes a no-cost, free option for Apple and Facebook female employees

Two Silicon Valley giants now offer women a game-changing perk:
Apple and Facebook will pay for employees to freeze their eggs

Apple and Facebook are offering their female employees the option to freeze their eggs.

The Silicon Valley companies are now offering up to $20,000 (£12,600) to help their women employees undergo the egg-freezing process and allow them to focus on building their careers! The two firms appear to be the first major employers to offer this coverage for non-medical reasons.

But what is the real price to this? Of course, there is no guarantee that it will eventually lead to a pregnancy. This 183 patients survey reported that overall, only 20% reported a successful conception after oocyte cryopreservation

Sources and more information:

  • What Apple and Facebook Don’t Know About Egg Freezing, pbs, October 15, 2014.
  • I didn’t freeze my eggs because my body is not a farm, and I am not a source of harvest, The Independent, 16 October 2014.
  • Apple and Facebook will pay for female employees to freeze their eggs, The Telegraph, 14 Oct 2014.
  • Perk Up: Facebook and Apple Now Pay for Women to Freeze Eggs, NBC News, October 14th 2014.
  • Egg Freezing as a Work Benefit? Some Women See Darker Message, NYTimes, OCT. 14, 2014.
  • Using Egg Freezing to Extend the Biological Clock: Fertility Insurance or False Hope?, law.harvard.edu, 2014.08.
  • What do reproductive-age women who undergo oocyte cryopreservation think about the process as a means to preserve fertility?, Fertility and Sterility, November 2013.

Beware of offers too good to be true

Know Your Source: Protecting Patients from Unsafe Drugs

The Know Your Source FDA program

Beware of Offers flyer image
Know Your Source: Protecting Patients from Unsafe Drugs.

The number of Rogue Wholesale Drug Distributors selling fake or unapproved prescription drugs in the U.S. market is growing…
The U.S. Food and Drug Administration warned that doctors need to:

  • be vigilant when purchasing medicines
  • verify that their supplier is licensed by the state
  • know the source for prescription drugs.

Sources and more information:

  • Know Your Source: Protecting Patients from Unsafe Drugs, FDA ucm389121, 09/23/2014 .
  • Reducing the Threat of Counterfeit and Unapproved Drugs in Clinical Settings, brookings, 2013/07/19.
On Flickr®

PRAC recommends strengthening the restrictions on the use of valproate in women and girls

Women to be better informed of the risks of valproate use during pregnancy

The European Medicines Agency (EMA)’s Pharmacovigilance and Risk Assessment Committee (PRAC) has recommended strengthening the restrictions on the use of valproate medicines due to the risk of malformations and developmental problems in children exposed to valproate in the womb.

More information
  • Published on 12 Oct 2014 by APESAC channel. Website.
  • Valproate should not be used to treat epilepsy or bipolar disorder in girls and in women who are pregnant or who can become pregnant unless other treatments are ineffective or not tolerated. Women for whom valproate is the only option after trying other treatments, should use effective contraception and treatment should be started and supervised by a doctor experienced in treating these conditions.” … continue reading EMA press release, 10/10/2014.
  • Watch more drugs and media videos on our YouTube channel.