Dalkon Shield, Essure, Paragard?

By Marcus Susen, Esq.

One question that is not raised enough, if at all, is why women disproportionally bear the burden of birth control. Almost all forms of birth control are aimed at women. Consequently, and unfortunately, women bear all the risks associated with these devices/drugs. Why is that?

From the 1970’s through today, women have been targeted by Big Pharma with different forms of birth control devices/drugs from the Dalkon Shield in the 1970s to Mirena, Essure, and Paragard in more recent years. Shockingly, all four of these devices/drugs have been the subject of mass litigation and two have been withdrawn from the market. (Dalkon Shield and Essure) On the other hand, there are no birth control devices for men. Many people are shocked to realize that male birth control pills are possible but Big Pharma is not pursuing this market with the same energy as it does with the devices/drugs aimed at women. Is this because Big Pharma has found, what it thinks, to be their easier “target”? If so, Big Pharma better rethink this strategy.

After the mass litigations regarding the Dalkon Shield, Mirena, and Essure, more recent news has been focused on Paragard birth control. Paragard is a temporary, non-hormonal, non-surgical IUD. It is essentially a T-shaped piece of plastic that is wrapped in copper wire which is intended to interfere with fertilization. However, more and more women have been reporting that the device has been breaking, especially upon removal, often causing significant and life altering injuries, such as infection, perforations, and infertility. Several reports have been made of surgical intervention to remove the broken device including hysterectomy- contradicting selling points made by the manufacturer (i.e. non-surgical, reversible). As a result of several of these incidents, a consolidated litigation has arisen involving Paragard in federal court in Northern GA against Teva Pharmaceuticals USA, Inc. and CooperSurgical, Inc. Once again, women across the country are speaking up.

Since Paragard was approved by the FDA, over 40,000 reports have been made by women and medical providers to the FDA according to the agency’s website. Over 16,000 of these have been labeled as “Serious Cases (including deaths).” However, drug safety experts estimate that only 10% of adverse events are actually reported to the FDA on a yearly basis.
The FDA relies on patients to report issues they have with medical devices or drugs on their MAUDE database. The FDA use this information to regulate devices and drugs. However, if the events are not being reported, the FDA does not have a complete picture of the risk/safety profile of a particular drug

or device. As a result, the FDA is less likely to require more safety studies, updated warnings, or even recall a device or drug.

The Paragard consolidated litigation may be yet another turning point for women. This is because when a woman files a lawsuit the manufacturer is required to report the event to the FDA. The amount of cases filed may help the FDA obtain a more accurate picture of the true risk/safety profile for Paragard. We saw this play out in the Essure litigation where after thousands of lawsuits were filed, the FDA required the manufacturer to conduct post-market studies, implement a black box warning, and patient-doctor decision checklist. Ultimately, the manufacturer pulled Essure from the market.

If manufacturers complain about lawsuits surrounding their drugs/devices, they might want to consider proactively following up with clients to see how their drug/device is doing and report the negative experiences to the FDA instead of waiting for the problems to come up in lawsuits. Maybe this is wishful thinking, but it would sure be cheaper than defending thousands of lawsuits. Then again, they can always begin to promote male birth control.

Marcus Susen

Marcus Susen is lead counsel of the Essure birth control litigation in the EDPA. After Essure was pulled from the market, for the global litigation settled for over $1.6B. He is currently on the Plaintiffs’ Steering Committee for the Paragard birth control litigation and focuses his practice on women’s health advocacy.

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Paragard IUD: Low Numerosity and Late Consolidation Present Obstacles

In December of 2020, the Paragard IUD device was consolidated in the Northern District of Georgia under Judge Leigh Martin May. Defendants include: Teva Pharmaceuticals USA, Inc., Teva Women’s Health, Inc., Teva Women’s Health, LLC, Teva Branded Pharmaceutical Products R&D, Inc., The Cooper Companies, Inc., and CooperSurgical, Inc.

The intake is very conservative for this case and consists of the following:

1.) Breakage in the T-arm (only)
2.) AND surgical removal, or otherwise egregious type of injury, such as a hysterectomy

It is the opinion of this office that the PPN is very low. Possibly less than 5,000. The SOL on this case will be the biggest hurdle due to Statute of Limitations issues.

That said, this action may lend itself to fighting the Learned Intermediary Doctrine against the Doctrine of Informed Consent, when deposing treating physicians. Most states require written (express) informed consent, when exposing a patient to potentially life-threatening risk. Failure to acquire Informed Consent is, at worst, battery under most state laws.

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