More than fifty years ago, the drug, diethylstilbestrol (DES), was invented

Posted On: March 27, 2012 by Stephen Bilkis

More than fifty years ago, the drug, diethylstilbestrol (DES), was invented and had been dispensed to women in the United States from 1941 to 1971. In 1947, the Federal Drug Administration approved the drug for treatment of complications relating to pregnancy. In 1971, its use was banned due to the link between its use and the later development of cancer in female offspring (defective product).

In the present case, it is alleged that a woman (mother of Plaintiff One and grandmother of Plaintiff Two) ingested DES "within the years 1959 and 1960". She gave birth to Plaintiff One on 29 January 1960. Plaintiff-One gave birth to Plaintiff Two on 9 August 1981. It is alleged that Plaintiff One sustained a (birth injury) malformed uterus, cervical and uterine dysfunction and squamous metaplasia as a consequence of her mother's ingestion of DES. As a result of those injuries, it is alleged that Plaintiff-Two was born prematurely and suffered cerebral palsy (brain injury), gran mal seizures and various related congenital defects (spinal injury). In addition, it is alleged that Plaintiff One suffered four spontaneous abortions before and after the birth of Plaintiff Two.

The exact dates of ingestion of DES by the mother of Plaintiff One, the names of the dispensing pharmacy and pharmacist, the prescription, the instructions for ingestion and the manufacturer of the drug ingested are all 'unknown' to Plaintiffs.

Plaintiff's theory of liability as set forth in their complaint is: "If Plaintiffs are unable to identify the specific manufacturer and/or manufacturers of the specific DES ingested by the mother causing injuries as aforesaid to Plaintiffs herein, then Plaintiffs will rely on the theory of concerted action in that the Defendants, their agents, servants and/or employees, in pursuance of a common plan or design committed tortious acts as aforesaid in consciously paralleling each other, in failing to test and/or warn due to some implied understanding or defendants, their agents, servants, and/or employees, acting independently of each other, failed to properly test said DES, having the effect of substantially aiding or encouraging the failure to adequately test and warn by the others.

Alternatively, Plaintiffs rely on the theories of alternative liability, and/or enterprise liability, and/or market share liability."

The issues are:

1. Does a granddaughter, born more than 20 years after the ingestion of drugs by her grandmother, have a cause of action against the drug manufacturer for birth defects claimed to have resulted from her mother's injuries which are linked to the drug ingestion?

2. Does New York recognize a joint theory of liability whereby all or any drug manufacturer of a harmful drug may be held responsible for injuries sustained from the drug regardless of whether they are identified as the manufacturer of the drug in the individual case?

3. Is the revival statute, which permits the late filing of the instant lawsuit, unconstitutional?

4. Does such revival statute permit a derivative claim for loss of consortium?

5. Are emotional claims resulting from the birth of a handicapped child cognizable in New York?

On the first issue, unquestionably, a cause of action exists for a child whose injuries occurred in utero; whereas, a cause of action does not exist for a child conceived after tort injury to the parent. Neither case considers the posture of Plaintiff One. Her claim is for injuries occurring in utero. Plaintiff Two’s cause of action is the claim of a child not in existence for injuries which resulted from injuries to a mother in utero, where the conduct complained of was directed to the grandmother.

Necessarily it is not for this court to determine the likelihood of Plaintiff's success should this action proceed. Rather, under a summary judgment review, it will be presumed that the facts set forth in the complaint are true. Plaintiff Two was born with severe congenital defects resulting from a premature birth. Her right to bring suit must now be determined by this Court as a matter of law. Her attorney asks this Court to cast liability backward two generations to a drug manufacturer. Sympathies lie with the infant Plaintiff. Sympathies however cannot form the legal foundation for the pioneering decision sought by Plaintiffs. The practical considerations articulated are perhaps nowhere as graphically illustrated as in this case. The Plaintiff's bill of particulars furnishes this insight. The Plaintiffs cannot provide the name of the pharmacy, the prescription, a physical description of the drug ingested by the grandmother, the name of the pharmacist, or the instructions for ingestion. Proceeding from such background, it must be assumed that Defendants will be equally unable to produce any definitive information for trial review. The passage of time and generations obscure such evidence to the extent that a third generation lawsuit must necessarily be posited solely upon sympathy and conjecture. Once all legal requirements of proof and rational limitations on the area of actionable causation are removed, the fact finding of the trial court will be severely impaired. There is no legal precedent for such liability. The precedent is to the contrary. That precedent is founded upon well-reasoned considerations to which this Court subscribes.

Hence, the claims of the Plaintiff Two are dismissed as well as those claims of Plaintiff One and the husband which are posited upon her claims.

On the second issue, the general rule casts the burden of proof upon the Plaintiff to identify both the specific substance and the manufacturer thereof in order to state a cause of action. The policy considerations for such rule have already been reviewed. Where a cause of action does exist, however, and the injury goes undetected, documented identification is impossible and where it is clear that the harmful product is manufactured in substantially the same form by a number of manufacturers, several jurisdictions have adopted theories to relieve the Plaintiff of its burden, and shift the identification problems to the manufacturers.

Plaintiffs who live in
Brooklyn and Manhattan, in the present case, tender a 'shotgun' offense, relying in the alternative upon four different theories of unidentified manufacturer liability:

1) Concerted action
2) Alternative liability
3) Enterprise liability
4) Market share liability

Several of these theories may be rejected outright. Plaintiffs have targeted six of the major drug companies, while it is conceded that upwards of one hundred manufactured DES and twelve were involved in a select committee to make recommendations to the Federal Drug Administration.

Both the alternative liability and the market share liability theories are unavailable where Plaintiff elects to join only a limited number of the potentially liable Defendants.

The enterprise liability concept is described as a "hybrid derived from concepts of alternative and concurrent liability and the law of products liability to form a type of absolute liability." It has been applied to DES cases, but not in New York.

The concerted action theory may be available to a plaintiff in spite of its targeting only a limited number of manufacturers as defendants.

Where it can be established that defendants acting jointly adopt a common plan or design to commit a tortious act or ratify such a common plan, those injured thereby may hold any one of the defendants liable. Consequently it is the joint tortious activity of the manufacturers which gives rise to the cause of action.

The compliance by the defendants here with the original Federal Drug Administration directive that they pool their information in 1941 unfortunately now forms the basis for the conclusion that the defendants acted jointly to commit a tort. The model then adopted set the pattern for later manufacturers. But factual matters do not come into play on this a motion for summary judgment. It is a legal issue which apparently has been ruled upon by the First Department. Accordingly, the summary judgment motion on this basis must fail.

Defendant RXDC asserts as a further defense to the concerted action theory, that it can establish exculpation. Clearly, where concerted action is an available remedy, a defendant who can establish that he was not the purveyor of the drug to a particular plaintiff and did not act tortiously in concert with those which did, stands on different footing from his co-defendants. Exculpation, however, necessarily must rest upon proof of factual allegations.

The court concludes that evidence may be adduced by defendants as to exculpation in defense of the concerted action theory, but a summary judgment does not lie in their favor prior to trial.

On the third issue, exceptional circumstances must be demonstrated to warrant legislative intervention in reviving a cause of action which is time barred. Such circumstances have been documented in the legislative history of this enactment. It is obvious that the DES injuries are undetectable until the second generation and an exposure statute affords no remedy for the injuries sustained. Exceptional circumstances have been demonstrated and any claims based upon the unconstitutionality of the revival statute are denied.

On the fourth issue, the statute herein revives "every action for personal injury, injury to property caused by the latent effects of exposure to diethylstilbestrol upon or within the body." Where the personal injury action is revived, the derivative loss of consortium claim is also revived.

While it is true that Plaintiff One brought her injuries to the marriage relationship, they were undiscoverable until child bearing. Accordingly the general tort rule is inapplicable, for the very purpose of the revival statute is to permit this type of litigation for an undiscoverable tort.

Lastly, on the fifth issue, the complaint claims damages for the husband of Plaintiff Two alleging "that he will never have a healthy child" and damages for Plaintiff Two alleging she "suffered emotional injury and distress due to her physical and emotional injuries as well as the physical and emotional injuries sustained by her daughter the infant Plaintiff.

The court rules that the claims of the parents in so far as they claim damages for emotional injuries resulting from the birth of their child are not cognizable under the laws of New York.

Birth injuries are devastating and heart-breaking. No one can easily bear the pain these injuries can create. It is unimaginable. To see a child who cannot live his life to its fullest extent is just distressing. For this reason, drug manufacturers and physicians must always do their best in the performance of their jobs. People rely on these manufacturers with their life. The medical field is a life or death situation where a simple mistake could lead to tragic consequences.

Medical malpractice exists when the treatment provided does not conform to the standard required. It happens alongside with negligence as the proximate cause. If injuries were sustained by reason of a medical malpractice, a lawsuit is proper. Do not waste your time and contact a legal expert immediately.

For free consultation, contact Stephen Bilkis & Associates. We have our legal teams ready to assist you. We are equipped with highly trained and experienced lawyers. Our legal experts include – New York City Medical Malpractice Lawyers, New York City Birth Injury Lawyers, New York City Brain Injury Lawyers, etc. For your convenience, we have offices available all over the metro. If you want to be properly compensated, hire only the best. Hire us.