Confidential Memorandum

To: Supervising Attorney

From: MaryAnn Roman

Re: File 923-04/ Availability of Tort Remedy

Date: November 17, 2013

CONFIDENTIAL

ATTORNEY CLIENT PRIVILEGED

Statement of Assignment

You requested that I prepare, for review, a legal memorandum addressing whether

the manufacturer, in the assigned case, has breached its duty to give adequate warning of

the dangers associated with its medication. No time constraints were given. The

information requested must be limited to New York case law and Federal law.

Issue

Whether under New York tort law a pharmaceutical manufacturer breaches its duty to

warn adequately of the dangers associated with its new medication by printing a warning

of adverse reaction and a recommendation of discontinued use on its label?

Brief Answer

No, a pharmaceutical corporation, which prints on its labels and on the insert

accompanying the medication, the warning of an adverse reaction and a recommendation

of discontinued use, according to federal regulation 21 CFR 201.57, cannot be found to

have breached its duty.

Statement of Facts

Our client, Miss Clara Client, is an elderly piano teacher who has recently moved

form New York State to Alaska. She has a minor heart ailment as well as diabetes, for which,

she has been taking a new medication.

Her medication was developed by Foster Pharmaceutical Corporation and has been

approved by the Food and Drug Administration (FDA). The prescription includes written

instructions specifying the correct dosage; as: two tablets every four hours. The box and

insert were printed with a warning which indicated that some persons might experience an

irregular heartbeat, and, if that be the case, to cease use immediately and consult a

physician. The warning was printed in the smallest print that is permissible under federal

regulations.

Miss Clara Client alleges that, due to the small print, she read the dosage instruction

incorrectly and consumed four pills every two hours. She took the incorrect dosage of the

prescription for two days, after which time, she experienced heart palpitations and was

taken to the hospital. Clara Client recovered from the incident but her heart condition has

worsened.

Miss Client would like to sue Foster Pharmaceutical Corporation for the alleged

damage to her heart.

Discussion

21 CFR 201.100(b)(2) states that labels for prescription drugs must have a

statement of dosage printed upon them. If the space available for printing on the label is

inadequate, then a statement of see package insert for dosage information fulfills the

requirement. Clara Clients diabetes prescription medication contained a warning in a print

size that is in accordance with the regulations of the Food and Drug Administration (FDA).

21 CFR 201.567 is the regulation which requires all print on or within the package from

which the drug is to be dispensed to be a minimum of six points.

Clara Client would like to know whether the pharmaceutical manufacturer can be

held liable for her worsened heart condition, due to the corporations alleged breach of

duty to adequately warn the consumer of adverse reactions.

21 CFR 201.57(a)(4) mandates that the boxed warning on the label contain a

concise summary briefly explaining the risk(s), and which also refers to more detailed

information in the Warnings and Precautions section. Miss Clients medication warning

stated that some persons might experience irregular heartbeat and should that occur, a

physician should be consulted immediately. The label must contain a summary of the most

clinically significant adverse reactions, other potential risks, limitations in use and the

steps that should be taken if any of these should occur. 21 CFR 201.57(c)(6).

There is a lack of detail in the facts known about Miss Clients medication. It is not

clear if the warning was boxed and whether it directed the consumer to view the insert. In

the case Martin v. Hacker., 628 N. E. 2d, 1308 (N.Y. 1933), the plaintiff sued for an alleged

breach of a pharmaceutical companys duty to adequately warn the user of the

medications adverse side effects. After the case was appealed twice, the court granted

the defendant summary judgment due to the face that the warnings were adequate as a

matter of law.

Based on what we have been told, Miss Clients medication does not constitute a

false or misleading label under 21 USCS 352. The manufacturer has a duty to provide

warning of all potential dangers related to the medication that the manufacturer knows to

exist. Tenuto v. Lederle., 181 Misc. 2d 367 (N.Y. Sup. Cr. 1999)

In order for foster Pharmaceutical to be found liable for Miss Clients injuries, it

would be necessary that the plaintiff be able to prove that her medications label was not in

conformity with 21 CFR 201.57.

Conclusion

The clients medication, as far as is known, is in accordance with the federal

regulation governing prescription medication labeling. Foster Pharmaceutical Corporation

will most likely not be found to have breached its duty to adequately warn the consumer of

adverse reactions to its medication.