Cases Outline

Food & Drug

FDAs Jurisdiction/Classification as Food or Drug
1) Nutrilab, p. 30 Co. produces pills that are starch blockers used in dieting
a) Issue: whether starch blockers are food
b) Court says it isnt a food; fails both statutory and common sense test for food
2) Natl Nutritional Foods, p. 42
a) FDA classifies that vitamin A & D pills as drugs, b/c people were taking them in high doses
b) Producer argues that high dosage use does not show intent on part of producer to sell as drugs
c) Court says FDAs fear of toxicity at high doses does not empower them to regulate the pills as drugs; pills must be used
almost exclusively at that dosage to be regulated as drugs
3) Sudden Change, p. 50 product claimed to give a facelift w/o surgery; represented that there was an actual physiological
alteration to the body rather than just hiding imperfections; court said It was a drug
4) Sensor Pad Breast Exam, p. 63
a) Facts
i) Breast pads used to feel for cancer lumps
ii) Producer argues that pads dont diagnose according to definition of devices; their function actually occurs before
diagnosis; it is a screening device
iii) Court doesnt accept this argument; the device is used as part of a diagnosis; diagnosis is a process, it is not just one
event; they cant divide it up
b) Basically, court felt it was important for FDA to regulate such products b/c if such products werent regulated, there is danger
of products giving incorrect info and harming people
5) 23 Articles (two cases), p. 71
a) Both cases involved recordings that purported to help with something, e.g. insomnia, etc.
b) In both cases the courts said the products were medical devices per the definition; they were intended to affect a function of
the body
6) Brown & Williamson, p. 82
a) US SC says cigarettes do not fall w/in FDAs jurisdiction
b) US SC applies Chevron deference, and finds that Congress has spoken on the topic
i) FDA has said in the past that cigs are not w/in their jurisdiction, and in reliance on this representation Congress has
enacted other laws regulating cigs
(1) Thus, Congress couldnt have intended for FDA to regulate it
(2) Thus, those other statutes are evidence that Congress has spoken to the issue
ii) Also, if cigs did fall under FDA jurisdiction, they couldnt allow cigs to go on market b/c their harmful (see annotations,
p. 84)
(1) Congress probably didnt intend this to happen, as the statutes enacted by them still allow them to remain in the
market
(2) Thus, Congress has spoken to the issue, and FDA interpretation is not accepted
Labeling and Misbranding
1) Apple Cider
a) Product actually didnt have any cider in it, although it was used in its production
b) Court said product couldnt be labeled as cider
2) Candy Lollipops, p. 108
a) On the labels the producer led consumer to believe there was liquor in the candy, even though there wasnt
b) Must have liquor in product to claim that it is there
3) Diet Thins, p. 110 these werent diet products b/c they werent any thinner than any other motza cracker, so the labeling was
misleading
4) Amestoy
a) Court invalidates a VT law that requires manufacturers to label genetically modified foods
b) Manufacturer argued that law was in violation of commercial speech rights
i) Court thus uses Central Hudson test, balancing govt. interest vs. speakers interest
ii) Court held that under the test, states interest wasnt strong enough, b/c there wasnt evidence that genetically modified
foods were any different than other foods
iii) Recognizes FDAs position on genetically modified foods
5) Bio-Integrity
a) Court here applies Chevron test
b) FDCA is ambiguous w/ respect to genetically modified foods, and so deference is given to agency (FDA) interpretation
Food
1) Bireleys Orange Beverage, p. 155 see book and annotations for notes

2) Milnot, p. 176
a) Company challenges Filled Milk Act
b) Company won, and act no longer enforced
3) American Frozen Food, p. 187
a) P complained that FDA was regulating by recipe again, and that it was not authorized to do so
i) Court says applicable statute (FDCA 701(a)) doesnt say it can do it, but it doesnt say it cant either (see 3rd full , p.
188)
ii) Thus, even if they are regulating by recipe, it is still okay
b) Basic point of this case: FDA has a lot of latitude provided it by legislature; courts will give much deference to its decisions
4) Dextra Sugar, p. 233
a) Govt. brings misbranding claim against D; D was saying its sugar was healthier than other sugars
b) Court says there isnt misbranding here
i) Labeling wasnt false or misleading
ii) Companys labeling was basically true
c) Basically, point of case is that:
i) Nutrient fortification is not misleading it doesnt make or imply the types of claims govt. asserted in this case (see
green highlights at beginning of case)
ii) More information is better than less
iii) The consumer and the market must determine what constitutes an appropriate diet; FDA can make
recommendations (food pyramid), but cant enforce this
5) V.E. Irons, p. 246
a) Irons claims that all food is making people sick, and that their product can alleviate those sicknesses
b) Issue: whether the labeling is false or misleading
c) Standard Used Court uses a different standard to determine false or misleading than reasonable person or ignoramus
standard
i) This is different from food labeling, where ignoramus standard is used
ii) Prospective Purchaser Standard whether a person who would normally buy a cure-all product would be deceived
by the labeling, e.g. b/c of a lack of expertise
(1) This is something different from other standards used; it seems like kind of a hybrid, i.e. an igno standard for the
subset of consumers that buy these products
(2) Policy behind using this standard is recognition that dietary supplements are used by a unique portion of the
consumer population; even though this case is older, the view that dietary supplement consumers are treated a little
differently (in terms of standards of liability) is still basically used today, so the standard is still relevant
d) Basically, the scientific claims are being litigated and determined by the court to be false; thus, the court determines that the
company is liable for misbranding
e) Finding: court found that the product was both a food and a drug, and thus subject to requirements of both; later on (see
below, DSHEA), dietary supplements were regulated separately
6) Pearson, p. 285 Basically, this case shows when a food or DS can make a disease/health claim
7) Whitaker, p. 287
a) Court puts burden on FDA to show their regulations are justified, b/c they are essentially trying to regulate a fundamental
right (speech)
i) Courts have said that regulating speech must be a last resort, not a first resort
b) For other stuff, see annotations and highlights in book
8) 1200 Cans, p. 312 (no info; just here to show page number if needed)
Drugs
1) Alberty Food, p. 479
a) This scenario/fact pattern is unlikely today, b/c all drugs are now required to be approved, including their labeling, prior to
being marketed
2) Bradley, p. 496
a) History/Facts - Study done on oral hypoglycemic agents used by diabetics revealed that the agents had some dangerous
effects, such as cardiovascular risks and that they weren't really any more effective than changing your diet - the FDA wanted
the labeling to change to reflect the warnings. Physicians and patients brought suit, it leaves doctors open to suit because the
product was still left on the market but with more warnings
b) The doctors/practitioners disagreed with the study - they filed a petition asking that the label also contain the information that
they disagree with the results - they ask FDA to rescind the requirement, they also asked for the raw data from the study and
let them analyze the data
c) However, in court their central argument was that the FDA's new requirement was incorrect and was misbranding
d) This argument failed because they made a completely different argument at the trial level. They didn't exhaust their
remedies, they should have stuck with what they argued to the agency at court

e)

3)

4)

5)

6)

7)

FDA published a policy statement as a follow up to this - saying that it is not required to list differences of opinion, unless
there is substantial evidence for the other info, they don't want warnings, supported by substantial evidence themselves,
diluted by these contrary opinions
f) Policy wise - they felt that allowing such would be motivation for manufacturers to come up with their own cooked up
studies to refute the warnings
Henney, p. 550
a) Court struck down FDAMA, which sought to regulate off-label promotion
i) Said that the speech was not inherently false or misleading
ii) Said that govt. had a legitimate interest in preventing false or misleading info from being disseminated, to protect public
health and safety
(1) However, the court said that the burden created on the speech was substantially greater than was needed
(2) FDA said that if they wanted to make off-label promotions, they had to make submissions to FDA to authorize, etc.;
basically same process as allowing on-label use court said this is too burdensome
b) Because of the finding of the court, FDA changed its stance
i) Instead of noncompliance w/ reqs of FDAMA constituting per se violation, compliance would now be considered a safe
harbor be used to guide FDA in its enforcement discretion
ii) Result of this case is that drug co.s still have minimal guidance as to how to go about promoting off-label
Barr Labs, p. 571
a) Facts
i) Co. was not testing its pharmaceutical batches for deficient product
b) Court decided not to issue the injunction and permanently close down the co.
i) This is b/c co. promised to bring manufacturing into compliance with FDA standards by fundamentally changing way
business was done
ii) If this happened, danger of recurrent violations was not cognizable, per second prong of rule (see outline)
Diso-Tate, p. 822
a) FDAs objection was to Evers promotion of off-label use of the drug
b) Court says injunction would not be a regulation of practice of medicine
i) Court distinguishes between prescribing and promoting; court isnt saying that prescribing cannot be done; only that
promoting cannot be done
ii) Also, states that FDA is acting w/in its jurisdiction to remove misbranded drugs from market it is mislabeled b/c offlabel use is being promoted
Evers, p. 823 & 826
a) Cortez says that this court does give distinctions from Diso-Tate case, but that real difference is that they just disagreed with
FDAs argument, and thus w/ Diso-Tate courts decision; thus, there is a split in authority
b) Most in h&as
c) Additional difference in this case from Diso-Tate case: in this case Evers was not promoting the off-label use nearly as much
as he was in Diso-Tate case
i) Thus, the question of physician misbranding may be a question of degree
ii) In other words, promotion of off-label use is misbranding according to the degree or extent of the promotion, which is
not a bright-line rule
iii) Thus, maybe the two cases can be reconciled, resulting in no split in authority
American Pharmaceutical Association, p. 829 (not much in notes; see h&as if needed)

Medical Devices
1) Acu-Dot, p. 1034
a) The device was a dot you put on your body where it hurts, and the dot would alleviate the pain
b) FDA argued:
i) Not that the claim was false, BUT
ii) That the claim was misleading (and so misbranded)
c) Data did show that the product did have a placebo effect and through that alleviated peoples pain
i) This is why FDA said the labeling was misleading b/c the product warranted that it actually did relieve pain, but the
way it did so was misleading b/c it did so through placebo effect and not through any active function; the product was
magnetic, but the magnetism didnt do anything
ii) The relief came from the marketing itself, not from the actual product
d) RULE data showing therapeutic effect is insufficient to show that a product is not misleading it must also do what it
purports to do (as far as the actual cause, not just the effect)
Biologics
1) Wyeth Labs, p. 900
a) Kid contracted polio from live virus oral vaccine
b) Signed a waiver of liability for state of Texas (native language was Spanish and didnt really know what she was signing)
c) Court doesnt use a negligence standard, but rather uses strict products liability

i) Acknowledged that other standards would have been

ii) Liable if product was defective or unreasonably dangerous
d) Because the vaccine had a live virus in it, it was an unavoidably unsafe product
i) We have a lot of these kind of products in the market (pools, guns, chainsaws)
ii) There was nothing Wyeth could have done manufacturing wise to make the product safer
e) Two questions
i) Is marketing the product at all unreasonable dangerous per se?
(1) Court dismisses this pretty easily because we need vaccines and on the whole the benefits outweigh the risks
(2) Cant blame Wyeth for merely marketing the product
ii) If it is not unreasonably dangerous per se, is it being sold without sufficient safeguards?
(1) Can market things without adequate safeguards (ak47 with tony the tiger on it)
(2) Essentially a failure to warn did they fail to warn and did they have a duty to do so?
(3) Wyeth sad they didnt need to warn the end user, just the physcian learned intermediary defense
(a) Manufacturer discharges its duty to warn when it warns in the prescribing information that goes to the physician
(b) It is the physicians duty to explain the risks to the patient once the manufacturer has disclosed them to the
physician
(c) TX Dept of Health should have warned the end user
f) So why did the court hold Wyeth liable?
i) It was foreseeable that the vaccine wouldnt have been subject to the traditional dr/patient relationship and so they
wouldnt have gotten the information
ii) There is a rebuttable presumption that the patient would have refused the vaccine if they knew of the risks (the dead
vaccine, etc.) doesnt have to be probable, just plausible
g) Its not hard to warn the patients here, just that Wyeth didnt think it had a duty to
h) This was a pretty groundbreaking case because manufacturers didnt want to be held liable for failure to warn
i) Almost everyone takes vaccines, so talking about potentially enormous liability
j) The government overturned this holding by passing the National Childhood Vaccination Act which absolved manufacturers
of liability if they informed the learned intermediary
2) Berkovitz, p. 906
a) 2 month old contracted polio and ended up with paralysis and had to be on a breathing machine
b) claims
i) Lederle Lab shouldnt have been licensed in the first place gov. screwed up in licensing
ii) Government screwed up for approving the drug for distribution
c) Governments defense
i) Usually the government is immune from suit under the 11th amendment, but there is a huge exemption in the Federal
Tort Claims Act
ii) Can sue the government if a government employee/agent injures you, but there is a big exception for discretionary
functions keeps the government from being paralyzed by the threat of lawsuits (has to be able to make discretionary
decisions unless they are inherently negligent or wrongful somehow) kind of analogous to business judgment
exception
d) How is the discretionary function exemption fit in
i) The decision to license is not a discretionary decision there are very clear criteria that determine whether they qualify
or dont
ii) As for the lot release, the agency had leeway to withhold lot statute empowered them to withhold, but they are not
required to do so
iii) Court couldnt determine if it was discretionary in approving lots remanded for further evidence (if discretion was
involved there would be no liability under Tort Claims Act
Tort Liability
1) MacDonald, p. 1475
a) Facts
i) P sues D for failure to warn of potential risks or adverse effects of a birth control medication
ii) D raises learned intermediary defense
b) Court felt that b/c use of birth control drugs is more independent on part of consumer, that there is a greater duty for drug
co.s to warn of risks
i) See notes above on Learned Intermediary defense
c) Why didnt FDA rules and regs preempt the state law tort claim?
i) b/c when this case was tried, FDA didnt want to preempt state tort law claims
ii) Now, however, FDA has changed position, and FDA rules and regs are now more likely to preempt state tort law claims
iii) Raises question of who is in best position to decide what should be on drug labeling
(1) Juries?
(a) Not scientifically sophisticated, but represents the common man, and so the standard of what would sufficiently
warn the common person might be represented

(b) Also, juries are retroactively making these decisions, while FDA, etc. makes more prospective decisions,
attempting to prevent harms instead of remedying them
(2) FDA?
(3) Consumers?
(4) Drug co.s?
(a) Can change labeling as soon as they learn of potential risks
(b) They dont need FDA approval to add potential risks to the labeling, but usually do it anyway just to make
sure its okay
2) Riegel (online case)
a) P sued for injury medical device (balloon catheter) caused to him during surgery
b) Preemption
i) P sued under state tort law claim for failure to warn
ii) Court said that the state tort law for failure to warn was expressly preempted by federal law (FDCA)
(1) P argued that state tort law shouldnt be preempted, b/c it would effectively prevent any consumer claims against
device manufacturers, and it could potentially allow harmful products to remain on the market
(a) This is b/c actual defective product claims are more difficult to prove, and are basically prohibitively expensive
and/or difficult
(b) Thus, if failure to warn is preempted, then plaintiffs essentially have no more claims
(2) Court disagreed policy reasons for allowing preemption
(a) Promotes uniformity in law
(b) Keeps costs of producing a product lower
iii) Distinction between 510(k) and PMA Medical Devices
(1) For a 510(k) product, FDA has a weaker argument for preemption, b/c these products havent gone through
regulatory process that PMAs have to go through
(2) 510(k) products are never expressly approved, they are just allowed on the market based on their equivalence to
PMA products
iv) Legislature has expressed interest in expressly overturning this court decision by including in FDCA provision that it
does NOT preempt state tort law