United States Court of Appeals Fifth Circuit 

## FILED August 22, 2006 Charles R. Fulbruge III Clerk 

## In the 

# United States Court of Appeals for the Fifth Circuit

_______________


### m 05-10509

_______________



### S UE 

### C. M C 

### N EIL 

### , Plaintiff-Appellant,

VERSUS



### W YETH 

### , F ORMERLY K

NOWN AS AMERICAN H OME P RODUCTS C ORPORATION , D OING B USINESS AS A.H. R OBINS C OMPANY , I NC ., 

### Defendant-Appellee.

_________________________ Appeal from the United States District Court fo r the Northern District of Texas

_________________________

Before K

ING , S MITH , and B ENAVIDES , Circuit Judges.

J ERRY E. S MITH , Circuit Judge:

Sue McNeil appeals a summary judgment fo r defendant Wyet h, a pharmaceutical com pany. We reverse and remand.

I. In August 2000, Dr. Eduardo Wilkinso n prescribed Reglan, whose generic name is met oclo pramide, manufact ured b y Wyet h, to treat McNeil’s sympt oms of gastroesophageal reflux disease ( “ GERD”). The prescription was for six mo nt hs, th ough the Food and Drug Administ ration had approved the drug only fo r use of no more than twelve weeks. Thereaft er, McNeil’s prescription was continued by Dr. Roy Ragsdale fo r six mo nt hs and then by Dr. William Mania for two months.2

GERD is a disease whose expression ranges from infrequent heartburn to frequent heartburn accompanied by regurgitation. In severe cases it can lead to a narrowing of the esophagus by scarring. Reglan is a “prokinetic” drug th at helps control GERD by blocking dopamine receptors in the brain and th

roughout the body, thus enhancing mo vement or c ontractions of the esophagus, stomach, and int estines. Dopam ine is a chemical produced naturally by the human body th at sends signals fr om on e nerve to the next. Simple mo vements of muscles, such as mo ving
a finger, are controlled by what is known as the pyramidal syst em. Mo re coordinated muscle
mo vements, such as dancing or tal king, require fine mo tor c o nt rol from the extrapy ramidal syst em. By blo cking dopam

ine receptors, Reglan can affect the extrapy

ramidal syst em by causing extrapy ramidal sympt oms (“EPS”), which “are
a group of adverse drug reactions referred to generally as extrapy

ramidal sympt oms because of the involvement of the extrapyramidal nervous sys tem .” 1 The clinical pharmacology section of Reg lan’s FDA-approved label explains th at, like other “dopamine antagonists ” such as phenothiazines, Reglan “may produce
e xt rapy ramidal reactions, alt hough these are com paratively rare.”

Tardive dyskin esia i s a particularly severe fo rm of EPS characterized by grotesque invo luntary mo vements of the mo ut h, tongue, l ips,
a nd extremities, invo lunt ary chewing mo ve
ment s, and a general sen s e of agitation. Reglan’s label warned th at Reglan may produce tardive dyskinesia. In October 2001, about fo urteen mo nt hs after she started taking Reglan, McNeil was admit ted to an emergency room com plaining of shortness of breath, anxiety, and an involuntary “chewing mo tion” of her mo uth. The nurse who first treated McNeil noted that she
was also fidgeting, appeared nervous, and had
an unsteady gait. The emergency room physician who lat er examined McNeil confirmed these observations and diagn o sed EPS, likely occasioned by exposure to Reglan.

McNeil’s primary care physician confirmed this diagnosis, discontinued Reglan, and prescr ibed a replacement drug. When McNeil’s EPS sympt oms failed to improve wit h time, she consulted a ne urol ogi st and two m edical specialists in mo vement disorder; all th ree concluded th at McNeil suffers from Reglan-induced tardive dyskinesia in addition to Reglaninduced EPS.

II. McNeil sued Wyeth in st ate court. Her
com plaint alleged th at Wyet h had failed adequatel y to warn physicians and co n sumers of the increased ri sk of tardive dyskin esia that accompanies lo ng-term use of Reglan. McNeil argued th at Wyet h’s failure to warn rendered the inherently unsafe product unreasonably dangerous. Further, McNeil alleged that the Reglan label was misleading as to the risk of tardive dyskines ia and failed adequately to
warn about the increase in ri sk associated wit h exposure to t he drug for more than twelve weeks. Wyet h removed to federal court pursuant to 28 U.S.C. § 1332(a)(1). Both parties consented to decision by a magistrate judge, whom we therefore refer to as the “district court.” Wyet h mo ved fo r summary judgment, 1 Windham v. Wyeth Lab., Inc. , 786 F. Supp. 607, 612 (S.D. Miss. 1992).3

which the court granted, conclu ding that the Reglan label was “adequate as a mat ter of law” because it “ specifically ment io ns the circumstances com

plained of

. . . .” M ore specifically, the court noted that the l abel specifies th at the drug is int ended for short-term use of 12 weeks or less, warns against the potenti al ri sk of tardive dyskinesia and other mo vement disorders, and discloses th at the ri sk of developing tardive dyskinesia is highest amo ng elderly wom en and increases wit h the duration of treatm ent and the total cumulative dose. The label also describes the possible sympt oms associated wit h mo vement disorders caused by t he drug 

### S S the very sympt oms of which plaintiff complains.

There fo re, the court concl uded that Wyeth
was entitled to summary judgment on McNeil’s marketing defect claims. I n an additional paragraph, the court s tated th at “Wyeth is entitled to summary judgment on plaint iff’s design defect claims.” McNeil appeals only the failureto-warn cl aims.

III. Summary judgment is proper “if the pleadings, depositi on s, answers to interrogatories, and admissions on fil e, together wit h the affidavits, if any, show that there is no genuine issue as to any mat erial fact and th at the mo ving party is entitled to a j udgment as a matter of law.” FE D

. R. C IV

. P. 56(c). Disputes about mat eri al facts are genuine “if the evidence is such th at a reasonable jury could return a verdict fo r the nonmoving party .” A nderson v. Liberty Lobby, Inc. , 477 U.S. 242, 248 (1986). We review the district court’s decision de novo
. Skotak v. Tenneco Resins, Inc. , 953 F.2d 909, 912 (5 t h Cir. 1992). The evidence and inferences from the summary judgment record must be viewed in the light mo s t favorable to the nonmovant. Minter v. Great Am. Ins. Co. , 423 F.3d 460, 465 (5th Cir. 2005).

IV. Texas, like most jurisdictions, has adopted section 402A of the Restatem ent of Torts for product liabilit y claims. Nobility Homes, Inc.
v. Shivers , 557 S.W.2d 77, 79-80 (Tex. 1977). Under th at section, “[i]f a product is unreasonably or inherently dangerous, a warning is required.” G ravis v. Parke-Davis & Co

. , 502 S.W.2d 863, 870 (Tex. Civ. App. 

### SS Corpus Christi 1973, writ ref’d n.r.e.) (citing RE

STATEMEN T (S ECOND ) OF T ORTS § 402A (1965)).

Texas law generally holds th at the adequacy of a product’s warning is a question of fact to be determ ined by the jury. W

illiams v. Upjohn Co. , 153 F.R.D. 110, 114 (S.D. Tex. 1994); Alm v. Alu minum Co. of Am. , 717 S.W.2d 588, 591-92 ( T ex. 1986)). In prescription drug cases invo lving t he learned int ermediary doctrine, however , when “a warning specifically ment io ns the circumstances com plained of , the warning is adequate as a mat ter of law.” R olen v. Burroughs Wellcome Co. , 856 S.W.2 d 607, 609 (Tex. App. 

### S S Waco 1993, writ denied). 2

McNeil argues that the district court’s reliance on Rolen to find adequacy as a mat ter of law is inapposite. We agree. Although Reglan’s l abel ment io ns the conditions of which McNeil com

plains, McNeil’s claim, unlike the

2 In Alm the court also cited with approval decisions f r om Texas appellate courts that have adopted and applied the learned intermediary doctrine in cases involving a drug ma nufacturer’s duty to warn about the potential hazards of prescription drugs.4

claim of the plaint iff in Rolen , i s not that the warning is inadequ ate b ecause her condition
was not ment io ned. Rather, her argument is th at the label is misleading as to the r isk level fo r developing the condition.

We are aware of no Texas case allo wing adequacy as a mat ter of law in such situations,
a nd therefore we apply the default Texa s rule th at adequacy questions go to the jury. Our position is consistent wit h Texas law and the Restatem ent of Torts, which Texas courts follo w, because, as the district court rec ognized,
even in the context of a learned in term ediary,

“ ‘if the warning to the intermediary is inadequate or m

isleading, the manufacturer remains liable fo r injuries sustained by the ult imat e user.’” 3 Warning the learned int ermediary of a much lo wer ri sk th an the actual ri sk could render the warning not just misleading, but ineffect ive. When the ri sk described on the label is so lo w as to induce a doctor to undertake the ri sk, had he not done so if he were warned of the real ri sk, we cannot say th at no reasonable jury could conclude th at a warning was inadequate. Thus, if the manufacturer decides to label a ri sk
as “ c om paratively rare” and also to provide a numerical quantification of th at ri sk, th at number must be wit hin a certain deg ree of accuracy. 4 V. The issue therefore is whether the re i s a genuine issue of mat erial fact as to whether the label was misleading. This must be viewed in terms of significant differences between th e disclosed ri sk and the actual ri sk of developing EPS and tardive dyskinesia, with use longer th an twelve weeks.

A. Wyet h argues th at it does not have a duty to warn about ri sks of use longer than twelve weeks because the label clearly states th at the drug is indic a ted fo r treatm ent fo r no mo re th an th at duration. Thus, not only would such
a warning be superfluous, but it would also be improper, because Wyet h allegedly cannot tell
a medical prof

essional how to exercise professio nal judgment on whether a drug should be used lo nger th an the pe ri od approved by th e FDA. We disagree. Wyeth was, or should have been, aware th at Reglan was prescribed routinely fo r lo ngterm use. Pl aint iff’s expert, Dr. Thompson, testified th at by 1988 Wyet h had it s “o wn market data th at 84 percent of people” were using Reglan lo ng-term . In 1992, an article by Dr. Ron Stewart and others drew attention to the
com mo n practice of lo ng-term treatm ent wit h met oclopram

ide. The study invo lved 4,515 elderly patients at the Flo rida Geriatric Re3 Wyeth-Ayerst Lab. Co. v. Medrano , 28 S.W.3d 87 (Tex. App. SS

Texarkana 2000, no writ) (citing Alm , 717 S.W.2d at 591) ; see also Bristol-Myers Co. v. Gonzales , 561 S.W.2d 801 (Tex. 1978); Crocker v. Winthrop Labs. , 514 S.W.2d 429 (Tex. 1974).

4 We do not mea n to suggest that de minimis differences in risk would send the adequacy question to the jury, but when the differences in risk are signifi- (continued...) 4 (...continued)

cant, their potential misleading impact is a question for the jury. Other courts have also recognized that warnings that are “unreasonably diluted” may be misleading and thus inadequate. S ee Salmon v. Par ke, Davis & Co. , 520 F.2d 1359 (4th Cir. 1975) (deciding that although a specific condition
was mentioned in the label, “[c]omparing the company’s warning with [that suggested in] the article,
a jury could i nfer that Parke, Davis’ version was unreasonably diluted”).5

search Program . Of the patients who reported using met ocl opram

ide, 32% had used it for
mo re th an one year. This led the authors to conclude th at lo ng-term treatm ent w it h met oclo pramide is “quite com mo n” and th at other prescription drugs were effective and safer for treating GERD:

The routine use of metoclopramide for gastroesophageal reflux should be questioned in light of the availabilit y of safer,
mo re effective drugs such as histamine-receptor b l

ocking agents cimet idine
a nd ranitidine, and om

eprazole. The lo ng-term efficacy and sympt omatic benefit of met oc lo pramide have not been docum ented.

Because the widespread lo ng-term use of Reglan suggests th at Wyet h’s indication fo r use fo r no mo re th an twelve weeks was widely disregarded, a jury could infer th at Wyet h’s warning was ineffect ive and thus inadequate. Therefo re, McNeil’s suggested a dditional warning about lo ng-term use would not be superfluous.

Moreover, the FDA regul ations require a manufacturer to info rm a medical prof essional precisely how to exercise his prof essional judgment in certain c ircumstances. The “Contraindications” regulation requires th at ‘[u]nder thi s section heading, the labeling shall describe th ose sit uations in which the drug should not be used because the ri sk of use clearly outweighs any possible benefit.’ 21 C.F.R. § 201.57(d) (2000). Thus, the manufact urer m ust tell t he physician when the drug should not be us ed if “t he ri sk of use clearly outweighs any possible benefit .”

One of McNeil’s experts testified th at the label should have indicated that use of Reglan fo r lo nger th an twelve weeks was contraindicated (absent com

pelling circumstances). Wyeth’s fo rm

e r m edical monitor for Reglan also testified similarly by agr e eing th at “Reglan should not be prescribed fo r lo ng-term therapy fo r GERD because the sid e effects are too dangerous and because it s e fficacy in longer term use has not been established.”

In sum, because the widespread lo ng-term use of Reglan suggests th at Wyet h’s indication f or use fo r not mo re th an twelve wee ks was widely disregarded, a jury could infer that the warning was ineffect ive and therefore inadequate. It f ollo ws that Wyeth had a duty, under Texas law, adequately to warn the learned interm ediary of known ri sks wit h lo ng term use and not to be misleading as to that risk.

B. Because Wyet h advertised th at the ri sk of d eveloping EPS is “comparatively rare, ” or th at it is 0.2% fo r short term use, just noting t hat the ri sk is higher fo r lo ng-term u se may not put a physician on notice th at certain studies have fo und th at the ri sk could be a hundred times higher. 5 That is, because the advertised ri sk is negligibly lo w, the mere statement that the ri sk increases wit h use doe s not put a

5 An 1989 study by Dr. Lucinda Miller and Dr. Joseph Jankovic looking at 1,031 patients concluded that the prevalence of metoclopramide-induced movement disorders is probabl y greater than Wyeth’s estimate of 1 in 500. An article published by Dr. Linda Ganzini and others in 1993 described that 29% of the patients in a case-control study exposed to metoclopramide met the case definition of tardive dyskinesia. The average duration of exposure t o the drug was 2.6 years. Another case-control study conducted by Dr. Daniel Sewell in 1994 found that 27% of the patients exposed to metoclopramide for longer than thirty days met the case definition of tardive dyskinesia.6

physician on notice th at the increase in ri sk is of
a com pletely different order of magnitude and
c lass of ri sk. Thus, a jury could find that t he ri sk of developing EPS from lo ng-term use was not just higher, bu t th at i t was “significantly” higher, and th at the label was therefore misleading and inadequate. Wyet h argues, however, th at it was not required to update it s label, because the studies indicating th at the ri sk for long-term use could be a hundred times higher showed mere association with a disease, not necessarily causation. Thus, Wyeth argues, because there could be a variety of other factors responsible fo r the “associ ation” found in these studies, that association does not necessarily r equi re a warning to physicians. This argument, however, is contradicted by the FDA regulations th at require th at the labeling “be revised to include a warning as soon as there is reasonable evidence of an association of a serious hazard wit h a drug; a causal relationship need not have been proved.” 21 C.F.R. § 201.57(e) (emphasis added).

Of course, it does not immediately follow, from the fact th at Wyet h is required under federal law to warn physicians of a significant “associ ation” between tardive dyskinezia and lo ngterm use of Reglan, th at Texas law requires the same thing. Texas law, however, does not absolve a manufacturer, as a mat ter of l aw, of a duty to warn on grounds that no existing studies or clinical trials prove actual causation.

In Jordan v. G eigy Pharms. , 848 S.W.2d 176 (Tex. App.—Fort Wo rth 1992, no writ), t he court observed that al th ough the drug manufacturer warned th at cases of “ significant renal failure in patients receiving Vol taren have been reported from postmarketing experience, but were not observed in over 4,000 patients in controlled clinical tri als,” it had not warned of the possibilit y of “ acute renal failure.” J ordan , 848 S.W.2d at 182. In other words, even if the clinical st udies did not show significant renal failure and thus, also did not show acute renal f ailure, there was a genuine issue o f mat erial fact on a dequacy raised solely by association evidence (anec dotal case reports, not cl inical t ri als).

McNeil’s expert, Dr. Thom pson, also noted th at manufacturers frequently change their labels and warn physicians of side effects based
on simple case repor ts, n ot on actual studies showing causation. For example, a pharmaceu ti cal company for which she was working at the time (Eli Lily) inserted a warning that a certain use of the drug Papaverine is contraindicated based only on a few case reports of it s apparently causing heart attacks, and no epidemio lo gical or other studies showing causation. She explained th at the contraindication attracted a lot of hate mail from physicians who had practiced the of

f-label use, but th at it had to be done, and it took little time to do. This is not to say t hat a manufacturer is always required to change a label based on case r eports; we ment io n Thom

pson’s testimo ny only to counter Wyet h’ s contention that manufacturers never change labels based on case reports (as distinguished from clinical tri als) and th at they never tell physicians how t o e xercise their judgment.
Thus, it is not uncom

mo n fo r drug com

panies to do precisely what Wyet h claims it cannot do: tell physicians th at a certain use is contraindicated even if no clinical or epidemiological studies exist th at confirm causation or degree of ri sk. Certainly, it is easier for a manufacturer to make an of

f-label use contraindicated when th at use provides only a minimal
amo unt of sales from that drug as opposed to when the of

f-label use provides the majo rity of7

it s sales, as allegedly it is wit h Wyet h and Reglan. But it is precisely this fact 

### SS th at of f-label
use allegedly pro v ided a majo rity of Wyet h’s sales 

### SS th at would create Wyet h’s duty to physicians n ot to b e misleading about the risk of lo ng-term use.
Admit tedl y, the physician, in the exercise of prof essional judgment, can disregard the warnings or contraindications provided by the manufacturer. But then he does so at hi s own risk, and mo st physicians are likely reluctant to do so absent mo re concrete evidence about the benefit s of lo ng-term use, evidence that is absent in this case. Even Dr. Wilkinson, who initially indicated th at he would not h ave changed his lo ng-term prescription of Reglan even if he had read the studies now cit ed by McNeil, acknowledged th at he would not have pre scribed Reglan fo r mo re th an twelve weeks had Wyet h provided a contraindication on Re glan’s label.
Therefore, we cannot say as a mat ter of law th at the peer-reviewed studies cit ed by McNeil do not describe a significant ri sk about which Wyet h should have warn e d Texas physicians. Of course, Wyet h is free to argue, to a jury, its view of the proper weight to be given to these studies; it can also challenge (if still timely) the admissibilit y of these pee r-reviewed studies under Daubert v. Merrell Dow Pharms., Inc. , 509 U.S. 579 (1993).

McNeil has also raised a genuine issue of mat erial fact as to whether pharmacological evidence should have alerted Wyeth about the significant ly increased ri sk from lo ng-term use. Under Texas law, causation is generally an issue of fact. L enger v. Physician’s Gen. Hosp., Inc. , 455 S.W.2d 703, 706 (Tex. 1970). An expert opinio n is legally sufficient evidence to establish a causal relationship between the condit io n and the event. See Rodriguez v. Reeves , 730 S.W.2d 19 (Tex. App.—Corpus Chri sti 1987, writ ref’d n.r.e.).

McNeil’s expert, Dr. Thom pson, tes ti fied th at the well-known, scientifically established pharmacology of dopam

ine antagonists that blo ck a D2 dopamine receptor such as metoclo pramide or schizophrenia medications (Haldol and Thorazine) is to diminish the effects of dopam ine in t he brain. The inabilit y of dopamine to produce it s effects causes EPS (including Parkinsonian side effects such as rigid i ty , trem or, and dystonia, and t he mo re severe side-effect known as tardive dyskinesia), because the extrapy

ramidal sy stem needs do pamine to function. Thompson also testified th at these side-effects fo r met oclopram ide
are “highly predictab le,” given the function it performs (blocking dopam ine r e ceptors) and the known effects of other dopam ine blo ckers:
[M]ost of [m

etoclopram

ide’s] side effects
are related to it s action, which is, in fact, blo cking the dopam

ine effects in the brain and elsewhere. And so what it does i s to produce the whole array of side effects th at we associate wit h dopam

ine blo ckers. And in this sense, it ’s really no different th at any so-called ne u roleptics, the drugs th at produce the calming effect in schizophrenia. So it ’s just like Thorazine or Haldol or any of the other antipsychotics. It’s highly predictable that this would be its effect . . . .

Thom pson testified th at the propensity of neuroleptics such as Thorazine and Haldol to
cause tardive dyskinesia was discovered about twenty years aft er the beginning of the use of Thorazine, th at is, in the lat e 1970’s. She further testified th at the rate of developing tardive dyskinesia wit h lo ng term use of D2 receptor blo ckers was 25%. Therefore, she found to be misleading the label’s claim th at like other8

“dopamine antagonists” such as phenothiazines (which include Thorazine), Reglan “may produce extrapy

ramidal reactions, although these
are com paratively rare. As Thompson testified,

Most o f the papers I’ve seen would give
a bout the same prevalence rate of tardi ve dyskinesia in Metoclopram ide lo ng term and Thorazine lo ng-term. So [the l abel] wouldn’t be c o rrect in terms of being comparatively rare
. . . . 25 percent isn’t rare com
pared to any

thing.
Therefore, we cannot say as a mat ter of law th at Reglan’s label was adequate even if it failed to warn th at the ri sk of de velo ping tardive dyskine s ia was not “comparatively rare,” but increased significantly with long-term use.

VI. Under Texas law, a plaintiff who com plains “t hat a prescription drug warning is inadequate must also show th at the alleged inadeq u acy caused her doctor to prescri be the drug for her.” P orterfield v. Ethicon, Inc. , 183 F.3d 464, 468 (5th Ci

r. 1999); a ccord Stew

art v
. Jannssen Pharm. , 780 S.W.2d 910, 912 (Tex. App.—El Paso 1989, writ denied). In other words, a pl aint iff must show not only that a warning was inadequate, but th at it was a “producing cause” of his injuries. Wyet h is correct th at alt h ough the district court has not addressed thi s issue, the matter was before the court, so we could affirm fo r this reason if we were to find fo r Wyet h on this question. We do not so decide, however, because there is a genuine issue of mat erial fact as to whether the label ’s inadequacy caused McNeil’s doctor to prescribe the drug.

Wilkinso n gave conflicting testimo ny. On the one hand, he stated th at he still would have prescribed the drug had he known th at the ri sk was “significant ,” but would hav e alerted the plaint if f t o th at ri sk. On the other hand, he testified th at he would not have prescribed the drug had it s label stated th at us e for longer th an twelve weeks is contraindicated because the ri sks are significant and the benefits have not been proven. Therefo re, McNeil has raised a genuine issue of fact as to whethe r Wilkinso n would have prescribed the drug had the label’s warning been adequate.
Moreover, because Wilkinso n testified th at he was never info rm

ed of the significant ri sk of tardive dyskinesia associated with long-term Reglan use and th at such info rmation certainly would have changed the “risk/benefit” analysis” and the conve rsati on he would have had wit h McNeil about the ri sks, the inadequate labeling could be a producing cause of the in jury even if Wilkinson had never testified th at he would not have prescribed Reglan had
a contraindication been inserted. Sworn testi

mo ny from McNeil establishes that she was
never told of the significant ly increased ri sk of tardive dyskinesia wit h use of Reglan fo r greater th an twelve weeks and th at, if she had known of such a ri sk, she would not h ave taken Reglan for longer than that.

The doctrine of the “learned int ermediary” pr esupposes that the phy sician will act as an int ermediary. This function includes discussi ng the cost-benefit ratio wit h the patient if necessary. Where the physician wo uld have adequately info rm

ed a plaint iff of the ri sks of
a disease, had the label been sufficient , but fails to do so on th at account, and where the plaintiff would have rej ected the drug if informed, the inadequate labeling could be a “producing”
cause of the injury, because it effectively sabo-9

tages the function of the intermediary. 6

We note th at our discussion of “permissible inferences is int ended ne it her to define nor to decide the issues in this ca se.” Salmon , 520 F.2d at 1364. It serves merely to illustrate our
reasons fo r concluding th at summary judgment is inappropriate. Reasonable minds can differ
on whether not mentioning that the increase in ri sk fo r lo ng-term use was significant would be misleading. But thi s is precisely why that question should go to the jury. The summary judgment is REVERSED, and this mat ter is REMANDED for further proceedings.

6 “[T]he mer e presence of an intermediary does not excuse the ma nufacturer from warning those whom it should re asonably expect to be endangered by the use of its product.” A lm , 717 S.W.2d at 591. Instead, the issue “in every case is whether the original ma nufa cture

r has a reasonable assurance that its warning will reach those endangered by the
use of its product.” I

d. Although usually the
ma nufacturer can rely on the “learned intermediary,” id. , this reliance seems less reasonable where the learned intermediary fails to pass necessary information to the patient because the ma nuf acture r has understated the degree of risk.