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. * COURT OF APPEAL FIFTH CNtCUR '
p JAN I 71006
ROCK P. KAMPMANN NO. 05-CA-423
VERSUS FIFTH CIRCUIT
DR. HELEN MASON AND JOSEPHINE COURT OF APPEAL HAMBACHER STATE OF LOUISIANA
ON APPEAL FROM THE TWENTY-FOURTH JUDICIAL DISTRICT COURT
PARISH OF JEFFERSON, STATE OF LOUISIANA
NO. 592-233, DIVISION "I"
HONORABLE JO ELLEN V. GRANT, JUDGE PRESIDING

JANUARY 17, 2006

JAMES C. GULOTTA
JUDGE PRO TEMPORE

Panel composed ofJudges Thomas F. Daley,
Marion F. Edwards, and James C. Gulotta, Pro Tempore

CHERYL A. MCANESPY-SMITH Attorney at Law 1732 Fourth Street Suite A Harvey, Louisiana 70058 COUNSEL FOR PLAINTIFF/APPELLANT
CRAIG R. NELSON Attorney at Law 234 Hector Avenue Metairie, Louisiana 70005 COUNSEL FOR DEFENDANT/APPELLEE
REVERSED
Rock Kampmann seeks review ofthe trial court decision granting a defense motion for summaryjudgment and dismissing his claim against defendant, Sidmark Laboratories, Inc. (Sidmark) for failure to adequately warn of adverse reactions to the generic drug, Trazodone. We reverse.
Plaintifffiled suit against his doctor, Helen Mason and his pharmacist, Josephine Hambacher, for injuries sustained as a side effect ofthe drug Trazodone. In the petition, Kampmann alleges that Dr. Mason prescribed Zoloft for depression, suicidal thoughts and alcohol abuse, and Trazodone for sleep. Plaintiff was instructedto take onetabletofTrazodonethirtyminutesbeforebedtime. After about two weeks, he experienced a painful erection and penile dysfunction. Ultimately, Kampmann had to undergo several surgeries, and has permanent impairment of erectile function.
Plaintiffmade a claim for malpractice against Dr. Mason and Ms.

Hambacher. The medical review panel convened for consideration ofplaintiff's
claim, rendered an opinion finding that both Dr. Mason and Ms. Hambacher met
the applicable standard of care, and holding that there was no medical malpractice.
The opinion did, however, state:
...there is a material issue of fact, not requiring expert opinion,
bearing on liability for consideration by the Court, as to whether Mr.
Kampman was informed of the risk ofpriapism by Dr. Mason.
Thereafter this suit against Dr. Mason and Ms. Hambacher followed alleging thattheywerejointlyliableforfailureto informplaintiffofthepossible side effects of the drug, Trazodone.
In a supplemental and amending petition, plaintiffadded Sidmark Laboratories, Inc., the manufacturer ofTrazodone as a defendant, alleging that the drug, Trazodone, was unreasonably dangerous because of inadequate warnings of the risks ofpriapism.
Sidmark filed exceptions ofprescription and no right/no cause of action, and amotionforsummaryjudgment. Thetrialjudgegrantedthatmotionforsummary judgment with written reasons and dismissed plaintiff's action based on a conclusion that the warning was adequate. Further, the trial judge determined the judgment should be immediately appealable.
In an inadequate warning claim against a drug manufacturer, a plaintiffmust show that the manufacturer failed to warn the physician of a potential risk oftaking the drug and, second that this failure to warn the doctor was the proximate cause of his injury. Stahl v. Novartis Pharmaceuticals Corp., 283 F. 3d 254 (5 Cir. 2002); cert. denied, 537 U.S. 824, 123 S.Ct. 111, 154 L.Ed.2d 34 (2002).
Thejudgmentonreview is the grantofa summaryjudgmentin favorofa drug manufacturer, dismissing plaintiff's claim of harm by an unreasonably
dangerous product because of inadequate waming. The defense argued by

defendant was the "leamed intermediary doctrine." Under the leamed intermediary the drug manufacturer has no duty to wam the customer directly. The manufacturer's duty is fulfilled when the prescribing or treating physician is informed ofthe risks from the drug use. It is then the physician's responsibility to advise the patient. In this regard Sidmark relies on Mikell v. Hoffman-LaRoche, Inc., 94-0242 (La.App. 1 Cir, 12/22/94), 649 So.2d 75. Under this theory as set forth in Mikell, a doctor acts as an informed intermediary and the decision to use the drug Trazodone rests with the doctor and the patient and not the manufacturer.
Sidmark argues its presentation on the "learned intermediary doctrine" defense is sufficient for summaryjudgment and defeats an essential element necessary for plaintiffto prevail on the merits. Specifically, Sidmark argues its insert giving adequate warnings to its customers, the wholesalers ofthe drug, is sufficient to fulfill its duty under the "learned intermediary doctrine." Therefore, underLa. C.C.P.art966C(2)theburdenofproofshiftstoplaintifftoproduce evidence sufficient to "establish that he will be able to satisfy his evidentiary burdenofproofattrial." Sinceplaintiffdidnotproducesuchevidence,Sidmark argues the summaryjudgment was correctly granted.
Insupportofitsmotionforsummaryjudgment, Sidmarkattachedan affidavit from Deborah L. Pakay, Director ofRegulatory Affairs for Sidmark. She asserteda"ProfessionalInsert,"usedin 1998whenplaintiffpurchasedthedrug was included in bottles ofTrazodone and sent to Sidmark's customers who are the wholesalers ofthe drugs. The wholesalers then sell the drugs to the pharmacies, who in turn sell the drug to the consumer. The insert used by Sidmark in bottles sent to the wholesalers was attached to the affidavit and contains the following warnmg:
WARNINGS: Trazodone has been associated with the occurrence of priapism. In many of the cases reported, surgical intervention was required and, in a portion ofthese cases, permanent impairment of erectile function or impotence resulted. Male patients with prolonged or inappropriate erections should immediately discontinue the drug and consult their physician.
Plaintiffopposedthe motionfor summaryjudgment, arguingthat the insert
he received in the medication did not contain the above warning, and that he was
neverwarnedofthedangerofpriapism. Insupportoftheopposition,plaintiff
attached the written reasons for judgment by the medical review panel. Those
reasons are:
Dr. Mason made the appropriate choice in prescribing Trazodone for sleep. The dosage was also appropriate. It is common practice to verbally warn a male patient ofthe risk ofpriapism when Trazodone is prescribed.
Ms. Hambacher, the pharmacist, properly dispensed the medication as prescribed and followed the standard protocol by providing the information to the patient and having him sign that he read and received the medication information sheet.
The literature provided to the patient by the West Jefferson Parish Mental Health Center correctly warned the patient of "other side effects" and to consult with the doctor should "any other effects"
occur.
Also attached is a portion ofplaintiff's deposition in which he states that he read
the "warning label" provided with the drug and it did not contain any warning that
indicated Trazodone could cause priapism. Plaintiffmaintains he was given a
different insert from the one attached to defendant's motion for summary
judgment. The warning presented by the defendant is from the United States
Pharmacopeial Convention, Inc., and is dated November, 1984. The warning of
priapism is not contained in that insert.'
i Plaintiffalso asserts thejudgmentis premature.
Summaryjudgment is appropriate when there remams no genume

issue as to material fact and the mover is entitled to judgment as a matter of law. La. C.C.P. art. 966. Summaryjudgments are now favored in the law and the rules should be liberally applied. Nutt v. City of Kenner, 00-1864 (La.App. 5 Cir. 5/16/01), 788 So.2d 617. When the movant does not bear the burdenofproofattrial, the "burdenonthe motion does notrequirehim to negate all essential elements ofthe adverse party's claim, action, or defense, but rather to point out to the court that there is an absence of factual support for one or more elements essential to the adverse party's claim, action, or defense." La. C.C.P. article 966 C(2). Once that burden is met, it shifts to the adverse party to "produce factual support sufficient to establish thathewillbeabletosatisfyhisevidentiaryburdenofproofattrial." Id. Ourreviewofsummaryjudgments is denovo, usingthe samecriteria appliedbytrial courtsto determinewhether summaryjudgmentis appropriate. Nutt v. City of Kenner, supra.
The Louisiana Products Liability Law is embodied in La. R.S. 9:2800.51 et.seq., the purpose ofwhich is to protect the consumer. The drug manufacturer's duty to the "user" as defined in La. R.S. 9:2800.57 is assumed by the doctor. Under La. R.S. 9:2800.57 A, the drug manufacturer's duty is to "provide reasonable care to provide an adequate warning" to the doctor.
However, Sidmark did not present evidence from any medical professional to show whether that warning was sufficient. That element is essential to the learned intermediary defense.
We find that the defendant's failure to produce evidence from a doctor that the warning was adequate defeats its motion for summaryjudgment.
AIIIIIIIIIIIIIIIIIIIk amin-I--Maa AIIIIIIIIlla
To successfully maintain a claim for failure to warn under the Louisiana Products Liability Law, a plaintiffmust show that the product has a potentially dangerous risk which caused him harm and that the manufacturer failed to use reasonable care to provide adequate warning of that characteristic to the doctor. La. R.S. 9:2800.57; Stahl v. Novartis Pharmaceuticals Corp., supra. Part A of 9:2800.57 imposes a duty on a manufacturer to "use reasonable care to provide an adequatewarningofsuchcharacteristicanditsdangerto usersandhandlersofthe product." (emphasis ours). Thus, the relevant statute imposes a duty on the manufacturer of the product to the consumer of the product. In our case, Sidmark has a duty under 9:2800.57 to "use reasonable care to provided adequate warning" to plaintiffas the "user" ofthe product.
Sidmark asks this court to lessen the duty owed by the manufacturer to the user under the learned intermediary doctrine by holding that a drug manufacturer's duty to warn is sufficient by notification to the wholesalers. Sidmark contends that no further notice to doctors is necessary. Consequently, Sidmark offered no evidence to show how it made a "reasonable attempt" to notify the doctor that the risk ofpriapism is serious, and that emergency treatment is necessary at the onset of symptoms. There is no testimony, or affidavit ofthe treating physician or any other medical professional to establish this vital link in Sidmark's defense.
We are not inclined to hold that a drug manufacturer fulfills its duty under the Louisiana Products Liability Law to use reasonable means to notify the user of the product by a mere warning to the wholesalers.
Without any medical testimony or affidavits from the treating physician or any other physician, that important element ofthe defense is missing. Therefore, we find Sidmark did not make the necessary showing that there is no question of
material fact undecided and that it is entitled to summaryjudgment as a matter of law. Accordingly, the trial court erred in granting summaryjudgment. The plaintiff's claim is reinstated. REVERSED
EDWARD A. DUFRESNE, JR. CHIEF JUDGE ,
SOL GOTHARD JAMES L. CANNELLA THOMAS F. DALEY
PETER J. FITZGERALD, JR. CLERK OF COURT
GENEVIEVE L. VERRETTE CHIEF DEPUTY CLERK
MARION F. EDWARDS GLYN RAE WAGUESPACK
SUSAN M. CHEHARDY CLARENCE E. McMANUS FIRST DEPUTY CLERK
FIFTH CIRCUIT
WALTER J. ROTHSCHILD JERROLD B. PETERSON
101 DERBIGNY STREET (70053)
DIRECTOR OF CENTRAL STAFF
POST OFFICE BOX 489
(504) 376-1400
JUDGES
GRETNA, LOUISIANA 70054 (504) 376-1498 FAX www.fiftheircuit.org
CERTIFICATE
I CERTIFY THAT A COPY OF THE OPINION IN THE BELOW-NUMBERED MATTER HAS BEEN MAILED
ON OR DELIVERED THIS DAY JANUARY 17, 2006 TO ALL COUNSEL OF RECORD AND TO ALL
PARTIES NOT REPRESENTED BY COUNSEL, AS LISTED BELOW:

PE ' . YZGE D,JR E FCO IT
05-CA-423
Cheryl A. McAnespy-Smith
Attomey at Law
1732 Fourth Street
Suite A
Harvey, LA 70058

Craig R. Nelson
Attomey at Law
234 Hector Avenue
Metairie, LA 70005

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