SUPREME COURT OF FLORIDA CASE NO. SC10-49 ADAM W. MASON, Petitioner, vs. HOFFMAN-LA ROCHE INC. and ROCHE LABORATORIES INC., Respondents. ON REVIEW FROM THE DISTRICT COURT OF APPEAL, FIRST DISTRICT, CASE NO. 1D08-2032 PETITIONER S JURISDICTIONAL BRIEF TALBOT D ALEMBERTE Fla. Bar No. 0017529 D ALEMBERTE & PALMER P.O. Box 10029 Tallahassee, Florida 32302 (850) 325-6292 MICHAEL D. HOOK Fla. Bar No. 309826 STEPHEN F. BOLTON Fla. Bar No. 327859 HOOK & BOLTON, P.A. 3298 Summit Boulevard, Suite 22 Pensacola, Florida 32503 (850) 433-0809 LOUIS K. ROSENBLOUM Fla. Bar No. 194435 LOUIS K. ROSENBLOUM, P.A. 4300 Bayou Boulevard, Suite 36 Pensacola, Florida 32503 (850) 475-1211 MARY JANE BASS Fla. Bar No. 0064858 BEGGS & LANE, RLLP 501 Commendencia Street Pensacola, Florida 32502 (850) 432-2451 Attorneys for Petitioner
TABLE OF CONTENTS TABLE OF CONTENTS i TABLE OF CITATIONS STATEMENT OF THE CASE AND FACTS 1 SUMMARY OF ARGUMENT 3 ARGUMENT 5 I. The district court decision in Mason expressly and directly conflicts with Felix and Buckner by erroneously removing the patient s decision from the proximate cause analysis in pharmaceutical manufacturer failure to warn actions decided under the learned intermediary doctrine. 5 II. The district court decision in Mason expressly and directly conflicts with Felix and Buckner by applying the learned intermediary doctrine a principle related solely to the manufacturer s duty to warn to the issue of proximate cause. 8 CONCLUSION 10 CERTIFICATE OF SERVICE CERTIFICATE OF TYPE SIZE AND STYLE i
TABLE OF CITATIONS CASES Aguilera v. Inservices, Inc., 905 So. 2d 84 (Fla. 2005)... 9 Aravena v. Miami-Dade County, 928 So. 2d 1163 (Fla. 2006)... 7 Buckner v. Allergan Pharm., Inc., 400 So. 2d 820 (Fla. 5th DCA), rev. denied, 407 So. 2d 1102 (Fla. 1981)... passim Felix v. Hoffmann-La Roche, Inc., 540 So. 2d 102 (Fla. 1989)... passim Hoffmann-La Roche Inc. and Roche Laboratories Inc. v. Adam W. Mason, Case No. 1D08-2032 (Fla. 1st DCA Oct. 27, 2009)... passim In re Diet Drug Litigation, 384 N.J. Super. 525, 895 A.2d 480 (N.J. Super. Law Div. 2005)... 6 In re Guardianship of Browning, 568 So. 2d 4 (Fla. 1990)... 8 Thomas v. Berrios, 348 So. 2d 905 (Fla. 2d DCA 1977)... 7 ZeBarth v. Swedish Hosp. Med. Ctr., 499 P.2d 1 (Wash. 1972)... 6 OTHER AUTHORITIES Article V, Section 3(b)(3), Florida Constitution... 1 ii
STATEMENT OF THE CASE AND FACTS Petitioner Adam W. Mason seeks review of the decision of the District Court of Appeal, First District, in Hoffmann-La Roche Inc. and Roche Laboratories Inc. v. Adam W. Mason, Case No. 1D08-2032 (Fla. 1st DCA Oct. 27, 2009), based on express and direct conflict with decisions of the District Court of Appeal, Fifth District, and the Supreme Court of Florida. See Art. V, 3(b)(3), Fla. Const. Respondents Hoffmann La-Roche Inc. and Roche Laboratories Inc. ( Roche ) manufacture and market the acne medication Accutane which a dermatologist, Dr. George Fisher, and a family practitioner, Dr. Kenneth Counselman, prescribed to Mason for severe acne. Mason, slip op. at 2. While taking the medication, Mason developed Crohn s disease, an incurable form of inflammatory bowel disease ( IBD ). Id. at 2. Mason subsequently filed suit against Roche under theories of strict liability and negligent failure to warn, alleging Accutane s label failed to warn that Accutane causes IBD. Id. When Dr. Fisher prescribed Accutane for Mason, the label contained the following warning: Inflammatory Bowel Disease: Accutane has been temporally associated with inflammatory bowel disease (including regional ileitis) in patients without a prior history of intestinal disorders. Patients experiencing abdominal pain, rectal bleeding or severe diarrhea should discontinue Accutane immediately. Id. at 3 (underlining supplied). Mason presented evidence at trial that Roche s 1
Accutane warning label was inadequate because the term temporal did not accurately describe the causal relationship between Accutane and IBD. Id. According to the district court opinion, Dr. Fisher testified that he understood the phrase temporally associated to mean that there was at least a possibility of a causal relationship between Accutane and IBD. Id. He also testified that he would have prescribed Accutane for Appellant even if the label warned that Accutane could cause IBD. Id. At the close of Mason s case, Roche moved for a directed verdict, arguing Mason failed to establish his injury was proximately caused by any inadequacies in the Accutane warning label. Id. After the trial court denied the motion, the jury returned a verdict in Mason s favor, finding that Roche placed Accutane on the market with an inadequate warning to Mason s physicians about the risk of developing IBD, and that the failure to provide an adequate warning was a substantial contributing cause of Mason s development of IBD. Id. at 1-2. On appeal, the district court acknowledged Mason s evidence showing Roche breached its duty to warn, but held Mason failed to establish proximate cause as a matter of law. The district court concluded: Because Appellee presented no evidence from either treating physician that a differently worded warning would have resulted in either physician not prescribing Accutane for his extreme acne, Appellee failed to establish that the allegedly deficient warning was the proximate cause of his injury; therefore, we reverse. 2
Id. at 2. Citing Felix v. Hoffmann-La Roche, Inc., 540 So. 2d 102 (Fla. 1989), and Buckner v. Allergan Pharm., Inc., 400 So. 2d 820 (Fla. 5th DCA), rev. denied, 407 So. 2d 1102 (Fla. 1981), the district court reasoned there was no causal connection between Roche s inadequate warning label and Mason s IBD because Dr. Fisher, who acted as the learned intermediary between Roche and Mason, testified that even if the warning label contained all of the information suggested by Appellee s expert, he would still have prescribed the medication for Appellee. Mason, slip op. at 4. The district court s opinion does not mention whether a differently worded warning would have led the physicians to give Mason different advice about the risks of taking Accutane or whether, with different advice on risks, the patient would have consented to the treatment. SUMMARY OF ARGUMENT This Court s decision in Felix and the fifth district s decision in Buckner apply the learned intermediary doctrine to Florida product liability actions which allege a pharmaceutical manufacturer s failure to warn. Under the learned intermediary doctrine, a prescription drug manufacturer discharges its duty to warn by providing physicians with accurate, clear, and unambiguous information concerning the risks associated with taking the drug. Felix, 540 So. 2d at 105. This information enables the physician to communicate to the patient the benefits 3
and risks of taking the prescription drug which in turn enables the patient to make an informed decision whether to take the medication. The district court decision in Mason expressly and directly conflicts with Felix and Buckner by misapplying the learned intermediary doctrine in two material respects related to proximate cause. First, the district court held Mason failed to establish Roche s inadequate warning label proximately caused Mason s IBD because Mason presented no evidence from either treating physician that a differently worded warning would have resulted in either physician not prescribing Accutane for his extreme acne. Mason, slip op. at 2. In reaching this conclusion, the district court erroneously failed to consider whether the prescribing physician would have communicated the stronger adequate warning to the patient and further failed to consider whether Mason would have taken Accutane had the prescribing physician communicated the stronger warning. The district court s decision conflicts with Felix and Buckner because both cases include the prescribing physician s advice and the patient s decision whether to take the drug as essential elements of proximate cause. Second, Mason expressly and directly conflicts with Felix and Buckner because the district court erroneously interjected the learned intermediary doctrine a principle related solely to the manufacturer s duty to warn into the separate issue of proximate cause. 4
ARGUMENT I. The district court decision in Mason expressly and directly conflicts with Felix and Buckner by erroneously removing the patient s decision from the proximate cause analysis in pharmaceutical manufacturer failure to warn actions decided under the learned intermediary doctrine. As noted by the court below, to prevail in a product liability action based on a pharmaceutical manufacturer s failure to warn, the plaintiff must establish (1) the warning label was inadequate, (2) the inadequacy of the warning proximately caused plaintiff s injury, and (3) plaintiff suffered damages from using the drug. See Mason, slip op. at 3-4. As the discussion below indicates, the first district s decision in Mason expressly and directly conflicts with Felix v. Hoffmann-La Roche, Inc., 540 So. 2d 102 (Fla. 1989), and Buckner v. Allergan Pharm., Inc., 400 So. 2d 820 (Fla. 5th DCA 1981), rev. denied, 407 So. 2d 1102 (Fla. 1981), in its approach to the second element, proximate cause. The first element whether the warning label was inadequate relates to the pharmaceutical manufacturer s duty to warn under the learned intermediary doctrine. As explained by this Court in Felix: [I]t is clear that the manufacturer s duty to warn of Accutane s dangerous side effects was directed to the physician rather than the patient. Buckner v. Allergan Pharmaceuticals, Inc., 400 So. 2d 820 (Fla. 5th DCA), review denied,407 So.2d 1102 (Fla.1981). This is so because the prescribing physician, acting as a learned intermediary between the manufacturer and the consumer, weighs the potential benefits against the dangers in deciding whether to recommend the drug to meet the patient s needs. 5
Felix, 540 So. 2d at 104. The second element, proximate cause, turns on the question whether the patient would have taken the drug after receiving the physician s warning. See Felix, 540 So. 2d at 105. The Buckner court explained this point: A doctor s duty is to inform his patient what a reasonable prudent medical specialist would tell a person of ordinary understanding of the serious risks and the possibility of serious harm which may occur from a supposed course of therapy so that the patient s choice will be an intelligent one, based upon sufficient knowledge to enable him to balance the possible risks against the possible benefits. Buckner, 400 so. 2d at 823 (quoting ZeBarth v. Swedish Hosp. Med. Ctr., 499 P.2d 1, 11 (Wash. 1972)). Thus, Buckner not only recognizes the physician s role in recommending a prescription medication based on information provided by the manufacturer, the decision also recognizes that the patient makes the final decision whether to follow the physician s advice. 1 The district court decision in Mason conflicts with Felix and Buckner by erroneously holding that proximate cause turns solely on the question whether a 1 One New Jersey court observed: In modern medicine, the decision-making process as to whether or not to employ a particular recommended treatment, including the use of prescription drugs, is collaborative. The physician should explain to the patient the risks and benefits of the medical procedure, as well as any reasonable alternatives. Ultimately, the patient, armed with this information, makes the decision whether to proceed. In re Diet Drug Litigation, 384 N.J. Super. 525, 895 A.2d 480, 489 (N.J. Super. Law Div. 2005). 6
stronger warning label would have changed the doctor s decision to prescribe the drug. In this respect, the court below held Roche was entitled to a directed verdict on proximate cause because Mason presented no evidence from either treating physician that a differently worded warning would have resulted in either physician not prescribing Accutane for his extreme acne. Mason, slip op. at 2. Under Felix and Buckner, however, the issue of proximate depends on whether an adequate warning would have caused the physician to warn his patient differently and whether the patient would have elected to take the medication after receiving the physician s different warning. The Mason decision, therefore, is irreconcilable with Felix and Buckner, creating express and direct conflict. See Aravena v. Miami-Dade County, 928 So. 2d 1163, 1166-67 (Fla. 2006) (invoking conflict jurisdiction where district court of appeals decisions are irreconcilable ). 2,3 2 In dicta, the Felix court found the manufacturer was entitled to a directed verdict on the issue of proximate cause because a stronger warning would not have enhanced the prescribing physician s understanding of the birth defect risk. In Mason, however, although the prescribing physician testified the existing warning label raised a possibility of a causal relationship between Accutane and IBD, the opinion below does not indicate whether the prescribing physician was aware of all the information contained in the stronger warning proposed by Mason s evidence. Mason, slip op. at 4 (emphasis supplied). 3 By removing the patient s decision from the proximate cause analysis, the district court decision below also conflicts with decisions recognizing the doctrine of informed consent which requires a physician to provide information essential to enable a patient of ordinary understanding to intelligently decide whether to incur the risk by accepting the proposed treatment or avoid that risk by foregoing it. Thomas v. Berrios, 348 So. 2d 905, 907 (Fla. 2d DCA 1977). In that same 7
II. The district court decision in Mason expressly and directly conflicts with Felix and Buckner by applying the learned intermediary doctrine a principle related solely to the manufacturer s duty to warn to the issue of proximate cause. Under the learned intermediary doctrine, a prescription drug manufacturer discharges its duty to warn by providing prescribing physicians with information about the risks associated with the drug. See Felix, 540 So. 2d at 104; Buckner, 400 So. 2d at 822. The sufficiency and reasonableness of a manufacturer s warning ordinarily raises a question of fact for the jury unless the warning is accurate, clear, and unambiguous as a matter of law. Felix, 540 So. 2d at 105. As indicated by Felix and Buckner, the learned intermediary doctrine relates solely to the manufacturer s duty to warn. See Felix, 540 So. 2d at 104; Buckner, 400 So. 2d at 822. The decision below, however, applied the learned intermediary doctrine to the separate issue of proximate cause. In this respect, the Mason court held Roche was entitled to a directed verdict on proximate cause because Mason presented no evidence from either treating physician that a differently worded warning would have resulted in either physician not prescribing Accutane for his extreme acne. Mason, slip op. at 2. The question, however, whether the vein, the Mason decision also conflicts with decisions recognizing that a competent person has the constitutional right to choose or refuse medical treatment, and that right extends to all relevant decisions concerning one s health. In re Guardianship of Browning, 568 So. 2d 4, 11 (Fla. 1990). 8
prescribing physician would have still recommended the drug had the manufacturer provided a stronger warning relates to the adequacy of the warning, that is, whether the manufacturer discharged its duty to warn, not to the issue of proximate cause which depends on whether an adequate warning would have caused the physician to advise his patient differently and whether the patient then would have taken the drug after receiving the physician s strengthened warning. By applying the duty-related learned intermediary doctrine to the separate issue of proximate cause, the decision below misapplies Felix and Buckner, creating express and direct conflict with those decisions. See Aguilera v. Inservices, Inc., 905 So. 2d 84, 95 (Fla. 2005) (finding conflict jurisdiction where district court s decision misapplied this Court s holding in another case). Roche will likely argue the decision below is consistent with Felix as both cases involve the same Roche product. Although the patient in Felix took the same drug as Mason (Accutane), the Felix decision involves a different side effect (birth defects) and distinguishable facts. Indeed, the contrast between the warnings given in Mason and those in Felix could not be more vivid. In Felix, Roche gave extensive warnings about the danger Accutane posed to pregnant women in several different ways in the CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections of the label. Id. at 103-04. Not surprisingly, the Felix court approved a directed verdict for the manufacturer because the warning label 9
related to birth defects was accurate, clear, and unambiguous. Id. at 105. In marked contrast, the Accutane warning label for IBD quoted in the opinion below contains language which is ambiguous on its face ( temporally associated ), Mason, slip op. at 3, leading the jury to find that Appellants placed Accutane on the market with an inadequate warning to Appellee s physicians about the risk of developing inflammatory bowel disease. Id. at 2. CONCLUSION This Court should accept jurisdiction and decide the case on the merits. Respectfully submitted: TALBOT D ALEMBERTE Fla. Bar No. 0017529 D ALEMBERTE & PALMER P.O. Box 10029 Tallahassee, Florida 32302 (850) 325-6292 MICHAEL D. HOOK Fla. Bar No. 309826 STEPHEN F. BOLTON Fla. Bar No. 327859 HOOK & BOLTON, P.A. 3298 Summit Boulevard, Suite 22 Jefferson Office Park Pensacola, Florida 32503 (850) 433-0809 (850) 433-8284 (fax) LOUIS K. ROSENBLOUM Fla. Bar No. 194435 LOUIS K. ROSENBLOUM, P.A. 4300 Bayou Boulevard, Suite 36 Pensacola, Florida 32503 (850) 475-1211 (850) 475-1290 (fax) lrosenbloum@rosenbloumlaw.com MARY JANE BASS Fla. Bar No. 0064858 BEGGS & LANE, RLLP 501 Commendencia Street Pensacola, Florida 32502 (850) 432-2451 (850) 469-3331 (fax) Attorneys for Petitioner 10
CERTIFICATE OF SERVICE I HEREBY CERTIFY that a copy of the foregoing has been furnished to the following by U.S. Mail this 19th day of January, 2010: Michael X. Imbroscio, Esquire Paul W. Schmidt, Esquire Covington & Burling LLP 1201 Pennsylvania Avenue, NW Washington, DC 20004 Attorneys for Respondents Michael J. Ryan, Esquire Krupnick, Campbell 700 SE Third Avenue Courthouse Law Plaza, Suite 100 Ft. Lauderdale, Florida 33316 Attorneys for Petitioner Charles F. Beall, Jr., Esquire Moore, Hill & Westmoreland Post Office Box 13290 Pensacola, Florida 32591 Attorneys for Respondents Edward A. Moss, Esquire Shook, Hard & Bacon LLP Miami Center, Suite 2400 201 South Biscayne Boulevard Miami, Florida 33131 Attorneys for Respondents Barry Richard, Esquire Arthur J. England, Jr., Esquire Greenberg Traurig 101 East College Avenue Tallahassee, Florida 32301 Attorneys for Respondents Timothy M. O Brien, Esquire Levin, Papantonio 316 South Baylen Street, Suite 600 Pensacola, Florida 32502 (850) 435-7000 (850) 435-7020 (fax) Attorneys for Petitioner CERTIFICATE OF TYPE SIZE AND STYLE The undersigned attorney hereby certifies that this brief was prepared using a 14-point Times New Roman font in accordance with Rule 9.210(a)(2), Florida Rules of Appellate Procedure. LOUIS K. ROSENBLOUM Fla. Bar No. 194435