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________________________________________________________________________ _______________________________________________________________________ SCHERING CORPORATION, SCHERING-PLOUGH CORPORATION, VICTORIA L. McGILLS, R.N.
________________________________________________________________________ On appeal from the Circuit Court of Cook County, Illinois, County Department, Law Division, No. 04 L 9028.
The Honorable Marcia Maras, Judge Presiding _________________________________________________________________ ILLINOIS TRIAL LAWYERS ASSOCIATION
AMICUS BRIEF IN SUPPORT OF PLAINTIFF-APPELLANT
________________________________________________________________________ Leslie J. RosenLESLIE J. ROSEN, ATTORNEY AT LAW30 N. LaSalle Street, Suite 4020Chicago, IL 60602(312) 994-2435 Member, Illinois Trial Lawyers AssociationAmicus Curiae Committee POINTS AND AUTHORITIES
ARGUMENT
THIS COURT SHOULD NOT APPLY THE LEARNED
INTERMEDIARY DOCTRINE IN THIS CASE WHERE
DEFENDANTS REPLACED PLAINTIFF’S PHYSICIAN AS THE
PRIMARY PROVIDER OF INFORMATION TO HIM ABOUT THE
RISKS AND BENEFITS OF PEG-INTRON.
Introduction
In re Norplant Contraceptive Prods. Liab. Litig., 215 F.Supp.2d 795 Reyes v. Wyeth Labs., 498 F.2d 1264 (5th Cir.1974) Sterling Drug, Inc. v. Cornish, 370 F.2d 82 (8th Cir.1966) David J. Cooner, “The Intersection of Madison Avenue and the Learned Kirk v. Michael Reese Hospital and Medical Center, When the doctrine came into being, drug companies did not engage in
direct marketing to consumers.
State ex Rel. Johnson & Johnson Co. v. Karl, 220 W.Va 463, Francis B. Palumbo & C. Daniel Mullins, The Development of Direct-to-Consumer Prescription Drug Advertising Regulation, 57 FOOD & DRUG L.J. 422 (2002) Ozlem A. Bordes, The Learned Intermediary Doctrine and Direct-to-Consumer Advertising: Should the Pharmaceutical Manufacturer Be Shielded from Liability, 81 U.DET, MERCY L.REV. 267 (Spring 2004) Jon D. Hanson & Douglas A. Kysar, Taking Behavioralsism Seriously: Some Evidence of Market Manipulation, 112 HARV. L.REV. 1420 (1999) The pharmaceutical advertising paradigm undergoes a seismic shift.
Perez v. Wyeth Laboratories, Inc., 734 A.2d 1245 (1999) State ex Rel. Johnson & Johnson Co. v. Karl, 220 W.Va. 463, Julie M. Donohue et al., A Decade of Direct-to-Consumer Advertising of PrescriptionDrugs, 357 New England J. Med. 673 (2007) Larkin v. Pfizer, Inc., 153 S.W.3d 758, 771 (Ky. 2004) Centocor, Inc. v. Hamilton, ___ S.W.3d ___, 2010 WL 744212 Based on this paradigm shift, the doctrine should not always apply.
Kirk v. Michael Reese Hospital and Medical Center, The trial court erred in relying on an article in the Harvard Journal
of Law and Public Policy.
Victor E. Schwartz, Cary Silverman, Michael J. Hulka & Christopher E. Appel Marketing Pharmaceutical Products in the Twenty-First Century: An Analysis of the Continued Viability of Traditional Principles of Law in the Age of Direct-to-Consumer Advertising,32 Harv. J.L. & Pub. Pol’y 333 (2009) ARGUMENT
THIS COURT SHOULD NOT APPLY THE LEARNED
INTERMEDIARY DOCTRINE IN THIS CASE WHERE
DEFENDANTS REPLACED PLAINTIFF’S PHYSICIAN AS THE
PRIMARY PROVIDER OF INFORMATION TO HIM ABOUT THE
RISKS AND BENEFITS OF PEG-INTRON.
Introduction
“The learned intermediary doctrine provides an exception to the general rule imposing a duty on manufacturers to warn consumers about the risks of their products.” In re Norplant Contraceptive Prods. Liab. Litig., 215 F.Supp.2d 795, 803 (E.D.Tex.2002) (citing Reyes v. Wyeth Labs., 498 F.2d 1264, 1276 (5th Cir.1974); Sterling Drug, Inc. v. Cornish, 370 F.2d 82, 85 (8th Cir.1966)). The doctrine, which emerged from the development of strict product liability law, including the recognition of a cause of action for failure to warn, is premised on the notion that physicians who prescribe drugs “are in the best position to evaluate the risks associated with their use” and that patients rely on their doctors, not manufacturers, “to determine the appropriateness of prescribing products.” David J. Cooner, “The Intersection of Madison Avenue and the Learned Intermediary Doctrine,” http://library.findlaw.com/2003/Mar/7/132622.html.
In Kirk v. Michael Reese Hospital and Medical Center, 117 Ill.2d 507 (1987), the Illinois Supreme Court adopted the learned intermediary doctrine in a product liability case where the plaintiff, Kirk, a passenger in a vehicle driven by his friend, McCarthy, was injured when McCarthy drove into a tree. McCarthy had been prescribed Thorazine and Prolixin, and Kirk alleged that the defendant drug manufacturers had failed to adequately warn of the drugs’ dangers. The trial court dismissed the claims and the Appellate Court reversed the dismissals, holding that the drug manufacturers owed McCarthy a duty to warn. The Supreme Court reinstated the dismissals. Under the learned intermediary doctrine, “manufacturers of prescription drugs have a duty to warn prescribing physicians of the drugs’ known dangerous propensities, and the physicians, in turn, using their medical judgment, have a duty to convey the warnings to their patients.” Kirk, 117 Ill.2d at 517. The Kirk Court reasoned that a doctor was in the best position to prescribe drugs and monitor their use because he was knowledgeable of the propensities of the drugs he was prescribing and the susceptibilities of his patient. Kirk, 117 Ill.2d at 518. Consequently, in selling prescription drugs, the manufacturer is only required to warn the prescribing doctor, who then acts as a “learned intermediary” between the manufacturer and the consumer. Kirk, 117 Ill.2d at 518. The decision in Kirk was appropriate. The drug manufacturers were not advertising Thorazine or Prolixin to the public. There was no indication in the case that McCarthy had any dealings with any drug representatives or that they tried to sell him on the drugs or give him any warnings or other information about the drugs at all.
The facts of Kirk, however, are nothing like the facts at bar, where the defendants directly marketed their drug to plaintiffs.
The world has changed dramatically in the twenty-three years since Kirk was decided and medical practice and pharmaceutical marketing have changed along with it. As will be discussed below, the reasons for granting pharmaceutical companies this blanket immunity in general products liability law have eroded over this time. This Court should recognize the changed circumstances and refuse to apply the doctrine in cases like this one, where the defendant pharmaceutical manufacturer so insinuated itself into the patient’s decision-making process and worked so hard to convince patients, like plaintiff here, to use and continue to use its product for long-term treatment.
When the doctrine came into being, drug companies did not engage in direct
marketing to consumers.
When the learned intermediary doctrine was first developed, drug manufacturers did not advertise directly to the public. State ex Rel. Johnson & Johnson Co. v. Karl, 220 W.Va 463, 647 S.E.2d 899, 907 (2007), citing Francis B. Palumbo & C. Daniel Mullins, The Development of Direct-to-Consumer Prescription Drug Advertising Regulation, 57 FOOD & DRUG L.J. 422, 424 (2002); Ozlem A. Bordes, The Learned Intermediary Doctrine and Direct-to-Consumer Advertising: Should the Pharmaceutical Manufacturer Be Shielded from Liability, 81 U.DET, MERCY L.REV. 267, 274-75 (Spring 2004). The UpJohn Company changed that in the 1980's with its advertisements for Rogaine, to treat men’s hair-loss. See Jon D. Hanson & Douglas A. Kysar, Taking Behavioralsism Seriously: Some Evidence of Market Manipulation, 112 HARV. L.REV. 1420, 1456 The pharmaceutical advertising paradigm undergoes a seismic shift.
By 1999, the Supreme Court of New Jersey noted a seismic shift in the way medicine was practiced and drugs were prescribed in the United States. In Perez v. Wyeth Laboratories, Inc., 734 A.2d 1245, 1246-7 (1999), the Court stated as follows: Our medical-legal jurisprudence is based on images of health care that no longer exist. At an earlier time, medical advice was received in thedoctor’s office from a physician who most likely made house calls ifneeded. The patient usually paid a small sum of money to the doctor.
Neighborhood pharmacists compounded prescribed medicines. Withoutbeing pejorative, it is safe to say that the prevailing attitude of law andmedicine was that the “doctor knows best.” Logan v. Greenwich Hosp.
Ass’n, 191 Conn. 282, 465 A.2d 294, 299 (1983).
Pharmaceutical manufacturers never advertised their products to patients, but rather directed all sales efforts at physicians. In thiscomforting setting, the law created an exception to the traditional duty of manufacturers to warn consumers directly of risks associated with theproduct as long as they warned health-care providers of those risks.
For good or ill, that has all changed. Medical services are in large measure provided by managed care organizations. Medicines arepurchased in the pharmacy department of supermarkets and often paid forby third-party providers. Drug manufacturers now directly advertiseproducts to consumers on the radio, television, the Internet, billboards onpublic transportation, and in magazines. For example, a recent magazineadvertisement for a seasonal allergy medicine in which a person isstanding in a pastoral field filled with grass and goldenrod, attests that to“TAKE [THE PRODUCT]” is to “TAKE CLEAR CONTROL.” Anotherrecent ad features a former presidential candidate, encouraging theconsumer to “take a little courage” to speak with “your physician.” Thefirst ad features major side effects, encourages the reader to “talk to yourdoctor,” and lists a brief summary of risks and contraindications on theopposite page. The second ad provides a phone number and the name ofthe pharmaceutical company, but does not provide the name of the drug.
Recently, the Supreme Court of Appeals of West Virginia echoed the Perez Court’s discussion of the history of the doctrine, in State ex Rel. Johnson & Johnson Co. v. Karl, 220 W.Va. 463, 467, 647 S.E.2d 899, 907 (2007). Like the Perez Court, it Significant changes in the drug industry have post-dated the adoption of the learned intermediary doctrine in the majority of states inwhich it is followed. We refer specifically to the initiation and intenseproliferation of direct-to-consumer advertising, along with its impact onthe physician/patient relationship, and the development of the internet as acommon method of dispensing and obtaining prescription druginformation. [footnote omitted] When the learned intermediary doctrine was developed, direct-to- consumer advertising of prescription drugs was utterly unknown.
“Historically, prescription drug advertising in the United States wasdirected primarily to prescribers, who were once the sole decision-makerswhen choosing prescription medications.”Francis B. Palumbo & C. DanielMullins, The Development of Direct-to-Consumer Prescription DrugAdvertising Regulation, 57 Food & Drug L.J., 422, 424 (2002). See alsoOzlem A. Bordes, The Learned Intermediary Doctrine and Direct-to-Consumer Advertising: Should the Pharmaceutical Manufacturer Be Shielded from Liability?, 81 U. Det. Mercy L.Rev. 267, 274-75 (Spring2004) (“Originally, pharmaceutical manufacturers advertised to physiciansdirectly via medical journals or pharmaceutical representatives. Thegeneral public was less aware of what name brand drugs were on themarket.”) Id. at 471, 907. The Karl Court then analzyed the trend in the law and ultimately rejected the doctrine, finding that it was “largely outdated and unpersuasive.” In explaining its result, the Court stated: Since the 1997 proliferation of drug advertising, only four high courts have adopted the learned intermediary doctrine. See Vitanza v.
Upjohn Co., 257 Conn. 365, 778 A.2d 829 (2001); McCombs v. Synthes,277 Ga. 252, 587 S.E.2d 594 (2003); Larkin v. Pfizer, Inc., 153 S.W.3d758 (Ky.2004); Freeman v. Hoffman-La Roche, Inc., 260 Neb. 552, 618N.W.2d 827 (2000). In deciding to adopt the learned intermediarydoctrine, none of those courts gave thorough consideration to the changesthat have occurred in the prescription drug industry with respect to direct-to-consumer advertising. We, however, find such changes to be asignificant factor in deciding this issue, especially the impact direct-to-consumer advertising has had on the physician/patient relationship. SeeLarkin v. Pfizer, Inc., 153 S.W.3d 758, 770-71 (Wintersheimer, J.,dissenting) (“This Court should take notice of the abundantly obvious factthat the development of direct to consumer pharmaceutical advertising hasindelibly changed the realities of physician/patient relationships. Anyonewho watches television is regularly bombarded with a variety ofpharmaceutical products which suggest that the ultimate consumer ask hisphysician to prescribe a particular advertised product.”).
Studying the issue further, a 2007 article in the New England Journal of Medicine detailed that between 1996 and 2005, the pharmaceutical industry went from spending $985 million annually to $4.2 billion – an increase of 330% – on direct-to-consumer advertising of prescription drugs. (Julie M. Donohue et al., A Decade of Direct-to- Consumer Advertising of Prescription Drugs, 357 New England J. Med. 673, 676 Indeed, by 2010, you could not watch an hour of commercial television without being bombarded by advertisements suggesting that you ask your doctor to prescribe some particular drug, either to improve your sex life, fix your allergies or help you with your depression. This fact of modern life has been acknowledged. See e.g. Larkin v. Pfizer, Inc., 153 S.W.3d 758, 771 (Ky. 2004).
Most recently (March 4, 2010), the Court of Appeals of Texas, Corpus Christi- Edinburg, recognized an exception to the learned intermediary doctrine, in the case of Centocor, Inc. v. Hamilton, ___ S.W.3d ___, 2010 WL 744212 (Tex.App.-Corpus Christi). In that case of first impression, the Texas appellate court began by quoting the Perez decision and then held that based on the defendant drug manufacture, Centocor’s, direct marketing of its drug, Remicade, could not “rely on its adequate warnings to physicians to satisfy its duty to warn the ultimate consumer, the patient, who suffered from Crohn’s Disease, when it directly advertised to the patient in a misleading fashion.” In Hamilton ,much like in the case at bar, the defendant drug manufacturer insinuated itself fully in “patient education.” Specifically, the jury hearing that case found that the defendant manufacturer showed the patient a video that over-emphasized the benefits of Remicade, but intentionally omitted warnings about the adverse side-effects the patient suffered (lupus-like syndrome). The evidence at trial also showed, much like the evidence in the case at bar, that Centocor’s marketing strategy included physician education and patient “education.” The Court noted: Centocor’s goal was to make Remicade “top of mind” for everyrheumatoid arthritis patient. A chart admitted into evidence showsCentorcor’s plan for addressing patients, and it states that the goal is to“[m]ake the consumer aware the [medical] problem is treatable” and to“[e]ncourage the patient to request a specific drug.” Id. at *3. The manufacturer also required its sale associates to aggressively market to doctors and it attempted to minimize negative publicity about the potentially dangerous side effects of its product. Id. at *4. After describing the case law and numerous articles analyzing articles discussing direct-to-consumer marketing, the Hamilton Court detailed the changes in the practice of modern medicine. This discussion, although lengthy. describes modern medical life to a Alongside the increase in direct marketing, the practice of medicine has dramatically changed. Although a doctor still must write aprescription for prescription drugs, “[i]nformed consent now requires apatient-based decision rather than the paternalistic approach of the 1970s.” [Citation omitted.] Physicians no longer make the final decision as towhether a patient will take a drug-patients make those decisions. SeeTeresa Moran Schwartz, Consumer-Directed Prescription DrugAdvertising and the Learned Intermediary Rule, 46 Food Drug Cosm. L.J.
829, 831 (1991). Moreover, the time doctors spend with their patients, andthus the time spent in a serious discussion of the risks of pharmaceuticals,has changed-managed care has reduced the time allotted per patient to ten-or fifteen-minute appointments, and now patients spend more time inwaiting rooms than they do with their doctor. See Perez, 734 A.2d at 1255.
“ ‘In a 1997 survey of 1,000 patients, the F.D.A. found that only one-thirdhad received information from their doctors about the dangerous sideeffects of drugs they were taking.’” Id. (quoting Sheryl Gay Stolberg,Faulty Warning Labels Add to Risk in Prescription Drugs, N.Y. Times,June 4, 1999, at A27).
The impact of advertising on the physician-patient relationship has been dramatic. In 1982, the FDA formally requested a moratorium ondirect advertising in order to allow it to study the issue. Palumbo &Mullins, 57 Food & Drug L.J. at 424. The FDA studies revealed thatconsumers who viewed advertising for prescription drugs typically“retained more information about the benefits of the products than therisks.” Id. (citing Louis A. Morris & Lloyd G. Millstein, Drug Advertisingto Consumers: Effects of Formats for Magazine and TelevisionAdvertisements, 39 Food & Drug L.J. 497 (1984)). The FDA also foundthat “consumers wanted more information about prescription drugs andwould view direct-to-consumer advertising favorably.” Id. (citing Louis A.
Morris, David Brinberg & Ron Klimberg et al., The Attitudes of Consumers Toward Direct Advertising of Prescription Drugs, 101 Pub.
Health Rep. 82 (1986)).
After years of patients being subjected to direct advertising, physicians state that they are increasingly asked and pressured by theirpatients to prescribe drugs that the patient has seen advertised. Forexample, the diet drug combinations known as fen-phen was prescribeddespite little hard scientific evidence of its potential side effects.
Physicians are under attack for prescribing pills too often and too readilyto inappropriate patients. Physicians argue it is not their fault; rather, theyclaim pushy patients, prodded by [direct-to-consumer] advertisements,pressed, wheedled, begged and berated them for quick treatments.
Physicians claim that it is impossible to compete with pharmaceuticalcompanies’ massive advertising budgets, and resign themselves to the factthat if consumers make enough noise, they will eventually relent to patient pressure.
Tamar V. Terzian, Note, Direct-to-Consumer Prescription DrugAdvertising, 25 Am. J.L. & Med. 149, 157-58 (1999).
Based on this shift in the world of medicine and pharmaceutical marketing, the Hamilton Court held that the theoretical underpinnings of the doctrine did not apply in First, although a doctor must still write a prescription for prescriptiondrugs, it is clear that many doctors are not spending the amount of timenecessary to pass along warnings by pharmaceutical companies. [Citationomitted.] The problem this creates is compounded by the fact that patientsnow make the ultimate decisions regarding the drugs they will take andoften ask for drugs by name. [Citation omitted.] Second, drugmanufacturers who directly market their products to consumers are hard-pressed to argue that only a physician would understand the propensitiesand dangers involved and that they lack effective means to communicatedirectly with consumers. In fact, by directly marketing to consumers andproviding warnings in those advertisements, drug manufacturers havecompletely undermined their own arguments. [Citation omitted.] Third,and similarly, “it is illogical that requiring manufacturers to provide directwarnings to a consumer will undermine the patient-physician relationship,when, by its very nature, consumer-directed advertising encroaches on thatrelationship by encouraging consumers to ask for an advertised product byname. [Citations omitted.] Based on this paradigm shift, the doctrine should not always apply.
ITLA maintains that this case at bar presents a situation where it would be “appropriate to impose on the manufacturer the duty to warn the patient directly.” Although Mr. Hernandez’s physician still had to write a prescription for Peg-Intron, defendants so insinuated themselves into the doctor-patient relationship, and so took it upon themselves to “educate”, or rather “indoctrinate” Mr. Hernandez about the side effects of their drug that they should not be absolved of liability for their negligent The testimony below was undisputed that Schering conducted 1½ hour patient education classes about Peg-Intron and that half of that time was spent discussing “the full range of possible side effects.” (R. C520, C1015; C3061.) These classes were for potential drug users, not just individuals who had already agreed to take Peg-Intron. (R.
C520, C1015, C3056.) Clearly, in today’s medical world, no doctor would ever spend that much time with a patient to discuss one particular drug that the doctor was considering prescribing to a patient. Schering knew that and jumped in to fill the void. (R. C3068.) Mr. Hernandez’s own doctor relied on Schering to fill the void. (R. C3079, Schering, through its marketing department, hired a nurse to teach the class. (R.
C518-21; C3067; C3074; C3097.) Schering trained the nurse to teach the class. (R.
Schering distributed promotional materials to the students at its class. (R.
C3041.) The most significant document it provided was entitled “Understanding the Side Effects of Interfreron Therapy.” (R. C3105.) Nothing in this document, or the oral presentation accompanying it, mentioned the potential for permanent vision loss. (R.
C3109-10; C3119; C2532-3.) Nor was this document approved by the FDA prior to its dissemination. (R. C3067.) Further, and quite significantly, nothing about the oral content of this promotional class was regulated by the FDA. (R. C3099.) Schering’s goal was to promote patient compliance, or as plaintiffs stated below, to get patients “on the drug and stay on it.” This class was purely promotional and most important to Schering’s goal because Schering had a problem with patients discontinuing use of Peg-Intron. (R. C3041; C3030-2.) Schering provided a 24-hour, 7 day-a-week call in service to talk to patients about side effects and management. (R. C3062; C3094.) Plaintiffs attended one of these classes months before Gilberto Hernandez began taking Peg-Intron. (R. C3106; C3116-7.) Gilberto relied on defendants’ promotional materials and the class in making his decision to use Peg-Intron. (R. C31399-6.) Had Gilberto Hernandez been properly and adequately informed of all of the risks associated with the drug, he could have declined the opportunity to take it. Indeed, he would have declined to take Peg Intron. (R. C3118.) In other words, due to defendants’ voluntary assumption of the responsibility to inform plaintiffs of the risks and benefits of Peg-Intron, and their failure to fully inform plaintiffs about the risks of Peg-Intron, Gilberto Hernandez never was able to give informed consent when he agreed to take the drug. As a result of this un-informed consent, Gilberto Hernandez sustained permanent optic neuropathy which rendered him Simply stated, this case is nothing like Kirk v. Michael Reese, 117 Ill.2d 507 (1987), and the Illinois Supreme Court never contemplated application of the learned intermediary doctrine to facts remotely similar to these when it adopted the learned intermediary doctrine. There was no direct-to-consumer advertising. There were no home computers. There was no internet. There was no cable television. The world was In a case like this one, this Court should hold that the learned intermediary doctrine is inapplicable as it is “largely outdated and unpersuasive.” The trial court erred in relying on an article in the Harvard Journal of Law
and Public Policy.
Finally, ITLA must note that the trial court’s reliance below on a seemingly unbiased and educational law review article that appeared in a venerable Harvard University journal, was grossly misplaced. The article, Marketing Pharmaceutical Products in the Twenty-First Century: An Analysis of the Continued Viability of Traditional Principles of Law in the Age of Direct-to-Consumer Advertising, 32 Harv.
J.L. & Pub. Pol’y 333 (2009), was hardly neutral and unbiased. It was authored by Victor E. Schwartz, Cary Silverman, Michael J. Hulka & Christopher E. Appel. Mr. Schwartz, a pre-eminent American lawyer, member of the Washington D.C. law firm of Shook, Hardy & Bacon L.L.P., and general counsel to the American Tort Reform Association, never misses an opportunity to weigh in in favor of manufacturers. The law firm’s web site In addition to its well-earned reputation as an international litigation powerhouse, Shook, Hardy & Bacon is equally as renowned forits expertise in tort reform. Members of Shook’s Public Policy Practicehave been involved in virtually every major legislative effort involvingcivil justice reform at the state and federal levels over the past twodecades.
Based on the nature of this firm’s strong commitment to tort reform, the authors’ conclusion, that the learned intermediary doctrine should remain the law, was a foregone conclusion. This Court should carefully consider the source when weighing the value of CONCLUSION
For all of the reasons stated above, and all of the reasons advanced in plaintiff’s appellant brief, amicus curiae Illinois Trial Lawyers Association urges this Court to reverse the trial court’s order granting summary judgment to defendants Schering Corporation, Schering-Plough Corporation and Victoria L. McGill, R.N. on the negligence claims in this product liability and fraud action.
Leslie J. Rosen Member, Amicus Curiae CommitteeIllinois Trial Lawyers AssociationLeslie J. Rosen, Attorney at Law30 N. LaSalle StreetSuite 4020Chicago, IL 60602(312) 994-2435 CERTIFICATE OF COMPLIANCE
I certify that this brief conforms to the requirements of Rules 343(a) and (b). The length of the brief, excluding the pages containing the Rule 341(d) cover, the Rule341(h)(1) statement of points and authorities, the Rule 341(c) certificate of compliance,the certificate of service, and those matters to be appended to the brief under Rule 342(a)is 14 pages.

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