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In re Accutane Litigation

Supreme Court of New Jersey

October 3, 2018

IN RE: ACCUTANE LITIGATION

          Argued April 23, 2018

          On certification to the Superior Court, Appellate Division.

          Paul W. Schmidt (Covington & Burling) of the District of Columbia bar, admitted pro hac vice, and Edward J. Dauber (Greenberg Dauber Epstein & Tucker) argued the cause for appellants/cross-respondents Hoffmann-La Roche Inc. and Roche Laboratories Inc. (Gibbons, Dughi Hewit & Domalewski, and Covington & Burling, attorneys; Natalie H. Mantell, Russell L. Hewit, Paul W. Schmidt, and Michael X. Imbroscio (Covington & Burling) of the District of Columbia bar, admitted pro hac vice, of counsel and on the briefs) .

          Bruce D. Greenberg and David R. Buchanan argued the cause for respondents/cross-appellants Angelo Annuzzi, et al. (Lite DePalma Greenberg, Seeger Weiss, Weitz & Luxenberg, and Beggs & Lane, attorneys; Bruce D. Greenberg, David R. Buchanan, Peter Samberg, and Mary Jane Bass (Beggs & Lane) of the Florida bar, admitted pro hac vice, on the briefs).

          Edward J. Fanning, Jr. argued the cause for amicus curiae Healthcare Institute of New Jersey (McCarter & English, and Reed Smith, attorneys; Edward J. Fanning, Jr., David R. Kott, Gary R. Tulp, Daniel K. Winters, and Philip W. Danziger, on the brief).

          Adam M. Slater argued the cause for amicus curiae New Jersey Association for Justice (Mazie Slater Katz & Freeman, attorneys; Adam M. Slater, of counsel and on the brief).

          ALBIN, J., writing for the Court.

         This appeal arises from 532 product-liability claims filed against Hoffmann-La Roche Inc. and Roche Laboratories Inc. (collectively Roche), corporations with their principal places of business in New Jersey. Roche developed, manufactured, marketed, and labeled Accutane, a prescription medication for the treatment of severe and persistent cases of acne. Plaintiffs allege that Accutane, prescribed by their physicians, caused them to contract inflammatory bowel disease (IBD) and that Roche failed to give adequate label warnings to advise them of the known risks of the medication. Of the 532 plaintiffs, 18 are New Jersey residents and 514 are residents of 44 other jurisdictions. Plaintiffs' claims are designated as Multicounty Litigation (MCL) and consolidated in the Atlantic County Superior Court.

         The Court considers two issues. The first is what law governs whether Roche's label warnings were adequate - the law of each of the 45 jurisdictions in which plaintiffs were prescribed and took Accutane or the law of New Jersey where the 532 cases are consolidated. The second issue is the adequacy of the label warnings for the period after April 2002. Because Roche's warnings received the approval of the FDA, they enjoy a "rebuttable presumption" of adequacy under New Jersey's Products Liability Act (PLA). See N.J.S.A. 2A:58C-4. That presumption provides pharmaceutical companies greater protection in New Jersey than in many other jurisdictions.

         By April 10, 2002, Roche had generated a variety of FDA-approved Accutane warning labels and materials for a target audience of prescribing physicians, pharmacists, and patients. The physician label advises prescribing physicians that not only has IBD been associated with the taking of Accutane, but that symptoms of the disease "have been reported to persist after Accutane treatment has been stopped." In addition, Roche provided physicians with a Best Practices Guide, as well as a Patient Safety Packet to give to their patients. Roche developed, in conjunction with the FDA, a Medication Guide for pharmacists to distribute to Accutane patients when they received their prescriptions. Like the Patient Safety Packet, the Medication Guide warned of "possible serious side effects" from Accutane and described IBD symptoms in simple and plain language. Roche also required pharmacists to dispense Accutane pills in "blister packaging" that again warned the patient that Accutane could have serious gastrointestinal side effects. Accordingly, by 2002, before taking Accutane, patients received the IBD warnings from their prescribing physicians and from their pharmacies. The FDA reviewed and approved each of Roche's warning tools.

         Plaintiffs focus on excerpts from several internal Roche documents as evidence that Roche should have given better warnings.

         In 2015, in a series of rulings, the trial court concluded that the New Jersey PLA governed not only the 18 in-state claims but also the 514 claims that involved plaintiffs who were prescribed and took Accutane in 44 other jurisdictions. The court granted Roche's motion for summary judgment, determining that plaintiffs failed to overcome the presumption of adequacy that attached to the post-2002 Accutane label warnings approved by the FDA. The court dismissed the 532 product-liability actions brought against Roche.

         The Appellate Division reversed in part and affirmed in part. Applying the relevant sections of the Restatement (Second) of Conflict of Laws ("Restatement"), the panel concluded that each individual case had to be judged under the substantive law of the jurisdictions where each plaintiff was prescribed and took Accutane - forty-five jurisdictions in all. The panel affirmed the grant of summary judgment in favor of Roche in those cases involving plaintiffs who were prescribed and took Accutane in seven states because "[i]t is enough in these jurisdictions that IBD was referenced" in Roche's label warnings to render them adequate as a matter of law. The panel also affirmed the grant of summary judgment in those cases involving the Texas plaintiffs because they had not overcome that jurisdiction's presumption of adequacy. The panel, however, found that the trial court improvidently granted summary judgment in the cases of those plaintiffs from the remaining thirty-seven jurisdictions because "the adequacy of the warnings could not be resolved as a matter of law." Under New Jersey's PLA, the panel held that plaintiffs had presented sufficient evidence to overcome the presumption of adequacy attached to Accutane's FDA-approved warnings and therefore genuine issues of material fact needed to be resolved by a jury.

         The Court granted Roche's petition for certification, 231 N.J. 419 (2017), and plaintiffs' cross-petition, 231 N.J. 428 (2017).

         HELD: The Court now reverses in all those cases in which the Appellate Division reinstated plaintiffs' actions against Roche. New Jersey has the most significant interests, given the consolidation of the 532 cases for MCL purposes. New Jersey's interest in consistent, fair, and reliable outcomes cannot be achieved by applying a diverse quilt of laws to so many cases that share common issues of fact. Plaintiffs have not overcome the PLA's presumption of adequacy for medication warnings approved by the FDA. As a matter of law, the warnings provided physicians with adequate information to warn their patients of the risks of IBD.

         1. The Court applies New Jersey's choice-of-law rules in determining whether this State's or another state's law governs the action. The Court thus compares New Jersey's PLA to the product-liability laws or analogues of forty-four other jurisdictions and notes that New Jersey's rebuttable presumption of adequacy, which specifically attaches to FDA-approved warnings, sets New Jersey law apart from most other states' laws. That conflict of substantive law requires choosing the law or laws that govern the 532 cases, (pp. 31-35)

         2. In this MCL setting, New Jersey's PLA intersects with the laws of 44 other jurisdictions in 514 cases. In Ginsberg v. Quest Diagnostics, Inc., the Court "acknowledge[d] that a defendant-by-defendant choice-of-law analysis is not feasible in every matter," particularly "[i]n a complex case with many parties from different states." 227 N.J. 7, 20 (2016). In such a scenario, "the trial court retains the discretion to decline a defendant-by-defendant approach and, utilizing a Restatement §§ 146, 145 and 6 analysis . . . apply the law of a single state to claims asserted against all defendants." Ibid. Under the most-significant-relationship test in personal injury cases, the analysis begins with section 146 and the presumption that the law of the state where the injury occurred applies. P.V. Ex rel. TV. v. Camp Jaycee, 197 N.J. 132, 135-36 (2008). That presumption may be overcome if "some other state has a more significant relationship with the parties and the occurrence based on an assessment of each state's contacts" viewed through the prism of section 145, which sets forth general principles for tort actions, and section 6, which lists overarching choice-of-law principles. McCarrell v. Hoffmann-La Roche. Inc.. 227 N.J. 569, 590 (2017). (pp. 35-38)

         3. In the case of 514 plaintiffs, the injuries caused by the putative failure to give adequate warnings occurred in forty-four other jurisdictions, but New Jersey is where the alleged conduct causing the injury occurred - the manufacturing and labeling of Accutane. Overall, the section 145 contacts do not point to one ineluctable result. The Court next reviews section 6 and notes that one reason for joining together so many cases before a single judge is administrative efficiency. The two most significant Restatement factors in this MCL matter are section 6 factors f ("certainty, predictability and uniformity of result") and g ("ease in the determination and application of the law to be applied"). Applying a single standard to govern the adequacy of the label warnings in the 532 individual cases will ensure predictable and uniform results. Each plaintiff can choose to bring suit in the state where he or she resides and the injury occurred. In this MCL setting, New Jersey has the most significant relationship to the occurrence and the parties, overcoming the presumption that the law of the place of injury governs. The Court therefore applies the PLA to the 532 cases, (pp. 38-46)

         4. The PLA defines "an adequate warning or instruction" as "one that a reasonably prudent person in the same or similar circumstances would have provided . . ., taking into account the characteristics of, and the ordinary knowledge common to, the prescribing physician." N.J.S.A. 2A:58C-4. The prescribing physician - as a learned intermediary - generally is in the best position to advise the patient of the benefits and risks of a particular drug. Under the learned intermediary doctrine, a pharmaceutical manufacturer generally discharges its duty to warn by supplying physicians with information about the drug's dangerous propensities. Under N.J.S.A. 2A:58C-4, a rebuttable presumption of adequacy attaches to a product's label warnings approved by the FDA. Ibid, (pp. 46-48)

         5. The Court reviews the relevant FDA premarketing and postmarketing regulations governing prescription drugs. Under federal law, the manufacturer is responsible for the adequacy of a drug label's warnings not only when it files a New Drug Application, but also during the period the drug is on the market after FDA approval. In Wyeth v. Levine, the United States Supreme Court concluded that state-law failure-to-warn lawsuits against manufacturers provide "a complementary form of drug regulation" in the postmarketing phase, when the FDA's monitoring is far from foolproof. 555 U.S. 555, 578-79 (2009). (pp. 48-54)

         6. In Perez v. Wyeth Laboratories, Inc., the Court addressed the role of the federal regulatory process in relation to the PLA's presumption of adequacy and held that "absent deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects, compliance with FDA standards should be virtually dispositive of [product-liability and failure-to-warn] claims." 161 N.J. 1, 25 (1999). Perez was decided twenty years before Wyeth's discussion of a manufacturer's duty to update label warnings in the postmarketing phase. The Appellate Division in McDarby v. Merck & Co. "note[d] that close scrutiny . . . commenced only after Perez was decided, and that scrutiny disclosed flaws in the regulatory system." 401 N.J.Super. 10, 64 (App. Div. 2008). In light of the limitations of the FDA postmarketing oversight process, the McDarby court articulated a further basis for overcoming the presumption of adequacy: a manufacturer's "economically-driven manipulation of the post-market regulatory process." Li at 63-64. In Cornett v. Johnson & Johnson, 211 N.J. 362, 388 (2012), the Court recognized that exception, (pp. 54-58)

         7. An FDA-approved warning for a drug on the market for many years may grow stale in light of "newly acquired information" about "a clinically significant hazard" in the use of the drug by certain consumers. 21 C.F.R. § 201.57(c); 21 C.F.R. § 314.70(c). Prior FDA approval of a label's warning is not a license for a manufacturer to withhold updating and revising that warning in accordance with federal regulations. The PLA provides manufacturers with the protection of a rebuttable presumption of adequacy of an FDA-approved label warning. N.J.S.A. 2A:58C-4. Consistent with Perez and McDarby, and the federal regulatory scheme, the Court holds that the rebuttable presumption of adequacy attaching to an FDA-approved drug label is overcome when a plaintiff presents clear and convincing evidence that a manufacturer knew or should have known, based on newly acquired information, of a causal association between the use of the drug and "a clinically significant hazard" and that the manufacturer failed to update the label accordingly. See 21 C.F.R. § 201.57(c); 21 C.F.R. § 314.70(c). The Court adds one caveat. A manufacturer that acts in a reasonable and timely way to update its label warnings with the FDA, in accordance with its federal regulatory responsibilities, will receive the protection of the rebuttable presumption. If not, it cannot seek shelter behind it. The standard articulated in this opinion is a natural extension of the decisions in Perez and McDarby. Faced with clear and convincing evidence of a label warning's inadequacy based on the FDA's label warning updating requirements, a responsible drug manufacturer will take action to revise its drug label warnings. The high standard for overcoming the rebuttable presumption of adequacy of an FDA-approved label warning represents a balance that protects pharmaceutical companies that act responsibly and the public that consumes their products, (pp. 59-64)

         8. Three pathways are available to overcome the presumption of adequacy that attaches to the FDA-approved post-April 2002 label warnings for Accutane. The first pathway is if a plaintiff can establish deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects. The second is if a plaintiff can demonstrate economically driven manipulation of the postmarket regulatory process. The third is if a plaintiff can prove by clear and convincing evidence that a manufacturer knew or should have known in the postmarketing phase that the drug warnings were inadequate based on the label warning updating requirements in a pertinent federal regulation. Plaintiffs have failed to show any of those bases for overcoming the presumption of adequacy. In the absence of evidence sufficient to rebut the presumption, as a matter of law, the warnings adequately conveyed to medical professionals - as well as to patients - that usage of Accutane was associated with a risk of IBD. Roche used multiple warning tools: the physician label and Best Practices Guide, intended for physicians, and the Patient Safety Packet, Medication Guide, and blister packaging, intended for patients. Plaintiffs' principal criticism is that the physician label and other warning materials should have used the language "causes" instead of "has been associated with" to describe the relationship between Accutane and IBD. Plaintiffs, however, have failed to present clear and convincing evidence that Roche's use of the word "associated" to describe the relationship between Accutane and IBD was inadequate. The isolated examples plaintiffs have exhumed from the volumes of evidence do not support a showing of deliberate nondisclosure to the FDA, economically driven manipulation of the regulatory process, or clear and convincing evidence that Roche knew or should have known of the inadequacy of the warnings in light of the relevant federal regulations. Plaintiffs argue that Roche had internally concluded that Accutane was causally - not just possibly - related to IBD. However, plaintiffs have failed to establish that Roche had in fact made such a determination, engaged in deliberate concealment or nondisclosure of such knowledge, or otherwise knew or should have known under the standard articulated above that the use of the word "associated" was inadequate. Finally, whatever continuing concerns there may be about the FDA's postmarketing oversight capacity, there is no evidence in this record of shortcomings in the FDA's oversight of Accutane. (pp. 64-70)

         9. The Court reverses the judgment of the Appellate Division in those cases in which it vacated the grant of summary judgment in favor of Roche and affirms its judgment in those cases in which it upheld the grant of summary judgment in favor of Roche. As a result, the 532 failure-to-warn cases brought by plaintiffs against Roche are dismissed, (p. 70)

         AFFIRMED in part and REVERSED in part.

          CHIEF JUSTICE RABNER and JUSTICES LaVECCHIA, FERNANDEZ-VINA, SOLOMON, and TIMPONE join in JUSTICE ALBIN's opinion. JUSTICE PATTERSON did not participate.

          OPINION

          ALBIN JUSTICE.

         This appeal arises from 532 product-liability claims filed against defendants Hoffmann-La Roche Inc. and Roche Laboratories Inc. (collectively Roche), corporations with their principal places of business in New Jersey. Roche developed, manufactured, marketed, and labeled Accutane, a prescription medication for the treatment of severe and persistent cases of acne. Plaintiffs allege that Accutane, prescribed by their physicians for the treatment of acne, caused them to contract inflammatory bowel disease (IBD) and that Roche failed to give adequate label warnings to advise them of the known risks of the medication. Of the 532 plaintiffs, 18 are New Jersey residents and 514 are residents of 44 other jurisdictions. Plaintiffs' claims are designated as Multicounty Litigation (MCL) and consolidated in the Atlantic County Superior Court, Law Division, for administrative purposes.

         Two issues are before us. The first is what law governs whether Roche's label warnings were adequate -- the law of each of the 45 jurisdictions where plaintiffs were prescribed and took Accutane or the law of New Jersey where the 532 cases are consolidated for MCL purposes. The second issue is the adequacy of the label warnings for the period after April 2002. Because Roche's warnings received the approval of the federal Food and Drug Administration (FDA), those warnings enjoy a "rebuttable presumption" of adequacy under New Jersey's Products Liability Act (PLA). See N.J.S.A. 2A:58C-4. That presumption provides pharmaceutical companies greater protection in New Jersey than in many other jurisdictions.

         After conducting a choice-of-law analysis, the trial court determined that New Jersey's PLA applies to each of the 532 consolidated cases and then concluded that plaintiffs failed to overcome the presumption of adequacy that attached to Roche's Accutane warnings. Accordingly, the court granted summary judgment in favor of Roche.

         The Appellate Division came to a different result. The panel held that the law of each jurisdiction where plaintiffs were prescribed and took Accutane would govern the adequacy of the label warnings. After conducting a state-by-state legal analysis, the panel concluded that summary judgment in favor of Roche was improvidently granted in all cases except those governed by the laws of California, Colorado, Indiana, Maryland, Mississippi, New York, Texas, and Virginia. In other words, under New Jersey's PLA and the laws of thirty-six other jurisdictions, the panel maintained that a genuine issue of material fact remained concerning the adequacy of the warnings.

         We now reverse in all those cases in which the Appellate Division reinstated plaintiffs' actions against Roche. Like the trial court and Appellate Division, we apply the Restatement (Second) of Conflict of Laws (Am. Law Inst. 1971, amended 1988) ("Restatement"), adopted for personal injury cases in McCarrell v. Hoffmann-La Roche, Inc., 227 N.J. 569, 593-94 (2017), and P.V. ex rel. T.V. v. Camp Jaycee, 197 N.J. 132, 143 (2008). Unlike the Appellate Division, we hold that New Jersey has the most significant interests, given the consolidation of the 532 cases for MCL purposes in Atlantic County. The aggregation of hundreds of cases under MCL allows the resolution of common issues of law. A trial judge cannot be expected to gain a mastery of the law of forty-five different jurisdictions. Construing New Jersey's PLA is challenging enough. New Jersey's interest in consistent, fair, and reliable outcomes cannot be achieved by applying a diverse quilt of laws to so many cases that share common issues of fact.

         The PLA's presumption of adequacy for medication warnings approved by the FDA gives a reasonable measure of protection to pharmaceutical companies, which are researching and developing medications to combat diseases and maladies that afflict people around the world. New Jersey also has an interest in ensuring that its companies are producing safe medications and attaching warnings that advise the public of their risks and benefits. On the record before us, even when viewed in the light most favorable to plaintiffs, we do not find that Roche withheld from the FDA material information that would have altered the nature of the warnings or engaged in economically driven manipulation of the regulatory process. We also find that plaintiffs did not present clear and convincing evidence that Roche knew or should have known that the label warnings were inadequate. Plaintiffs therefore have not overcome the statutory presumption of adequacy.

         Consequently, as a matter of law, the warnings provided physicians with adequate information to warn their patients of the risks of IBD. We therefore reverse in part and affirm in part the judgment of the Appellate Division and dismiss all plaintiffs' complaints.

         I.

         A.

         In this appeal, we address the adequacy of Roche's FDA-approved post-April 10, 2002 warnings for Accutane, the brand name for isotretinoin, a prescription drug developed and marketed nationwide by Roche for the treatment of severe cases of acne. See Kendall v. Hoffmann-La Roche, Inc., 209 N.J. 173, 180 (2012). Plaintiffs are 532 individuals from 45 jurisdictions, including New Jersey, who were prescribed Accutane by their treating physicians for their acne conditions. After taking the medication, plaintiffs claim they developed IBD, which encompasses "a number of chronic, relapsing inflammatory diseases of the gastrointestinal tract." See Tabor's Cyclopedic Medical Dictionary 1252 (23d ed. 2017) ("Tabor's") .

         The two most common forms of IBD are ulcerative colitis and Crohn's disease. The 532 plaintiffs in this case state that they suffer from ulcerative colitis, "a chronic condition characterized by ulceration of the colon and rectum," which leads to frequent and bloody bowel movements as well as fatigue, dehydration, anemia, and abdominal pain. See Kendall, 209 N.J. at 181. "The symptoms often wax and wane, but the condition is regarded as permanent." Ibid.

         The heart of this case is plaintiffs' contention that the taking of Accutane caused their IBD and that Roche failed to adequately warn of that risk. A Long Form Complaint, filed on behalf of all plaintiffs, alleges that Roche knew or should have known that taking Accutane "was causally related" to IBD based on information contained in its adverse event database and the conclusions drawn by its scientists. Plaintiffs further allege Roche "did not adequately inform physicians or consumers of [Accutane's] propensity to induce, aggravate or cause IBD." Plaintiffs contend that Roche's failure to provide adequate warnings is the proximate cause of the "permanent physical and emotional injuries" they continue to suffer, and therefore they seek compensatory and punitive damages.

         Roche moved for summary judgment, claiming that the warnings were adequate as a matter of law.[1] We start with the relevant facts from the summary judgment record.

         B.

         In 1982, the Food and Drug Administration approved Roche's application to market Accutane for the treatment of recalcitrant nodular acne. As part of the FDA pre-approval process, Roche conducted a human clinical study involving 523 patients who took Accutane. No reports of IBD arose from that clinical study, although approximately twenty-two percent of the patients suffered certain gastrointestinal side effects. Roche submitted the study to the FDA.

         When Roche launched Accutane commercially, the label warnings did not mention IBD. By 1983, during the postmarketing phase and while monitoring the safety of Accutane use, Roche received reports of six to eight patients -- out of a total population of 300, 000 -- who had taken Accutane and developed IBD. Those reports prompted Roche to issue label warnings in 1984 to prescribing physicians, generally dermatologists, stating that Accutane "has been temporally associated with inflammatory bowel disease (including regional ileitis) in patients without a prior history of intestinal disorders."

         Roche collected additional data as it continued to monitor the effects of Accutane on patients. Between 1985 and 2001, Roche received at least twenty case reports called "challenge," "dechallenge," and "rechallenge" events. The reports described patients who, while taking Accutane, suffered intestinal disorders, with symptoms such as abdominal cramping and rectal bleeding (the "challenge" event), which subsided when Accutane use was discontinued (the "dechallenge" event), but reappeared when the medication regimen resumed (the "positive rechallenge" event). Those reports, many filed by the patients' treating physicians, were registered with MedWatch, an FDA-administered database that compiles adverse events concerning medications approved by the FDA.

         In February 1999, the FDA asked Roche whether its data demonstrated the "reversibility" of Accutane-associated IBD. By that time, Roche had received information concerning nearly 300 cases that associated Accutane usage with the onset of IBD. An internal Roche email explained that approximately two-thirds of 188 patients who stopped using Accutane recovered. Although Roche responded to the FDA inquiry by stating that there was "not sufficient information to recommend additional label changes related to [IBD]," the FDA nevertheless requested that Roche remove from its label warning the word "temporally" and add that symptoms of IBD "have been reported to persist after Accutane treatment has stopped." Roche complied.

         By April 10, 2002, Roche had generated a variety of FDA-approved warning labels and materials for a target audience of prescribing physicians, pharmacists, and patients. The information provided to physicians is of particular importance because New Jersey has adopted the "learned intermediary" doctrine, which recognizes that a prescribing doctor has the primary responsibility of advising the patient of the risks and benefits of taking a particular medication. See N.J.S.A. 2A:58C-4; see also Niemiera v. Schneider, 114 N.J. 550, 565-66 (1989) ("[I]t is the physician's responsibility to pass on to the parties the information that enables the patient to use the product safely.").

         Presented below are the five key warning tools that were provided to physicians, pharmacists, and patients.

         1.

         Roche's primary means of communicating to healthcare providers such information as Accutane's dosages, drug interactions, commonly occurring side effects, and serious side effects is through the physician label (also known as a package insert). Roche's approximately twenty-four-page package insert provided medical professionals with specific IBD warnings.

         Physician Label

         WARNINGS:

Inflammatory Bowel Disease: Accutane has been associated with inflammatory bowel disease (including regional ileitis) in patients without a prior history of intestinal disorders. In some instances, symptoms have been reported to persist after Accutane treatment has been stopped. Patients experiencing abdominal pain, rectal bleeding or severe diarrhea should discontinue Accutane immediately. (see ADVERSE REACTIONS: Gastrointestinal) . [2]

         Importantly, this warning advises prescribing physicians that not only has IBD been associated with the taking of Accutane, but that symptoms of the disease "have been reported to persist after Accutane treatment has been stopped."

         2.

         In addition, Roche provided physicians with a Best Practices Guide, which, although mostly focused on the risks of Accutane causing birth defects, also identified IBD as a specific risk associated with Accutane use. The Guide advised physicians to fully counsel their patients "about the warnings and precautions in the Accutane package insert."

         Best Practices Guide

Accutane use is associated with other potentially serious adverse events, as well as more frequent, but less serious side effects.
Adverse Event Warnings include inflammatory bowel disease ....
Patients should be reminded to read the Medication Guide, distributed by the pharmacist at the time Accutane is dispensed.

         3.

         Roche also prepared a Patient Safety Packet for physicians to give to their patients that explained in plain language the risks and possible side effects of taking Accutane. An attached Informed Consent Form required the patient to acknowledge in writing that he or she read and understood the Patient Safety Packet. It also required the prescribing doctor to certify that the "benefits and risks" of Accutane treatment were "fully explained" to the patient.[3]

         Patient Safety Packet

You should be aware that certain SERIOUS SIDE EFFECTS have been reported in patients taking Accutane. Serious problems do not happen in most patients. If you experience any of the following side effects or any other unusual or severe problems, stop taking Accutane right away and call your prescriber because they may result in permanent effects.
Abdomen (stomach area) problems. Certain symptoms may mean that your internal organs are being damaged. These organs include the . . . bowel (intestines). If your organs are damaged, they may not get better even after you stop taking Accutane. Stop taking Accutane and call your prescriber if you get severe stomach or bowel pain, diarrhea, [or] rectal bleeding ....

         4.

         Roche also developed, in conjunction with the FDA, a Medication Guide for pharmacists to distribute to Accutane patients when they received their prescriptions. Like the Patient Safety Packet, the Medication Guide warned of "possible serious side effects" from Accutane and described IBD symptoms in simple and plain language.

         Medication Guide

Accutane has possible serious side effects
Abdomen (stomach area) problems. Certain symptoms may mean that your internal organs are being damaged. These organs include the . . . bowel (intestines) .... If your organs are damaged, they may not get better even after you stop taking Accutane. Stop taking Accutane and call your prescriber if you get severe stomach, chest or bowel pain diarrhea, [or] rectal bleeding ....
Serious permanent problems do not happen often. However, because the symptoms listed above may be signs of serious problems, if you get these symptoms, stop taking Accutane and call your prescriber. If not treated, they could lead to serious health problems. Even if these problems are treated, they may not clear up after you stop taking Accutane.

         The Medication Guide makes clear the potential permanency of harm to the patient's bowels and intestines by taking Accutane, indicating to the patient that "[i]f your organs are damaged, they may not get better even after you stop taking Accutane" and that symptoms "may not clear up after you stop taking Accutane."

         5.

         Last, Roche required pharmacists to dispense Accutane pills in "blister packaging" that again warned the patient that Accutane could have serious gastrointestinal side effects.

         Blister Packaging

Other serious side effects to watch for
Stop taking Accutane and call your prescriber if you develop any of the problems on this list or any other unusual or severe problems. If not treated, they could lead to serious health problems. ...

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