Health Law--Plaintiff's State Law Claim Regarding Generic Drug Labeling Was Preempted By Federal Law--Dolin v. GlaxoSmithKline LJLC, 901 F.3d 803 (7th Cir. 2018).
Plaintiff, Wendy Dolin, executor of the Estate of Stewart Dolin, brought suit against defendant, GlaxoSmithKline LLC, in the Circuit Court of Cook County Illinois. (6) After the case was removed to federal court based on diversity of citizenship, Dolin brought a motion to remand the case back to state court, which the court denied. (7) Dolin alleged that GSK negligently failed to include a drug label warning of suicidality in adults. (8) The jury awarded Dolin three million dollars in damages for wrongful death. (9) The court held there was sufficient evidence for the jury to conclude that the label was inadequate and misleading. (10) The court also found there was no clear evidence the FDA would have rejected the Paxil-specific warning outside of the class warning. (11)
Following the jury verdict, GSK appealed to the Seventh Circuit Court of Appeals. (12) GSK's appeal challenged the lower court's conclusion about liability under Illinois law, preemption law, and also claims the evidence at trial did not support the jury's verdict. (13) The Seventh Circuit agreed with GSK and held that federal law prevented GSK from adding a warning about the alleged association between paroxetine and suicides in adults. (14) Plaintiff's husband, Stewart, was taking paroxetine, the generic brand of Paxil, for depression and anxiety. (15) Six days after Stewart began the medication, he committed suicide. (16) Although GSK manufactures Paxil, under federal law the brand-name manufacturer is responsible for producing the drug label and the generic manufacturer is responsible for matching the brand-name label. (17) Paroxetine's label only warned of suicide risks for people under the age of twenty-four. (18) Stewart was fifty-seven when he took paroxetine and subsequently died by suicide. (19)
The FDA officially approved paroxetine, and its label, in 1992. (20) After continuous studies about the risks of the drug, the FDA rejected any link between paroxetine and suicidality. (21) In 2004, however, there was a link between pediatric patients and suicidality, which led to the label that warns patients under twenty-four. (22) After finding a link of an increase in suicide attempts in adults with major depressive disorder treated with paroxetine, GSK changed the label for adults without approval of the FDA pursuant to the Changes Being Effected regulation ("CBE"). (23) Soon after the change, the FDA ordered GSK to revise the paroxetine labeling back to only include patients under age twenty-four. (24) Subsequently, GSK asked the FDA more formally to change the label on four separate occasions and the FDA rejected their proposals each time, but offered to set up a formal meeting if GSK wished to discuss the matter further. (25) Drug application and drug labeling laws were virtually nonexistent until the early 1900s. (26) The start of federal concern for drug regulation began in 1848 with the establishment of the United States customs laboratories to administer the Drug Importation Act of 1848. (27) The Drug Importation Act required United States customs to inspect for entry of adulterated drugs from overseas. (28) Although the Drug Importation Act regulated the adulterated drugs coming into the country, the United States was still slow to recognize the need for national food and drug laws to regulate drugs manufactured in the United States. (29) Before the 1900s, it was a societal accepted norm that a drug buyer should "look out for himself". (30) Numerous medicines sold to the general public contained drugs, such as heroin, cocaine, morphine, and opium, without labels to notify the buyer. (31) There were no drug labels listing ingredients, warnings of misuse, or risks of taking the drugs. (32) The need for federal rulemaking became widely realized once interstate commerce expanded after the Civil War. (33) Even with many safety concerns about the unregulated drug manufacturing, the public was split on the new proposed need for federal drug regulations. (34)
Congress regulated food and drugs for the first time when it enacted the Pure Food and Drug Act in 1906. (35) The Act prohibited both manufacture and interstate shipment of adulterated and misbranded foods and drugs. (36) It finally enabled the governments to take action against illegal products, but still did not require manufacturers to prove effectiveness of the drugs. (37) The 1906 Act eventually lost its value due to technological changes, which revolutionized the production and marketing of food and drugs. (38) After more than one hundred people died from a poisonous solvent, diethylene glycol, President Roosevelt signed the Federal Drug and Cosmetic Act of 1938 ("FDCA"). (39) The FDCA was the first law that required drug manufacturers to perform premarket safety testing. (40) A European tragedy pushed the United States to tighten control over prescription drugs, new drugs, and investigational drugs in 1962. (41) The 1962 Kefauver-Harris Drug Amendment forced the drug manufacturers to prove to the FDA the drug was effective. (42) Following the 1962 amendments, the federal government emphasized the importance of the drug label in the 1966 Fair Packaging and Labeling Act. (43) The Act required all consumer products to be honestly and informatively labeled. (44)
Following the new government standards, a manufacturer proposing a new drug application is required to prove that "safety has been demonstrated by adequate tests by all methods reasonably applicable to show whether such drug is safe for use under the conditions prescribed, recommended or suggested in the proposed labeling thereof'. (45) The drug manufacturer begins with an Investigational New Drug Application before the actual New Drug Application. (46) If the clinical studies show the drug is relatively safe and does not pose unreasonable risks, the manufacturer can file a New Drug Application with the proposed labeling. (47) There are no completely risk free drugs, so the FDA does not require the manufacturer to prove the drug is one hundred percent safe and effective for all patients. (48) Once an approved drug patent expires, other manufacturers are allowed to produce the drug in its generic form with an abbreviated drug application. (49) Even after the FDA approves a drug, the manufacturer is responsible for updating the drug's label with any new risks or benefits as long as the drug is marketed. (50) After a drug is marketed, if safety concerns arise, a manufacturer can withdraw the drug completely or edit the labeling to warn of the newly discovered effects. (51) The changes being effected regulation ("CBE") allows manufacturers to change or strengthen a drug label warning to reflect newly acquired information. (52) CBE is an exception to the FDA's approval for a label change as long as the manufacturer has newly acquired information and there is a causal connection between the drug and the effect that warranted the stronger warning. (53)
The Seventh Circuit Court of Appeals in Dolin v. GlaxoSmithKline rejected plaintiffs argument that GSK was at fault for not changing paroxetine's label pursuant to the CBE regulation. (54) In reversing the lower court, the appeals court reasoned that GSK was not at fault because the manufacturer tried to change the drug's label, but was preempted by federal law. (55) The FDA analyzed data investigating the link between SSRIs and suicidal behavior. (56) After a specific committee researched suicide connections to paroxetine and found no connection, the FDA continued to reject a link between paroxetine and suicidality. (57) As the law requires, GSK continued to do research and found evidence of a 6.7-fold increase in suicide attempts in adults with major depressive disorder treated with paroxetine. (58) Due to the newly discovered data, GSK changed the label for adults without the FDA's approval, pursuant to CBE. (59) The FDA rejected the new label change, also pursuant to CBE regulations, concluding that the significance of the recent findings must be discounted for the large number of comparisons being made. (60) The plaintiffs argument failed because federal law preempts GSK from acting any further regarding the label change. (61) The court reasoned that the plaintiff must allege a label deficiency GSK was responsible for. (62) There is evidence the FDA would have rejected another warning and GSK lacked new data after 2007 that would have allowed them to change the label to add suicide risks in adults. (63) GSK repeatedly asked the FDA to change the paroxetine label to include adult suicide risks, but the FDA rejected it each time. (64) GSK tried to change the label to include a warning of suicidality for adults, but lacked the authority after the FDA rejected their attempts, showing that GSK was preempted by FDA's action. (65)
The Seventh Circuit Court of Appeals correctly held that federal law preempted GSK from including a warning on the paroxetine label of suicidal behavior in adults over age twenty-four. (66) The court addressed every argument the plaintiff made, but did not solve the overlying issue. (67) GSK did everything in their power to change the drug label to include a warning to adults over twenty-four, but the FDA rejected these warnings. (68) Plaintiffs claims against GSK lost because the drug's label centers around the FDA's continued rejection of GSK's attempts. (69) As the court noticed in its reasoning, GSK submitted additional data to the FDA specifically analyzing suicidal behavior in adults, but the FDA dismissed the data. (70) The FDA's own analysis showed a 2.76-fold increase in suicidal behavior for adults treated with paroxetine, but again the agency dismissed the results concluding that "the significance of those findings must be discounted for the large number of comparisons being made." (71) The problem with the drug's label centers around the FDA's dismissal of data showing the exact risk the plaintiff argued needed to be included in the warning. (72) GSK had a substantial basis to believe the added warning was required and expressed this concern when submitting the requested data, as well as unilaterally changing the label themselves based on their own data. (73) Prior to GSK's unilateral change, the label listed the risks of adults as unknown. (74) After discovering known risks, GSK logically acted and removed the unknown portion, adding a warning to adults of the increase in frequency of suicidal behavior. (75) Following the CBE regulation, the FDA rejected GSK's label change and warned of suicide risks in people under age twenty-four. (76) GSK did not stop after the FDA rejected their new label showing there was a real concern for the risks of suicide in adults. (77)
Dolin v. GlaxoSmithKline is not the only case dealing with the issue of adult suicide warnings. (78) The plaintiff in Dolin cites to Tucker v. SmithKline Beecham Corp., but the court does not address the case because it was decided prior to Devine and Mensing, which set the preemption standard. (79) Although Tucker cannot be used to dispute preemption, it does show the need for FDA change. (80) Tucker was decided in 2008, soon after GSK changed their label and the FDA rejected the change. (81) The FDA dismissed GSK's concerns in Dolin with no repercussions. (82) Without rigid guidelines for the FDA to follow, similar cases will continue to occur. (83) There is an emphasis on the drug manufacturer's obligation to continue research of a drug as long as it is on the market. (84) As long as the FDA has the overriding power, labels such as paroxetine's will never adequately warn people of certain risks. (85)
The need for FDA change does not mean the manufacturer should have overriding power to do what they wish with a drug's label. (86) History has shown the lack of FDA regulation also poses dangers to society. (87) For example, the Federal Food, Drug, and Cosmetic Act of 1938 has allowed most cosmetic manufacturers to continue to be self-regulating. (88) The FDA has only recendy noticed the need to regulate products after many complaints regarding WEN hair products. (89) Even with the FDCA, the FDA has no authority to recall certain cosmetic products without the manufacturers consent. (90) Therefore, there needs to be a balance between the manufacturer's control of a product and the FDA's overriding authority. (91)
In Dolin v. GlaxoSmithKline the Seventh Circuit Court of Appeals dealt with whether GlaxoSmithKline was responsible for the death of deceased because the drug's label did not contain a warning of suicide attempts in adults over age twenty-four. The court concluded that GSK was preempted by federal law and was unable to change the label to include such a warning. Using language from Irvine and Mensing, the court reasoned that the FDA preempted GSK because GSK had submitted data on several occasions and subsequently changed the drug's label using the CBE regulation. After the FDA rejected the label change, there was nothing else for GSK to do. Dolin exemplifies the need for FDA change. The drug manufacturer may have a continued duty of care to update drug labels based on new information found while the drug is on the market, but the FDA is the ultimate decision maker of whether the label is changed. Without change in the FDA's guidelines, situations like Dolin will continue to arise.
Ashlyn Dowd *
* J.D. Candidate, Suffolk University Law School, 2020; B.S., Roger Williams University, 2017.
Ms. Dowd may be contacted at email@example.com.
(1) See 21 U.S.C. [section] 355 (2018). All new drug's must be approved before they can be introduced to the market. Id. The new drug application makes sure the drug is safe and effective for the general public to use. Id.
(2) See 21 C.F.R. [section] 314.70 (2018). Applicants must notify the FDA when making a change in a new drug application, unless the change was already listed in the original application. Id.
(3) See Dolin v. GlaxoSmithKline LLC, 901 F.3d 803 (7th Cir. 2018).
(4) See id. GSK changed the label of the warning one time, pursuant to the Changes Being Effected Regulation, but after the FDA rejected this change they lacked new information to change it again. Id.
(5) See id.
(6) See Dolin v. GlaxoSmithKline LLC, 269 F. Supp. 3d 851, 854 (N.D. Ill. 2017).
(7) See id. The federal court had jurisdiction over Dolin's claim pursuant to 28 U.S.C. [section][section] 1332 and 1441. See id. Diversity of citizenship is between citizens of different states: citizen of a state and a citizen of a foreign state; a foreign state as plaintiff and citizen of state or of different states, and requires the amount of controversy to exceed $75,000. 28 U.S.C. [section] 1332 (2018). Removal of civil actions is governed by [section] 1441, which states "any civil action brought in a State court of which the district courts of the United States have original jurisdiction, may be removed by the defendant or the defendants, to the district court of the United States for the district and division embracing the place where such action is pending." 28 U.S.C.S. [section] 1441 (LexisNexis 2018).
(8) See Dolin, 269 F. Supp. 3d 851. Plaintiff asserted that GSK allowed an affirmative misrepresentation with respect to the drug's label. Id. Plaintiff also claimed GSK negligently "misled the medical profession ... by concealing and misrepresenting adult suicide risk data relating to paroxetine." Id. at 854-55.
(9) See Dolin, 269 F. Supp. 3d 851.
(10) See id. at 864. The court also took into account GSK's history of misconduct with the drug "by failing to warn and providing false information to consumers and the FDA." Id. at 865; see also Tucker v. SmithKline Beecham Corp., 596 F. Supp. 2d 1225 (S.D. Ind. 2008) (addressing a case where a middle-aged man committed suicide after taking paroxetine).
(11) See Tucker, 596 F. Supp. 2d. The court emphasized the FDA's statement about scheduling a formal meeting if GSK wanted to discuss the matter of a Paxil specific label further. Id. The court noted that GSK never followed up with the FDA after this statement and reasoned that they could have done more to add the adult suicide warning. Id.
(12) See Dolin v. GlaxoSmithKline LLC, 901 F.3d 803 (7th Cir. 2018). GSK's appeal followed a three-million-dollar judgement for the plaintiff. Dolin, 269 F. Supp. 3d 851.
(13) See Dolin, 901 F.3d at 805.
(14) See id. The Seventh Circuit disagreed with the lower court's holding that GSK could have done more to change the label and held that the FDA prevented them from doing anything else to the warning label. Id.
(15) See id. Stewart was prescribed Paxil in 2010, but his prescription was filled with the generic brand of the drug, paroxetine, instead. Id. Paroxetine is not manufactured by GSK, but since the brand-name drug is responsible for creating the drug label and the generic drug manufacturer is responsible for matching the brand-name, the plaintiff was capable of suing GSK. Id.
(16) See Dolin, 901 F.3d at 805. Blood tests confirmed that Stewart had paroxetine in his system when he committed suicide. Id.
(17) See id. (explaining why plaintiff sued GSK instead of the manufacturer of paroxetine). It is basically impossible to sue generic drug manufacturers on a state law theory for failure to warn, so the plaintiff sued the brand name manufacturer who has more control over the drug's label.
(18) See id. at 809. At the time Stewart took paroxetine, the FDA had ordered GSK to change the label to "warn of a suicidality risk in patients 24 years old or under, and to state that 'studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24"'. Id.
(19) See Dolin v. GlaxoSmithKline LLC, 901 F.3d 803, 805 (7th Cir. 2018).
(20) See Dolin, 901 F.3d at 806. The brand-name version of the drug, Paxil, began marketing in 1992 and generic versions of the drug, including paroxetine, began in 2003. Dolin, 269 F. Supp. 3d 851. The first New Drug Application was submitted in 1989, containing data related to suicides. Id.
(21) See Dolin, 901 F.3d at 808.
(22) See id.
(23) See id. The CBE regulation is an exception to the requirement of FDA permission. Id. at 806. FDA permission is required to change a drug label unless GSK had newly acquired information about paroxetine that showed a causal association between the drug and an effect that warranted a new or stronger warning. Id. After the manufacturer makes the change, the FDA can still review and reject the new label. Id.
(24) See Dolin v. GlaxoSmithKline LLC, 901 F.3d 803 (7th Cir. 2018).
(25) See id. at 814-15.
(26) See WALLACE F. JANSSEN, The Story of the 1 Mm Behind the iMbels, FDA CONSUMER MAG. (June 1981), https://www.fda.gov/downloads/aboutfda/history/forgshistory/evolvingpowers/ucm593437.p df. The drug manufacturing requirements took nearly a century of rulemaking to became the current standards. BLANCHARD RANDALL IV, The U.S. Drug Approval Process: A Primer, CRS Rep. FOR CONGRESS (June 2001), https://tinyurl.com/yynblqjx (requires LexisNexis access to view source).
(27) See JANSSEN, supra note 26, at 1. The U.S. had become a dumping ground for drug waste material, creating a harmful situation in the country. See id. The new Customs laboratories aimed to purify "standards of the U.S. Pharmacopeia, established by trade and professional leaders in 1820." Id.
(28) See Milestones in U.S. Food and Drug Law History, U.S. FOOD & DRUG Admin. (Feb. 2018) (hereinafter Milestones], https: //www.fda.gov/aboutfda/history/forgshistory/evolvingpowers/ucm2007256.htm.
(29) See Janssen, supra note 26.
(30) See id. at 3 (explaining that the government was not regulating the safety of drugs for public use).
(31) See id.
(32) See id.
(33) See id. at 2. The first act of support for the FDA was the Pure Food Movement in the 1870s, which was a "grass roots phenomenon." Id. The movement was originally a trade movement spurring from "competition from a new breed of food products ... and second, intolerable variations in the laws of the states." Lee Janssen, supra note 26, at 2.
(34) See id. at 6. Some argued that the federal government "had no business policing what people ate, drank, or used for medicine," while other people pushed for the government's involvement. Id.
(35) See id.
(36) See id. at 8.
(37) See id.
(38) See JANSSEN, supra note 26, at 9.
(39) See Milestones, supra note 28; see also J ANSSEN, supra note 26. Although the Federal Drug and Cosmetic Act of 1938 brought change, it still allowed most cosmetic manufacturers to be self-regulating. See Priyanka Narayan, The cosmetics industry has avoided strict regulation for over a century. Now rising health concerns has FDA inquiring, CNBC (Aug. 2, 2018), https://www.cnbc.com/2018/08/01 / fda-begins-first-inquiry-of-lightly-regulated-cosmeticsindustry.html.
(40) See JANSSEN, supra note 26, at 10. The start of World War II in 1939 contributed to the new interest in regulating drugs, such as penicillin and other antibiotics. Id. Following the war in 1949, a two-year hearing resulted in new amendments to the FDCA, the Pesticide Amendment, the Food Additive Amendment, and the Color Additive Amendment. Id.
(41) See id. at 12. Thousands of babies in Europe were born with birth defects after their mothers took a new sedative thalidomide. Id. After the amendment, drug firms were required to send adverse reaction reports to the FDA, reporting every risk and benefit of the drug. Id. The institution of this amendment resulted in thousands of drugs to be taken off the shelves or required label changes. JANSSEN, supra note 26, at 12.
(42) See Milestones, supra note 28. Prior to the 1962 amendments, the Ninth Circuit Court of Appeals ruled that drug manufacturers are also responsible for providing labels for the drugs that include the purpose for which the drug is offered. Alberty Food Products v. United States, 194 F.2d 463 (9th Cir. 1952). The 1962 amendments also switched the burden of proof from the FDA proving a drug was harmful, to the manufacturer proving the drug was safe. Wyeth v. Levine, 555 U.S. 555, 567 (2009).
(43) See Milestones, supra note 28. In 1970, the federal government also required drugs to have patient package inserts, which listed specific risks and benefits of each product. Id.
(44) See id.
(45) See RANDALL, supra note 26. New drug applications require adequate testing and research to prove effectiveness to the FDA. Id. The FDA cannot approve the drug if there is not enough evidence of the drug's effectiveness described in the proposed label. Id. at 6.
(46) See id. The manufacturer has to outline the drug's intent, use, and protocols for safety. Id. Once the FDA approves the investigational application the manufacturer can start clinical testing, which includes three phase clinical trials. Id. The third phase of the clinical trial includes testing the drug on a larger body of people to provide more information on the drug's side effects. RANDALL, supra note 26, at 9.
(47) See id. at 10. The New Drug Application is an actual request to manufacture and sell the drug. Id. The application must include all clinical testing data, so the drug can undergo further lab analysis and official checks to make sure the product's labeling is accurate and comprehensive. Id.
(48) See id. The FDA looks at the product's benefit to risk ratio to decide whether to approve it. Id. If the drug does show signs of creating a serious risk, the FDA can make the manufacturer do additional studies. RANDALL, supra note 26. In 1992, Congress enacted Prescription Drug User Fee Act, which allowed the FDA to collect fees to speed up the New Drug Application review process. Id. at 2. In 1997, the FDA Modernization Act eased the data reporting requirements and modified the law so few clinical studies are required to confirm the drug's effectiveness. Id. at 3.
(49) See id. at 11. The abbreviated application does not require additional research or clinical testing for approval. Id. The 1984 Drug Price Competition and Patent Term Restoration Act established a statutory mechanism to create faster approval of generic drugs. Id. at 2. Brand name manufacturers and generic manufacturers have different duties for drug labeling. Plivia, Inc. v. Mensing, 564 U.S. 604 (2011). The brand name drug manufacturer is responsible for the accuracy and adequacy of the label, while the generic brand must show the label matches the approved brand name drug. Mutual Pharm. Co., v. Bardett, 570 U.S. 472 (2013); Mensing, 564 U.S. 604.
(50) See Wyeth v. Levine, 555 U.S. 555, 568 (2009). Post marketing surveillance of a drug is effective for a full analysis of the drug's side effects because it applies to a large population. RANDALL, supra note 26. In 1993, a system called MedWatch made it easier for manufacturers, patients, and physicians to report side effects or marketed drugs. See generally MedWatch: The FDA Medical Products Reporting and Safety Information Program, U.S. FOOD & DRUG ADMIN. (Aug. 2018), https://www.fda.gov/Safety/MedWatch/default.htm. Reporting to MedWatch is voluntary for physicians and patients, but it is required for manufacturers while their drug is on the market. Id. Post marketing surveillance provides another chance for the FDA to recognize a product needs more regulation. RANDALL, supra note 26, at 13.
(51) See RANDALL, supra note 26. When serious side effects arise, the FDA has to analyze the magnitude of the health risks involved, make sure the drug in question is actually responsible for the health risks, and decide if there needs to be an immediate action taken. RANDALL, supra note 26.
(52) See Ferine, 555 U.S. at 568. The new information is not limited to a new date found; it can also include new analysis of previously submitted data. Id. at 569.
(53) See 21 C.F.R. [section] 314.70(c) (LexisNexis 2018). When a manufacturer is changing a drug label pursuant to CBE, they simultaneously submit the new label to the FDA, which can reject the label change. See Sykes v. Glaxo-SmithKline, 484 F.Supp.2d 289 (E.D. Pa. 2007); Perry v. Novartis Pharm. Corp., 456 F. Supp. 2d 678 (2006).
(54) See Dolin v. GlaxoSmithKline LLC, 901 F.3d 803 (7th Cir. 2018). Plaintiff alleged that GSK had the ability to change the drug's label since 1992 by asking the FDA for approval or changing it on their own with the changes being effected regulation. Id
(55) See U.S. CONST, art. VI, [section] 20, cl. 2 (stating when federal law and state law conflict, federal law presides); see also Dolin, 901 F.3d 803.
(56) See Dolin, 901 F.3d at 807. Paroxetine is a selective serotonin reuptake inhibitor (SSRI), a class of antidepressants. Id. The predecessor of GSK submitted a New Drug Application for paroxetine in 1989 and GSK submitted additional analysis of suicidal behavior to the FDA in 1990. Id. At this time, the FDA concluded there was no additional risk of suicide from taking the drug. Id. at 807-08.
(57) See id. at 808. In 2004, the FDA finally recognized a link with pediatric patients and changed the label for young adolescents, but not for adults. Id. at 808. The FDA summarized its findings stating:
FDA has done several analyses on completed suicides for adult data sets provided to us in response to a request for patient level data sets for all relevant studies involving 20 antidepressant drugs studied in 234 randomized controlled trials with [major depressive disorder]. Based on our initial analyses of these data, we have reached a similar conclusion, i.e., that there does not appear to be an increased risk of completed suicide associated with assignment to either active drug or placebo in adults with [major depressive disorder].
Dolin v. GlaxoSmithKline LLC, 901 F.3d 803 (7th Cir. 2018).
(58) See id.
(59) See id. at 809; see also supra note 23 and accompanying text (explaining the changes being effected regulation).
(60) See Dolin, 901 F.3d at 809. The FDA ordered GSK to revise the paroxetine labeling to specify suicidal tendencies for people under age twenty-four. Ids, see also supra note 23 and accompanying text (explaining the changes being effected regulation).
(61) See U.S. CONST, art. VI, [section] 20, cl. 2; see also Dolin, 901 F.3d 803.
(62) See Dolin, 901 F.3d 803 (citing In re Celexo Lexapro Mktg & Sales Practices Litig., 779 F.3d 34, 41 (1st Cir. 2015)).
(63) See id. at 812. After the initial label change based on the 6.7-fold increase got rejected, GSK had no new data to justify a CBE regulation label change. Id. CBE regulation requires newly acquired information about the drug that shows a causal association between the drug and an effect that warrants a new and stronger warning. Id. at 806.
(64) See id. at 816. After the FDA rejected each of GSK's proposed label changes, the FDA suggested setting up a meeting to discuss the matter further, but GSK never followed up. Id.
(65) See U.S. CONST, art. VI, [section] 20, cl. 2; see also Dolin v. GlaxoSmithKline LLC, 901 F.3d 803 (7th Cir. 2018).
(66) See Dolin, 901 F.3d 803. The Seventh Circuit Court of Appeals held that plaintiff's state law claim was preempted by federal law because there was clear evidence that the FDA would have rejected another proposed warning and GSK lacked new information after 2007 to add another adult suicidality warning. Id.
(67) See id. The issue of mislabeled drugs is still present. Id. The Dolin court answered the question presented to them, which was whether GSK negligently labeled paroxetine neglecting to include a suicide risk for adults over age twenty-four. Id. The issue lies in the FDA's control over these drug labels. Dolin v. GlaxoSmithKline LLC, 901 F.3d 803 (7th Cir. 2018). The FDA clearly needs to regulate what the manufacturer is doing, but as in Dolin, the agency's regulation might have hurt the consumer rather than helped. Id.
(68) See id.
(69) See id.
(70) See id. at 808. The FDA had requested the drug manufacturer to submit more data specifically investigating the risk of suicidal behavior in adults. Id. The FDA limited this investigation to "completed, double-blind, randomized, placebo-controlled trials". Dolin v. GlaxoSmithKline LLC, 901 F.3d 803 (7th Cir. 2018). GSK complied with the FDA's requests and also conducted their own re-analysis where they found the 6.7-fold increase of suicide attempts in adults taking paroxetine. Dolin, 901 F.3d 803.
(71) See id. at 809. The FDA's own analysis considered 372 placebo-controlled clinical trials and involved 100,000 adult patients. Id.
(72) See id.
(73) See id. at 808. After discovering an increase in adult suicidal behavior, GSK changed paroxetine's label without FDA approval, pursuant to the CBE regulation. Id. GSK was acting on the newly found information about paroxetine that showed a causal connection between the drug and suicide risks in adults. Dolin v. GlaxoSmithKline LLC, 901 F.3d 803 (7th Cir. 2018).
(74) See id.
(75) See id. The new label emphasized the possibility of the risk extending past the age of 24:
In adults with [major depressive disorder] (all ages), there was a statistically significant increase in the frequency of suicidal behavior in patients treated with paroxetine compared with placebo (11/3,455 [0.32%] versus 1/1,978 [0.05%]); all of the events were suicide attempts. However, the majority of these attempts for paroxetine (8 of 11) were in younger adults aged 18-30 years. These [major depressive disorder] data suggest that the higher frequency observed in the younger adult population across psychiatric disorders may extend beyond the age of 24.
Id. at 809. GSK's actions were logical because a drug manufacturer has a duty of care to continue updating a drug's label based on new information found. See supra note 50 and accompanying ext. Here, GSK's investigations led them to believe an adult suicide warning was required. Dolin, 901 F.3d 803.
(76) See id. Although GSK has the power to change the label unilaterally, the FDA always has the final say and can reject the label change. Id.
(77) See id. at 810. GSK asked the FDA to keep their label several times and the FDA said no each time. Id. GSK then formally asked for a paroxetine specific label, but the FDA rejected that as well stating that all SSRI labels should be the same. Id.
(78) See Tucker v. SmithKline Beecham Corp., 596 F. Supp. 2d 1225 (S.D. Ind. 2008). The court in Tucker recognizes that the FDA regulatory process is not perfect and "failure-to-warn litigation can serve to reinforce the FDA's regulations, which already place the obligation to strengthen the warnings on a drug's label squarely on the shoulders of the drug's manufacturer." Id. at 1234.
(79) See Dolin, 901 F.3d 803; see also Plivia, Inc. v. Mensing, 564 U.S. 604 (2011); Wyeth v. Levine, 555 U.S. 555, 567 (2009). The court in Dolin did not address the plaintiffs argument about Tucker because Tucker was decided in 2008, prior to the Mensing and Levine decisions. Dolin, 901 F.3d 803. Mensing and Levine set precedent for preemption cases that is now available to the Dolin court. Id. Levine held that "state law claims based on labeling deficiencies are not preempted if the manufacturer could have added the warning unilaterally under the CBE regulation." Dolin, 901 F.3d at 811 (citing Levine, 555 U.S. at 573). See also Mensing, 564 U.S. 604 (applying Devine against manufacturers of generic drugs).
(80) See Dolin, 901 F.3d 803.
(81) See id.
(82) See id.
(83) See id. The FDA was allowed to reject GSK's new label after GSK had evidence of adult suicide risks. Id. The FDA should be blamed for the lack of the warning on paroxetine, not the manufacturer who attempted to add the warning. Id.
(84) See Dolin v. GlaxoSmithKline LLC, 901 F.3d 803 (7th Cir. 2018).
(85) See id. Plaintiffs need to go after the FDA specifically, instead of the drug manufacturers, in order to promote more change and regulation. Id.
(86) See Narayan, supra note 39 (describing the dangers of allowing a manufacturer to have complete control of a product).
(87) See JANSSEN, supra note 26 (explaining history before FDA regulation where drugs contained harmful chemicals).
(88) See Narayan, supra note 39 (addressing lack of regulation in cosmetics even after the FDCA).
(89) See id. (reviewing WEN hair products complaints); see also Marcia Breen, Popular Hair Product Line Wen Sued for Allegedly Making Women Go Bald, CNBC (last updated Dec. 16, 2015), https://www.cnbc.com/2015/12/15/popular-hair-product-line-wen-sued-for-allegedly-makingwomen-go-bald.html.
(90) See Narayan, supra note 39. Under the FDCA, the FDA is not required to recall potentially dangerous products or monitor ingredients, making cosmetics basically self-regulating. Id.
(91) See id. (emphasizing the need of FDA regulation amongst the balance of manufacturer control).
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|Publication:||Journal of Health & Biomedical Law|
|Date:||Sep 22, 2019|
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