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In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings

United States District Court, N.D. Illinois, Eastern Division

May 8, 2017

In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings This order applies to all cases MDL No. 2545

          CASE MANAGEMENT ORDER NO. 48 (RULINGS ON ABBVIE'S MOTION FOR SUMMARY JUDGMENT ON "OFF-LABEL" MARKETING CLAIMS AND MOTION TO EXCLUDE TESTIMONY AND ABBVIE'S MOTIONS TO EXCLUDE OPINIONS OF DR. STEVEN WOLOSHIN AND DR. CURT FURBERG (DKT. 1727, 1731 & 1746))

          MATTHEW F. KENNELLY, UNITED STATES DISTRICT JUDGE

         Plaintiffs in this multidistrict litigation proceeding allege that they have suffered either arterial cardiovascular injuries or injuries related to blood clots in the veins (venous thromboembolisms, or VTEs) as a result of taking prescription testosterone replacement therapy (TRT) drugs. Defendants AbbVie Inc., Abbott Laboratories, AbbVie Products LLC, and Unimed Pharmaceuticals, LLC (collectively, AbbVie) manufacture AndroGel, one of the TRT drugs at issue in this litigation. Seven plaintiffs who have sued AbbVie have been selected to proceed with bellwether trials beginning June 2017.

         Each bellwether plaintiff-Edward Cribbs, Cecile Frost, Jeffrey Konrad, Jesse Mitchell, Arthur Myers, Robert Nolte, and Robert Rowley-alleges that AndroGel caused him to suffer either a cardiovascular or VTE injury. AbbVie has filed three motions for summary judgment, each one addressing different claims or issues. In this opinion, the Court addresses AbbVie's motion for summary judgment on what it calls plaintiffs' "off-label marketing claims"-more precisely, plaintiffs' claims of fraud, negligent misrepresentation, violation of consumer protection statutes, breach of express warranty, breach of implied warranty of merchantability, and negligence. The Court also addresses AbbVie's motions to exclude the testimony of certain experts retained by plaintiffs, specifically, Drs. David A. Kessler, Peggy Pence, Steven Woloshin, David J. Handelsman, Hossein Ardehali, and Curt Furberg.

         Background

         The Court takes the following factual background from the parties' briefs and exhibits on summary judgment. Where facts are in dispute, the Court takes them in the light most favorable to plaintiffs, the non-moving parties.

         1. Hypogonadism

         In men, testosterone is a hormone produced by the Leydig cells in the testicles. Testosterone is the primary androgenic hormone responsible for normal male physical and sexual development.

         Male hypogonadism is an absence or deficiency of testosterone resulting from a pathological condition of the testes, the hypothalamus, or the pituitary. It is generally characterized as "primary" or "secondary" hypogonadism. Primary hypogonadism is the result of testicular failure to produce adequate levels of testosterone. Secondary hypogonadism results from a disorder of the pituitary gland or the hypothalamus. Hypogonadism in adult males can result in decreased sexual interest and desire, erectile dysfunction, benign breast enlargement, decreased muscular strength, sparse body hair, and reduced bone mass. Primary and secondary hypogonadism are sometimes called "classical" hypogonadism.

         As men age, it is normal for their testosterone levels to decline. This is not a result of any pathology, and it has not generally been considered to be a medical condition that requires treatment. The plaintiffs in this litigation contend that AbbVie (along with other pharmaceutical manufacturers) engaged in a concerted marketing campaign to convince physicians and the public that reduced testosterone levels resulting from age-what has been referred to as "low T;" "andropause;" or age-related hypogonadism-is a medical condition that is appropriately treated with testosterone replacement therapy drugs.

         2. FDA approval of AndroGel

         Testosterone replacement therapy has been used to treat hypogonadism for more than 75 years. In April 1996, AbbVie's predecessor submitted to the FDA an Investigational New Drug Application (INDA) for a topical testosterone gel intended for use in treating primary and/or secondary hypogonadism in men. The INDA proposed clinical trials designed to demonstrate the safety and efficacy of AbbVie's T-gel product to raise testosterone levels to that of a male with healthy and functioning testes. In April 1999, AbbVie submitted a New Drug Application for its T-gel product, which was named AndroGel 1%. The FDA approved AndroGel 1% on February 28, 2000. The FDA approved AndroGel 1% as "safe and effective for use as recommended in the agreed upon labeling text." Defs.' Ex. 30.

         On September 15, 2006, AbbVie submitted an INDA for AndroGel 1.62%. The FDA's determination to approve AndroGel 1.62% was based on a two-phase, 364-day controlled clinical study. AbbVie later submitted an NDA for AndroGel 1.62%. On April 29, 2011, the FDA approved AndroGel 1.62% for "replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone" as described on the approved product label. Defs.' Ex. 32 at ABBVIE-FST01906236.

         3. AndroGel's indicated uses

         When the FDA approves a drug, the drug is deemed effective and safe for certain medical conditions. The use for which a drug has been approved is referred to as an "indication." A label for an approved drug-including both the physical label and the package inserts for physicians and patients-may indicate use only for the approved indications. A drug manufacturer may not include a new indication on its labels without receiving prior approval from the FDA.

         In February 2000, when the FDA first approved AndroGel 1%, the indication on the label read as follows:

AndroGel™ is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:
1. Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (FSH, LH) above the normal range.
2. Hypogonadotropic hypogonadism (congenital or acquired) - idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum levels but have gonadotropins in the normal or low range.

Defs.' Ex. 35 at ¶ 35-003.

         In April 2011, when AndroGel 1.62% was approved by the FDA, this language was modified as follows (with new wording in bold):

AndroGel™ is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:
1. Primary hypogonadism (congenital or acquired) - testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
2. Hypogonadotropic hypogonadism (congenital or acquired) - idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum levels but have gonadotropins in the normal or low range.

Defs.' Ex. 36 at ¶ 36-003.

         In 2006, AbbVie requested an indication for a third type of hypogonadism: "hypogonadism due to multiple defects in the hypothalamus-pituitary-gonadal (HPG) axis in men - e.g. DAX-1 mutations, hemochromatosis, sickle disease, glucocorticoid, age, alcoholism, HIV-infected, or chronic opioid use." Pls.' Ex. 17 at Vol. 1, p. 0003 (emphasis added). AbbVie referred to this type of hypogonadism as "combined primary and secondary hypogonadism" and/or mixed hypogonadism. Pls.' Ex. 45 at AbbVie-FST06104728. In effect, AbbVie sought an indication for what it now calls non-classical hypogonadism. The FDA rejected AbbVie's proposed third indication, stating that "[t]he indications for AndroGel 1.62% will be the same as for all previously approved products in this class. No specific claims for the treatment of age-related hypogonadism (‘andropause') will be allowed in the labeling." Pls.' Ex.18 at ABBVIEFST00009098.

         4. AndroGel promotional materials

         On March 21, 2000, AbbVie submitted its planned introductory promotional materials for AndroGel 1% to the FDA for advisory review and comment prior to disseminating them. The FDA provided AbbVie with its comments on April 12, 2000. The FDA took issue with AbbVie's claims that AndroGel was an appropriate treatment for age-related hypogonadism. The proposed materials stated that AndroGel delivers "[n]ormal 24-hour serum testosterone levels-[r]egardless of hypogonadal causes (primary, secondary, age-associated)." Defs.' Ex. 42 at ¶ 42-004. The materials also claimed that "[g]reater than 60% of men over 65 have free testosterone levels below normal values of men aged 30-35." Id. The FDA said that this language should be removed from the proposed promotional materials because "[c]laims and representations that suggest AndroGel is indicated for men with 'age-associated' hypogonadism or 'andropause' are misleading." Id. The FDA explained that AndroGel is only "indicated in males with primary hypogonadism or hypogonadotropic hypogonadism." Id. The FDA also took issue with AbbVie's claim that AndroGel will "increase muscle strength and stamina, " commenting that the claim was misleading because it "has not been demonstrated by substantial evidence." Id. The FDA noted that its "comments on a particular claim or representation should be applied to all future materials that contain similar claims and representations." Id. at ¶ 42-002.

         Following the FDA's initial approval of AndroGel 1.0%, AbbVie launched a comprehensive advertising campaign for AndroGel. AbbVie's strategy was to "[p]ursue age-related hypogonadism market expansion"; "[e]ducate and motivate physicians to treat low T"; and "[e]ducate patients about the symptoms of and benefits of treating low testosterone." Pls.' Ex. 37. AbbVie's strategy for advertising AndroGel to primary care physicians, specifically, was to "sell market expansion first and AndroGel second." Pls.' Ex. 38. To accomplish this, AbbVie directed its pharmaceutical representatives to talk "in terms of low testosterone and not hypogonadism" because it found that primary care physicians did not respond well to the term "hypogonadism." Id.

         This same strategy is reflected in AbbVie's approach towards its direct-to-consumer advertisements. AbbVie's direct consumer marketing of AndroGel during this period generally consisted of branded and unbranded advertising. AbbVie needed the FDA's prior authorization before disseminating a new advertisement for AndroGel. Generally, the FDA sought to keep AbbVie's branded advertisements of AndroGel consistent with the product's approved label. For example, in June 2003, AbbVie submitted to the FDA a proposed television advertisement featuring a man discussing symptoms of low testosterone. In the proposed advertisement, a man states, "I hadn't been feeling like myself for a while . . . I was tired, felt down and my sex drive was in neutral. My doctor said any one of these symptoms, among others, could be a sign of low testosterone." Defs.' Ex. 48 at ¶ 48-008. While the man makes this statement, the language "LOW TESTOSTERONE (hypogonadism)" is superimposed on the image in bold text. In a later shot of the advertisement, the man states that "over 4 million men have low testosterone and . . . while AndroGel might not be right for everyone . . . your doctor will know . . . if it's right for you." Id. In that same frame, the language "NOT FOR EVERYONE" and "INDIVIDUAL RESULTS MAY VARY" are superimposed on the image. Id. at ¶ 48-009. According to an AbbVie report, the FDA took no issue with this advertisement because the agency believed the advertisement did not "differ substantially from the material currently in use." Defs.' Ex. 49.

         Unbranded advertisements do not require FDA review because the FDA considers unbranded advertisements educational rather than promotional. AbbVie's unbranded advertisements focused on "disease awareness" and made no product-specific claims. Specifically, AbbVie launched a disease awareness advertising campaign for men with low testosterone or "Low T." AbbVie distributed direct-to-consumer advertisements through unbranded websites, third parties, and television advertisements, encouraging aging men to ask their healthcare professionals to test them for low testosterone or "Low T." For example, in 2001, AbbVie released an unbranded advertisement that appeared in question-and-answer format. The advertisement stated:

Q: Should I just accept my low testosterone as a natural part of getting old?
A: Experts have determined that testosterone replacement therapy (TRT) may help counter some of the more serious debilitating, effects of aging. In addition to its known role in aiding sexual desire and function, TRT may also help patients maintain bone mineral density (which is important for avoiding bone fractures), increase their amount of muscle, and decrease body fat. There is also evidence to suggest that TRT can help improve mood. If you're hypogonadal, TRT may help you maintain your health and preserve your lifestyle.

Pls.' Ex. 40.

         In 2005, AbbVie distributed a direct-to-consumer print advertisement showing a coffee cup and an energy bar with the following text superimposed on the image: "For nearly 8 million men, no amount of coffee can replace the energy they've lost. If fatigue, depressed mood, or low sex drive is part of your daily grind, you have low testosterone (Low T)." Defs.' Ex. 54 at ABBVIE-FST00383450. One page of the advertisement invites consumers to answer a 10-question survey to identify if they suffer from low T. The page bears the caption, "Could your thirst for energy be caused by Low T?" Id. The advertisement suggests TRT as treatment for low T, claiming that TRT "can raise testosterone levels, which may improve your energy, mood, and sex drive." Id.

         In 2009, an AbbVie unbranded commercial encouraged men who felt they had less energy to investigate an unbranded website, IsItLowT.com, to consider whether they suffered from low T. Pls.' Ex. 1 (Kessler Report) ¶ 251 & n.235. The advertisement stated:

Millions of men 45 and older just don't feel like they used to. Are you one of them? Remember when you had more energy for 18 holes with your buddies? More passion for the one you love? More fun with your family and friends? It could be a treatable condition called low testosterone or Low T.

Id.

         AbbVie's unbranded commercials, slide kits for physicians, and other promotional material during the relevant period encouraged physicians and patients to investigate testosterone replacement for aging males. AbbVie's advertisements suggested that having testosterone levels below 300 ng/dL is indicative that a patient has age-related hypogonadism or age-related low testosterone.

         Prescriptions for TRTs overall rose after the introduction of AndroGel 1%.

         5. Risks associated with AndroGel

         On February 9, 2015, the FDA directed AbbVie to change its labels for AndroGel 1% and AndroGel 1.62% because it had become aware "of the risk of major adverse cardiovascular outcomes associated with testosterone replacement therapy." Pls.' Ex. 80 at ABBVIE-FST03767438. The FDA directed AbbVie to remove "idiopathic" from AndroGel's indication for hypogonadotropic hypogonadism, which stated, "idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation." Pls.' Ex. 79 at ABBVIE-FST02620706; Pls.' Ex. 80 at ABBVIE-FST03767441. The FDA also directed AbbVie to add language indicating that AndroGel had not been determined to be safe and effective for age-related hypogonadism. For example, under AndroGel's "indications and usage" section, the FDA directed AbbVie to add the language that, "[s]afety and efficacy of AndroGel [1% and 1.62%] in men with age-related hypogonadism have not been established" and that "[a]ge-related hypogonadism refers to men with serum testosterone concentrations below the normal range for no apparent reason other than age, and who experience signs and symptoms of aging that overlap with those of hypogonadism." Pls.' Ex. 79 at ABBVIE-FST02620705; Pls.' Ex. 80 at ABBVIE-FST03767442.

         In March 2015, the FDA issued a drug safety communication for testosterone products and cautioned medical practitioners against prescribing the drug for conditions for which it was not indicated:

The U.S. Food and Drug Administration (FDA) cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man's symptoms seem related to low testosterone. We are requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. We are also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests.
Testosterone is FDA-approved as replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause a condition called hypogonadism. Examples of these disorders include failure of the testicles to produce testosterone because of genetic problems, or damage from chemotherapy or infection. However, FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.

Pls.' Ex. 6 (emphasis added).

         Discussion

         AbbVie has moved for summary judgment on what it refers to as plaintiffs' off-label marketing claims.[1] Summary judgment is appropriate if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law. Fed.R.Civ.P. 56 (a); Wedemeyer v. CSX Transp., Inc., 850 F.3d 889, 894 (7th Cir. 2017). In making this ...


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