I have been quite dilatory in getting this post put together, but I had promised, as part of the MDL transfer order news (re these 33 cases), on Friday last, that I would summarize the more salient allegations of those complaints -- so, here we go:
The Marketing of Zetia and Vytorin
. . . .16. Defendants have consistently marketed Zetia to consumers and physicians as a drug that lowers LDL in a “different” manner, stressing that lowering LDL allegedly reduces or slows the buildup of plaque in arteries. For example, the Zetia website stresses that LDL cholesterol is bad because it allegedly builds up in the walls of arteries and forms plaque:Cholesterol is a type of fat found in your blood. Your total cholesterol is made up of LDL and HDL cholesterol. LDL cholesterol is called “Bad” Cholesterol because it can build up in the wall of your arteries and form plaque. Over time, plaque buildup can cause a narrowing of the arteries. This narrowing can slow or block blood flow to your heart, brain, and other organs. High LDL cholesterol is a major cause of heart disease and stroke.
HDL cholesterol is called “Good” Cholesterol because it keeps the bad cholesterol from building up in the arteries.
17. The Zetia website also stresses that Zetia reduces “bad” cholesterol, i.e., LDL. For example, a video on the Zetia website states in part that “when added to a healthy diet, [Zetia] is proven to lower Bad Cholesterol. In a clinical study of people with high cholesterol, ZETIA lowered Bad Cholesterol by an average of 30 points—that’s 18%.* These are average results. Individual results may vary.”
18. Similarly, the Vytorin website asserts that LDL is “bad” cholesterol because it allegedly builds up in artery walls to form plaque. The website states, “LDL (low-d ensity lipoprotein) cholesterol is known as ‘bad cholesterol’ because it can build up in the walls of your arteries and form a thick, hard plaque that clogs your arteries and blocks the flow of blood to your heart and brain.” The Vytorin website also states: “Having high LDL (bad) cholesterol can put you at risk for heart disease, heart attack, or stroke—especially if you have any of these additional risk factors. . . .”
19. The Vytorin website then asserts that Vytorin lowers “bad” cholesterol, creating the plain impression that taking Vytorin will decrease the buildup of plaque by lowering LDL.
The website states, “VYTORIN is proven to lower bad cholesterol 45%–60% (average effect depending on dose; 52% at the usual starting dose) when diet and exercise aren’t enough. It’s the only product to help block the absorption of cholesterol and reduce the cholesterol your body makes naturally. You should still exercise and watch your diet while taking VYTORIN.”
20. Before and throughout the Class Period, Defendants marketed Zetia as lowering “bad” cholesterol, while also claiming that the reduction of “bad” cholesterol decreases the buildup of plaque in arteries.
. . . .23. The ENHANCE trial was completed in April 2006, but Defendants did not release any results in either 2006 or 2007.
24. After several news reports about the delay of the results, Merck/Schering announced in December 2007 that it would be releasing the results shortly. Instead, in November 2007, Defendants announced that they had changed the ENHANCE trial’s “primary endpoint,” i.e., the main medical result being measured. Specifically, Defendants stated that they would focus on the common carotid artery.
Previously, Defendants had stated that the primary objective of the ENHANCE trial was to measure changes at three points of the carotid artery –- the internal carotid, the carotid bulb and the common carotid –- at the beginning of the study and after two years. After an outpouring of criticism, Defendants announced that they would not change the primary endpoints. But Defendants still did not release any results of the trial.
25. Finally, on January 14, 2008, Defendants issued a press release to announce results of the ENHANCE trial. . . .VIOLATION OF NEW JERSEY
CONSUMER FRAUD ACT
. . . .40. Under the New Jersey Consumer Fraud Act, N.J. Rev. Stat. §§ 56:8-1, et seq., Defendants have a duty to refrain from unfair acts or practices in the promotion and sale of Vytorin and Zetia to Plaintiff and the Class Members.
41. By means of the conduct alleged in this Complaint, Defendants violated the New Jersey Consumer Fraud Act in the promotion and sale of Vytorin and Zetia. By failingto timely release the results of the ENHANCE trial, which demonstrates that Zetia does not reduce or slow the buildup of arterial plaque, Defendants reaped billions of dollars in profits that they otherwise would not have obtained and caused Plaintiff and the Class Members to suffer an ascertainable loss by expending monies on the expensive drugs Zetia and Vytorin when they would have obtained the same results by paying for the generic form of Zocor, known as simvastatin.
42. Defendants engaged in that unlawful conduct for the purpose of obtaining billions of dollars in sales of Vytorin and Zetia during the Class Period.
43. Under N.J. Rev. Stat. §§ 56:8-2.11 and 56:8-2.12, Plaintiff and Class Members are entitled to a refund of all moneys acquired by Defendants by means of the unlawful practices alleged in this Complaint, in an amount to be determined at trial. . . .
. . . .47. Plaintiff believes that New Jersey law should apply nationwide. However, if New Jersey law does not apply nationwide, Defendants’ deceptive, unconscionable and/or fraudulent representations and material omissions to consumers and the public, including Plaintiff and the Class Members, constituted unfair and deceptive acts and practices in violation of the following state consumer protection statutes:a. Defendants have engaged in unfair competition or unfair or deceptive acts or practices in violation of Ariz. Rev. Stat. § 44-1522, et seq.;
b. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of Ark. Code § 4-88-101, et. seq.;
c. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of Cal Bus. & Prof. Code § 17200, et seq.;
d. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of Colo. Rev. Stat. § 6-1-105, et. seq.;
e. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of Conn. Gen. Stat. § 2-1 10a, et seq.;
f. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of 6 Del. Code §§ 2511, et seq. and 2531, et. seq.;
g. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of D.C. Code § 28-3901, et. seq.;
h. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of Fla. Stat. § 501.201 et seq.;
i. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of Haw. Rev. Stat. § 480-1, et seq.;
j. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of Idaho Code § 48-601, et seq.;
k. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of 815 ILCS §505/1, et seq.;
l. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of Iowa Code § 714.16, et seq.;
m. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of Kan. Stat. § 50-623, et seq.;
n. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of Ky. Rev. Stat. § 367.170, et seq.;
o. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of La. Rev. Stat. § 51:1401, et seq.;
p. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of Md. Com. Law Code § 13-101, et seq.;
q. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of Mich. Comp. Laws Ann. § 445.90 1, et seq.;
r. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of Minn. Stat. §§ 325D.43, et seq.; 325 F.67, et seq.; and
325F.68 et seq.;
s. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of Vernon’s Ann. Missouri Stat. § 407.010, et seq.;
t. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of Mont. Code Ann. § 30-14-101, et. seq;
u. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of Neb. Rev. Stat. § 59-1601, et seq.;
v. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of Nev. Rev. Stat. Ann. § 598.0903, et seq.;
w. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of N.H. Rev. Stat. § 358-A:1, et seq.;
x. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of N.J. Rev. Stat. § 56:8-1, et seq.;
y. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of N.M. Stat. § 57-12-1, et seq.;
z. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of N.Y. Gen. Bus. Law §§ 349 et seq. and 350-e, et seq.;
aa. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of N.C. Gen. Stat. § 75-1.1, et seq.;
bb. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of N.D. Cent. Code §§ 51-12-01, et seq., and 51-15-01, et
seq.;
cc. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of Ohio Rev. Stat. § 1345.01, et seq.;
dd. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of Okla. Stat. § 15 751, et seq.;
ee. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of Or. Rev. Stat. § 6464.605, et seq.;
ff. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of 73 Pa. Stat. § 201-1, et seq.;
gg. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of R.I. Gen. Laws. § 6-13.1-1, et seq.;
hh. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of S.C. Code Laws § 39-5-10, et seq.;
ii. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of S.D. Codified Laws § 37-24-1, et seq.;
jj. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of Tenn. Code § 47-18-101, et seq.;
kk. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of Utah Code § 13-11-1, et seq.;
ll. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of 9 Vt. § 2451, et seq.;
mm. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of Va. Code § 59.1-196, et seq.;
nn. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of Wash. Rev. Code. § 19.86.010, et seq.; and
oo. Defendants have engaged in unfair competition or unfair or deceptive acts
or practices in violation of Wis. Stat. § 100.20, et seq.
48. Either directly or indirectly (through their physicians), Plaintiff and the Class Members relied upon Defendants’ misrepresentations and/or omissions (as described herein) in purchasing Vytorin and Zetia.
49. As a direct and proximate result of Defendants’ wrongful conduct, Plaintiff and the Class Members have been damaged by purchasing Vytorin and Zetia during the Class Period.
50. As a direct and proximate result of Defendants’ wrongful conduct, Plaintiff and the Class Members are entitled to compensatory damages, including treble damages and attorneys’ fees where permitted by law, and cost of this suit. . . .
. . . .52. Defendants have received benefits from Plaintiff and the Class Members in the form of the prices Plaintiff and the Class Members paid for Vytorin and Zetia during the Class Period. By failing to timely release the results of the ENHANCE trial, which demonstrates that Zetia does not reduce or slow the buildup of arterial plaque, Defendants reaped billions of dollars in profits that they otherwise would not have obtained and caused Plaintiff and the Class Members to expend money on the expensive drugs Zetia and Vytorin when they would have obtained the same results by paying for the generic form of Zocor, known as simvastatin.
53. Defendants are aware of their receipt of those benefits.
54. Defendants received those benefits to the detriment of Plaintiff and each of the
other Class Members.
55. Defendants continue to retain those benefits to the detriment of Plaintiff and the Class Members.
56. Under the circumstances, it would be inequitable for Defendants to retain those
benefits.
57. As a result of Defendants’ unjust enrichment, Plaintiff and the Class Members have sustained damages in an amount to be determined at trial and seek full disgorgement and restitution of Defendants’ ill-gotten gains acquired as a result of the unlawful or wrongful conduct alleged above. . . .
. . . .59. As a result of Defendants’ wrongful conduct, Plaintiff and the other individual Class Members were prescribed Vytorin or Zetia when they did not know, but would have known if Defendants had acted lawfully, that the ENHANCE trial reveals that patients who took Vytorin in the trial experienced more plaque growth than patients in the trial who took simvastatin.
60. Even though Defendants knew that patients who took Vytorin experienced more plaque growth than patients who took simvastatin, Defendants withheld that knowledge from the public until January 14, 2008. Defendants have thus placed members of the class at an increased risk of heart disease.
61. Plaintiff and the individual Class Members are entitled to recover the costs of visiting their physicians to determine which course of action to take in light of the fact that patients who took Vytorin in the ENHANCE trial experienced more plaque growth than patients who took simvastatin as well as the costs incurred for necessary testing. . . .
Now, I haven't forgotten -- I
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