A Pre-Acquisition Organon Mess has been Unsealed by Judge Cavanaugh. . . .

April 15, 2008 · Leave a Comment

As many other capable bloggers have indicated, it appears that Organon was involved in some highly irregular efforts to keep one of its drugs, used in the operating suite, on the market, long before Organon was acquired by Schering (1999 through 2002). Ultimately, these marketing efforts failed, and Organon withdrew the product — allegedly, in part, due to increased incidence of mortality — while the drug was employed in the OR.

What interested me about this particular lawsuit — as I read through the docket — was (1) that the same predicate events did result in a criminal investigation, out of the Boston US Attorney’s office (which has since apparently been closed), and (2) that it was, for the vast length of its prior existence, held under a very strict — nay, all-but-air-tight — seal. Click it to enlarge, here:

This sealing — and the February 2008 unsealing — seem unusual, and are thus what I’ll focus on, here, tonight. At one point, there were in camera proceedings held, and orders entered, by the federal District Court in Boston — that the nominal claimant/plaintiff was entirely prevented from learning about — even after the fact.

That is rather extraordinary, even in the otherwise cloak-and-dagger world of federal Qui Tam Act (QTA) suits, brought by individuals (but in the name of the United States of America). Some times, when a criminal indictment is contemplated, but not yet unsealed, the civil QTA matter will be stayed (or “put on hold“) until the indictment issues, or the investigation otherwise closes, without any indictment issuing.

But to hold hearings, and to enter orders, on a claimant’s case — without letting his lawyer be present — or even notifying his own lawyer, after the fact, is in my experience, all but jaw-slacking. That this case stayed sealed for almost seven years, is likewise astonishing. It was transferred down to New Jersey (when the claimant moved there), and into the federal district courts there, about a year and a half ago. More on that in a second.

I am still reviewing all the formerly-sealed documents I downloaded last night, out of Boston, and New Jersey, to try to ultimately sort out what happened — and why, procedurally, this remained in a “Star Chamber” for so long. I’ll update prominently, here, if anything really interesting turns up, in that regard.

But, now — and my punchline, here — the case was unsealed in February 2008 by none other than Judge Cavanaugh’s own Magistrate Falk — the very same Judge Cavanaugh who will now oversee all 33-plus of the consolidated Schering consumer fraud suits in MDL 1938. At first blush, that makes a lot of sense, as he will no doubt, become an expert in the intricacies of Schering’s inner workings — as part of his review of the consumer fraud multi-district litigation.

I have set, in running-text, the entire the order, below, though, to point out that Judge Cavanaugh’s court unsealed the case “sua sponte” — which means “on his own intiative” — or, without anyone moving to ask him unseal it. The Court felt it important to unseal this case. Why? I hope to sort the answer to that question out in the next few days. Until then, take a look at this truly extraordinary order:

~~~~~~~~~~~~~~~
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY

~~~~~~~~~~~~~~

UNITED STATES OF AMERICA,
Plaintiff,

v.

ORGANON, INC., et al.,
Defendants.

Hon. Dennis M. Cavanaugh
Civil Action No. 07-2690 (DMC)

~~~~~~~~~
ORDER
~~~~~~~~~

THIS MATTER having come before the Court sua sponte; and it appearing that this case has been proceeding under seal pursuant to 31 U.S.C. § 3730(b)(2); and it further appearing that the Government has filed a notice of election not to intervene in this matter; and for good cause shown;

IT IS on this 11th day of February, 2008 ORDERED that the complaint in this matter be and hereby is unsealed; and it is further ORDERED that plaintiff serve the complaint in accordance with Rule 4 of the Federal Rules of Civil Procedure.

/s/Mark Falk

MARK FALK

United States Magistrate Judge

Orig.: Clerk of the Court
cc: Hon. Dennis M. Cavanaugh, U.S.D.J.

All Parties

File

Wild. What was up with all of that, I wonder. But, fret not, gentle readers — I’ll go find out. Heh.

Categories: Raplon Dennis Cavanaugh Mark Falk Schering Organon Feld

Some More Details, here — the Schering Consumer Fraud Complaints. . . .

April 15, 2008 · Leave a Comment

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 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 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 still haven’t finally found time had a chance to summarize my thoughts on the Schering ERISA claims yet. That post will be out by week’s end. Done.

Categories: ENHANCE consumer fraud MDL 1938 Dechert LLP Schering Me

Some More Details, here — the Schering Consumer Fraud Complaints. . . .

April 15, 2008 · Leave a Comment

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 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 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 still haven’t finally found time had a chance to summarize my thoughts on the Schering ERISA claims yet. That post will be out by week’s end. Done.

Categories: ENHANCE consumer fraud MDL 1938 Dechert LLP Schering Me

Some More Details, here — the Schering Consumer Fraud Complaints. . . .

April 15, 2008 · Leave a Comment

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 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 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 still haven’t finally found time had a chance to summarize my thoughts on the Schering ERISA claims yet. That post will be out by week’s end. Done.

Categories: ENHANCE consumer fraud MDL 1938 Dechert LLP Schering Me