FDA Investigating Vytorin

Coming on the revelations that Vytorin is no more effective than generics, the FDA announced that it would investigate the drug and its manufacturers,Merck & Co Inc. and and Schering-Plough Corp.

Here is the url for more information on FDA action: http://www.msnbc.msn.com/id/22847409/

The press accounts don't specify the scope of the investigation, but based upon an earlier study released this month, it appears that the companies knew that Vytorin was no more effective than generic drugs in treating cholesterol issues.

Consumer laws, like Oregon's Unlawful Trade Practices Act give consumers a way to obtain refunds when a drug manufacturer falsely represents that its new drug is more effective than a less expensive generic. While there is certainly more to this story, it looks as if consumers are filing class actions in multiple states.

David F. Sugerman
www.pspc.com
Paul & Sugerman, PC

Zetia and Vytorin Subject of Consumers' Class Actions

New studies released earlier this month raise troubling questions about the effectiveness of two prescript medications used to control cholesterol. The generic products Ezetimibe--marketed under the registered trademark Zetia--and Ezetimibe/Simvastatin--marketed under the registered trademark Vytorin--apparently aren't effective, as represented by their manufacturers.

Disclosure: the author of this blog routinely handles consumer class actions and may become involved in this litigation in the future.

Consumers are lining up in various states to pursue claims for reimbursements and refunds for money spent on these drugs. According to a complaint filed in U.S. District Court of Kansas, the drugs are alleged to increase the formation of fatty plaques, which raises the risk of heart attack.

It's going to be interesting to see how this plays out.

David F. Sugerman
www.pspc.com
Paul & Sugerman, PC

Finally-The Press Asks OHSU the Hard Questions

I have to say that Steve Duin's column in today's Oregonian (24 January 2008) is a breath of fresh air. Here is the url: http://www.oregonlive.com/news/oregonian/steve_duin/index.ssf?/base/news/1201137918314500.xml&coll=7&thispage=1

The back story is that the Oregon Supreme Court ruled recently that Oregon Health Sciences cannot cap a child's damages at $200,000 when OHSU's negligent treatment causes profound brain damage.

Rather than take responsibility, OHSU started up the scare machine. We were treated to a parade of horribles. OHSU will be forced to limit or cut care, it will be closing clinics, and it will be laying off many people all because of--they claimed--Jordaan Clarke.

Steve Duin's column debunks the myth. I mean, for crying out loud, can you say, "Aerial tram"? And don't even get me started on the OHSU waterfront developments. Or how about the recent loss of the biotech research group to Florida? The reality is that OHSU hides from public scrutiny by claiming to be private and hides from market reality by claiming to be public.

The best part of Steve Duin's article is this quote from Sen. Walker (Eugene): "They've finally found a way for people to overlook years of financial mismanagement," state Sen. Vicki Walker, D-Eugene said, "and it's Jordaan Michael Clarke. It's a great PR move, but it's ridiculous. And it's a snow job."

Couldn't agree with her more.

David F. Sugerman
www.pspc.com
Paul & Sugerman, PC

Supreme Court Cases Focus on Whether Corporate Actors Must Answer to Juries

The Supreme Court recently announced that it will hear two cases that may impact consumers. Two cases address a troubling area--federal preemption. Both threaten to further restrict consumers' abilities to obtain compensation when wrongdoers cause harms and losses.

In Wyeth v. Levine, the Supreme Court will decide whether state law claims for injuries that seek payment for harms and losses caused by a dangerous drug are preempted, when federal law requires a warning on the drug. In the Levine case, Ms. Levine lost her arm as a result of complications from defendant's drug. The jury awarded money to make up for Ms. Levine's harms and losses. Now Wyeth argues that federal law protects it from answering for harms and losses caused by its misconduct.

In Altria v. Good, the Supreme Court will decide whether requirements that relate to the labels on cigarettes preempt consumers claims that they were deceived when Philip Morris sold Marlboro Lights. In the case--arising in Maine--consumers claim that Philip Morris failed to disclose that Marlboro "Lights" that were "lowered tar and nicotine" are only "light" when smoked by a machine. (Full disclosure: The author of this blog has been pursuing a similar claim on behalf of Oregon purchasers of Marlboro Lights.) In Altria, Philip Morris wants the Court to put a stop to these consumer cases because--Philip Morris claims--its labels were regulated by federal rules.

Nice try. Actually, nothing in any federal rule or law required Philip Morris to claim that its cigarettes were light or lowered tar and nicotine. They made that choice. And they also chose not to disclose that the "light" and "lowered tar and nicotine" labels apply to machines, not to people.

Still, this court seems to tilt in favor heavily in favor of corporate interests. As well, this court seems to distrust the jury's ability to hear and weigh the evidence and decide whether a consumer's harms and losses were caused by misconduct.

I long ago stopped making predictions about what any court will do. It's a waste of energy and time, and I imagine that I'm about as good at predicting as I am at calling heads or tails. Still, if these cases go the wrong way, consumers could find themselves with nowhere to turn when corporate misconduct causes serious harms and losses.

David F. Sugerman
Paul & Sugerman, PC
www.pspc.com