lawsuits

Whistleblower backlog may start clearing

Tracy Staton — Thu, 03 Jul 2008 09:48:37 -0400

Lawmakers and not-for-profit groups are pushing the feds to help clear a backlog of some 900 whistleblower lawsuits--and a sizable number of those were filed against drugmakers, the Washington Post reports.

You know the type: Consider the Merck case, which the drugmaker paid $650 to settle; it alleged that the company failed to repay Medicaid rebates. Then there was the $515 million Bristol-Myers Squibb deal, which settled claims of illegal marketing and pricing. Sen. Charles Grassley (R-IA) is among those calling for the Department of Justice to make these investigations a priority. Whether that means we'll see more pharma settlements--well, we'll just have to wait and see.

- read the WP story

J&J and Red Cross remove boxing gloves

Christe Bruderlin-Nelson — Wed, 18 Jun 2008 06:04:27 -0400

While Johnson & Johnson and the Red Cross companies apparently thought it worthwhile to expend significant time and energy fighting over their common red cross emblems, they've now decided to call it quits. J&J has officially released all claims against the Red Cross.

The two spent almost a year battling in court over the red cross symbol, but J&J decided to leave the legal scene after a judge threw out most of its suit against the Red Cross last month. Although both J&J and the nonprofit organization have had the same symbol for ages, the Red Cross began licensing its emblem for use on retail products, so J&J filed suit against the nonprofit. The Red Cross then counter-sued. Both companies hoped to thwart any confusion over who was behind a particular product placement, as either could be responsible for a red cross emblazoned on a first-aid kit.

Apparently the courts thought there was no good case for branding rights in this instance and the non-settlement leaves everything pretty much as it was before. Now the real question is: Will you still find those J&J Band-Aids in your Red Cross first-aid kits?

- read the Wall Street Journal blog post
- here's more from Pharmalot

Companies sue over generic Prevacid SoluTab

Christe Bruderlin-Nelson — Wed, 11 Jun 2008 03:45:42 -0400

Ethypharm, Takeda, and TAP Pharmaceuticals are suing Barr Pharmaceuticals for patent infringement. The suit is over Barr's plan to market a generic version of Prevacid SoluTab tablets, the popular delayed-release heartburn drug that dissolves without water. The drug had sales of over $400 million in the last year in the U.S. alone.

Barr went to the Food and Drug Administration to request approval of a generic version of Prevacid late last year, but the plaintiffs are hoping to block the approval, which they claim violate patents set to expire in 2012 and 2019. At the same time, Barr shares appear to be on a downward trend, falling 34 cents on Tuesday. Takeda stock also fell in Japan.

- see the story at Forbes
- find out more at CNN Money

AZ appeals $215M Medicaid verdict

Tracy Staton — Tue, 10 Jun 2008 09:54:06 -0400

AstraZeneca asked an Alabama judge to toss out or reduce a $215 million jury verdict in a Medicaid drug price fraud lawsuit, saying that the state didn't prove that AstraZeneca deliberately caused the Medicaid system to overpay for drugs. A ruling is expected within 10 days. Report

No monitoring for Vioxx-takers, court says

Tracy Staton — Wed, 04 Jun 2008 21:24:10 -0400

Slowly but surely Merck is working its way off the Vioxx hook. First, the successful fight-em-one-by-one strategy, then the big settlement, then a few key overturned verdicts--and now, the New Jersey Supreme Court has ruled that the drugmaker doesn't have to monitor Vioxx patients for future health problems. The 5-1 decision nullifies a class action lawsuit, filed by Vioxx users who don't have symptoms but wanted to be tested for any hidden problems.

The ruling states that patients can't pursue claims for medical monitoring unless they show "harm." Because these plaintiffs had no injuries to report, no harm done--in a legal sense, anyway.

- check out Merck's release
- read the Los Angeles Times story
- see the article in the Star-Ledger

Bayer fined $16.2M in price-fixing probe

Tracy Staton — Thu, 29 May 2008 10:50:12 -0400

Bayer was fined $16.2 million for fixing the prices of aspirin and other over-the-counter meds in Germany; the government alleged that a local Bayer subsidiary made illegal rebate deals with more than 21,000 pharmacies. Bayer denied the allegations, saying it agreed to the fine to avoid a long legal fight. Report

Biovail to pay $25M in doc payoff claims

Tracy Staton — Mon, 19 May 2008 10:57:12 -0400

If only this were the last bit of old business Biovail needed to clear. In a deal with the U.S. Department of Justice, the Canadian drugmaker agreed to pay almost $25 million to settle claims that it paid docs and their office managers to get patients onto its Cardizem heart drug. CEO Bill Wells sounded pleased about the deal, saying that it "eliminates the significant exposure to the corporation" and would "immediately reduce our ongoing legal expenses."

And what a bunch of legal expenses they've been. Biovail has been under investigation by various government watchdogs and plagued by an ongoing fight with its founder and ex-chief Eugene Melnyk (photo). Little by little, the company has been extricating itself from these legal snarls, but it's not finished yet: the U.S. Securities and Exchange Commission charged the company and several former and current execs with misleading investors and puffing up financial statements.

- see Biovail's release
- read the story at CNN Money
- check out the Pharmalot item

Group wants Ortho patch withdrawn

Fri, 09 May 2008 06:59:54 -0400

We've all heard the safety warnings about the Ortho-Evra birth control patch and its link to life-threatening blood clots. The FDA has updated the Johnson & Johnson drug's labeling three times to notify about the risks, including once early this year. And demand for the patch has dropped to 2.7 million prescriptions in 2007 from 9.9 million in 2004. But Public Citizen isn't satisfied. It wants the patch taken off the market completely.

In a petition to the FDA, the consumer advocacy group argued that the patch doesn't offer better contraception to outweigh the extra risk of blood clots. And it alleges that plaintiff's lawsuits have uncovered two unpublished studies by J&J researchers, who found higher estrogen exposure from the patch even before it won agency approval in 2001.

Johnson & Johnson defended its product, saying it's safe and effective when used according to its labeling. The agency had no comment because it hadn't yet reviewed the petition.

- read the New York Times article

Judge wary of certifying Zyprexa classes

Mon, 14 Apr 2008 06:59:57 -0400

Score one for Eli Lilly in federal court. A district judge says he probably won't give class-action status to patients and insurers who paid for Zyprexa for FDA-approved uses. And he doesn't expect the plaintiffs to be able to claim punitive damages. The case "ought to be settled," Judge Jack Weinstein said. "I really think that we're not dealing with very much money."

Why? Apparently, an appeals court ruled April 3 that "light" cigarette smokers couldn't sue tobacco makers as a group; the smokers were alleging that cigarette companies fraudulently convinced them that those products were safer than regular smokes. The appeals court said the smokers were too different to have their cases tried together.

A Lilly lawyer argued that this ruling blocks Weinstein from granting class status to the Zyprexa customers; Weinstein appeared to agree. But the judge also said that he wouldn't certify a class based on uses approved by the FDA--though he might reconsider that position before his final ruling. He did say he'd consider certifying a class of off-label purchasers.

- read the item at Pharmalot

ALSO: The New York Times editorializes against preemption, saying that disallowing lawsuits over federally approved drugs would deprive the public "of a vital tool for policing companies and unearthing documents that reveal their machinations." Report

Related Articles:
Shareholders sue Lilly over Zyprexa. Zyprexa report
Lilly could pay $1B to settle on Zyprexa. Lilly report
Zyprexa--Top 10 Warnings and Recalls of 2007. Special report
Lilly strengthens Zyprexa warnings. Lilly report
Study: 86% of docs cut Zyprexa use. Zyprexa report
Lilly to pay $500M to settle Zyprexa claims. Lilly Port

If J&J misled FDA, can patients sue?

Mon, 07 Apr 2008 06:59:57 -0400

Drug companies appear to be close to gaining a long-coveted prize: A shield against patient lawsuits. The Bush administration has been arguing in favor of it, saying that only the FDA has the expertise to regulate pharma. And the Supreme Court will rule during its next term on a case that could make FDA approval pre-empt any liability claims.

In the meantime, Johnson & Johnson is using the argument in a case over the Ortho Evra birth control patch. Company documents show that J&J knew the patch delivered more estrogen to patients than low-dose birth-control pills did--knew this even before the FDA approved the product in 2001. A 1999 trial showed the patch delivering 30 to 38 micrograms into the bloodstream daily. But the company marketed the product as delivering 20 micrograms daily. High doses of estrogen are known to raise the risk for blood clots that can cause heart attack and stroke. Families and patients have sued, alleging a variety of health problems, including death, ensued after women began using the patch--and that the company either hid or altered data to mislead the FDA and patients.

The FDA didn't warn women of the product's dangers until 2005, after receiving reports of at least 50 deaths associated with the drug. As one FDA official admitted during the Zyprexa trial last month, the agency doesn't always ask for strong warnings even on risky drugs because companies typically oppose them. "We at the FDA know what we can and cannot obtain," the official said, according to the New York Times. Plus, the fiddling J&J did with the estrogen numbers--a "correction factor"--was only disclosed once in its 435-page approval app for the patch.

Nevertheless, patients shouldn't be allowed to sue, the company's lawyers say, because the agency approved the product and its label: "FDA is responsible for making those decisions." We'll see how that defense fares.

- read the NYT story
- see the item at PharmaGossip

Related Articles:
FDA issues warning for Ortho Evra patch. Report
Patch delivers killer doses. Report
Bush: FDA's word shields against lawsuits. Report
Supremes to mull block on drug suits. Report