lawsuit

Pfizer aims for settlement on Trovan

Tracy Staton — Tue, 28 Oct 2008 11:48:01 -0400

The long legal saga of Pfizer versus Nigeria could come to a close quite soon. The drugmaker and alleged victims of a drug trial hope to reach out-of-court settlement next month, lawyers told a Nigerian high court Monday. The two sides asked for an adjournment until Nov. 27 to give them time to pursue a deal.

"We are making a push for final settlement out of court," prosecution counsel Suleiman Na-Malam said. Athony Idigbe, Pfizer's lawyer, said, "We are optimistic we will make progress on the settlement issue and then brief the court on what we will have agreed on."

Settlements have been rumored before, but this is the first time both sides have admitted to progress in negotiations. If they come to an agreement, the deal would end several years of bitter legal argument over Trovan, an experimental meningitis drug administered to Nigerian children during a severe epidemic. Plaintiffs accused Pfizer of improperly conducting the trial--and of leaving 11 children dead and many others disfigured. Pfizer maintained that it acted properly, and that the deaths and injuries stemmed from the disease, not the drug.

- read the story from AFP

Fund sues to block Lilly-ImClone match

Tracy Staton — Tue, 28 Oct 2008 10:15:01 -0400

Just when we thought the ImClone Systems buyout drama was over, shareholders are mounting their own major production. A pension fund, the State-Boston Retirement System, has sued putative buyer Eli Lilly, along with ImClone and its directors, claiming that the biotech's board didn't live up to its fiduciary duty. And the suit is pursuing class-action status to get other shareholders in on the fight.

The suit lambastes the $70-a-share Lilly/ImClone deal as "the result of a hopelessly flawed process" and claims that ImClone's board "failed to provide ImClone's shareholders with material information to make an informed decision as to whether to tender their shares," the companies disclosed in SEC filings. Both Lilly and ImClone say the suit is "without merit;" Lilly intends to "vigorously defend" its deal.

You'll recall that ImClone's Erbitux partner Bristol-Myers Squibb started off the bidding with a $60-per-share offer, which it eventually raised to $62. But ImClone Chairman Carl Icahn swept in with Lilly's $70 bid, Bristol bowed out, and the deal appeared to be done. Does the pension fund expect to get more than $70? We'll keep you posted.

- read the Forbes story
- check out the Wall Street Journal Health Blog post

Lilly: $1.4B ding in profits for Zyprexa charge

Christe Bruderlin-Nelson — Wed, 22 Oct 2008 05:43:17 -0400

Earlier this month, Eli Lilly came to a settlement regarding consumer protection laws with 32 different states over inappropriate marketing of Zyprexa. Now, the company says it is in "advanced discussions" regarding a criminal investigation, in addition to a class-action lawsuit it might face.

Lilly's senior vice president and general counsel, Robert Armitage, released a statement saying that, because of the ongoing investigation, "We now have a heightened sense of responsibility to all our stakeholders to intensify efforts to resolve these issues."

Big pharma companies paying fines is now so commonplace, it's almost unsurprising. In fact, Lilly is just another on the long list of fined drug companies that includes Pfizer, Merck and Schering-Plough, to name a few. Accountability rests with the corporation (and fines with its shareholders), thereby protecting the individuals within the company who made the choices that got it into hot water. Some critics say the setup is very convenient.

Eleven states that were not part of the initial 32-state probe have also filed lawsuits over the atypical antipsychotic medication, which the company launched in 1996. Lilly said yesterday that will record in the third quarter of 2008 a charge of $1.415 billion, or $1.29 per share, as a result of its Zyprexa problems, and that the company is in "advanced discussions" to resolve the ongoing investigations.

- check out Lilly's release
- read the story in the Wall Street Journal
- see more at Forbes
- here's the Wall Street Journal blog post

Court: Wyeth can be sued over thimerosal

Tracy Staton — Tue, 07 Oct 2008 11:08:50 -0400

The Georgia Supreme Court has allowed an Atlanta couple to pursue a suit that attempts to prove a Wyeth vaccine containing thimerosal caused their son's disability. The state's high court upheld a first-of-its-kind ruling by an appellate court that had drawn fierce opposition from the vaccine industry; Wyeth says it will appeal the decision to the U.S. Supreme Court. Report

Lawsuit: Medtronic perks wooed docs

Tracy Staton — Thu, 25 Sep 2008 11:12:05 -0400

What do a Memphis gentlemen's club, trips to Alaska and ill-gotten patent royalties have in common? They're all perks that Medtronic gave to doctors, according to a lawsuit brought by a former Medtronic lawyer. The incentives were handed out by the company's $3 billion spinal devices unit, which has already been under investigation for its physician relationships.

As you know, Sen. Charles Grassley has been probing off-label use of Medtronic's spine products, examining whether those unapproved uses were driven by incentives given to doctors. The FDA has warned that off-label use of a Medtronic bone graft has led to potentially life-threatening side effects in dozens of patients.

The allegations were made in a lawsuit, filed in 2002 but only recently--and partially--unsealed. A heavily redacted copy of the complaint is the only version publicly available. But the Wall Street Journal got an unredacted copy, which alleged that kickbacks were "pervasive" in the spinal unit.

Medtronic says that it's changed many business practices since that lawsuit was filed. The company says it's "committed to reform and transparency in the industry."

- read the Wall Street Journal story

Judge unseals secret Zyprexa papers

Tracy Staton — Mon, 08 Sep 2008 10:51:19 -0400

Eli Lilly will face a class-action suit over Zyprexa, now that a federal judge has certified a group of insurance companies, pension funds, and unions that want the drugmaker to repay them for the billions they spent on the controversial antipsychotic drug. The plaintiffs allege that Lilly hid the drug's side effects--including excessive weight gain and diabetes--and marketed it for off-label uses.

The judge, Jack Weinstein, said in his 295-page ruling that the plaintiffs have presented "sufficient evidence of fraud under RICO," the Racketeer Influenced and Corrupt Organizations Act originally designed to prosecute organized crime but now often used in corporate cases.

Weinstein refused class status to individual patients who are suing Lilly over their own injuries from Zyprexa in the same ruling. But he unsealed some documents that have been at issue since the New York Times published a story based on them. They showed that Lilly execs had withheld info about Zyprexa side effects. The company said the documents had been "cherry-picked" to give that impression, and denied having kept back any side-effects data on the drug.

Now, the papers will be open to view, because Weinstein figures that they could have bearing on "the health of hundreds of thousands of people." So, the judge ruled, Lilly's interest in keeping the documents secret is outweighed by "the public interest." Insurers, unions, medical researchers, and media organizations have petitioned for the documents, so the public is sure to get an earful.

- read the New York Times story
- check out the post at Pharmalot

Big Pharma balks at lawsuit rule

Tracy Staton — Tue, 12 Aug 2008 11:03:43 -0400

Fighting lawsuits is bad enough. After all, the pharma business is full of them: patent fights, product liability cases, regulatory disputes. Now, the Financial Accounting Standards Board--the accounting organization that sets the rules for companies' numbers-reporting--wants businesses to regularly disclose how much various lawsuits will cost them. Six Big Pharma companies--Johnson & Johnson, Novartis, Pfizer, Merck, Eli Lilly, and Wyeth--weighed in with a protest.

Estimating those costs is well nigh impossible, not to mention expensive, the companies contended in a letter to FASB. Examples? Take the fight over Merck's painkiller Vioxx. First, a Texas jury awarded one survivor more than $250 million, then a court struck the ruling down completely. Wyeth's fen-phen troubles are also an example. The company thought it might settle those claims for $3.75 billion, but instead has set aside or paid out more than $21 billion in legal fees, judgments and settlements. With numbers all over the map like that, how could estimates be valuable to investors, they argue. A former FASB chairman agrees; he told the Wall Street Journal, "I think the board has gone too far."

- read the WSJ story

Judge strikes down Biogen preemption case

Maureen Martino — Thu, 07 Aug 2008 14:01:22 -0400

Biogen and Elan--along with proponents of preemption--were dealt a setback today as a federal judge declined to transfer a case from Massachusetts to a federal court in Iowa. The lawsuit stems from the death of a patient who contracted PML after taking Tysabri; the drug was pulled from the market 11 days later. The patient's wife sued the drugmakers in Massachusetts, where Biogen is based. But drugmakers are waiting for the Supreme Court to rule on the issue of preemption, which asserts that the FDA's approval of a drug shields companies from lawsuits. They're expected to hear a precedent-setting case--Wyeth v. Levine--this fall. Biogen and Elan argued that the Massachusetts case should be moved to federal court because the fundamental question is whether the FDA's word protects drugmakers.

However, Judge Douglas Woodcock ruled against the developers, saying that preemption is not part of the law at this time and as such, the suit should stay in state court where it was filed. "The Defendants are essentially proposing that I exercise federal jurisdiction given the unsettled nature of the law in this area. I decline their offer," he said in his opinion. "Present posture of case law does not justify removal from state court to this [federal] court.

- here's the Wall Street Journal article
- check out the Pharmalot post for more

J&J pays up for Pfizer consumer unit error

Christe Bruderlin-Nelson — Wed, 06 Aug 2008 10:22:19 -0400

In 2006, Johnson and Johnson acquired a plant in Lititz, PA when it bought Pfizer's consumer health care division. Now federal lawmakers contend that the plant violated paperwork regulations for controlled substances in Pennsylvania during the preceding five years, from 2001 to 2005.

Pseudophedrine is the controlled substance under question, and authorities allege that Prizer's consumer unit imported Benadryl-D, which contains pseudophedrine, from Canada without officially notifying the US Drug Enforcement Agency under the Controlled Substances Act. The Act requires companies to provide written notification of importation of any controlled substances.

J&J settled the case; it will pay $511,000 to the federal government because of the error.

- check out the story at CNN Money
- read the Pharmalot blog post
- get more from the Wall Street Journal
- check out the US Department of Justice statement

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Wyeth wrestles with Prempro suits

Christe Bruderlin-Nelson — Wed, 16 Jul 2008 10:29:28 -0400

Two women in Nevada claimed that Prempro and Premarin led to them developing breast cancer, and rather than go to trial, Wyeth paid the women an undisclosed settlement amount. The women asserted that Wyeth did not adequately warn them about their increased risk of developing breast cancer because of taking the menopause medications.

According to Wyeth, the company has more than 5,000 lawsuits regarding the menopause meds facing it, but plaintiff attorneys say the real number is likely double that. It has lost four out of seven cases so far. Prizer will also continue to hit the courts over its drug, Provera. So far, it's zero for two.

On July 11, New Jersey Judge Jamie Happas dismissed two lawsuits aimed at Wyeth and Pfizer's Pharmacia & Upjohn unit, saying the plaintiffs did not provide sufficient proof that the companies failed to warn them adequately.

The drugs are still on the market, despite the fact that women taking these medicines have almost a 25 percent increased risk of breast cancer, according to a 2002 study. Over 6 million women have taken the drugs, which have brought Wyeth in excess of $2 billion dollars in sales.

- see the LA Times story
- read more at MarketWatch

Suicide widow sues Pfizer over Chantix

Tracy Staton — Fri, 11 Jul 2008 09:30:52 -0400

It had to happen sometime: The widow of a man who committed suicide in January has sued Pfizer, alleging that the drugmaker should have warned Chantix patients sooner about its psychiatric side effects. Report

Judge: Lilly should settle Zyprexa case

Tracy Staton — Mon, 07 Jul 2008 10:09:17 -0400

A federal judge is urging Eli Lilly to negotiate a worldwide settlement with Zyprexa plaintiffs, who are asking for some $7.7 billion. As you know, Lilly has already agreed paid $1 billion to settle claims about the antipsychotic drug's side effects. The company is under state and federal investigation for its Zyprexa marketing. Now, the drugmaker faces claims that it marketed Zyprexa improperly and overcharged for it, too. Insurers and labor unions claim that Lilly hid the drug's risks, spread misinformation about its effectiveness, and promoted it off-label, and are suing the company under the Racketeer Influenced and Corrupt Organizations act (RICO).

In a draft order issued last week, U.S. District Judge Jack Weinstein said the case against Lilly is strong enough to justify a trial and noted that the company may have pushed questionable uses for the antipsychotic drug. "There is sufficient evidence of fraud under RICO to go to a jury," the judge concluded. "A global settlement...is desirable."

- read the story in the Indianapolis Star

Pfizer starts settling Celebrex claims

Mon, 05 May 2008 06:59:58 -0400

Pfizer is starting to settle the thousands of lawsuits over painkillers Celebrex and Bextra, the Wall Street Journal reports. Three groups of plaintiffs who allege that the meds caused heart attacks and strokes--some 200 claimants in all--are involved in the tentative settlement deals. Just in time, too; the first Bextra trial was set to begin today, but was postponed to allow time for negotiations.

One lawyer said Pfizer had offered an average of $200,000 per client in Bextra cases and $40,000 to $50,000 on average for Celebrex claims. Pfizer lawyers have said that the company will pay up to $500 million to resolve all the cases. Pfizer hasn't yet commented on the settlement news.

Rather than coming up with a blanket deal like Merck did in with Vioxx litigation, Pfizer is said to be working out its Celebrex/Bextra cases on a law firm-by-law firm basis. (Of course, Merck started out defending its Vioxx claims on a case-by-case basis.) The three drugs are all Cox-2 inhibitors; Celebrex is the only one still sold in the U.S. The other two were taken off the market amid safety concerns.

- read the story in the Wall Street Journal
- see the WSJ Health Blog item

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

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Conn. sues FDA for OxyContin warnings

Wed, 02 Apr 2008 07:59:55 -0400

If your petition doesn't succeed, go to court. That's what Connecticut Attorney General Richard Blumenthal has done: He's sued the FDA to force the agency to act on his bid for tougher warnings on the painkiller OxyContin, so-called "hillbilly heroin" that is widely abused. At issue, Blumenthal says, is that drug labeling recommends dosing every 12 hours, but 20 percent of all OxyContin scrips were written for dosing every eight hours or less. Drugmaker Purdue Pharma's internal documents show that many docs have been prescribing the drug inappropriately, the AG alleges.

Blumenthal's 2004 petition asked the agency to require Purdue Pharma to strengthen the med's black-box warning and issue a "Dear Healthcare Professional" letter about the shorter-term dosing risks. "The FDA has irresponsibly and illegally ignored the clear need for warnings about OxyContin prescription practices," the AG alleges. "Prescription narcotic abuse of drugs like OxyContin has become the biggest drug threat in the Northeast."

- read the AG's press release
- see the Pharmalot item
- check out the article at Legal Newsline

ALSO: OxyContin abuse in the Seattle area has soared, with the med quickly replacing crystal meth as the recreational drug of choice. Addicts have even been breaking into nursing homes and robbing people's personal medicine chests. Report

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Confused jury prompts Wyeth appeal

Tue, 16 Oct 2007 06:59:56 -0400

Was the jury confused? Apparently so. When a Nevada jury decided in favor of three women who claimed that the company's hormone replacement drugs caused their breast cancer, some jurors thought the $134.5 million awarded included punitive damages. It didn't.

The judge sent the jury back to the drawing board. Compensatory damages: $35 million. After the subsequent punitive phase, the jury tacked on another $99 in punitive damages. No harm, no foul? Not so fast. Wyeth says the confusion strengthens its inevitable appeal.

- see Wyeth's release
- check out the article from CNN Money

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Read more on: Wyeth

GSK sues over new patent rules

Mon, 15 Oct 2007 06:59:55 -0400

Pharma is one of few industries where patent law doesn't inspire a yawn. So when the U.S. Patent Office introduced unfriendly rules governing patent continuations--vital to protecting brand-name meds--GlaxoSmithKline was first in line to sue.

There's a bunch of legal mumbo-jumbo using terms like "ultra vires," but the gist of the suit is that the rules would weaken patent protection and thus undermine innovation. They could even make it easier to bring patent challenges. Consider that Indian generics makers have praised the new rules, and you'll see which way they lean. Glaxo is asking for an injunction to keep the rules from taking effect November 1 as scheduled.

- read discussion of the suit from Patent Blog

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Kentucky sues Purdue over drug abuse

Fri, 05 Oct 2007 06:59:56 -0400

There's been a lot of hand-wringing lately over the huge spike in painkiller abuse. Well, now the State of Kentucky is doing something about it--whether it's the right thing is up for debate. The state has sued Purdue Pharma, the maker of the oft-abused OxyContin.

The state wants Purdue to pay, not only for Medicaid prescriptions for the drug, but for drug-abuse programs and law enforcement costs stemming from OxyContin use. "This is war," one of the lawyers involved said.

For its part, Purdue is pledging to vigorously defend itself. But fueling Kentucky's fire is a May plea agreement in which the drug maker admitted to misleading the public about OxyContin's addictive properties, agreeing to pay some $635 million in fines.

- see the Kentucky Attorney General's press release
- read the AP report

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Pfizer, Nigerians talk out of court

Thu, 04 Oct 2007 06:59:55 -0400

Oh, to be a fly on the appropriate Nigerian wall. The case of Nigeria versus Pfizer over the 1996 meningitis drug trial adjourned yesterday until November, but behind the scenes, there's plenty of activity. According to Attorney General Ibrahim Umar, Nigerian officials have been meeting with Pfizer representatives to discuss settling the case out of court. The parties will next meet October 17.

- read the All Africa report

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Nigeria calls Pfizer execs to trial

Wed, 03 Oct 2007 06:59:56 -0400

Nigeria v. Pfizer in the matter of a meningitis vaccine trial went back to court today, with a judge allowing the authorities there to summon Pfizer and nine company officials to the country to defend themselves. The summons aims to compel the execs to a hearing November 6.

Civil rights groups are all set to protest against the drug maker, which is criminally and civilly accused misconduct when it tried out its Trovan treatment during a 1996 meningitis epidemic. Eleven children participating in the trial died, and others ended up with permanent injuries. Pfizer denies wrongdoing, saying it answered pleas for help when it brought the experimental drug to Nigeria.

Trovan, of course, proved a safety risk when it was licensed by the FDA a few months after the Nigerian trial. Three years later, the agency restricted the drug because of possible liver damage.

- read the article from the International Business Times
- see this item from the Wall Street Journal

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