Articles Posted in Drug Companies

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A Maryland federal judge last week put some tough limitations on plaintiffs’ expert in the Aredia/Zometa jaw injury case that was remanded back to Maryland from the MDL.

In Zimmerman v. Novartis Pharmaceuticals, plaintiffs brought a wrongful death lawsuit in the MDL. Plaintiff asserted strict liability and negligence claims against Novartis. Plaintiff was prescribed Aredia and Zometa, two bisphosphonate drugs that are administered intravenously to treat cancer patients for hypercalcemia, a potentially fatal elevation of calcium in the blood. Plaintiff developed osteonecrosis of the jaw which caused her death.

The case sat for years in the MDL in Tennessee but has since been remanded to Maryland to be tried before Judge Roger W. Titus. Novartis sought to exclude the testimony of a key plaintiff’s expert. The expert, a doctor, is a key witness for the plaintiff because she was, at one time, a medical officer with the FDA in the Office of Health Affairs. Defendants use the tacit backing of the FDA at every trial – WE WERE FDA APPROVED! – is a common theme banged over the heads of the juries. So having a doctor who worked for the FDA sometimes helps plaintiffs considerably.

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The 5th Circuit Court of Appeals knocked out a Prempro wrongful death case, finding that Mississippi’s three-year statute of limitations has no exception for drug product liability claims.

The court found that under Mississippi law (and most states, unfortunately) a cause of action accrues when the plaintiff has knowledge of the injury, not knowledge of the injury and its cause.
You can find the unpublished opinion in Bryant v. Wyeth here.

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Pfizer’s lawyers took their best shot at winning these cases with the only strategy that will work: keep the cases away from a jury that will weigh the evidence.

This strategy took a hit on Tuesday when the MDL judge overseeing the 2,500 Chantix lawsuits in federal court shot down Pfizer’s motion to exclude the general causation and liability opinions of five plaintiff experts.

Judge Inge Prytz Johnson ruled that while Pfizer has interesting arguments, they are jury arguments not “the expert should be excluded” arguments. I’m not sure a jury will be too impressed with hypertechnical attacks on these experts’ methodology as long as they swallow the big picture: these drugs put users at risk for homicidal and suicidal behavior that they would not have committed if there were not on the drugs. It is that simple.

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Johnson & Johnson has agreed to pay about $600,000 to settle three, the first three, of approximately 8,000 lawsuits over hip implants that were recalled in 2010. The suits were scheduled to go to trial later this year.

J&J’s DePuy unit recalled approximately 93,000 ASR hips worldwide in 2010, saying that over 12% of the devices failed within five years. The defective implants caused patient pain and immobilization by joint dislocations, and infections and bone fractures.

According to a university professor who follows the pharmaceutical industry, J&J should have expected to pay between 200k and 500k, so they could settle at the low end of what they should have expected to pay. What does he know? Probably not much. What I can tell you is that it is always easy to pick off a few plaintiffs and underpay on the claim as a way of getting plaintiffs’ lawyers thinking that the cases are worth less than they think. Excellent strategy on their part, but let’s not fall for it. Some of these DePuy ASR cases will settle north of $1 million.

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Eager to underscore the point I made last week, GlaxoSmithKline has agreed to plead guilty to misdemeanor criminal charges – read that again, criminal charges – and pay $3 billion – read that again, $3 billion – to settle the largest case of healthcare fraud in American history.

Among other things, Glaxo was pushing the drug Wellbutrin for uses for which it was not approved, such as weight loss and treatment of sexual dysfunction.

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This is the interesting story of a woman who scheduled to speak today to an FDA advisory panel hearing looking into the problems of metal-on-metal hip replacement systems. The woman’s husband has a hip implant and is one of the thousands of plaintiffs who have sued Johnson & Johnson’s DePuy Orthopedics division, claiming its metal-on-metal ASR hip system was defective.

 

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Plaintiffs’ lawyers are men with a hammer who see everything as a nail. They refuse to give drug and medical device companies the benefit of the doubt on anything. Plaintiffs’ lawyers – particularly product liability lawyers – have a positional (and economic bias) that makes it impossible for them to be balanced towards these companies that indisputably make life-saving products.

I don’t think this quote, which I made up, is unfair. The plaintiffs’ lawyers are the haters that will hate. So, for more evidence, we have to look elsewhere to see if others are having bad experiences with drug and medical device companies who put profit above patient safety.

The government drives us nuts, but most people see them as an honest power broker (at least over time). Additionally, the government (both Republican and Democratic administrations at national and local levels) seems to be in a 1984ish endless war with drug companies.

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Drug wholesaler McKesson Corp. has settled charges against it, agreeing to pay more than $190 million for government claims that it reported inflated drug prices that caused federal government – specifically Medicaid – to overpay for drugs.

McKesson put out the same press release that goes out in every single one of these cases:

We did not manipulate drug prices and did not violate any laws. However, when we weighed our conviction that we did not violate any laws against the inherent uncertainty of litigation, we determined that this settlement was in the best interest of our employees, customers, suppliers and shareholders.

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Zoloft can allegedly cause serious birth defects to developing fetuses when ingested during pregnancy. These defects include pulmonary atresia,  deformed limbs, patent ductus arteriosus, ventricular and septal defects, hypoplastic heart syndrome, aortic and ventricular outflow tract obstruction defects, craniosynostosis, omphalocele, gastroschisis, spina bifida, and cleft palate. The lawsuits filed throughout the country allege that Pfizer failed to adequately warn patients and healthcare professionals of these risks. Pfizer denies the association.

Lawsuits alleging birth defects caused by the antidepressant Zoloft/sertraline were consolidated on Tuesday before Judge Cynthia M. Rufe in the U.S. District Court for the Eastern District of Pennsylvania. About 92 federal lawsuits – and counting – will be included in this MDL.

What does this mean for Zoloft birth injury plaintiffs? The cases are technically not a class action, but the cases are merged together for discovery on issues common to all the Zoloft birth defect lawsuits. The upside for individual Zoloft birth defect lawyers is the efficiency of pulling together resources to really discover what Pfizer knew about the harmful effects their drugs had on unborn children whose moms were on Zoloft.

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Merck can proceed with a lawsuit against the Kentucky Attorney General for violating its constitutional due process rights in its claims against Merck involving Vioxx. Why? A federal judge has found that Kentucky improperly struck a contingency fee arrangement with plaintiffs’ lawyers to sue Merck for their marketing of Vioxx.

Is this a new trend? Last year, a South Carolina judge allowed a similar claim by AstraZeneca against the South Carolina AG. My question for Merck and AstraZeneca is whether the juice is worth the squeeze. If you are Merck, you can’t be happy about anything that happened with Vioxx other than the fact that you settled the cases for a few billion less than you originally thought. Is it possible that you are losing the war even if you win this petty technical battle with Kentucky? I don’t think you gain a ton of moral high ground by screaming that you sued me for doing something wrong with the wrong lawyers. I can’t see John Q. Public covering your back on this. You have a lot of great products that are not hurting people. Spend your time talking about them and let your mistakes fade away.