Washington, DC Personal Injury Lawyer - FDA & Prescription Drugs

Federal Judge Unseals Wyeth "Ghostwriting" Documents

Christopher Nace — Thu, 30 Jul 2009 14:25:12 GMT

A federal judge in Little Rock, Arkansas has ordered drugmaker Wyeth to turn over thousands of pages indicating that it paid "ghostwriters" to author and place studies about one of its profitable drugs, Prempro. The Chicago Tribune recently reported that:

A federal judge has ordered the unsealing of thousands of pages of documents pertaining to the ghostwriting practices of Wyeth Pharmaceuticals, which is being sued over hormone replacement drugs.

U.S. District Judge Bill Wilson ordered the papers unsealed Friday at the request of a medical journal and The New York Times. Plaintiffs attorneys presented the papers earlier at trial to show Wyeth routinely hired medical-writing firms to ghostwrite articles that appeared in seemingly objective medical journals but included only the name of a scientific researcher as the author.

This is a truly disturbing practice that has gained the attention of at least one U.S. Senator:

The New Jersey drugmaker already had turned over the documents, which it says concern about 40 articles in medical journals and other publications, to Sen. Charles Grassley, R-Iowa. Grassley sought them last year without a subpoena as part of a congressional investigation into drug-industry influence on doctors.

This is a true victory for consumers and was achieved in part by Public Justice, America's public interest law firm. (I recently blogged about Public Justice here.) The Tribune wrote that:

On June 11, a biomedical journal, PLoS, published by the Public Library of Science, filed a motion to intervene in the Prempro litigation. PLoS, represented by a public-interest law firm, Public Justice, wanted to set aside the confidential designation that had been placed on the documents before a series of trials began in 2006. The documents were shown to jurors at trial but were otherwise unavailable publicly.

Public Justice has said that they became involved because these practices are at odds with public health and safety:

"We are thrilled by the Court’s decision to stop Wyeth’s attempt to hide evidence of its ghostwriting,” said Amy Radon, Public Justice's lead attorney for PLoS Medicine. "Public health and safety is put at serious risk when a drug company fails to reveal its role in authoring a medical journal article touting its own product."

The federal judge ruling on the matter found that there was no good cause for keeping the documents under seal:

In his July 24 ruling, U.S. District Court Judge Bill Wilson, Jr., held that there was no good cause for secrecy and ordered that the documents be made publicly available as of 5:00 p.m. on Friday, July 31.

In fact,

“Wyeth did not even attempt to show good cause for keeping these documents secret," said Morgan "Chip" Welch of Arkansas’ Welch and Kitchens, LLC. “Judge Wilson’s decision will undoubtedly save lives."

A copy of Judge Wilson's order can be read here.

Originally posted at InjuryBoard by Christopher Nace

Epilepsy Drug Zonegran Linked to Blood Disorder

Christopher Nace — Thu, 26 Feb 2009 09:31:12 GMT

According to the FDA a drug used to treat epilepsy, Zonegran, can cause serious heart problems:

Federal health officials warned doctors Monday that a drug used in epilepsy patients can cause chemical imbalances in the blood, leading to heart problems and other serious complications.

More specifically:

The Food and Drug Administration said recent data show patients taking the antiseizure pill Zonegran face higher risk of metabolic acidosis, which causes dangerously high levels of acid to accumulate in the blood. The imbalance can cause breathing difficulties, irregular heart rhythms and fatigue.

It would appear that use of the drug can be dangerous in the short or long term. In the short term, irregular heart rhythms should not be treated lightly. In the long term,

the condition can do long-term damage to the kidneys and bones and slow growth in children

If you or a loved one are currently taking Zonegran, or the generic zonisamide, you should immediately consult your physician and request that certain blood work be monitored consistently.

Originally posted at InjuryBoard by Christopher Nace

Supreme Court Rules in Cigarette Pre-emption Case

Christopher Nace — Tue, 16 Dec 2008 06:00:00 GMT

The Supreme Court issued a surprise ruling on Monday in Altria Group v. Good, refusing to exempt the cigarette maker from a state lawsuit on the grounds of pre-emption.

Justice John Paul Stevens, writing for the majority in Altria Group v. Good, rejected Altria’s assertion that the Federal Cigarette Labeling and Advertising Act pre-empts state tort actions. The ruling runs against the Court’s recent trend in favor of federal pre-emption in cases involving tort litigation against businesses.

Pre-emption has been a major issue before the Court in recent years. Pre-emption is the legal theory that when a federal agency sets minimum requirements for a product or safety standard, state law is "pre-empted" and someone--or some business--adhering to that standard cannot be held responsible for injuring another under state law. In other words, if you follow the federal minimum, it doesn't matter how negligent your actions may otherwise be.

In Riegel v. Medtronic the Court held that if a medical device is approved by the FDA after undergoing the FDA's "rigorous" pre-market approval process, an individual cannot maintain a product liability action against the manufacturer. The problem is, there is nothing "rigorous" about the pre-market approval process. In fact, as many have learned with the Vioxx situation, the FDA simply does not have the resources to make any type of meaningful evaluation of products or drugs.

Pre-emption has been asserted by corporations to escape wrongdoing that they would otherwise be held responsible for.

But in this case, the Court did not give the cigarette company a free pass:

Ruling against Altria Group Inc’s Philip Morris USA (PM) unit, the court ruled for a group of Maine smokers who sued under a state law to stop PM from advertising its light cigarettes. The high court held that the Federal Cigarette Labeling and Advertising Act does not bar or preempt these state court lawsuits.

Pre-emption will still be a major issue this term. The Court is expected to issue its opinion in Wyeth v. Levine, a case that addresses pre-emption as it relates to pharmaceutical products. With the Court's ruling in the cigarette case, consumers are now 1-1 when it comes to maintaining the right to bring suit in a state court. All eyes remain focused on the Court as its opinion in Wyeth is due.

Originally posted at InjuryBoard by Christopher Nace