Sabatini and Associates, LLC

Gallbladder disease is one of the dangerous side effects of Yaz and Yasmin birth control pills. Throughout the U.S., women who have taken Yaz or Yasmin have developed gallstones as a result. In many cases, these women have had to undergo gallbladder removal surgery.  Yasmin and Yaz present an increased risk of gallbladder disease because of the ingredient drospirenone. Drospirenone is a diuretic, and medical studies have shown that long-term use of diuretics can lead to gallbladder disease. The gallbladder assists with the body’s digestive process. Bile is stored in the gallbladder until the body needs it to digest fats. The gallbladder then contracts, pushing the bile into the common bile duct. Gallstones form when bile is stored in the gallbladder for too long, allowing the liquid to harden into small stone-like pieces. Yaz and Yasmin can increase the level of cholesterol in the bile while at the same time decreasing gallbladder contractions. The symptoms of Yaz gallbladder disease include:

• Abdominal pain and bloating
• Diarrhea
• Nausea
• Jaundice

If you or a loved one have been using Yaz and have been experiencing such symptoms, contact your doctor immediately.

In one of the most important cases in years for injured plaintiffs, the Supreme Court on Wednesday ruled that a drug company is not protected from injury claims in state court merely because the federal government had approved the product and its labeling.

The 6-to-3 ruling went in favor of a Vermont musician, Diana Levine, who was awarded more than $6 million after losing much of her arm following a botched injection of an anti-nausea drug. It was a defeat for the pharmaceutical company, which had asked the justices to throw out the award, and by extension other companies that might have pursued Wyeth’s line of argument in similar cases. 

This decision has destroyed the drug companies defense that failure to warn claims were barred by federal preemption.  The case marks a great victory for the rights of injured people.  Read the Levine decision here.

A federal judge in Pennsylvania ruled on Wednesday, October 1, 2008 that a lawsuit filed by the parents of a 16-year-old New Jersey boy who committed suicide while taking Paxil can proceed to a jury trial. In doing so, the Court denied the motion for summary judgment filed by Paxil manufacturer GlaxoSmithKline (GSK).

This was GSK’s second attempt at stopping this particular Paxil suicide case arising from the death of Harold Stanley “Jake” Garrison. Just last month Senior Judge Ronald L. Buckwalter, of the United States District Court for the Eastern District of Pennsylvania, rejected GSK’s preemption arguments recognizing the vital role tort litigation has played in protecting the health and safety of its citizens, Knipe v. SmithKline Beecham Corp., 2008 WL 4090995 (E.D.Pa., Aug. 28, 2008).

In denying GSK’s latest motion to prevent the case from proceeding with a jury trial, the judge made the following statements relating to GSK’s legal arguments:

“Defendant’s arguments, however, offer a myopic view of the record and misconstrue the relevant jurisprudence. It is well-established that a plaintiff need not hear the misrepresentation from the defendant directly for there to be actionable fraud”

“Defendant cites to no law – nor can this Court find any case – that applies the New Jersey presumption of adequacy to use of a drug in an unapproved population. More importantly, it is contrary to all reasonable logic to adopt Defendant’s suggestion that it may hide behind an FDA-approved warning regarding adult use of Paxil, when the FDA never had the opportunity, during the pertinent period, to review the propriety of a proposed warning with respect to pediatric use of Paxil.”

“Moreover, the fact that, when given the crucial data, the FDA finally required Defendant to revise its label in October 2004, to reflect what Defendant possibly knew as of 1998, ‘provides powerful evidence’ that the label originally approved by the FDA, which contained no precautions or warnings regarding pediatric use, was inadequate, at least from 1998 forward.”

“Finally, the Court takes note of the inherent hypocrisy in Defendant’s argument. On one hand, Defendant contends that it had no duty to warn of known risks involved in off-label usage of the drug, whether or not it had reason to know of such off-label uses. On the other hand, it contends that once its drug was approved by the FDA for some indications, it was protected by the presumption of adequacy for FDA warnings for usage in all indications, even where the FDA had never considered the propriety of the warning. On a hypothetical third hand, it claims that any attempt to rebut the presumption by proof of nondisclosure is preempted by federal law, thereby making the presumption effectively unrebuttable. Applying such logic, a pharmaceutical manufacturer possessing information regarding hazards associated with off-label use of its drug would never have to warn the medical community of any off-label usage dangers or submit data regarding these dangers to the FDA. Such a result is contrary to New Jersey’s ‘strong interest in encouraging the manufacture and distribution of safe products for the public and, conversely, in deterring the manufacture and distribution of unsafe products within the state’…”

In allowing plaintiffs’ punitive damages claims to proceed, the Court commented that:

“Beyond the evidence already discussed throughout this opinion showing that GSK knew of the risk of pediatric suicidality as of 1998, internal GSK documents suggest that Defendant acted with a wanton and willful disregard for the safety of its consumers.”

“The (court) system represents one of the key defense mechanisms that individuals have if a manufacturer has not made the risks of a product clear to the public.”  This statement was not made by a plaintiff’s attorney.  It was made by the editor of the New England Journal of Medicine, Dr. Jeffrey M. Darien.  The Journal has filed a friend-of-the-court brief in the case of Wyeth v. Levine and argues that federal law does not and should not preempt state products liability law thereby prohibiting injured citizens from suing drug manufacturers for serious injuries caused by unsafe drugs.  The doctors are arguing that lawsuits help to create safe drugs and the FDA simply is not equiped to do the job alone.  You can read more about the New England Journal Medicine’s position here.

Based on internal company documents revealed in Vioxx litigation, JAMA authors uncover how the company, without disclosing it, compensated ghostwriters who aren’t even doctors, to create articles for professional journals that have the potential to influence doctors and popularize drugs prescribed to the public. In the 250 documents reviewed by the authors, Merck employees either working by themselves or in collaboration with a medical publishing company helped create the study on Vioxx. They would then recruit academics or leaders in the medical field to lend their name as the lead author. For scientific review papers, Merck would outline the plan for the manuscript then ghostwriters were hired from medical publishing companies, which typically pay about $20,000 per submission to the ghostwriter.

The scientist then recruited to be the named author would be offered honoraria for their participation.

This review in JAMA finds that among 96 published articles, 92 percent of clinical trials disclosed Merck,s financial support. But only half disclosed Merck’s involvement in the creation of the publication or whether the author had received compensation. In another JAMA article in the same issue, the documents suggest the company’s control of the data allowed it to downplay the risk of death from Vioxx in patients with Alzheimers disease.

Vioxx was taken off the market in 2004 but not before it was linked to an increase in heart attack and strokes. The FDA says the drug lead to up to 139,000 heart attacks, 30-40 percent of them fatal.

Litigation followed and ultimately resulted in a $4.85 billion settlement against Merck to settle U.S. cases. The internal company documents were released as part of�the settlement.