Segal McCambridge Legal Blog

In a recent ruling in New Jersey by The Hon. Carol Higbee, a Segal McCambridge client was dismissed from over 900 cases.  In her May 4, 2012 decision, Judge Higbee granted the motion to dismiss filed by the firm, agreeing that a generic drug manufacturer whose product is unilaterally designated by FDA as the Reference Listed Drug (RLD) does not have regulatory responsibilities beyond those of any other generic drug manufacturer.  The client in these matters is represented by Bob O’Malley, a partner in the Chicago office.

An article about this decision was published in Bloomberg BNA’s Product Safety & Liability Reporter on May 14, 2012. To read the article, click here.

The Supreme Court of the United States (”SCOTUS”) has issued an opinion in Brusewitz v. Wyeth LLC, holding that a 1986 federal law setting up a program to compensate for injuries due to administration of vaccines preempts all design defect claims against vaccine manufacturers by individuals seeking compensation for injury or death.

The opinion was written by Justice Scalia in a 6-2 decision which affirmed the Third Circuit. Justice Breyer filed a concurring opinion. Justice Sotomayor dissents joined by Justice Ginsburg. Justice Kagan took no part.

Here is the SCOTUS opinion in Brusewitz v. Wyeth LLC

Here is a New York Times article on the decision

Selected portions from the Rand.org article Vaccine Myths Could Cost Lives: They Don’t Give You Autism, and They’ll Hardly Ever Make You Sick

Suspicion of vaccines is a serious problem. Last year, even when awareness of the H1N1 flu pandemic was widespread, fully 20% of American adults said they would not get vaccinated—even if some people in their communities were sick or dying. Over the course of the 2009 H1N1 pandemic, more than half of all health care workers declined vaccinations, although they could inadvertently pass flu to medically vulnerable patients.

America can’t afford a repeat of that intransigence. This year, H1N1 flu has already killed 24 people in Britain, according to health officials there. Some 300 others are hospitalized.

Americans of all ages should take heed; children and young adults are particularly at risk, and complacency is dangerous for everyone.

In any community, most people must get vaccinated to stop a disease in its tracks. Vaccination gives the immune system an “advance look” at germs able to hurt or kill, thus boosting the body’s natural ability to fight back. So when a large number of people get vaccinated, they create a human fire wall that can slow or stop the spread of infection. Holes in the fire wall let an infectious disease spread fast. And that could be unfortunate the next time America has to face an outbreak of pandemic flu, or something worse.

Although the 2009 H1N1 flu vaccine was safe and effective, 70 million doses sat unused. People who got H1N1 shots in 2009 tended to be the same folks who get a seasonal flu shot every year, and annual users were four times more likely than irregular or nonusers to be vaccinated.

Why did the rest decline vaccinations? We know only a few reasons. For example, every major study has shown no link between vaccines and autism. In fact, one of the biggest pieces of evidence behind this supposed link was just definitively debunked as outright fraud. Yet that myth persists.

Second, we know for scientific fact very few people can get sick from vaccines themselves. Yet that myth also shows up too often in public surveys.

Perhaps there are other reasons for the reluctance to get vaccinated. Currently, 95% of research funding on vaccines goes for cutting-edge lab science. That’s money well spent. But the best vaccine can’t work if the public won’t accept it. We need more research on why people resist vaccines and how to counteract that.

Remember that before vaccines were developed, Americans could expect whooping cough to kill 8,000 children prior to their first birthday; measles to sicken 4 million children annually and kill 3,000; diphtheria to kill 15,000 teenagers a year, and German measles to cause 20,000 babies to be born deaf, blind or mentally disabled. Polio stalked every American neighborhood.

Today’s parents can assume their children will grow up safe from these diseases—only because of vaccines. Immunization remains the best and first line of defense against serious infectious illness. This year’s seasonal flu shot incorporates vaccine for H1N1. It’s safe, and it’s vitally important to get it.

The first study to link a childhood vaccine to autism was based on doctored information about the children involved, according to a new report on the widely discredited research.

The conclusions of the 1998 paper by Andrew Wakefield and colleagues was renounced by 10 of its 13 authors and later retracted by the medical journal Lancet, where it was published. Still, the suggestion the MMR shot was connected to autism spooked parents worldwide and immunization rates for measles, mumps and rubella have never fully recovered.

A new examination found, by comparing the reported diagnoses in the paper to hospital records, that Wakefield and colleagues altered facts about patients in their study.

The entire British Medical Journal (BMJ) article is here

The website of journalist Brian Deer is here
and a link to his article “Solved – the riddle of MMR”

Courtesy of the Wall Street Journal

MINNEAPOLIS— A federal court jury on Wednesday ordered health- care company Johnson & Johnson to pay damages of $1.8 million in the case of an 82-year-old man who sued over claims the antibiotic Levaquin caused him severe tendon injuries.

John Schedin was prescribed Levaquin five years ago to treat a diagnosed case of bronchitis. After three days on the drug, Mr. Schedin ruptured both his Achilles tendons. In 2008, the Food and Drug Administration required Johnson & Johnson and makers of similar drugs to print warnings on the risks of tendon injuries.

That same year, Schedin sued Ortho-McNeil-Jansen Pharmaceuticals, the unit of New Brunswick, N.J.-based J&J that markets Levaquin. The Minneapolis jury on Wednesday decided the company must pay Mr. Schedin $700,000 in actual damages and $1.1 million in punitive damages, though actual damages will be reduced by $70,000 under the jury’s finding of 10% liability for Mr. Schedin in response to the allegation that he exacerbated the condition by initially responding to his tendon pain by exercising.

The trial was the first on more than 2,600 other U.S. lawsuits making similar claims. Mr. Schedin’s attorney Mikal Watts called the trial a bellwether case that he expected would hasten settlement talks in those suits.

“Johnson & Johnson failed to warn these doctors of something they knew would hurt these patients and that’s conduct that should not be tolerated,” the attorney said. “The award of punitive damages in particular sends a powerful message.”

Michael Heinley, spokesman for Ortho-McNeil-Janssen Pharmaceuticals, said the company was disappointed with the jury’s decision and plans to fight the plaintiff’s claims on appeal.

“The verdict and the amount of the compensatory and punitive damages are at odds with the evidence presented at trial,” Mr. Heinley said in a prepared statement. “We believe Ortho-McNeil-Janssen Pharmaceuticals Inc. properly informed of the benefits and risks associated with the use of Levaquin, and that the company acted responsibly by providing appropriate and timely information about Levaquin.”

The article can be found here

From the Indianapolis Business Journal

Eli Lilly and Co. on Friday won reversal of a ruling that granted class-action status to a lawsuit by pension funds, unions and insurers who alleged that improper marketing of Zyprexa, its schizophrenia treatment, raised their costs.

A U.S. appeals court in New York threw out a September 2008 ruling by U.S. District Judge Jack Weinstein in Brooklyn. He had said the plaintiffs could pursue as a group claims that Indianapolis-based Lilly’s Zyprexa marketing caused them to pay more for the drug than what it was worth. The plaintiffs were seeking $6.8 billion in damages.

The story can be found here