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Battling the prescription drug and medical device industries

Battling the prescription drug and medical device industries
This content is supplied by Girardi | Keese and produced by Motiv8. The newsroom or editorial department of Tribune Publishing was not involved in its production. (Photograph Courtesy of Girardi | Keese)

Pharmaceutical and medical device litigation has become big business, with plaintiffs' lawyers nationwide helping consumers seek compensation for drugs and devices that have been found to cause more harm than good–sometimes with the manufacturers' knowledge.

At Girardi | Keese, attorneys work to put a stop to this practice of choosing profits over the health and welfare of patients. Over its history, the firm has handled cases involving nearly every major type of pharmaceutical drug that has caused serious injury or death, including Phen-Fen, Celebrex, Bextra, and Rezulin, among many others.



Vioxx was one of the first blockbuster "Big Pharma" litigations, resulting in a $4.85 billion settlement in November 2007 by its maker, Merck. It took plaintiffs' lawyers five years to persuade Merck to take the pain reliever off the shelves, as it put patients at risk of heart attack or stroke. Three years and $1.5 billion in legal fees later, Merck settled.


Tom Girardi was one of the primary negotiators of the Vioxx settlement on behalf of 50,000 plaintiffs, and he notes, "The real issue in the cases was a moral one because Merck absolutely knew they were going to harm a bunch of people, and they just said, 'Go for it.'"


GlaxoSmithKline’s Avandia used to be the world’s bestselling diabetes pill, producing $3 billion in annual sales for the pharmaceutical giant. But after studies linked the drug to an increased risk of heart attack, Avandia sales were suspended in Europe and temporarily restricted in the United States. Still, the Food and Drug Administration estimates that Avandia has caused as many as 100,000 heart attacks.

Girardi and Keith Griffin were quick to head up the litigation team against Glaxo on behalf of the thousands of men and women harmed by Avandia. "Hopefully, our success in litigating the Avandia cases will prompt drug manufacturers to reevaluate the safety of their products before putting them to market," Griffin notes.



In 1991, GlaxoSmithKline obtained FDA approval to market Zofran, an anti-nausea medication for cancer patients undergoing chemotherapy and radiation treatment. Zofran became a top-selling drug for the company, but in December 2006 it lost its patent protection, and to keep the drug profitable, Glaxo began marketing it off-label to doctors as a treatment for pregnant women experiencing morning sickness — despite the fact that the drug had never been tested or approved for such use by the FDA.

The result was catastrophic: Women who had been taking Zofran for morning sickness began giving birth to children with birth defects. Girardi | Keese currently represents several women and their young children affected by the drug, with Girardi and Griffin heading up the litigation team against Glaxo.


The diabetes drug Actos was developed by the Japanese corporate giant Takeda and approved by the FDA in 1999. Beginning in 2005, several studies showed that Actos users were at greater risk of bladder cancer than those who used other diabetes drugs. In 2011, the FDA ordered that this risk be added to the information provided to doctors and patients through a "black box" warning.

Since then, more than 9,000 cases have been filed by Actos users who developed bladder cancer. Girardi | Keese continues to fight for the victims of Actos and their families, and partner James O'Callahan presently serves on the plaintiffs' steering committee for the Actos Judicial Council Coordinated Proceedings.

DePuy ASR hip implant

In 2004, Johnson & Johnson received approval from the FDA to market a metal-on-metal hip implant in the U.S. called the DePuy ASR. Within a year, the ASR received criticism for its poor design, and the Australian Joint Registry later reported a failure rate of over 5 percent. While Johnson & Johnson at first defended the ASR, the company finally recalled it in 2010; though by then it had been surgically implanted in more than 90,000 patients, who have since had to have the implants removed due to metallosis, chronic infection, and device failure.


O'Callahan, who served as the California Liaison to the DePuy ASR MDL as well as on the plaintiffs' steering committee for the California DePuy ASR JCCP, notes that Girardi | Keese continues to represent the victims of the ASR and is committed to seeing justice done.

Aredia and Zometa

Adriann Georges was seriously ill and facing the fight of her life in 1999. She had been diagnosed with Stage 4 breast cancer and was undergoing chemotherapy and other treatment in hopes of beating the disease when her oncologists recommended the drugs Aredia and Zometa to strengthen her bones. 

What Georges' doctors didn't know is that the drugs can eat away at a person's jaw. As a result, John Girardi ended up representing Georges in her ensuing case against the drugs' manufacturer and was able to obtain a $2.1 million award from a Los Angeles federal court jury for her injuries.