Showing posts with label Claudine. Show all posts
Showing posts with label Claudine. Show all posts

Monday, July 30, 2012

Pliva, Inc. v. Mensing: Consumers lose right to pursue justice for injury caused by generics

Here's a communication I received as a member of the Leaders Forum for the American Association for Justice.

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Dear Colleagues,

As a Leaders Forum member, you are among the first to receive the latest update on the work of the Center for Constitutional Litigation.

In this last year since the Supreme Court of the United States ruled in Pliva, Inc. v. Mensing, the Center for Constitutional Litigation has worked on a number of cases that challenge the reach of that decision. As you know, in Mensing, the court ruled 5-4 that in most cases generic drug makers cannot be sued for failure to warn. The Court held that it was impossible for the generic manufacturers to comply with federal law—which requires generic labels to match brand-name labels—and state law—which may require a stronger warning.

In particular, among other issues, CCL is arguing that “impossibility preemption” does not apply to design defect cases. At this point, among the courts, there is a difference in opinion.

Thank you for your dedication and support of AAJ as a member of Leaders Forum.

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Mensing Does Not Preempt…

In the case of Bartlett v. Mutual Pharm. Co., Inc., the U.S. Court of Appeals for the First Circuit ruled that the Supreme Court’s decision in Mensing did not preempt state law design defect claims against the generic drug manufacturer.

In this case, CCL worked with the New Hampshire Association for Justice and filed an amicus brief in support of the plaintiff who used a drug called sulindac, which blinded her and caused much of her skin to burn off. The doctor had prescribed the brand name version of this non-steroidal anti-inflammatory drug, but the pharmacy dispensed the generic form, sulindac.

At trial, the district court told the jury that in order to find for the plaintiff, it must find that “sulindac’s design was in a defective condition unreasonably dangerous to consumers.” The jury decided in favor of the plaintiff and awarded her $21 million.

In his opinion for the court, Judge Michael Boudin wrote that, “…it is up to the Supreme Court to decide whether [Mensing’s] exception is to be enlarged to include design defect claims. Given the widespread use of generic drugs and the developing split in the lower courts…this issue needs a decisive answer from the only court that can supply it.”

Mensing Does Preempt…

One of the courts that concluded differently is the U.S. District Court, Eastern District of Kentucky. In a joint motion to dismiss filed by multiple defendants in In re: Darvocet, Darvon and Propoxyphene Products Liability Litigation, Judge Danny C. Reeves ruled that the Mensing decision applies to design defect and failure-to-warn claims.

One of the most compelling arguments for preserving these cases is that the clients took a generic form (propoxyphene) of Darvon/Darvocet which has been pulled off the market. The removal of the drug from the market bolsters the design defect argument that the drug’s risks outweighed its limited benefits.

CCL Senior Litigation Counsel, Lou Bograd, will handle the appeal of this ruling to the Sixth Circuit. Briefing in the Court of Appeals is scheduled to begin in August.

Tuesday, April 10, 2012

Claudine Homolash Featured on "Legally Speaking" WMPV 1440 on April 4

I was featured on Radio Show, "Legally Speaking," on WMPV 1440 on Wednesday, April 4, 2012. www.wnpv1440.com Click on the image below to listen to the program.



Topics included pharmaceutical whistleblower cases, cash payments made to doctors by pharma co.'s and general discussion about pharmaceutical injury cases.

Friday, September 16, 2011

Fosamax, Actonel and Boniva May Cause Femur Fractures and Esophageal Cancer

Two FDA committees on Sept. 9 recommended that labels for bisphosphonate drugs be changed due to the risk of fractures.

In a 17-6 vote, the committees said the FDA should clarify how long patients should take the drugs, which are prescribed to treat osteoporosis.  The committees were the Reproductive Health and the Drug Safety and Management advisory committees.
The drugs, sold as Fosamax, Actonel and Boniva, have previously been linked to osteonecrosis of the jaw (ONJ), a condition in which new jaw bone fails to grow and the jaw "dies." More recently, studies have linked the drugs to fractures of the femur and to esophageal cancer.

Litigation of claims for ONJ has been ongoing in a multidistrict litigation in the U.S. District Court for the Southern District of New York and in the Atlantic City Superior Court in New Jersey. An MDL for cases alleging femur fractures was recently created in the District of New Jersey.

If you or someone you know took either Fosamax, Actonel and Boniva and either suffered a femur fracture or have been diagnosed with esophageal cancer, please call Claudine Homolash at (215) 790-7379 or email chomolash@sheller.com

Thursday, April 14, 2011

Johnson & Johnson . . .ANOTHER RECALL!

Johnson & Johnson is yanking two lots, or about 57,000 bottles, of its Topamax epilepsy drug (100 mg tablets). These were distributed in the U.S. last fall and winter, but J&J’s Ortho-McNeil Neurologics unit believes only about 6,000 are still circulating. Topamax has recently been in the news because on March 4, 2011, the FDA informed OB/GYN doctors and neurologists about new data demonstrating that infants born to women treated with Topamax during pregnancy have an increased risk for developing cleft palate or cleft lip.

Interestingly, Topamax is also widely prescribed “off-label” for weight management, or night eating. The drug has an appetite suppressant effect.

Why are the lots being pulled? There were four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole), a chemical used in wooden pallets that transport and store packaging materials.

J&J maintains no adverse events have been reported. In any event, this latest recall adds to a long and impressive list of products that J&J has pulled over the past year due to assorted manufacturing gaffes - tens of millions of over-the-counter meds, including Tylenol, Motrin and Benadryl; contact lenses, syringes and hip replacement devices.

Makes you wonder who’s in charge of manufacturing these drugs and whether J&J is properly overseeing their manufacture? This could potentially become a big issue for J&J -- let’s not forget the recent whistleblower, Cheryl Eckard, who was the catalyst for an investigation into GlaxoSmithKline’s plant in Cidra that ultimately led to GSK receiving a $750 million fine for manufacturing adulterated medicines.  The whistleblower received $96 million for reporting the misconduct. Watch out J&J ... you could be next!

Claudine Q. Homolash, Esq. is a partner at Sheller, P.C. who represents pharmaceutical whistleblowers, as well those injured by dangerous pharmaceutical products and medical devices. She can be contacted at (215) 790-7379 or at chomolash@sheller.com

Monday, June 30, 2008

Critics blast feds' legal shields for manufacturers

On June 29, 2008, the Chicago Tribune published an article recapping Bridget Robb's horrific tale of being shocked 31 times in 13 minutes due to a faulty, Medtronic Sprint Fidelis Lead. The article is one of many discussing how injured people, like Ms. Robb, are many times are precluded from recovering for their injuries due to a legal doctrine called "preemption." In effect, injured individuals are precluded from recovering against a company for defects in a product's design and labeling.

Proponents of preemption argue that manufacturers are not insurers and the FDA always has the option of holding a product from the market. During the June 11, 2008 Senate Judiciary Committee hearing at which Ms. Robb testified, Senator Specter called the FDA a joke and said that it is ludicrous to have preemption by an agency that is dysfunctional.

Before the hearing abruptly came to a halt because of a 2-hour rule invoked by a certain Republican Senator, Senator Whitehouse discussed "Regulatory Capture" -- which is when an agency that purports to be a public agency is taken over by the groups it was meant to regulate. Senator Whitehouse believes that the FDA falls within this definition.