J&J Loses Third Trial Over Cancer Link to Talcum Powder

Johnson & Johnson lost a third straight trial over claims its talcum powder can cause ovarian cancer with a St. Louis jury awarding a California woman more than $70 million.

J&J is accused in about 1,700 lawsuits in state and federal court of ignoring studies linking its baby powder and Shower-to-Shower talc products to ovarian cancer and failing to warn customers about the risk. Thursday’s verdict follows damages verdicts of $72 million and $55 million against the company this year in the first two talc claims to go to trial in St. Louis. Both are being appealed.

Deborah Giannecchini, 62, used J&J’s baby powder for feminine hygiene for more than four decades until her diagnosis with ovarian cancer three years ago, according to her lawyers. She has an 80 percent chance of dying in the next two years, and has undergone surgery, radiation and chemotherapy, they said.

A J&J unit was ordered to pay $65 million in punitive damages and 90 percent of about $2.5 million for medical costs and pain and suffering. Co-defendant Imerys Talc America, the supplier of the talc, was hit with $2.5 million in punitive damages. Jurors returned the verdict after deliberating for about three hours.

You can find the rest of the article from Bloomberg at this link.


Taxotere Lawsuits Multi-District Litigation Created in New Orleans

Taxotere Lawsuits across the country have been consolidated in the U.S. District Court for the Eastern District of Louisiana in front of The Honorable Kurt D. Engelhardt.

A large number of breast cancer patients in the U.S. receive Sanofi’s chemotherapy drug, Taxotere, as a part of their treatment. However, some women who were left with disfiguring, permanent hair loss from the drug are filing lawsuits against Sanofi. They claim the manufacturer failed to warn them and even hid the risk from them and their health care providers.

If you or a loved one took Taxotere and suffered from permanent hair loss you may be entitled to compensation.

Contact us today.


Johnson & Johnson ordered to pay $55M to family in ovarian cancer-talcum powder case

Per CBC Business News:

For the second time in three months, a St. Louis jury has ordered Johnson & Johnson to pay a huge award over claims that its talcum powder causes cancer.

The jury deliberated eight hours Monday before ordering the company to pay $55 million to a South Dakota woman who blamed her ovarian cancer on years of talcum powder use.

In February, another St. Louis jury awarded $72 million to the family of an Alabama woman who died from ovarian cancer, which she said was caused by using Johnson & Johnson's baby powder and other talcum products.

New Jersey-based Johnson & Johnson will appeal the latest ruling.

APTOPIX Earns Johnson and Johnson

Johnson & Johnson has now been ordered to pay damages to two different families who have sued the company for what they say is a link between the company's talcum powder and ovarian cancer. (Matt Rourke/Associated Press)

"Unfortunately, the jury's decision goes against 30 years of studies by medical experts around the world that continue to support the safety of cosmetic talc," Johnson & Johnson spokeswoman Carol Goodrich said in a statement.

"For over 100 years, Johnson & Johnson has provided consumers with a safe choice for cosmetic powder products and we will continue to work hard to exceed consumer expectations and evolving product preferences."

But Jim Onder, attorney for the plaintiff, Gloria Ristesund, said researchers began linking talcum powder to ovarian cancer in the 1970s, and he said internal Johnson & Johnson documents showed that the company was aware of those studies.

"The evidence is real clear that Johnson & Johnson has known about the dangers associated with talcum powder for over 30 years," Onder said. "Instead of giving a warning, what they did was targeted the groups most at risk for developing ovarian cancer," specifically marketing to overweight women, he said.

Talc is naturally occurring, mined from the soil and composed of magnesium, silicon, oxygen, and hydrogen. It's widely used in cosmetics and personal care products, such as talcum powder, to absorb moisture, prevent caking and improve the product's feel.

In February, a St. Louis jury awarded $72 million to the family of Jackie Fox of Birmingham, Alabama. Her son took over as plaintiff after his mother death in October at age 62. She had used the talcum powder for decades.

Johnson & Johnson faces at least 1,200 still-pending talcum powder lawsuits, including about 1,000 in St. Louis and 200 in New Jersey, Onder said.

Johnson & Johnson previously has been targeted by health and consumer groups over possibly harmful ingredients in items including its iconic Johnson's No More Tears baby shampoo.

In May 2009, a coalition of groups called the Campaign for Safe Cosmetics began pushing Johnson & Johnson to eliminate questionable ingredients from its baby and adult personal care products. After three years of petitions, negative publicity and a boycott threat, the company agreed in 2012 to eliminate the ingredients 1,4-dioxane and formaldehyde, both considered probable human carcinogens, from all products by 2015.



Zoloft MDL Scrapped by Judge

Per The Legal Intelligencer:

The federal judge presiding over the Zoloft multidistrict litigation has granted Pfizer’s request to toss the MDL on the grounds that the plaintiffs couldn’t muster an expert to illustrate a link between the drug and birth defects.

On Tuesday, U.S. District Judge Cynthia Rufe of the Eastern District of Pennsylvania effectively ended the MDL—pending any appeals to the Third Circuit—which has been going on for over three years. According to Rufe’s order, the clerk was instructed to close all but 23 of the more than 300 remaining cases, which were against defendants other than Pfizer and co-defendant Wolters Kluwer Health.

Rufe wrote in her opinion that while it hasn’t been proven that Zoloft doesn’t cause birth defects, the attempts in court to prove that it does have failed.

“Dismissal without prejudice under the circumstances of this MDL and in the face of this essential defect of proof would work against the fair administration of justice,” Rufe said. “The court recognizes that the final scientific verdict as to whether Zoloft can cause birth defects may not be delivered for many years. Nevertheless, plaintiffs chose when to file their cases, and the court concludes that for the plaintiffs who have continued to pursue their claims, the ­litigation gates must be closed.”

She added, “At the end of the day, plaintiffs have failed to raise a jury question on the necessary predicate to success in any case: that Zoloft was capable of causing their injuries.”

The plaintiffs have had difficulty in offering causation experts, with Rufe shooting down one after the other.  In December, Rufe barred the testimony of the plaintiffs’ general causation expert, Dr. Nicholas Jewell, a professor of biostatistics at the University of California, Berkeley. Rufe’s ruling came after the dismissal of hundreds of noncardiac birth-defect cases in the litigation over the summer—halving the litigation in size. Jewell was put forth as the expert for the remaining, cardiac-related cases. At its peak, the MDL numbered around 600 cases.



Jury Awards Just Under $500 Million Total to Plaintiffs in 5 Separate Cases at Conclusion of Pinnacle Hip Implant Consolidated MDL Trial

DALLAS — A Texas federal jury has awarded just under $500 million total to five separate plaintiffs at the conclusion of a consolidated trial involving allegedly defective Pinnacle Hip Implants manufactured by DePuy Orthopaedics and Johnson & Johnson, HarrisMartin Publishing is reporting.

The U.S. District Court for the Northern District of Texas jury reached the verdict on March 17 after hearing 37 days of testimony, sources said. The jury received the case late in the afternoon on March 10 and deliberated for four more days before reaching the verdict.




Reuters News:

Johnson & Johnson (JNJ.N) was ordered by a Missouri state jury to pay $72 million of damages to the family of a woman whose death from ovarian cancer was linked to her use of the company’s talc-based Baby Powder and Shower to Shower for several decades.

In a verdict announced late Monday night, jurors in the circuit court of St. Louis awarded the family of Jacqueline Fox $10 million of actual damages and $62 million of punitive damages, according to the family’s lawyers and court records.

The verdict is the first by a U.S. jury to award damages over the claims, the lawyers said.


Johnson & Johnson faces claims that it, in an effort to boost sales, failed for decades to warn consumers that its talc-based products could cause cancer. About 1,000 cases have been filed in Missouri state court, and another 200 in New Jersey.

Fox, who lived in Birmingham, Alabama, claimed she used Baby Powder and Shower to Shower for feminine hygiene for more than 35 years before being diagnosed three years ago with ovarian cancer. She died in October at age 62.

Jurors found Johnson & Johnson liable for fraud, negligence and conspiracy, the family’s lawyers said. Deliberations lasted four hours, following a three-week trial.

Jere Beasley, a lawyer for Fox’s family, said Johnson & Johnson “knew as far back as the 1980s of the risk,” and yet resorted to “lying to the public, lying to the regulatory agencies.” He spoke on a conference call with journalists.

Carol Goodrich, a Johnson & Johnson spokeswoman, said: “We have no higher responsibility than the health and safety of consumers, and we are disappointed with the outcome of the trial. We sympathize with the plaintiff’s family but firmly believe the safety of cosmetic talc is supported by decades of scientific evidence.”

Trials in several other talc lawsuits have been set for later this year, according to Danielle Mason, who also represented Fox’s family at trial.

In October 2013, a federal jury in Sioux Falls, South Dakota found that plaintiff Deane Berg’s use of Johnson & Johnson’s body powder products was a factor in her developing ovarian cancer. Nevertheless, it awarded no damages, court records show.

Valeant Pharmaceuticals International Inc (VRX.TO) now owns the Shower to Shower brand but was not a defendant in the Fox case.

The case is Hogans et al v. Johnson & Johnson et al, Circuit Court of the City of St. Louis, Missouri, No. 1422-CC09012.



From Lexology:

In a 5-4 decision issued on June 24, 2013, the United States Supreme Court held that state law design defect claims against manufacturers of generic pharmaceuticals are preempted by federal law when the claim hinges on the adequacy of the drug’s warning. In the case at issue, the plaintiff argued at trial that the maker of sulindac (a generic form of the nonsteroidal anti-inflammatory drug Clinoril) was liable on a defective design theory because the drug “was unreasonably dangerous and had an inadequate warning.”Finding that it would have been impossible for the manufacturer to have complied with both the FDA’s regulations promulgated under the Hatch-Waxman Amendments and state tort law duties, the Court reversed the First Circuit’s decision affirming a $21 million verdict in favor of the plaintiff based on the premise that the defendant manufacturer could have complied with both federal and state law by choosing not to make the drug.

Because generic drugs must be chemically equivalent and bioequivalent to the brand-name drug and utilize warning labels that are the same as the brand-name’s, generic manufacturers are “prohibited from making any major changes to the ‘qualitative or quantitative formulation of the drug product, including active ingredients or in the specifications provided in the approved application’” and they are “prohibited from making any unilateral changes to a drug’s label.” Mutual Pharmaceutical Co. Inc. v. Bartlett, No. 12-142, Slip op. at 3-4 (U.S. June 24, 2013), 570 U.S. ___ (2013). To satisfy their duty to provide products that are not “unreasonably dangerous” under New Hampshire law, however, manufacturers must either change the drug’s design or its labeling. Id. 9-11. According to the Court, because redesigning sulindac was not possible under the FDCA and because of the drug’s simple composition, “New Hampshire’s design-defect cause of action imposed a duty on [the defendant] to strengthen sulindac’s warnings.” Id. at 10-11. And, as the Court held in its decision in PLIVA v. Mensing, 113 S.Ct. 2567 (2011), “federal law prevents generic drug manufacturers from changing their labels.” Id. at 13. Federal law thus prohibited the manufacturer of sulindac from taking the action required by New Hampshire law, and the plaintiff’s state law design defect claims based on the adequacy of the drug’s warnings were preempted. Id.

The Court rejected the First Circuit’s reasoning that it was not “impossible” for the manufacturer of sulindac to comply with federal and state law because it could have simply stopped selling the drug. Id. at 14-16. Indeed, the Court recognized that the adoption of the “stop-selling” theory would mean that PLIVA as well as most other cases involving impossibility preemption were wrongly decided. Id. at 16.

In conclusion, the Court acknowledged the “passionate responses” engendered from the often serious injuries in products liability cases, “[b]ut sympathy for [the plaintiff] does not relieve [the Court] of the responsibility of following the law.” Id. at 17.




The U.S Food and Drug Administration (FDA) has finally agreed to look at the huge safety discrepancy between generic and brand named drugs.  The FDA signaled the move by notifying the Office of Management and Budget of its plans to publish a proposed new rule that would make create similar requirements for generic and brand-name drug makers with respect to how they update their warning labels.

Currently, only brand drug makers can legally update their warning labels if they learn of new or undisclosed risks.  This means generic drug makers effectively have no responsibility to monitor the drugs they sell for safety, because the company has no responsibility to warn about new risks.

Public Citizen first raised the issue with the FDA in a Citizen Petition back in August, 2011 after the U.S. Supreme Court ruled that generic drug makers cannot be held responsible for their drugs’ safety because the company is only making a “copy” of a brand drug.

Finally the FDA has agreed to tackle the issue.  While this will not bring relief to the hundreds of victims injured by generic drugs’ dangerous side-effects, it will help make generic drugs safer for all consumers in the future because generic drug makers will now have the responsibility to disclose new safety risks and not rely on the brand maker to do so.

Every corporation should have a responsibility to make sure their product is safe and properly warn about their products’ dangers.  Safety should not be a matter of brand or generic.



The U.S. Food and Drug Administration (FDA) just issued a proposed rule to allow generic drug makers to update labels should they receive information on potential safety issues associated with their drugs.

Today, only brand name drug makers are permitted to make such label changes. The proposed rule, if approved, will also enable litigation to proceed against generic drug manufacturers, noted The New York Times.

The Supreme Court has ruled that, under state law, the makers of generic drugs may not be sued for adverse reactions allegedly associated with their products, finding that companies that produce branded drugs are liable for any inadequacies on their drugs warning labels.