J&J gets hit with $72M verdict over link between Talc powder and cancer

Litigation alleging that Johnson & Johnson Talc-based powder caused a woman to develop ovarian cancer led to a $72 million verdict against the manufacturer on February 22, 2016. The Missouri litigation was one of almost 1,200 similar pending cases across the country. To date, only two Talc powder cases have gone to trial. In both cases, women alleged that their ovarian cancer was caused by the use of J&J’s talc-powder products for feminine hygiene over the course of decades.

Verdict

When the first case was litigated in 2013, a federal Jury in South Dakota found that J&J was negligent, but the jury did not award damages to the injured woman, who was in remission at the time of the trial. In the latest litigation, the jury found in favor of the survivors of the Talc powder user, finding against J&J on negligence, failure to warn, and conspiracy claims. The jury assessed $10 million in compensatory damages for the personal injuries of the deceased woman and $62 million in punitive damages against J&J. One of the jurors in the Missouri litigation indicated that he was persuaded by evidence that J&J was aware of concerns about a cancer risk and instead of investigating the problem, seemed to begin preparing for potential litigation.

Other litigation

The next ovarian cancer and Talc-based powder case is set for trial in April 2016. While the most recent verdict suggests that other plaintiffs may find success in similar litigation, the conclusion is not a certainty. To succeed at trial, plaintiffs in such litigation need to demonstrate a causal link between Talc and ovarian cancer as well as proof that the Talc, and not something else, was responsible for the individual’s cancer. While the Talc litigation is significant in scope, it is minor when compared to other legal threats faced by J&J. For example, J&J’s Ethicon unit is facing 44,000 cases from women allegedly harmed by pelvic mesh (see $3.2M verdict stands in transvaginal mesh device injury suit, Health Law Daily, August 20, 2015).The company’s DePuy subsidiary has another 8,000 cases related to its metal-on-metal hip system (see DePuy’s preemption argument falls apart in hip implant litigation, Health Law Daily, July 22, 2014).

FDA’s sunblock would ban tanning beds for minors

Addressing health concerns related to indoor tanning beds, the FDA is issuing two proposals that would restrict minors from using indoor tanning beds, regulated as sunlamp products, and require adults to sign documentation stating awareness of potential health risks prior to use of tanning beds; and sunlamp manufacturers and tanning facilities would be required to take additional measures to improve the overall safety of these devices. The proposed rules will be officially published in the Federal Register on December 22, 2015 and available for public comment for 90 days.

According to the Centers for Disease Control and Prevention (CDC), an average of more than 3,000 emergency department room visits occurred for injuries related to indoor tanning each year in the U.S. between 2003 and 2012. Indoor tanning is a known contributor to skin cancer, including melanoma, and other skin damage. Overall, the proposed device requirements and restrictions would apply to manufacturers and tanning facility operators. There are approximately 18,000 to 19,000 indoor tanning salons and 15,000 to 20,000 other facilities, such as health clubs, spas, and other commercial establishments, that offer tanning services in the U.S.

Age-related measures

In an advance release of the first Proposed rule, use of sunlamp products would be restricted to individuals 18 and older. CDC data reported in the 2013 National Youth Risk Behavior Survey indicated that almost 1.6 million minors indoor tan each year, increasing their risk of skin cancer and other damage. According to the American Academy of Dermatology, those who have been exposed to radiation from indoor tanning are 59 percent more likely to develop melanoma than those who have never tanned indoors. In addition, the effects of exposure to UV radiation add up over one’s lifetime. Therefore, UV radiation exposure in children and teenagers puts them at a greater risk for skin and eye damage later in life.

In addition to the age restriction, adult users over age 18 would have to sign a risk acknowledgement certification that states that they have been informed of the risks to their health that may result from use of sunlamp products before their first tanning session and every six months thereafter.

Device safety measures

In an advance release of the second Proposed rule, sunlamp manufacturers and tanning facilities would have additional requirements imposed related to safe use of the devices. Specifically, some of the key proposed changes would include: (1) making warnings easier to read and more prominent on the device; (2) requiring an emergency shut off switch, or “panic button”; (3) improving eye safety by adding requirements that would limit the amount of light allowed through protective eyewear; (4) improving labeling on replacement bulbs so tanning facility operators can make sure they are using the proper replacement bulbs, reducing the risk of accidental burns; and (5) prohibiting dangerous device modifications, like installing stronger bulbs, without re-certifying and re-identifying the device with the FDA.

The second FDA proposal would incorporate certain elements of the International Electrotechnical Commission (IEC) International Standard 60335-2-27 to harmonize the FDA standard with the current IEC standard. Harmonization would benefit sunlamp product manufacturers because many firms producing sunlamp products for sale within the United States and abroad have to follow both IEC and FDA standards. Aligning these standards would mean that such firms would need to comply with a single set of rules instead of two different ones.

Bipartisan bill would strengthen FDA’s oversight of cosmetics

The Personal Care Products Safety Act (S. 1014), a new bill sponsored by Senators Dianne Feinstein (D-Cal) and Susan Collins (R-Me), seeks to protect consumers and streamline compliance in the cosmetics industry by giving the FDA enhanced authority to regulate the ingredients of such products.

Notably, the bill would allow the FDA to force the recall of dangerous products, whereas under the Food, Drug, and Cosmetic Act (29 USC §301 et seq.) manufacturers are not required by law to disclose adverse health effects reported by consumers, and the FDA is only able to request the voluntary recall of products. Scott Faber, the vice president of government affairs for the Environmental Working Group, told the New York Times, “Most consumers don’t have much faith in voluntary company commitments. The absence of a credible regulator has undermined consumer confidence in everyday products.”

The bill also requires that companies report serious adverse health effects, including reactions to products resulting in death, disfigurement or hospitalization, within 15 business days of obtaining the information from consumers. All nonserious events, such as rashes, must be included in an annual report.

According to a press release from Sen. Feinstein, the FDA would also be mandated under the new bill to annually study five chemicals in order to determine their safety and appropriate use: urea, lead acetate, methylene glycol/formaldehyde, propyl paraben, and quaternium-15.  The process will help provide companies with clear guidance about whether the products should continue to be used and at what concentration levels. The FDA will also provide guidance regarding the consumer warnings needed for products containing these chemicals.

Funding for the FDA’s expanded oversight will come from user fees from personal care products manufacturers.

FDA Commissioner Stepping Down After 6 Controversial Years

Dr. Margaret Hamburg, the FDA’s leader for the last six years, announced that she will be stepping down in March 2015. The FDA’s chief scientist, Stephen Ostroff, will become acting commissioner while Commissioner Hamburg’s permanent successor is appointed by the President and confirmed by the Senate. Commissioner Hamburg’s stint in the top role was one of the longest in decades. She was well-prepared for the job as a Harvard Medical School graduate and the former New York City health commissioner. While Commissioner Hamburg states that she is unsure of her next move, she says that she’s pondered leaving for some time and never planned to stay in the position for this long but found the agency “extraordinary.”

Legacy

Commissioner Hamburg’s reviews are mixed after years of FDA-centered controversy, some of which her defenders point out were not her fault or within her control. For example, in 2012, a compounding pharmacy in Massachusetts released tainted steroids that caused 64 deaths and hundreds of other illnesses from fungal meningitis. Lawmakers argued that Commissioner  Hamburg and the FDA had failed in their regulatory duties, but others pointed out that compounding pharmacies are regulated by states and not under federal purview.

Key Moments

Commissioner Hamburg led the agency through the implementation of the Food Safety Modernization Act (FSMA) (P.L. 111-353) and the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (P.L. 111-31). She was at the center of a controversy between the courts, the White House, HHS, and the FDA, regarding age restrictions on emergency contraception with the Secretary of HHS overruling her decision to make emergency contraception available to all women of child-bearing potential.

Industry Responses

Commissioner Hamburg was named to the job in 2009 by President Obama after problems at the agency grew increasingly alarming, and she describes the agency morale as “low” when she started. In years prior to her appointment, the FDA failed to publish warnings regarding the anti-inflammatory drug Vioxx®, which was believed to have caused thousands of deaths before it was pulled from the market, and a previous commissioner had hidden his investments in pharmaceutical companies regulated by the agency. Although many find that her presence stabilized the agency and allowed it to flourish, others were concerned about overreaching. The FDA approved 51 new drugs and biologics last year, the most in 20 years. Some think the agency has gotten too close with pharmaceutical companies and is approving drugs too quickly without clearly studying the effects. Others praise the expedited development and streamlined process of drug testing and approval. Many are concerned about the FDA’s lack of involvement in opioid dependency. Regardless of opinion, most agree that the FDA has many important steps to take in the future regarding obesity, electronic cigarettes, opioids, cancer treatments, and food safety.