Personal Injury & Product Liability Blog

The Physician Payment Sunshine Act (PPSA) was not established to replace state laws, but to build on them and remove redundancies. The PPSA requires “applicable manufacturers,” defined as “a manufacturer of a covered drug, device, biological, or medical supply,” to disclose payments and additional transfers of value to physicians or teaching hospitals. The Act defines “physician” as a doctor of medicine, a podiatrist, a dentist, a chiropractor or an optometrist.

In addition to disclosing all payments and transfers of value to physicians, the PPSA also requires that manufacturers report aggregate marketing expenses by state. Since several states and the District of Columbia have established their own laws related to disclosure of payments/gifts to physicians, the PPSA includes a preemption clause that overrules state laws that require disclosure of the same types of payments, or transfers of value. Aside from this, nearly all existing state regulations are kept intact. As a result, however, manufacturers may be required to report payments to the U.S. Department of Health and Human Services as well as state health care authorities.

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In addition to the gift ban laws discussed in our last series post, certain states require drug companies to adopt general compliance programs. Both Connecticut and California require drug companies to adopt such programs in accordance with the Office of Inspector General’s “Compliance Program Guidance for Pharmaceutical Manufacturers.” There are several elements in the guidance for manufacturers to consider when developing a compliance program, including:

• Written policies;
• Training program;
• Designation of a compliance officer and other appropriate bodies;
• Line of communication between all employees and compliance officer;
• Risk evaluation to monitor compliance;
• Policies for investigating noncompliance; and
• Development of policies to deal with employees and entities excluded from participation in federal healthcare programs.

This legal requirement is generally not burdensome for manufacturers thanks to the autonomous nature of the laws and the broad language of the guidance.
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Daniels v. Sunrise Senior Living, Inc., (Fourth District, January 4, 2013) 212 Cal.App.4th 674, 151 Cal.Rptr.3d 273, 13 Cal. Daily Op. Serv. 250, 2013 Daily Journal D.A.R. 185

A woman whose 93-year-old mother died following her stay at a residential care facility for the elderly filed an action against the owners and operators of the facility, asserting elder abuse and survivor claims as her mother’s successor in interest, and a wrongful death claim on behalf of herself as an individual. The Plaintiff alleged that her mother, who had been suffering from dementia with psychosis, had received inadequate treatment at the facility, resulting in injuries which ultimately led to her death.

The defendants petitioned the trial court to compel arbitration of the claims pursuant to an arbitration clause in a “residency agreement” which had been signed by the plaintiff as her mother’s attorney in fact. Although it had not been signed by the plaintiff in her personal capacity, the agreement nevertheless purported to cover all claims regarding the mother’s care, and to bind all of her heirs and representatives. The trial court denied the petition to arbitrate, finding that as a third party to the arbitration agreement in her capacity as an individual, the plaintiff could not be compelled to arbitrate her wrongful death claim, and that there was a possibility of conflicting rulings on common issues if the survivor claims were arbitrated but not the wrongful death claim. The court of appeal affirmed, holding that there was no basis to infer that the plaintiff had agreed to arbitrate the wrongful death claim: Read the rest »

In the first part of our Physician Payment Sunshine Act blog series, the experienced pharmaceutical litigation lawyers at Robinson Calcagnie Robinson Shapiro Davis, Inc. discussed existing disclosure laws of several jurisdictions. The disclosure of high-cost gifts was one of the stipulations of these laws, but there are also states which have established laws banning certain gifts from medical device and pharmaceutical manufacturers.

Vermont, Minnesota and Massachusetts outlawed certain gifts outright while other states, such as Nevada, Connecticut and California, and the District of Columbia, require device and drug companies to comply with the “Code on Interactions with Health Care Professionals,” written in by the Pharmaceutical Research and Manufacturers of America (PhRMA). In Colorado, certain gifts were banned for physicians affiliated with state university hospitals.

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The Patient Protection and Affordable Care Act of 2010 includes, among its provisions, the Physician Payment Sunshine Act (PPSA), which generally requires that pharmaceutical companies disclose payments to physicians for the marketing of their products. It is the first Congressional effort in the regulation of disclosure-related pharmaceutical marketing. The PPSA took effect in January 2012, but, as a federal law, does have an effect on any existing state regulations of drug marketing practices.

In this five-part blog series, we will identify particular state regulations in place before the Sunshine Act and then discuss the ultimate effect the federal law has on these state regulations.

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Fortman v. Förvaltningsbolaget Insulan AB, (Second District, January 10, 2013) 212 Cal.App.4th 830, 151 Cal.Rptr.3d 320, 13 Cal. Daily Op. Serv. 437, 2013 Daily Journal D.A.R. 441

A woman who suffered severe emotional distress when she witnessed her brother drown while they were scuba diving together, filed a products liability action against the manufacturer of a component in the scuba gear known as a flow restriction insert. Asserting a claim for negligent infliction of emotional distress, the plaintiff alleged that the plastic component had become lodged in the decedent’s regulator during the dive, and had prevented him from getting enough air to breathe while underwater.

The defendant moved for summary judgment, contending that because the plaintiff believed at the time of the accident that her brother was having a heart attack, and that she was unaware that his injury was being caused by a defective product until after a subsequent investigation, her claim did not meet the requirement of Thing v. LaChusa (1989) 48 Cal.3d 644 that she be contemporaneously aware of what caused the injury. The trial court granted summary judgment and the court of appeal affirmed, holding that in a products liability action asserting a claim for negligent infliction of emotional distress “the plaintiff must have a contemporaneous awareness of the causal connection between the defendant’s product as causing harm and the resulting injury”:

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Gregory v. Cott, (Second District, January 28, 2013) — Cal.Rptr.3d —-, 13 Cal. Daily Op. Serv. 1027, 2013 Daily Journal D.A.R. 1217

An employee of a home care agency who was working as an in-home caregiver for an 85-year-old woman suffering from Alzheimer’s, was seriously injured when the woman attempted to reach for a knife that she was holding. The caregiver then brought an action for damages against the woman and her husband, asserting theories of battery, negligence and premises liability. The defendants moved for summary judgment, arguing that the plaintiff had assumed the risk, in that the plaintiff had been trained in dealing with Alzheimer’s patients, was aware that they could become violent, and had been the woman’s caretaker for several years.

The trial court granted summary judgment and the court of appeal affirmed, holding that the trial court had properly determined that the causes of action as to both negligence and intentional torts were barred by the doctrine of primary assumption of risk, and that the plaintiff “could not have been under any illusions concerning the [patient’s] condition or the premises”: Read the rest »

In the first entry of our Product Safety blog series, the legal team at Robinson Calcagnie Robinson Shapiro Davis, Inc. discussed general issues related to defective products. While any product may potentially be defective, drugs and medical devices often pose the greatest danger.

Millions of medications and medical devices are used on a daily basis. Consumers and patients look to these products to protect them against health risks, but many of these products can cause serious injury, illness, or death due to defects. Because of the length of time it takes to get approval from the U.S. Food and Drug Administration (FDA), the public may incorrectly assume that these products are safe.

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Greyhound Lines, Inc. v. Department of the California Highway Patrol, (Fifth District, January 23, 2013) — Cal.Rptr.3d —-, 13 Cal. Daily Op. Serv. 1839

Six people were killed when a Greyhound bus struck a disabled SUV which had been involved in a single vehicle collision. In the resulting actions for damages, the defendant bus company cross-complained against the California Highway Patrol, contending that CHP 911 operators were negligent in failing to properly report calls from motorists regarding the first accident to highway patrol officers. The cross-complaint alleged that CHP 911 operators had negligently failed to include lane blockage information in their description of the accident, despite the fact that lane blockage is one of the CHP’s highest priorities, and that their error resulted in an unreasonable delay in the CHP’s response. The defendant further alleged that a special relationship existed in that the 911 operators’ assurances that help was on its way lulled the callers into a false sense of security and dissuaded them from rendering further assistance, which could have prevented the second accident. Read the rest »

On Friday, April 26, 2013, a Los Angeles jury awarded $6.5 million to the plaintiff, finalizing the suit filed against Japanese pharmaceutical company, Takeda Pharmaceuticals, for hiding the link between Actos® and the high risk of bladder cancer. The action was brought by 79-year-old Jack Cooper, who was diagnosed with bladder cancer after taking Actos for five years.

This verdict is a strong first step in the pursuit of justice for the many Actos users who have been harmed by the drug. Our attorneys at Robinson Calcagnie Robinson Shapiro Davis, Inc. have represented many clients in pharmaceutical litigation and hope that the lawsuits that follow this verdict in the ongoing Actos matter are equally successful.

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