Roundup: 1st, 3rd, 5th and D.C. Circuits

Design defect claims against generic drugs not preempted; Employer owns copyright of computer program worker developed at home; Texas cannot defund Planned Parenthood; Citations under OSHA subject to six-month statute of limitations

1st Circuit
Maine, Massachusetts, New Hampshire, Puerto Rico, Rhode Island 

Design defect claims against generic drugs not preempted

When Karen Bartlett suffered severe burns and near-blindness after taking the generic anti-inf lammatory drug sulindac, she sued the maker, Mutual Pharmaceutical Co., in New Hampshire state court for fraud, negligence and design defect, among other claims. When Mutual moved the case to federal court, the district court dismissed all but the design defect claim, upon which a jury awarded Bartlett $21 million.

Mutual appealed to the 1st Circuit, arguing that the Federal Food, Drug, and Cosmetic Act (FDCA) preempts design defect claims against generic drugs. In its May 2 decision in Bartlett v. Mutual Pharmaceutical Co., the 1st Circuit ruled that Supreme Court precedent in PLIVA, Inc. v. Mensing, which found that the FDCA preempts failure-to warn-claims against generics, did not extend to design defect claims.

The Food and Drug Administration does not allow generic drug makers to change the composition of their drugs, but the 1st Circuit claims they do have a choice: not to make the drug at all. “Although Mutual cannot legally make sulindac in another composition,” the court wrote, “the FDCA might permit states to tell Mutual it ought not to be [making sulindac] if risk-benefit analysis weights against the drug.”


3rd Circuit
Delaware, New Jersey, Pennsylvania

Employer owns copyright of computer program worker developed at home

The 3rd Circuit upheld a district court ruling April 24 that said an employer owns the copyright to a computer program that a worker builds at home if it can be considered a work for hire.

In Le v. City of Wilmington, Le T. Le worked in the city’s Network Division. He claims that at home, in his spare time, he developed an instant ticketing program for tracking traffic citations, which he later installed on the city’s computer network for testing. The city eventually adopted the program and employees began giving Le feedback on how to improve it. 

In 2007, Le filed a Certificate of Registration with the U.S. Copyright office, and then removed the source code of his program from the city’s server. The city demanded he reinstall it, and after he did, the city fired him.

The district court granted the city summary judgment on the copyright claim, and the 3rd Circuit upheld it on appeal, finding that although Le worked on the program during his personal time, he developed it with the express purpose of helping the city reduce its workload, making Wilmington, not Le, the copyright owner.


5th Circuit
Louisiana, Mississippi, Texas

Texas cannot defund Planned Parenthood

For the time being, Texas is not allowed to enforce a regulation that disqualifies affiliates of abortion providers from participating in its state-funded women’s health program. Eight Planned Parenthood affiliates, which care for about half of the state program’s participants, according to Bloomberg Businessweek, sued Texas over this rule in April.

In Planned Parenthood v. Suehs, a district court granted an injunction against enforcing the rule, then reversed its decision less than 24 hours later when Texas requested a stay pending appeal, saying the state would be “irreparably injured” otherwise.

On May 4, the 5th Circuit reversed that stay, saying there was no emergency need for a stay because federal funding for the program wouldn’t run out until November, even with an injunction. To expedite Texas’ appeal, the court asked for oral arguments to be placed on the next available docket.

“We won’t let politics interfere with the health care that nearly 3 million people a year rely on Planned Parenthood for in Texas and around the country,” Planned Parenthood Action Fund President Cecile Richards told the Associated Press in response to the ruling.

D.C. Circuit

Citations under OSHA subject to six-month statute of limitations

The D.C. Circuit’s April 6 decision in AKM LLC d/b/a Volks Constructors v. Secretary of Labor drastically limits the ability of the Occupational Safety and Health Review Commission (OSHRC) to issue citations for recordkeeping violations.

The Occupational Safety and Health Act requires employers to keep records of workplace injuries and illnesses. They must prepare a report within seven days of hearing of an incident, as well as a year-end summary of all incidents, and keep the records for five years. Using these standards, OSHRC issued a set of citations in November 2006 to Volks Constructors for not completing its records between 2002 and 2006. It was not cited, however, for failing to preserve
records for five years.

The D.C. Circuit ruled that because the citations were issued at least six months after the last unrecorded injury occurred, which is forbidden under 29 U.S.C. Section 658 (c), the citations should be vacated.

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