Administrative Agency Personal Injury Products Liability

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Product Liability Law Medical Device Law Update: December 2012 - “A State of Profound Uncertainty”: The Crisis in Pennsylvania

Since the mid-1960s, Pennsylvania has adhered to the strict liability tenets of section 402A of the Restatement (Second) of Torts. Its version of strict liability had a number of unique features, including the determination...more

Meningitis Outbreak Spawns Dicey Treatment Claims

Meningitis—a life-threatening inflammation of the membranes surrounding the brain and spinal cord—has seldom been more prominent in the news, and for all the wrong reasons. The contaminated steroid made and distributed by a...more

INSIGHTS - Patton Boggs Safety & Health and Crisis Management Newsletter - October 2012

In This Issue: 1. Rockefeller Reintroduces Mine Reform Legislation 2. Whistleblower Protections Added to Highway Bill 3. GAO Endorses Studies Supporting Black Lung Rule 4. Demolition, Underground Construction...more

Pharmaceutical Law Update -- October 2012: New Jersey Court Grants Summary Judgment Based on Lack of Warning Causation

A New Jersey federal court granted summary judgment to Baxter Healthcare Corporation (Baxter) last month based on a familiar legal concept rarely applied in the Garden State – warning causation. In Baker et al. v. APP...more

Insurance Coverage for Food and Beverage Contamination

Damages owed from illness and death claims resulting from actual or alleged food and beverage contamination, along with the cost of recalls of potentially contaminated products, present serious financial risk to companies...more

Tarion Overhaul of Major Structural Defect Procedures

Tarion has introduced significant changes to the major structural defect claims process. These changes will affect all condominium projects where the first arm’s length agreement of purchase and sale was signed after July 1,...more

Should Brake-Override Systems in Cars be Mandatory?

Are brake-override systems necessary? Should they be mandatory for all new vehicles? Federal regulators seem to think so. In fact, the National Highway Traffic Safety Administration just recently proposed that all automobile...more

Female Crash Test Dummies Now Regularly Being Used

It may surprise you to learn that it wasn’t until 2003 that the National Highway Traffic Safety Administration (NHTSA) began to sometimes use female crash test dummies when simulating crashes to determine the safety of...more

How much should automakers be fined for not complying with recall rules?

In late March, the United States Senate approved legislation that would increase the fines levied against U.S. automakers who failed to comply with automobile recall regulations. Currently, automakers are fined a maximum of...more

Diabetes Warning Issued for Statin Drugs

A class of drugs called statins lowers blood cholesterol levels by reducing the production of cholesterol by the liver. Lipid regulators, which are primarily statin drugs, are the most commonly prescribed medication in the...more

Court of Appeals Affirms Dismissal of FEMA Trailer Claims

The Fifth Circuit last week upheld the dismissal of putative class actions filed by Mississippi and Alabama residents against the federal government alleging trailers provided to Hurricane Katrina-impacted citizens contained...more

FDA Must Improve Monitoring of Food Safety

According to a report by the Department of Health and Human Services, every year 128,000 Americans are hospitalized and 3,000 die from food poisoning. The FDA is responsible for safeguarding the food supply and for inspecting...more

Another Warning on Baby Acetaminophen (Tylenol)

If you give your baby acetaminophen to reduce fever and pain, pay close attention to the packaging. Several months ago, we reported about the FDA’s interest in more accurate dosing information for children’s Tylenol ....more

Presumption-of-Adequacy Defense Is Clarified and Reinforced

On Sept. 29, the Appellate Division took a significant step forward in clarifying and reinforcing the presumption-of-adequacy defense provided to manufacturers of prescription drugs under the New Jersey Product Liability Act...more

Two New PMA Preemption Cases

You all know we love preemption. So, when two favorable medical device preemption decisions are entered on the same day, well that’s a two-fer we can’t wait to blog about. In both cases, plaintiffs tried to plead and argue...more

Study Shows No Advantage to Metal Hip Replacements

A new study in BMJ , the British medical journal, has revived interest in the issue of the kind of materials best used for hip replacements. Problems have long been reported from many quarters when metal is used to...more

Youth and Tanning Beds: Do Not Mix

The groundswell against the use of tanning beds got an additional boost last week when California Gov. Jerry Brown signed legislation prohibiting children younger than 18 from using the body-bronzers as of January 2012....more

FDA Issues a Warning for Avastin – Again

The problems with the cancer drug Avastin are never ending. The FDA has issued a another warning about the drug’s dangers, this time involving ovarian failure, jaw necrosis (bone decay), blot clots and excessive...more

Bills Introduced to Halt New Federal Regulations

We from time to time have called our readers attention to developments in the important field of tort reform. While often this takes the form of state legislation affecting substantive legal doctrine, there is another...more

Consumers Seek Recall of Brazilian Blowout

It sounds like a World Cup Soccer match result, but in fact, Brazilian Blowout is a hair-straightening product. And thanks to a wave of unpleasant responses to its use, the FDA has issued a warning letter to its...more

Turkey Salmonella Outbreak

The Centers for Disease Control and Prevention (CDC) is working with public health officials across the country and the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA-FSIS) to determine the cause of...more

AMA Seeks New Policies on BPA, Competitive Eating and Airport Scanners

At its annual meeting last month, the American Medical Association's House of Delegates adopted several new policies, including one that recognizes that bisphenol A (BPA) interferes with human hormones, one that decries the...more

Defective Hip Implants Prove that New Isn't Always Improved in Medical Devices

DePuy's now notorious metal-on-metal artificial hip, known as the ASR, was marketed as the next great thing in orthopedics, but actually was a recycled old design that ignored warnings from industry insiders that the...more

New Sharkey Preemption Article

Catherine Sharkey, one of the leading academic commentators on preemption in the administrative context, has released a new article on the subject, entitled "Inside Agency Preemption." Here's a link to an online copy of the...more

How Is Generic Preemption Like Fraud On The FDA?

A couple of months ago, we provided our stream-of-consciousness impressions of the Mensing/Demahy generic preemption argument to the Supreme Court. As we mentioned then, we were all set to write an obituary on generic...more

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