Friday, February 25, 2011

SCOTUS limits lawsuits against vaccine makers

A win for all. Legal burdens could easily wipe out vaccine provision

Vaccine makers such as Pfizer are breathing much easier today: The Supreme Court ruled they can't be sued for defective vaccine designs. That puts the kibosh on some 5,000 cases in which parents blame vaccines for their children's autism, and generally gives the pharmaceutical companies much more certainty about their potential liability. The decision was 6-2, with Justice Elena Kagan sitting out. Justices Sonia Sotomayor and Ruth Bader Ginsburg dissented.

When a product hurts someone, one possible way the victim can sue is to claim that the product was designed defectively. Claiming a defective design is the tricky, because products can be inherently dangerous, but still be good products -- chainsaws or cars, for example. While different courts use different tests to determine if a design was defective, the basic idea is to strike a balance between the product's usefulness as intended and the risks it creates.

Let's apply this to a hypothetical vaccine: Imagine it's possible to have a vaccine that has no side effects, but isn't particularly effective at preventing the disease it targets, and another formulation that's extremely effective at disease prevention, but does have side effects, including -- in very rare cases -- horrible ones such as brain damage or even death. Because of society's interest in promoting the use of effective vaccines -- when someone fails to immunize their child, both that child and other people are put at risk, particularly infants and the elderly -- Congress has emphatically endorsed vaccines that are effective but have some rare risks as the better design.

To prevent vaccine makers from being bankrupted by lawsuits over those rare but horrible side effects, Congress created a special vaccine compensation program for victims. If a victim's claim is rejected by that program, the victim can still sue under state law, claiming the vaccine was defective. In the case the Court just decided, the issue was whether Congress allowed all kinds of defective vaccine claims, or just claims a vaccine was defectively manufactured or defectively marketed (i.e.: that the maker failed to warn users of known risks.)

The court heard the case of Hannah Bruesewitz, who developed a seizure disorder and mental disabilities as an infant, shortly after being given Wyeth's DPT vaccine. (Wyeth is now part of Pfizer.) Her family's claim for compensation was rejected by the federal program, and they turned to state court, alleging the vaccine was defectively designed because Wyeth owned a different design that was safer, but chose not to market it. Wyeth disputes the claim that the other design was safer.

In deciding the Bruesewitz's claim was barred, the Court turned to the text and structure of the law creating the federal compensation program. Effectively the decision turned on what the three words "even though" and "unavoidable" meant in this context:
"No vaccine manufacturer shall be liable [for] a vaccine-related injury or death...if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings."

Justice Scalia, a famous textualist, wrote the opinion. The majority decided that the language meant that only manufacturing and marketing defects, which follow the "even though", are allowed. If design defects were allowed, it should have said something like "properly prepared and designed and accompanied..."

The dissent disagreed, arguing that the word "unavoidable" had a special meaning from a law treatise, which changed the analysis, and Congress hadn't clearly said it was preempting the state claims. Finally, the dissenters emphasized that shielding vaccine makers from design defect cases eliminates a powerful incentive for manufactures to keep improving their designs. As to the last argument, Scalia conceded the tort liability motive for design improvement was indeed eliminated by his opinion, but insisted the law provided other incentives.

Scalia, who has a reputation for witty, readable and caustic opinions, clearly reveled in parsing the sentence's structure as well as talking trash (in polite Supreme Court fashion) about Sotomayor and Ginsburg's dissent. For example, Justice Scalia noted that the "even though" clause is known as a "concessive subordinate clause by grammarians" and said things like "dissent's principal textual argument is mistaken ... We do not comprehend ... its reasoning."

Justice Scalia also took a passing swipe at Congress, noting that it had been unnecessarily wordy:

"Petitioners and the dissent contend that the interpretation we propose would render part of [the vaccine law] superfluous: ... ("the injury or death resulted from side effects that were unavoidable even though") is unnecessary. True enough. But the rule against giving a portion of text an interpretation which renders it superfluous does not prescribe that a passage which could have been more terse does not mean what it says."

At the end of the day, vaccine makers win. Society also wins -- especially if the vaccine makers' threats of withdrawing from the business if they lost this case were sincere. But the Bruesewitz family loses, painfully, as their now teenage daughter still suffers from the seizure condition and mental disabilities. And if the dissent is right, and manufacturers will fail to improve their vaccine designs as a result of the decision, we will all lose eventually as side effects that could have been reduced or eliminated continue to hurt people.


Moderate amounts of alcohol protect against heart disease

But the effect is small

Drinking a glass of wine or pint of beer every evening reduces the risk of heart disease by up to a quarter, according to research.

Just days after a warning that Britain faces up to 250,000 extra deaths from liver disease unless its binge-drinking culture is tackled, two reports claim that moderate amounts of alcohol are actually good for the health.

They say that a small glass of wine for women and up to two bottles or one pint of beer can prevent the build-up of bad cholesterol, and so sensible drinkers are at lower risk of developing heart disease than teetotallers.

This is because alcohol taken in moderation increases the amount of “good” cholesterol circulating in the body.

Prof William Ghali, of the University of Calgary, said: “With respect to public health messages there may now be an impetus to better communicate to the public that alcohol, in moderation, may have overall health benefits that outweigh the risks in selected subsets of patients - any such strategy would need to be accompanied by rigorous study and oversight of impacts.”

However Cathy Ross, senior cardiac nurse at the British Heart Foundation, warned: “Drinking more than sensible amounts of alcohol does not offer any protection and can cause high blood pressure, stroke, some cancers and damage to your heart.

“If you don't drink, this is not a reason to start. Similar results can be achieved by being physically active and eating a balanced and healthy diet.”

In the first study, published online by the BMJ on Wednesday, Prof Ghali and colleagues reviews 84 previous studies of alcohol consumption and disease. They compared the number of drinkers and non-drinkers who suffered, or died from, heart disease and stroke, and concluded that “alcohol consumption was associated with lower risk”, of between 14 and 25 per cent.

The second paper, led by Dr Susan Brien at the same Canadian university, looked at 63 existing studies on alcohol consumption and cholesterol and fat levels. It concluded that consumption of one drink (of about 15g of alcohol) for women and two for men was good for the health, and that the benefit was felt regardless of whether beer, wine or spirits was drunk.

The study said that alcohol “significantly increased” high-density lipoprotein cholesterol, the “good” form that cleans blood vessel walls of “bad” cholesterol and returns it to the liver, preventing the build ups that can lead to heart disease.


1 comment:

Anonymous said...

Hannah Bruesewitz's parents have long known that her seizures are caused by a known genetic defect. They have continued their lawsuit in an attempt to provide for their daughter's future care by stealing from someone with deep pockets.

The vaccine makers have not gotten off, there is a fund (financed by a tax on the purchase of the vaccines) set up to take care of people who truly do have negative reactions to vaccines and the average payout from that fund is around seven and a half million dollars.