Information on Required Text- Spring 2016

You are not required to purchase online access to the publisher's website.  All students must have the required text available on the first day of class.

Conte vs. Wyeth

Conte vs. Wyeth, INC

Court of Appeal, First District, Division 3

Decided: November 7, 2008

http://caselaw.findlaw.com/ca-court-of-appeal/1114587.html

Plaintiff Elizabeth Conte developed a serious and irreversible neurological condition. She alleges her condition is due to her long-term consumption of a generic prescription drug, and that the warnings provided by the manufacturers of the drug failed to adequately warn of known dangers resulting from its long-term use.

The trial court granted summary judgment in favor of all the manufacturers. Judgment was entered in favor of Wyeth, Inc. (Wyeth), the name-brand manufacturer of the drug, on two grounds:  (1) Conte could not show that she or her physician relied upon warnings or product labeling disseminated by Wyeth;  and (2) a name-brand pharmaceutical manufacturer owes no duty to individuals who take only generic versions of its product. The court granted summary judgment in favor of three generic manufacturers on grounds of federal preemption and Conte's lack of reliance on their warnings or product labeling.

We hold that the common law duty to use due care owed by a name-brand prescription drug manufacturer when providing product warnings extends not only to consumers of its own product, but also to those whose doctors foreseeably rely on the name-brand manufacturer's product information when prescribing a medication, even if the prescription is filled with the generic version of the prescribed drug. We further conclude that Conte has shown there is a material factual dispute as to whether her doctor relied on Wyeth's product information, but that she is unable to show he relied on any information supplied by the generic manufacturer defendants.  

Accordingly, we reverse the judgment in favor of Wyeth and affirm the summary judgment in favor of each of the three generic manufacturers. In light of our disposition of this appeal, it is unnecessary for us to reach the generic defendants' further contention that federal law preempts state tort claims based upon allegedly inadequate drug labeling.

The defendants in these consolidated appeals manufacture and market metoclopramide, which Conte's physician prescribed in its generic and name brand form, Reglan, to treat her gastro esophageal reflux disease. Wyeth manufactures and markets Reglan. Defendants Pure Pac Pharmaceutical Company (Pure Pac), Teva Pharmaceutical USA, Inc. (Teva), and Pliva, Inc. (Pliva) manufacture generic versions of metoclopramide.

Conte developed tardive dyskinesia, a debilitating and incurable neurological disorder.   She alleges she developed her condition as a result of taking metoclopramide for almost four years between August 2000 and April 2004. It is undisputed that Conte took only the generic version of the medication, not Reglan. She claims that defendants knew or should have known of a widespread tendency among physicians to misprescribe Reglan and generic metoclopramide for periods of 12 months or longer, even though the medication is only approved for 12 weeks of use, because the drugs labeling substantially understates the risks of serious side-effects from extended use.

Her complaint, after various pretrial amendments, asserts claims for fraud, fraud by concealment and negligent misrepresentation 1 against Wyeth;  negligence, strict products liability, negligence per se, and breach of express and implied warranties against the generic manufacturers;  and medical negligence against her doctor, Robert Elsen, M.D. The crux of Conte's claims against all of the drug company defendants is that she was injuriously overexposed to metoclopramide due to their dissemination of false, misleading and/or incomplete warnings about the drug's side effects.

Purepac successfully moved for summary judgment on the ground that Conte's claims against it are preempted by the federal Food, Drug and Cosmetic Act (FDCA) (21 U.S.C. § 301 et seq.) and its implementing regulations.  

Pliva and Teva subsequently filed a joint motion for summary judgment on the same basis. While the Pliva/Teva motion was pending, Wyeth moved separately for summary judgment arguing its product information had no causal relationship to Conte's injuries and it owed her no duty of care. Unlike the generic manufacturers, it did not assert that Conte's claims were preempted by federal law. Pliva (but not Purepac or Teva) joined in Wyeth's motion asserting a lack of causation, and argued Conte could not prove any alleged inadequacies in its own labeling 2 caused her injuries because neither she nor her doctor relied on it.

The court granted Wyeth's motion on both grounds. The court found that neither Conte nor her doctor relied on drug information provided by Wyeth, and that as a name-brand manufacturer; Wyeth owes no duty of care to the users of generic versions of its name-brand drug. The court subsequently granted the Pliva/Teva summary judgment motion on the ground that Conte's state tort claims were preempted by federal law.

Conte timely appealed the judgments in favor of each company. We granted her unopposed motion to consolidate the appeals for purposes of briefing, oral argument, and decision.

Similar to Pliva vs. Mensing, it is said that generic brand drugs are not at fault for the injury that happens to the patient, but rather it is the name brand’s liability. The court decided that "those whose doctors foreseeably rely on the name-brand manufacturer's product information when prescribing a medication, even if the prescription is filled with the generic version of the prescribed drug." Thus making name brands to be held accountable since generic brands are using the same ingredients and warnings as the name brands. In this specific case, because the court found it foreseeable that physician would prescribe a generic version in reliance on Wyeth’s representations about Raglan  the court allowed the negligence claims against Wyeth.

California Proposition 65 Bounty Hunter Provisions

Please take a look at the following interesting article:

http://www.calbizlit.com/00129662.pdf (DEFENDING THE PROPOSITION 65 BOUNTY-HUNTER CASE

A DIFFERENT APPROACH- AN ADAMS | NYE | SINUNU | BRUNI | BECHT WHITE PAPER)

The authors discuss the unintended consequences of the Safe Drinking Water and Toxic Enforcement Act of 1986 and it's impact on business.  Is this proposition another example of dysfunctional government in California? 

Causes of Students’ Emotional Fragility: Five Perspectives Teachers, professors, employers, parents, and students weigh in.

Please see the following link:

https://www.psychologytoday.com/blog/freedom-learn/201511/causes-students-emotional-fragility-five-perspectives

Comments?

Gun Control

The United States gun control debate has been especially prevalent following an upward trend in devastating shootings. From the elementary school massacre in Newton, Connecticut to the recent office shooting in San Bernardino, gun violence has lead to thousands of deaths in the past decade. In fact, San Bernardino marked the 355^th mass shooting in the year 2015 (www.patch.com).

            To determine one’s stance on the gun control debate, one must weigh their opinion on the importance of keeping weapons out of the wrong hands, against the significance of the Second Amendment, “the right to bear arms”.  This personal right has been engrained in our society since it’s founding, so it as a more historical school of interpreting the law. However, when considering a mindset based on legal realism, we can also weigh the fact that we are living in a changing environment that may not parallel the conditions of centuries ago.

            Just yesterday, President Obama induced significant executive action on federal gun legislation. This order widens background checks, increases information required on mental illness, and tightens these checks at a federal level. Previously, 32 states had followed federal background check requirements, while 18 adopted state laws. Additionally, the action increases the number of FBI agents and invests $500 million to improve access to mental healthcare.

            While these actions appear to be plausible measures to combat increasing gun violence in America, they have sparked outrage among many politicians. Conservative lawmakers contend that this executive action completely over-extended the administration’s power, while also “violat[ing] the constitutional separation of powers in which the legislative branch enacts laws and the executive branch executes those laws” (Senator Jim Risch). The President avoided public debate and opposition by issuing the order on a topic that has been discussed extensively by the Congress, who have been unable to reach a consensus.

            Through federal preemption, the government has previously placed gun laws that can be made stricter by individual states. An essential question when examining the gun debateis: is it the responsibility of the federal government or state governments to decide regulations on firearms?  I view these mass shootings as a national issue, so I do concede that changes must be made on a federal level. Mentally ill persons who seek to obtain a gun for this purpose live in every state, so background checks must be increased universally. If states choose to further tighten their controls, then they should also be able to do so. Yet, after Obama’s action, certain predominately conservative states have retaliated by “pushing measures intended to expand access to firearms”. For instance, Indiana lawmakers are aiming to relax their restrictions on who can purchase a gun, despite record homicide rates. This backlash is partially a consequence of states’ frustration over the President’s “unfair” control of the agenda.

I do accept that laws must be enacted to reduce the increasing gun violence in America. Obama’s new laws appear to contain appropriate solutions to keep weapons out of the hands of those with criminal records and some of the mentally ill, who have often been found to cause a large proportion of shootings. However, the way by which Obama implemented the law was flawed. In order to preserve the fair legal processes that the country was founded on, presidents cannot overextend their power. The legislative branch of the government is intended to make decisions once the citizens of the country are ready to elect a Congress that is driven to achieve the public’s objectives. When this condition transpires, laws will be passed through the branch and then confirmed by the President. When examining both positions on Obama’s new gun laws, I also considered the action a breach on the checks and balances system, which is vital in order to maintain a fair system. Increasing power in the executive branch detracts from that of the Congress. If the citizens of the United States had elected a Congress that supported stricter gun control, then a similar law would have already been passed. The elected Congress represents the citizens of the country, and the fact that the President took control to pursue his objectives both diminishes the democratic nature of the Congress and violates the founding principles of the country.

Ultimately, action needed to be taken some way or another on this pressing issue. Perhaps the President wanted to invoke motion on the debate before leaving office this year. Whether or not he took the right approach is debatable. The nation should just beware of the expanding powers of the federal government and the executive branch. The right to bear arms is an individual freedom that has been protected on the Bill of Rights since the country’s founding, and its regulation is a matter that should be taken into serious consideration. The purpose of the amendment was to bestow citizens with a means of protection. However, in this day and age, are we actually better off infringing upon this fundamental right in order to keep weapons out of the wrong hands?

The difference between fear and apprehension in an assault

Can anyone explain the difference between apprehension and fear in an assault? I read the section in the book a few times but it confuses me when the book says: "An assault occurs if apprehension exists, regardless of fear" which is saying that whether the fear exists or not, as long as there is an apprehension of the physical harm, it is an assault. However, the definition of assault in the book suggests that: " An assault occurs when one person places another in fear or apprehension of an immediate, offensive bodily harm" which is suggesting either fear or apprehension occurs, assault occurs.