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When drug manufacturers are sued for refusing to properly label products that have resulted in personal injuries or wrongful  deaths, they argue that under state laws personal injury claims are barred under the doctrine of federal preemption. When a court orders that a claim is subject to federal preemption it precludes the defendant from being held responsible under state laws. Once preemption is granted against drug manufacturers injured plaintiffs are denied any forum to litigate their claim and are precluded from obtaining any compensate for the damages they have suffered. This is because no federal law or regulation exists which allows recovery for such claims in federal courts. When a defendant drug company is granted preemption, it is free of any liability to injured claimants. Federal law mandates accurate warning labels on prescription drugs and requires pharmaceutical companies to supplement warning labels when new information is available. As this article explains, federal law does not preempt a state’s ability to allow one of its citizens to sue a manufacturer who breaches that duty and does not preclude citizens from seeking damages for personal injury or wrongful death in court.

Current law supports the right of an injured person to sue a drug manufacturer for personal injuries caused by a manufacturer’s concealment of adverse reports or promotion of “off label” use with serious side effects.

But, a recent victory for a medical device manufacturer in the U.S. Supreme Court has fueled renewed interest by drug manufacturers to push to change the law to insulate themselves from personal injury and wrongful death lawsuits.

A conservative and pro-business U.S. Supreme Court ruled in February 2008 in the case of Reigel v. Medtronic that medical device manufacturers were insulated from being held accountable in state courts when their products were responsible for personal injuries and deaths.

The Court opined that the Food and Drug Administration was the sole protector of citizens, ignoring both the FDA‘s proven ineptitude and failure to exercise any meaningful supervision over numerous defective pacemakers, defibrillators, stents, and artificial joints that have plagued consumers during the past decade, let alone contaminated foods shipped into the U.S.

Under Reigel, once a medical device receives Pre-Market Approval from the FDA the device is held above state law. But as the New York Times reported on February 22, 2008: “Many of the industry’s most sophisticated and profitable Class III devices – implants like defibrillators, newer pacemakers that balance the heart rate in different chambers of the heart, drug-coated stents to prop open arteries, artificial hips, spinal disks, knees and stimulators that control pain – are seen as so different from pre-1976 devices that they must undergo a more thorough safety and effectiveness review.”

Unfortunately, they do not.

For example, in the case of the October 2007 recall of the Fidelis Sprint pacemaker leads manufactured by Medtronics, the FDA never subjected the leads to a full review. Multiple versions of this product have evolved over 15 years. Medtronic has filed 37 amendments to the PMA issued for its original pacemaker leads. The supplemental approval for the Sprint Fidelis lead, which is dramatically different from the original pacemaker lead invented by Medtronics, took just 90 days. The FDA never should have approved this product in the first place, becaused it was never properly tested, as confirmed by early failures occurring at an alarming rate, which prompted a total recall.

Emboldened by the Supreme Court’s 2008 decision in Reigel, drug manufacturers want the same immunization from liability that device makers claim and they are pushing for federal preemption, the equivalent of killing personal injury and death claims caused by mislabeled drugs and medications promoted for “off-label” use by the companies. Once a drug is on the market a doctor can legally use it for any reasonable purpose. Botox was approved for one very limited purpose: to kill nerves that cause forehead wrinkles. But Allergan’s millions of dollars in sales have come from dermatologists injecting Botox at other sites, not approved by the FDA, but allowed by the “off-label” legal exception. “Off-label” uses are major moneymakers for drug companies.

An impressive and compelling analysis why drug manufacturers should be held to answer under state law for personal injuries and wrongful deaths caused by their misconduct was authored by the Honorable Allan L. Tereshko, Judge of the First Judicial District of Pennsylvania in his Findings and Order of March 11, 2008 in Collins v. SmithKline Beecham Corporation d/b/a GlaxoSmithKline.

Judge Tereshko’s decision is significant because he serves as the Coordinating Judge of the Philadelphia Court of Common Pleas Complex Litigation Program, which supervises numerous cases involving pharmaceutical companies. This Court has substantial experience with lawsuits against drug companies and the preemption defenses raised by manufacturers seeking to avoid liability for their products. This article republishes below substantially all of Judge Tereshko’s excellent decision in a condensed and generalized form, separate from the specific facts of the Collins case, because this analysis merits widespread understanding by the press and the public. The complete decision is posted on the Court’s website.

When state laws interfere with or contradict Federal law they are nullified under a legal doctrine known as preemption. See Gibbons v. Ogden, 9 Wheat 1, (1824). The doctrine is based on Article VI, clause. 2 of the U.S. Constitution:

This Constitution, and the laws of the United States which shall be made in pursuance thereof; …shall be the supreme law of the land; and the judges in every State shall be bound thereby…

Federal preemption can occur where Congress explicitly pre-empts State law or where there is an implied preemption.

Implied preemption can be found where Congressional legislation occupies the entire field to the exclusion of state law or there is an actual conflict between federal and state law. See Pokorny v. Ford Motor Co., 902 F.2d, 1116. (1990).

In cases where a drug label fails to include specific warnings, drug manufactures argue such cases must be preempted, nullified and dismissed, because the content of any label is exclusively controlled by the FDA. That defense is raised even in cases where the plaintiffs charge a manufacturer has violated its duty to comply with federal regulations concerning the study, testing, design, development, manufacture, labeling, marketing, promotion, distribution, and/or sale of prescription drugs.

The argument made by the drug companies ignores the fact that under a federal system of government states are independent sovereigns and that Congress does not cavalierly preempt state causes of action. See Rice v. Santa Fe Elevator Corp. 331 U.S. 218, 230, 91 L.Ed.1447.

In Retail Clerks v. Schemerhorn, 375 U.S. 96, 11 L.Ed. 2d 179, 84 S.Ct. 219 (1963), the Court began its analysis of the preemption issue by first focusing on “[t]he purpose of Congress [as] the ultimate touchstone.” Id. at 103 (emphasis supplied). Where Congress has legislated in a field which the states have traditionally occupied, the historic police powers of the states (to protect the health, welfare and safety of citizens) were not to be superseded by a federal act unless that was the clear and manifest purpose of Congress. See Rice, supra.

Historically, the states have possessed broad powers to protect the “lives, limbs, health, comfort and quiet of all persons” within the State. Slaughter House Cases, 16 Wall 36, 62 (1873) (quoting, Thorpe v. Rutland & Burlington R. Co., 27 Vt. 140, 149 (1855)). This is what is known as the police power.

In Metropolitan Life Insurance Co. v. Massachusetts, 471 U.S. 724, 105 S.Ct. 2380, 85 L.Ed. 2d 728 (1985), the Court had before it a case wherein it was required to interpret two competing statutory provisions of the Federal Employee Retirement Security Act (ERISA) which appeared to give back to the states what it had previously taken away in the same act (referring to a general preemption clause which was qualified by a savings clause). The Court said:

[Although] [f]ully aware of this statutory complexity, we still have no choice but to “begin with the language employed by Congress and the assumption that the ordinary meaning of that language accurately expresses the legislative purpose.” We also must presume that Congress did not intend to pre-empt areas of traditional State regulation.

Id. at 740 (internal citations omitted).

Under federal preemption law the following precepts control the adjudication of claims:

  1. If the police powers of a state are to be superseded it must be the clear and manifest purpose of Congress to have ordered such preemption; and
  2. There is a presumption against preemption, which must be rebutted by the party that claims it is entitled to federal preemption. See Rice, supra.

The first expression of Congress’ intent not to preempt a lawsuit filed under state law against a drug manufacturer is found in the Congressional Hearings leading up to the passage and implementation of the original version of the Federal Drug and Cosmetic Act.

The draft version of the Act included a provision for creating a Federal cause of action. This provision was rejected because, “a common law right of action exists.” See Adler v. Mann, “Preemption and Medical Devices: The Courts Run Amok”, 59 Mo. L. Rev. 895, 924 and supporting cite at N. 130.

The next expression of Congressional intent, or in this case the lack of intent to preclude state lawsuits against drug companies, is found in statutes adopted by Congress.

The process for approval of any new drug in the Unites States begins with an application for approval, pursuant to Section 505(b) of the Federal Food, Drug and Cosmetic Act, (FDCA), 21 U.S.C. § 355b. 21 U.S.C. § 355d prohibits false and misleading statements in product labeling as part of the requirements for approval of a New Drug Application.

A review of 21 U.S.C. § 355d shows that the burden on an applicant at all stages of the New Drug Application is to support its claims with, “investigation,” “adequate testing,” and “substantial evidence” that the drug will do what it claims in the proposed labeling thereof.

With respect to the labeling requirement, Subsection (7) provides that a New Drug Application may be refused if the labeling is false or misleading in any particulars. Of note is the definition of the term “substantial evidence” which means “evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.” See 21 U.S.C. § 355d.

Subordinate regulations which govern this area are found in 21 C.F.R. § 201.80(e). 21 C.F.R. 201.80 generally controls the “specific requirement on content and format of labeling for human prescription drugs . . .” Subsection (e) further requires that “[t]he labeling shall be revised as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved.” Id. (emphasis supplied).

Further and critical is C.F.R § 314.70(c) (6) (iii). Section 314.70 is titled “Supplements and Other Changes to an Approved Application” and subsection (a) thereunder requires that “an applicant must notify the FDA about each change in each condition established in an approved application.” Under Subsection (c) (6), “the holder of an approved application may commence distribution of the drug product involved upon receipt by the agency of a supplement for change.”

These changes include but are not limited to . . .

Changes in the labeling … to accomplish any of the following:

(A) To add or strengthen a contraindication warning, precaution or adverse reaction;

(B) To add or strengthen a statement about drug abuse, dependence, psychological effect or overdosage. See C.F.R § 314.70(c) (6).

Under a plain reading of these statutes and regulations, a company that has an existing New Drug Application shall supplement the label on its product when it has reasonable evidence of a hazard even though “a causal relationship need not have been proved.” See C.F.R § 314.70(c) (6); 21 C.F.R. § 201.80(e).

The use of the word “shall” in the statutory scheme means that an act becomes mandatory and by its very nature creates a duty to act. A necessary element to maintain an action in negligence is a duty or obligation recognized by the law, requiring the actor to conform to a certain standard of conduct. See Prosser Law of Torts, § 30 (4th Ed., 1971). Drug labeling statutes and regulations impose that duty and a breach of that duty provides the basis for a lawsuit for resulting damages.

In Merrell Dow Pharmaceuticals, Inc. v. Thompson, et al., 478 U.S. 804, 106 S. Ct. 3229, 92 L.Ed, 2nd 650 (1986), the Supreme Court had before it a misbranding claim against the drug Bendectin.

The Thompson respondents are residents of Canada and the MacTavishes reside in Scotland. They filed virtually identical complaints against petitioner, a corporation, which manufactures and distributes the drug Bendectin. The complaints were filed in the Court of Common Pleas in Hamilton County, Ohio. Each Complaint alleged that a child was born with multiple deformities as a result of the mother’s ingestion of Bendectin during pregnancy. In five of the six counts, the recovery of substantial damages was requested on common-law theories of negligence, breach of warranty, strict liability, fraud, and gross negligence. In Count IV, respondents alleged that the drug Bendectin was “misbranded” in violation of the Federal Food, Drug, and Cosmetic Act (FDCA), 52 Stat. 1040, as amended, 21 U.S.C. § 301 et seq. (1982 ed. and Suppl III), because its labeling did not provide adequate warning that its use was potentially dangerous. Paragraph 26 alleged that the violation of the FDCA “in the promotion” of Bendectin “constitutes a rebuttable presumption of negligence.” Paragraph 27 alleged that the “violation of said federal statutes directly and proximately caused the injuries suffered” by the two infants.

Merrell Dow, 478 U.S. at 805.

The issue before the Merrell Dow Court was whether the Plaintiffs’ allegation regarding a violation of federal law was sufficient to trigger exclusive federal jurisdiction. The Court held that such issue raised in a state tort claim along with other tort claims was an appropriate matter to be tried in State Court. In arriving at this conclusion, the Court placed significant reliance upon the fact that the Food Drug and Cosmetic Act did not provide a Federal cause of action.

It is also noted that at the time of its analysis of the “federal question” issue in Merrell Dow, supra, the Court had before it substantially the same Food Drug and Cosmetic Act that is at issue before this Court. By virtue of its holding that the tort claim was an appropriate matter to be tried in State court, the Court implicitly found that preemption did not exist as an impediment to a State court action for a “misbranded label”.

In Silkwood v. Kerr-McGee, 464 U.S. 238, 104 S.Ct. 615, 78 L.Ed. 2nd 443 (1984) a plutonium leak was found to have injured plaintiff, an employee of the defendant.

In discussing the reach of Congress’ regulatory enactments, the Court said:

Congress’ decision to prohibit the State from regulating the safety aspects of nuclear development was premised on its belief that the Commission was more qualified to determine what type of safety standards should be enacted in this complex area. As Congress was informed by the AEC, the 1959 legislation provided for continued federal control over the more hazardous materials because “the technical safety considerations are of such complexity that it is not likely that any State would be prepared to deal with them during the foreseeable future.” H.R. Rep. No. 1125, 86 Cong., 1st Sess., 3 (1959). If there were nothing more, this concern over the States’ inability to formulate effective standards and the foreclosure of the States from conditioning the operation of nuclear plants on compliance with state-imposed safety standards arguably would disallow resort to state-law remedies by those suffering injuries from radiation in nuclear plant. There is, however, ample evidence that Congress had no intention of forbidding the States to provide such remedies.

Indeed, there is no indication that Congress even seriously considered precluding the use of such remedies either when it enacted the Atomic Energy Act in 1954 or when it amended it in 1959. This silence takes on added significance in light of Congress’ failure to provide any federal remedy for persons injured by such conduct.

Silkwood, 464 U.S. at 250-51.

Congress in its enactment of the Food Drug and Cosmetic Act specifically chose not to provide a federal remedy under the Act in the face of the availability of a state common law right of action. See H.R.6110, 73d Cong., 1st Sess.Section 25 (1933), supra; Merrell Dow, supra.

“Congress has neither provided nor suggested any substitute for the traditional state court procedure for collecting damages for injuries caused by tortious conduct. For us to cut off the injured [Plaintiffs] from this right of recovery…. will, in effect, grant Defendant immunity from liability for its tortious conduct.” United Constr. Workers v. Laburnum Constr. Corp., 347 U.S. 656, 663-664 (U.S. 1954).

In light of the foregoing and Congress’ silence on this issue, claims for personal injuries and wrongful deaths against drug makers for misbranding and failing to warn are not preempted from the jurisdiction and control of state courts.

The same should be true for personal injuries and wrongful deaths caused by defective medical devices.

We have substantial experience in prosecuting claims for dangerous drugs and medical devices.

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Richard Alexander